Evaluation of Council Directive 85/374/EEC on the approximation of laws, regulations and administrative provisions of the Member States concerning liability for defective products : final report.
Date: 2018-05-07
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
Subjects: EC conformity marking, EU Member State, administrative procedure, approximation of laws, consumer protection, defective product, directive (EU), liability, new technology, product quality, report, single market, technological change

Evaluation of Council Directive 
85/374/EEC  
on the approximation of laws, 
regulations and administrative 
provisions of the Member States 
concerning liability for defective 
products 

FINAL REPORT 

Written by EY, with the support of Technopolis Group and VVA 
January 2018 

 
 
 
 
 
 
 
 
 
EUROPEAN COMMISSION 

Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs 

Directorate B —Single Market Policy, Regulation and Implementation 

Unit B.1 — Single Market Policy, Mutual Recognition and Surveillance 

E-mail:  GROW-B1@ec.europa.eu   

European Commission 
B-1049 Brussels 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EU R OP E AN  C O MM IS S ION  

Evaluation of Council Directive 
85/374/EEC  
on the approximation of laws, 
regulations and administrative 
provisions of the Member 
States concerning liability for 
defective products 

Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs 

2018 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Luxembourg: Publications Office of the European Union, 2018 

ISBN 978-92-79-85814-7 
doi: 10.2873/477640 

© European Union, 2018 
Reproduction is authorised provided the source is acknowledged. 

Printed in Belgium 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Our thanks go particularly to Professor Eleonora Rajneri and Professor Duncan Fairgrieve for 
their continuous support and careful participation all along the evaluation project.  

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Table of Contents 

1 

INTRODUCTION .................................................................................................. 1 

1.1 
Scope of the evaluation ............................................................................................ 1 
1.2  Objectives of the evaluation...................................................................................... 1 
1.3  Content of the report ............................................................................................... 2 

2 

BACKGROUND OF THE MEASURE .......................................................................... 3 

2.1 
2.2 

Legislative background ............................................................................................. 3 
The Product Liability Directive ................................................................................... 6 

3  METHODOLOGY ................................................................................................ 10 

3.1 
Evaluation questions and criteria .............................................................................. 10 
3.2  Reconstruction of the intervention logic and development of evaluation grids ................. 10 
The data collection approach ................................................................................... 12 
3.3 
Limitations and mitigation measures ......................................................................... 14 
3.4 

4 

IMPLEMENTATION – LEGAL ANALYSIS AND STATE OF PLAY .................................... 16 

Legislation transposing the Directive ......................................................................... 16 
4.1 
Legislation concurring with transposition of the Directive ............................................. 17 
4.2 
Systems used to settle the claims for damages caused by defective products ................ 17 
4.3 
Products at cause for the purpose of recovery of damages and types of defects ............. 19 
4.4 
4.5 
Type of damages .................................................................................................... 21 
4.6  Cases brought to the courts and level of success ........................................................ 21 
4.7  Difficulties encountered by consumers when obtaining compensation ............................ 23 
4.8  Cases brought to the national courts relating to new technological developments ........... 24 

5 

ANSWERS TO THE EVALUATION QUESTIONS ........................................................ 26 

Effectiveness ......................................................................................................... 26 
5.1 
5.2 
Efficiency .............................................................................................................. 42 
5.3  Coherence ............................................................................................................. 54 
5.4  Relevance ............................................................................................................. 63 
EU added value ...................................................................................................... 87 
5.5 

6 

CONCLUSIONS.................................................................................................. 94 

Effectiveness ......................................................................................................... 94 
6.1 
Efficiency .............................................................................................................. 94 
6.2 
6.3  Coherence ............................................................................................................. 95 
6.4  Relevance ............................................................................................................. 96 
EU added value ...................................................................................................... 97 
6.5 

ANNEX 1 

ANNEX 2 

ANNEX 3 

EVALUATION QUESTIONS............................................................... 99 

EVALUATION GRIDS .................................................................... 103 

SYNOPSIS REPORT ...................................................................... 119 

Introduction ........................................................................................................ 119 
1. 
Objectives of the consultation ................................................................................ 119 
2. 
3. 
Consultation methods and tools ............................................................................. 119 
3.1.  Public Consultation ............................................................................................... 119 
3.2.  Surveys  119 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

3.3. Conference on the Evaluation of the Product Liability Directive ..................................... 120 
Main results of the consultation activities ................................................................ 120 
4. 
4.1 
Effectiveness ....................................................................................................... 120 
Efficiency ............................................................................................................ 123 
4.2 
4.3  Coherence ........................................................................................................... 123 
4.4  Relevance ........................................................................................................... 123 
EU added value .................................................................................................... 124 
4.5 
Main conclusions .................................................................................................. 124 
5. 

ANNEX 4 

ANNEX 5 

ANNEX 6 

TARGETED SURVEY QUESTIONNAIRE ............................................ 126 

CATI SURVEY QUESTIONNAIRE ..................................................... 153 

INTERVIEW QUESTIONNAIRE........................................................ 157 

Industry associations, producers, importers and suppliers (including SMEs) .......................... 157 
Consumer organisations ................................................................................................. 158 
PAs, individual experts from academia, think tanks, law firms, and others ............................ 159 
Insurance companies (including federations) ..................................................................... 161 
Technical experts .......................................................................................................... 162 

ANNEX 7 

ANNEX 8 

ANALYSIS”) 

TEMPLATE OF THE COUNTRY FICHES ............................................. 164 

LEGAL ISSUES IN THE CONTEXT OF EMERGING TECHNOLOGIES (“LEGAL 
 ................................................................................................. 174 

ANNEX 9 

EU  LEGISLATION  ON  SAFETY:  THE  SECTORIAL  SAFETY  LEGISLATION 
AND THE GENERAL PRODUCT SAFETY DIRECTIVE ............................................... 177 

ANNEX 10 

BIBLIOGRAPHY ........................................................................... 193 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Index of figures 

Figure 1: Intervention logic of the Product Liability Directive ........................................................ 11 

Figure 2: Systems used to settle the claims, EU-28 average percentage ........................................ 18 

Figure 3: Breakdown of product category causes of claims per Member States from 2000-2016 ....... 20 

Figure 4: Number of claims per year, adjusted per new Member State entries ................................ 22 

Figure 5: Number of times producers were brought to court from 2000 to 2016 ............................. 22 

Figure 6: Reasons for rejecting a claim, EU-28 ........................................................................... 23 

Figure 7: Reasons for rejecting a claim, at Member-State level (no data available for DK, MT, SI, SK)24 

Figure 8: Costs of proceedings vs. number of claims ................................................................... 32 

Figure 9: Consumers’ satisfaction with benefits deriving from the Directive .................................... 50 

Figure 10: Relationship between the Product Liability Directive and the Safety legislation ................ 59 

Figure 11: The Directive and consumer protection in case of Health and Safety Standards ............... 62 

Figure 12: Contexts where the claimed damages occurred (Average % across Member States) ........ 72 

Figure 13: Adequacy of the Directive to some concepts ............................................................... 74 

Figure  14:  The  definitions  and  the  categories  of  exemptions  are  adequate  for  a  firm  business  model 
building upon new technological developments .................................................................... 81 

Figure 15: The exemptions of producers from liability, e.g. the defect appeared after the product was 
put into circulation ........................................................................................................... 81 

Figure  16:  The  three-year  period  for  the  injured  party  to  start  the  proceeding  for  the  recovery  of 
damage .......................................................................................................................... 82 

Figure 17: Compensation is granted only for damage to property of at least €500 .......................... 82 

Figure  18:  10-year  period  from  the  moment  that  the  producer  put  the  product  into  circulation  after 
which the claimant’s rights expire ...................................................................................... 83 

Figure  19:  Adequacy  of  the  Directive  to  cover  strict  liability  caused  by  defect  in  any  of  the  following 
new technological developments ....................................................................................... 86 

Figure 20: “What would be the effects of the following modifications of the Directive?” .................... 89 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Index of tables 

Table 1: Consultation activities, scope and number of stakeholders involved .................................. 13 

Table 2: Number of stakeholders per Member State and consultation activity ................................. 13 

Table 3: Key challenges and mitigation measures ....................................................................... 14 

Table 4: Recurrence of product categories subject to claims in national case law from 2000-2016..... 19 

Table  5:  Ratio  between  the  number  of  cases  over  2000-2016  relating  to  producers’  liability  for 
defective products and 100,000 inhabitants (average over the period 2000-2016), per MS ....... 30 

Table 6: Mapping of costs due to the Directive ............................................................................ 42 

Table 7: Examples of costs relating to the Directive .................................................................... 46 

Table 8: Mapping of benefits .................................................................................................... 49 

Table 9 – Evaluation grids ...................................................................................................... 104 

Index of boxes 

Box 1:  New technological developments and related challenges 

Box 2:  Focus on consumers’ difficulties in obtaining compensation in the pharmaceutical / 
medical sector 

Box 3:  Focus on the concept of “put into circulation” in the pharmaceutical / medical sector 

Box 4:  Focus on liability issues relating to some new technological development 

6 

28 

31 

64 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Index of findings 

Finding 1 
Finding 2 
Finding 3 
Finding 4 
Finding 5 
Finding 6 
Finding 7 
Finding 8 
Finding 9 
Finding 10 
Finding 11 
Finding 12 
Finding 13 
Finding 14 
Finding 15 
Finding 16 
Finding 17 
Finding 18 
Finding 19 
Finding 20 
Finding 21 
Finding 22 

16 
16 
16 
16 
17 
17 
17 
17 
17 
18 
19 
21 
21 
21 
21 
22 
22 
22 
22 
23 
23 
23 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

List of Abbreviations  

AI 

Artificial Intelligence 

AVIMEDI 

French Association of Victims of Medicines 

CATI 

CJEU 

DG 

Computer-Assisted Telephone Interviewing 

Court of Justice of the European Union 

Directorate General 

DG GROW 

Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs 

DMS 

EC 

Digital Single Market Strategy 

European Commission 

EQ(s)   

Evaluation Question(s) 

EU 

European Union 

GPSD   

General Product Safety Directive 

IoT 

MS 

NLF 

OPC 

PAs 

Internet of Things 

Member State(s) 

New Legislative Framework 

Open Public Consultation 

Public Administrations 

SME(s)  

Small- and Medium-sized Enterprise(s) 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

List of Countries  

BE  
BG  
CZ  
DK  
DE  
EE  
IE  
EL  
ES  
FR  
HR 
IT  
CY  
LV  
LT  
LU  
HU  
MT  
NL  
AT  
PL  
PT  
RO  
SI  
SK  
FI  
SE  
UK 

Belgium 
Bulgaria 
Czech Republic 
Denmark 
Germany 
Estonia 
Ireland 
Greece 
Spain 
France 
Croatia 
Italy 
Cyprus 
Latvia 
Lithuania 
Luxembourg 
Hungary 
Malta 
Netherlands 
Austria  
Poland 
Portugal 
Romania 
Slovenia 
Slovakia 
Finland 
Sweden  
United Kingdom 

viii 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

ABSTRACT (EN) 
Directive  85/374/EEC  on  Product  Liability  aims  to  guarantee  the  protection  of  consumers’ 
health  and  property,  the  free  movement  of  goods,  and  undistorted  competition  among 
market operators in the Single Market. 

The  evaluation  aimed  to  understand  to  what  extent  the  Directive  has  achieved  these 
objectives.  Moreover,  it  analysed  implementation  of  the  Directive  in  Member  States  and 
assessed its capacity to deal with new technological developments.  

It  concludes  that  the  Directive  is  effective  in  guaranteeing  producers’  liability  and  a  well-
functioning internal market for goods.  Given the limited evidence gathered  concerning new 
technological developments, it  is not possible to  conclude the  effectiveness  of the Directive 
vis-à-vis  new  technological  developments.  Its  efficiency  is  recognised  by  producers.  As  for 
consumers,  its  efficiency  is  reduced  by  factors  external  to  the  Directive  (i.e.  the  costs 
stemming from judicial claims) or those relating to the burden of proof.  

The  Directive’s  coherence  with  European  legislation  and  sectorial  directives  has  been 
acknowledged,  with  minor  omissions  regarding  the  product  definition  presented  in  the 
sectorial safety legislation and that in the Directive.  

The needs addressed by the Directive are still relevant, although the requirements vis-à-vis 
new technological developments seem to question its relevance.  

Finally,  the  evaluation  confirms  the  EU  added  value  of  the  Directive  in  terms  of 
harmonisation  of  product  liability  rules  and  the  balance  between  consumer  protection  and 
innovation in Europe. 

ABSTRACT (FR) 
La Directive 85/374/CEE sur la responsabilité du fait des produits défectueux vise à garantir 
la  protection  de  la  santé  et  des  biens  des  consommateurs,  la  libre  circulation  des 
marchandises  ainsi  que  le  maintien  d’une  concurrence  non  faussée  entre  les  acteurs  du 
Marché Unique. 

L’évaluation visait à comprendre dans quelle mesure la Directive a atteint ces objectifs. De 
plus, la mise en œuvre de la Directive dans les États membre et sa capacité à faire face aux 
nouveaux développements technologiques ont été analysés. 

L’évaluation  conclue  que  la  Directive  est  efficace  pour  garantir  la  responsabilité  des 
producteurs,  et  le  bon  fonctionnement  du  marché  de  marchandises.  Compte  tenu  du  peu 
d’éléments rassemblés concernant les nouveaux développements technologiques, il n’est pas 
possible  de  conclure  sur  l’efficacité  de  la  Directive  dans  ce  domaine.  L’efficience  de  la 
Directive  est  reconnue  par  les  producteurs.  En  ce  qui  concerne  les  consommateurs,  son 
efficience  est  réduite  par  des  facteurs  externes  à  la  Directive  (i.e.  le  coût  des  procédures 
judiciaires) ou en lien avec la charge de la preuve. 

La  cohérence  de  la  Directive  en  ce  qui  concerne  la  législation  et  les  directives  sectorielles 
européennes  est  confirmée,  avec  des  écarts  mineurs  entre  la  définition  de  produit  inclue 
dans les législations sectorielles de sécurité et celle de la Directive. 

Les besoins auxquels répond la Directive sont encore pertinents, bien que ceux en lien avec 
les nouveaux développements technologiques  semblent remettre  en  cause la pertinence de 
la Directive. 

Enfin,  l’évaluation  confirme  la  valeur  ajoutée  de  l’UE  de  la  Directive,  en  termes 
d’harmonisation des règles sur la responsabilité du fait des produits défectueux et d’équilibre 
entre la protection du consommateur et l’innovation en Europe. 

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ABSTRACT (DE) 
Die  Richtlinie  85/374/EWG  über  die  Produkthaftung  soll  eine  Garantie  darstellen  für  den 
Schutz  des  Verbrauchers  vor  Gesundheits-  und  Eigentumsschädigungen,  für  einen  freien 
Warenhandel  und  einen  unverfälschten  Wettbewerb  für  die  im  Binnenmarkte  tätigen 
Wirtschaftsakteure. 

Zweck  der  Untersuchung  war  es,  zu  verstehen,  inwiefern  die  Richtlinie  diese  Ziele  erreicht 
hat. Zudem wurde die Umsetzung der Richtlinie in den einzelnen Mitgliedstaaten und deren 
Fähigkeit, mit neuen technologischen Fortschritten umzugehen, festgestellt und analysiert.  

Die  Ergebnisse  der  Untersuchung  rechtfertigen  die  Aussage,  dass  die  Richtlinie  wirksam  ist 
in  der  Gewährleistung  der  Produzentenhaftung  und  des  reibungslosen  Ablaufs  des 
Binnenmarktes.  Da  nur  wenige  Beweise  mit  Bezug  auf  die  neuen  technologischen 
Entwicklungen  gesammelt  werden  konnten,  ist  es  nicht  möglich,  die  Wirksamkeit  der 
Richlinie hinsichtlich neuer technologischer Entwicklungen festzustellen. Was die Effizienz der 
Richtlinie  betrifft,  wurde  diese  von  den  Herstellern  bestätigt.  Die  Verbraucher  hingegen 
führten  einige  Effizienzeinschränkungen  an,  sei  es  was  externe  Faktoren  betrifft  (z.B.  die 
anfallenden Verfahrenskosten) sei es mit Hinsicht auf die Beweislast. 

Die  Richtlinie  ist  zudem  kohärent  bezüglich  der  europäischen  Gesetzgebung  und  der 
sektorspezifischen  Richtlinien.  Es  bestehen  nur  einige  geringfügige  Unterschiede  zwischen 
der Definition der in der sektoriellen Sicherheitsgesetzgebung enthaltenen Produkte und der 
Produktdefinition der Richtlinie selbst. 

Die  Richtlinie  ist  nach  wie  vor  relevant,  obwohl  die  mit  den  neuen  technologischen 
Entwicklungen verbundenen Bedürfnisse diese Relevanz teilweise in Frage stellen. 

Die Untersuchung bestätigt schlieβlich den EU-Mehrwert der Richtlinie, welcher vor allem auf 
die  Harmonisierung  der  Produkthaftungsvorschrifen  und  auf  das  Gleichgewicht  zwischen 
Verbraucherschutz und Innovation in Europa zurückzuführen ist. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

EXECUTIVE SUMMARY (EN) 
Directive 85/374/EEC1 on the approximation of laws, directives and administrative provisions 
of  the  Member  States  concerning  liability  for  defective  products  (“Product  Liability 
Directive”),  sets  the  conditions  under  which  consumers  may  claim  compensation  for  the 
damage caused by defective products on the internal market. The Product Liability Directive 
has  three  strategic  objectives:  namely,  to  ensure  the  free  movement  of  goods,  the 
protection  of  consumers’  health  and  property,  and  undistorted  competition  among  market 
operators  in  the  Single  Market.  To  reach  such  objectives,  it  applies  to  all  movable  goods, 
even  if  incorporated  into  another  movable  or  immovable  good,  including  electricity, 
marketed  in  the  European  Economic  Area  (i.e.  Member  States,  Norway,  Liechtenstein  and 
Iceland). 

The evaluation 

The evaluation aimed to analyse to what extent the Product Liability Directive has achieved 
its  original  objectives  in  terms  of  effectiveness,  efficiency,  coherence,  relevance  and  EU 
added value, with a focus on new technological developments. It also took into consideration 
the state of its implementation in the Member States. 

Status of implementation of the Product Liability Directive 

All Member States have transposed the Product Liability Directive. Only four have opted for 
the derogation allowed by the said Product Liability Directive, for which the producer shall be 
liable even if he/she proves that the state of scientific and technical knowledge at the time 
he/she put the product into circulation was not sufficient to enable the existence of a defect 
to  be  uncovered.  Most  Member  States  have  adopted  provisions  to  clarify  some  concepts  of 
the Product Liability Directive (such as, for instance, when a product is “put into circulation”, 
what is the “reasonable time”  by when the  supplier of the product must inform the injured 
person of the producer’s identity, and the nature of damages that can be made good under 
the  Product  Liability  Directive).  One  Member  State  (Lithuania)  extended  the  rules  of  the 
Product  Liability  Directive  to  ensure  indemnification  of  damages  provoked  by  defective 
services under the same strict liability regime. 

The  Product  Liability  Directive  is  applied  to  all  kinds  of  products,  including  raw  materials, 
pharmaceuticals,  vehicles  and  machineries.  Claimants  seek  compensation  for  damages  to 
both  property  and,  more  often,  physical  well-being.  From  2000  to  2016,  those  suffering 
injuries  brought  at  least  798  claims  to  court  invoking  the  Product  Liability  Directive; 
however, it is likely that more cases were decided in court and even more were settled out 
of court. Courts uphold most claims based on the Directive in favour of the injured person, 
and  sometimes  this  happens  on  a  different  legal  basis  (such  as  tort  law  or  contract  law) 
even  if  the  claimant  invoked  the  Product  Liability  Directive.  When  courts  reject  claims,  the 
prevailing reason by far is the claimant’s failure to  either prove the defect or to link it with 
the  damage.  Over  the  period  considered,  only  one  case  brought  to  court  (and  published) 
concerned new technological developments. 

Effectiveness 

The  evaluation  concludes  that,  overall,  the  Product  Liability  Directive  is  an  effective 
instrument  to  guarantee  producers’  liability  for  damage  caused  by  defective  products, 

1  Council  Directive  85/374/EEC  of  25  July  1985  on  the  approximation  of  the  laws,  regulations  and  administrative 
provisions  of  the  Member  States  concerning  liability  for  defective  products.  http://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX:31985L0374. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

ensuring  at  the  same  time  the  protection  of  injured  persons  and  an  internal  market  for 
goods which operates effectively. 

First,  stakeholders  consider  the  Product  Liability  Directive  to  effectively  protect  consumers’ 
rights  and  guarantee  consumers  (and  injured  persons  in  general)  that  producers  are  liable 
for  damages,  thanks  to  a  clear  identification  of  the  operators  liable,  strict  liability  (with  no 
need to prove negligence) and the extension of liability to suppliers and importers. The fact 
that most of (the relatively few) cases brought before court are successful for the claimant is 
another indication of the Product Liability Directive’s effectiveness. Such a success rate may 
be  an  incentive  for  producers  to  avoid  going  to  court,  thereby  explaining  why  the  parties 
settle most of cases out of court.  

However, despite such elements, consumers indicate how provisions, such as the  burden of 
proof (which can be difficult to satisfy), the  €500 threshold (which prevents claimants from 
claiming  for  small  damages  to  property)  and  the  exceptions  to  liability  (considered  as  too 
wide), can limit its effectiveness. In particular, these provisions have an impact with regard 
to pharmaceutical products and health safety. 

The  Product  Liability  Directive  contributed  to  harmonising  rules  on  strict  liability,  creating 
more  uniform  consumer  protection,  and  ensuring  an  internal  market  able  to  operate  more 
effectively thanks to its uniform transposition across Member States – with some exceptions 
allowed  under  the  Product  Liability  Directive.  Judgments  of  the  European  Court  of  Justice, 
reiterating  the  importance  of  maintaining  a  competitive  market  and  the  free  movement  of 
goods,  stated  that  any  strict  liability  on  the  part  of  service  providers  might  be  established 
under national law  – but only on condition that it does not affect the producer’s liability as 
established by the Product Liability Directive – since such service-provider liability does not 
appear  to  distort  competition  between  operators  in  the  production  and  marketing  chain.2 
Despite  such improvements, cross-border cases are quite limited (e.g.  in only 3%  of cases 
did  the  injured  person  summon  a  defendant  from  another  Member  State),  given  the 
possibility to avoid them following Brussels Regulation I3 and IA,4 and the difficulty perceived 
in bringing an action against a producer based in another Member State.  

The  limited  evidence  (only  one  court  case  was  found)  and  sources  of  information  (limited 
literature, no official data on cases settled out of court, little experience from stakeholders) 
do  not  allow  for  a  comprehensive  conclusion  of  the  effectiveness  of  the  Product  Liability 
Directive  vis-à-vis  new  technological  developments  (apps  and  non-embedded  software, 
components of the Internet of Things, artificial intelligence, robots, and so on). 

2 The European Court of Justice (Grand Chamber) 21 December 2011, C-495/10 rules that: “[…] Directive 85/374 
does not […] prevent a Member State from applying rules […] under which […] a provider is liable for damage thus 
caused, even in the absence of any fault on its part, provided, however, that the injured person and/or the service 
provider retain the right to put in issue the producer’s liability on the basis of the directive when the conditions laid 
down by the latter are fulfilled”. 
3 Council Regulation (EC) No 44/2001 on jurisdiction and the recognition and enforcement of judgments in civil and 
commercial  matters  (“Brussels  Regulation  I”),  dated  22  December  2000.  The  Brussels  Regulation  applies  to 
disputes between individuals from different Member States of the European Union and regulates the enforcement of 
a judgment handed down in another Member State, so that there is a uniform set of provisions which apply across 
the  EU.  The  Brussels Regulation  applies  exclusively  to  civil  and  commercial  matters  and,  in  particular,  it  does  not 
extend  to  matters  of  personal  status,  including  matrimonial  matters,  wills  and  succession,  bankruptcy,  social 
security and arbitration. 
4 Regulation (EU) 1215/2012 of the European Parliament and of the Council on jurisdiction and the recognition and 
enforcement of judgments in civil and commercial matters (“Brussels Regulation IA”) regulates jurisdiction and the 
recognition  and  enforcement  of  judgments  between  EU  Member  States.  The  recast  Regulation  introduces  rules  to 
address  the  drawbacks  of  the  Brussels  Regulation  by  enhancing  access  to  justice  and  by  improving  the  free 
circulation of judgments in the EU. It applies to civil and commercial court proceedings, authentic instruments, and 
court settlements initiated, produced or concluded from 10 January 2015 onwards. 

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Evidence  shows  that  consumers  do  experience  product  liability  issues  involving  some  new 
technological developments and related products (e.g. smart devices). Most respondents to 
the open public consultation seem aware that there is no specific legislation at national level 
(e.g.  on  robots,  artificial  intelligence  or  3D  printing)  and  that  damages  caused  by 
malfunctioning services are not covered by specific rules). 

The desk research highlighted a lively debate around new technological developments, which 
may challenge the Product Liability Directive’s effectiveness given their specificities (e.g. the 
fact that they may be considered closer to services than products). Some of the provisions 
put its effectiveness up for discussion: e.g. the €500 threshold may be too low when dealing 
with new technological developments; and the development risk and exemption clauses can 
be less effective when dealing with technologies such as artificial intelligence and robotics. A 
legal  analysis  based  on  theoretical  examples  was  carried  out  to  highlight  possible issues  in 
applying the Product Liability Directive to five different new technological developments (i.e. 
smartphones,  3D  printers,  cloud  technologies,  robots  and  self-driving  cars).  This  analysis 
shows  that  the  Product  Liability  Directive  would  not  apply  in  some  cases  (such  as  cloud-
computing services). 

Efficiency  

The  limited  data  collected  do  not  allow  for  the  quantification  of  such  costs  –  as  well  as 
benefits – relating to implementation of the Product Liability Directive.  

The  Product  Liability  Directive  is  a  private  law  instrument  which  leaves  to  the  parties  (i.e. 
the  consumer)  the  burden  to  enforce  its  rules.  Therefore,  the  main  costs  relating  to  the 
Product Liability Directive concern enforcement (e.g. court fees, lawyers’ and experts’ fees) 
which fall on either the consumers or producers, according to the outcome of the decision.  

Their  extent  varies  considerably  across  Member  States:  survey  respondents  indicated  how 
the  average  cost  for  legal  assistance  could  range  from  €75  to  over  €3,000,  and  desk 
research  highlighted  costs  for  civil  proceedings  between  less  than  €200  to  over  €2,000. 
Costs  also  vary  depending  on  whether  the  claim  is  settled  in  or  out  of  court.  Overall,  such 
costs  have  no  direct  relation  with  the  Product  Liability  Directive,  but  mainly  depend  on 
national procedures and systems.  

Substantive  compliance  costs  for  producers  comprise  the  compensation  to  be  paid  –  if  the 
claim is  successful.  Producers  also  bear  indirect  costs  relating  to  the  payment  of  insurance 
premiums.  

Substantive  compliance  costs  for  consumers  are  more  numerous.  They  relate  to  the  €500 
threshold (preventing a number of claims for injured persons), and the burden of proof, such 
as proving the damage, the defect, and the link between the defect and the damage (with 
an average time to provide proof varying across Member States,  from over 10 days to just 
one  day).  The  effort  relating  to  the  burden  of  proof  varies  from  sector  to  sector  and  from 
one  Member  State  to  another,  also  taking  into  account  the  differences  in  the  number  of 
claims across the EU. Despite this burden, the cost relating to the provision cannot be linked 
uniquely  to  the  Product  Liability  Directive,  since  the  burden  of  proof  weighing  on  the 
claimant  is  an  essential  requirement  across  judicial  systems.  Moreover,  consumers  are 
subject to a three-year expiration period (which, however, does not  seem to be one of the 
major  reasons  for  rejecting  a  claim)  and  the  ten-year  limitation  period  (especially  in  cases 
involving  pharmaceutical  products  and  medications,  although  once  again  this  does  not 
appear to be a major reason for rejection). 

In  addition,  research  and  development  and  reputational  costs  are  relevant 
for 
manufacturers, especially those dealing with new technological developments, since  related 
products usually bring a high liability risk.  

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Substantive compliance costs are not easily quantifiable due to both  a lack of data and the 
fact that they are closely intertwined with enforcement costs, which are also evaluated in the 
context of a claim settlement.  

The  Product  Liability  Directive  includes  only  one  provision  on  information  obligation  (and 
therefore  possible  administrative  burden),  but  such  obligation  –  and  related  costs  –  is 
deemed to be residual (it affects only five Member States and is a one-off obligation).  

As  regards  producers’  benefits,  the  Product  Liability  Directive’s  provisions  increase  market 
efficiency  and  legal  certainty,  as  the  threshold  prevents  many  claims  arising  for  small 
amounts, and the burden of proof (for the consumer) needs to provide clear evidence of the 
damage,  the  defect  and  the  link  between  the  two.  As  for  consumers,  the  Product  Liability 
Directive  has  produced  benefits  on  their  well-being,  with  greater  respect  and  protection  of 
their health and their rights as consumers, thanks to the provision of strict liability and the 
possibility  to  obtain  compensation  for  damage  caused  by  a  defective  product  –  at  least  in 
principle.  

Both categories also benefit from greater harmonisation among Member States, as the result 
of national laws complying with the Product Liability Directive, and the clarifying judgements 
of the Court of Justice of the European Union.  

As  to  the  cost-effectiveness  for  producers,  the  Product  Liability  Directive  seems  efficient. 
However, the analysis shows that, as far as consumers are concerned, its cost-benefit ratio 
is  not  always  straightforward.  This  is  mainly  due  to  the  presence  of  the  burden  of  proof 
which,  however,  is  a  prerequisite  of  any  European  judicial  system  and  therefore  not  only 
linked to the Product Liability Directive, being reasonable compared to the benefits achieved, 
and external factors not specifically relating to the Product Liability Directive (e.g. costs and 
length  of  proceedings),  but  which  can  influence  its  implementation.  The  adoption  of 
‘presumptions’  in  the  case  of  pharmaceutical  products  and  medications  has  helped  to 
simplify  the  process  of  proving  the  link  between  the  defect  and  the  damage.  Any  further 
simplification  would  require  tackling  and  dealing  with  elements  and  factors  not  directly  (or 
only) relating to the Product Liability Directive.  

Coherence  

The evaluation concludes that the Product Liability Directive is coherent with:  

  EU rules on consumer protection in the area of contractual liability (i.e. the  Directive on 

Consumer Rights5 and the Sales and Guarantee Directive6);  

  The  ‘digital  contracts  proposals’  (i.e.  the  Proposal  for  a  Directive  on  Contracts  for  the 
Online and Other Distance Sales of Goods and the Proposal for a Directive on Contracts 
for the Supply of Digital Content);  

  EU  product  safety  policies,  safety  sectorial  legislation  and  the  General  Product  Safety 
Directive. Indeed, the concept of “safety” proposed by the Product Liability Directive also 
covers the technical meaning of safety (and in particular each essential health and safety 
requirement) provided by the General Product Safety Directive; 

5  Directive  2011/83/EU  of  the  Parliament  and  of  the  Council  of  25  October  2011  on  consumer  rights,  amending 
Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing 
Council  Directive  85/577/EEC  and  Directive  97/7/EC  of  the  European  Parliament  and  of  the  Council  http://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32011L0083. 
6  Directive1999/44/EC  of  the  Parliament  and  of  the  Council  of  25  May  1999  on  certain  aspects  of  the  sale  of 
http://eur-lex.europa.eu/legal-
consumer 
content/EN/TXT/PDF/?uri=CELEX:31999L0044&from=EN. 

guarantees. 

associated 

goods 

and 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

  EU rules on applicable law, litigation and alternative dispute resolutions (i.e. the Rome II 
Regulation, the Brussels IA Regulation, and the Directive on consumer alternative dispute 
resolution). 

The  analysis  concludes  with  the  coherence  of  the  Product  Liability  Directive  with  the 
Directive on Consumer Rights, mainly in light of the fact that their scopes of application are 
mutually  exclusive  and  do  not  conflict.  The  same  conclusions  can  be  drawn  for  the 
relationship  between  the  Product  Liability  Directive  and  the  Sales  and  Guarantee  Directive, 
which are complementary and coherent. The small lexical inconsistencies identified are due 
to  the  Directives’  different  scopes,  as  the  Sales  and  Guarantee  Directive  addresses  “non-
conformity”,  while  the  Product  Liability  Directive  tackles  the  “defect”.  Evidence  seems  to 
imply  that  the  few  inconsistencies  identified  do  not  affect  the  application  of  the  Product 
Liability Directive.  Its coherence with both the  proposal for a  Directive  on  contracts for the 
supply of digital content7 and for one on contracts for the online and other distance sales of 
goods8  is  confirmed,  besides  some  minor  lexical  inconsistencies  that  seem  justified  by  the 
different scopes of these pieces of legislation, and appear not to affect the implementation of 
the legislation.  

Safety  legislation  aims  to  ensure  that  only  safe  products  are  placed  on  the  market,  and 
states that its provisions should not affect victims’ rights within the meaning of the Product 
Liability  Directive  –  which  remains  an  autonomous  legal  regime.  Thus,  the  Product  Liability 
Directive, the safety sectorial legislation and the General Product Safety Directive9 appear to 
be  coherent,  and  the  combined  effect  between  the  Directive  and  (sectorial  and  general) 
safety  legislation  is  particularly  important.  Market  surveillance  is  used  to  check  whether 
products meet such safety requirements and to implement the necessary actions to ensure 
compliance.  Within  this  framework,  and  at  a  later  stage,  the  Product  Liability  Directive 
operates  as  a  ‘safety  net’,  each  time  a  marketed  product  turns  out  to  be  defective  and 
causes damage to consumers.  

The evaluation clarified how the whole safety legislation system is coherent with the Product 
Liability Directive. 

Considering  other  pieces  of  legislation,  the  Rome  II  Regulation  enhances  consumer 
protection  based  on  the  possibility  to  “predict”  the  law  applicable  to  the  possible  damage 
affecting  consumers  (first,  the  law  of  his/her  place  of  residence),  while  striking  a  balance 
with  the  defendant’s  needs,  taking  into  account  where  the  product  was  marketed.  In  this 
sense,  it  has  synergies  with  the  Product  Liability  Directive.  The  coherence  between  the 
Product Liability Directive and the Brussels I Regulation has been confirmed by a decision of 
the Court of Justice of the European Union. The Court clarified that claims under the Product 
Liability Directive were subject to Article 5(3) of the Brussels I Regulation, which aims to set 
clear rules on jurisdiction in civil and commercial matters. Furthermore, the  Court of Justice 
of the European Union also stated that, where a manufacturer faces a claim of liability for a 
defective  product,  the  place  of  the  event  giving  rise  to  the  damage  is  the  place  where  the 
product  was  manufactured.  The  provision  at  stake,  as  interpreted  by  the  Court,  does  not 

7 Proposal for a directive of the Parliament and of the Council on certain aspects concerning contracts for the supply 
of  digital  content  (Brussels,  9.12.2015  COM(2015)  634  final  2015/0287  (COD)).  http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:52015PC0634&from=EN. 
8  Proposal  for  a  directive  of  the  Parliament  and  of  the  Council  of  on  certain  aspects  concerning  contracts  for  the 
online and other distance sales of goods. (Brussels, 9.12.2015 COM(2015) 635 final 2015/0288(COD)). http://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2015%3A635%3AFIN. 
9  Directive  2001/95/EC  of  the  European  Parliament  and  of  the  Council  of  3  December  2001  on  general  product 
safety. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32001L0095&from=EN. 

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conflict  with  the  Product  Liability  Directive.  Conversely,  the  Directive  on  the  consumer 
alternative dispute resolution is limited to the resolution of contractual disputes and does not 
cover those that can arise from damages from defective products, according to the Product 
Liability  Directive.  Indeed,  there  are  currently  no  EU  rules  in  place  for  an  alternative 
resolution of claims relating to the Product Liability Directive. Since their scopes are seen as 
mutually exclusive, the two Directives are deemed coherent. 

Relevance  

Overall, the Product Liability Directive is still relevant to the initial needs, which continue to 
be  the  needs  of  manufacturers  and  consumers.  In  particular,  the  trend  in  the  number  of 
claims relating to defective products, as well as the average EU litigation rate, has not fallen 
in  recent  years,  demonstrating  that  consumer  protection,  producers’  strict  liability,  and 
ensuring free movement of products and a level playing field are all still relevant. 

The  discussion  on  the  relevance  of  the  Product  Liability  Directive  is  less  straightforward 
when  considering  new  technological  developments.  The  general  needs  relating  to 
technological  development  are  still  the  same,  although  further  technological  developments 
(e.g. which are particularly complex or incorporate both products and services, such as cloud 
technologies,  or  create  new  paradigms  and  frontiers,  such  as  artificial  intelligence, 
potentially  affecting  definitions  and  the  list  of  exemptions  of  liability)  are  an  issue  as  they 
challenge  the  distinctions  between  services  and  products,  private  and  professional  use  of 
products  and  some  definitions  provided  for  in  the  Product  Liability  Directive.  Among  them, 
the definitions of product, damage, defect, and the list of exemptions of liability in favour of 
the  producer,  such  as  the  development  risk  clause,  are  the  most  challenged  by  the  rise  of 
new technologies. 

In particular, the existence of products for which the Product Liability Directive is (or might) 
become  uncertain  or  problematic  is  confirmed  by  open  public  consultation  respondents, 
indicating how such products (e.g. connected to the Internet, or performing automated tasks 
based on algorithms and data analysis) mainly fall under the definition of new technological 
developments,  and  how  the  Product  Liability  Directive  might  need  to  be  adapted  to  better 
deal with them. 

This  has  been  confirmed  by  the  legal  analysis  carried  out  on  purely  theoretical  examples, 
which  considered  five  different  new  technological  developments  (i.e.  smartphones,  3D 
printers, cloud technologies, robots and self-driving cars). This analysis shows that, in terms 
of the Product Liability Directive’s relevance, the notion of product (Article 2), the notion of 
producer (Article 3), and the notion of defect (Article 6) could be problematic when applied 
to new technological developments. 

However,  stakeholders  appear  to  have  different  opinions  on  the  possible  actions,  with 
producers and distributors believing that, for instance, the distinction between product and 
service  can  become  merely  academic  in  some  cases,  while  others  indicate  the  need  for  an 
EU approach to deal with liability for products interconnected with services. 

Despite the needs highlighted, only one relevant case has been found, involving a  defective 
new technological development (a storage unit), suggesting that, at the moment, this issue 
remains  mainly  theoretical,  with  smart  devices  hardly  subject  to  legal  actions  despite  their 
wide-spread use and the defects experienced in mobile applications. 

The  desk  research  confirmed  such  uncertainty  on  the  application  of  the  Product  Liability 
Directive  (and  its  relevance)  to  new  technological  developments,  with  most  sources 
appearing to favour an adaptation, and others underlining how this issue can be reasonably 
resolved by means of interpretation only.  

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Despite  such  conflicting  conclusions,  the  Product  Liability  Directive’s  relevance  is  confirmed 
as  regards  its  initial  objectives  concerning  the  protection  of  consumers,  the  liability  of  the 
producers,  and  the  free  movement  of  products  without  distorting  competition,  while  its 
relevance vis-à-vis new technological developments is less straightforward (e.g. linked to a 
blurred  distinction  between  products  and  services,  and  the  private  and  professional  use  of 
products). 

EU added value 

The  evaluation  confirms  the  Product  Liability  Directive  provides  EU  added  value,  even  if 
differences exist when looking at its different objectives.  

In  particular,  stakeholders  consider  the  uniform  consumer  protection  across  the  EU  as  a 
strong  advantage  –  protection  that  could  have  not  been  achieved  by  national  legislation 
alone.  Eleven  out  of  12  consumers’  representatives  confirmed  that  the  protection  achieved 
by virtue of the Product Liability Directive could not be reached by individual Member State 
action. 

The Product Liability Directive’s EU added value is also due to harmonisation of the product 
liability rules and the right  balance between consumer protection and innovation in Europe, 
not  only  with  regard  to  the  protection  that  consumers  may  find  in  court,  but  also  to  the 
prevention measures taken by producers who, nonetheless, do not refrain from innovation. 
In particular, the desk research confirmed how the development risk clause can be seen as a 
satisfactory  compromise  between  the  need  to  stimulate  innovation  and  consumers’ 
legitimate  expectations  regarding  safer  products,  the  removal  of  which  would  not  be 
beneficial for EU innovation.  

Moreover, in the opinion of most stakeholders, reducing the scope (or repealing) the Product 
Liability  Directive  may  change  consumer  protection,  leading  to  negative  consequences  for 
producers, too. These could include uncertainty and subsequent difficulty in predicting rules 
applicable  in  each  Member  State,  less  harmonisation,  and  internal  market  fragmentation. 
Indeed, stakeholders usually either consider the Product Liability Directive as future-proof or 
call  for  a  revision  of  it  to  enlarge  its  scope.  Furthermore,  should  the  Product  Liability 
Directive  be  repealed,  it  is  the  study’s  country  correspondents’  shared  opinion  that  either 
national  tort  law  or  contract  law  or  both  would  apply  with  negative  impacts  on  consumer 
protection,  on  the  free  movement  of  goods,  on  competition,  and  on  the  uniformity  of  EU 
legislation. The heterogeneous rules in terms of protection and liability and the uncertainties 
due  to  the  different  interpretation  by  national  courts  would  have  negative  effects  on  both 
consumers and producers. 

Looking at the possible consequences of reducing the scope of the Product Liability Directive 
or repealing it appears to confirm its EU added value. 

EXECUTIVE SUMMARY (FR) 
La  Directive  85/374/CEE10  relative  au  rapprochement  des  dispositions  législatives, 
réglementaires  et  administratives  des  États  membres  en  matière  de  responsabilité  du  fait 
des produits défectueux (« Directive sur la responsabilité du fait des produits défectueux »), 
pose les conditions sous lesquelles les consommateurs peuvent réclamer la réparation pour 
les dommages causés par des produits défectueux sur le marché intérieur. La Directive  sur 

10  Directive  85/374/CEE  du  Conseil  du  25  juillet  1985  relative  au  rapprochement  des  dispositions  législatives, 
réglementaires et administratives des États membres en matière de responsabilité du fait des produits défectueux. 
http://eur-lex.europa.eu/legal-content/FR/TXT/HTML/?uri=CELEX:31985L0374&from=EN 

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la  responsabilité  du  fait  des  produits  défectueux  a  trois  objectifs  stratégiques :  à  savoir, 
garantir la libre circulation des marchandises, garantir la protection de la santé et des biens 
des consommateurs, ainsi que le maintien d’une concurrence non faussée entre les acteurs 
du Marché Unique. Afin d’atteindre ces objectifs,  elle s’applique aux biens mobiliers, même 
lorsqu’ils  sont  incorporés  dans  un  autre  bien  mobilier  ou  immobilier,  incluant  électricité, 
commercialisés  dans  l’Espace  économique  européen  (c’est-à-dire  les  États  membres,  la 
Norvège, le Liechtenstein et l’Islande). 

L’évaluation 

L’évaluation  visait  à  comprendre  dans  quelle  mesure  la  Directive  a  atteint  ces  objectifs  en 
termes d’efficacité, d’efficience, de cohérence, de pertinence et de valeur ajoutée de l’Union 
Européenne (UE), l’accent étant mis sur les nouveaux développements technologiques. Elle 
a également pris en considération l’état de sa mise en œuvre dans les États membres. 

Statut de la mise en œuvre de la Directive sur la responsabilité du fait des produits 
défectueux  

Tous les États membres ont transposé la Directive sur la responsabilité du fait des produits 
défectueux. Seuls quatre États ont opté pour la dérogation autorisée par la  Directive sur la 
responsabilité du fait des produits défectueux, qui prévoit que le producteur est responsable 
même si il/elle démontre que l’état de la connaissance scientifique et technique au moment 
où  il/elle  a  mis  le  produit  en  circulation  n’était  pas  suffisant  pour  permettre  de  détecter 
l’existence  d’un  défaut.  La  plupart  des  États  membres  ont  adopté  des  dispositions  pour 
clarifier  quelques  concepts  de  la  Directive  sur  la  responsabilité  du  fait  des  produits 
défectueux  (tels  que  par  exemple  quand  un  produit  est  « mis  en  circulation »,  ce  qu’est  le 
« délai raisonnable » que le fournisseur du produit doit respecter pour informer la victime de 
l’identité du producteur, et la nature des dommages qui peuvent entrer dans le périmètre de 
la Directive sur la responsabilité du fait des produits défectueux). Un État membre (Lituanie) 
a étendu les règles de la Directive sur la responsabilité du fait des produits défectueux pour 
garantir  l’indemnisation  des  dommages  provoqués  par  des  services  défectueux  sous  le 
même régime de responsabilité stricte. 

La Directive sur la responsabilité du fait des produits défectueux s’applique à tous les types 
de produits, notamment les matières premières, les produits pharmaceutiques, les véhicules 
et les machines. Les réclamants demandent une compensation pour les dommages causés à 
des biens  et, plus souvent, à l’intégrité physique.  De 2000 à 2016, les victimes  ont fait au 
moins  798  réclamations  devant  la  justice  en  se  référant  à  la  Directive  sur  la  responsabilité 
du fait des produits défectueux ; cependant, il est probable que plus de cas encore aient été 
réglés  devant  les  tribunaux  et  encore  plus  de  cas  aient  été  de  façon  extrajudiciaire.  Les 
tribunaux  font  droit  dans  la  plupart  des  réclamations  basées  sur  la  Directive  sur  la 
responsabilité du fait des produits défectueux en faveur de la victime, et parfois cela se fait 
en s’appuyant sur une autre base juridique (telle que le droit de la responsabilité civile ou le 
droit  des  contrats)  même  lorsque  le  réclamant  évoque  la  Directive  sur  la  responsabilité  du 
fait  des  produits  défectueux.  Quand  les  tribunaux  rejettent  les  réclamations,  la  raison 
dominante  est  de  loin  l’incapacité  du  réclamant  à  soit  prouver  le  défaut  soit  le lien  avec  le 
dommage. Sur la période considérée, seul un cas a donné lieu à une procédure judiciaire (et 
été publié) en ce qui concerne les nouveaux développements technologiques. 

Efficacité 

L’évaluation conclue que, globalement, la Directive sur la responsabilité du fait des produits 
défectueux est un instrument efficace pour garantir la responsabilité des producteurs du fait 

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des produits défectueux, en garantissant en même temps la protection des victimes et que 
marché intérieur pour les marchandises fonctionne efficacement. 

D’abord, les parties prenantes considèrent que  la Directive sur la responsabilité  du fait des 
produits  défectueux  protège  efficacement  les  droits  des  consommateurs  et  garantie  aux 
consommateurs (et aux victimes en général) que les producteurs sont responsables pour les 
dommages,  grâce  à  une  claire  identification  des  acteurs  responsables,  la  responsabilité 
stricte  (sans  devoir  prouver  la  négligence)  et  l’extension  de  la  responsabilité  aux 
fournisseurs et aux importateurs. Le fait que la plupart des (relativement rares) cas qui ont 
donné  lieu  à  une  procédure  judiciaire  soient  résolus  en  faveur  du  réclamant  est  une  autre 
preuve de l’efficacité de la Directive sur la responsabilité du fait des produits défectueux. Un 
tel taux de succès peut être une incitation pour les producteurs pour éviter de devoir passer 
par  une  procédure  judiciaire,  ainsi  expliquant  pourquoi  les  parties  résolvent  la  plupart  des 
cas de façon extrajudiciaire. 

Cependant,  malgré  ces  éléments,  les  consommateurs  indiquent  comment  les  dispositions, 
telles que la charge de la preuve (qui peut être difficile à satisfaire), le seuil des 500€ (qui 
empêche  les  réclamants  de  faire  une  réclamation  pour  des  dommages  peu  importants 
causés  à  des  biens)  et  les  exceptions  à  la  responsabilité  (considérées  comme  trop  larges), 
peuvent  limiter  son  efficacité.  En  particulier,  ces  dispositions  ont  un  impact  en  ce  qui 
concerne les produits pharmaceutiques et la sécurité sanitaire. 

La  Directive  sur  la  responsabilité  du  fait  des  produits  défectueux  a  contribué  à 
l’harmonisation  des  règles  sur  la  responsabilité  stricte,  en  créant  une  protection  du 
consommateur plus uniforme, et en garantissant un marché intérieur capable de fonctionner 
plus  efficacement  grâce  à  une  transposition  uniforme  entre  les  États  membres  –  avec 
quelques  exceptions  autorisées  par  la  Directive  sur  la  responsabilité  du  fait  des  produits 
défectueux. Les décisions de la Cour de justice de l’Union Européenne, réitérant l’importance 
du  maintien  d’un  marché  compétitif  et  de  la  libre  circulation  des  marchandises,  indiquent 
qu’une responsabilité stricte de la part du fournisseur de service peut être établie par le droit 
national – mais seulement à condition que cela n’affecte pas la responsabilité du producteur 
telle  qu’établie  par  la  Directive  sur  la  responsabilité  du  fait  des  produits  défectueux  – 
puisque  une  telle  responsabilité  du  fournisseur  de  service  ne  semble  pas  fausser  la 
concurrence  entre les acteurs de la chaîne de  production  et de commercialisation.11 Malgré 
de  telles  améliorations,  les  cas  transnationaux  restent  plutôt  limités  (par  exemple  dans 
seulement 3% des cas  la victime convoque un accusé provenant d’un autre  État membre), 
étant  données  la  possibilité  de  les  éviter  selon  Brussels  Regulation  I12  and  IA,13  et  la 

11 La Cour de justice de l’Union européenne (grande chambre). 21 décembre 2011, C-495/10 déclare que: « Cette 
dernière [Directive 85/374/CEE] ne s’oppose dès lors pas à ce qu’un État membre institue un régime, tel que celui 
en  cause  au  principal,  prévoyant  la  responsabilité  d’un  tel  prestataire  à  l’égard  des  dommages  ainsi  occasionnés, 
même en l’absence de toute faute imputable à celui-ci, à condition, toutefois, que soit préservée la faculté pour la 
victime  et/ou  ledit  prestataire  de  mettre  en  cause  la  responsabilité  du  producteur  sur  le  fondement  de  ladite 
directive lorsque se trouvent remplies les conditions prévues par celle-ci. » 
12  Règlement  (CE)  n°  44/2001  du  Conseil  du  22  décembre  2000  concernant  la  compétence  judiciaire,  la 
reconnaissance et l'exécution des décisions en matière civile et commerciale (Règlement Bruxelles I). Le Règlement 
Bruxelles  s’applique  aux  litiges  entre  les  individus  de  différents  États  membres  de  l’UE  et  règlemente  la  mise  ne 
œuvre  d’une  décision  rendue  dans  un  autre  État  membre,  de  façon  à  ce  qu’il  y  ait  un  ensemble  uniforme  de 
dispositions qui s’appliquent à  travers  l’UE.  Le  Règlement Bruxelles s’applique  exclusivement  aux questions  civiles 
et  commerciales  et,  en  particulier,  ne  s’étend  pas  aux  statuts  personnels,  comprenant  le  statut  marital,  les 
testaments et successions, banqueroutes, sécurité sociale et arbitrages. 
13 Le Règlement (UE) No 1215/2012 DU PARLEMENT EUROPÉEN ET DU CONSEIL du 12 décembre 2012 concernant 
la compétence judiciaire, la reconnaissance et l’exécution des décisions en matière civile et commerciale (refonte) 
(Règlement Bruxelles IA) règlemente la compétence judiciaire, la reconnaissance et la mise en œuvre des décisions 
entre les États membres de l’UE. La refonte du Règlement introduit des règles pour traiter des inconvénients liés au 

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difficulté  perçue  pour  mener  une  procédure  contre  un  producteur  situé  dans  un  autre  État 
membre. 

Le  nombre  limité  de  preuves  (seul  un  cas  d’action  en  justice  a  été  trouvé)  et  de  sources 
d’information  (documentation  limitée,  absence  de  données  officielles  sur  les  cas  réglés  de 
façon  extrajudiciaire,  le  manque  d’expérience  des  parties  prenantes)  ne  permet  pas  de 
formuler une conclusion exhaustive sur l’efficacité de la Directive sur la responsabilité du fait 
des  produits  défectueux  en  ce  qui  concerne  les  nouveaux  développements  technologiques 
(applications  mobiles  et  logiciels  non-embarqués,  composants  de  l’Internet  des  objets, 
l’intelligence artificielle, les robots, etc.). 

Les  preuves  démontrent  que 
les  consommateurs  rencontrent  des  problèmes  de 
responsabilité du fait des produits en lien avec les nouveaux développements technologiques 
et  les  produits  associés  (tels  que  les  appareils  intelligents).  La  plupart  des  répondants  à  la 
consultation publique ouverte semblent être conscients de l’absence de législation spécifique 
au niveau national (par exemple  sur les robots, l’intelligence artificielle  ou l’impression 3D) 
et  du  fait  que  les  dommages  causés  par  le  dysfonctionnement  de  services  ne  sont  pas 
couverts par des règles spécifiques. 

La  recherche  documentaire  a  mis  en  avant  un  débat  animé  autour  des  nouveaux 
développements technologiques, qui peuvent remettre en question l’efficacité de la Directive 
sur  la  responsabilité  du  fait  des  produits  défectueux  étant  données  leurs  spécificités  (par 
exemple  le  fait  qu’ils  puissent  être  considérés  plus  comme  des  services  que  comme  des 
produits). Certaines des dispositions créent un débat sur son efficacité : par exemple le seuil 
de 500€ est peut-être trop bas lorsqu’il s’agit de nouveaux développements technologiques ; 
et  les  clauses  sur  le  risque  de  développement  et  d’exemption  peuvent  être  moins  efficaces 
lorsqu’il s’agit de technologies telles que l’intelligence artificielle et la robotique. Une analyse 
juridique  basée  sur  des  exemples  théoriques  a  été  réalisée  pour  mettre  en  exergue 
d’éventuels  problèmes  liés  à  l’application  de  la  Directive  sur  la  responsabilité  du  fait  des 
produits  défectueux  dans  le  cadre  de  cinq  nouveaux  développements  technologiques  (i.e. 
smartphones,  imprimantes  3D,  les  technologies  d’informatique  en  nuage,  les  robots  et  les 
voitures sans chauffeur). Cette analyse a démontré que la Directive sur la responsabilité du 
fait  des  produits  défectueux  ne  pourrait  pas  s’appliquer  dans  certains  cas  (tels  que  les 
services d’informatique en nuage). 

Efficience 

Le peu de données  recueillies ne permet pas  de quantifier de  tels coûts – ni les avantages 
associés  –  en  lien  avec  la  mise  en  œuvre  de  la  Directive  sur  la  responsabilité  du  fait  des 
produits défectueux. 

La Directive sur la responsabilité du fait des produits défectueux est un instrument de droit 
privé qui laisse aux parties (i.e. le consommateur) la charge d’appliquer ses règles. Ainsi, les 
principaux coûts liés à la Directive sur la responsabilité du fait des produits défectueux sont 
son application (par exemple les frais de justice, les honoraires des avocats et des experts) 
qui  retombent  soit  sur  le  consommateur  soir  sur  le  producteur  en  fonction  de  l’issue  du 
procès. 

Leur  étendue  varie  considérablement  entre  les  États  membres  :  les  répondants  au 
questionnaire ont indiqué comment en moyenne le coût de l’assistance juridique va de 75€ à 

Règlement Bruxelles en renforçant l’accès à la justice et en améliorant ka libre circulation des décisions de justice 
au  sein  de  l’UE.  Il  s’applique  aux  procédures  judiciaires  civiles  et  commerciales,  aux  actes  authentiques,  et  aux 
transactions judiciaires initiées, produites ou conclues à partie du 10 janvier 2015. 

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plus  de  3000€,  et  la  recherche  documentaire  a  mis  en  exergue  que  les  coûts  pour  les 
procédures  civiles  vont  de  moins  de  200€  à  plus  de  2000€.  Les  coûts  varient  aussi  en 
fonction de si le règlement est intra ou extrajudiciaire. Globalement, de tels coûts n’ont pas 
de  lien  direct  avec  la  Directive  sur  la  responsabilité  du  fait  des  produits  défectueux  mais 
dépendent principalement des procédures et systèmes nationaux. 

Les coûts de conformité substantifs pour les producteurs incluent la compensation à payer – 
si  la  réclamation  est  fructueuse.  Les  producteurs  supportent  également  les  coûts  liés  au 
paiement des primes d’assurance. 

Les coûts de conformité substantifs sont plus nombreux pour les consommateurs. Ils sont en 
lien avec le seuil de 500€ (empêchant de faire une réclamation pour un certain nombre de 
victimes), la charge de la preuve, telle que prouver le dommage, le défaut, et le lien entre le 
défaut et le dommage (avec un délai moyen pour fournir la preuve variable entre les  États 
membres,  allant  de  plus  de  10  jours  à  juste  une  journée).  L’effort  relatif  à  la  charge  de  la 
preuve varie d’un secteur à l’autre et d’un État membre à l’autre, aussi lorsque l’on prend en 
compte  les  différences  de  nombre  de  réclamations  dans  l’UE.  Malgré  cette  charge,  le  coût 
relatif à la disposition ne peut pas être uniquement lié à la Directive sur la responsabilité du 
fait  des  produits  défectueux,  puisque  le  fait  que  la  charge  de  la  preuve  repose  sur  le 
réclamant  est  une  exigence  essentielle  à  travers  les  systèmes  judiciaires.  De  plus,  les 
consommateurs  sont  sujets  à  un  délai  de  prescription  de  trois  ans  (qui,  cependant,  ne 
semble pas  être une des  raisons majeures pour  rejeter une réclamation)  et de dix ans (en 
particulier  dans  les  cas  impliquant  les  produits  pharmaceutiques  et  les  médicaments,  bien 
qu’une fois encore cela ne semble pas être une raison majeure de rejet). 

En outre, les coûts de recherche et développement et de réputation sont pertinents pour les 
fabricants,  en  particulier  pour  ceux  qui  travaillent  avec  des  nouveaux  développements 
technologiques,  puisque  les  produits  associés  représentent  d’ordinaire  un  risque  de 
responsabilité plus important. 

Les coûts de conformité substantifs ne sont pas facilement quantifiables à cause du manque 
de données et du fait qu’ils sont étroitement imbriqués avec les coûts d’application, qui sont 
également évalués dans le contexte de règlement de réclamation. 

La  Directive  sur  la  responsabilité  du  fait  des  produits  défectueux  comprend  seulement  une 
disposition sur les obligations d’information (et ainsi sur l’éventuelle charge administrative), 
mais une telle obligation – et coûts associés – est considéré comme résiduelle (cela affecte 
seulement quatre États membres et il s’agit d’une obligation ponctuelle). 

En ce qui concerne les avantages pour les producteurs, la  Directive sur la responsabilité du 
fait  des  produits  défectueux  augmente  l’efficience  du  marché  et  la  sécurité  juridique, 
puisque  le  seuil  empêche  la  multiplication  de  réclamations  pour  des  petits  montants,  et  la 
charge  de  la  preuve  (pour  le  consommateur)  requiert  de  fournir  une  preuve  claire  du 
dommage,  du  défaut  et  du  lien  entre  les  deux.  En  ce  qui  concerne  les  consommateurs,  la 
Directive sur la responsabilité du fait des produits défectueux a généré des avantages en lien 
avec  leur  intégrité  physique,  avec  un  plus  grand  respect  et  une  plus  grande  protection  de 
leur  santé  de  leurs  droits  en  tant  que  consommateurs,  grâce  à  la  disposition  sur  la 
responsabilité stricte et la possibilité d’obtenir une compensation pour les dommages causés 
par un produit défectueux – au moins en principe. 

Les deux catégories bénéficient également d’une plus grande harmonisation entre les États 
membres, grâce au fait que le droit national soit conforme à la Directive sur la responsabilité 
du fait des produits défectueux, et aux décisions éclairantes de la Cour de justice de l’Union 
européenne.  

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En  ce  qui  concerne  l’efficacité  en  termes  de  coûts  pour  les  producteurs,  la  Directive  sur  la 
responsabilité  du  fait  des  produits  défectueux  semble  être  efficiente.  Cependant,  l’analyse 
démontre  que,  en  ce  qui  concerne  les  consommateurs,  le  ratio  coûts-avantages  n’est  pas 
toujours évident. Cela est surtout dû à la présence de la charge de preuve qui, cependant, 
est  un  prérequis  de  tout  système  judiciaire  européen  et  ainsi  n’est  pas  liée  seulement  à  la 
Directive  sur  la  responsabilité  du  fait  des  produits  défectueux,  qui  est  par  ailleurs 
raisonnable comparé aux avantages obtenus, et à des facteurs externes pas spécifiquement 
en  lien  avec  la  Directive  sur  la  responsabilité  du  fait  des  produits  défectueux  (tels  que  les 
coûts  et  la  longueur  des  procédures),  mais  qui  peuvent  influencer  sa  mise  en  œuvre. 
L’adoption  de  « présomptions »  dans  le  cas  des  produits  pharmaceutiques  et  des 
médicaments  a  aidé  à  simplifier  le  processus  pour  prouver  le  lien  entre  le  défaut  et  le 
dommage.  Toute  simplification  complémentaire  requerrait  de  s’attaquer  à  des  éléments  et 
des  facteurs  pas  directement  (ou  pas  seulement)  lié  à  la  Directive  sur  la  responsabilité  du 
fait des produits défectueux. 

Cohérence 

L’évaluation conclue que la Directive sur la responsabilité du fait des produits défectueux est 
cohérente avec:  

  Les  règles  de  l’UE  concernant  la  protection  du  consommateur  dans  le  domaine  de  la 
responsabilité contractuelle (i.e. la Directive relative aux droits du consommateur14 et la 
Directive sur la vente et des garanties des biens de consommation15) ; 

  La  “proposition  pour  les  contrats  numériques”  (i.e.  la  Proposition  de  Directive  du 
Parlement européen et du Conseil concernant certains aspects des contrats de ventes en 
ligne  et  de  toute  autre  vente  à  distance  de  biens  et  la  Proposition  de  Directive  du 
Parlement européen et du Conseil concernant certains aspects des contrats de fourniture 
de contenu numérique) ; 

  Les politiques de l’UE pour la sécurité des produits, la législation sectorielle de sécurité et 
la  Directive  relative  à  la  sécurité  générale  des  produits.  En  effet,  le  concept  de 
« sécurité » proposé par la Directive sur la responsabilité du fait des produits défectueux 
recouvre  également  le  terme  technique  de  sécurité  (et  en  particulier  chacune  des 
exigences de santé et de sécurité)  inclu dans la Directive relative à la sécurité générale 
des produits;  

  Les règles de l’UE sur le droit, les litiges et le règlement extrajudiciaire des litiges (i.e. le 
Règlement  Rome  II,  le  Règlement  Bruxelles  IA,  et  la  Directive  sur  le  règlement 
extrajudiciaire des litiges). 

L’analyse  démontre  la  cohérence  de  Directive  sur  la  responsabilité  du  fait  des  produits 
défectueux avec la Directive sur les droits du consommateur, principalement à la lumière du 
fait que leurs périmètres d’application sont mutuellement exclusifs et ne sont pas en conflit. 
Les  mêmes  conclusions  peuvent  être  tirées  pour  la  relation  entre  la  Directive  sur  la 
responsabilité  du  fait  des  produits  défectueux  et  la  Directive  sur  la  vente  et  des  garanties 
des  biens  de  consommation,  qui  sont  complémentaires  et  cohérentes.  Les  incohérences 

14 Directive  2011/83/UE  du  Parlement  européen  et  du  Conseil du  25  octobre  2011 relative  aux  droits  des  
consommateurs,    modifiant    la    directive    93/13/CEE    du    Conseil    et    la    directive    1999/44/CE    du    Parlement  
européen    et    du    Conseil    et    abrogeant    la    directive    85/577/CEE    du    Conseil    et    la    directive    97/7/CE    du  
Parlement 
du 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:304:0064:0088:fr:PDF 
15 Directive 1999/44/CE du Parlement européen et du Conseil, du 25 mai 1999, sur certains aspects de la vente et 
http://eur-lex.europa.eu/legal-
des 
des 
content/FR/TXT/HTML/?uri=CELEX:31999L0044&from=FR 

consommation. 

http://eur-

européen 

garanties 

Conseil. 

biens 

de 

et 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

lexicales  mineures  identifiées  sont  dues  au  fait  que  les  Directives  ont  des  périmètres 
différents,  puisque  la  Directive  sur  la  vente  et  des  garanties  des  biens  de  consommation 
traite  de  la  « non-conformité »  alors  que  la  Directive  sur  la  responsabilité  du  fait  des 
produits  défectueux  traite  le  « défaut ».  Les  preuves  semblent  indiquer  que  les  quelques 
incohérences  identifiées  n’affectent  pas  l’application  de  la  Directive  sur  la  responsabilité  du 
fait  des  produits  défectueux.  Sa  cohérence  avec  à  la  fois  avec  la  Proposition  de  Directive 
relative  aux  contrats  de  fourniture  de  contenu  numérique16  et  avec  la  Proposition  de 
Directive concernant certains aspects des contrats de ventes en ligne et de toute autre vente 
à  distance  de  biens17  est  confirmée,  malgré  quelques  incohérences  lexicales  mineures  qui 
semblent  être  justifiées  par  les  périmètres  différents  des  deux  législations,  et  ne  semblent 
pas affecter la mise en œuvre de la législation. 

La  législation  en  matière  de  sécurité  vise  à  garantir  que  seuls  des  produits  sûrs  sont 
commercialisés sur le marché, et déclare que ses dispositions ne doivent pas affecter le droit 
des victimes au  sens de la  Directive  sur la responsabilité  du fait des  produits défectueux – 
qui reste un  régime juridique autonome. Ainsi, la  Directive sur la responsabilité  du fait des 
produits défectueux, la législation sectorielle de sécurité et la Directive  relative à la sécurité 
générale des produits18 semblent être cohérentes, et les effets combinés entre la Directive et 
législation  en  matière  de  sécurité  (sectorielle  et  générale)  est  particulièrement  importante. 
La surveillance de marché est utilisée pour contrôler si les produits satisfont les exigences de 
sécurité et pour mettre en œuvre les actions nécessaires pour garantir la conformité. Dans 
ce  cadre,  et  à  un  stade  ultérieur,  la  Directive  sur  la  responsabilité  du  fait  des  produits 
défectueux  opère  comme  un  « filet  de  sécurité »,  chaque  fois  qu’un  produit  commercialisé 
s’avère défectueux et cause des dommages aux consommateurs.  

L’évaluation a clarifié comment toute la législation en matière de sécurité est cohérente avec 
la Directive sur la responsabilité du fait des produits défectueux 

Étant  donné  les  autres  législations,  le  Règlement  Rome  II  renforce  la  protection  du 
consommateur  en  se  basant  sur  la  possibilité  de  “prévoir”  le  droit  applicable  à  l’éventuel 
dommage affectant les consommateurs (d’abord, le droit de son lieu de résidence), tout en 
créant un équilibre entre les besoins de l’accusé, prenant  en compte le lieu où le produit a 
été  commercialisé.  Dans  ce  sens,  il  présente  des  synergies  avec  la  Directive  sur  la 
responsabilité  du  fait  des  produits  défectueux.  La  cohérence  entre  la  Directive  sur  la 
responsabilité  du  fait  des  produits  défectueux  et  le  Règlement  Bruxelles  I  a  été  confirmée 
par  une  décision  de  la  Cour  de  justice  de  l’Union  européenne.  La  cour  a  précisé  que  les 
réclamations  au  titre  de  la  Directive  sur  la  responsabilité  du  fait  des  produits  défectueux 
étaient sujettes à l’Article 5(3) du Règlement Bruxelles I, qui vise à fixer des  règles claires 
sur la compétence judiciaire en matière civile et commerciale. De plus, la Cour de justice de 
l’Union européenne a également déclaré que, lorsqu’un fabricant fait face à une réclamation 
de  responsabilité  du  fait  d’un  produit  défectueux,  le  lieu  de  l’événement  donnant  lieu  aux 
dommages  est  le  lieu  où  le  produit  a  été  fabriqué.  La  disposition  en  question,  telle 
qu’interprétée par la Cour, n’est pas en conflit avec la  Directive sur la responsabilité du fait 

16  Proposition  de  Directive  du  Parlement  européen  et  du  Conseil  concernant  certains  aspects  des  contrats  de 
fourniture  de  contenu  numérique.  (Bruxelles,  le  9.12.2015  COM(2015)  634  final  2015/0287(COD)  http://eur-
lex.europa.eu/legal-content/FR/TXT/HTML/?uri=CELEX:52015PC0634&from=EN. 
17 Proposition de Directive du Parlement européen et du Conseil concernant certains aspects des contrats de ventes 
en  ligne  et  de  toute  autre  vente  à  distance  de  biens.  (Bruxelles,  le  9.12.2015  COM(2015)  635  final 
2015/0288(COD). http://eur-lex.europa.eu/legal-content/FR/TXT/HTML/?uri=CELEX:52015PC0635&from=FR. 
18 Directive  2001/95/CE  du  Parlement  européen  et  du Conseil  du  3 décembre 2001 relative  à  la  sécurité  générale 
http://eur-lex.europa.eu/legal-
l'intérêt 
des 
content/FR/TXT/HTML/?uri=CELEX:32001L0095&from=EN.  

présentant 

produits 

l'EEE). 

(Texte 

pour 

de 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

des  produits  défectueux.  Inversement,  la  Directive  sur  le  règlement  extrajudiciaire  des 
litiges  est  limitée  à  la  résolution  des  litiges  contractuels  et  ne  couvre  pas  ceux  qui 
surviennent  suite  à  des  dommages  du  fait  de  produits  défectueux,  selon  la  définition  de  la 
Directive sur la responsabilité du fait des produits défectueux. En effet, il n’y a aujourd’hui 
aucune  règle  de  l’UE  en  place  pour  une  résolution  extrajudiciaire  des  réclamations  en  lien 
avec la Directive sur la responsabilité du fait des produits défectueux. Comme les périmètres 
d’applications  semblent  être  mutuellement  exclusifs,  les  deux  Directives  sont  estimées 
cohérentes. 

Pertinence 

Globalement,  la  Directive  sur  la  responsabilité  du  fait  des  produits  défectueux  est  encore 
pertinente  par  rapports  aux  besoins  initiaux,  qui  continuent  de  correspondre  aux  besoins 
actuels  des  fabricants  et  des  consommateurs.  En  particulier,  la  tendance  en  termes  de 
nombre  de  réclamations  relatives  à  des  produits  défectueux,  ainsi  que  le  taux  moyen  de 
litiges  de  l’UE,  n’a  pas  baissé  ces  dernières  années,  démontrant  que  la  protection  du 
consommateur,  la  responsabilité  stricte  du  producteur  et  la  garantie  de  la  libre  circulation 
des produits et d’un terrain de jeu égal sont encore pertinentes. 

La  discussion  sur  la  pertinence  de  la  Directive  sur  la  responsabilité  du  fait  des  produits 
défectueux  est  moins  évidente  lorsque  l’on  considère  les  nouveaux  développements 
technologiques. Les besoins généraux en lien avec les développements technologiques sont 
encore  les  mêmes,  bien  que  des  développements  technologiques  ultérieurs  (par  exemple 
ceux  qui  sont  particulièrement  complexes  ou  comprennent  à  la  fois  des  produits  et  des 
services, tels que l’informatique en nuage, ou créent de nouveaux paradigmes et frontières, 
tels  que  l’intelligence  artificielle,  potentiellement  affectant  les  définitions  et  la  liste 
d’exemptions  de  la  responsabilité)  sont  un  problème  car  ils  remettent  en  question  la 
distinction  entre  services  et  produits,  utilisation  professionnelle  et  personnelle  et  quelques 
définitions contenues dans la Directive sur la responsabilité du fait des produits défectueux. 
Parmi ces dernières, les définitions de produit, dommage, défaut, et la liste d’exemptions de 
la responsabilité en faveur du producteur, telles que la clause de risque de développement, 
sont les plus remises en question par la montée de ces nouvelles technologies. 

En particulier, l’existence de produits pour lesquels la  Directive sur la responsabilité  du fait 
des  produits  défectueux  est  (ou  pourrait  être)  devenue  incertaine  ou  problématique  est 
confirmée par les répondants à la consultation publique ouverte, qui indiquent comment de 
tels produits (par exemple ceux connectés à Internet, ou réalisant des tâches automatiques 
basées sur des algorithmes et de l’analyse de données) entrent en général dans la définition 
de nouveaux développements technologiques, et comment la  Directive sur la responsabilité 
du  fait  des  produits  défectueux  pourrait  nécessiter  une  adaptation  pour  mieux  traiter  ces 
produits. 

Cela a été confirmé par l’analyse juridique réalisées sur des exemples purement théoriques, 
qui  a  considéré  cinq  nouveaux  développements  technologiques  (i.e.  les  smartphones,  les 
imprimantes  3D,  l’informatique  en  nuage,  les  robots  et  les  voitures  sans  chauffeur).  Cette 
analyse démontre que, en termes de pertinence de la  Directive sur la responsabilité du fait 
des produits défectueux, la notion de produit (Article 2), la notion de producteur (Article 3), 
et  la  notion  de  défaut  (Article  6)  pourraient  être  problématiques  lorsqu’appliquées  à  de 
nouveaux développements technologiques. 

Cependant,  les  parties  prenantes  semblent  avoir  des  opinions  divergentes  sur  les 
éventuelles  actions  à  mener,  avec  les  producteurs  et  les  distributeurs  soutenant  que,  par 
exemple,  la  distinction  entre  produit  et  service  peut  devenir  purement  académique  dans 
certains  cas,  alors  que  d’autres  indiquent  le  besoin  pour  une  approche  au  niveau  de  l’UE 
pour traiter de la responsabilité des produits interconnectés avec des services. 

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Malgré  les  besoins  soulevés,  un  seul  cas  pertinent  a  été  trouvé,  impliquant  un  nouveau 
développement  technologique  défectueux  (une  unité  de  stockage),  suggérant  que,  pour  le 
moment,  ce  problème  reste  principalement  théorique,  avec  des  appareils  intelligents 
pratiquement  pas  sujets  aux  recours  judiciaires  malgré  leur  utilisation  très  répandue  et  les 
défauts rencontrés avec les applications mobiles. 

La  recherche  documentaire  a  confirmé  une  incertitude  concernant  l’application  de  la 
Directive sur la responsabilité du fait des produits défectueux (et sa pertinence) relative aux 
nouveaux développements technologiques, avec la plupart des sources apparaissant comme 
en  faveur  d’une  adaptation,  et  d’autres  soulignant  comment  ce  problème  peut  être 
raisonnablement résolu seulement grâce à l’interprétation. 

Malgré  de  telles  conclusions  divergentes,  la  pertinence  de  la  Directive  sur  la  responsabilité 
du  fait  des  produits  défectueux  est  confirmée  en  ce  qui  concerne  ses  objectifs  initiaux 
relatifs  à  la  protection  des  consommateurs,  la  responsabilité  des  producteurs,  et  la  libre 
circulation  des  produits  sans  fausser  la  concurrence,  alors  que  sa  pertinence  vis-à-vis  des 
nouveaux  développement  technologiques  est  moins  évidente  (par  exemple  liée  à  la 
distinction  floue  entre  les  produits  et  les  services,  et  l’utilisation  professionnelle  et 
personnelle des produits).  

Valeur ajoutée de l’UE 

L’évaluation confirme que la Directive sur la responsabilité du fait des produits défectueux a 
apporté une valeur ajoutée de l’UE, même si des différences existent en ce qui concerne ses 
différents objectifs. 

En  particulier,  les  parties  prenantes  voient  la  protection  du  consommateur  uniforme  à 
travers  l’UE  comme  un  fort  avantage  –  protection  qui  n’aurait  pas  pu  être  atteinte  par  les 
législations  nationales  seules.  Onze  sur  12  représentants  des  consommateurs  ont  confirmé 
que  la  protection  atteinte  grâce  à  la  Directive  sur  la  responsabilité  du  fait  des  produits 
défectueux n’aurait pas pu être atteinte avec l’action des États membres seulement. 

La valeur ajoutée de l’UE de la Directive sur la responsabilité du fait des produits défectueux 
est  aussi  due  à  l’harmonisation  des  règles  sur  la  responsabilité  du  fait  de  produits 
défectueux  et  le  juste  équilibre  entre  la  protection  du  consommateur  et  l’innovation  en 
Europe,  pas  seulement  en  ce  qui  concerne  la  protection  dont  les  consommateurs  peuvent 
bénéficier  au  tribunal  mais  également  les  mesures  préventives  entreprises  par  certains 
producteurs  qui,  cependant,  ne  sont  pas  entravé  pour  innover.  En  particulier,  la  recherche 
documentaire a confirmé que la clause de risque de développement peut être vue comme un 
compromis  satisfaisant  entre  le  besoin  de  simuler  l’innovation  et  les  attentes  légitimes  des 
consommateurs  en  ce  qui  concerne  la  sécurité  des  produits ;  son  retrait  ne  serait  pas 
bénéfique pour l’innovation au sein de l’UE. 

En  outre,  l’opinion  de  la  plupart  des  parties  prenantes  est  que  réduire  le  périmètre  (ou 
abroger) la Directive sur la responsabilité du fait des produits défectueux pourrait changer la 
protection  du  consommateur,  menant  à  des  conséquences  négatives  pour  les  producteurs 
également. Ces dernières pourraient inclure l’incertitude et les difficultés sous-jacentes liées 
à 
la  prévision  des  règles  applicables  dans  chacun  des  États  membres,  moins 
d’harmonisation,  et  la  fragmentation  du  marché  intérieur.  En  effet,  les  parties  prenantes 
d’ordinaire  soit  considèrent  que  la  Directive  sur  la  responsabilité  du  fait  des  produits 
défectueux  est  à  l’épreuve  du  temps  soit  qu’elle  nécessite  une  révision  afin  d’élargir  son 
périmètre. De plus, les correspondants nationaux de cette étude partagent l’opinion que si la 
Directive  sur  la  responsabilité  du  fait  des  produits  défectueux  devait  être  abrogée,  soit  le 
droit  de  la  responsabilité  civile  soit le  droit  des  contrats  soit  les  deux  s’appliqueraient  avec 
des  impacts  négatifs  sur  la  protection  du  consommateur,  la  libre  circulation  des 

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marchandises,  la  concurrence,  et  l’uniformité  de  la  législation  de  l’UE.  Les  règles 
hétérogènes  en  termes  de  protection  et  de  responsabilité  et  les  incertitudes  dues  aux 
différentes  interprétations  par  les  tribunaux  nationaux  auraient  des  effets  négatifs  sur  les 
consommateurs et les producteurs.  

L’examen  des  conséquences  possibles  d’une  réduction  du  périmètre  de  la  Directive  sur  la 
responsabilité  du  fait  des  produits  défectueux  ou  de  son  abrogation  semble  confirmer  sa 
valeur ajoutée de l’UE. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

1  INTRODUCTION  

This  report  presents  the  results  of  the  evaluation  of  Council  Directive  85/374/EEC  on  the 
approximation  of  laws,  regulations  and  administrative  provisions  of  the  Member  States 
concerning  liability  for  defective  products  (hereafter  referred  to  as  the  “Product  Liability 
Directive”  or  the  “Directive”).  The  study  was  commissioned  by  the  European  Commission, 
Directorate-General for  Internal Market,  Industry,  Entrepreneurship and SMEs (DG  GROW). 
The  study  was  led  by  EY,  with  the  support  of  Technopolis  Group  and  VVA.  The  evaluation 
took place from January through to September 2017. 

1.1  Scope of the evaluation 

The scope of the study is defined as addressing the following:  

  Legislation:  Directive  85/374/EEC  on  the  approximation  of  laws,  regulations  and 
administrative  provisions  of  the  Member  States  concerning  liability  for  defective 
products as modified by Directive 1999/34/EC;19 

  Time frame: from 2000 to 2016; 

  Territory: the 28 EU Member States; 

  Stakeholders:  industry  associations,  producers,  importers  and  suppliers  (including 
SMEs  and  software  developers,  pharmaceutical  companies  and  others),  consumer 
organisations,  public  administrations,  insurance  companies  (including  federations  of 
insurers), the European Parliament and Commission officials, individual experts from 
academia,  think-tanks,  law  firms  and  others,  e.g.  the  Product  Liability  Forum  of  the 
British Institute of International and Comparative Law. 

1.2  Objectives of the evaluation 

The study assesses the overall functioning and performance of the Product Liability Directive 
and whether it is effective, efficient, coherent and relevant and has EU added value. 

Attention is paid to analysing whether the Product Liability Directive is fit for purpose,  as 
regards  new  technological  developments.  In  this  context,  the  evaluation  aims  to 
examine  how  the  liability  regime  established  by  the  Product  Liability  Directive  adequately 
addresses  the  damage  caused  by  malfunctioning  apps  and  non-embedded  software  and, 
more  generally,  damage  caused  by  a  malfunctioning  component  of  an  Internet  of  Things 
(IoT)20 environment or other connected objects. 

The evaluation also aims to: 

  Provide  quantitative  and  qualitative  data  on  the  application  of  the  Product  Liability 
Directive in Member States, with detailed explanations regarding successful experiences 
or problems encountered by stakeholders; 

19  Following  the  kick-off  meeting,  the  scope  was  extended  to  identify  national  legislation,  case  law  and  doctrine 
related  to  fields  not  currently  explicitly  covered  by  the  Product  Liability  Directive,  such  as  the  liability  of  service 
providers  and  software  developers.  The  exercise  aimed  to  help  reveal  any  aspects  pointing  to  legal  gaps, 
uncertainties or inconsistencies in implementation of the Directive, in particular in the context of new technological 
developments. 
20  The  IoT  is  a  network  of  (digital)  products,  communicating  and  interacting  with  the  environment  and  other 
devices. In some cases, the IoT may create interdependencies between products, gathered or generated data and 
service providers. There is a wide variety of IoT systems and ways in which these systems can be used. See: SWD 
(2016)110/2  Advancing  the  Internet  of  Things  in  Europe,  accompanying  the  Communication  Digitising  European 
industry  -  Reaping  the  full  benefits  of  a  Digital  Single  Market  {COM(2016)180  of  19  April  2016}  as  part  of  the 
Digital Single Market package. 

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  Mention  Member  States  where  consumers  have  made  greater  use  of  the  provisions laid 

down by the Product Liability Directive; 

  Provide  an  evidence-based  assessment  per  Member  State  of  whether  and  how  national 
transpositions  of  the  Product  Liability  Directive  are  applied  to  new  technological 
developments, specifically analysing the following indicative aspects: 

   Establish whether apps and non-embedded software, or components of the IoT or 
AI  are  considered,  notably  by  national  courts  or  doctrine,  as  "products"  for  the 
purpose of the Directive; 

   Find  out  whether  unintended  autonomous  behaviour  of  an  advanced  robot  is 
considered, notably by national courts or doctrine, as a "defect" according to the 
criteria of the Directive; 

   Establish how the strict liability for damages is distributed between the different 
participants in  the  IoT,  in  particular in  the  case  of  connected  objects  or  sensors 
relying  on  each  other  and  on  external  data  that  are  not  necessarily  under  the 
control of a single ‘producer’. 

1.3  Content of the report 

The report is structured as follows: 

  Chapter 1 presents a summary of the scope (section 1.1) and objectives (section 1.2) of 

the evaluation, as well as a description of the content of the report (section 1.3); 

  Chapter  2  discusses  the  background  and  policy  context  of  the  measures  (section  2.1) 
and  the  Directive  itself  –  in  terms  of  objectives,  scope,  relevant  provisions  and 
stakeholders concerned (section 2.2); 

  Chapter  3  outlines  the  study  methodology,  explaining  how  the  evaluation  was  carried 
out,  as  well  as  presenting  the  evaluation  questions  and  criteria  (section  3.1),  the 
intervention  logic  and  evaluation  grids  (section  3.2),  and  the  overall  methodological 
approach  comprising  desk  and  field  research  (section  3.3).  Limitations  and  mitigation 
measures are also presented (section 3.4); 

  Chapter 4 discusses the implementation of the Directive; 

  Chapter 5 presents all of the detailed answers to the evaluation questions; 

  Chapter 6 draws the evaluation conclusions; 

  Annexes include:  

   All the evaluation questions; 
   All the evaluation grids; 
   An  overview  of  the  stakeholder  consultation  performed  in  the  context  of  the 

study (the synopsis report); 

   The  questionnaires  used  in  all  the  consultation  activities  (e.g.  surveys, 

interviews); 

   The  template  used  to  gather  information  at  national  level  and  prepare  country 

fiches; 

   An overview of legal issues in the context of new technological developments; 
   An overview of legislation on safety;  
   The bibliography. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

2  BACKGROUND OF THE MEASURE 

2.1  Legislative background 

Council Directive of 25 July 1985 on the approximation of the laws, regulations and 
administrative  provisions  of  the  Member  States  concerning  liability  for  defective 
products  applies  within  the  framework  of  the  Single  Market  and  sets  the  conditions  under 
which consumers  may  claim compensation for the damage  caused by defective products  in 
circulation  in  the  internal  market.  The  Directive  has  been  substantially  amended  by 
Directive  1999/34/EC,21  which  extended  its  scope  to  include  agricultural  and  fishery 
products. 

2.1.1  The producer’s liability before the Directive 

Discussions  on  product  liability  resulted  from  the  occurrence  of  mass  product  disasters  in 
Europe  in  the  60s,  specifically  that  relating  to  Thalidomide/Contagen.22  As  a  result, 
governments acknowledged that traditional  legislative responses were not sufficient to deal 
with  such  situations.  However,  until  the  adoption  of  the  Product  Liability  Directive  in  1985, 
no  Member  State  had  specific  legislation  in  place  to  protect  victims  of  defective  products 
(Machnikowski,  2016;  Rajneri  Karageorgevitch,  n.d.).  Indeed,  until  then,  courts  had 
endeavoured to build a producers’ liability to injured persons on the basis either of tort law – 
by presuming the fault of the producer in re ipsa, i.e. based on the sole fact that the product 
was  defective  and  damaging  –  or  contract  law  –  by  assuming  that  the  producer  was  liable 
for  the  breach  of  guarantees  implied  in  the  contract  (Borghetti  2004).  In  all  these  cases, 
liability was constrained  within the limits of these areas of law, such as the requirement to 
prove the negligence of the person liable in the area of tort law, and so on. 

2.1.2  Legal framework of the Directive 

The Product Liability Directive was introduced in a particular phase of the EU legislation for 
goods, known as the “New Approach”.23 The New Approach was later replaced by the “New 
Legislative  Framework”  (NLF),  adopted  in  July  2008.24  Among  other  measures,  the  NLF 
established  a  common  legal  framework  for  industrial  products  in  the  form  of  a  toolbox  of 
measures for use in future legislation.25 This includes definitions of terms commonly used in 
product  legislation,  and  procedures  to  allow  future  sectorial  legislation  to  become  more 

21 Directive 1999/34/EC of the European Parliament and of the Council of 10 May 1999 amending Council Directive 
85/374/EEC  on  the  approximation  of  the  laws,  regulations  and  administrative  provisions  of  the  Member  States 
concerning  liability  for  defective  products:  http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31999
L0034&from=EN. 
22  Thalidomide  was  sold  in  the  50s  and  60s  as  a  sedative,  anti-nausea  and  hypnotic  medicine  used  by  pregnant 
women.  It  was  withdrawn from  the  market  at  the end  of 1961  (having  been  distributed  in 50  countries  under  40 
different  commercial  names,  including  Contergan)  following  the  discovery  of  the  teratogenicity  as  one  of  its 
components. Thalidomide-treated babies were affected by severe congenital alterations in the development of the 
arts.  The  Thalidomide  disaster  affected  DE,  NL  and  UK  in  particular.  Governments  eventually  acknowledged  that 
traditional responses of law were no longer sufficient to deal with such situations. 
23  Introduced  by  Council  Resolution  of  7  May  1985  on  a  new  approach  to  technical  harmonisation  and  standards. 
According  to  the  New  Approach,  the  EU  adopts  legislation  that  defines  “essential  requirements”,  leaving  the 
technical details to European harmonised standards.  
24  The  NLF  has  been  introduced  by  Regulation  (EC)  765/2008,  setting  out  the  requirements  for  accreditation  and 
the  market  surveillance  of  products;  Decision  768/2008  on  a  common  framework  for  the  marketing  of  products, 
which  includes  reference  provisions  to  be  incorporated  whenever  product  legislation  is  revised.  In  effect,  it  is  a 
template for legislating future product harmonisation; Regulation (EC) 764/2008 laying down procedures relating to 
the application of certain national technical rules to products lawfully marketed in another EU country. 
25 https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

consistent  and  easier  to  implement.  The  Product  Liability  Directive  has  not  been  aligned  to 
the NLF; as a consequence, its terminology is different from that used therein.26  

The Product Liability Directive interacts with other relevant pieces of legislation that pursue 
the  same  general  objectives,  thus  making  it  difficult  to  isolate  the  Product  Liability 
Directive’s specific contribution to its objectives.  

First, there are interactions with safety legislation.  

Sectorial  harmonisation  legislation  (e.g.  directives  such  as  those  relating  to  machinery, 
electrical  equipment,  radio  equipment,  medical  devices,  and  cosmetics)27  and  the  General 
Product  Safety  Directive28  are  the  main  pieces  of  legislation  to  be  considered.  Both  the 
specific  safety  legislation  and  the  General  Product  Safety  Directive  aim  to  guarantee  the 
functioning  of  the  internal  market  and  the  protection  of  users  (workers  or  consumers).  EU 
sectorial  harmonisation  legislation  and  the  General  Product  Safety  Directive  aim  to  prevent 
damages  by  ensuring  that  products  placed  on  the  EU  market  are  safe  ex  ante.  Producers 
should  only  place  products  on  the  EU  market  that  meet  specific  health  and  safety 
requirements.29 Those that are not safe under normal (or reasonably foreseeable) conditions 
of  use  should  be  withdrawn  or  recalled  from  the  market.  At  the  interplay  with  safety 
legislation, the Product  Liability Directive seeks to compensate consumers for damages due 
to  a  defective  product,  therefore  intervening  ex  post.  Under  the  Product  Liability  Directive, 
the producer is liable for the damage caused by a product that does not provide the safety a 
person is entitled to expect, taking into account all circumstances, including its presentation, 
reasonable  use  or  when  it  was  put  into  circulation.  To  the  extent  that  safety  legislation 
ensures the safety of products on the market, it will reduce the need for consumers to seek 
compensation under product liability rules. 

Secondly,  as  regards  contractual 
complementary to other European legislation. 

liability, 

the  Product  Liability  Directive 

is 

The Directive on Consumer Rights30 aims to ensure a high level of consumer protection and 
the free movement of goods within the internal market by providing a regulatory framework 

(recast). 

Directive 

95/16/EC 

26  Specifically,  the  concept  of  ‘producer’  in  the  Product  Liability  Directive  is  different  from  that  of  ‘manufacturer’ 
under  the  NLF.  For  the  latter,  legal  or  administrative  action  may  take  place  against  any  persons  in  the  supply  or 
distribution  chain  who  can  be  considered  responsible  for  a  non-compliant  product,  even  if  the  producer  is 
established outside the Union. 
27  Directive  2006/42/EC  of  the  European  Parliament  and  of  the  Council  of  17  May  2006  on  machinery,  and 
amending 
http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32006L0042&from=FRN. Directive 2014/35/EU of the European Parliament and of 
the  Council  of  26  February  2014  on  the  harmonisation  of  the  laws  of  the  Member  States  relating  to  the  making 
available on the market of electrical equipment designed for use within certain voltage limits (recast).   http://eur-
the 
lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0035&from=EN.  Directive  2014/53/EU 
European  Parliament  and  of  the  Council  of  16  April  2014  on  the  harmonisation  of  the  laws  of  the  Member  States 
relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC.  http://eur-
lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0053&from=EN;  Regulation  (EU)  2017/745  of  the 
European  Parliament  and  of  the  Council  of  5  April  2017  on  medical  devices,  amending  Directive  2001/83/EC, 
Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 
93/42/EEC.  http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN;  Regulation 
(EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices 
and  repealing  Directive  98/79/EC  and  Commission  Decision  2010/227/EU.  http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN;  Regulation  (EC)  No  1223/2009  of  the  European 
Parliament 
http://eur-
of  30  November  2009 
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF. 
28  Directive  2001/95/EC  of  the  European  Parliament  and  of  the  Council  of  3  December  2001  on  general  product 
safety: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32001L0095&from=EN. 
29 Or, where applicable, put into service, install and maintain. 
30  Directive  2011/83/EU  of  the  European  Parliament  and  of  the  Council  of  25  October  2011  on  consumer  rights, 
amending Council Directive 93/13/EEC and Directive 1994/44/EC and repealing Directive 85/577/EEC and Directive 

the  Council 

products. 

cosmetic 

and 

on 

of 

of 

4 

 
                                                 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

for  contracts  concluded  between  consumers  and  traders.  It  aims  to  harmonise  certain 
aspects  of  consumer  distance  and  off-premises  contracts  to  promote  a  real  consumer 
internal  market.  The  Directive  on  Consumer  Rights  provides  for  various  requirements  that 
traders  must  meet,  such  as  consumer  information  and  the  right  of  withdrawal.  While  the 
Directive  on  Consumer  Rights  regulates  contractual  aspects,  the  Product  Liability  Directive 
defines the concept of liability independently from contractual obligations. 

The  Sales  and  Guarantees  Directive31  aims  to  provide  minimum  rules  on  consumer  law  to 
strengthen  consumers’  confidence  and  enable  them  to  make  the  most  of  the  internal 
market, in particular in relation to product non-conformity with the contract, which is one of 
the main issues encountered by consumers and a main source of disputes with sellers. This 
Directive  provides  for  a  definition  of  “consumer”  and  “consumer  goods”  and  defines 
consumers’  rights  for  any  lack  of  conformity  of  the  goods  at  the  time  they  were  delivered. 
The  Sales  and  Guarantee  Directive  seeks  to  set  up  rules  ensuring  that  consumers  receive 
appropriate  redress  for  the  lack  of  conformity  of  the  goods,  whereas  the  Product  Liability 
Directive  provides  for  a  redress  mechanism  in  case  of  damage  caused  by  product 
defectiveness. 

Thirdly,  also  as  regards  the  applicable  law  and  disputes  resolution  across  Member 
States, the Product Liability Directive is complementary to the following pieces of legislation 
and proposals, further analysed in section 5.3: 

  The  ‘Digital  contracts  proposals’,  and  in  particular  (i)  the  Commission's  proposal  for  a 
Directive  on  contracts  for  the  supply  of  digital  content;32  and  (ii)  the  Commission's 
proposal for a  Directive on contracts for the  online and other distance  sales  of goods.33 
The  two  proposals,  which  may  still  be  amended  by  the  legislator,  will  tackle  the  main 
obstacles  to  cross-border  e-commerce  in  the  EU:  legal  fragmentation  in  the  area  of 
consumer  contract  law  and  the  resulting  high  costs  for  businesses  –  especially  SMEs  – 
and low consumer trust when buying online from another country;  

  The Rome II Regulation on the law applicable to non-contractual obligations;34 

  The  Brussels  IA  Regulation  on  jurisdiction  and  the  recognition  and  enforcement  of 

judgments in civil and commercial matters;35  

  The Directive on alternative dispute resolution for consumer disputes.36 

Finally, the Product Liability Directive raises the question of how to consider, for the purpose 
of product liability, new technological developments.  

97/7/EC. 
31  Directive  1999/44/EC  of  the  European  Parliament  and  of  the  Council  of  25  May  1999  on  certain  aspects  of 
consumer goods and associated guarantees. 
32 Proposal for a Directive of the European Parliament and of the Council on certain aspects concerning contracts for 
the supply of digital content (Brussels, 9.12.2015 COM(2015) 634 final 2015/0287 (COD): https://ec.europa.eu/tra
nsparency/regdoc/rep/1/2015/EN/1-2015-634-EN-F1-1.PDF. 
33  Proposal  for  a  directive  of  the  Parliament  and  of  the  Council  of  on  certain  aspects  concerning  contracts  for  the 
online and other distance sales of goods. (Brussels, 9.12.2015 COM(2015) 635 final 2015/0288(COD)). http://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2015%3A635%3AFIN. 
34 Regulation (EC) No 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable 
to 
http://eur-lex.europa.eu/legal-
non-contractual 
content/EN/TXT/PDF/?uri=CELEX:32007R0864&rid=1.  
35  Regulation  (EU)  No  1215/2012  of  the  European  Parliament  and  of  the  Council  of  12  December  2012  on 
jurisdiction and the recognition and enforcement of judgments in civil and commercial matters: http://eur-lex.euro
pa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32012R1215&rid=1.  
36  Directive  2013/11/EU  of  the  European  Parliament  and  of  the  Council  of  21  May  2013  on  alternative  dispute 
resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC: http://eu
r-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32013L0011&rid=1.  

obligations: 

5 

 
                                                                                                                                                              
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

In the context of the Digital Market Strategy (DMS),37 the legal certainty as to the allocation 
of liability in the case of damages (other than relating to personal data) is important for the 
introduction and implementation of the IoT. Also, in the context of the Building a European 
Data  Economy  Initiative,38  a  key  issue  concerns  assessing  whether  the  Directive  is  fit  for 
purpose vis-à-vis new technological developments.  

The  following  box  presents  the  concept  of  ‘new  technological  developments’  used  in  the 
context of this study. 

Box 1: New technological developments and related challenges 

New  technological  developments  may  concern  a  wealth  of  different  domains.  Nonetheless,  for 
the  purposes  of  this  study,  the  definition  adopted  considers  recent  and  prospective 
information  technology  developments  implying,  to  some  extent,  an  interaction  between 
software  (i.e.  computer  instructions  or  encoded  information  governance)  and  tangible 
objects.  

Within this perspective, new technological developments include, amongst others: 

  Software embedded in products; 
  Products  on  which  software  and  applications,  such  as  apps  and  other  non-embedded 

software, from different sources can be installed after purchase; 

  Products connected to and through the Internet (IoT); 
  Products shared with other users through collaborative platforms; 
  Devices for 3D printing/additive manufacturing and products manufactured with them; 
  Advanced  robots  and  autonomous  systems  guided  by  AI,  i.e.  physical  machines  able  to 
perceive  their  environment,  process  this  information  correctly  and  carry  out  complex 
actions autonomously, e.g. advanced driver-assistance systems or completely self-driving 
cars, also with the capacity to learn from their actions; 

  Software-based  systems  incorporating  AI,  i.e.  software  processing  information  correctly 
then  acting  appropriately,  e.g.  autonomous  trading  algorithms  or  any  other  big-data 
algorithms. 

Some  of  these  definitions  have  been  the  subject  of  controversy  and  the  boundaries  between  the 
different items listed above are far from clearly defined and can often overlap. However, even though 
new technological developments are used extensively in every field of human activity, this evaluation 
does  not  take  into  account  specific  analyses  of  individual  sectors  (such  as  agriculture,  construction, 
energy, life science and materials science). 

2.2  The Product Liability Directive 

2.2.1  Objectives and scope of the Product Liability Directive 

The Product Liability Directive has three strategic objectives: 

1)  Enhancing the free movement of goods; 

2)  Protecting consumers’ health and property; 

3)  Ensuring undistorted competition in the Single Market between market operators. 

According to the preamble of the Product Liability Directive: “the approximation of the laws 
of  the  Member  States  concerning  the  liability  of  the  producer  for  damage  caused  by  the 
defectiveness  of  his  products  is  necessary  because  the  existing  divergences  may  distort 
competition  and  affect  the  movement  of  goods  within  the  common  market  and  entail  a 

37 A Digital Single Market Strategy for Europe – COM(2015) 192 final: http://eur-lex.europa.eu/legal-content/EN/TX
T/PDF/?uri=CELEX:52015DC0192&from=EN.  
38 https://ec.europa.eu/digital-single-market/en/news/digital-single-market-free-flow-data-initiative.  

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

differing  degree  of  protection  of  the  consumer  against  damage  caused  by  a  defective 
product to his health or property”. 

To  reach  such  objectives,  and  following  the  previously  mentioned  1999  amendment,  the 
Product Liability Directive applies to all movables, even if incorporated into another movable 
or into an immovable, including electricity, marketed in the European Economic Area (i.e. in 
the Member States, Norway, Lichtenstein and Iceland). 

The Product Liability Directive applies only to defective products, i.e. products not providing 
the safety ‘the public at large’ is entitled to expect. Electricity is explicitly included under the 
definition  of  product,  while  nuclear  energy  is  expressly  excluded  from  the  scope  of  the 
Product Liability Directive. 

2.2.2  Relevant provisions 

This section describes the provisions of the  Product Liability Directive applicable in the case 
of damage caused by a defective product. The intervention logic of the Directive is described 
in section 3.2.1. 

i.  Definitions 

Together with the definition of product provided by Article 2 and framing the material scope 
of  the  Directive,  the  Directive  defines  the  producer  and  his  responsibilities  (Article  3),  the 
concept of damage (Article 9) and of defect (Article 6): 

 

“Producer”  means  the  manufacturer  of  a  finished  product,  the  producer  of  any  raw 
material  or  the  manufacturer  of  a  component  part  and  any  person  who,  by  putting  his 
name,  trademark  or  other  distinguishing  feature  on  the  product  presents  himself  as  its 
producer.  Any  person  who  imports  into  the  European  Union  from  non-EU  countries  a 
product  for  sale,  hire,  leasing  or  any  form  of  distribution  in  the  course  of  his  business 
shall  be  deemed  to  be  a  producer  within  the  meaning  of  the  Product  Liability  Directive 
and  shall  be  responsible  as  a  producer.  In  addition,  where  the  producer  of  the  product 
cannot be identified, each supplier of the product shall be treated as its producer unless 
he informs the injured person, within a reasonable time, of the identity of the producer 
or of the person who supplied him with the product.39 

 

“Damage”  means:  a)  damage  caused  by  death  or  by  personal  injuries;  and  b)  damage 
to, or destruction of, any item of property other than the defective product itself, with a 
lower threshold of €500, provided that the item is intended for private use. The definition 
does not include reference to non-material damages.40 

  A product is “defective” when it does not provide the safety which a person is entitled to 
expect,  taking  into  account:  (a)  its  presentation;  (b)  its  reasonable/expected  use;  and 
(c) the time when it was put into circulation. 

ii.  Strict liability of the producer and burden of proof upon the injured person  

According to Article 4, “the injured person shall be required to prove the damage caused by 
the defective product, the defect of the product and the causal relationship between defect 

39  Pursuant  to  Article  5  of  the  Product  Liability  Directive,  where  two  or  more  persons  are  liable  for  the  same 
damage, they shall be liable jointly and severally without prejudice to the provisions of national law concerning the 
rights of contribution or recourse. 
40 Non-material damages can be defined as “losses which do not relate to a person’s assets, wealth or income and, 
as  such,  cannot  be quantified  in  an  objective manner  by reference  to  a  market  price or  value”  (CJEU  C‑371/12): 
they  might  include,  for  instance,  moral  damages.  In  any  case,  Article  9  shall  be  construed  without  prejudice  to 
national provisions relating to non-material damage. 

7 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

and  damage”.  The  injured  person  does  not  have  to  prove  the  fault  of  the  producer  and 
therefore the producer is subject to a regime of strict liability. 

iii.  Categories of exemptions for the producers and derogations 

Article  7  of  the  Directive  provides  for  six  cases  of  exemptions  from  the  producer’s  strict 
liability, i.e. circumstances which exclude the producer’s liability in  the case of damages for 
defective products. In particular, the producer shall not be liable if he proves that: 

a) He did not put the product into circulation;41 

b) With  regard  to  the  circumstances,  it  is  probable  that  the  defect  which  caused  the 
damage did not exist at the time when the product was put into circulation by him or 
that this defect came into being afterwards;  

c)  The product was neither manufactured by him for sale  or any form  of distribution for 
economic  purpose  nor  manufactured  or  distributed  by  him  in  the  course  of  his 
business; 

d) The  defect  is  due  to  compliance  of  the  product  with  mandatory  regulations  issued  by 

the public authorities; 

e) The  state  of  scientific  and  technical  knowledge  at  the  time  when  he  put  the  product 
into circulation was not such as to enable the existence of the defect to be discovered 
– also known as the “development risk clause” or “development risk defence”, further 
discussed below; 

f)  The  defect  is  attributable  to  the  design  of  the  product  in  which  the  component  has 
been fitted or to the instructions given by the manufacturer of the product, in the case 
of a manufacturer of a component. 

Pursuant to Article 15§1(b), each Member State may derogate to Article 7(e), providing that 
the  producer  shall  be  liable  even  if  he  proves  that  the  state  of  scientific  and  technical 
knowledge  at  the  time  when  he  put  the  product  into  circulation  was  not  such  as  to  enable 
the existence of a defect to be discovered.  

iv.  Bottom and upper threshold 

Pursuant  to  the  definition  of  damage  as  per  Article  9,  the  damage  caused  by  the  defective 
product to an item of property other than the defective product itself shall be at least equal 
to €500, provided that the item of property: i) is of a type ordinarily intended for private use 
or  consumption;  and  ii)  was  used  by  the  injured  person  mainly  for  his  own  private  use  or 
consumption. 

In  addition  to  the  €500  threshold,  Member  States  may  provide  that  a  producer's  total 
liability  for  damage  resulting  from  death  or  personal  injury  shall  be  limited  to  an  amount 
which may not be less than €70 million. 

v.  Limitation and expiry period  

According  to  Article  10,  a  limitation  period  of  three  years  applies  to  proceedings  for  the 
recovery of damages caused by defective products. The plaintiff must start the proceedings 
within three years from the day when the plaintiff became aware, or should reasonably have 
become aware, of the damage, the defect and the identity of the producer. 

In addition, as provided for by Article 11 of the Directive, Member States shall provide that 
the rights conferred upon the injured person pursuant to this Directive shall be extinguished 

41 The notion of “put into circulation” has been clarified by the CJEU in C-127/04, where it has established that “a 
product  is  put  into  circulation  when  it  is  taken  out  of  the  manufacturing  process  operated  by  the  producer  and 
enters a marketing process in the form in which it is offered to the public in order to be used or consumed”. 

8 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

after  10  years  from  the  date  when  the  producer  put  the  defective  product  into  circulation, 
unless the injured person has in the meantime instituted proceedings against the producer. 

2.2.3  Stakeholders concerned 

The  Product  Liability  Directive  specifies  the  requirements  for  those  concerned  by  defective 
products and related damages, namely: 

  The injured person (Article 4), who can act as plaintiff for the recovery of the damages 
from the producer by proving the damage, the defect and the casual link between defect 
and damage;  

  The  producer  (Article  3(1)),  who  shall  be  strictly  liable  for  the  damages  caused  by 

defects in his products towards the injured person; 

  The  importer  (Article  3(2)),  who  is  any  person  who  imports  into  the  EU  a  product  for 
sale,  hire,  leasing  or  any  form  of  distribution  in  the  course  of  his  business.  Without 
prejudice to the liability of the producer, the importer shall be deemed to be a producer 
within the meaning of this Directive and shall be responsible as a producer; 

  The supplier (Article 3(3)), who distributes the products manufactured by producers. In 
case  the  producer  cannot  be  identified,  or  if  the  supplier  fails  to  comply  with  the 
obligation  of  communicating  to  the  injured  person  the  identity  of  the  producer  within  a 
reasonable time, he shall be treated as the producer of the defective product; 

  The EU Member States which are responsible for the implementation and enforcement 

of the Product Liability Directive; 

  The European Commission which should present a report to the European Parliament 
and to  the Council on the application of the Product Liability Directive and, if necessary, 
submit appropriate proposals relating to the Product Liability Directive.  

In addition to the above-mentioned actors, the Product Liability Directive also has an impact 
on the following stakeholders: 

  Technical experts acting in court, who may play a relevant role in the framing of the 
burden of proof upon the injured party, namely: proof of the defect, proof of the damage 
and  proof  of  the  causal  link  between  them.  Technical  experts  may  have  a  deeper 
knowledge  of  the  product  concerned,  and  hence  can  be  extremely  helpful  for  both 
consumers, on the  one hand, who may lack the necessary information on the products, 
and for producers, on the other hand, who shall not be deemed liable in case of lack  of 
the  above-mentioned  proof.  Thus,  technical  experts  play  a  role  in  the  possible 
information  asymmetry  between  the  Product  Liability  Directive’s  two  main  actors,  the 
producers and the consumers; 

  Insurers,  who  may  play  a  role  in  managing  the  risk  of  claims  for  product  liability, 
especially  for  producers  and  suppliers,  and  in  particular  with  regard  to  specific  kinds  of 
products, such as those relating to new technological developments. 

9 

 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

3  METHODOLOGY 

3.1  Evaluation questions and criteria 

The  assessment  of  the  Product  Liability  Directive  was  guided  by  37  evaluation  questions 
(EQs)  which  referred  to  the  five  evaluation  criteria:  effectiveness,  efficiency,  coherence, 
relevance and EU added value. The evaluation criteria were understood to mean:  

  Effectiveness: whether and to what extent the Product Liability Directive’s objectives in 
terms  of  the  protection  of  consumers,  undistorted  competition  and  free  movement  of 
goods have been achieved so far at both national and EU levels (EQs 1-20); 

  Efficiency: whether the Product Liability Directive has delivered its results proportionally 
in  terms  of  the  resources  used.  The  analysis  included  an  assessment  of  the  costs  as 
perceived and reported by stakeholders (EQs 21-25); 

  Coherence: whether the  Product Liability  Directive is consistent with other  relevant EU 
legislation and to what extent the divergences (if  any) prevent the achievements of the 
Product  Liability  Directive’s  overall  objectives.  The  analysis  also  included  identifying  the 
scope and nature of any overlaps and/or contradictions between different  MS legislation 
(EQs 26-27); 

  Relevance:  whether  the  objectives  of  the  Product  Liability  Directive  still  correspond  to 
current problems, needs and challenges. In particular, the study assessed to what extent 
its  scope  and  mechanisms  allowed  the  main  issues  arising  from  new  technological 
developments to be addressed (EQs 28-32); 

  EU added value: to what extent the results of the EU action are in addition to the value 

that would have resulted from action at Member-State level (EQs 33-37). 

Annex 1 lists the EQs that have been addressed in the study. Evaluation questions relating 
to  the  implementation  of  the  Product  Liability  Directive  have  been  addressed  in  chapter  4, 
while the other EQs have been addressed in chapter 5. 

3.2  Reconstruction of the intervention logic and development of evaluation grids 

3.2.1  The intervention logic of the Directive  

The  Product  Liability  Directive’s  intervention  logic  has  been  reconstructed  as  part  of  the 
methodological approach.  

The intervention logic presented in the figure below outlines the three main needs or drivers 
that  led  to  the  definition  of  the  three  strategic  objectives,  namely  the  protection  of 
consumer  health  and  property,  the  free  movement  of  goods,  and  undistorted  competition 
among market operators in the Single Market. These are disaggregated and complemented 
by  two  specific  objectives  that  represent  the  operational  orientations  of  the  measure.  To 
achieve the strategic and specific objectives, the Product Liability Directive provides a set of 
rules  which  are  a  prerequisite  for  its  implementation.  Such  provisions  were  expected  to 
produce a number of key outputs and results, and eventually to trigger a set of impacts. 
To  fully  understand  how  the  above  factors  interact  to  deliver  the  proposed  changes  over 
time,  the  intervention  logic  also  considers  external  factors  and  the  legislative  context  that 
may influence the Product Liability Directive’s performance. 

10 

 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Figure 1: Intervention logic of the Product Liability Directive 

11 

EQ26EQ27EQ21 -EQ25EXTERNAL FACTORSWidespreadmass-marketproduction–newtechnologicaldevelopments(i.e.software,Cloud,InternetofThings,advancedrobotsandautomatedsystems)-supplychainfragmentation–safetylegislation–contractualandextra-contractualliability–nationaljudicialsystemsLEGISLATIVE CONTEXTOther EU legislation on consumer protection, or new EC initiativesin the digital contextPLD COHERENCEPLD EFFICIENCYPLD RELEVANCEEQ1-EQ20PLD EFFECTIVENESSEQ33-EQ37PLD EU ADDED VALUEEQ28-EQ32•Clear rules for the consumer to claim compensation in case of damages for defective products•Harmonisation across EU MS with a common rule on strict liability of the producer for damages due to a defective productRESULTS•Overall consumer protection•Same degree of strict liability of producers for damage caused by a defective product •Establishment of a level playing field for businesses and of conditions for the free movement of products within the internal marketIMPACTS•Definitions(product,damageandproducers)•Strictliability•Burdenofproof(damageandrelationtodefect)•Exemptionsandderogations•Bottom-upandthresholds(€500,€70m)•Limitation(3years)andexpiryperiod(10years)RULES –PLD PROVISIONS•Right of consumers to claim damages suffered from a defective product•Having a common rule on strict liability of the producer for damages due to a defective productSPECIFIC OBJECTIVES•Protection of consumers’ health and property•Undistorted competition in the Single Market between market operators•Free movement of goods STRATEGIC OBJECTIVES•High degree of protection of EU consumers against damage caused by a defective product •Ensure the liability of producers for damage caused by a defective product •Ensure the free movement of goods without distortion of competitionNEEDS•Responsible actors are clearly identified•The provisions on burden of proof, bottom-ups and limitations may limit but do not exclude consumers from bringing a claimOUTPUTS 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

3.2.2  Evaluation grids 

The  approach  used  to  respond  to  the  EQs  has  been  defined  in  specific  evaluation  grids, 
presenting:  

  The judgment criteria used to specify the meaning of each evaluation question;  

  The  analytical  approach  used  to  answer  the  EQ,  given  the  judgment  criteria,  i.e.  the 

approach for collecting the relevant input and understanding the analysis;  

  The  indicators  used  to  evaluate  the  achieved  results  and  to  identify  potential 

shortcomings; 

  The sources of information, including primary sources (i.e. stakeholders) and secondary 

sources (i.e. existing documents, publications, reports). 

The evaluation grids are presented in Annex 2. 

3.3 

 The data collection approach 

The tools and techniques adopted to gather information included both desk and field research. 
These are briefly described below.  

3.3.1  Desk research 

The  desk  research  focused  on  collecting  relevant  data  and  information  from  existing 
documents and legislative texts at international, EU and national level. They were identified by 
means of an Internet search. More specifically, the desk research covered: 

  EU and national case law relating to the Product Liability Directive; 

  The national legislation transposing the Product Liability Directive in the 28 Member States; 

  EU  legislation  relevant  to  safety  and  consumer  protection  (e.g.  sector-specific  safety 
legislation  and  the  General  Product  Safety  Directive,  the  Directive  on  Consumers’  rights, 
and the Sales and Guarantees Directive);  

  Literature relevant to the Product Liability Directive, its policy context and the main issues 

relating to its implementation. 

Please  refer  to  Annex  10  for  a  complete  overview  of  the  sources  used  during  the  desk 
research. 

Information  on  national  case  law  and  the  national  transposition  of  the  Product  Liability 
Directive was gathered through a specific questionnaire (see Annex 7).  

3.3.2  Field research 

The field research used a combination of tools, namely: 

  An  open  public  consultation  aimed  at  collecting  stakeholders’  feedback  on  the 
application  and  performance  of  the  Product  Liability  Directive  on  liability  for  defective 
products;  

  A  targeted  survey  aimed  at  collecting  specific  stakeholders'  feedback  on  the  application 
and  performance  of  the  Product  Liability  Directive.  Annex  3  presents  the  targeted  survey 
questionnaires; 

  A  CATI42  survey  aimed  at  collecting  feedback  on  the  experience  of  producers,  importers 
and  suppliers  with  the  Product  Liability  Directive.  Annex  5  presents  the  CATI 
questionnaires;  

42 Computer-assisted telephone interviewing (CATI) is a telephone survey technique in which the interviewer follows a 
script provided by a software application. 

12 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

  Telephone  interviews  aimed  at  collecting  qualitative  feedback  and  discussing  in  depth 
the  issues/topics  which  emerged  during  the  desk  research.  The  interview  questionnaire  is 
presented in Annex 5. 

Altogether, 657 stakeholders replied, covering 25 Member States, with the exception of 
Latvia,  Portugal  and  Slovenia.  All  target  groups  (producers,  consumers,  insurers,  public 
authorities  and  civil  society,  including  lawyers  and  think-thanks)  with  the  exception  of 
technical experts acting in court, contributed to the consultation by means of the various 
tools.  A  few  stakeholders  participated  in  both  the  targeted  survey  and  the  interviews.  The 
tables  below  summarise  the  scope  and  the  number  of  stakeholders  consulted  during  each 
activity and their distribution per country.  

Table 1: Consultation activities, scope and number of stakeholders involved  

Stakeholder category 

Consultation activity 

Open Public 
Consultation 

Targeted 
survey 

CATI 

Interviews 

Total 

and 

Businesses 
related 
associations 
(including SMEs) 

Consumer 
associations 
Insurers’ 
associations 
Public authorities 
and civil society  
Technical experts  
Total 

40 

48 

N/A 

25 

N/A 
113 

4 

11 

0 

11 

0 
26 

457 

0 

0 

0 

0 
457 

17 

11 

9 

24 

0 
61 

518 

70 

9 

60 

0 
657 

Table 2: Number of stakeholders per Member State and consultation activity 

100

90

80

70

60

50

40

30

20

10

0

T
A

E
B

G
B

Y
C

Z
C

E
D

K
D

E
E

L
E

S
E

I
F

R
F

R
H

U I
E
H

T
I

T
L

U
L

V
L

T
M

L
N

L
P

T
P

O
R

I

E S
S

K
S

K
U

U
E

r
e
h
t
O

OPC (113)

TS (26)

CATI (457)

INTERVIEWS (61)

In  addition,  the  team  participated  in  a  Conference    on  the  Product  Liability  Directive  on  20 
October  2017,  in  Brussels,  BE,  organised  by  the  Commission    to  check  with  the  different 

13 

 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

categories  of  stakeholders  and  public  authorities  the  preliminary  results  on  the  Study  related 
to the evaluation of the Directive.43  

The  results  of  the  OPC  on  Building  a  European  Data  Economy  initiative44  were 
considered where relevant to the evaluation questions.  

Finally, the team took part in four workshops which provided inputs for the study, namely: 

  Workshop with the Member States  on the emerging issues of the data economy  follow-up 
to the Communication ‘Building a European Data Economy’, 31 May 2017, Brussels, BE; 

  Product Liability Forum Seminar on reviewing the Product Liability Directive, 14 June 2017, 

London, UK; 

  The  23rd  Annual  Common  Core  of  European  private  law,  hosted  by  Collegio  Carlo  Alberto, 
University  of  Torino,  and  the  International  University  College  of  Turin,  on  6,  7  and  8  July 
2017, Turin, IT; 

  Workshop  on  ‘Liability  in  the  area  of  Autonomous  Systems  and  Advanced  Robots/IoT-

Systems’, 13 July 2017, Brussels, BE. 

The synopsis report in Annex 2 provides more details on the consultation activities. 

3.4  Limitations and mitigation measures 

Table  3  presents  an  overview  of  the  problems  encountered  and  the  mitigation  measures 
adopted. 

The reliability of data collected through desk and field research is limited by the following: 

  Data  from  the  desk  research  at  national  level:  in  each  single  Member  State,  not  all  the 

cases relating to the Product Liability Directive are published and thus available; 

  For claims settled out of court no documentation is publicly available; 

  Data from the field research have been affected  by the low number of respondents to the 

open public consultation and targeted survey. 

Activity 

Challenge/issue 

Mitigating measure  

Table 3: Key challenges and mitigation measures 

Desk research  Low 

availability/reliability  of 
data  on  national  case 
law 

Low  availability  on  out-
of-court settlements 

level.  Such 

The number of cases resolved judicially in the 28 Member 
States  was  retrieved  from  country  fiches  filled  through 
desk  research  at  national 
information, 
however, should be  treated  with  caution  as  each  country 
fiche  was  completed  on the basis of the  specific features 
of national jurisdiction and the public databases available. 
For  instance,  the  French  country  fiche  reports  cases 
retrieved  through  the  main  public  legal  databases,  in 
which  the 
listed. 
Therefore,  the  analysis  for  France  is  limited  to  the 
decisions of the courts of  appeal  and the  Supreme  Court 
between  1  January  2000  and  31  December  2016.  As 
these  cases  were  retrieved  from  commercial  and  public 
databases of case law which rarely report all cases, it may 
be  assumed  that  this  figure  underestimates  the  real 
dimension  of  claims  based  on  product  liability  rules  in 
Europe  (for  instance,  no  published  cases  were  reported 

instance  decisions  are  not 

first 

43 See Minutes of the Product Liability Conference at https://ec.europa.eu/docsroom/documents/26661 
44 https://ec.europa.eu/digital-single-market/en/news/public-consultation-building-european-data-economy.  

14 

 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Activity 

Challenge/issue 

Mitigating measure  

for  Malta,  although  the  targeted  survey  has  shown  that 
product  liability  cases  are  often  decided  in  the  country’s 
small claims courts). 

The  availability  of  out-of-court  settlements,  including 
arbitration  awards,  mediation  and  direct  negotiations  are 
either  confidential  or  not  provided  in  official  databases. 
Hence, the data have been retrieved only on the basis of 
the available information for each Member State. 

  Extension  of  the  deadline  for  answering  the  targeted 

survey until 20 May 2017; 

  Solicitation  of  stakeholders  via 

rounds  of 
reminders, through  which  they  were asked  to explicitly 
indicate  their  unwillingness  to  participate 
in  the 
survey/interviews; 

four 

of 

  Involvement 

the  EY  network 

country 
correspondents active in all EU Member States, to invite 
and  solicit  any  entity  or  individual  to  participate  in  the 
targeted survey/interviews; 

of 

  Activation  of  the  EY  Business  Development  Units 
responsible  for some  relevant  industries (i.e.  consumer 
products  and  retail,  technology,  financial  services  and 
government) to activate their contacts to be involved in 
the survey/interviews; 

  Despite  these  efforts,  the  rate  of  response  to  the 
targeted  surveys  continued  to  be  poor.  Collected  data 
have  been  validated/triangulated through  the  literature 
and the interviews. 

The  costs  and  benefits  could  only  be  qualitatively 
evaluated.  The  Product  Liability  Directive’s  provisions 
were  mapped  and  discussions  developed  on  whether, 
compared to the situation previous to its entry into force 
(i.e.  in  the  absence  of  it),  these  provisions  entail  a  cost 
rather than a benefit for the relevant stakeholders.  

All  elements  provided  by  stakeholders  were  used  for  the 
quantification of costs and benefits, where possible.  

Moreover, 
to  provide 
three  cases  were  analysed 
quantitative  examples  of  the  costs  placed  on  producers 
and consumers due to the Product Liability Directive.  

However,  the  limited  amount  of  information  provided  on 
this  aspect  did  not  allow  a  proper  and  reliable 
quantification of costs and benefits to be made.  

Moreover, the lack of an impact assessment did not allow 
for a baseline scenario to be used that would have helped 
to quantify (and compare) costs and benefits. 

An analysis of each piece of safety legislation was carried 
out  to  identify  the  exact  moment  they  can  apply.  This 
enabled  the  possible  interactions  between  the  Product 
Liability  Directive  and  the  safety  legislation  to  be 
understood. However, conclusions could not be drawn on 
the  role  of  the  Product  Liability  Directive  in  enhancing 
product safety.  

15 

Targeted 
survey/ 
interviews 

the 

  Low  rate  of  response 
to 
targeted 
surveys.  The  survey 
to  more 
was  sent 
than 
400 
stakeholders, but only 
26  complete  answers 
were received 
  Stakeholders’ 
reluctance 
involved 
interviews 

be 
the 

to 

in 

Evaluation of 
Product 
Liability 
Directive 
efficiency 

Although  data  on  costs 
the 
and  benefits  of 
Product 
Liability 
Directive  should  have 
been  retrieved  through 
targeted  survey, 
the 
the  poor  response  rate 
hampered  the  proper 
quantification  of  these 
variables 

Analysis of 
the 
relationship 
between the 
Product 
Liability 
Directive and 
the safety 
legislation  

The  concept  of  defect 
provided  in  the  Product 
Liability  Directive 
is 
strictly  relating  to  the 
concept  of  safety.  It  is 
challenging  to  draw  the 
connection between the 
“expected safety” under 
the  Product  Liability 
Directive and the safety 
required  by  the  safety 
legislation, both general 
and sectorial. 

 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

4  IMPLEMENTATION – LEGAL ANALYSIS AND STATE OF PLAY45 

This  chapter  briefly  reports  on  the  legislation  transposing  and  concurring  with  the  Product 
Liability  Directive.  This  is  followed  by  an  updated  overview  of  the  current  state  of 
implementation of the  Product Liability Directive in each Member State, with specific focus on 
the issues raised by the evaluation questions. 

4.1  Legislation transposing the Directive 

All  Member  States  have  transposed  the  Product  Liability  Directive  into  their  legislation 
(finding 1). Five Member States (ES, LU, HUFI, and FR) have adopted the derogation 
under  Article  15  §1(b)  of  the  Product  Liability  Directive,  thereby  regulating  that  the 
producer shall be liable even if he proves that the state of scientific and technical knowledge at 
the  time  he  puts  the  product  into  circulation  was  not  such  as  to  enable  the  existence  of  a 
defect to be discovered (finding 2). However, the derogation has not been transposed 
uniformly across the fove Member States, with two Member States (LU and FI) having 
adopted  it  without  limitations,  thereby  applying  to  all  categories  of  producers  and 
products,46 and the other three excluding some categories of producers and products: 
in Hungary, the derogation does not apply to  medical products; in Spain, it does not apply to 
medical  and  food  products;  in  France,  it  does  not  apply  when  the  damage  is  caused  by  an 
element of the human body or by products derived therefrom.47  

When  transposing  the  Directive,  seven  Member  States  (EE,  EL,  HR,  LT,  LU,  MT  and  FI)  have 
not  introduced  any  measures,  procedures  or  burden  for  the  application  of  the  Directive  in 
addition to those expressly provided for therein (finding 3). The other Member States have 
introduced some provisions to clarify certain concepts of the Directive: 

  Four  Member  States  have  introduced  a  criterion  to  determine  when  a  product  is  “put  into 

circulation” (BE, CZ, CY, FR and AT); 

  Six  Member  States  have  set  the  “reasonable  time”  by  which  the  supplier  of  the  product 
must  inform  the  injured  person  of  the  identity  of  the  producer  or  of  the  person  who 
supplied him with the product where the producer of the product cannot be identified, so as 
not to be treated as its producer (ES, IT, FR, HU, PL, PT and SE); 

  Other  Member  States  have  introduced  additional  provisions  to  clarify  issues  potentially 
raised  by  transposing  the  Product  Liability  Directive.  Germany  specified  the  nature  of 
damages  that  can  be  indemnified,  while  the  Netherlands  specified  the  term  for  recourse 
against  the  producer  held  liable  for  a  defect.  Romania  extended  the  definition  of  the 
producer  to  any  person  who  imports  from  another  Member  State  into  Romania  a  product 
for sale, hire, lease or any form of distribution in the course of his business (finding 4); 

  Some  Member  States  have  transposed  Article  9  of  the  Product  Liability  Directive 
interpreting the sum of €500 as a threshold, whereas others (DE, ES, FR, NL) transposed it 

45 This chapter provides answers to the EQs under the “effectiveness” criterion that are mainly descriptive, i.e. EQs 8-
20, with the exception of EQ13. In this chapter, the evidences worth to be used for the evaluation are referred to as 
“findings” and used and cross referenced to answer the EQs in chapter 5. 
46 In LU, the legislator does not make any distinction, therefore the producer can invoke the  development risk clause 
for any products, regardless of  their nature. In FI, according to the  government text regarding the enactment of the 
Product Liability Act and the implementation of the Product Liability Directive, the extent of the derogation has yet to 
be explicitly defined so it should be interpreted as applying to all products according to the Product Liability Directive. 
47 The Hungarian Civil Code states that the producer of any medical products is liable even if the state of scientific and 
technical  knowledge  at  the  time  the  product  was  put  into  circulation  was  not  such  as  to  enable  detection  of  the 
existence  of  the  defect.  Along  the  same  lines,  the  Spanish  Royal  Legislative  Decree  1/2007  of  16  November  2007 
states  that  producers  of  medicinal  products,  foods  or  foodstuffs  intended  for  human  consumption  cannot  invoke  the 
exemption provided under Article 15 §1(b) of the Directive. According to article 1245-11 of the French Civil Code, the 
producer may not invoke this exonerating circumstance when the damage is caused by an element of the human body 
or by products derived therefrom. 

16 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

as a deductible, i.e. as a sum to be deducted from the compensable damage (Machnikowski 
2016). 

4.2  Legislation concurring with transposition of the Directive  

Overall, 18 Member States48 do not have any type of extra-contractual liability in place 
to  protect  consumers  from  damages  caused  specifically  by  defects  in  either  intangibles  (e.g. 
software),  or services (finding 5).49 On the contrary, nine Member States (DE, EE, EL, FR, 
LT,  MT,  NL,  SI,  SK)  ensure  an  extra-contractual  liability  to  protect  consumers  from  damages 
caused by defects in both intangibles (e.g. software) and services (finding 6). 

A distinction can be made between these Member States. 

In  some  (DE,  EE,  MT,  NL,  SI,  SK)  the  protection  of  consumers  from  damages  caused  by 
defects  of  either intangibles or services  stems from  general  rules, normally tort law: in these 
cases, protection essentially stems from the interpretation of general rules to include services 
or intangibles (finding 7). 

In two Member States  (EL  and LT), the rules  set  out in the Directive are  stretched to  ensure 
strict liability for services and intangibles, too ( finding 8). 

In  Greece,  scholars  interpret  Article  6  of  Law  2251/1994  (transposing  the  Directive)  as 
allowing  the  liability  to  be  extended  to  damages  caused  by  intangibles  or  services,  provided 
that  such  services  are  strictly  relating  to  the  products.  In  that  case,  all  those  involved50  are 
potentially liable. However, to date, no court cases have been registered which provide for the 
application of the Directive to services/intangibles. 

In  Lithuania,  Articles  6.292-6.300  of  the  Civil  Code  regulate  not  only  the  liability  for 
compensation for damage caused by defective products, but also by defective services. For the 
purpose  of  this  piece  of  legislation,  the  term  “service”  refers  to  activities  that  meet  users’ 
specific  tangible  or  intangible  needs,  with  the  exception  of  health  care,  legal,  educational, 
thermal  energy,  gas,  water  supply,  sewage  disposal  and  transport  services.  Through  this,  all 
the Directive’s rules apply to such services, too. 

Finally,  in  France,  liability  depends  on  both  the  application  of  general  rules  on  tort  law,  as  is 
the  case  for  the  Member  States  in  the  first  group,  and  specific  sectorial  rules:  for  instance, 
Article L.1142-1 of the Public Health Code provides for the strict liability of health professionals 
(finding 9). The French regime has already been scrutinised by the CJEU, which has stated 
that  Member  States  may  provide  for  the  liability  of  a  service  provider,  on  condition  that  the 
same service provider has a right to recourse against the producer when the producer is liable 
under  the  Directive,  as  one  objective  of  the  Directive  is  to  avoid  Member  States  creating 
legislative spaces where producers can benefit from a liability-free regime (CJEU C-495/10). 

4.3  Systems used to settle the claims for damages caused by defective products  

EQ  8/12  What  are  the  systems  used  to  settle  the  claims  by  injured  persons  from  damages  caused  by 
defective products? 

The  systems  used  to  settle  the  claims  by  injured  persons  for  damages  caused  by  defective 
products are those normally available for claims based on private law in the different  national 
legal systems. Amongst those, the most common is direct negotiation. 

As for the first step to seek compensation, consumers contact: 

  The producer/manufacturer/supplier/retail shop in around 12% of cases;  

48 BE, BG, CZ, DK, IE, ES, HR, IT, CY, LV, LU, HU, AT, PL, PT, RO, SE, UK. Information not available for FI.  
49 According to data provided by the country correspondents. 
50  i.e.  the  manufacturer  of  a  finished  product,  the  producer  of  any  raw  material,  the  manufacturer  of  a  component 
part, the person presenting himself as the producer by putting his distinguishing feature on a product, the importer, 
the  supplier,  the  software  developer,  the  software  owner,  the  software  licence  distributor,  the  service  provider,  the 
subcontractor of the service provider. 

17 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

  A lawyer/consumer association in around 8% of cases.51 

These data were confirmed by producers who stated that they were contacted directly by the 
consumers who incurred the damage in around 10% of the cases.52  

As  for  the  systems  to  settle  claims  for  damages  caused  by  defective  products,  the 
Directive does not give any indications. Consequently, consumers can pursue the recovery 
of  damages  based  on  product  liability  either  through  direct  negotiation  with  the  person  or 
entity  held liable,  alternative  dispute  resolution  methods  (such  as  mediation  and  arbitration), 
or litigation in court.53  

Based  on  the  desk  research,  and  as  shown  in  Figure  2,  the  parties  settle  Directive-related 
claims through direct negotiation in 46% of the cases, whereas 32% are resolved in court and 
15%  through  alternative  dispute  resolution  systems.  Only  a  small  share  (7%)  of  the  claims 
under  the  Directive  are  settled  through  other  means,  such  as  settlements  with  the insurer  of 
the responsible entity (finding 10)54.  

Figure 2: Systems used to settle the claims, EU-28 average percentage 

If data are broken down per Member State, 60% or more of the claims are settled: 

Source: EY elaboration of desk research at national level 

 

In court (in EE, FR, PL, RO, FI); 

  Through  alternative  dispute  resolution  mechanisms,  such  as  arbitration,  mediation, 
negotiation,  conciliation  or  other  mechanisms  provided  for  by  national  legislation  (in  BG, 
EL, LT); 

  Through direct negotiation (in CZ, HR, IT, HU, IT, CY, PT, SE); 

  Through settlement with the insurer (in SI). 

This evidence is confirmed by data gathered from consumers and producers responding to the 
OPC.  All  categories  of  stakeholders55  indicated  that  extra-judicial  arrangements  represent  a 
common way to settle cases, and that most cases are settled out of court.56  

reply 

51  Source:  OPC.  80%  of  Consumers  did  not 
(n=38  out  of  48).  Those  who  did  answer 
producer/manufacturer/supplier/retail shop in most of the cases (n=6 out of 48), and a lawyer/consumer association 
in around 8% in the others (n=4 out of 48). 
52 OPC feedback: four out of 40. 78% of producers did not reply (n=31 out of 40). 
53  The  desk  research  at  national  level  and  other  data-collection  tools  have  not  allowed  the  team  to  identify  official 
sources and public data specifically reporting on the settlement of cases falling within the scope of the Directive. 
54 Averages based on the answers from 28 Member States. 
55 Around 60% of Consumers responding to the specific questions in the OPC (n=6) replied that they were not involved 
in a judicial proceeding to claim compensation for a damage caused by a defective product, whilst the remaining 40% 
(n=4) were involved in a judicial proceeding. 38 consumers  did not reply to the specific question (“Did you launch a 
judicial proceeding against the producer to obtain compensation for damage caused by a defective product?”). 66.7% 
(n=6  out  of  9  respondents)  of  producers  providing  a  response  answered  that  they  had  received  claims  for 

18 

0%5%10%15%20%25%30%35%40%45%50%In courtThrough ADRThrough directnegotiationOther 
 
                                                 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

The prevalence  of out-of-court settlements is also confirmed by some interviewees57 and 
from  the  results  of  the  CATI  survey,  according  to  which  most  claims  are  settled  out  of 
court58. There is no significant difference when firms are broken down by size.  

Finally,  as  for  compensation,  most  producers  have  a  general  insurance  contract 
covering  different  risks,  including  the  cost  of  compensation  in  case  of  defective 
products.  Only  a  small  share59  have  a  specific  insurance  contract  covering  the  risks 
relating to Directive (finding 11).60  

4.4  Products at cause for the purpose of recovery of damages and types of defects  

EQ 9 Which products have been most frequently at cause for the purpose of recovery of damages? 

EQ 10. Which types of defects have been most frequently detected in those products? 

All  types  of  products  have  been  at  cause  for  the  recovery  of  damages  under  the  product 
liability rules. However, four product categories are prevalent, recurring in 64% of the cases: 
raw materials, pharmaceutical products, vehicles, and machineries and mechanical appliances.  

It is not possible to track recurrent types of defects. 

The analysis of the cases at national level allows the products at stake to be identified using 
the combined nomenclature61 in 547 cases. Table 4 shows that raw materials represent 21.2% 
of  products  at  stake,  followed  by  pharmaceutical  products  (16.1%),  vehicles62  (15.2%)  and 
machinery63 (12.4%). Each of the other product categories64 does not exceed 8% of the cases. 
It  is  to  be  noted  that  the  categories  of  raw  materials  and  machinery  are  extremely 
heterogeneous and, thus, include a wide range of different products.65 

Table 4: Recurrence of product categories subject to claims in national case law from 2000-
2016 

Product categories 

Raw materials 

Pharmaceutical products 

Vehicles 

Total 

116 

88 

83 

% 

21.2% 

16.1% 

15.2% 

compensation regarding damages caused by defective products and that the claimant obtained compensation though 
an  extra-judicial  arrangement.  31  out  of  40  of  producers  responding  to  the  OPC  did  not  provide  an  answer  to  the 
question,  and  did  not  indicate  whether  compensation  was  paid  on  the  basis  of  an  extra-judicial  or  a  judicial 
arrangement.  In  addition,  78%  (n=7)  of  producers  responding  to  the  question  “Did  you  go  through  a judicial 
proceeding  to  defend  your  activity  from  the  claim  of  a  damage  caused  by  a  defective  product?”  answered  in  the 
negative. 
56 For instance, 71.4% (n=14) of Pas responding to the OPC indicated that damaged parties have been compensated 
either “rarely” or “never” through a judicial decision (11 respondents did not answer this question). 
57 For instance, IT representatives from legal experts and from large producers. 
58 As stated by 53% of respondents, n=132. 
59 OPC feedback: 13% (n=5 out of 40) of Producers. 
60  OPC  feedback:  58%  (n=23  out  of  40)  of  Producers.  Based  on  the  CATI  survey,  57%  (n=262  out  of  457)  of 
enterprises have a general insurance covering different risks, 22% (n=100 out of 457) of enterprises have a specific 
insurance for strict liability, and 21% (n=95 out of 457) are not covered by any insurance contract. 
61 
is 
https://ec.europa.eu/taxation_customs/business/calculation-customs-duties/what-is-common-customs-
tariff/combined-nomenclature_en). 
62 Vehicles (railway/tramway locomotives, ships, boats and others). 
63 Nuclear reactors, boilers, machinery and mechanical appliances; parts thereof.  
64  Miscellaneous  manufactured  articles;  chemicals;  agricultural  goods;  electrical  machinery  and  equipment  and  parts 
thereof;  sound  recorders  and  reproducers,  television  image  and  sound  recorders  and  reproducers,  and  parts  and 
accessories of such articles; foods & beverages; clothing and accessories; cosmetics.  
65 The products identified in the raw materials category range from rubber pneumatic types to articles made from fur 
skin, from fuel wood and coal to gypsum and plasters.  The products identified in the machinery category range from 
engines  and  motors  to  pumps,  from  air-conditioning  machines  to  burners,  from  refrigerators  and  freezers  to 
centrifuges, from dishwashing machines to lifts, from knitting machines to washing machines, from automatic goods-
vending machines to taps, cocks, valves and similar appliances. 

nomenclature 

classifying 

combined 

products 

(see 

tool 

The 

for 

a 

19 

 
                                                                                                                                                                  
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Product categories 

Nuclear reactors, boilers, machinery and mechanical appliances; parts thereof 

Miscellaneous manufactured articles 

Chemicals 

Agricultural goods 

Electrical machinery and equipment and others 

Foods & beverages 

Clothing and accessories 

Cosmetics 

Total 

Total 

% 

68 

44 

40 

38 

33 

16 

11 

10 

12.4% 

8.0% 

7.3% 

6.9% 

6.0% 

2.9% 

2.0% 

1.8% 

547 

100% 

Source: EY elaboration of desk research at national level 

Even when looking at categories of defective products per Member State (see  Figure 3), there 
appears to be no clear pattern or specific product category which is particularly the subject of 
claims in specific Member States. 

Figure 3: Breakdown of product category causes of claims per Member States from 2000-2016 

Source: EY elaboration of desk research at national level 

The analysis of case law and specifically of the CJEU judgments show a different distribution of 
cases across different categories of products, with a peak for pharmaceutical products and 
medical  devices:  67%  of  the  CJEU  decisions  concern  pharmaceutical  products  and  medical 
devices,66 17% electrical machinery,67 8% food and beverages, and 8% vehicles.68 As for the 
types of defect, evidence from both the desk and field research does not allow any recurrent 
types  of  defect  to  be  tracked  (finding  12).  Indeed,  the  wide  variety  of  products  at  cause 
appear to make it impossible to track  some patterns in defects. To understand  the  variety  of 
possible  defects,  cases  brought  before  the  CJEU  can  be  considered:  for  instance,  CJEU  cases 

66 The CJEU case law related to pharmaceutical products refers to a defective profusion fluid used in kidney transplants 
(CJEU C-203/99), infected blood for transfusion (CJEU C-183/00), vaccines (CJEU C-127/04, C-358/08 and C-621/15) 
and  insulin  (CJEU  C-310/13).  For  medical  devices,  the  EU case  law refers  to pacemakers  and  defibrillators  (CJEU  C-
503/13) and to a heated mattress (CJEU C-495/10). 
67 Electrical machinery and equipment and parts thereof; sound recorders and reproducers, television image and sound 
recorders and reproducers, and parts and accessories of such articles.  
68 Based on a total of 12 CJEU case law decisions.  

20 

0102030405060ATBEBGCYCZDEDKEEELESFIFRHRHUIEITLTLULVNLPLPTROSESISKUKVehiclesRaw materialsPharmaceutical productsNuclear reactors, boilers, machinery and mechanical appliances; parts thereofMiscellaneous manufactured articlesFoods & beveragesElectrical machinery and equipment and othersCosmeticsClothing and accessoriesChemicalsAgricultural goods 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

concerning  pharmaceutical  products  and  medical  devices  range  from  one  relating  to  a 
profusion fluid used in kidney transplants, to blood for transfusion infected by the  hepatitis C 
virus,  poorly  identified  defects  in  vaccines,  a  medication  causing  lipoatrophy  (the  loss  of 
subcutaneous fat tissue at injection sites), and battery depletion causing a pacemaker to stop 
prematurely. The responses to the OPC in this respect also refer to a wide variety of possible 
defects,  strongly  connected  to  the  nature  of  the  product  at  cause  (ranging  from  glass 
kitchenware that breaks with normal use to embedded software not updating, from a sole not 
well glued to the rest of the shoe, to causing teratogenicity to the foetus. 

4.5  Type of damages  

EQ  11  Which  type  of  damages  (personal  injuries  or  property)  have  been  more  often  the  object  of 
recovery? 

Compensation  is  sought  for  both  types  of  damages  expressly  provided  for  in  the  Directive 
(relating  to  either  personal  injuries  or  property),  but  claimants  also  seek  compensation  for 
other types of damages, such as loss of profit and moral damage. 

Analysis  of  the  frequency  of  the  type  of  damages  subjected  to  claims  is  somewhat 
complicated.69  

The  CJEU  made  it  clear  that  Member  States  cannot  restrict  the  types  of  material  damage 
resulting  from  death  or  from  personal  injury  or  from  damage  to  or  destruction  of  an  item  of 
property  which  are  to  be  compensated,  provided  that  the  item  of  property  is  intended  for 
private use and the damage exceeds €500. This principle does not seem to be under discussion 
in Member States (CJEU C-203/99).  

The  desk  research  shows  that  claimants  more  often  seek  compensation  in  court  for 
damages  to  physical  well-being  (finding  13).  This  was  also  confirmed  by  the 
stakeholders consulted who declared that the damages suffered tend to concern physical well-
being more than items of property.70 

The  evidence  is  clear  as  to  the  context  in  which  consumers  tends  to  suffer  damages  that  fall 
under the scope of the product liability rules: according to the outcomes of both the desk and 
field research, consumers incur damages mostly at home, during social activities, and in 
a medical environment (finding 14). 

4.6  Cases brought to the courts and level of success 

4.6.1  Number of cases brought to court and types of issues 

EQ 14 How many cases have been brought to the courts on the applicability of the Directive?  Which was 
the issue in question and the ruling? 

From 2000 to 2016, at least 798 claims based on product liability rules were brought to court 
in the EU. The product at stake usually originates from the Member State where the claim was 
brought  and  the  defendant  was,  in  most  cases,  the  manufacturer  of  a  finished  product. 
Sometimes  claimants  invoke  the  national  law  implementing  the  Directive,  but  courts  allow 
compensation  on  a  legal  basis  other  than  the  Directive:  these  represent  20%  of  the  cases  in 
which the Directive is invoked. 

At least 798 claims based on product liability rules were brought to court across all 28 Member 
States from 2000 to 2016 (finding 15). The number of claims brought to court each year in 
the  EU  has  nearly  doubled  over  that  period:  while  it  was  30  in  2000,  in  2016  it  reached  59 

69  To  the  question  “Based  on  your  experience,  can  you  provide  an  estimation  of  the  relative  frequency  (in%)  of  the 
types of damages claimed?” 68% of the respondents said “no” against 32% who said “yes” (n=25). 
70 OPC feedback: physical well-being was indicated in 9% of overall responses (eight out of  88), and property in 3% 
(three  out  of  88)  of  overall  responses.  There  is  also  a  significant  rate  of  response  of  “other”  (9%,  eight  out  of  88), 
although the vast majority did not give an answer (78%, 69 out of 88). 

21 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

(finding  16).  In  particular,  it  can  be  pointed  out  that  the  2004  entrants  led  initially  to  a 
significant increase in claims, which stabilised later (see Figure 4).  

Figure 4: Number of claims per year, adjusted per new Member State entries 

Source: EY elaboration of desk research at national level 

According to data gathered at national level over the period 2000-2016, on average across all 
the  Member  States  the  majority  of  claims  (81%)  reported  concerned  a  product 
originating in the same Member State as where the claim was brought (finding 17). 
Only  3%  of  the  cases  concerned  products  originating  from  another  Member  State,  with  0% 
involving  products  from  third  countries.71  In  the  majority  of  cases,  the  producer  sued  was 
the manufacturer of a finished product, although a significant role was also played by 
suppliers and importers (finding 18): as shown in  

Figure  5,  they  were  brought  to  court  almost  half  as  many  times  as  the  manufacturers  of 
finished products. 

Figure 5: Number of times producers were brought to court from 2000 to 2016 

Source: EY elaboration on desk research at national level 

Based  on  the  results  of  the  desk  research  at  national  level,  it  also  appears  that  claimants 
sometimes invoked the national law implementing the Directive as  main law, but the courts 
allowed  for  compensation  on  a  different  legal  basis,  either  tort  or  contract  law,  in 
around 20% of the cases72 (finding 19). In those cases, on average, the legislation allowing 
the injured persons to raise a claim was contract law in 68% of the cases, general tort law in 
21%  of  the  cases,  similar  legislation  to  that  implementing  the  Directive  in  7%  of  the  cases, 
specific legislation in 3% of the cases, and another legislation in 1% of the cases.  

71 16% of country correspondents declared that the information is not available. 
72 This occurred in 14 Member States for which information was available (BE, BG, DE, IE, EL, FR, IT, LT, HU, NL, AT, 
PT, FI, UK) but is particularly prevalent in three Member States: two-thirds of these cases are concentrated in DE, EL 
and FR. 

22 

302933333244465041394246453036464201225875776696542224297987010203040506020002001200220032004200520062007200820092010201120122013201420152016EU172004 entriesBG and ROHR0510152025303520002001200220032004200520062007200820092010201120122013201420152016The manufacturer of a finished productThe producer of any raw materialThe manufacturer of a component partThe person who, by putting his name, trademark, or other distinguishing feature on the product, presents himself as the producerThe importerThe supplier 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

For  more  detailed  information  on  the  products  and  damages  that  are  the  subject  of  claims, 
please refer to sections 4.3 and 4.4 above; for the reasons for rejecting claims, please refer to 
section 4.7 below.  

4.6.2  Number  of  judicial  cases  in  which  the  claimant  was  successful  in  obtaining 

compensation  

EQ 16 In general, have the claimants been successful in the litigation? 

Around 60% (476 out of 798) of the claims for defective products were successful from 2000 
to 2016. 

Based on the results of the desk research at national level, around 60% (476 out of 798) of 
the  claims  regarding  defective  products  were  successful  during  the  period  2000-2016 
(finding  20).73  The  field  research  seems  to  confirm  the  fact  that  consumers  are  generally 
successful, as on average 75% of the respondents to the CATI survey stated that 0% of the 
claims had been resolved in favour of businesses.  

There is no particular difference in the level of success of injured parties if the case is settled in 
rather than out of court.74 

4.7  Difficulties encountered by consumers when obtaining compensation  

EQ  15  In  the  judicial  cases,  what  have  been  the  most  frequent  difficulties  encountered  by  consumers 
when  obtaining  compensation,  in  particular  during  the  last  five  years?  The  identification  of  the  defect? 
The establishment of the causal link between damage and defect? The threshold of €500? The allocation 
of the liability among the economic players? Other? 

The most frequent reason for rejecting a claim for a defective product concerns the burden of 
proof,  and  specifically  the  proof  of  the  defect  and  of  the  link  between  defect  and  damage. 
These  two  instances  together  account  for  53%  of  the  rejected  cases.  The  burden  of  proof  is 
particularly difficult in the medical/pharmaceutical sector.  

Based  on  the  desk  research  at  national  level,  the  most  frequent  reason  for  rejecting  a 
claim  for  defective  product  is  relating  to  the  burden  of  proof,  and  specifically  to:  (i) 
prove  the  defect  (32%  of  the  cases);  and  (ii)  prove  the  link  between  the  defect  and  the 
damage (21% of the cases). These two instances together comprise 53% of the rejected cases 
(finding  21).  The  causes  of  rejection  connected  to  liability  exemptions  for  the 
producer appear to be the least frequent (overall representing 10% of the cases). Among 
these,  the  most  recurring  liability  exemption  is  the  development  risk  clause  (4%  of 
the cases). Other frequent reasons for rejection are expiry of the three-year period (4%), the 
fact that the injured person did not use the product mainly for private use/consumption, and 
that the damage caused was also the fault of the injured person (each at 7%) (finding 22). 
Figure 6 shows the total number of cases rejected and the related reasons. 

Figure 6: Reasons for rejecting a claim, EU-28 

73  However,  it  seems  that  the  court  rarely  specifies  compensation  equal  to  the  amount  that  was  claimed,  usually 
granting lower sums. 
74 Data retrieved from the OPC and in particular from the consultation of PAs and civil society.  

23 

110267710021212323144550102030405060708090100110Consumer gave up trying to achieve compensation before the claim was launchedProof of defectProof of the linkProducer did not put the product into circulationThe defect did not exist at the time when the product was marketedThe product was not for sale or for distribution for economic purposesThe defect was due to compliance of the product with mandatory regulationsDRCProducer manufactured only a component, following the instructions of the…The damage was caused also by the fault of the injured personThe injured person did not use the product mainly for private use/consumptionExpiration of the3-year periodExpiration of the 10-year periodOther 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Source: EY elaboration of desk research at national level 

Figure  7  details  the  breakdown  of  reasons  for  rejection  in  each  Member  State.  The 
development  risk  clause  was  used  as  a  cause  for  rejecting  claims  more  frequently  in  Italy, 
France,  Hungary  and  Belgium.  Among  these  Member  States,  as  mentioned  in  section  4.1, 
Hungary  and  France  adopted  a  partial  derogation  to  the  development  risk  clause  for  specific 
categories of products. 

Figure 7: Reasons for rejecting a claim, at Member-State level (no data available for DK, MT, 
SI, SK) 

Source: EY elaboration of desk research at national level 

4.8  Cases  brought  to  the  national  courts  relating  to  new  technological 

developments  

EQ  17  Have  cases  been  brought  to  the  national  courts  relating  to  the  application  of  the  Directive  to 
damages  caused  by  a  defect,  for  instance  the  malfunctioning,  in  apps  or  in  another  non-embedded 
software? If it is the case, which was the issue at stake and what was the ruling? 

EQ 18 Have there been cases brought to the national courts or solved through an out of court settlement 
relating  to  the  application  of  the  Directive  to  damages  caused  by  a  robot,  in  particular  in  an  advanced 
robot or an autonomous system? If it is the case, what was the issue at stake and the ruling? 

EQ  19 Have there  been cases in which the damage was caused by a product interconnected with other 
products  or  services,  for  instance  in  the  context  of  IoT  and  automated  systems?  How  has  the  liability 
been allocated in those cases? 

EQ  20  In  the  context  of  new  technological  developments,  have  there  been  discrepancies  between  the 
judgements made by the courts on similar cases? What were the problems at stake? 

The  desk  research  at  national  level  allowed  for  the  identification  of  just  one  case  in  Bulgaria 
where a claim was specifically relating to new technological developments. 

The  desk  research  at  national  level  mapped  no  cases  specifically  relating  to  new 
technological  developments,  with  the  exception  of  one  case  in  Bulgaria75  (see  also 
section 5.1.4). This case concerned a storage unit, a product in which software and apps from 

75 Bulgarian case no. 20942/2012. 

24 

0%10%20%30%40%50%60%70%80%90%100%ATBEBGCYCZDEEEELESFIFRHRHUIEITLTLULVNLPLPTROSEUKOtherExpiration of the 10-year periodExpiration of the3-year periodThe injured person did not use the product mainly for his own private use or consumptionThe damage was caused also by the fault of the injured personProducer manufactured only a component of the product, following the instructions given by the producer of the productDRCThe defect was due to compliance of the product with mandatory regulationsThe product was not for sale or for distribution for economic purposesThe defect did not exist at the time when the product was marketedProducer did not put the product into circulationProof of the linkProof of defectConsumer gave up trying to achieve compensation before the claim was launched 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

different sources can be installed after purchase. The issue at stake was that the storage unit 
was  defective  and  malfunctioning  which  meant  the  computer  could  not  recognise  it.  The 
resulting damage was the loss of stored information due to defects in the external hard disk. 
The  claimant  asked  for  a  compensation  of  around  €800  (BGN  1600).  The  consumer  was 
neither  able  to  prove  that  the  information  had  been  stored  on  the  external  disk  prior  to  the 
occurrence of the defect nor the damages he suffered through the loss of the information. 

25 

 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

5  ANSWERS TO THE EVALUATION QUESTIONS 

5.1  Effectiveness  

EQ 1 To what extent does the Directive meet its objective of guaranteeing at EU level the liability of the 
producer  for  damage  caused  by  a  defective  product  and  in  turn,  contribute  to  an  effectively  operating 
internal market for goods and to the protection of the consumer? 

5.1.1  Effectiveness of specific provisions 

The Directive seems to have generally met its objective of guaranteeing the producer’s liability 
for damage caused by a defective product, and, in turn, the protection of consumers at the EU 
level,  while  ensuring  an  effectively  operating  internal  market  for  goods.  Overall  the  Directive 
has  reached  a  reasonable  uniformity  in  its  implementation  and  its  set  of  rules  makes  it 
effective, even though some elements might undermine effectiveness. 

The  Directive  pursues  its  specific  and  strategic  objectives  by  implementing  the  provisions 
described in the intervention logic (see section 3.2.1). 

If  all  provisions  are  properly  implemented,  the  Directive  is  expected  to  ensure  the  right  of 
consumers  to  claim  damages  suffered  from  defective  products,  and  to  create  a  common  and 
harmonised  set  of  rules  on  strict  liability  (specific  objectives)  in  order  to  enhance  the 
protection  of  consumer  health  and  property,  the  free  movement  of  goods,  and  undistorted 
competition  among  market  operators  in  the  Single  Market  (strategic  objectives),  producing  a 
harmonised level playing field across Member States.  

The findings of the evaluation are therefore based on the assessment of the implementation of 
these provisions, together with the analysis of the evidence relating to the achievement of the 
specific and strategic objectives.  

5.1.1.1  Producer and extension of the liability to suppliers and importers 

Evidence  gathered  shows  that  the  concept  of  producer  and  the  extension  of  the  liability  to 
suppliers and importers support the Directive’s effectiveness.  

Firstly, as shown in chapter 4, suppliers and importers have been brought to court almost half 
as many times as the manufacturers of finished products (see finding 18). Secondly, the CJEU 
confirms  that  the  categories  of  individuals  liable  are  to  be  regarded  as  exhaustive  (CJEU  C-
402/03),76 and that Member States are allowed to extend the liability for defective products to 
suppliers  and  other  actors,  provided  that  the  strict  liability  of  the  producer  is  effectively 
guaranteed  by  way,  for  instance,  of  the  right  of  recourse  (as  stated  in  CJEU  C-402/03  and 
CJEU  C-495/10),  since  an  objective  of  the  Directive  is  to  avoid  that  Member  States  create 
legislative  spaces  where  producers  can  benefit  from  a  liability-free  regime.  Indeed,  this  has 
been  the  case  in  some  Member  States,  such  as  Romania  and  France,  in  which  the  CJEU  has 
clarified that it is not possible to apply the strict liability to service providers, without granting 
them with the right of recourse against producers (see finding 9). 

Finally,  in  general  terms,  the  identification  of  producers  and  other  business  operators  which 
are  potentially  liable  for  defective  product  claims  is  something  that  does  not  raise  any 
concerns, even among scholars and generally speaking other stakeholders. 

Two drawbacks emerged from the analysis. The first one relates to the specific requirement for 
the  supplier  to  inform  the  injured  person  within  a  “reasonable  time”  of  the  identity  of  the 
producer. This requirement appeared to be vague for some Member States that clearly defined 

76 The Directive must be interpreted as precluding a national rule under which the supplier is strictly liable beyond the 
cases  listed  exhaustively  in  Article  3(3)  of  the  Directive.  On  the  contrary,  the  Directive  must  be  interpreted  as  not 
precluding  a  national  rule  according  to  which  the  supplier  is  liable  without  restriction  for  the  producer’s  fault-based 
liability  (CJEU  C-402/03).  Therefore,  on  the  one  hand,  the  Directive  must  be  interpreted  as  precluding  a  Member 
State  from  attributing  strict  liability  to suppliers  tout  court  “beyond  the cases  listed  exhaustively  in Article  3(3)”. On 
the other hand, the Directive must be interpreted as allowing Member States to adopt a legislation according to which 
the supplier is liable without restriction for the “producer's fault-based liability”. 

26 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

what is meant by “reasonable time” (see finding 3). The second one relates to the applicability 
of the definition of producer in the case of new technological developments (in particular those 
that  can  be  deemed  very  close  to  services,  such  as  cloud  technologies),  which  most 
stakeholders  deem  subject  to  future  proof,  also  considering  the  general  uncertainty  of  the 
relevance  of  the  Directive  in  this  sense  (see  section  5.4).  Somehow  relating  to  this  are  the 
difficulties  highlighted  by  stakeholders  to  allocate  liability  in  case  of  products  interacting  with 
other products or services.77 

5.1.1.2  Damage 

As regards damage, the Directive is effective, particularly for damages to physical well-being. 

The  CJEU  made  it  clear  that  a  Member  State  may  not  restrict  the  types  of  material 
damage,  resulting  from  death  or  from  personal  injury,  or  from  damage  to  or 
destruction  of  an  item  of  property,  which  are  to  be  made  good  (CJEU  C-203/99)  and 
this does not seem to be under discussion in Member States. 

Indeed, the Directive is an  effective tool to cover both types  of damages.  However, the desk 
research shows that  claimants more often  seek compensation  in  court for damages to 
physical  well-being  (see  finding  13).  Even  if  there  is  no  clear  evidence  to  explain  this 
pattern, one may conjecture that damages to physical well-being are more likely to exceed the 
€500 threshold and have a greater impact on the lives of the injured persons. This conjecture 
is supported by evidence that one of the main reasons not to make a claim for compensation is 
the value of the damage.78 

With  regard  to  damaged  items  of  property,  when  the  distinction  between  private  and 
professional use is made, evidence gathered suggests that the Directive is applied irrespective 
of the type  of use: when comparing the  number  of  claims rejected because the injured party 
did not use the item of property for his own private use or consumption (23 cases)79 with the 
number of  successful claims even if the item was subject to professional use (150 cases) the 
latter is higher,80 suggesting that this distinction is no longer important.  

5.1.1.3  Strict liability, defect, and burden of proof 
Issues relating to the burden of proof raise significant concerns among consumers81 and some 
scholars  (among  others,  Delforge  2014;  Lewiatan  2017;  Maras  2015):  these  concerns  are 
mainly  relating  to  (i)  the  applicability  of  the  definition  of  defective  product  to  some  kinds  of 
products (especially pharmaceutical products)  and to (ii) the difficulties faced by  claimants in 
proving these elements in court. This is particularly important since, overall, it seems that all 
types of products have been at cause for product liability, with a tendency for pharmaceutical 
products  and  generally  products  concerning  health  to  be  more  often  subject  to  litigation,  as 
well as to judicial escalation. These concerns are further described in the following section. 

Difficulties in applying the definition of defective product and subsequently in proving the link 
between  damage  and  defect  are  particularly  relevant  in  the  pharmaceutical/medical  sector. 
They  have  been  addressed  by  the  CJEU  (C-503/13,  C-504/13,  C-621/15)  that  contributed  to 
clarifying  such  definition  by  specifying  the  defect  to  be  proved  and  the  possibility  to  take 
advantage of presumptions, as further detailed in the box below. 

77 OPC feedback: 83.3%, (n=15) Burdensome, 11.1%, (n=2) Neutral, 5.5%, (n=1) Easy.  
78 OPC feedback: 82% (n=23) of Consumers. 
79  Claims  rejected  because  the  damaged  item  of  property  was  subject  to  professional  use  occurred  in  the  following 
Member States: BE, DE, IT, LV, LU, HU, NL, AT, and PT.  
80  Countries  that  did  not  report  claims  in  which  the  damages  where  suffered  in  the context of  a professional  activity 
were CZ, EE, IE, LV, MT, RO, SI, SE, UK. 
81 OPC feedback: More than half of the responding consumers declared to agree on the fact that it is difficult to prove 
the defect of a product to obtain compensation.  

27 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Box  2  –  Focus  on  consumers’  difficulties  in  obtaining  compensation  in  the  pharmaceutical/ 
medical sector  

The difficulties relating to the burden of proof are confirmed by CJEU case law, particularly for judgments 
relating to the medical sector. For instance, the Court stated that, where a product belongs to the same 
group  or  forms  part  of  the  same  production  series  (such  as  pacemakers  and  implantable  cardioverter 
defibrillators)  having  a  potential  defect,  it  may  be  classified  as  defective  without  any  need  to  establish 
that the same  product has such a defect  (C-503/13 and C-504/13). Similarly,  the  CJEU  stated  that the 
Directive does not require the consumer to collect information about the adverse reactions of a defective 
pharmaceutical product. Thus, a national legislation can compensate for the gap by implementing specific 
national  legislation  introducing  this  kind  of  provision.  Finally,  in  the  last  published  CJEU  case  law  (C-
621/15) on vaccines, the Court clarifies that the Directive does not preclude the judge from considering 
as  a  suitable  means  of  proof  serious,  specific  and  consistent  presumptions,  notwithstanding  the  finding 
that general medical research does not establish a relationship between the vaccine and the occurrence 
of  the  disease,  provided  that  such  a  method  of  proof  does  not  effectively  result  in  a  reversal  of  the 
burden of proof of default, damage or causal link between those two. The link between the damage and 
the defect, especially in the complex field of medicine, should be evaluated taking into consideration the 
specific circumstances of the case, and not general abstract rules, even if scientifically supported.  

Data  collected  through  field  research  confirm  difficulties  relating  to  the  burden  of  proof,  and  allowed 
identifying  some  examples:  a  consumer  association  indicated  that  proving  the  defect  was  much  more 
difficult in the pharmaceutical domain, as the claimant must use scientific evidence showing that the risk 
is known; however, the producer can dismiss his liability by indicating the risk in the product leaflet. The 
Association  of  Victims  of  Medicines  (AVIMEDI)  more  specifically  affirms  that  it  is  almost  impossible  for 
injured  persons  to  provide  evidence  to  support  the  burden  of  proof  in  case  of  damages  for  defective 
medicines.  Indeed,  to  prove  liability  it  is  necessary  to  use  a  scientific  imputation,  which  is  extremely 
difficult due to the highly technical nature of the task. Moreover, the use of leaflets by producers helps in 
creating  a  zone  of  non-imputability,  as  the  producer  is  not  imputable  if  the  leaflet  reports  the  risks 
connected  to  the  medicine.  In  addition,  even  in  the  rare  case  in  which  the  risk  is  not  reported  in  the 
leaflet  and  the  injured  person  is  able to prove  the  imputation,  the  Product  Liability  Directive  allows  the 
exemption of liability of the producer due to the development risk clause. Other difficulties, according to 
AVIMEDI,  are  relating  to  the  limitation  periods  of  three  and  10  years,  which  are  too  short  for  injuries 
stemming  from  defective  pharmaceutical  products  and  medications,  which  sometimes  appear  after  30 
years. 

Another  example  refers  to  the  three-year  expiry  period:  this  period  tends  to  be  too  short,  considering 
that some medicines could have adverse effects a long time after consumption. Finally, another example 
refers to the complexity of the product that would make it more difficult to raise a claim. 

The  stakeholders  participating  in  the  study  confirmed  the  difficulties  faced  by  claimants  in 
proving  the  damage  and  the  link  between  damage  and  defect.  The  cases  analysed  for  this 
study provide specific examples of these difficulties that were experienced.  

The  majority  of  respondents  to  the  OPC82  and  three  consumer  organisations83  that  were 
consulted  state  that  the  proof  of  the  defect  and  of  the  link  between  damage  and  defect  is 
difficult to ascertain. This is even more so in the case of pharmaceutical products (see box  2) 
and  products  interacting  with  other  products  or  services  (e.g.  a  smartphone  malfunctioning 
because of an app downloaded from the Internet).84 In such cases the proof of the defect and 
of  the  causal  link  between  defect  and  damage  requires  specific  scientific  knowledge  or 
technical expertise that is more difficult to access for the average injured persons. 

The analysis of the cases mapped at the national level confirms the existence of issues relating 
to the burden of proof. Indeed, the most frequent reasons to reject claims relate to the proof 

82 OPC feedback: according to 60% (n=6 out of 10) and to 20% (n=2 out of 10) of PAs and civil society, it is difficult 
for consumers to prove, respectively, the defect and the link between the defect and the damage. According to 52% 
(n=25 out of 48) and to 62.5% (n=30 out of 48) of consumers it is difficult to prove, respectively, the link between 
the defect and the link between the damage and the defect.  
83 Consumer associations from EL, IT and CY. 
84 According to 79% of consumers (n=30 out of 38) contributing to the OPC and to consumer associations from EL, IT 
and CY that have been interviewed. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

of  the  damage  and  its  link  with  the  defect,  which  together  account  for  53%  of  the  cases  of 
rejection (see finding 21). Considering that rejected cases account for 40% of the total number 
of  cases  analysed  (see  finding  20),  this  means  that  roughly  one  case  out  of  five  is  rejected 
because  of  the  failure  to  meet  the  requirements  of  the  provision,  with  no  differences  across 
Member States (this showing that the difficulties relating to the burden of proof are common to 
all Member States).  

Even though both the desk research and the field research point to specific difficulties relating 
to the burden of proof, it is worth underlining that, in successful cases (which account for 60% 
of total cases mapped,  see  finding 20, the burden of proof did not represent an obstacle and 
the  injured  person  was  able  to  prove  the  defect,  the  damage  and  the  connection  between 
them). Moreover the CJEU judgments described in Box 2 contributed to overcoming difficulties 
in proving the defect and the causal link, and therefore lightened the burden of proof upon the 
injured person, especially in the case of pharmaceutical products.  

Considering that the defect and its causal link to the damage are the key items to be proved 
for product liability, and that more generally the burden  of proof upon the  claimant is one  of 
the  basic  principles  in  the  European  legal  tradition  and  specifically  of  the  European  litigation 
systems  of  private  law,  this  provision  does  not  seem  to  be  an  actual  impediment  to  the 
effectiveness of the Directive.  

This  provision  could  represent  an  obstacle  to  the  full  potential  of  the  Directive,  as  least  as 
regards  cases  brought  to  court,  since  the  burden  of  proof  can  become  a  probatio  diabolica 
(e.g. in the case of products entailing a high degree of sophistication or technical complexity, 
or pharmaceutical products and medications, as described in box 2, where proving the damage 
and  the  link  to  the  defect  may  become  overly  burdensome).  Nevertheless,  it  is  worth 
mentioning that most cases are settled out of court (see section 4.3), which means that in all 
of  these  cases  the  injured  person  can  provide  reasonable  pieces  of  evidence  that  induce  the 
producers to settle before receiving a summon in court. 

5.1.1.4  Exceptions and derogations 

Most  stakeholders  find  it  difficult  to  deal  with  exemptions  from  producers’  liability  (such  as 
compliance of a product with mandatory rules or the state of scientific and technical knowledge 
when  the  product  was  marketed).85  However,  the  role  of  exceptions  in  the  reasons  for 
rejection of claims relating to exemptions is very limited (see finding 22). 

When  analysing  the  exceptions  in  detail,  most  of  the  issues  that  emerged  from  the  analysis 
relate to the development risk clause. The development risk clause, provided by Art.7(e) of 
the Directive, envisages an exemption of liability of the producer in case the state of scientific 
and technical knowledge at the time when he put the product into circulation was not such as 
to enable the existence of the defect to be discovered. This creates an exception to the liability 
of  the  producer  and  leaves  room  for  cases  where  the  consumer  cannot  obtain  compensation 
under  the  Directive)  (see  Figure  6  and  finding  22).  Nonetheless,  the  development  risk  clause 
has played a crucial role (Rosselli Foundation, 2004; Machnikowski, 2016) in ensuring the right 
balance  between  the  protection  of  the  consumer  in  terms  of  expectations  for  safer  products 
and  the  development  of  innovation  in  Europe  well  beyond  its  limited  use  in  courts. 
Furthermore,  the  development  risk  clause  could  represent  a  key  factor  in  determining  the 
relative stability of product liability insurance costs in European industry and keeping litigation 
at a reasonable level. The decisive topic of the debate on the development risk clause is that 
removing this clause would stifle innovation  (Machnikowski, 2016; Rosselli Foundation, 2004; 
European Commission, COM( 547), 201186).87 Interestingly, a rough analysis of data collected 

85 OPC feedback: 60% (n=26) of consumers. 
86  European  Commission,  Report  from  The  Commission  to  the  European  Parliament,  the  Council  and  the  European 
Economic and Social Committee, Fourth Report on The Application of Product Liability Directive, COM (547), 2011. 
87 Several interviews with stakeholders contributed to the debate on the development risk clause: the majority of them 

29 

 
                                                 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

at  the  national  level  shows  that  in  some  Member  States  that  have  derogated  from  the 
development  risk  clause  (HU,  LU),  the  ratio  between  the  number  of  product  liability  cases  in 
each Member State and the Member State’s population is slightly higher than the EU average 
(see Table 5).  

Table 5: Ratio between the number of cases over 2000-2016 relating to producers’ liability for 
defective products and 100,000 inhabitants (average over the period 2000-2016), per MS 

MS 

BE 

BG 

CZ 

DK 

DE 

EE 

CY 

AT 

Ratio 

0.42 

0.36 

0.13 

0.20 

0.08 

0.07 

0.38 

0.53 

MS 

ES 

FI 

HR 

IE 

HU 

IT 

FR 

EL 

Ratio 

0.27 

0.24 

0.21 

0.28 

0.32 

0.06 

0.13 

1.34 

MS 

LU 

LV 

NL 

PT 

PL 

RO 

MT 

LT 

Ratio 

0.81 

0.55 

0.21 

0.30 

0.02 

0.08 

0.00 

0.34 

MS 

SI 

SK 

Ratio 

0.05 

0.06 

Average 

0.27 

UK 

SE 

0.02 

0.02 

Source: Authors’ calculation based on desk research at national level and Eurostat data 

The low significance of this ratio however might be due to an additional aspect to be taken into 
consideration. The development risk clause works for “the individual” producer, i.e. a producer 
whose defective product caused a damage and who can prove he/she is not liable given that 
“the  state  of  scientific  and  technical  knowledge  at  the  time  when  he  put  the  product  into 
circulation was not such as to enable the existence of the defect to be discovered”. However, 
from  that  moment  on,  “the  state  of  the  art”  has  changed,  and  all  producers  of  the  relevant 
product  have  to  adapt  accordingly.  As  a  consequence,  this  working  mechanism  would  in  any 
case  raise  the  number  of  claims  also  in  those  Member  States  where  the  development  risk 
clause applies. 

It  is  worth  mentioning  that  the  effectiveness  of  the  development  risk  clause  is  perceived  as 
problematic by some of the literature (Machnikowski 2016), believing that a broad application 
of this exception may significantly restrict the practical significance of the rules in question, in 
particular  with  regard  to  AI  and  robots  which  are  out  of  the  control  of  the  producer  and  are 
self-learning systems. This has also been supported by several stakeholders interviewed on the 
matter who believe that the clause cannot be applied to AI and robotics. However, as of now 
no  evidence  is  available  on  this  point,  so  it  is  not  possible  to  come  to  a  conclusion  on  the 
effectiveness of this clause regarding AI and robots.  

All in all, despite some  difficulties  mentioned by stakeholders, there is no  clear  evidence that 
exceptions represent an obstacle to consumer protection.  

5.1.1.5  Limitation and expiry period  

The  three-year  period  has  been  challenged  by  stakeholders,  who  expressed  a  general 
dissatisfaction with it: on average, 41% of the businesses consulted and around a third of the 
stakeholders  responding  to  the  OPC  declared  that  this  limitation  needs  to  be  subject  to  an 
update to deal with new developments.88 Moreover, most stakeholders  indicated difficulties in 

(  an  IT  expert,  an  IT  industry  association,  a  FR  expert,  an  EU  association  representing  producers  as  well  as  a  UK 
lawyer,  believe  that  the  development  risk  clause  is  crucial  in  the  competition  within  the  EU,  and  that  such  a  clause 
should  not be optional  in  the  next Directive);  others  (an EU  federation  representing pharmaceutical  industries,  a UK 
lawyer  and  an  IT  expert),  believe  that  it  should  simply  be  removed  because  producers  should  be  considered  always 
liable, and the risk of unforeseeable damages shall be borne as a risk of enterprise. 
88 OPC feedback: 31.7% (n=13 out of 41 respondents, 7 additional stakeholders with “no opinion”) of consumers, 36% 
(n=8 out of 22 respondents, 3 additional stakeholders with “no opinion”) of PAs, and 26% (n=8 out of 31 respondents, 

30 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                                                                                                                  
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

observing the three-year period in making a claim to recover damages.89 Again, issues related 
to  the  three-year  period  emerged  specifically  for  the  pharmaceutical  sector,  as  further 
discussed in the box below. However, the three-year period is one of  reasons  for rejection of 
the claim only in 4% of the cases analysed for this study (see finding 22). 

As for the 10-year period, the analysis has identified issues mainly relating to the concept  of 
“put into circulation”. Evidence gathered shows that the concept, as stated in the Directive, is 
not  fully  clear,  and  that  it  needs  to  be  clarified,  especially  in  cases  relating  to  the 
pharmaceutical/medical sector, as further described in the box below.  

Box 3 – Focus on the concept of “put into circulation” in the pharmaceutical/medical sector  

Although the concept of “put into circulation” does not raise serious concerns for consumers, it has been 
addressed  in  three  CJEU  judgments.  The  CJEU  stated  that  a  medical  device  is  deemed  to  be  “put  into 
circulation” when it is used to provide the relevant medical service, and the damage caused results from 
that service (CJEU C-203/99). In a second case concerning vaccines, the Court stated that a product is 
considered  as  “put  into  circulation”  when  it  is  taken  out  of  the  manufacturing  process  and  enters  a 
marketing process through which it is offered to the public to be used and consumed (CJEU C-127/04). In 
a  third  case,  the  Court  stated  that  the  expiration  term  of  10  years  starts  from  the  moment  when  the 
product has been put into circulation by the producer and not by the retailer (CJEU C-45/13). 

Besides the CJEU case law, some Member States (BE, CZ, CY, AT) determined when a product 
is “put into circulation”. 

Having clarified that the 10-year period starts from the moment in which the producer has put 
the product into circulation implies that, for products remaining long in the distribution chain or 
deploying their effects over a long time span, the protection of the consumer may be reduced 
in  comparison  with  his  possible  expectations:  this  is  particularly  the  case  of  pharmaceutical 
products.90 In any case, the limitation period of 10 years must be calculated from the moment 
in which the product is put into circulation and not from the moment in which it is taken out of 
the distribution chain. However, reasons  for rejection of  claims relating to the 10-year period 
are  very  residual  (see  Figure  6).  This  suggests  that  the  limitation  periods  do  not  hamper  the 
effectiveness  of  the  Directive,  except  for  the  pharmaceutical  products  for  which  some  doubts 
can be raised.  

5.1.1.6  Bottom and upper threshold 

The effectiveness of the provision on the €500 threshold is overall questionable.  

Firstly,  there  are  issues  with  regard  to  its  interpretation.  Some  Member  States  transposed 
Article 9 of the Directive interpreting the threshold of €500 as a threshold, whereas others (FR, 
DE, NL, ES) transposed it as a deductible, i.e. as a sum to be deducted from the compensable 
damage (Machnikowski, 2016). 

Secondly,  according  to  information  gathered  from  stakeholders  and  as  already  mentioned  in 
previous  sections,  in  four  out  of  five  cases  a  compensation  is  not  claimed  as  the  damage  is 
below  the  threshold.  Some  stakeholders  specifically  declared  difficulties  in  exceeding  the 
threshold  of  €500  for  property  damages,91  this  preventing  them  from  launching  any  judicial 
proceedings.  This  could  explain  why  this  is  rarely  cited  as  a  reason  for  rejecting  a  claim  in 
court  (see  finding  22) and  why  most  cases  relate  to  physical  well-being  (see  finding  13,  also 
confirmed  by  the  respondents  to  the  OPC).  Indeed,  as  previously  discussed,  damages  to 
physical well-being are usually more serious compared to damages to an item of property and 
are therefore more likely to go to court.  

additional 9 stakeholders with “no opinion”) of producers.  
89 OPC feedback: 67% (n=32) of Consumers responding to the specific question.  
90 As indicated by interviewed stakeholders, such as AVIMEDI and a consumer association from LU, the problems with 
medicines and vaccines are the adverse effects, which can appear way after the timeframe of three and 10 years. 
91 OPC feedback: 82% (n=23) of Consumers. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

The  analysis  therefore  suggests  that  the  €500  threshold  represents  an  obstacle  to  claims  for 
compensation in many cases of material damage.  

5.1.1.7  External factors 

One element that could make the Directive less effective is external to it. 

The  Directive  does  not  provide  specific  details  and  procedures  on  how  to  settle  claims  for 
damages  caused  by  defective  products,  and  most  of  the  settlements  occur  out  of  court, 
involving negotiations between the parties (see finding 10). 

As shown in the figure below, there is a slightly negative correlation between the costs of the 
proceeding  as  a  percentage  of  the  claim  and  the  number  of  claims  between  2000  and  2016. 
This correlation shows that with increasing cost of the proceedings, the number of claims per 
Member State decreases. 

Figure 8: Costs of proceedings vs. number of claims 

Source: EY elaboration on desk research at national level 

This is certainly an external factor, but it coincides with the consideration of some stakeholders 
that costs borne by consumers to engage in litigation have an impact on decisions on how to 
settle claims.92  

5.1.2  Effectiveness towards the right for consumers to claim damages and consumer 

protection 

Evidence on the overall effectiveness of the Directive in ensuring consumers the right to claim 
damages and subsequently their protection is mixed.  

While  the  field  research  did  not  gain  much  feedback  from  stakeholders  on  this  issue,  the 
majority of  respondents representing consumers and PAs and civil society93 consider that the 
Directive  is  effective  in  guaranteeing  consumers  that  producers  are  liable  for  damage  caused 
by defective products, although this view is partly contradicted by five consumer organisations 
responding to the targeted survey.94 Producers and insurers generally consider the Directive95 
as  actually  guaranteeing  protection  of  consumers.  Based  on  the  few  interviews  that  were 

92 Source: targeted survey. 
93 OPC feedback: 67% (n=29) Consumers and 68% (n=17) PAs and civil society. 
94 Five consumer organisations (BG, IT, LU, MT, FI) out of six responding to this question. The sixth one answered “I 
don’t know”. 
95  74.34%  of  the  respondents  to  the  OPC  believe  that  it  is  a  strong  advantage  that  consumers  can  enjoy  the  same 
rights  in  terms  of  compensation  wherever  they  are  in  the  EU.  A  HU  insurance  association  and  an  EU  association 
representing producers confirm these views.  

32 

 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

carried out, it seems that there are differing perceptions on the effectiveness of the Directive 
among  experts  and  lawyers:  some96  considering  it  to  be  effective,  and  others97  as  not 
effective. Stakeholders supported their opinions by making reference to different provisions of 
the  Directive.  Specifically,  producers  deem  the  Directive  to  be  effective  in  protecting 
consumers because:  

  The same mechanism of strict liability allows the claimants to claim for compensation with 

no need to prove the fault or negligence of the producer;98 

 

It  is  almost  always  possible  to  identify  an  operator  to  be  held  liable  thanks  to  the 
extension of the liability to suppliers and importers in the cases under Article 3 of the 
Directive;99  

Consumers believe the Directive is not effective in protecting consumers mainly because: 

  Claimants  have  to  prove  the  defect,  the  damage  and  their  link,  which  can  be  sometimes 

burdensome;100  

 

 

 

the  €500  threshold  prevents  injured  persons  from  obtaining  compensation  in  case  of 
lower damages;101  

the time limit of three and 10 years to obtain compensation is too short;102  

It  is  not  possible  to  obtain  compensation  if  the  damage  is  caused  on  items  of  property 
intended for professional use;103 

  The  exceptions  to  liability  in  favour  of  the  producers  are  too  wide  (such  as  the 

development risk clause). 

Overall, in the discussion around the effectiveness of the Directive, stakeholders tend to take 
the  position  expected104  by  their  role  (with  some  significant  exceptions,  such  as  consumers 
associations considering the Directive to be effective). 

It was also  found that the evidence from the desk research was not  fully convergent.  On the 
one hand, some literature suggests that the Directive contributed to protecting consumers by 
increasing  the  level  of  safety  of  products  marketed  in  the  EU  (Lovells  2003,  Cafaggi  2008, 
Hans 2016). However when further analysing these positions, it is to be noted that the impact 
of  the  Directive  on  safety  cannot  easily  be  disentangled  from  the  impact  of  other  legislation. 
The  Directive  is  part  of  a  more  complex  legislative  system  where  safety  legislation  (the 

96 Such as experts from CY. 
97 Such as a UK lawyer. 
98 According to the CATI survey, the large majority of producers (69%), irrespective of their size, positively evaluate 
the burden of proof of the injured party. 
99  As  an  example,  a  European  association  representing  producers  and  suppliers  declared  in  an  interview  that  the 
Directive has brought clarity and solidity and that all producers know they can  be liable pursuant to the Directive for 
defects in their products. 
100  OPC  feedback:  80%  (80=10)  of  responding  consumers  find  the  procedure  for  recovering  damages  burdensome. 
Similarly, consumer associations interviewed believe that the burden of proof is quite difficult and burdensome. 
101 OPC feedback: 30% (3 out of 10) of responding consumers believe that the  common minimum threshold of €500 
for  compensation  of  damages  to  property  is  a  strong  disadvantage.  According  to  a  consumer  association  from 
Luxemburg,  the  €500  threshold  may  not  be  justified  since  it  excludes  many  small  products,  or  products  for  which 
prices have decreased over the years. 
102 OPC feedback: 87.5% (7 out of 8) of responding consumers believe that the time limit of 10 years is a burdensome 
provision of the Directive. This is supported also by some consumer associations interviewed. 
103  OPC  feedback:  83%  (n=5  out  of  6)  of  responding  consumers,  believe  that  it  is  sometimes  difficult  to  distinguish 
between private and professional use of a product. 
104 This is similar to the conclusions drawn by the previous report on the application of the Directive, where besides the 
acknowledgment  of  the  effectiveness  of  the  Directive,  it  was  found  that  stakeholders  tended  to  take  the  position 
expected:  “In  general,  consumers  would  like  more  protection  at  a  lower  cost,  which  would  mean,  for  example, 
removing  the  threshold. In  contrast,  producers  and  insurers  mention  the  risk of  increasing  the  number  of claims  for 
minor damages and are therefore in favour of increasing the threshold. These two differing stances are also reflected 
among  the  national  experts”.  European  Commission,  Report  from  the  Commission  to  the  European  Parliament,  the 
Council  and  the  European  Economic  and  Social  Committee,  Fourth  Report  on  the  Application  of  Product  Liability 
Directive, 
http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:52011DC0547&from=EN. 

(547), 

2011, 

COM 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

sectorial safety legislation and the General Product Safety Directive) and the system of market 
surveillance intervene to ensure the protection of consumers (ex ante) through product safety: 
in  this  context,  the  Directive  aims  to  guarantee  the  right  of  consumers  to  claim  damages 
suffered because of a defective product and to harmonise strict liability rules. 

On the other hand, other scholars tend to view the Directive as not that effective in protecting 
consumers (among  others, Ueffing, M., 2013;  Peopil, 2017; Bloch, L., & Le Pallec, S., 2012), 
considering that the producers of defective products are rarely required to compensate victims, 
especially in the field of pharmaceutical products and medications where consumers encounter 
difficulties  in  demonstrating  both  the  causal  link  from  a  scientific  point  of  view  between  the 
pharmaceutical  products  and  medications  and  the  damage  suffered  and  the  defect  in  such 
product. Also a position paper by a consumer organisation claims that the rules on liability for 
defective  products  appear  to  be  ineffective  in  reaching  their  objectives,  with  the  lack  of 
effectiveness  reported  to  be  relating  to  e.g.  the  concepts  of  defect,  burden  of  proof  and 
causality,  the  threshold  of  €500,  the  time  limitations,  and  exceptions  (Beuc  2015),  as  also 
underlined by some stakeholders and discussed in the previous sections.  

However,  not  all  issues  raised  by  stakeholders  and  scholars  appear  to  be  relevant  when 
looking at additional evidence. As discussed in section  5.1.1, some  of  the reasons mentioned 
by  stakeholders  are  confirmed  by  evidence,  such  as  the  extension  of  the  liability  to  suppliers 
and  importers,  the  difficulties  relating  to  the  burden  of  proof,  and  the  €500  threshold.  Some 
others, such as the relevance of the time limitation and expiry periods to obtain compensation 
and the role of exceptions, do not seem to hamper the effectiveness of the Directive.  

Moreover,  when  one  considers  how  the  Directive  works  in  practice,  it  appears  that,  in  most 
claims brought to court, claimants are successful and the majority of claims do not even get to 
court,  but  are  settled  out  of  court:  this  means  that  producers  “fear”  the  Directive  and  prefer 
agreeing to a payment out of court rather than facing a trial in court.  

All  in  all,  when  considering  all  of  evidence  collected,  it  seems  possible  to  conclude  that  the 
Directive is somewhat effective in protecting consumers. 

The effectiveness of the Directive is supported by the following provisions and results:  

 

 

It  is  possible  for  consumers  to  identify  operators  from  which  they  can  claim  for 
compensation; 

In  most  of  the  cases  consumers  are  successful  in  courts  (see  finding  20)  and  even 
more cases are settled out of court (see finding 10); 

  The  Directive  represents  a  “threat”  to  be  avoided,  considering  that  the  majority  of 
claims  are  settled  out  of  court  in  order  to  avoid  facing  a  trial  in  court  (see  finding 
10);105  

  Consistently  with  the  previous  point,  there  is  a  tendency  to  invoke  the  Directive  as 
the  legal  basis  of  claims  also  in  cases  that  are  eventually  decided  based  on  tort  or 
contract law (see finding 10), this showing that the Directive is appealing as a tool for 
strengthening claims that would be better supported on a different legal basis. 

the 
However, 
effectiveness:  

implementation  of  some  specific  provisions  hampers 

the  Directive’s 

  Consumers  face  difficulties  in  proving  the  damage,  the  defect  and  the  related  link 
(especially in complex cases requiring technical expertise), this also representing one 
of the main reasons to reject claims;  

  The  €500  threshold  denies  the  possibility  for  injured  persons  to  bring  claims  and 
receive  compensation  for  small  damages.  Such  threshold  does  not  apply  to  physical 

105 However, this happens more often in some Member States than in others. For instance, in DE, the implementation 
of the Directive was not completed until August 2002. 

34 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

damages.  As  a  result,  damages  to  physical  well-being  are  most  often  the  object  of 
recovery, both in court or out of court. 

5.1.3  Effectiveness  towards  harmonisation  of  strict  liability  rules  and  an  effectively 

operating internal market 

The  Directive  seems  to  have  met  its  objective  to  harmonise  rules  on  strict  liability  and  to 
ensure an effectively operating internal market for goods, even if it still seems difficult to bring 
actions against producers abroad. 

The analysis of national legislation transposing the Directive presented in chapter 4 shows that 
the Directive has been uniformly transposed in Member States, with some exceptions that are 
in  fact  consistent  with  either  the  provisions  of  the  Directive  (for  example,  in  terms  of 
derogations) or  some judgments of the CJEU  (in terms  of  extensions of the liability). Indeed, 
some judgments of the CJEU (C-127/04, C-285/08) clarified that the scope of the Directive can 
be  extended  (for  instance,  by  extending  the  same  rules  of  the  Directive  to  compensation  for 
damage  to  an  item  of  property  intended  for  professional  use  and  employed  for  that  use)  by 
each  Member  State  when  implementing  the  Directive,  provided  that  this  does  not  trigger 
distorted  competition  between  traders  and  impede  the  free  movement  of  goods.  Thus,  the 
legislation  of  Member  States  can  extend  strict  liability  also  to  other  subjects  (such  as  the 
service provider), as long as this guarantees the possibility to claim the ultimate liability of the 
producer through, for instance, the right of recourse of the service provider against the latter. 
Otherwise,  the  system  established  by  the  Directive  would  be  adversely  affected  as  the 
producer  would  benefit  from  a  liability-free  regime  in  case  the  service  provider  is  deemed 
strictly liable.106  

According to the reviewed literature, the harmonisation of the rules and the judgments of the 
CJEU mentioned above contributed to a harmonised environment for businesses by preventing 
distorted  competition  in  the  internal  market  (Foerste,  Kreifels,  and  Mühlbauer  2012).  In 
addition,  to  underline  the  importance  of  the  Directive  in  contributing  to  a  harmonised  and 
balanced  environment,  the  analysis  highlighted  that  the  Directive  and  particular  provisions, 
such as the development risk clause, represent a satisfactory compromise between the need to 
stimulate innovation and consumers’ legitimate expectations for safer products  (Machnikowski 
2016; Rosselli Foundation 2004). Also the majority of  survey respondents  confirm107 that the 
Directive  is  effective  in  guaranteeing  a  level  playing  field  for  businesses  across  the  EU  with 
respect  to  the  liability  from  damages  caused  by  defective  products,  thanks  to  the 
harmonisation of liability rules in case of damage caused by a defective product across Member 
States. 

Despite  improvements  in  creating  a  harmonised  set  of  conditions,  bringing  a  claim  for 
compensation across borders is quite an exceptional event. In fact, in most cases the Directed 
enabled the injured person to bring a claim in the courts of the place where the harmful event 
occurred,  which  in  most  cases  is  likely  to  be  the  Member  State  where  the  injured  person 
resides.  However,  based  on  the  legal  mapping  performed,  over  the  period  2000-2016,  there 
were only 21 cross-border cases (i.e. 3% of the total number) for defective products where the 
injured  person  summoned  a  defendant  from  another  Member  State.  Only  four  cases  (i.e. 
0.05% of the cases) involved a third-country defendant. It is possible that a consumer believes 
that bringing a claim against a defendant abroad as more difficult than bringing a claim within 
the  jurisdiction  of  his/her  own  Member  State,  maybe  due  to  lack  of  knowledge  of  procedural 
rules  as  well  as  difficulties  relating  to  possible  language  barriers.  When  considering  these 
aspects,  even  though  not  relating  to  a  lack  of  harmonised  rules,  one  may  conjecture  that 

106 Judgment of the Court (Grand Chamber) 21 December 2011, in C-495/10. 
107 In particular, the few answers to the targeted survey were: Strongly agree = 1 law firm (UK); agree = 2 law firms 
(NL, UK) and 1 self-employed barrister (UK). Total respondents to this question: six. One of them answered “I don’t 
know”. A UK law firm disagrees. 

35 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

enterprises mainly operating across borders might be subject to strict liability to a lower extent 
than those focused on national markets. 

5.1.4  Effectiveness vis-à-vis new technological developments 

EQ  5/6/13.  What  is  the  impact  of  the  new  technological  developments  on  the  effectiveness  of  the 
Directive?  Are  there  cases  of  damages  caused  to  consumers  by  new  technological  products  (e.g.  apps 
and other non-embedded software, interconnected devices in the context of Internet of Things, advanced 
robots, automated and autonomous systems)? 

Just  one  case  concerning  new  technological  developments  (in  the  definition  adopted  for  the 
purposes of this study) has been brought to, and decided in, court in the period from 2000 to 
2016  and  the  debate  about  effectiveness  with  respect  to  all  types  of  new  technological 
developments  is  open  and  wide.  Moreover,  given  respondents'  limited  experience  with  actual 
cases  of damage in the context of new technological developments, no clear picture  emerges 
of who should be held liable for defects in them. As a consequence, it is not possible to assess 
the level of effectiveness of the Directive vis-à-vis new technological developments.  

To  assess  the  impact  of  the  new  technological  developments  on  the  effectiveness  of  the 
Directive and whether there are cases of damages caused to consumers by new technological 
products,  information  was  gathered  through  the  OPC,  the  targeted  survey  and  the  desk 
research.  

As  a  starting  point,  in  the  context  of  the  targeted  survey,  even  though  the  number  of 
respondents  is  limited  to  six,  five  consumer  organisations108  see  difficulties  in  obtaining 
compensation  for  the  damages  suffered  in  case  of  defective  products  based  on  new 
technological  developments,  while  only  in  one  case,  a  consumer  organisation  from  Malta 
reports  that  in  less  than  25%  of  the  claims  relating  to  new  technological  developments  the 
consumers were successful.109 

The evidence gathered from the OPC shows that consumers experience product liability issues 
with  regard  to  electrical  appliances  and  equipment,110  medical  devices,111  pharmaceutical 
products,112 machinery,113 and smart devices.114 

Based on recent CJEU case law, claimants were able to benefit from the judgment of the CJEU 
on Joint Cases C-503/13 and C-504/13 and the judgment on C-621/15, reported under section 
4.74.7. Based on the first case, where a product belongs to the same group or forms part of a 
production series (the case relating to pacemakers and implantable cardioverter defibrillators) 
having a potential defect, such a product may be considered as defective without any need to 
establish  that  the  same  product  has  such  a  defect.  Furthermore,  based  on  the  second 
judgment, a Member State judge can consider as a suitable means of proof – for the purposes 
of product liability – serious, specific and consistent presumptions, upon given conditions. As it 
would be the case for any other products, the defectiveness presumption could apply to some 
new technological developments, such as smartphones or tablets or even robots. However, the 
application of such presumption could be more controversial with regard to AI and self-learning 
systems because of the difficulties inherent in interpreting the concepts of defect and damage 
and the possibility for the producer to foresee them. 

In any case, as reported under section 4.8, the desk research identified just one case relating 
to  a  new  technological  development,  namely  in  Bulgaria  (see  section  4.8).  This  case 

108 5 consumer organisations (two IT, LU, MT, FI,). 
109 The desk research did not lead to identifying any published, relevant judgments given by courts in MT. It is possible 
that the judgments to which the organisation referred were actually given but not published. 
110 OPC feedback: 33% (n=16) of consumers. 
111 OPC feedback: 40% (n=10) of PAs and civil society. 
112 OPC feedback: 20.83% (n=10) of consumers. 
113 OPC feedback: 22.5% (n=9) of producers. 
114 OPC feedback: 22.5% (n=9) of producers. 

36 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

concerned  a  storage  unit,  which  is  a  product  on  which  software  and  apps  from  different 
sources  can  be  installed  after  purchase:  the  defect  at  stake  was  that  computers  could  not 
recognise it and some other problems with the software. The court rejected the claim because 
the claimant could not prove the damage. 

The  legal  mapping  shows  that,  even  at  the  national  level,  there  is  no  specific  legislation 
concerning the product liability for new technological developments or specific types of 
products  that  incorporate  them  (be  they,  for  instance,  robots,  artificial  intelligence  or  3D 
printing).  

This  fact  suggests  that  there  are  obstacles  to  reporting  a  claim  relating  to  new  technological 
developments, for instance due to the  perception of not having solutions for these situations: 
87%  of  the  OPC  respondents  believe  that  in  their  EU  countries  there  are  no  specific  rules  on 
liability  for  damage  caused,  for  instance,  by  smart  objects,  robots  and  other  new 
technologies115  and  72%  of  the  OPC  respondents  are  aware  that  damages  caused  by 
malfunctioning services are not covered. 

Nonetheless, in some jurisdictions, such as Estonia116 and France,117 courts consider computer 
software to be products and thus the Directive could apply to damages caused by software. 

Besides  the  limited  evidence  gathered  through  the  legal  mapping  and  the  consultation  of 
stakeholders, several contributions, which show a quite lively debate over the effectiveness of 
the  Directive  on  new  technological  developments,  have  been  retrieved  through  the  desk 
research:  

First,  there  are  some  doubts  about  the  possibility  to  consider  an  open-source  software  as  a 
product pursuant to Article 2 of the Directive: in particular, one author believes that in case of 
open-source  software  used  in  the  medical  field,  it  could  be  difficult  to  prove  the  damage 
resulting  from  a  misdiagnosis  due  to  a  failure  in  an  open  source  software  used  for  medical 
devices (Tränkle, 2004).  

Moreover, with regard to cloud computing, the European Commission has considered that this 
technology may challenge the effectiveness of the Directive, because of its unique specificities 
compared  to  other  kinds  of  products:  indeed,  there  are  questions  about  how  service  failures 
such  as  downtime  or  loss  of  data  will  be  compensated,  user  rights  with  regard  to  system 
upgrades decided unilaterally by the provider, ownership of data created in cloud applications 
and disputes will be resolved (European Commission, 2012).118  

Indeed, considering more broadly the fact that some new technological developments  appear 
to  be  closer  to  services,  the  uncertainty  as  to  the  applicability  of  the  Directive  has  been 
pointed  out  also  with  regard  to  electronic  services  (Prins,  2010)  and  e-printers  and  design 
(STOA, 2015).  

In  this  same  context,  some  interviewed  stakeholders,  including  a  German  consumer 
association and a French legal expert, highlighted that new technological developments such as 
3D  printers,  which  enable  consumers  to  become  manufacturers,  could  potentially  undermine 
the  attribution  of  the  product  that  caused  the  damage  (Verbraucherzentrale  Bundesverband 
2017). 

Still, the European Commission points out that there have been problems with the application 
of  the  Directive  in  the  interpretation  and  application  of  standards  in  the  field  of  technological 
progress  (for  example,  interpretative  uncertainties  also  have  been  identified  in  the  case  of 

115 OPC feedback: 87% (N=59 out of 68) of respondents.  
116 According to their general rules on contracts (section 1063 subsection 1 of the Law of Obligations Act). 
117 Question N° 15677, de M. de Chazeaux Olivier, Question publiée au JO le 15/06/1998 page 3230; Réponse publiée 
au JO le 24/08/1998 page 4728. 
118 Communication from the Commission to the European Parliament, the Council, the European Economic and Social 
Committee  and  the  Committee  of  the  Regions.  Unleashing  the  Potential  of  Cloud  Computing  in  Europe,  2012,  
Brussels, 
content/EN/TXT/PDF/?uri=CELEX:52012DC0529&from=EN. 

http://eur-lex.europa.eu/legal-

COM(2012) 

27.9.2012 

final. 

529 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

accidents  involving  malfunctions  of  medical  devices)  and,  to  address  this  problem,  the 
Commission  submitted  two  legislative  proposals  on  medical  and  in  vitro  diagnoses:  these 
proposals were adopted by European Parliament and the Council on 5 April 2017119 (European 
Parliament, 2017).120  

More in general, the effectiveness of the Directive vis-à-vis new technological developments is 
put under discussion in the following cases: 

  The  development  risk  clause  and  the  exemption  clause  provided  for  in  Article  7(b)  are 
not deemed to be effective specifically when dealing with AI and robotics. Some literature 
(Courtois,  2016)  as  well  as  opinions  retrieved  through  interviews,  affirmed  that  these 
clauses would not provide for the liability of the producer in the case of damages caused by 
robots, since the producer would always try to invoke the development risk clause. 

  The threshold of €500: according to  some interviewed stakeholders, such as consumers 
and legal experts, this threshold is too high. On the opposite, others, affirm that it is even 
too low. In particular, an Italian expert suggested that the fixed threshold of €500 might be 
low  when  dealing  with  new  technological  developments,  and  suggests  to  apply  it  as  a 
relative  concept  rather  than  an  absolute  one:  in  other  terms,  the  threshold  should  be 
quantified  as  a  percentage  of  the  overall  amount  of  the  damage  and  not  just  as  a  fixed 
amount. 

  More  in  general,  according  to  the  majority  of  respondents  to  the  OPC  on  Building  a 
European Data Economy initiative, there should be a liability cap (i.e. an upper bound to 
the compensation of damages) regardless of who is considered liable. In particular out 
of  the  164  respondents,  20%  answered  that  this  should  apply  only  to  specific  products 
abiding by strict safety standards, 6% that it should apply only to specific products in the 
experimentation/testing  phase,  27%  that  it  should  apply  to  all  IoT  products,  and  the 
remaining share that there should not be a liability cap. 

However,  other  stakeholders  consider  that  the  Directive  properly  covers  new  technological 
developments,  based  on  the  current  state  of  play  of  the  new  technological  developments. 
Insurers believe that emerging technologies will not have an impact on the effectiveness of the 
Directive,  so  that  there  is  no  need  for  a  new  dedicated  legislation.  Business  representatives 
consider  that  the  impact  of  new  technological  developments  on  the  Directive  is  not  that 
significant, as new technologies are most often considered to be movable items and therefore 
products pursuant to the Directive (even though incorporated into another movable or into an 
immovable  property).  Regardless  of  the  level  of  complexity  of  new  technologies,  it  does  not 
seem so difficult to identify which part of the  system failed and to allocate the liability of the 
producer.121  

More analytical indications as to the impact of new technological developments seem to come 
from the OPC and particularly from the views expressed by PA and civil society. 

With reference to the burdens in the context of new technological developments, as, for 
instance,  smartphones  or  software,  PAs  and  civil  society  consider  as  burdensome  the 
requirement that the injured party has to prove the defect of a product interacting with other 
products  or  services  (e.g.  a  smartphone  malfunctioning  because  of  an  app  downloaded  from 

Directives 

90/385/EEC 

119  Regulation  (EU)  2017/745  of  the  European  Parliament  and  of  the  Council  of  5  April  2017  on  medical  devices, 
amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No  1223/2009  and  repealing 
http://eur-lex.europa.eu/legal-
Council 
content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN. 
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical 
devices  and  repealing  Directive  98/79/EC  and  Commission  Decision  2010/227/EU.  http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN.. 
120 European Parliament resolution of 16 February 2017 with recommendations to the Commission on Civil Law Rules 
on Robotics (2015/2103(INL)).. 
121 A similar opinion has been expressed in literature with regard to new technological developments in the automotive 
sector (WG2, 2017). 

93/42/EEC. 

and 

38 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

the  Internet),122  the  exemption  of  liability  under  certain  circumstances,123  and  the  need  to 
distinguish a product from a service when they are bundled together,124 while they consider as 
neutral the application of the principle of liability without fault to some innovative products that 
need experimentation.125 

OPC  results  suggest  that  PAs  and  civil  society  agree  that  liability  could  be  better  allocated  in 
case of products interacting with other products or services,126 to help the injured party having 
to  prove  the  defect  of  a  product  interacting  with  other  products  or  services,127  in  the 
application  of  the  principle  of  liability  to  some  innovative  products  that  need  experimentation 
(e.g. autonomous cars or other connected devices),128 and in deciding on how to distinguish a 
product from a  service  when they are bundled together,129 as well as that there are products 
for which the application of the Directive is or might become uncertain and/or problematic.130 
In  this  regard,  PAs  and  civil  society  also  consider  that  the  application  of  the  Directive  is 
problematic  for  products  on  which  software  and  applications  from  different  sources  can  be 
installed  after  purchase,131  that  are  connected  to  the  Internet,132  purchased  as  a  bundle  with 
related  services,133  used  both  in  private  and  professional  life,134  perform  automated  tasks 
based  on  algorithms  and  data  analysis,135  perform  automated  tasks  based  on  self-learning 
algorithms136 or shared with other users through collaborative platforms.137 

With particular reference to the case of interconnected products (especially for electronics), 
some  interviewed  stakeholders,  such  as  an  Italian  large  producer,  confirmed  that  correctly 
attributing liability for defects can be difficult, since it can be problematic to identify the source 
of defect and therefore to correctly allocate liability between the producers of  individual parts 
of  the  product  and  the  system  integrators.  In  particular,  in  case  of  defective  software 
interconnected with other products, it is being discussed whether liability is attributable to the 
producer of the software or the finished product.  

5.1.5  The main drivers to the objectives achieved 

EQ 2/3. Which are the main drivers to the objectives achieved?  

The main drivers to the effectiveness of the Directive  are relating to the level of uniformity in 
its  implementation,  its  role  as  “safety  net”  within  a  broader  legislative  framework  to  protect 
consumers,  the  level  of  generality  of  some  provisions  that  allow  for  flexibility  and  wide 
coverage, and the high level of awareness of stakeholders.  

The analysis has identified some drivers contributing to the effectiveness of the Directive.  

Firstly,  as  discussed  in  previous  sections,  the  Directive  has  reached  a  reasonable 
uniformity in its implementation. Also the number of cases in comparison to the population 
of  each  Member  State  does  not  vary  so  much  that  one  might  suspect  that  in  some  Member 

122 OPC feedback: 83.3%, (n=15) Burdensome, 11.1%, (n=2) Neutral, 5.5%, (n=1) Easy.  
123  OPC feedback 50%,  (n=10) Burdensome, 45%,  (n=9)  Neutral,  5%,  (n=1)  Easy.  For  instance  when  the producer 
proves  that  at  the  time  when  the  product  was  marketed,  he  was  not  able  to  detect  the  defect  due  to  the  state  of 
scientific and technical knowledge.  
124 OPC feedback 68.4%, (n=13) Burdensome, 21.1%, (n=4) Neutral, 10.5%, (n=2) Easy. 
125 OPC feedback 36.8%, (n=7) Burdensome, 42.1%, (n=8) Neutral, 5%, (n=1) Easy. 
126 OPC feedback: 70% (n=14 out of 20) of PAs and civil society. 
127 OPC feedback: 57% (n=12 out of 21) of PAs and civil society. 
128 OPC feedback: 60% (n=12 out of 20) of PAs and civil society. 
129 OPC feedback: 58% (n=11 out of 19) of PAs and civil society. 
130 OPC feedback: 76% (n=16 out of 21) of PAs and civil society. 
131 OPC feedback: 20% (n=13 out of 66) of PAs and civil society. 
132 OPC feedback: 14% (n=9 out of 66) of PAs and civil society. 
133 OPC feedback: 14% (n=9 out of 66) of PAs and civil society. 
134 OPC feedback: 12% (n=8 out of 66) of PAs and civil society. 
135 OPC feedback: 12% (n=8 out of 66) of PAs and civil society. 
136 OPC feedback: 14% (n=9 out of 66) of PAs and civil society. 
137 OPC feedback: 8% (n=5) of PAs and civil society. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

States  there  are  interpretations  materially  more  favourable  to  the  injured  persons  than  in 
others (see Table 5: Ratio between the number of cases over 2000-2016 relating to producers’ 
liability for defective products and 100,000 inhabitants (average over  the period 2000-2016), 
per MSTable 5). 

Secondly, the Directive is fully integrated in a wider legislative framework.  Even if the 
number of case law examples identified in the EU from 2000 to 2016 can be seen as low, these 
data need to be interpreted while considering that the Directive acts as a “safety net” in the 
framework of European legislation. Indeed, there are several layers of protection which coexist 
and contribute to  reducing the need to invoke  the Directive: first, the  safety legislation, both 
sectorial and general, ensuring the marketing of safe products in the internal market; second, 
the  system  of  market  surveillance;  third,  the  contractual  obligations  and  the  guarantee 
available to the consumer.138  

Thirdly,  some  provisions  of  the  Directive  are  general  enough  to  make  the  measure  able  to 
cover a wide variety of situations:  

  The  Directive  does  not  provide  indications  on  the  systems  to  settle  claims,  allowing 
consumers  to  choose  the  most  effective  system  (either  direct  negotiation  with  the  person 
or  entity  held  liable,  alternative  dispute  resolution  methods  such  as  mediation  and 
arbitration, or litigation in court, see finding 10). This is one of the positive features of the 
Directive, allowing for adaptation to national contexts (including their judicial systems) and 
specific circumstances. 

  The  concepts  of  product  and  defect  are  wide  enough  to  cover  a  wide  range  of 
situations, with some possible exceptions relating to new technological developments, thus 
making  the  Directive  suitable  to  cover  all  types  of  products  with  the  entire  variety  of 
defects  they  may  have.  The  desk  research  at  the  national level  has  shown  that  the  cases 
mapped cover a wide variety of products (see section 4.4), with the different categories of 
products  fairly  evenly  distributed  across  Member  States  (Figure  3).  The  wide  definition  of 
products is therefore adequate to cover the vast variety of cases relevant to strict liability, 
even  though  many  consumers  claim  to  experience  difficulties  in  distinguishing  a  product 
from a service,139 and in distinguishing between private and professional use of a product. 
Also  the  case  law  shows  that  almost  any  kinds  of  movable  can  be  the  subject  of  product 
liability (see Table 4 and Figure 3). All in all, evidence suggests there are no difficulties in 
interpreting what is considered a product. Similar evidence has been gathered with regard 
to defects: the cases analysed for this  study cover a wide variety  of  defects  linked to the 
wide  variety  of  products,  which  makes  it  impossible  to  track  some  patterns  (see  finding 
12).  

  The  methods for compensation are not defined in the  Directive and producers are free 
to  choose  their  preferred  approach,  with  most  producers  having  a  general  insurance 
contract covering different risks,140 including the cost of compensation in case of defective 
products  (see  finding  11).  Based  on  the  field  research,141  the  choice  of  having  either  a 
general  or  a  more  specific  insurance  policy  depends  on  the  individual  company  and  the 
relevant sector/product.142 

138 As supported, in the frame of the limited answers obtained through the targeted survey, for instance, both by a EU 
representative and by an IT large producer. 
139 OPC feedback: 85% (n=29) of Consumers. 
140 According to the results of the CATI survey, half of interviewed small enterprises has a general insurance covering 
different  risks  (n=79).  A  large  share  (31%)  of  them  does  not  have  any  insurance  contract.  Medium  and  large 
enterprises are equally distributed, with around 60% of them (86 medium and 97 large) having a general insurance, 
around 25% having a specific insurance for strict liability (36 medium and 42 large) and less than 20% (29 medium 
and 20 large) not being covered by any insurance contracts. 
141 Two businesses interviewed. 
142 Companies tend to take the most effective option: for some products, there is a higher incentive to sign a specific 
liability  insurance  (e.g.  if  the  product  represents  the  core  business  of  the  company  or  if  it  is  the  most  marketed 

40 

 
                                                 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Finally,  stakeholders’  awareness  of  the  right  to  seek  compensation  for  damage  caused  by  a 
defective  product  is  also  relevant  to  the  effectiveness  of  the  Directive.  Indeed,  most 
stakeholders  are  aware  of  the  fact  that  consumers  in  the  European  Union  have  the  right  to 
seek  compensation  for  damage  caused  by  a  defective  product.143  More  specifically,  the 
majority is aware that:  

  Producers  and/or  importers  into  the  European  Union  must  compensate  consumers  for 
damage caused by their defective product,  regardless  of whether producers/importers are 
at fault or negligent;144  

  The injured party has to prove the defect, the damage and the causal  link between defect 

and damage to be compensated;145  

  The  Directive  applies  to  defects  caused  by  any  product,  including  primary  agricultural 

products but also electricity;146  

  Liability  for  property  loss  is  limited  to  cases  where  the  defective  product  was  used  for 

private purposes (i.e. non-professional use);147  

  There is an expiry period of 10 years from the moment the producer put the product into 

circulation;148 

 

In  case  of damage caused to an item of property, the liability of the producer/importer is 
limited to property damage above €500.149 

5.1.6  Unexpected outcomes 

The analysis identified two circumstances as unexpected outcomes: quite interestingly they are 
closely linked to pharmaceutical products and medical devices and highlight to some extent the 
attention paid to health risks: 

  The judgments of the CJEU have gone beyond the Directive in defining specific methods to 
provide proof  of the defect (i.e. the possibility for the claimant to invoke presumptions to 
prove  the  defect),  which  have  been  elaborated  in  connection  with  drugs  and  medical 
devices, is also seen as an unexpected outcome (see section 5.4.2.3.3);150 

  German courts have gone beyond the Directive in the definition of defective product as per 
Article 6 of the Directive by implicitly referring to the safety to be expected by the general 
community  rather  than  by  a  person:  in  particular,  they  applied  the  risk/utility  test  when 
scrutinising product liability cases on vaccines--this led to the rejection of the claims based 
on the consideration that vaccines cause benefits to the general community that outweigh 
the risks; these cases refer to the special legislation on vaccines (which is dated 1976 and 
has never been repealed after the Directive) providing that a vaccine is defective only if the 
damages they cause are greater than the benefits they bring (Rajneri Karageorgevitch). In 
this  context,  the  defect  in  the  vaccine  is  proved  only if it is  possible  to  demonstrate  that, 
for the general public, the benefits stemming from the vaccine are lower than the damages 
to individuals. 

product). 
143 OPC feedback: 93% (n=37) producers, 89.58% (n=43) consumers and 100% (n=25) of PAs and civil society.  
144 OPC feedback: 79%; (n=38) of consumers; 84% (n=21) of PAs and civil society; 85%; (n=34) of producers. 
145 OPC feedback: 83%; (n=40) of consumers; 92% (n=23) of PAs and civil society; 77.5%; (n=31) of producers. 
146 OPC feedback: 73%; (n=35) of consumers; 88% (n=22) of PAs and civil society; 65%; (n=31) of producers. 
147 OPC feedback: 73%; (n=35) of consumers; 76% (n=19) of PAs and civil society; 45%; (n=18) of producers. 
148 OPC feedback: 67%; (n=32) of consumers; 72% (n=18) of PAs and civil society; 42.5%; (n=17) of producers. 
149 OPC feedback: 65%; (n=31) of consumers; 72% (n=18) of PAs and civil society; 60%; (n=24) of producers. 
150 Interview feedback: a UK lawyer. The lawyer quoted the CJEU decision in Joint Cases C-503/13 and C-504/13 of 5 
March 2015, which recognised that “where it is found that such products (i.e. medical devices such as the pacemakers 
and implantable cardioverter defibrillators) belonging to the same group or forming part of the same production series 
have  a  potential  defect,  it  is  possible  to  classify  as  defective  all  the  products  in  that  group  or  series,  without  there 
being any need to show that the product in question is defective”. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

5.2  Efficiency  

As presented in section 3.4, the limited data available in relation to the costs  entailed by the 
Directive  do  not  allow  for  the  application  of  any  standard  quantitative  methodologies  for  a 
cost-benefit assessment. Hence, the analysis of the Directive’s efficiency is mainly based on a 
qualitative evaluation. 

5.2.1  Analysis of costs 

EQ 21 What are the regulatory (including administrative) costs for relevant stakeholders stemming from 
the Directive?  

The  Directive  regulates  the  conditions  for  producer  liability  in  case  of  damages  to  consumers 
caused  by  defective  products.  The  relevant  stakeholder  groups  affected  by  the  Directive  and 
related obligations are producers, consumers, and Member States’ authorities.  

The main costs entailed by the Directive are mapped in Table 6, while a detailed description of 
these costs is provided in the following paragraphs.  

Table 6: Mapping of costs due to the Directive151 

Types of cost 

Provision 

Given  that  the  Directive  is  a  private  law 
leaves  to  the  parties  (and 
instrument, 
specifically 
to 
“enforce” its rules, i.e. to raise a claim in case of 
damage caused by a defective product.  

it 
to  consumers) 

the  burden 

Strict liability of producer (Art.1) 

Burden of proof (Art.4) 

Joint liability of producers (Art.5) 

€500 threshold (Art.9) 

three-year limitation period (Art.10) 

10-year limitation period (Art.11) 

Stakeholder affected 

Consumers, 
producers.  Member 
States 
affected 
only  in  case  of  in-
court settlement  

Producers 

Consumers 

Producers 

Consumers 

Consumers 

Consumers 

Communicate to the Commission the derogation 
to Art.7(e) (Art.15(2)) 

Member States 

Not required by any Directive provision 

Producers 

Enforcement costs152 
(e.g.  court  fees,  lawyers’  and 
experts’ fees) 

Substantive compliance 
costs153 (e.g. the amount of 
compensation to be paid) 

Administrative burden154 

Indirect costs155 
(e.g.  specific  liability  insurance, 
reputational costs) 

Enforcement costs 

The  Directive  is  a  private  law  instrument.  Therefore,  there  is  no  involvement  of  any  public 
authorities  to  ensure  that  its  rules  are  enforced.  As  a  private  instrument,  it  leaves  to  the 
parties  (i.e.  to  consumers)  the  burden  to  “enforce”  its  rules,  i.e.  to  raise  a  claim  in  case  of 
damage  caused  by  a  defective  product.  Therefore,  the  enforcement  costs  relating  to  the 
Directive can be of two types, based on whether the claim is settled in court or out-of-court. 

151 Based on the Better Regulation Toolbox. This Toolbox complements the main Guidelines on better regulation in the 
staff working document (SWD (2017) 350). The better regulation guidelines set out the principles that the European 
Commission  follows  when  preparing  new  initiatives  and  proposals  and  when  managing  and  evaluating  existing 
legislation.  The  Toolbox  provides  more  specific  and  operational  guidance  to  those  involved  with  the  various  better 
regulation instruments. Source: https://ec.europa.eu/info/sites/info/files/better-regulation-toolbox_1.pdf. 
152  These  costs  are  associated  with  activities  linked  to  the  implementation  of  initiatives  such  as  monitoring, 
enforcement and adjudication (Better Regulation Toolbox, p.341). 
153 Substantive compliance costs encompass those investments and expenses that are faced by businesses and citizens 
to comply with obligations or requirements contained in a legal rule (Better Regulation Toolbox, p.339). 
154 Administrative burdens are costs borne by businesses, citizens, civil society organisations and public authorities as 
a  result  of  administrative  activities  performed  to  comply  with  information  obligations  included  in  legal  rules  (Better 
Regulation Toolbox, p.339). 
155  These  costs  are  experienced  by  consumers,  government  agencies  or  other  stakeholders  that  are  not  directly 
targeted  by  the  initiative/regulation.  These  costs  are  usually  transmitted  through  changes  in  the  prices  and/or 
availability and /or quality of the goods or services produced in the regulated sector.  

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If  the  claim  is  settled  in  court,  the  enforcement  costs  are  comprised  of,  for  instance, 
lawyers’,  bailiffs’  and  experts’  fees,  court  fees,  taxes,  and  all  costs  relating  to  judicial 
proceedings. These costs vary considerably across Member States156 and depend, among other 
factors, on the type of litigation, the overall proceeding length, the compensation amount, the 
court, and the final decision.157 Considering, for instance, proceeding fees, in a civil proceeding 
they  can  range  from  less  than  €200  (e.g.  in  BE,  EE  and  SE)  to  over  €1,000  (e.g.  in  HU  and 
SK).158 

For example, these costs vary on the basis of the final decision, as usually fees are reimbursed 
(wholly or in part) if the claimant is successful. Enforcement costs of this type primarily weigh 
on  consumers,  on  producers  or  on  the  insurance  company  (if  the  producer  has  a  specific 
insurance),  and  partly  on  national  budgets,  as  courts  are  public  institutions  and  not  all  court 
costs may be fully covered by court fees. 

If  the  claim  is  settled  out  of  court,  the  enforcement  costs  are  relating  to  lawyers’  and 
experts’ fees. This type of enforcement cost weighs on consumers and producers (or insurance 
companies). 

A quantification of enforcement costs is not possible due to data limitations and to the fact that 
they  are  determined  on  a  case-by-case  basis  depending  on  specific  systems  in  each  Member 
State  jurisdiction.  However,  these  costs  (including  procedural,  court,  experts’  and  lawyers’ 
fees)  do  not  seem  to  have  any  connection  to  the  Directive,  being  that  they  mainly 
relate to national practices and judicial systems.159 

Substantive compliance costs  

A first issue to point out is that each substantive compliance cost stemming from the Directive 
and  falling  on  consumers  represents  a  potential  benefit  (or  a  lower  cost)  for  producers, 
whereas  if  it  falls  on  producers  it  represents  a  potential  benefit  for  consumers.  Moreover, 
substantive compliance costs are not directly quantifiable, as they are closely intertwined with 
enforcement  costs,  and  they  are  evaluated  in  the  context  of  a  claim  settlement.  More 
specifically,  compliance  costs  introduced  by  the  Directive  are  detailed  below  per  category  of 
stakeholder. 

As to costs for producers, the study identified the following: 

  Strict liability (Article 1): introduces a cost that – if the claim is successful ̶ will be equal to 
the  amount  of  compensation  to  be  paid.  This  cost  is  case-dependent.  Moreover,  it  will 
depend on the definition of “producer” adopted by the Member State when transposing the 
Directive.160 As a consequence, this cost is likely to be unequal across the EU;  

 

Joint liability of producers (Article 5): the study identified no cases where this provision was 
applied. 

156 Hoche (2007). Study on the Transparency of Costs of Civil Judicial Proceedings in the European Union. Final Report. 
CONTRACT JLS/2006/C4/007-30-CE-0097604/00-36. Data retrieved from the targeted survey show that average costs 
for legal assistance range from €75 (Malta) to €3,434 (Austria). 
157 Ibid.  
158  For  instance,  in  a  case  between  a  producer  and  a  buyer  involving  €20,000  worth  of  goods,  the  evidence  from  a 
majority  of  Member  States  shows  fees  between  €400  and  €800.  The  calculation  of  fees  depends  on  several  factors, 
and  largely  varies  across  Member  States.  In  Finland,  for  instance,  proceeding  fees  depend  on  the  stage  of  the 
proceedings  (e.g.  they  amount  to  €72  if  the  litigation  ends  up  before  the preliminary  hearing,  they rise  to €164  if  a 
proper audience is complete). Appeal fees also vary across Member States, since they depend on the fees of the first 
degree of judgment. Some Member States (e.g. FR, LU, SE) may not have fees at the appeal stage; in some countries 
(e.g. CZ, PL, SK) fees for the appeal are the same as those required for the first degree proceeding. (Source: Hoche 
(2007). Study on the Transparency of Costs of Civil Judicial Proceedings in the European Union. Final Report). 
159  The  CATI  survey  results  showed  that  43%  (n=198)  of  respondents  felt  that  the  Directive  had  no  impact  on  the 
costs  of  legal  settlement,  while  29%  (n=134)  of  respondents  think  that  the  Directive  increased  the  costs  for  legal 
settlements, and 9% (n=43) think costs have decreased, with no significant differences in terms of firm size.  
160  Romania,  for  instance,  extended  this  definition  to  any  person  who  imports  into  Romania  a  product  for  sale,  hire, 
leasing or any form of distribution in the course of his business. 

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The  provisions  entailing  a  potential  cost  for  consumers  are  more  numerous  than  those 
entailing a cost for producers, and namely: 

  The burden of proof (Article 4) represents a cost for consumers (and a potential benefit for 
the  producer).  This  provision  appears  to  be  the  most  burdensome  to  consumers,161  who 
deem particularly costly: 

   Proving the link between the defect and the damage;162  
   Attributing liability to a specific person or entity;163 
   Proving that the product was defective;164 
   Discovering where exactly the defect occurred;165 
   Proving the damage.166 

The  average  time  to  prove  the  right  to  be  compensated  is  quite  variable  across  Member 
States, for example, more than 10 days, between two and five days, and maximum one day, 
as  stated  by  three  consumer  organisations  from  Malta,  Italy,  and  Austria,  respectively.  As 
discussed  in  section  4.7,  the  costs  relating  to  the  burden  of  proof  vary  from  sector  to  sector 
and they seem to be particularly relevant in the pharmaceutical and medical sector, where one 
of  the  major  problems  appears  to  be  relating  to  demonstrating  the  link  between  the  damage 
and  the  defect.167  Although  burdensome,  the  costs  relating  to  this  provision  cannot  be  fully 
attributable to the Directive, given that the burden of proof weighing on the claimant is at the 
basis of the Western legal tradition and judicial system. 

  The  €500  threshold  (Article  9)  represents  a  cost  for  consumers  (and  a  benefit  for  the 
producer)  inasmuch  as  it  prevents  any  claims  (and  related  possible  compensation)  under 
€500 from being raised, which is often the case.168 Evidence of this is seen in that six out of 
11  consumer  representatives  responding  to  the  survey  declared  that  lowering  this 
threshold would have a positive impact.169 

  The three-year limitation period (Article 10) for the recovery of damages entails a cost for 
consumers (and a potential benefit for the producer) in terms of missed compensation after 
its  conclusion,  as  also  confirmed  by  OPC  results.170  However,  the  expiration  of  the  three-
year  period  does  not  seem  to  represent  one  of  the  major  causes  for  rejection  of  a  claim 
(equal to 4% of the cases mapped at the national level, see). 

  The  10-year  limitation  period  (Article  11)  to  make  a  claim  from  the  date  on  which  the 
producer  put  into  circulation  the  product  which  caused  the  damage  potentially  entails  a 
significant cost in terms of missed compensation. As previously discussed, this provision is 
particularly  costly  in  the  case  of  damages  caused  by  defective  pharmaceutical  or  medical 
products  that  are  amongst  the  products  most  frequently  subject  to  claims  (see  Table  4). 
Moreover, 
that  damages  caused  by  defective 
pharmaceutical/medical  products  are  likely  to  have  significant  consequences  (and  costs). 
The  consumer  associations  responding  to  the  targeted  survey  deem  this  provision  as 

to  assume 

reasonable 

is 

it 

161 Survey feedback: 80% (n=8) of consumers. 
162 Survey feedback: 88% (n=7) of consumers. Similarly, PAs and civil society responding to the OPC stated that the 
most burdensome provision is providing the proof of link between defect and damage (84%, n=21). 
163 Survey feedback: 88% (n=7) of consumers. 
164 Survey feedback: 75% (n=6) of consumers. Similarly, PAs and civil society responding to the OPC stated that the 
most burdensome provisions is providing the proof of defect (64%, n=16). 
165 Survey feedback: 75% (n=6) of consumers. 
166 Survey feedback: 75% (n=6) of consumers. 
167 As an example, laboratories which produce medicines do not always recognise risks for patients but indicate them 
in the leaflet, which serves as a “legal umbrella”. In other terms, the risks connected to the medical sector are reduced 
by laboratories through the disclaimer represented by the leaflet. 
168 According to the OPC, 68% of respondents agree that property damages are often below € 500. 
169 As also confirmed by an interviewed IT consumer association. 
170 Survey feedback: 63% (n=5) of Consumers. 

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burdensome.171  However,  this  provision  does  not  seem  to  represent  one  of  the  major 
causes for rejection of a claim (see Figure 6). 

As  a  final  consideration,  the  large  variations  in  the  number  of  claims  per  Member  State  (see 
Figure 8) demonstrate that both enforcement and substantive compliance costs have different 
impacts on consumers, producers and Member States across the EU. 

Administrative burden 

The only provision of the Directive entailing an information obligation is Article 15(2), requiring 
Member States to inform the Commission in case they derogate to the development risk clause 
(i.e.  to  Article  7(e)).  This  cost  is  deemed  to  be  residual,  given  that,  based  on  findings  of  the 
desk research at  the national level, it affected only  five Member States, it is one-off, and the 
provision per se does not require anything more than a simple transmission of information. 

Indirect costs 

Indirect costs are not introduced by the Directive, but are its direct consequence. These costs 
affect  producers  and  mainly  relate  to  the  payment  of  insurance  premiums  related 
specifically to strict liability. Responses to the CATI survey show that these costs, although 
high, have an overall impact on a small number of firms172 and are basically unchanged from 
2000173, also considering sectors characterised by new technological developments. According 
to  the  inputs  received  from  three  insurer  associations,  the  coverage  offered  by  strict  liability 
insurances  varies  from  one  case  to  another.  For  instance,  in  Denmark  and  France,  product 
liability insurance usually covers damages resulting from the defective product, the costs of the 
technical  analyses  made  by  the  expert  and  the  proceeding  costs.  Therefore,  the  producer  is 
fully  covered  and  does  not  need  to  bear  any  additional  expenses.  In  Germany,  insurance 
options seem to be more differentiated and the product liability insurance may: 

  Cover  damage  compensation  up  to  a  certain  limit,  and  cover  in  addition  the  extra  costs 

(expert, lawyer, proceeding costs);  

  Cover up to a certain limit both damage compensation and proceeding costs;  

  Negotiate a deductible, i.e. a threshold up to which the insured party still has to pay;174 

  Foresee  policy  exclusions,  meaning  that  the  claims  cannot  be  refunded  in  case  of  specific 

circumstances (e.g. asbestos, war objects), even if defective products are involved. 

Reputational  costs  and  research  and  development  costs  are  definitely  relevant,  especially  for 
those  manufacturers  that  produce  robotic  devices.  Indeed,  investments  in  research  and 
development  could  lead  to  the  creation  of  products  with  a  certain  technological  added  value, 
but also with high liability risk. In these cases, producers tend to delay the introduction of the 
products to the market, up to the moment when the technology is considered safe enough to 
avoid potential reputational damages.175  

The following table presents three cases with related costs based on the implementation of the 
Directive  in  three  different  Member  States.  As  shown,  the  duration  of  a  proceeding  can  vary 
significantly,  e.g.  from  one  to  four  years.  Consumers  bear  as  upfront  costs  the  cost  of  the 
damage  as  well  as  all  costs  relating  to  the  proceeding.  However,  based  on  findings  from  the 
desk  research  at  the  national  level,  the  average  ratio  of  compensation  awarded  with 
respect to compensation requested in the EU over 2000-2016 was equal to 53%.  

171 Survey feedback: 88% (n=7) of Consumers. 
172 Only 22% (n=99 out of 457) of businesses responding to the CATI survey had a specific insurance to cover strict 
liability. Interviewees declared this is due to its excessively high cost. 
173 Two industry associations (EL, EU). 
174  There  are  usually  deductibles  when  the  premium  is  low,  in  order  to  avoid  having  too  many  small  claims,  which 
would be costly for insurers in terms of administration. 
175  RoboLaw  (2014).  Regulating  Emerging  Robotic  Technologies  in  Europe:  Robotics  facing  Law  and  Ethics  - 
Collaborative project (CP), FP7-SiS-Challenge 1-3: Regulating emerging scientific and technological developments. 

45 

 
                                                 
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IE 

EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Table 7: Examples of costs relating to the Directive176 

Case description 

Enforcement costs 

Substantive compliance costs 

Indirect costs 

These  costs  are  not  specified  in  the 
case.  Based  on  the  Irish  judicial 
system,  the  winning  party  is  also 
compensated  for  the  costs  of  the 
proceeding.  The  value  of  the  claim 
dictates  the  level  of  court  in  which 
take  place,  and 
the  case  will 
therefore influences the level of costs 
that will arise. 

For  a  value  of  claim  greater  than 
€100,000,  the  overall  proceeding 
costs  in  High  court  will  be  around 
€70,000.177  

Compensation  paid  by 
producer to the consumer:  

the 

No 
available 

information 

Special  damages  (past  care  and 
travel expenses, future revision and 
care  costs,  future  home  care/aids 
and appliances) to date and into the 
future = €482,455.11  

Physical  damages  to  date  and  into 
the future = €300,000  

SUBTOTAL: €782,455.11  

Less  10%  (amount  of  damages  
relating 
defendant’s 
the 
to 
dysplasia) = €78,245.51  

TOTAL = €704,209.60 

Case No. 10576 P., 2012. 

The  High  Court  between  Gillian  O’Sullivan 
(plaintiff)  v.  DePuy  International  Limited 
(defendant) 

The  fact:  The  plaintiff  was  born  with 
bilateral  acetabular  dysplasia,  which  is  a 
congenital  deformity  of  her  hips.  She  was 
operated  on  by  Mr.  O.,  an  orthopaedic 
surgeon who implanted her with a Metal on 
Metal  (MOM)  hip,  produced  by  DePuy,  in 
2005.  Five  years  later  the  product  was 
recalled.  In  the  meantime,  between  2007 
and  2010,  the  plaintiff  was  very  seriously 
debilitated  and  suffered  from  a  number  of 
complications  due  to  the  defective  product, 
which  was  eventually  replaced  in  2012.  At 
the  time  of  the  proceeding,  she  had  not 
completely  recovered  and  was  expected  to 
suffer  from  reduced  mobility  also  in  the 
future. 

Decision:  The  Court  held  the  producer 
responsible  for  the  damage  caused  by  the 
defective MOM hip. 

Duration: four years 

Degree: the High Court of Ireland 

IT 

Case  N.  34848/  2004,  S.N.  v.  Azienda 
Sanitaria Locale 8 (Local health agency, the 
supplier) v. S.r.l. MECC SAN (the producer). 

to 
Proceeding 
reimbursed 
full  by 
producer to the consumer:  

costs 

in 

be 
the 

Compensation  paid  by 
producer to the consumer:  

the 

No 
available 

information 

176 All costs not provided by the case are retrieved from: https://e-justice.europa.eu/content_costs_of_proceedings-37-en.do (country reports). 
177 Costs cover solicitors’ fees, consultation fees and other barristers’ fees (e.g. attendance at pre-trial motion, drafting documents, etc.), and, depending on the type of claim, 
witness  expenses,  expert  witnesses,  court  fees  and  VAT.  (Source:  Hoche  (2007).  Study  on  the  Transparency  of  Costs  of  Civil  Judicial  Proceedings  in  the  European  Union. 
Country report – Ireland). 

46 

 
                                                 
MS 

Case description 

Enforcement costs 

Substantive compliance costs 

Indirect costs 

EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

The  fact:  The  local  health  agency  supplied 
Mr  S.N.  with  a  medical  bed  –  produced  by 
MECC  SAN  -  to  be  used  by  his  84-year  old 
father. After eight months of use, while the 
elderly man was being transferred from the 
wheelchair  to  the  bed,  the  bed  broke, 
causing the old man’s leg to break.  

Decision:  The  Court  held  the  producer 
responsible  for  the  damage  caused  by  the 
defective bed. 

Duration: one year 

Degree: first instance court 

DE 

Case VI ZR 327/12  

The 
fact:  The  plaintiff,  Mr.  F.,  was 
implanted  in  2005  with  a  cardioverter 
insufficiency 
defibrillator  as  a  cardiac 
therapy  (ICD)  by  the  company  G.  In  June 
2005 G. sent a letter that could be classified 
as a “recall” of the product, saying that the 
technical  analysis  showed  that  a  magnetic 
switch  of  the  ICD  might  fail  due  to  a  serial 
defect,  compromising  the  ICD’s  overall 
functionality.  G.  ensured  that  adequate 
functionality for the treatment of ventricular 

a.  Lawyers’ fees = €6,403.2 

For physical damages = €6,500  

b.  Lawyers’  operating  expenses  = 

Interest = €1,092  

€391.5 

TOTAL = €7,592 

c.  Lump  sum  payment  (for  lawyers’ 
(a+b)*15%  = 

expenses)  = 
€1,019.2 

d.  Contribution  to  lawyers’  pension 
fund = (a+b+c)*4% = €312.6 

e.  VAT  = 
€1,787.8 

(a+b+c+d)*22%  = 

f.  Court fee = €170 

g.  Technical  advice  by  two  medical 

experts = €145*2 = €290 

TOTAL = €10,374.23 

No  reimbursement  of  proceeding 
costs  is  paid  to  the  local  health 
agency,  although  held  not  liable. 
Therefore, this cost falls on the public 
budget. 

These  costs  are  not  specified  in  the 
case. 

the  German 

the  winning  party 

judicial 
Based  on 
is 
system, 
compensated  for  the  costs  of  the 
proceeding,  namely 
lawyer’s 
statutory  fees  and  expenses,  travel 
costs,  and  including  any  loss  of 
earning  incurred  through  attendance 
at court.178 

the 

The losing party also covers the costs 
of  an  expert  engaged  by  the  court 

The  Federal  Court  remitted  the 
ruling  of  the  Court  of  Appeals  and 
instructed a new judgment.  

Different  amounts  were  foreseen  in 
the different instances: 

No 
available 

information 

Compensation  paid  by 
producer 
to 
(district court):  

the 

the 
consumer 

Costs 
for 
€20,315.01 

hospitalisation 

= 

Costs for treatment = €122.50  

178 https://e-justice.europa.eu/content_costs_of_proceedings-37-de-en.do?member=1.  

47 

 
                                                 
MS 

Case description 

Enforcement costs 

Substantive compliance costs 

Indirect costs 

EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

(or  shared  by  the  parties  if  they  are 
only  partially  successful).  Costs  for 
experts  privately  engaged  do  not 
form  part  of  the  procedural  costs 
covered by the reimbursement. 

TOTAL = €20,437.01 

Compensation  paid  by 
producer 
the 
to 
(Court of Appeals):  

the 
consumer 

Treatment costs = €5,952.80 

TOTAL  =  €5,952.80  (plus  interest 
– not specified by the Court) 

and  atrial  tachyarrhythmia  was  available, 
even  with  the  magnetic  switch  stuck  in  the 
closed position, but that the failure can limit 
utility of the functioning.  

G.  recommended  patients  to  contact  their 
doctors  or  hospitals  in  order  to  assess  the 
equipment  and,  in  case  of  defect,  to 
deactivate  the  magnetic  switch  from  the 
outside  (without  surgery).  Four  incidents 
were  confirmed,  and  the  devices  were 
replaced  in  all  cases.  Among  these,  Mr  F, 
who  wore  a  device  belonging  to  the  family 
of  such  products,  was  in  a  University 
Hospital  from  28  February  to  March  2006, 
where the ICD unit was extracted.  

Decision:  The  district  court  originally 
granted  the  claim  of  the  plaintiff,  while  the 
Court  of  Appeals,  still  confirming  that  the 
device  did  not  offer  the  safety  that  is 
reasonably expected, partially amended the 
of 
judgment, 
compensation to be paid. 

reducing 

amount 

the 

The Federal Court, also after and due to the 
respective  judgment  of  the  CJEU,  annulled 
the  previous  judgment  of  the  Court  of 
Appeals,  remitting  the  case  to  the  Court  of 
Appeals 
for  renegotiation  and  a  new 
decision,  including  on  the  costs  of  the 
appeal procedure. 

Duration: four years 

Degree: Federal Court decision  

48 

 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

5.2.2  Analysis of benefits  

EQ 22 What are the main benefits for stakeholders and civil society that derive from the Directive? 

The Directive has set the basis for a common rule on the strict liability of the producer and for 
consumers’  right  to  claim  compensation  for  damages  due  to  a  defective  product.  In  this 
context, the relevant stakeholder groups affected by the benefits of the Directive are producers 
and consumers. 

Available data only allow for a qualitative assessment of benefits. A summary of the analysis is 
reported  in  Table  8,  while  a  detailed  description  of  the  benefits  is  provided  in  the  following 
paragraphs. 

Table 8: Mapping of benefits 

Types of benefit 

Provision 

Stakeholder affected 

Improved well-
being179 

Market 
efficiency180 

Strict liability of producer (Art. 1) 

Consumers 

Joint liability of producers (Art. 5) 

Burden of proof (Art. 4) 

Exemptions (Art. 7) 

€500 threshold (Art. 9) 

three-year limitation period (Art. 10) 

10-year limitation period (Art. 11) 

Producers 

Increased 
harmonisation181 

Compliance  with  the  Directive  (Art.  19)  and 
harmonisation through the cases of the CJEU 

Consumers;  Producers,  including 
suppliers and importers. 

Consumers’ improved well-being 

Both the strict liability and the joint liability (where two or more entities are liable for the same 
damage)  of  producers  are  immediate  consequences  of  the  Directive  and  represent  a  clear 
benefit  for  consumers,  especially  since  these  principles  were  introduced  by  the  Directive  for 
the first time. Thanks  to the Directive, since 1985 all EU consumers  enjoy the right to obtain 
compensation for damage caused by a defective product directly from its producer. Therefore, 
at  least  in  principle,  the  Directive  has  increased  consumer  protection  and  reduced  the  legal 
costs  relating  to  claims  for  defective  products.  Moreover,  consumers’  claims  have  been 
successful in 60% of the cases examined (see finding 20).182 

Such  an  evidence  is  confirmed  by  the  results  of  the  OPC,  since  stakeholders  strongly  agree 
that consumers can enjoy the same rights in terms of compensation wherever they are in the 
EU183 (see Figure 9). 

179 Such benefits include, most notably, health, safety and environmental benefits (Better Regulation Toolbox, p. 350). 
180  This  might  include  improved  allocation  of  resources,  removal  of  regulatory  or  market  failures  or  cost  savings 
generated by new initiatives/regulation (Better Regulation Toolbox, p.350). 
181 This refers to the creation of a level playing field for producers and consumers, guaranteeing at EU level the liability 
of the producer in all Member States, and ensuring an increased homogeneity of procedures.  
182 The number of cases published and thus available for this study (which may seem at first sight to be limited) and 
the occurrence of cases in which the court decides the claim on a legal basis different from the Directive do not imply 
that the injured persons do not seek compensation for damages that occurred because of defective products based on 
contract law or tort law. As mentioned in section  5.1, the Directive is a sort of a last possible course of action which 
may function when other options or legislation have not worked. Then, the “iura novit curia” doctrine is at work across 
all civil law systems (that is, in most Member States) and to some significant extent also in common law systems: this 
rather suggests that sometimes the Directive is invoked inappropriately. 
183 94% (n=45) Consumers; 90% (n=36) Producers; 88% (n=22) PAs and civil society. 

49 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Figure 9: Consumers’ satisfaction with benefits deriving from the Directive184 

Source: OPC 

Market efficiency 

The Directive provisions entailing benefits for producers are  those relating to the existence of 
burden  of  proof,  the  €500  threshold  and  the  three-  and  10-year  limitation  period,  as  these 
provisions  limit  the  possibility  for  consumers  to  issue  claims  for  compensation.  More  in 
particular, the €500 threshold is seen as beneficial in limiting the number of small claims that 
are raised against the producers.  

In  addition,  the  exemptions  provided  in  Article  7  are  beneficial  to  producers  as  they  exclude 
some cases where the producer can be considered not liable, despite the fact that the defect in 
his  product  has  caused  a  damage.  More  specifically,  this  provision  requires  the  producer  to 
demonstrate that he is  not liable for the damages caused by his defective product.  However, 
as  shown  in  Figure  6  in  section  4.7,  the  causes  of  rejection  connected  to  the  producer’s 
exemption from liability are the least frequent (overall equal to 10% of the cases). This seems 
to  suggest  that  exemption  from  liability  either  occurs  rarely  or  it  is  difficult  to  demonstrate, 
thus possibly entailing a high cost. Moreover, as discussed in section 4.1, five Member States 
(ES,  FI,  FR,  HU,  LU)  have  adopted  the  derogation  under  Article  151(b)  (see  finding  2).  This 
possibility causes variability in the benefits relating to Article 7 across the EU. As the majority 
of claims reported across Member States concerned a product originating in the same Member 
States  were  the  claim was  brought  (see  Figure  5),  this  means  that  businesses  located  in  the 
five Member States which have derogated to the development risk clause will benefit less from 
this provision. Furthermore, the development risk clause helps to maintain a relative stability 
in  product  liability  insurance  costs  and  a  reasonable  level  of  litigation,  which  together  enable 
innovation (Rosselli Foundation, 2004). In any  case, if the producer manages to demonstrate 
that  he  is  not  liable  according  to  Article  7,  this  provision  translates  into  a  cost  for  the 
consumer.  

The  benefits  relating  to  these  provisions  translate  into  the  development  of  a  clear  and  stable 
legal framework, as stated,  for  example, by  one  stakeholder interviewed185 and confirmed by 
the results of the OPC, as stakeholders strongly agree that a benefit of the Directive is that it 
creates  the  same  liability  rules  for  all  producers  across  the  EU,  thus  granting  a  level  playing 
field.186  This  is  further  reinforced  by  the  fact  that  Member  States  cannot  implement  product 

184 Total number of respondents to this question = six. Rating from 1 to 5. The height of the bars results from the sum 
of the rates given by each respondent. 
185 Interview feedback from a representative from EU institutions. 
186 79% (n=38) Consumers; 90% (n=36); Producers; 88% (n=22) PAs and civil society. 

50 

0510152025Harmonised right tocompensation across MSLower legal costs for theproof of fault/negligenceof the producerIncreased protection ifcompared to the situatioprevious to the entry intoforce of the PLDWeight given by consumers 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

liability rules diverging from those already covered by the Directive for national producers,  as 
this would lead to different levels of consumer protection.187  

The findings from the desk research reinforced this view, highlighting how the wide acceptance 
of  the  Directive  and  the  related  harmonisation  can  be  considered  as  beneficial  for  both 
stakeholders from civil society and industry (Lovells, 2001).  

Increased harmonisation 

The increased harmonisation stemming from the Directive is a benefit that most stakeholders 
consulted perceived. Indeed, the large majority of the respondents to the OPC believe that the 
fact that consumers can enjoy the same rights in terms of compensation wherever they are in 
the EU is a strong advantage,188 together with the fact that Member States cannot implement 
product liability rules that are different from those already covered by the Directive for national 
producers  and  that  would  lead  to  different  levels  of  protection.189  Several  insurances 
interviewed190 also believe that the Directive effectively contributes to the achievement of the 
guarantee  at  the  EU  level  of  the  liability  of  the  producer  for  damage  caused  by  a  defective 
product. Three of them, in particular, emphasised that the level of harmonisation in the EU is 
sufficient. 

5.2.3  Balance and distribution between costs and benefits 

EQ 23 Are the benefits achieved at reasonable cost for consumers and producers (with focus on SME)? 

The benefits are achieved at a reasonable cost for producers, but enforcement costs may be a 
material  obstacle  for  consumers  as  they  must  pay  them  up  front  in  order  to  bring  a  claim  in 
court. 

As discussed in the previous sections, the costs for producers due to the Directive are mainly 
indirect costs relating to insurance, and enforcement costs relating to the settlement of claims 
(when  consumers  are  successful).  Overall,  few  producers  choose  to  pay  for  specific  strict 
liability insurance directly relating to the Directive, but most of them have an insurance policy 
covering  product  liability  jointly  with  other  risks  (see  finding  11)  and,  if  they  do,  they 
incorporate  this  cost  in  product  prices  and  pass  it  to  consumers.191  As  for  the  enforcement 
costs, they are in principle paid by producers in 60% of the cases ̶ as they are paid whenever a 
consumer  claim  is  successful  (see  finding  11)  –  and  are  perceived  as  “rightful”  costs.192 
However,  some  literature193  argued  that  in  specific  sectors,  e.g.  robotics,  the  Directive  could 
have  distortive  effects  on  the  time-to-market  of  products  with  a  high  technological  added 
value. Liability risks could indeed appear to be so high that producers may decide to delay the 
introduction of their products (e.g. self-driving cars) until technology allows ensuring a higher 
level of safety. Nonetheless, Palmerini & others (2014) suggest that there are few reasons not 
to hold manufacturers liable on the basis of product liability, also taking into consideration the 
characteristics  of  the  insurance  market.194  Moreover,  further  evidence  of  such  instances  has 

187 71% (n=34) Consumers; 77.5% (n=31); Producers; 68% (n=17) PAs and civil society. 
188 Overall, 74.34%. 
189 Overall, 58.41%. 
190 9 insurance associations and representatives. 
191 HU industry association. 
192 EU industry association. 
193  RoboLaw  -  Regulating  Emerging  Robotic  Technologies  in  Europe:  Robotics  facing  Law  and  Ethics  -  Collaborative 
project (CP), FP7-SiS-Challenge 1-3: Regulating emerging scientific and technological developments - www.robolaw.eu 
– Start of the project 01/03/2012, Delivery date 22.9.2014. 
194 It depends particularly on the competitiveness of the insurance market. When the insurance market is competitive 
and  individual  insurers  cannot  increase  the  premiums  they  charge  to  their  customers,  they  are  interested  from  an 
economic perspective in reducing the number of accidents and the compensations they have to pay out. Reduction in 
pay-out  would  be  a  way  to  maximise  profit.  If,  however,  the  insurance  market  is  not  competitive,  insurers  may 
increase premiums to compensate for higher pay-outs. In such a non-competitive market, a larger volume of damages 
may  actually  be  an  attractive  scenario  for  insurers,  since  it  increases  turnover  and  profit.  In  particular,  in  Italy, 
automobile  insurers  are obliged  to  accept  new  customers;  however,  there  are other  Member  States  (e.g.  NL)  where 

51 

 
                                                 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

not  been  found  in  the  field  research.  Benefits  therefore  seem  to  be  achieved  at  a 
reasonable cost, as confirmed also by the findings of the field research, where no significant 
difference is registered when firms are broken down by size.195 The cost-benefit ratio remains 
reasonable also when SMEs are considered. Evidence gathered from the desk research shows 
that, due to lack of knowledge of the relevant legal requirements, it seems very unlikely that 
liability rules have a direct effect on SMEs.196  

As  for  consumers,197  the  relevant  costs  are  relating  to  enforcement  costs,  i.e.  all 
requirements  weighing  on  consumers  to  prove  the  rightfulness  of  the  claim  and  the  costs 
associated  with  the  damage  suffered,  which  can  be  high  if  the  claim  is  settled  in  court,  and 
which  can  be  a  substantial  obstacle  when  the  claimant  must  pay  for  them  up  front  (as  it 
normally happens). In this context, a Croatian consumer association suggests that a stronger 
consultation  role  should  be  granted  to  EU-level  consumer  associations,  which  should  also  be 
empowered  to  represent  consumers  in  court.  Similarly,  a  Maltese  consumer  association 
considers  the  overall  cost  and  burden  weighing  on  consumers  as  being  high.  However,  the 
possibility for the producer to end up in court provides some leverage in claim resolution to the 
benefit of the consumer.  

Overall, considering that the burden  of proof is a basic rule in the Western legal tradition, all 
costs  associated  with  it  (and  thus  with  the  Directive)  appear  to  be  unavoidable.  Considering 
that claims for defective products tend to have a relatively high rate of success (i.e. 60%), this 
cost  seems  reasonable  in  comparison  to  the  benefit  gained.  However,  as  discussed,  it  is 
uncertain  whether  benefits  outweigh  costs  in  the  cost-benefit  ratio  of  the  Directive  due  to 
external factors – such as the costs and length of proceedings, varying from one Member State 
to another, and the very fact that the claimant must normally pay for them up front. 

EQ 24 Does the Directive strike the right balance between the costs borne by the producers to cover the 
strict liability and the requirements on the injured party to obtain compensation? 

Overall,  it  seems  that  the  Directive  has  managed  to  strike  the  right  balance  between  the 
costs  borne  by  producers.  However,  this  conclusion  is  not  so  clearly  evident  when 
consumers are concerned. Moreover, the balance between costs and benefits relating to the 
Directive is not uniform across Member States and sectors/ product types.  

On  the  one  hand,  the  literature  reviewed  mainly  expresses  negative  opinions  on  the  balance 
achieved  by  the  Directive.198  On  the  other  hand,  notwithstanding  the  fact  that  there  is  a 
general lack of feedback from stakeholders, those who have been consulted do not seem to be 

insurers are allowed to decline applications for motor vehicle insurance. In any case, insurance reduces the unsettling 
effect  that  product  liability  may  have  on  manufacturers:  a)  compensating  the  victim;  b)  exhibiting  opportunistic 
behaviors and suing manufacturers in anticipation of a pay-out; c) being party to a possible legal dispute. This helps 
take emotion out of the case (Palmerini, Azzarri, Battaglia & Others, 2014). 
195 CATI survey respondents: costs and benefits of the Directive are well-balanced (50%, n=230). 
196  Havinga  (2007).  An  interview  conducted  in  the  UK  in  2005  with  SMEs  in  the  food  industry found  that  most  were 
unable  to  assess  their  own  compliance  with  food  safety  regulations  because  of  lack  of  knowledge  of  the  legal 
requirements.  The  compliance  process  proved  to  be  highly  reactive,  with  businesses  responding  to  external 
intervention rather than initiating action.  
197  In  particular,  in  the  interviews,  consumer  representatives  indicated  the  following:  according  to  a  European 
consumer  organisation,  many  victims  will  not  go  to  court  individually  as  it  is  often  expensive,  complicated,  time 
consuming  and  intimidating  for  many,  and  even  more  so  in  cross-border  cases,  so  they  call  for  collective  redress 
mechanisms. According to a FR consumer organisation, when it comes to medicines, the Directive implies huge costs 
because  victims  cannot  win  a  case  on  the  basis  of  its  provisions,  and  therefore  do  not  get  compensation  for  their 
damages. This creates social costs, and also human costs (around 30,000 deaths per year from Lyell Syndrome= high 
reaction  to  adverse  effects  of  some  medicines).  According  MT  consumer  representatives,  many  consumers  find  the 
system  for  recovering  compensation  somewhat  cumbersome,  and  not  worth  it  if  the  value  of  the  product  is  low. 
According to HR consumer representatives, the main costs come from the burden of proof (expert, court proceedings) 
and  the  consumer  often  needs  the  help  of  the  manufacturer  to  determine  what  caused  the  defect  when  several 
manufacturers  took  part  in  the  production.  According  to  CY  consumer  representatives  there  should  not  be  a  lot  of 
costs, while an IT consumer organisation stated that it is too much of a burden for the injured party to prove that the 
product was defective (including expert and access to information). 
198 Rajneri Karageorgevitch (2015) and Peopil (2017).  

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

particularly concerned by an unfair balance created by the Directive.199 Some diverging views 
emerged from the interviewees.200 According to a Croatian consumer association, the Directive 
does  not  provide  for  a  fair  balance  between  the  costs  borne  by  the  producers  to  cover  the 
strict liability and the requirements on the injured party to obtain compensation. The position 
of  the  manufacturer  is  indeed  stronger,  since  firms  (especially  the  largest)  have  legal 
departments  that  support  them,  while  consumers  have  to  act  alone  in  most  cases.  Two 
consumer  associations  also  argue  that  the  duration  of  procedures  and  costs  of  the  justice 
systems  generally  discourage  consumers  from  enforcing  their  rights  through  legal  action,  as 
demonstrated by the analysis performed (Figure 8). 

However,  using  the  words  of  a  large  Italian  producer,  “the  relationship  between  costs  and 
benefits  borne  by  consumers  and  producers  in  case  of  a  product  liability  trial  is  mostly 
dependent upon the type of defect for which the producer is held liable”. Indeed, if the alleged 
defect  is  a  design  defect,  the  producer  is  exempt  from  liability,  as  per  the  development  risk 
clause. In case the injuries are attributed to ‘informational defects’ or ‘manufacturing defects’, 
it is up to the injured party to prove the  existence of the etiological link between the specific 
defect  of  the  product  and  the  actual  damage  suffered.  The  different  types  of  defects  lead  to 
different  scenarios  that  may  vastly  shift  the  allocation  and  management  of  resources  by  the 
producer. For the same reason, costs and benefits ratios can vary significantly across different 
sectors  (see  section  5.2).  Some  products  require  a  more  complicated  and  costly  assessment 
procedure,  in  terms  of  both  the  technological  complexity  of  the  procedure  itself  and  of  the 
capacity of service centres to verify defects (e.g. cell phones), whereas other products require 
less onerous systems of assessment (e.g. washing machines). 

EQ  25  What  aspects  of  the  Directive  are  most  efficient  or  inefficient  to  reach  the  objective  of  having  a 
system of strict liability on the producer? 

The  positive  or  negative  assessment  with  respect  to  the  aspects  of  the  Directive  that 
contribute  to  its  efficiency  depends  on  the  category  of  stakeholder.  The  aspects  that  are 
usually valued positively by producers are those that are mostly criticised by consumers, and 
vice versa. 

The  most  controversial  provision  is  represented  by  the  burden  of  proof.  According  to 
producers, this provision is the most efficient, as it is up to the injured person to justify his/her 
claim.201  According  to  the  consumer  associations  surveyed,  this  is  the  most  burdensome 
provision and does not allow benefits to be achieved at a reasonable cost. This is even more so 
in the case of new technological developments, which will further increase the  burden relating 
to this provision. According to  a UK lawyer, the  requirement for proof of defect is  completely 
inefficient because of the uncertainty of the definition of defect, as further discussed in section 
5.4.2.  Finally,  two  consumer  associations  assert  that  the  heavy  burden  of  proof  represents  a 
weakness in product safety rules in terms of consumer protection.  

The 10-year expiry period has also been pointed out as a particularly inefficient provision,202 
especially in the pharmaceutical and medical sectors (see section 4.7). 

The  €500  threshold  is  an  obstacle  to  the  Directive’s  efficiency,  according  to  stakeholders 
raising this specific point,203 thus it should be considerably lowered. However, businesses are 

199 Consumers contributing to  the OPC consider that the Directive provides for a fair balance between the interest of 
consumers  and  those of producers  (65%,  n=30).  According  to businesses  surveyed  through  the CATI,  the  costs  and 
benefits  of  the  Directive  are  well-balanced  (50%,  n=230).  PAs  and  CS  consider  the  Directive  as  providing  for  a  fair 
balance  between  the  interests  of  consumers  and  those  of  producers  to  a  significant  and  moderate  extent  (66%, 
n=15).  This position  has  been  confirmed  also  by  five  EU  industry  associations,  one  of which  represents producers  in 
the automotive industry and one represents producers in the digital technology industry; a CY expert, an IT and a FR 
industry association, a DE, EU and FR insurer association, two UK and one FR lawyers. 
200 An ES and a HR consumer association, an ES and an NL expert, three UK and one BE lawyers. 
201 A large IT producer, a Belgian Association representing e-commerce industry. 
202 Three UK lawyers. 
203 An ES and LU consumer association, a CY expert. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

overall  satisfied  with  the  lower  threshold  of  €500  for  damage  compensation,  although  this  is 
supported more strongly by medium-sized and large firms.204 

The development risk clause represents another inefficient aspect according to a UK lawyer 
and a PA, as the circumstances for its application should be clarified. However, some scholars 
(Rosselli Foundation, 2004) argued that the development risk clause represents a satisfactory 
compromise between the need to stimulate innovation and consumers’ legitimate expectations 
for safer products.  

Overall, the Directive seems to work well and is a well-established instrument. Producers have 
learned  to  deal  with it since  1985,  incorporating  possible  additional  costs  into  product  prices, 
and  consumers  are  aware  of  the  rights  related  thereto.  Moreover,  given  that  it  is 
complementary  to  other,  already  existing  legal  frameworks  (as  also  discussed  in  section 
5.3),205 the Directive had no significant legal impact on EU businesses, and therefore its costs 
can  be  considered  marginal.  Moreover,  as  discussed  in  the  previous  section,  there  are  also 
external factors that play a significant role in determining the efficiency of the Directive, such 
as  the  costs  and  duration  of  judicial  procedures,  which  vary  substantially  from  one  Member 
State to another. 

Therefore,  in  terms  of  simplification  and  reduction  of  burden,  further  efforts  would  entail 
addressing  factors  not  directly  (or  only)  relating  to  the  Directive,  but  to  the  overall  judicial 
system.  As  presented  in  section  5.4,  the  adoption  of  specific  “presumptions”,  for  specific 
categories  of  products,  according  to  which,  for  instance,  the  proof  of  the  link  between  the 
defect  and  the  damage  is inferred  by  the  sole  proof  of  the  defect  and  the  damage  itself,  has 
helped to simplify the overall process relating to the burden of proof. 

5.3  Coherence 

EQ  26  To  what  extent  is  the  intervention  consistent  and  coherent  with  the  EU  rules  on  consumer 
protection  in  the  area  of  contractual  liability  (for  example,  new  Commission  initiatives  in  the  digital 
context)? 

EQ 27 To what extent is the Directive coherent with wider EU policy, such as the free movement of goods 
and/or the protection of the consumers, including EU product safety? 

The  Product  Liability  Directive  appears  fully  coherent  both  with  the  EU  rules  on  consumer 
protection in the area of contractual liability and with wider EU policy.206 The following pieces of 
legislation  have  been  analysed  to  assess  the  coherence  of  the  Product  Liability  Directive  with 
EU policies and rules:  

1) The EU rules on consumer protection in the area of contractual liability, and, in particular: 
  The Directive on Consumer Rights;207 

  The Sales and Guarantee Directive;208 

2) The ”Digital contracts proposals”, and in particular:  
  The proposal for a directive on contracts for the supply of digital content;209 

the  Product  Liability  Conference  Brussels,  Friday  20  October  2017  at  

204 CATI survey, 13% (n=19) of small firms, 55% (n=83) of medium and 49% (n=78) of large firms.  
205 For  example,  a  large IT  producer states  that  no great distinction  exists between  guarantee  and defective product 
liability. 
206  See  also  Minutes  of 
https://ec.europa.eu/docsroom/documents/26661 
207  Directive  2011/83/EU  of  the  European  Parliament  and  of  the  Council  of  25  October  2011  on  consumer  rights, 
amending Council  Directive 93/13/EEC  and Directive  1999/44/EC  of  the  European  Parliament  and  of  the Council  and 
repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council. 
208 Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale 
of consumer goods and associated guarantees. 
209 Proposal for a directive of the Parliament and of the Council on certain aspects concerning contracts for the supply 
of  digital  content  (Brussels,  9.12.2015  COM  (2015)  634  final  2015/0287  (COD)).  http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:52015PC0634&from=EN 

54 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 

the proposal for a directive on contracts for the online and other distance sales of goods;210 

3)  The EU product safety policies and in particular the sectorial safety legislation211 and the 

General Product Safety Directive (the “General Product Safety Directive”);212 

4) The EU rules on applicable law, litigation and alternative dispute regulation: 
  The Rome II regulation;213 

  The Brussels IA regulation;214 

  The Directive on consumer alternative dispute resolution.215 

5.3.1  EU rules on consumer protection in the area of contractual liability 

The  Directive  on  Consumer  Rights  establishes  rules  on  information  to  be  provided  for 
distance contracts, off-premises contracts, as well as other types of contracts. It also regulates 
the  right  of  withdrawal  for  distance  and  off-premises  contracts  and  harmonises  certain 
provisions  dealing  with  the  performance  and  some  other  aspects  of  business-to-consumer 
contracts. Based on the Directive on Consumer Rights, both consumers and traders can rely on 
a single regulatory framework clearly defining legal concepts that would avoid disparities that 
create  significant  internal  market  barriers.  Therefore,  the  Product  Liability  Directive  is 
coherent  with  the  Directive  on  Consumer  Rights  as  their  scopes  of  application  are 
mutually exclusive: indeed, they do not overlap and rather they are complementary as they 
concur in the overall protection of consumers by regulating different fields. 

The  analysis  identified  some  lexical  divergences  –  though  not  affecting  the  overall 
implementation  of  the  Directive  –  between  the  two  pieces  of  legislation.  The  legal  concepts 
defined  in  the  Directive  on  Consumer  Rights  are  different  from  those  defined  in  the  Product 
Liability  Directive,  but  some  links  can  be  identified.  For  instance,  under  the  Directive  on 
Consumer  Rights,  “goods”  are  “any  tangible  movable  items,  with  the  exception  of  items  sold 
by  way  of  execution  or  otherwise  by  authority  of  law;  water,  gas  and  electricity  shall  be 
considered  as  goods  within  the  meaning  of  this  Directive  where  they  are  put  up  for  sale  in  a 
limited volume or a set quantity”. Under the Product Liability Directive, a “product” means all 
movables,  even  if  incorporated  into  another  movable  or  into  an  immovable,  including 

limits 

certain 

voltage 

(recast). 

210  Proposal  for  a  directive  of  the  Parliament  and  of  the  Council  of  on  certain  aspects  concerning  contracts  for  the 
online  and  other  distance  sales  of  goods.  (Brussels,  9.12.2015  COM  (2015)  635  final  2015/0288(COD)).  http://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2015%3A635%3AFIN. 
211 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending 
Directive 95/16/EC (recast). http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006L0042&from=FRN.  
Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the 
laws  of  the  Member  States  relating  to  the  making  available  on  the  market  of  electrical  equipment  designed  for  use 
within 
http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32014L0035&from=EN  
Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws 
of  the  Member  States  relating  to  the  making  available  on  the  market  of  radio  equipment  and  repealing  Directive 
1999/5/EC.  http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0053&from=EN;Regulation  (EU) 
2017/745  of  the  European  Parliament  and  of  the  Council  of  5  April  2017  on  medical  devices,  amending  Directive 
2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No  1223/2009  and  repealing  Council  Directives 
90/385/EEC and 93/42/EEC. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN; 
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical 
devices  and  repealing  Directive  98/79/EC  and  Commission  Decision  2010/227/EU.  http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN;  Regulation  (EC)  No  1223/2009  of  the  European  Parliament 
and 
http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF. 
212  Directive  2001/95/EC  of  the  European  Parliament  and  of  the  Council  of  3  December  2001  on  general  product 
safety. 
213 Regulation (EC) no 864/2007 of the European Parliament and of the Council of 11 July 2007 on the law applicable to 
non-contractual obligations. 
214 Regulation (EU) no 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction 
and the recognition and enforcement of judgments in civil and commercial matters. 
215  Directive  2013/11/EU  of  the  European  Parliament  and  of  the  Council  of  21  May  2013  on  alternative  dispute 
resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC. 

November 

products. 

cosmetic 

Council 

2009 

the 

30 

on 

of 

of 

55 

 
                                                 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

electricity. While the Directive makes reference to the protection of consumers, the concept of 
“injured  person”  is  not  limited  to  consumers.  In  contrast,  the  Directive  on  Consumer  Rights 
precisely  defines  the  consumer  (Article  2).  The  Directive  on  Consumer  Rights  also  defines 
“trader”  as  “any  natural  person  or  any  legal  person,  irrespective  of  whether  privately  or 
publicly owned, who is acting, including through any other person acting in his name or on his 
behalf,  for  purposes  relating  to  his  trade,  business,  craft  or  profession”.  The  concept  of 
“trader” is therefore broader than the concept of “producer” under the Directive. Finally, while 
the Directive on Consumer Rights states that a provision of another EU act governing specific 
sectors should prevail in case of conflict with the Directive on Consumer Rights (following the 
lex specialis principle), the Product Liability Directive does not provide for such a principle. The 
Product Liability Directive does not affect any rights that an injured person may have according 
to  the  rules  of  contractual  or  non-contractual  liability  or  a  special  liability  system  existing  at 
the  moment  when  the  Directive  is  notified.  Overall,  it  appears  that  these  lexical 
divergences  are  due  to  the  different  scopes  of  the  two  directives  and  there  is  no 
evidence  that  they  affect  the  effectiveness  or  efficiency  of  the  Product  Liability 
Directive.  

The  Sales  and  Guarantee  Directive  provides  for  a  common  set  of  minimum  rules  of 
consumer law, to strengthen consumers’  confidence and to  reduce difficulties encountered by 
consumers  in  relation  to  product  non-conformity  with  the  contract.  To  achieve  this  goal,  the 
Sales  and  Guarantee  Directive  introduces  a  presumption  of  conformity  of  products  with  the 
contract  when  certain  conditions  are  fulfilled.  For  instance,  products  are  presumed  to  be  in 
conformity with the contract if they: (i) comply with the description given by the seller, (ii) are 
fit  for  the  purpose  for  which  the  consumer  purchased  them  and  (iii)  show  the  quality  and 
performance  which  are  normal  for  the  products  of  the  same  type.  The  concept  of  (non-) 
“conformity” is therefore broader than the concept of “defect” used under the Directive. While 
the Sales and Guarantee Directive makes reference to the normal use of products to evaluate 
their  conformity,  the  Product  Liability  Directive  makes  reference  to  the  use  which  could 
reasonably be expected, in order to assess their defectiveness beyond normal use. Moreover, 
the  Sales  and  Guarantee  Directive  defines  the  “guarantee”  as  any  undertaking  by  a 
seller/producer to the consumer, given without extra charge, to reimburse the price paid or to 
replace, repair or handle products in any way if they do not meet the specifications set out in 
the  guarantee  statement  or  in  the  relevant  advertising.  The  guarantee  applies  automatically 
and  does  not  require  that  the  consumer  proves  any  damage  suffered  due  to  the  non-
conformity  of  the  product.  Finally,  the  Sales  and  Guarantee  Directive  uses  the  concept  of 
“producer”  like  the  Product  Liability  Directive.  Importers  and  any  person  putting  his  name, 
trademark or other distinctive signs are deemed to be producers.  

The Product Liability Directive and the Sales and Guarantee Directive do not overlap. 
Rather  they  are  complementary  as  they  concur  in  the  overall  protection  of  consumers  by 
regulating different fields. 

The  result  of  the  field  research  showed  that  no  material  inconsistencies  are  perceived  with 
regard  to  the  coherence  between  the  Directive  and  the  other  pieces  of  legislation  aimed  at 
protecting consumers in the contractual field: in particular, the majority of interviewed lawyers 
tend to confirm the coherence,216 while some producers and suppliers217 highlight that, even if 
the  Product  Liability  Directive  and  the  contractual  liability  legislation  have  different  but 
complementary scopes, often clients do not know the difference between the  Product Liability 
Directive  and  the  guarantee  and  thus  first  activate  the  guarantee  and  only  then  the  Product 
Liability Directive. This leads to think that, besides the possible confusion over the distinction 

216 The majority of the lawyers and other experts interviewed (7 out of 13). 
217 Half of the producers and suppliers interviewed (3 out of 6). 

56 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

between  the  tort  liability  of  producers  according  to  the  Product  Liability  Directive  and  the 
contractual guarantee for products, the two pieces of legislation seem to still be coherent. 

5.3.2  Digital contracts Communication and proposals 

According  to  the  Communication  for  digital  contracts  for  Europe,  consumers  will  have  a  fully 
harmonised  clear  set  of  rights  throughout  the  EU  and  will  therefore  be  more  confident  in 
accessing  digital  content  or  buying  goods  cross-border:  the  proposal  for  a  directive  on 
contracts  for  the  online  and  other  distance  sales  of  goods  and  proposal  for  a  directive  on 
contracts for the supply of digital content are the first legislative initiatives for this purpose in 
the framework of the Digital Single Market Strategy. 

The  proposal  for  a  directive  on  contracts  for  the  supply  of  digital  content  aims  to 
provide  a  set  of  requirements  applicable  to  contracts  for  the  supply  of  digital  content  to 
consumers,  in  particular  rules  on  (i)  conformity  of  digital  content  with  the  contract,  (ii) 
remedies in case of the lack of such conformity and (iii) the modalities for the exercise of the 
remedies as well as on modification and termination of such contracts. This proposal applies to 
any contract where the supplier sells digital content to the consumer and, in exchange, a price 
paid  by  the  consumer  or  the  consumer  provides  a  counter-performance  other  than  money  in 
the form of personal data or any other data. 

The  proposal  for  a  directive  on  contracts  for  the  online  and  other  distance  sales  of 
goods aims to provide a set of requirements applicable to distance sales contracts concluded 
between  the  seller  and  the  consumer,  in  particular  (i)  rules  on  conformity  of  goods,  (ii) 
remedies in case of non-conformity and (iii) the modalities for the exercise of these remedies. 
This proposal does not apply to distance contracts for the provision of services. 

Both the proposal for a directive on contracts for the supply of digital content and the one for a 
directive on contracts for the online and other distance sales of goods provide for a definition 
of  the  consumer  identical  to  the  definition  provided  in  the  Directive  on  Consumer  Rights.  In 
both  these  proposals,  digital  contents  and  goods  are  presumed  to  be  in  conformity  with  the 
contract  if,  notably,  they  (i)  are  of  the  quantity  and  quality  required  by  the  contract  and  (ii) 
are fit for any particular purpose. The same is provided by the Sales and Guarantee Directive. 

The remedies for non-conformity with the contract are: 

  The possibility to have the digital content brought into conformity with the contract free of 

charge; 

  The proportionate reduction of the price or the termination of the contract if the remedy to 

bring the digital content into conformity is impossible, disproportionate or unlawful.  

In addition, the consumer may claim compensation for any economic damage caused by non-
conformity with the contract or a failure to supply. Damage means a  sum of money to  which 
consumers may be entitled as compensation for economic damage to their digital environment 
(i.e. hardware, digital content and any network connection to the  extent that they are  within 
the control of the user). This is different from the definition of damage in the Directive, which 
also includes damage caused by death or by personal injuries. No right to damages is provided 
in  the  proposal  for  a  directive  on  contracts  for  the  online  and  other  distance  sales  of  goods, 
save for the repair or the replacement of goods. 

The burden of proof with respect to conformity with the contract is on the supplier as per the 
proposal  for  a  directive  on  contracts  for  the  online  and  other  distance  sales  of  goods.  In  the 
Product Liability Directive, on the contrary, the burden of proof of the damage, the defect and 
the causal relationship between defect and damage is on the injured person.  

Any lack of conformity  with the contract which becomes apparent within two years (from the 
acquisition of the physical possession of the products) is presumed to have existed at the time 
of  the  acquisition  (unless  this  is  incompatible  with  the  nature  of  the  products  or  with  the 
nature of non-conformity). As for the  time period when the consumer  is entitled to a remedy 

57 

 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

for product non-conformity with the contract, the proposal for a directive on contracts for the 
online and other distance sales of goods provides for two years. 

Overall,  even  though  there  may  be  a  few  divergences  between  the  terminology  used  in  the 
Product  Liability  Directive  and  in  the  Directive  on  Consumer  Rights,  Sales  and  Guarantee 
Directive, the proposal for a directive on contracts for the supply of digital content and the one 
for a directive on contracts for the online and other distance sales of goods, such divergences 
seem  justified  by  the  respective  scopes  of  the  different  pieces  of  legislation  and  there  is  no 
evidence  that  they  have  an  impact  (or  may  have  an  impact)  the  functioning  of  the  Product 
Liability Directive: for instance, the definition of “goods” in the Directive on Consumer Rights is 
narrower than the concept of “product” under the  Product Liability Directive, but the first one 
sets  forth rules applicable to contracts, while the latter sets forth a liability independent from 
possible  contractual  relationships.  Also,  the  lack  of  a  definition  of  “consumer”  in  the  Product 
Liability  Directive  –  to  as  opposed  to  the  “injured  person”  –  appears  to  be  coherent  with  the 
protection of consumers because of the exclusion of the product liability in case of use of the 
product mainly for professional purposes. 

5.3.3   EU product safety legislation 

EU  product  safety  legislation  aims  at  guaranteeing  consumer  protection  in  the  EU  and  in 
particular in ensuring that only safe products can be placed on the internal market. 

All products placed on the market in the EU are subject to safety rules, spelled out under: 

  Sectorial safety legislation (such as the CE marking legislation) which applies to specific 
products  or  product  groups  and  provides  for  specific  requirements,  the  so-called  essential 
health  and  safety  requirements  (EHSR).  The  manufacturer  is  responsible  for  ensuring  the 
safety of products placed on the market or put into service through a set of measures such 
as  conducting  a  risk  assessment,  applying  the  relevant  essential  health  and  safety 
requirements or carrying out specific conformity assessment procedures, before affixing the 
CE marking. 

  The  General  Product  Safety  Directive  (GPSD),  that  establishes  a  general  obligation 
upon  manufacturers  to  ensure  that  their  products,  which  do  not  fall  within  the  scope  of 
sectorial  legislation  covering  safety  aspects  or  national  regulations  relating  to  product 
safety,  are  manufactured  in  compliance  with  the  general  safety  requirements  provided 
therein (see section 5.3.3.2). 

Before the product is placed on the market or brought into use for the first time, designers and 
manufacturers must meet all essential requirements relevant to the specific product based on 
the  state  of  the  art  (see  section  5.3.3.1).  In  other  words,  the  product  safety  legislation 
operates before the product is placed on the market in order to ensure that the product is safe 
when marketed.  

Then,  within  the  market  surveillance  system,  relevant  national  authorities  check  whether 
products meet the requirements of the applicable safety legislation and take appropriate action 
to  ensure  that  non-compliant  products  are  brought  into  conformity  or  withdrawn  from  the 
market, including applying sanctions if necessary. 

In this context, the Product Liability Directive operates as a “safety net” when a product turns 
out  to  be  unsafe  and  causes  damages  to  the  user,  notwithstanding  the  other  two  tiers  of 
protection. 

Figure 10 describes the complementary relationship between the different pieces of legislation 
aiming at ensuring consumer protection. 

58 

 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Figure 10: Relationship between the Product Liability Directive and the Safety legislation 

5.3.3.1  Sectorial safety legislation 

Source: Author’s elaboration 

Specific  rules  exist  for  the  safety  of  toys,  electrical  and  electronic  products,  cosmetics, 
chemicals, medical devices and other specific product groups, as listed inAnnex 9. 

Providing just a few examples, the Directive 2009/48/EC on the safety of toys218 (hereinafter 
“Toy  Safety  Directive”)  lays  down  the  safety  criteria  that  toys  must  meet  before  they  can  be 
marketed in the EU. The essential safety requirements cover: 

  General risks: the health and safety of children, as well as other people such as parents 

or caregivers 

  Particular risks: physical and mechanical, flammability, chemical, electrical, hygiene and 

radioactivity risks 

The  Toy  Safety  Directive  2009/48/EC  replaced  the  former  Directive  88/378/EEC.  It  adapted 
the  legal  framework  to  technological  developments  and  previously  unknown  safety  issues. 219 
The  application  and  enforcement  are  aligned  with  the  so-called  “New  Legislative 
Framework”.220 

With reference to electrical and electronic products, it is important to consider: 

  Directive  2014/35/EU  on  low  voltage  electrical  equipment221  (hereinafter  also  “Low 
Voltage Directive” or “LVD”), applicable to electrical equipment within certain voltage limits, 

218 Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys. Source: 
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009L0048-20140721&from=EN. 
219  For  example,  compared  to  the  former  Directive  88/378/EEC,  the  Toy  Safety  Directive  2009/48/EC  puts  in  place 
stricter requirements for chemicals: 
-  Chemicals that are susceptible to cause cancer, change genetic information, harm fertility or harm an unborn child 
(so-called CMR substances) are no longer allowed in the accessible parts of toys beyond the concentration limits set 
in  the  Regulation  on  Classification,  Labelling  and  Packaging  of  substances  and  mixtures,  or  unless  they  are 
considered safe following a rigorous scientific evaluation. 

-  19 so-called 'heavy elements' like mercury and cadmium are not allowed in toy parts accessible to children beyond 

the limits laid down in Toy Safety Directive 2009/48/EC. 

-  55 allergenic fragrances have been banned. However, some of them, and another 11, may be used in certain toys 

provided that they are indicated on the label and comply with additional requirements. 

220  Further  information  about  the  “New  Legislative  Framework”  is  available  at  https://ec.europa.eu/growth/single-
market/goods/new-legislative-framework_en. 
221 Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of 
the laws of the Member States relating to the making available on the market of electrical equipment designed for use 
http://eur-lex.europa.eu/legal-
within 

Source: 

voltage 

certain 

limits. 

59 

EHSR (2008)SAFETY LEGISLATIONNO DEFECTDEFECTMarket SurveillanceDAMAGENO DAMAGECOMPLIANCENO COMPLIANCEPLD (1985)RisksProducerProductUse(user) 
 
 
                                                 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

provides  a  high  level  of  protection  for  European  citizens.  Electrical  equipment  under  the 
LVD covers a wide range of consumer and professional products e.g. household appliances, 
cables, power supply units, laser equipment and some components such as fuses. 

  Directive  2014/53/EU  on  radio  equipment222  (hereinafter  also  “Radio  Equipment 
Directive”  or  “RED”)  ensures  a  Single  Market  for  radio  equipment  by  setting  essential 
requirements for health and safety, electromagnetic compatibility, and the  efficient use  of 
the radio spectrum and applies to all products using the radio frequency spectrum. 

The  legislation  on  machinery,  specifically  the  Machinery  Directive  2006/42/EC223,  covers  a 
wide range of machines and  equipment for consumers  and commercial or industrial purposes 
from products used in the home environment such as hand-held power tools or lawnmowers to 
3D printers and robots (service, collaborative or industrial). This Directive ensures a high level 
of health and safety for consumers, users and other exposed persons as regards the products 
in  its  scope  that  are  placed  on  the  market.  An  extensive  list  of  essential  health  and  safety 
requirements  addresses  the  intended  use  and  any  foreseeable  misuse  by  ensuring  safety 
through design via a set of hierarchical principles also called "principles of safety integration". 
Any residual risks are to be addressed by means of manual of instruction or warnings.  

As  regards,  chemicals,  the  European  Parliament  and  Council  Regulation  (EC)  No  1907/2006 
(Corrigendum  29  May  2007)224  (hereinafter  also  “REACH”)  aims  to  ensure  a  high  level  of 
protection for human health and the  environment, including the promotion of alternative test 
methods,  as  well  as  the  free  circulation  of  substances  on  the  internal  market  and  the 
enhancement of competitiveness and innovation. 

With  respect  to  medical  devices,  on  April  2017  two  new  regulations  were  adopted.  The 
Regulation  (EU)  2017/745  on  medical  devices  and  the  Regulation  (EU)  2017/746  on  in  vitro 
diagnostic medical devices225 establish a modernised and more robust EU legislative framework 
to  ensure  better  protection  of  public  health  and  patient  safety.  Moreover  both  the  two 
regulations  state  that  software  is  considered,  under  the  provisions  of  the  regulation,  as  a 
product. Further, the Regulations on medical devices provide that the liability they set forth is 
without prejudice to the Directive. 

5.3.3.2  The General Product Safety Directive 

As  mentioned  above,  the  General  Product  Safety  Directive  aims  to  ensure  that  only  safe 
products  are  placed  on  the  market.  A  product  is  safe  when  under  normal  or  reasonably 
foreseeable  conditions  of  use,  including  duration,  and,  where  applicable,  putting  into  service, 
installation and maintenance requirements, it does not present any risks or only the minimum 
risks compatible with the product use, considered to be acceptable and consistent with a high 
level of protection for the safety and health of persons, taking into account particular aspects 
such  as  the  (i)  characteristics  of  the  product,  (ii)  the  effect  on  other  products,  (iii)  the 

content/EN/TXT/PDF/?uri=CELEX:32014L0035&from=EN. 
222 Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the 
laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 
1999/5/EC. Source: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0053&from=EN. 
223 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending 
Directive 95/16/EC. Source: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006L0042&from=EN. 
224 Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), establishing a European 
Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council  Regulation  (EEC)  No  793/93  and 
Commission  Regulation  (EC)  No  1488/94  as  well  as  Council  Directive  76/769/EEC  and  Commission  Directives 
91/155/EEC, 
http://eur-lex.europa.eu/legal-
content/EN/TXT/PDF/?uri=CELEX:32006R1907R(01)&from=EN. 
225  Regulation  (EU)  2017/745  of  the  European  Parliament  and  of  the  Council  of  5  April  2017  on  medical  devices, 
amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No  1223/2009  and  repealing 
Council Directives  90/385/EEC  and 93/42/EEC  and Regulation  (EU)  2017/746 of  the  European  Parliament  and  of  the 
Council  of  5  April  2017  on  in  vitro  diagnostic  medical  devices  and  repealing  Directive  98/79/EC  and  Commission 
Decision 2010/227/EU. Source : http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745. 

2000/21/EC. 

93/67/EEC, 

93/105/EC 

Source: 

and 

60 

 
                                                                                                                                                                  
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

presentation of the product, (iv) the categories of consumers at risk when using the product. 
The General Product Safety Directive applies in the absence of other EU or national regulations 
relating  to  product  safety,  complementing  sector  specific  legislation.  The  General  Product 
Safety  Directive  establishes  obligations  for  the  producers,  distributors  and  Member  States 
authorities.  Producers  must  place  only  products  which  are  safe  on  the  market  and  inform 
consumers of any risks associated with these products. They also have to make sure that any 
dangerous products presented on the market can be traced226 so they can be removed to avoid 
any  risks  to  consumers.  Distributors  are  required  to  act  with  due  care  to  help  ensure 
compliance with the applicable safety requirements, they shall participate in the monitoring of 
the  safety  of  the  products  and  cooperate  with  the  producers  and  competent  authorities.  The 
General  Product  Safety  Directive  states  that  its  provisions  should  not  affect  victims’  rights 
within  the  meaning  of  the  Product  Liability  Directive  (which  remains  an  autonomous  legal 
regime).  The  Product  Liability  Directive  and  the  General  Product  Safety  Directive 
appear  therefore  to  be  coherent.  In  this  respect,  a  producer  has  noted  that,  when  a 
product  does  not  comply  with  the  General  Product  Safety  Directive  requirements,  it  will  be 
probably  also  considered  defective  for  the  purposes  of  the  Directive,  thus  showing  a  full 
complementarity between the two pieces of legislation.  This interpretation is consistent 
with Article 6 of the Product Liability Directive which states that “a product is defective when it 
does not provide the safety which a person is entitled to expect”. The concept of “legitimately 
expected  safety”  provided  by  the  Product  Liability  Directive  includes  the  expectation  that  the 
products  placed  on  the  market  do  not  present  risks  for  the  physical  safety  and  health  of 
persons,  according  to  the  General  Product  Safety  Directive.  The  non-conformity  with  General 
Product  Safety  Directive  does  not  necessarily  imply  defectiveness:  indeed,  the  concept  of 
defectiveness  under  in  the  Product  Liability  Directive  is  different  and  wider  that  the  non-
conformity  to  safety  requirements.  Nevertheless,  in  a  producer’s  view,  when  a  product  does 
not comply with the safety  requirements, it can be regarded as defective for the purposes  of 
the Directive. 

Thus  it  appears  that  the  overall  system  of  safety  legislation,  both  general  and 
specific, is in general coherent with the provisions of the  Product Liability Directive, 
which  provides  that  the  user  of  products  has  a  legitimate  right  to  expect  a  specific  level  of 
safety from the products placed on the market. In particular, as described above, the notion of 
defect  in  the  Directive  provides  that  a  product  may  be  considered  defective  if  it  does  not 
provide  the  safety  that  a  person  is  entitled  to  expect.  The  concept  of  safety  used  by  the 
Product Liability Directive includes, but is not limited to, the minimum level of safety expected 
from  the  manufacturer  in  the  production  of  goods.227  As  illustrated  in  the  figure  below,  the 
safety  legislation  and  the  Product  Liability  Directive  have  a  clear  relationship  that  coincide  in 
the  pursuit  of  consumer  protection  in  relation  to  the  safety  of  the  product  placed  on  the 
market. 

226 By establishing notification obligations on producers and distributors concerning information on products that do not 
comply with the general safety requirements to the competent authorities, the General Product Safety Directive aims 
at  having  the  risks  notified  as  soon  as  possible  in  order  to  avoid  damages  caused  to  consumers  by  dangerous 
products. 
227 This conclusion is confirmed also by the opinion of stakeholders that attended the Product Liability Conference held 
in  Brussels  on  20 October 2017(see  Minutes of  the  Product  Liability  Conference Brussels,  Friday  20  October 2017  at 
https://ec.europa.eu/docsroom/documents/26661. For example, ELITE explained that the Product Liability Directive is 
consistent  with  product  safety  legislation,  as  it  is  an  integral  part  of  it.  All  products  placed  on  the  European  market 
must  comply  with  Community  harmonisation  legislation,  in  which  harmonised  technical  standards  define  the 
presumption of conformity of the product with the legislative requirements, and these standards are published in the 
Official  Journal  of  the  European  Union.  Protection for  consumers  is ensured by  the fact  that  the  consumer can  bring 
legal  action  against  the  producer  and,  having  demonstrated  the  product’s  “unusual  performance”  (this  evidence 
becomes sufficient, as legally binding evidence, to demonstrate that the product was already objectively faulty when it 
was placed on the market), demand that the product meet the legal requirements. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Figure 11: The Directive and consumer protection in case of Health and Safety Standards 

The analysis carried out suggests that: 

  The two directives are different in terms of scope. 

Source: Author’s elaboration 

  A  product,  even  if  in  compliance  with  the  related  EHSR,  can  cause  a  damage  that  can  be 

compensated under the Directive.  

  However,  a  product  not  complying  with  the  related  EHSR  is  more  likely  to  be  considered 

defective under the Directive. 

  Hence,  the  non-compliance  of  the  product  with  the  related  EHSR  seems  to  act  as  an 
indicator of the violation of the safety level legitimately expected when assessing the defect 
of the product. 

 

In  any  case,  the  Directive  acts  as  a  safety  net,  regardless  of  the  compliance  of  products 
with EHSR. 

Nevertheless, the analysis carried out in Annex 9 also shows possible gaps between the safety 
legislation and the Product Liability Directive:228 

  As  for  the  definition  of  "product":  the  Product  Liability  Directive  never  explicitly  mentions 
any  new  technological  development,  such  as  software  or  artificial  intelligence  or 
interconnected products.  

  On the contrary, it may happen that specific safety legislation, such as the Medical Devices 

Directive, refer to software as a product. 

  Therefore,  software,  which  can  be  considered  as  a  product  under  the  sectorial  safety 

legislation, is not necessarily covered by the Product Liability Directive. 

228  See  also  Minutes  of  the  Product  Liability  Conference  Brussels,  Friday  20  October  2017  CCAB,  at  
https://ec.europa.eu/docsroom/documents/26661For  example,  AMALYSTE  claimed  that  one  of  the  inconsistencies  is 
that  while  pharmaceuticals  are  covered  by  the  general  "defective  product"  liability,  they  are  not  covered  by  the 
General Product Safety regime (in particular the definition of "safe product") but by a specific safety regime, and this 
should be adjusted by defining a specific liability regime for drugs. This means that drugs should be removed from the 
scope of the directive. 

62 

 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

  As  regards  robots  or  other  interconnected  products,  the  safety  legislation  does  not 
expressly  refer  to  them,  even  though  they  can  be  covered  by  the  latter  according  to  the 
legal  definitions  of  the  regulatory  framework.  For  instance,  e.g.  robots  are  specifically 
mentioned  within 
the  Machinery  Directive  and  Medical  Devices  Directive  and 
Interconnectivity is covered by the Radio Equipment Directive.  

5.3.4   EU rules on applicable law and dispute resolution 

The  Rome  II  Regulation  sets  forth  the  conflict-of-law  rule  in  matters  of  product  liability 
(Article 5) by means of a cascade system, where the first element to be taken into account is 
the  law  of  the  country  in  which  the  person  sustaining  the  damage  had  his  or  her  habitual 
residence when the damage occurred, if the product was marketed in that country; the other 
elements are triggered if the product was not marketed in that country and, in essence, make 
the  law  applicable  to  the  claim  depend  on  the  place  where  the  product  was  marketed. 
However, this does not preclude (a) that, where both the person claimed to be liable and the 
person sustaining damage have their habitual residence in the same country at the time when 
the damage occurs, the law of that country shall apply and (b)  the possibility of a manifestly 
closer connection to another country. This being said, the Directive and the Regulation appear 
to  be  in  synergy  in  allowing  protection  of  consumers  based  on  the  opportunity  for  the  same 
consumer to resort to the law applicable to the possible damage affecting him (first, the law of 
his  place  of  residence),  while  striking  a  balance  with  the  defendant’s  needs  by  taking  into 
account where the product was marketed. 

The  Brussels  IA  Regulation  aims  to  set  clear  rules  on  jurisdiction  in  civil  and  commercial 
matters.  The  CJEU  recently  clarified  that  claims  under  the  Directive  were  subject  to  Article  5 
(3)  of  Brussels  I  Regulation  (CJEU  C-45/13),  which  provided  that  a  person  domiciled  in  a 
Member  State  may,  in  another  Member  State,  be  sued  in  matters  relating  to  tort,  delict  or 
quasi-delict,  in  the  courts  for  the  place  where  the  harmful  event  occurred  or  may  occur,  just 
like  Article  7  of  the  Brussels  IA  Regulation  states.  Furthermore,  the  CJEU  also  stated  that, 
where a manufacturer faces a claim of liability for a defective product, the place of the event 
giving rise to the damage is the place where the product in question was manufactured (CJEU 
C-45/13).  

The  Directive  on  consumer  alternative  dispute  resolution,  in  contrast,  is  limited  to  the 
resolution of contractual disputes and does not cover the disputes that can arise from damages 
from defective products according to the Directive. Indeed, there are currently no EU rules in 
place for the alternative resolution of  claims relating to the Directive. Given that their scopes 
are mutually exclusive, the two directives are deemed to be coherent. 

There is no incoherence between the Product Liability Directive and the EU pieces of 
legislation considered. 

5.4  Relevance  

5.4.1  Relevance  of  the  Directive  to  current  needs,  including  needs  relating  to  new 

technological developments 

EQ  28  To  what  extent  do  the  initial  objectives  correspond  to  the  current  needs,  including  new  needs 
created by innovative products? 

The Directive is relevant with reference to the current needs, which include the need for 
protection of consumers, the need for ensuring producers’ liability and the need for enhancing 
the  free  movement  of  goods  without  distorting  competition.  However,  it  is  not  possible  to 
evaluate  the  relevance  of  the  Directive  with  reference  to  the  needs  created  by  new 
technological developments, in particular AI, cloud technologies and 3D printing. 

5.4.1.1  Relevance of the Directive to the original needs which continue to be current needs 

 The Directive entered into force in order to respond to the following needs, identified in 1985 
(see Figure 1): 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

  Ensure  a  high  degree  of  EU  consumer  protection  against  damages  to  health  and  property 

caused by a defective product; 

  Ensure producers’ liability for damages caused by a defective product; 

  Enhance  the  free  movement  of  products  without  distorting  competition  by  setting  a 

common rule on strict liability of the producer. 

The  Directive  is  still  relevant  as  the  initial  needs  still  correspond  to  current  needs,  and 
the Directive has been designed to address them. In particular, the trend in  the numbers of 
claims  relating  to  defective  products  as  well  as  the  average  EU  litigation  rate  have 
not  been  decreasing  over  the  last  several  years  (see  finding  16,  Figure  4),  demonstrating 
that the needs for consumer protection, producers’  strict liability and ensuring a level playing 
field are all still relevant. 

5.4.1.2  Relevance of the Directive to needs relating to new technological developments 

With  regard  to  the  new  technological  developments,  however,  the  situation  is  different.  The 
general  needs  relating  to  new  technological  developments  are  still  the  same  as  they  were 
when  the  Directive  was  introduced,  though  new  technological  developments  represent  an 
issue229  as  they  challenge  the  abovementioned  needs  and  how  they  develop  over  time.  The 
applicability  of  the  Directive  to  these  technologies  is  not  straightforward,  given  the  inherent 
features of some of them, and specifically:  

  The  complexity  of  some  IT  products,  incorporating  both  product  and  service,  such  as 

cloud technologies;230 

  The  interconnectedness  of  automated  systems  (IoT)  and  the  increased  interaction 

between humans and smart devices;  

  The  increasing  autonomy  and  learning  capacity  involved  in  artificial  intelligence  (AI), 

autonomous vehicles and robots;231  

  The increasing blurriness of the distinction between producers and consumers due 
to  the  growing  importance  of  the  sharing  economy  (peer-to-peer  instead  of  business-to-
consumer)232 as well as to the development of technical solutions such as 3D printers; 

  The difficulty in distinguishing between private and professional use of a product in 

light of the development of smart working;233 

  The  rising  concerns  about  privacy  and  the  protection  of  the  large  amount  of  data 

generated by the multitude of new smart products (Big Data).234 

The following box reports some issues specifically relating to robots and autonomous systems. 

Box 4 – Focus on liability issues relating to some new technological development 

The  recent  development  of  robotics  poses  new  challenges  for  the  legislator  as  well  as  for 
jurisprudence,  as  it  is  likely  to  have  an  impact  on  current  normative  concepts,  such  as  that  of  risk, 

229 European Commission (2016). Communication from the Commission to the European parliament, the Council, the 
European  Economic  and  Social  Committee  and  the  Committee  of  the  Regions.  Digitising  European  Industry  Reaping 
the full benefits of a Digital Single Market. 
230 The different layers of components that compose IoT systems increase the complexity of liability issues. Workshop 
on Liability in the area of Autonomous Systems and Advanced Robots / IoT Systems. 
231  The  more  autonomous  a  system  becomes,  the  more  difficult  it  can  be  to  foresee  its  future  decisions  and  actions 
when  creating/developing  it.  Workshop  on  Liability  in  the  area  of  autonomous  systems  and  advanced  robots/IoT 
systems. 
232 Meller-Hannich, C. (2016). Share Economy and Consumer Protection. In Digital Revolution: Challenges for Contract 
Law  in  Practice  (pp.  119–132).  https://www.nomos-elibrary.de/10.5771/9783845273488-119/share-economy-and-co
nsumer-protection. 
233 Interview  feedback:  interview with  an  EU Association representing  producers  in  the  automotive  industry  and  with 
an IT expert..  
234 European Commission, 2013, Definition of a Research and Innovation Policy Leveraging Cloud Computing and IoT 
Combination. This is not a new need, moreover, the issue of liability in case, e.g. of a defective IT product, is in scope 
of the Directive. (European Commission 2013). 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

predictability  and  causality.  For  example,  the  allocation  of  liability  is  more  difficult  with  regard  to  an 
autonomous, learning and decision-making robot, since it is difficult to establish the causal link in such 
cases (Bayamlioğlu, 2008).235  

However,  according  to  other  authors  (Holder  et  al.  2016),  the  strict  liability  is  likely  to  apply  also  in 
cases of a defective automotive robot, a defective prosthesis or a defective surgical robot, as covered 
by the wider concept of “defective product” under the Directive. This opinion appears similar to that of 
Courtois (Courtois, 2016), who distinguishes between low and high AI. The current AI is still at a low 
level,  as  robots  perform  the  actions  for  which  they  have  been  programmed  and  are  still  under 
complete control of their producers. This is why the liability regime of the Directive is still apt to 
cover new technological developments, including robots. According to other authors (Čerkaa, P., 
Grigienėa,  J.,  &  Sirbikytė,  G.,  2015),  even  though  AI  is  different  from  conventional  computer 
algorithms  and  robots  are  able  to  act  independently,  make  decisions,  and  “train”  themselves  – 
accumulating experience and learning from it, in the absence of specific and national legislation on AI, 
the prevailing rule is the principle of the producer of a tool being responsible for the results 
obtained by the use thereof, since the tool has no independent will of its own. The concept of AI as 
tool makes strict liability applicable to AI actions. 

Findings from field research provide further evidence on the relevance of the Directive vis-
à-vis new technological development.  

Respondents to the OPC236 agree that there are products for which the application of the 
Directive  is  or  might  become  uncertain  and/or  problematic.  These  products  mainly 
come under the definition of new technological developments, as already underlined in section 
5.1.4. As a consequence, 62% of respondents237 think that the Directive should be adapted to 
new technological developments.238 The products indicated are mainly those on which software 
and  applications  from  different  sources  can  be  installed  after  purchase,239  connected  to  the 
Internet240, purchased as a bundle with related services,241 performing automated tasks based 
on  algorithms  and  data  analysis  (e.g.  cars  with  parking  assistance),242  or  performing 
tasks  based  on  self-learning  algorithms  (Artificial  Intelligence).243  Quite 
automated 
consequently  consumers  consider  that  there  is  a  need  to  adapt  the  Directive  on  Liability  of 
Defective  Products  for  these  products.244  Similarly,  in  the  context  of  the  targeted  survey,  six 
out of six consumer organisations declare that the Directive should be adapted in this sense. 

In contrast, two out of two producers responding to the targeted survey declare that in some 
cases  there  is  no  need  to  extend  the  scope  of  the  Directive  also  to  new  technological 
developments,  as  the  Directive  already  guarantees  a  wide  protection.  Indeed,  some 
interviewed stakeholders, such as an Italian association representing distributors, believe that 
there are several products in which hardware, software and services are connected and mixed 
up: the distinction between them is purely academic and does not have concrete relevance in 
practice. In the end, according to the stakeholder, the producer is simply the one who sells the 
tangible item connecting all of the parts together. A UK lawyer suggests that in some cases the 
components of a product are interconnected so closely that they are the same thing, so that it 
would  be  even  wrong  to  divide  them  into  two  different  products.  Yet  according  to  an  EU 

235 A possible solution put forward by the literature could be to ascribe a specific legal status to autonomous machines, 
similar to the status of legal persons. 
236 OPC feedback: 69% (n=62 out of 89). 89 respondents include Consumers (total=40), Producers (total=28) and PAs 
and civil society (total=21).  
237 OPC feedback: n=46 out of 74. More specifically: 72% of  Consumers (n=26 out of 36), 48% of  Producers (n=10 
out of 21) and 59% of PAs and civil society perceive the need to adapt the Directive.  
238 The issues which according to the OPC requires action at the EU level, such as other OPC results, have already been 
described under section 5.1.4. 
239 OPC feedback: 18% (n=22 out of 125) of Consumers. 
240 OPC feedback: 14% (n=18 out of 125) of Consumers. 
241 OPC feedback: 15% (n=19 out of 125) of Consumers. 
242 OPC feedback: 14% (n=17 out of 125) of Consumers. 
243 OPC feedback: 14% (n=17 out of 125) of Consumers. 
244 OPC feedback: 72% (n=26 out of 36) of Consumers. 

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association  representing  producers  in  the  automotive  industry,  there  is  a  need  for  an  EU 
approach for dealing with liability for products interconnected with services. 

This being said, not all of the provisions of the Directive seem to  need to be modified 
in  order  to  cover  the  specific  needs  arising  from  the  new  technologies:  for  instance, 
PAs  and  civil  society  do  not  agree  that  there  should  be  special  exemptions  from  the  general 
liability framework foreseen for innovative products under experimentation245 nor do they see 
a  need  to  remove  the  obligation  for  the  injured  party  to  prove  the  defect  to  obtain 
compensation246  or  to  remove  the  obligation  for  the  injured  party  to  prove  the  causal  link 
between defect and damage to obtain compensation for the products in List 1.247 The choice to 
remove the threshold of €500 for property damage is very controversial.248  

As  to  possible  interventions  regarding  the  new  technological  developments,  the 
stakeholders suggest that these should consist of:  

  Extending  liability  to  damages  caused  by  services  when  they  are  bundled  with  the 

product;249 

  Attributing liability to the entity best positioned in the value chain to avoid accidents, and 

not necessarily to the producer;250 

  Removing  the  requirement  prescribing  that  the  damage  shall  be  caused  by  defective 

products intended and used for private purposes only to be compensated;251 

  Making  providers  of  software,  applications  and  algorithms252  as  well  as  data  providers253 

potentially liable under the Directive;  

  Maintaining  the  rule  of  liability  without  fault  in  case  of  damage  caused  by  a  defective  or 

malfunctioning product.254  

Stakeholders  are  not  fully  aware  of  the  existence  of  specific  rules  in  their  country  on  liability 
for  damage  caused,  for  instance,  by  smart  objects,  robots  and  other  new  technologies,255 
which  creates  further  challenges  for  the  relevance  of  the  Directive  in  this  regard.  This  is 
confirmed  by  the  results  of  the  desk  research  at  the  national  level:  the  legislation  of  some 
Member States provides for protection from damages caused by software and/or service on the 
basis  of  their  general  rules  in  civil  law  rather  than  on  the  basis  of  specific  rules  for  IT 
systems.256 

Findings from the desk research confirmed this scenario of uncertainty on whether the 
Directive  applies  to  new  technological  developments.257  On  the  one  hand,  the  majority  of 
sources  identified  seem  favourable  to  a  revision  of  the  Directive  to  clarify  to  which 

245 OPC feedback: 61% (n=11 out of 18) of PAs and civil society. 
246 OPC feedback: 78% (n=18 out of 23) of PAs and civil society. 
247 OPC feedback: 83% (n=19 out of 23) of PAs and civil society. 
248 OPC feedback: 53% (n=10 out of 19) of PAs and civil society are against the removal of the threshold. 
249 OPC feedback: 70% (n=14 out of 20) of PAs and civil society. 
250  OPC  feedback:  56%  (n=10  out  of  18)  of  PAs  and  civil  society.  However,  86%  (n=19  out  of  21)  of  PAs  and  civil 
society agrees that liability for damage by a defective or malfunctioning new technological development should be on 
the producer.  
251 OPC feedback: 52% (n=11 out of 21) of PAs and civil society. 
252 OPC feedback: 100% (n=19 out of 19) of PAs and civil society. 
253 OPC feedback: 88% (n=15 out of 17) of PAs and civil society. 
254 OPC feedback: 91% (n=21 out of 23) of PAs and civil society. 
255 OPC feedback: 87% (n= 59 out of 68) of respondents from all categories.  
256 For instance, in EE, computer software is deemed to be a product according to the section 1063 subsection 1 of the 
Law of Obligations Act; in MT, the protection against new technological developments stems from general rules of torts 
or quasi-torts (Sub-Title II, Title IV, Part II, and Civil Code Chapter 16 of the Laws of Malta). 
257  STOA  (2015).  The  Collaborative  Economy  Impact  and  Potential  of  Collaborative  Internet  and  Additive 
Manufacturing. Türkan Hazal, K. (2015). Legal Liability Issues of Mobile Application Relationships in Europe: Liability of 
mobile  application  distributors  towards  developers  and  end-users  with  regard  to  developers  stance  as  consumers. 
University of Oslo. Loukakis, A. (2015). Product Liability Ramifications for Damage Caused by Erroneous GNSS Signals. 
In Dispute Settlement in the Area of Space Communication. Workshop on Space and Satellite Communication Law.  

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extent  the  Directive  is  applicable  to  the  different  new  technological  developments,  and  to 
clarify the relevant juridical framework, especially with the adoption of a strict liability rule for 
all  kinds  of  software.258  In  addition,  the  European  Commission259  and  the  European 
Parliament260  indicate  that  it  could  be  necessary  to  adapt  the  Directive  to  make  it  more 
coherent  with  the  challenges  brought  by  the  new  digital  context.  On  the  other  hand,  other 
authors consider it reasonable to resolve the issue created by new technological developments 
by  means  of  interpretation  of  the  Courts  only,  waiting  for  the  future  evolution  of  the  new 
technologies.261  

is  only  one  relevant  case 

Despite  the  needs  that  have  emerged  from  the  desk  research  and  from  stakeholders’ 
consultation,  there 
involving  a  new  technological 
development, a storage unit (see section 4.8).262 This seems to suggest that the issue with 
new  technological  developments  remains,  at  the  moment,  theoretical. Nevertheless,  although 
more  than  half  of  mobile  applications  users  experience  a  defect  in  mobile  applications  and  a 
damage caused thereby, these devices are hardly subject to legal actions, despite the fact that 
they have become mass-consumer goods as much as “traditional” products.263 This fact could 
lead  one  to  think  that  there  are  obstacles  to  reporting  a  claim  relating  to  new  technological 
developments, for instance due to the perception of not having remedies for these situations: 
87%  of  the  OPC  respondents  believe  that  in  their  EU  countries  there  are  no  specific  rules  on 
liability  for  damage  caused,  for  instance,  by  smart  objects,  robots  and  other  new 
technologies264  and  72%  of  the  OPC  respondents  are  aware  that  damages  caused  by 

258  Beuc.  (2015).  Review  of  product  liability  rules.  Staub,  R.  (2016).  Softwarefehler  –  Wer  haftet  für  was?  Täger,  J. 
(1995).  Außervertragliche  Haftung  für  Fehlerhafte  Computerprogramme.  J.  C.  B.  MOHR  (PAUL  SIEBECK)  and  others 
(2016).  Towards  Harmonised  Duties  of  Care  and  Diligence  in  Cybersecurity,  pp.  78-107.  O’Brien,  H.  M.  (2015).  The 
Internet  of  Things:  The  Inevitable  Collision  with  Product  Liability.  Andoulsi,  I.,  &  Wilson,  P.  (2012).  Understanding 
Liability  in  eHealth:  Towards  Greater  Clarity  at  European  Union  Level.  In  eHealth:  Legal,  Ethical  and  Governance 
Challenges, pp. 165–180. Springer. Zollers, F. E., and others (2005). No More Soft Landings for Software: Liability for 
Defects  in  an  Industry  That  Has  Come  of  Age.  Delforge,  C.  (2014).  Hojnik,  J.  (2017).  Technology  neutral  EU  law: 
digital  goods within  the  traditional  goods/services distinction.  Verbrauchezentrale Bundesverband.  (2017).  ‘Safety by 
design’ - Produkthaftungsrecht für das Internet der Dinge. Iconoclast Tech LLC. (2017). Filing to EC on Review of the 
Council Directive 85/374/EEC concerning Liability for Defective Products. Médicaments dangereux: qui est responsable 
de quels défauts ? Revue Belge du Dommage Corporel et de Médecine Légale - Consilio Manuque.  
259 European Commission (2016). Communication from the Commission to the European  Parliament, the Council, the 
European  Economic  and  Social  Committee  and  the  Committee  of  the  Regions.  Digitising  European  Industry  Reaping 
the full benefits of a Digital Single Market. 
260  European  Parliament  (2016,  May  31).  Report  with  recommendations  to  the  Commission  on  Civil  Law  Rules  on 
Robotics.  Retrieved  from  http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML%2BCOMPARL%
2BPE-582.443%2B01%2BDOC%2BPDF%2BV0//EN. 
261 “The discussed new technologies most often take the final form of movable items and can be considered ‘products’ 
from the perspective of consumers and business users" and "regardless of the level of complexity of new technologies, 
identifying which  part  of  the system  failed  and  allocating  the  responsibility  of  the  producer  does  not  seem  a difficult 
task (pursuant to the Directive 'product' covers movables (…) even though incorporated into another movable or into 
an  immovable)”  (Lewiatan.  (2017).  Position  paper  on  the  evaluation  of  Directive  85/374/EEC  on  the  liability  for 
defective  products.  Holder,  C.,  and  others  (2016).  Robotics  and  law:  Key  legal  and  regulatory  implications  of  the 
robotics age. Courtois, G. (2016). Robot intelligents et responsabilité: quels régimes, quelles perspectives? The author 
underlined the concept of “human control” of technology: in particular, it is stated that since innovative products like 
robots  are  at  the  moment  totally  controlled  by  a  human  user  the  actual  rules  correspond  to  the  current  needs.  A 
revision of  liability  rules  shall  be  needed since robots would gain  real  autonomy  so being  not  controlled by  a  human 
user.  WG2  (2017). WG2 conclusions/recommendations on  ‘liability  and  data  storage/recording  needs’.  The  defects  in 
software  programs,  Implanted  Cardioverter  Defibrillators,  apps,  interconnected  devices  such  as  connected  cars  are 
covered by the provisions of the Directive. The German Court BGH, through a decision of 9 June 2015, recognised the 
damage caused by a defect in an implanted cardioverter defibrillator by applying the provisions of the Directive  BHG. 
(2015). 
262 Source: country fiches. Bulgarian case no. 20942/2012. 
263  Türkan  Hazal,  K.  (2015).  Legal  Liability  Issues  of  Mobile  Application  Relationships  in  Europe:  Liability  of  mobile 
application distributors towards developers and end-users with regard to developers’ stance as consumers’. According 
to  the  author,  the  dissatisfaction  in  user  experiences  regarding  mobile  applications  need  not  always  arise  from  a 
certain defect  in  the digital  good  itself which  can be  controlled by  the  end-user. In  certain  situations,  the  manner of 
marketing/distribution of an application can cause some complications in user experience. https://ec.europa.eu/digital-
single-market/en/news/public-consultation-building-european-data-economy. 
264 N=59 out of 68.  

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malfunctioning services are not covered.265 The results of the OPC on Building a European Data 
Economy show few cases of reported damages caused by those devices (Building a European 
Data Economy – Synopsis Report, 2017).266  

However,  despite  the  above-mentioned  findings,  there  are  not  enough  elements  to  conclude 
whether  the  Directive  is  or  is  not  adequate  to  cover  the  needs  of  consumers267  and 
producers268 of innovative technological products.269 However, the general perception by 
stakeholders270 at the moment is that, despite all legal uncertainties, the  Directive could be 
adequate to cover new technological developments, especially those which are more diffused 
in  the  market,  such  as  smartphones.  As  reported  by  a  European  association  representing 
producers  in  the  digital  technology  industry,  the  Directive  adequately  covers  the  needs  of 
producers  dealing  with  innovative  technological  developments,  such  as  smart  devices,  robots 
or  automated  systems.  The  association  further  highlights  that  “undue  and  premature 
legislation  specifically  directed  to  liability  in  the  field  of  technological  innovation  risks  stifling 
development and innovation”. 

Moreover, stakeholders consider the following characteristics of the Directive as  future-proof 
with respect to new needs:  

  The  Directive  applies  to  a  range  of  very  heterogeneous  products  (e.g.  to  damages 

caused by malfunctioning pacemakers or by defective staplers);271 

  The producer is considered liable independently of his fault or negligence;272 

  The  injured  party  has  to  prove  the  defect273  and  the  causal  link  between  defect  and 

damage to obtain compensation;274 

  The  three  year  period  for  the  injured  party  to  start  the  proceeding  for  the  recovery  of 

damages;275 

  The expiry period of  10 years from the moment that the producer put the product into 

circulation.276 

To  conclude,  the  issue  of  new  technological  developments  is  subject  to  a  vivid  doctrinal 
debate,  and  stakeholders  deem  that  these  technologies  will  cause  uncertainties  in  the 
application  of  the  legislation.  The  lack  of  case  law  hampers  a  thorough  assessment  of  the 
relevance of the Directive to issues raised by new technological developments.  

The lack of significant case law relating to new technological products (and being that the only 
registered case was unsuccessful) combined with stakeholders’ opinion cannot confirm whether 

265 N=81 out of 113.  
266  The  vast  majority  of  producers  taking  part  in  the  consultation  were  not  aware  of  any  specific  problems,  nor  had 
they experienced any difficulties as regards liability in the context of IoT products and services, autonomous systems 
and  advanced  robotics.  Very  few  had  encountered  problems  with  the  classification  of  IoT  products  and  services, 
autonomous systems  and  advanced robotics  as  products or  services, or  had  experienced  any significant  problems  in 
this  area.  Overall,  damage  in  the  context  of  IoT  products  and  services,  autonomous  systems  and  advanced  robotics 
seems to be very rare. This could be because IoT products and services are new to consumers and have low market 
penetration.  
267 OPC feedback: 35% (n=19 out of 54).  
268 OPC feedback: 43% (n=20 out of 47).  
269 The result of the TS does not lead to clear confirmation of this result, with seven respondents in favour (one UK and 
one  BE  representatives  from  SME  associations,  one  FR  and  three  UK  representatives  from  law  firms,  one  LT 
representative  from  public  administration)  and  six  against  (one  EL  representative  from  an  SME  association,  one  BE 
representative from a large-sized enterprises association, one NL and two UK law firms, an IT expert).  
270  In  particular,  producers,  which,  in  the  context  of  the  CATI  survey  agreed  (67%)  that  apps  and  non-embedded 
software or components of IoT can be considered “products” with regard to product liability rules. 
271 OPC feedback: 57% (n=54 out of 94). 
272 OPC feedback: 65% (n=51 out of 78). 
273 OPC feedback: 64% (n=64 out of 100).  
274 OPC feedback: 60% (n=45 out of 75). 
275 OPC feedback: 69% (n=65 out of 94). However, some interviews underline that the three year period may be too 
short for damage caused by more complex products, such as pharmaceutical products and medical devices. 
276 OPC feedback: 55% (n=53 out of 96).  

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the  initial  objectives  correspond  to  the  current  needs,  including  new  needs  created 
by  innovative  products.  However,  due  to  the  novelty  and  characteristics  of  these  new 
technologies, further investigations and legal analysis should be pursued (see Annex 8).  

In  the  following  section  the  relevance  of  specific  provisions  of  the  Directive  will  be  analysed 
and some of the issues highlighted in Annex 8 will be addressed, based on the limited evidence 
available. 

5.4.2  Relevance of specific provisions of the Directive 

5.4.2.1  Distinction between products and services 
EQ  29  To  what  extent  does  the  distinction  between  products  and  services  when  dealing  with  product 
liability continue to be apt for dealing with the new technological developments?  

The  distinction  between  products  and  services  when  dealing  with  product  liability  does  not 
continue to be apt for dealing with new technological developments. 

The Directive does not make any reference to the concept of service nor does it provide for the 
distinction  between  products  and  services.  It  solely  provides  for  the  definition  of  product, 
according to Article 2.  

ARTICLE 2 OF THE DIRECTIVE 

FOR  THE  PURPOSE  OF  THIS  DIRECTIVE  ‘PRODUCT’  MEANS  ALL  MOVABLES,  WITH  THE  EXCEPTION  OF  PRIMARY 
AGRICULTURAL  PRODUCTS  AND  GAME,  EVEN  THOUGH  INCORPORATED  INTO  ANOTHER  MOVABLE  OR  INTO  AN 
IMMOVABLE. ‘PRIMARY AGRICULTURAL PRODUCTS’ MEANS THE PRODUCTS OF THE SOIL, OF STOCK-FARMING AND 
OF  FISHERIES,  EXCLUDING  PRODUCTS  WHICH  HAVE  UNDERGONE  INITIAL  PROCESSING.  ‘PRODUCT’  INCLUDES 
ELECTRICITY. 

In  particular,  the  notion  of  product  mainly  refers  to  movables  even  though  incorporated  into 
another  movable  or  into  an  immovable.  With  the  exception  of  electricity,  which  has  been 
included in the notion of product, the main feature of products in the Directive is the fact that 
they are tangible, material objects. On the contrary, services do not  fall into the definition of 
product. 

However, such distinction does not seem to be always apt when dealing with new technological 
developments (see Annex 8).  

Preliminarily  it  is  worth  recalling  that  the  Directive  does  not  prevent  a  Member  State  from 
applying rules which provide for the liability of a service provider, even in the absence of any 
fault, with the only condition being that the injured person and/or the service provider retains 
the right to claim the producer’s liability on the basis of the Directive when the conditions laid 
down by the latter are fulfilled (CJEU C-402/03 and CJEU C-495/10).277 Evidence from legal 
mapping  shows  that,  overall,  18  Member  States278  do  not  have  any  forms  of  extra-
contractual  liability  in  place  to  protect  consumers  from  damages  caused  specifically  by 
defects  of  either  intangibles  (e.g.  software)  or  services  (finding  5).279  On  the  contrary,  nine 
Member  States  (DE,  EE,  EL,  FR,  LT,  MT,  NL,  SI,  SK)  ensure  an  extra-contractual  liability  to 
protect  consumers  from  damages  caused  by  defects  both  of  intangibles  (e.g.  software)  and 
services (finding 6). A distinction can be made between these Member States. In some of them 
(DE,  EE,  MT,  NL,  SI,  SK)  the  protection  of  consumers  from  damages  caused  by  defects  of 
either  intangibles  or  services  stems  from  general  rules,  normally  tort  law:  in  these  cases, 
protection  essentially  stems  from  the  interpretation  of  general  rules  to  include  services  or 

277 In particular, the French regime was scrutinised by the CJEU, which stated that Member States may provide for the 
liability  of  a  service  provider,  upon  condition  that  the  same  service  provider  has  a  right  of  recourse  against  the 
producer  when  the  producer  is  liable  under  the  Directive,  as  an  objective  of  the  Directive  is  to  avoid  that  Member 
States create legislative spaces where producers benefit from a liability-free regime (CJEU C-495/10). 
278 BE, BG, CZ, DK, ES, HR, IT, CY, LV, LU, HU, AT, PL, PT, RO, SE, UK. Information not available for FI. 
279 According to data gathered at national level. 

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intangibles (finding 7).  In two Member States  (EL and LT) the rules set forth in the Directive 
are stretched to ensure strict liability for services and intangibles as well (finding 8). 

theory.  Some 

literature  (Lewiatan,  2017)  highlights 

Evidence from literature shows contrasting views. As discussed  in the previous section, 
this  is  associated  with  the  fact  that  the  application  of  liability  rules  to  new  technological 
developments ̶ some of which are more similar to services than to products ̶ is mainly unclear 
in 
that  new  technological 
developments  most  often  take  the  form  of  movable  items  and  can  be  considered 
‘products’ from the perspective of consumers and business users, so that courts will consider 
software  a  product.  Other  literature  considers  treating  digital  goods  as  analogous  to 
physical  goods  in  certain  legal  fields,  where  it  has  recently  been  demonstrated  that  the 
categorisation of digital goods is of paramount legal importance, most notably in the fields of 
copyright, taxation, and consumer protection law (Hojnik 2017). Other literature observes that 
an  “individual  software”  is  not  considered  a  product  but  a  service,  as  it  is  the  object  of  a 
specific  contract  intended  to  meet  individual  customers’  needs.  This  is  not  the  case  for 
“standard software” that should therefore not fall within the definition of a product pursuant to 
the  Art.2  of  the  Directive  (Beuc,  2015).  With  specific  regard  to  software,  the  French 
government  deemed  that  the  Directive  should  apply  to  software,  provided  that  the  “logiciel” 
was causing damages within the limits stated in the Directive.280 In addition, the Estonian Law 
of  Obligations  Act  considers  computer  software  as  products  (section  1063  subsection  1).  The 
CJEU itself contributed to the definition of software, which is to be considered a medical device 
(i.e. a product) when intended by the manufacturer to be used specifically for one or more of 
the  medical  purposes  set  out  under  the  definition  of  ‘medical  devices’.281  Moreover,  two 
Regulations282  on  medical  devices  were  adopted  in  April  this  year,  according  to  which  the 
liability  regime  established  by  the  Directive  may  include  software,  without  prejudice  to  more 
protective national rules.283 Finally, products purchased as a bundle with related services 
are  sometime  considered  as  a  service  and  sometimes  as  a  product,  this  possibly 
creating different levels of consumer protection and of producers’ liability across the EU. More 
specifically,  based  on  the  available  data,  products  purchased  in  bundle  with  services  are 
products in Finland and Luxembourg. They are not considered products in Greece, Italy, Malta, 
Netherlands, and United Kingdom. 

These views are shared by stakeholders consulted. Five out of five respondents to the targeted 
survey  believe  that  the  distinction  between  products  and  services  is  not  appropriate 
particularly  in light of new technological developments. Similarly, the large majority of 
respondents284 to the OPC believe that it is sometimes difficult to distinguish a product from a 
service,  since  they  are  often  bundled  together,  and  that  it  is  even  more  burdensome  to 
distinguish  a  product  from  a  service  when  they  are  bundled  together  in  the  context  of  new 

280 Question N° 15677, de M. de Chazeaux Olivier, Question publiée au JO le 15/06/1998 page 3230; Réponse publiée 
au JO le 24/08/1998 page 4728. 
281 CJEU C-219/11. This requires a case-by-case analysis, as demonstrated also in pending judgment (CJEU C-329/16) 
in which the Court has to determine whether a certain type of software should be considered a medical device where 
that  software  has  at  least  one  function  that  permits  the  use  of  data  specific  to  a  patient  to  help  his  doctor  issue  a 
prescription.  
282  (i)  Regulation  (EU)  2017/745  of  the  European  Parliament  and  of  the  Council  of  5  April  2017  on  medical  devices, 
amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and  Regulation  (EC)  No  1223/2009  and  repealing 
Council  Directives  90/385/EEC  and  93/42/EEC  and  (ii)  Regulation  (EU)  2017/746  of  the  European  Parliament  and  of 
the  Council  of 5 April  2017  on  in  vitro  diagnostic  medical devices  and  repealing Directive 98/79/EC  and  Commission 
Decision 2010/227/EU. 
283 Recital 19 of Regulation (EU) 2017/745 states that: “It is necessary to clarify that software in its own right, when 
specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition 
of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare 
setting,  or  software  intended  for  life-style  and  well-being  purposes  is  not  a  medical  device.  The  qualification  of 
software, either as a device or an accessory, is independent of the software's location or the type of interconnection 
between the software and a device”. 
284 85% (n=29) of Consumers. 

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technological  developments,  especially  when  dealing  with  cloud  technologies  and  IoT.285  An 
Italian association representing distributors, for instance, clarified that, in practice, the supply 
of a stand-alone software is comparable to the supply of a product. A large producer, however, 
suggested  that  it  was  necessary  to  distinguish  the  non-embedded  from  the  embedded 
software,  as  well  as  the  non-native  from  the  native  software.  The  producer  should  be indeed 
be  held  liable  only  for  the  embedded  and  native  software  under  the  Directive,286  while  the 
liability  for  the  non-embedded  and  non-native  software  shall  be  borne  by  the  software 
manufacturer. 

This is confirmed  by interviewees who consider the distinction  as becoming extremely blurry, 
especially for new systems. According to findings from the targeted survey, the categorisation 
as a product and or as a service leads to different regulatory systems in the case of  software. 
An  Italian  consumer  association  explains  that  the  scope  of  the  Directive,  which  is  limited  to 
moveable  products,  creates  legal  uncertainty,  since  it  excludes  services  and  it  is  not  always 
clear if it includes digital technologies. Indeed, also the legal analysis (see Annex 8) shows that 
Article  2  of  the  Directive  could  create  some  interpretative  problems  especially  with  regard  to 
cloud technologies and smartphones.  

Moreover,  the  majority  of  respondents  to  the  targeted  survey  think  that  the  distinction 
between  products  and  services  is  not  appropriate,  particularly  in  light  of  new 
technological  developments287  and  that  the  scope  of  the  Directive  should  be  extended  to 
cover services.288  

This  being  said,  some  observe  that,  even  if  service  contracts  mostly  contain  obligations  of 
conduct,  besides  these,  there  are  ancillary  and  sometimes  quite  relevant  obligations 
concerning  results  (e.g.  the  obligation  to  carry  out  a  medical  examination  also  involves  the 
duty to make a correct blood transfusion) and, therefore, in principle it is possible to apply 
strict liability to services, in connection to their obligations of conduct (Koziol 2013).  

Nonetheless,  with  specific  reference  to  new  technological  developments,  the  majority  of 
producers289  of  IoT/robotics  devices  responding  to  the  survey  on  Building  a  European  data 
economy290  answered  that  they  have  never  experienced  problems  so  far  in  not  knowing  in 
which  category  (product/service)  to  classify  the  device  in  order  to  comply  with  a  specific 
liability regime.  

As  also  confirmed  through  the  interview  with  an  Italian  expert,  the  key  provision  regarding 
interconnected  products  lies  in  Article  5  of  the  Directive,  which  states  that  in  case  two  or 
more persons are liable for the same damage, they shall be liable jointly and severally, without 
prejudice  to  the  provisions  of  national  law  concerning  the  rights  of  contribution  or  recourse. 
This provision should be applicable also to new technological developments with interconnected 
sub-parts.  The  distinction  between  products  and  services  when  dealing  with  product  liability 
and particularly the relevance of such distinction is a matter of discussion. 

In  conclusion,  the  distinction  between  products  and  services  does  not  seem  to  be  always 
appropriate when dealing with new technological developments, in particular software, IoT and 
cloud technologies. Hence, it might be considered to either extend the scope of the Directive or 
to  make  it  more  specific  in  order  to  better  determine  whether  they  are  covered  by  the 
Directive or not.  

285 68% of respondents to the OPC. 
286  The  large  producer  discussed  the  case  of  a  defective  smartphone  application  for  photos,  which  prevented  the 
smartphone camera (i.e. the hardware) from working. According to the producer, the Directive should not apply in this 
case.  
287 (i.e. 10 out of 16 responding to the question). 
288 (i.e. 12 out of 17 responding to the question). 
289 66%, n=43 out of 65. The remaining part of respondents have experienced these problems to a moderate extent 
(25%, n=16 out of 65) and to a significant extent (9%, n=9 out of 65). 
290 https://ec.europa.eu/digital-single-market/en/news/public-consultation-building-european-data-economy. 

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5.4.2.2  Distinction between private and professional use 
EQ  30  How  well  adapted  is  the  intervention  to  the  changing  market  environment:  often  with  a  blurred 
distinction between private and professional use of products? 

The intervention in the changing market environment is not well adapted since the distinction 
between the private and professional use of a product is blurred. 

The  Directive  does  not  expressly  refer  to  the  professional  use  of  products.  The  distinction 
between the professional and private use of products emerges, nonetheless, with regard to the 
definition of damage to an item of property  other than the defective  product itself: according 
to Article 9(b), such item of property shall be (i) of a type ordinarily intended for private use or 
consumption,  and  (ii)  used  by  the  injured  person  mainly  for  his  own  private  use  or 
consumption.  Hence,  only  in  such  cases  would  the  damage  be  subject  to  compensation:  the 
compensation  would  not  be  allowed,  on  the  contrary,  if  the  item  of  property  is  not  of  a  type 
ordinarily  intended  for  private  use  (i.e.  intended  for  professional  use)  and  is  not  used  by  the 
injured  person  mainly  for  his  own  private  use  or  consumption  (i.e.  professional  use  or 
consumption). 

ARTICLE 9  

FOR THE PURPOSE OF ARTICLE 1, ‘DAMAGE’ MEANS : 
(A) DAMAGE CAUSED BY DEATH OR BY PERSONAL INJURIES; 
(B)  DAMAGE  TO,  OR  DESTRUCTION  OF,  ANY  ITEM  OF  PROPERTY  OTHER  THAN  THE  DEFECTIVE  PRODUCT  ITSELF, 
WITH A LOWER THRESHOLD OF 500 ECU, PROVIDED THAT THE ITEM OF PROPERTY: 
(I) IS OF A TYPE ORDINARILY INTENDED FOR PRIVATE USE OR CONSUMPTION, AND  
(II) WAS USED BY THE INJURED PERSON MAINLY FOR HIS OWN PRIVATE USE OR CONSUMPTION.  
THIS ARTICLE SHALL BE WITHOUT PREJUDICE TO NATIONAL PROVISIONS RELATING TO NON-MATERIAL DAMAGE. 

In  this  respect,  as  mentioned  in  section  4.5,  damages  often  occur  in  the  context  of 
professional activities as showed in the figure below. 

Figure 12: Contexts where the claimed damages occurred (Average % across Member 
States) 

Source: EY elaboration based on desk research at national level 

Nonetheless, the majority of claims brought to court were relating to damages that occurred in 
the  private  life  of  the  injured  persons  (see  finding  14).  On  the  other  hand,  according  to  the 
results of the desk research  at  the national level, in at least 150 cases the court allowed the 
compensation  even  if  the  item  of  property  was  subject  to  professional  use  (see  section 
5.1.1.2),  suggesting  that  the  damage  occurred  to  the  item  of  property  intended  for 
professional use, even though it  is not evident whether a specific legislation on this has been 

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0%50%100%150%200%250%300%20002001200220032004200520062007200820092010201120122013201420152016Within a householdSport, leisure, or other social activityProfessional activityMedicalOther 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

adopted  by  the  Member  States.291  These  cases  seem  to  be  concentrated  in  a  few  countries: 
Austria (14 cases), Denmark (25) and France (6).292  It is noteworthy  that the Directive must 
be  interpreted  to  mean  that  it  does  not  preclude  the  interpretation  of  domestic  law  or  the 
application  of  settled  domestic  case  law,  according  to  which  an  injured  person  can  seek 
compensation for damage to an item of property intended for professional use and employed 
for that purpose as  shown by  CJEU C-285/08.  In addition, the majority of  respondents to the 
OPC293 and to the TS294 agree that it is sometimes difficult to distinguish between private and 
professional use of a product. 

With  regard  to  damage  caused  by  death  or  by  personal  injuries  (Article  9(a)),  the  Directive 
does not limit its application to private activities: this has been interpreted (Rajneri, 2016) as 
meaning  that  in  case  of  damage  caused  by  death  or  by  personal  injuries,  the  compensation 
shall  be  allowed  regardless  of  whether  the  injured  person  was  operating  in  a  private  or 
professional activity.295 As a matter of fact, the text of the Directive refers always to the notion 
of “injured person” rather than the “consumer”.296  

Therefore,  the  distinction  between  private  and  professional  use  of  products  is  relevant  only 
with  regard  to  the  damage  caused  to  another  item  of  property:  such  distinction,  however,  is 
not  always  clear  and  can  cause  some  problems  of  interpretation,  also  with  regard  to  new 
technological  developments,  especially  those  mostly  used  in  professional  fields,  such  as 
smartphones, cloud technologies and IoT. 

First, the distinction itself represents a  cause  of uncertainty since it requires  a qualification 
of the activity to be made on a case-by-case basis, depending on the specific circumstances at 
hand, as the distinction is not absolute but relative. Indeed, the large majority of respondents 
to the OPC297 find it difficult to make the difference, and a slight majority of respondents to the 
related  question  in  the  targeted  survey  think  the  distinction  is  no  longer  adequate:298  thus  a 
need to clarify or remove such distinction has emerged.  

Second, the distinction appears to be no longer appropriate with reference to the latest social 
and  economic  changes.  As  indicated  by  the  majority  of  stakeholders  consulted299  through 
interviews, not only can products be used increasingly for both areas of activities, but also the 
economic  structure  of  the  society  is  changing:  on  the  one  hand,  new  big  producers  have 
appeared in the market which cannot be compared to the small producers, on the other hand, 
the way consumers and professionals use products is not substantially different. 

Third, the distinction between private and professional use of products is made more and more 
uncertain when applied to new technological developments, such as software or IoT. As 
highlighted in literature (Staub, R., 2016), there are significant damages (financial losses and 
business damages) caused by errors in standard software, which is mostly used by those who 

291 On the contrary, according to the data collected through the country fiches, the claim brought by the injured party 
was rejected in at least 23 cases from 2000 on, because the injured person did not use the product mainly for his own 
private use or consumption. 
292 National mapping. 
293 65.22% Agree. 
294 Two respondents out of four, in which one agrees and the other has not responded. 
295 This interpretation has also been confirmed by an IT court of cassation. Cass. 29-5-2013, n. 13458: in the case at 
hand the damage was caused by a medical scalpel used in the context of a surgical operation on a patient and causing 
a physical injury to the hand of the surgeon.). 
296 Exception made for the recitals of the Directive and Articles 15 and 16 in which the notion of “consumer protection” 
appears. 
297 65.22% of respondents to the OPC. 
298 5 consumer associations, a DE law firm, a EL industry association representing large and SMEs. 
299 19 stakeholders out of 32 respondents. In particular, an IT expert, a European association representing producers 
in  the  automotive  industry  and  a  consumer  association  from  MT  note  that  repealing  the  distinction  between  private 
and professional use of products would help in eliminating a big qualification problem and would facilitate the claims 
resolution. 

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buy  it  for  professional  purposes  and  who  because  of  such  utilisation  are  excluded  from  the 
protection of the Directive in case of damages caused by the defective software. 

In addition, as confirmed by interviewees and scholars, the rules of liability stemming from the 
Directive appear to be easily applicable also to items of property intended for professional use 
and the need to provide for two different systems of liability in this regard does not seem to be 
meaningful anymore.300 

In  conclusion,  considering  the  aforementioned  evidence  and  reasoning,  the  relevance  to  the 
changing  market  environment  is  not  well  adapted  since  the  distinction  between  private  and 
professional use, and hence damages  caused to items  of property intended  for private rather 
than professional use, is blurred. 

5.4.2.3  Concepts of product, producer, damage, and category of exemptions 
EQ  31  To  what  extent  are  the  concept  of  product,  producer,  damage  or the  category  of  exemptions  as 
defined in the Directive adequate to correspond to the technological and scientific developments? 

The  concepts  of  product,  producer,  damage  or  the  category  of  exemptions  as  defined  in  the 
Directive  are  not  always  adequate  to  the  technological  and  scientific  developments,  as 
presented in the figure below.  

Figure 13: Adequacy of the Directive to some concepts 

The main issues emerging from both the desk and the field research are listed in the following 
sections. 

Source: targeted survey 

5.4.2.3.1  Product 

ARTICLE 2 
FOR  THE  PURPOSE  OF  THIS  DIRECTIVE  ‘PRODUCT’  MEANS  ALL  MOVABLES,  WITH  THE  EXCEPTION  OF  PRIMARY  AGRICULTURAL 
PRODUCTS AND GAME, EVEN THOUGH INCORPORATED INTO ANOTHER MOVABLE OR INTO AN IMMOVABLE. ‘PRIMARY AGRICULTURAL 
PRODUCTS’  MEANS  THE  PRODUCTS  OF  THE  SOIL,  OF  STOCK-FARMING  AND  OF  FISHERIES,  EXCLUDING  PRODUCTS  WHICH  HAVE 
UNDERGONE INITIAL PROCESSING. ‘PRODUCT’ INCLUDES ELECTRICITY. 

The  definition  of  “product”  as  per  Article  2  of  the  Directive  is  relating  to  the  concept  of 
“movable”. This has been interpreted as meaning that only tangible goods shall be considered 
products:  indeed,  at  the  time  in  which  the  Directive  has  been  adopted,  no  clear  examples  of 
non-tangible goods, such as new technological developments like IoT  and cloud technologies, 
were diffused in the market.  

According to some literature  (Koch 2015), the Directive does not expressly establish whether 
products should or not  be tangible: this lack of specification enables the interpreters to more 
easily  include  the  new  technological  developments  in  the  concept  of  products.  However,  the 
lack  of  specification  also  contributes  to  uncertainty  to  the  classification  of  products;  for 

300 Interview to an IT expert and UK lawyer. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

instance,  it  is  not  clear  whether  information  as  such  falls  under  the  regime  or  not  (Koch 
2015). 

Particular  concerns  are  raised  with  regard  to  robotics:  according  to  the  Report  with 
recommendations  to  the  Commission  on  Civil  Law  Rules  on  Robotics  of  the  European 
Parliament301  ”the  concepts  of  product,  producer,  damage  or  the  category  of  exemptions  as 
defined in the Directive […] could not be apt anymore when dealing with the emerging  field of 
robotics:  “[…]  in  the  scenario  where  a  robot  can  take  autonomous  decisions,  the  traditional 
rules  will  not  suffice  to  activate  a  robot’s  liability,  since  they  would  not  make  it  possible  to 
identify  the  party  responsible  for  providing  compensation  and  to  require  this  party  to  make 
good the damage it has caused”. 

In particular, the spread of the use of robots and AI may not be covered by the Directive and, 
therefore, it is necessary to define whether the strict liability or the risk management approach 
should be applied to them. 

Similarly,  the  majority  of  stakeholders  consulted  through  the  targeted  survey  think  that  the 
Directive does not adequately define “product”.302 The respondents specify that such definition 
is too narrow and not fit for purpose in this digital age. Nowadays, digital items (whether web-
based,  cyber,  cloud,  cloud  edge,  IoT  and  so  on)  are  increasingly  needed  in  the  society,  are 
spread throughout all sectors of activities and do not represent exceptional products anymore. 
The Product Liability Directive, dated 1985, does not provide for a definition of product which 
clearly  comprises  the  new  technological  developments.  However,  a  supporting  argument  in 
favour of including the new technological developments in the scope of the Directive is the fact 
that  several  pieces  of  specific  safety  legislation  explicitly  refer  to  some  of  them  as  products 
(e.g. software) (see section 5.3.3 and Annex 9). However, it is not possible to make the same 
supporting argument for other kinds of new technological developments, such as IoT or apps, 
which are not indicated in the sectorial safety legislation as products. 

In  addition,  as  discussed  above,  the  non-tangible  nature  of  some  new  technological 
developments  (software,  applications,  IoT)  makes  it  difficult  to  classify  them  as  products 
rather  than  services  (Arthur’s  legal,  2015),  even  though  the  majority  of  producers  of 
IoT/robotics  devices  responding  to  the  OPC  on  Building  a  European  Data  Economy  initiative 
answered  that  they  have  never  experienced  problems  in  the  qualification  of  the  good  as  a 
product or as a service.303 Furthermore, as suggested by an Italian expert, it seems harder to 
apply  the  rules  of  strict  liability  to  the  obligations  of  a  producer  that  more  like  a  service 
provider:  for  instance,  it  is  uncertain  that  the  defect  of  an  intangible  new  technological 
development, for example a cloud technology, can be proved without taking into consideration 
the fault of the service provider in delivering the service. In addition, the non-tangible nature 
of new technological developments makes it harder to identify the perimeter of the product (as 
the product is composed of data, which incessantly interact with each other).  

The  contributions  received  through  the  interviews  show  that  the  definition  of  product  is  no 
longer  adequate  vis-à-vis  certain  new  technological  developments.  According  to  an  Italian 
association  representing  distributors,  uncertainties  emerge  when  dealing  specifically  with 
cloud  technologies.  In  particular,  according  to  another  Italian  large  producer,  there  is  the 
need  to  pay  proper  attention  to  the  immaterial  and/or  intellectual  nature  of  the 
product  and  to  the  potentially  harmful  consequences  it  might  have  on  other 

301  European  Parliament  (2016,  May  31).  Report  with  recommendations  to  the  Commission  on  Civil  Law  Rules  on 
Robotics.  Retrieved  from  http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML%2BCOMPARL%
2BPE-582.443%2B01%2BDOC%2BPDF%2BV0//EN. .  
302 Three out of five respondents. 
303  The  majority  has  never  experienced  problems  in  not  knowing  in  which  category  (product/service)  to  classify  the 
device in order to comply with a specific liability regime (66%, n=43 out of 65). The remaining  share of respondents 
have experienced these problems to a moderate extent (25%, n=16 out of 65) and to a significant extent (9%, n=9 
out of 65). 

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interconnected  (material  and  immaterial)  items  of  property.  A  UK  lawyer  as  well  as  a 
German  consumer  association  believe  that  the  notion  of  product  should  be  clearly  developed 
because  of  IoT,  robots,  etc.,  and  should  encompass  some  services  in  the  cases  where  the 
services are embedded in the products.  

In  conclusion,  the  definition  of  product  vis-à-vis  new  technological  developments,  particularly 
non-tangible products, such as cloud technologies, software, Iot and applications, is not always 
adequate  and  brings  uncertainties  in  its  application.  These  uncertainties  are  particularly 
relating to the possibility of applying liability without fault (strict liability) to producers, such as 
in the case of AI, where the self-learning systems perform autonomous actions. Furthermore, 
uncertainties arise  with regard to the possibility of identifying  the liable  product,  especially in 
cases  of  interconnected  products,  and  products  which  consist  of  non-tangible  items,  such  as 
apps.  Stakeholders  indicated  the  need  for  interpretation  of  the  concept  of  product304  or  an 
enlargement  of  the  concept  of  product  to  include,  for  instance,  some  new  technological 
developments such as AI or cloud technologies, as well as applications. 

5.4.2.3.2 

Producer 

ARTICLE 3 
1. ’PRODUCER’ MEANS THE MANUFACTURER OF A FINISHED PRODUCT, THE PRODUCER OF ANY RAW MATERIAL OR 
THE  MANUFACTURER  OF  A  COMPONENT  PART  AND  ANY  PERSON  WHO,  BY  PUTTING  HIS  NAME,  TRADE  MARK  OR 
OTHER DISTINGUISHING FEATURE ON THE PRODUCT PRESENTS HIMSELF AS ITS PRODUCER.  
2. WITHOUT PREJUDICE TO THE LIABILITY OF THE PRODUCER, ANY PERSON WHO IMPORTS INTO THE COMMUNITY 
A PRODUCT FOR SALE, HIRE, LEASING OR ANY FORM OF DISTRIBUTION IN THE COURSE OF HIS BUSINESS SHALL BE 
DEEMED  TO  BE  A  PRODUCER  WITHIN  THE  MEANING  OF  THIS  DIRECTIVE  AND  SHALL  BE  RESPONSIBLE  AS  A 
PRODUCER.  
3. WHERE THE PRODUCER OF THE PRODUCT CANNOT BE IDENTIFIED, EACH SUPPLIER OF THE PRODUCT SHALL BE 
TREATED  AS  ITS  PRODUCER  UNLESS  HE  INFORMS  THE  INJURED  PERSON,  WITHIN  A  REASONABLE  TIME,  OF  THE 
IDENTITY OF THE PRODUCER OR OF THE PERSON WHO SUPPLIED HIM WITH THE PRODUCT. THE SAME SHALL APPLY, 
IN THE CASE OF AN IMPORTED PRODUCT, IF THIS PRODUCT DOES NOT INDICATE THE IDENTITY OF THE IMPORTER 
REFERRED TO IN PARAGRAPH 2, EVEN IF THE NAME OF THE PRODUCER IS INDICATED. 

With  regard  to  the  notion  of  producer,  provided  for  in  Article  3  of  the  Directive,  the 
stakeholders consulted find it quite adequate.  

In  particular,  nine  out  of  13  respondents  answering  this  question  in  the  targeted  survey 
declare that they either agree or strongly agree with the statement that it is adequate.  

However,  some  suggest  that  this  concept  does  not  appear  adequate  in  relation  to  re-
production  systems,  such  as  for  example  3D  printing  (Courtois  2017)  (Beuc  2015).  Indeed, 
according  to  a  French  lawyer,  the  definition  of  producer  in  the  text  from  1985  refers  only  to 
producers involved in large manufacturing: in other words, the producer was mainly someone 
who  was  manufacturing  large  quantities  of  products.  The  economic  and  social  paradigm  in 
which  the  Directive  was  conceived  was  mass  production  and  mass  manufacturing.  With  the 
spread  of  3D  printing,  mass  production  is  moving  more  and  more  toward  personalised 
production,  since  the  third  party  can  now  decide  how  to  produce/print  his  own  product  by 
means of 3D printing: it seems hence inadequate that the company possessing the 3D printer 
would be liable under the Directive as the producer. 

However,  according  to  some  scholars  (Verbruggen  2016),  the  multi-layered  concept  of 
producer  as  presented  by  the  Directive  would  closely  fit  with  the  characteristics  of  the 
Information  and  Communication  Technology  (ICT)  supply  chain,  in  which  almost  all  goods 
and  services  are  composite  ‘products’.  The  Directive  notes  that  if  two  or  more  producers  are 
liable under its regime, they are jointly and severally liable. 

304 Such as was done in 1999 with the amendment of the Directive to include “electricity” under Article 2. 

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However  there  is  no  uniform  opinion  on  the  issue  of  interconnected  products:  other 
stakeholders,  like  an  Italian  large  producer,  believe  that  in  case  of  complex  products  the 
subject  that  shall  be  considered  liable  under  the  Directive  is  the  system  integrator  and  not 
jointly the producers of the single components.  

With  regard  to  robots  and  AI  systems,  scholars  (Courtois  2016a,  2016b)  have  identified  an 
issue  in  applying  the  definition  of  producer  to  the  manufacturer  of  the  robot:  the  issue 
concerns the fact that highly developed robots and AI are not subject anymore to the control 
of  their  producers,  since  they  make  autonomous  decisions  based  on  complex  algorithms.  It 
would  be,  instead,  necessary  to  understand  how  the  algorithms  within  these  robots  work  in 
order  to  understand  the  possible  liability  of  the  producer  of  the  software  embedded  in  the 
robot in case of defects or “wrong decisions”. However, the authors conclude that these robots 
are  not  currently  available  in  the  market  and  it  is  not  possible  to  come  to  a  clear  conclusion 
over the applicability of the Directive or not. 

In conclusion, the definition of producer in the Directive is quite appropriate as it is stands, but 
there  is  a  need  to  better  specify  such  definition  with  regard  to  new  technological 
developments, especially the digital applications, AI, robotics, and 3D printing. 

5.4.2.3.3  Damage and the burden of proof 

ARTICLE 9 
FOR THE PURPOSE OF ARTICLE 1, ‘DAMAGE’ MEANS : 
(A) DAMAGE CAUSED BY DEATH OR BY PERSONAL INJURIES; 
(B) DAMAGE TO, OR DESTRUCTION OF, ANY  ITEM OF PROPERTY  OTHER THAN THE DEFECTIVE PRODUCT ITSELF, WITH A  LOWER 
THRESHOLD OF 500 ECU, PROVIDED THAT THE ITEM OF PROPERTY: 
(I) IS OF A TYPE ORDINARILY INTENDED FOR PRIVATE USE OR CONSUMPTION, AND  
(II) WAS USED BY THE INJURED PERSON MAINLY FOR HIS OWN PRIVATE USE OR CONSUMPTION.  
THIS ARTICLE SHALL BE WITHOUT PREJUDICE TO NATIONAL PROVISIONS RELATING TO NON-MATERIAL DAMAGE. 

The  definition  of  damage  provided  for  in  the  Directive  concerns  basically  two  kinds  of 
damages: physical injuries and damage to items of property. The former damage also covers 
economic  losses,  such  as  incapacity  to  work.  In  the  latter  case,  the  notion  is  limited  only  to 
damages to items of property mainly intended for private use.  

Consequently,  the  question  as  to  whether  the  definition  of  damage  is  still  relevant  needs  to 
take  into  consideration  two  aspects:  first,  whether  the  notion  described  above  is  still  apt  to 
appropriately  cover  all  possible  damages  or  whether  there  are  damages  which  are  excluded 
from protection; second, whether the notion of damage is still apt to cover damages caused by 
new technological developments.  

As to the first question, the results showed that scholars noted that the definition of “damage” 
does not take into account “damage to digital environment” or pure economic losses not linked 
to  property  losses:  in  particular,  it  seems  that  stakeholders  perceive  the  need  to  extend  the 
concept  of  damage  to  “non-material  damage”,  as  also  stated  in  some  other  desk  findings 
(Beuc,  2015).  In  particular,  some  of  the  interviewed  stakeholders,  like  a  German  consumer 
association  and  Belgium  lawyers,  believe  that  the  definition  of  damage  does  not  cover  non-
material damage and non-material digital damage and it should be extended  so as to include 
damages  to  digital  data,  loss  of  information  or  pure  economic  losses  relating  to  property 
damages. The majority of the respondents to the TS, think that there is a need to cover “pure 
economic  loss”  (i.e.  a  pecuniary  loss  not  resulting  from  injury  or  physical  damage)  amongst 
the damages caused by a defective product by design or as an add-on feature.  

Furthermore, in relation to physical damage, the concept of damage is not always applicable in 
the field of pharmaceutical products and medications (Belgium), often because of the scientific 
advances (Delforge, 2014). 

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Moreover,  the  notion  of  damage  regarding  items  of  property  is  perceived  as  not  being  that 
relevant  anymore  because  of  the  exclusion  from  protection  of  damages  to  those  items  of 
property which are intended for  professional use:305 as mentioned above in section 5.4.2.2, 
the desk research at the national level showed that often the court allowed compensation even 
if the product was subject to professional use (see section 5.1.1.2), that in case of damages to 
items of property, these were intended for professional use. In addition, the  responses to the 
TS,  even  though  limited,306  showed  that  the  majority  of  respondents  disagree  with  the 
statement  that  the  distinction  between  private  and  professional  use  is  still  relevant.  The 
majority  of  respondents  to  the  OPC307  agree  that  it  is  sometimes  difficult  to  distinguish 
between private and professional use of a product. As iterated in the literature (Machnikowski, 
2016): “Along with the hazards we have noted so far that are inherent in products  – risks to 
life, health and property ̶ there are new  ones  relating to a broader category of non-economic 
rights and the interests of the user”. 

The  second  question  is  closely  relating  to  the  first  one,  since  the  current  notion  of  damage 
appears  to  be  limited  especially  when  dealing  with  new  technological  developments.  Indeed, 
scholars have pointed out that “a number of […] technologies are relating to serious hazards of 
personal rights other than life and health of their users and third parties, in particular privacy” 
(Machnikowski  2016).  In  other  words,  damages  caused  by  new  technological  developments, 
such as cloud technologies and IoT, which involve infringement of privacy because of defects in 
the  new  technological  developments,  are  not  clearly  covered  by  the  Directive.  This  is  also 
supported  by  the  legal  analysis  which  evidenced  some  interpretative  problems  especially 
regarding cloud technologies and apps (see Annex 8). 

The  overall  opinion  that  the  concept  of  damage  is  not  adequately  defined  in  the  Directive  is 
also  shared  by  the  majority  of  respondents  to  the  TS,  as  it  does  not  cover  all  types  of 
damages,  especially  with  regard  to  the  damages  which  can  be  caused  by  some  new 
technological developments, such as IoT, and loss of information.  

In conclusion, the notion of damage is partially relevant both regarding “traditional products”, 
because it does not cover damages to items of property intended for professional use nor pure 
economic losses; and, similarly, the notion of damage is not that relevant anymore with regard 
to new technological developments, particularly cloud technologies and IoT, where the damage 
also can consist of infringement of privacy or other damages to information. 

This said, it should also be noted that the  relevance  of the notion of  damage  also affects the 
burden  of  proof  upon  the  injured  person  when  making  a  claim  for  compensation  in  court 
(together with the proof of the defect in the product and the proof of the link between damage 
and defect). 

ARTICLE 4 -  
THE  INJURED  PERSON  SHALL  BE  REQUIRED  TO  PROVE  THE  DAMAGE,  THE  DEFECT  AND  THE  CAUSAL  RELATIONSHIP  BETWEEN 
DEFECT AND DAMAGE. 

According to the consumer associations,308 the burden of proof continues to be an issue, as the 
consumer has to pay in advance  for the  costs  of the  expert witness  to appear in front  of  the 
court, as the consumer cannot easily point to the cause of the damage and this leads to 

305  The  original  motivation  for  the  exclusion  of  compensation  of  damages  to  item  of  properties  intended  for 
professional  use  lies  in  the  fact  that  the  Directive  is  a  business-to-consumer  directive.  However,  as  commentators 
noted (Machnikowski, 2016) and as stated by the judgment of the CJEU C-285/08, Member States have the possibility 
to  grant  the  right  to  obtain  compensation  for  damage  to  an  item  of  property  intended  for  professional  use  and 
employed  for  that  purpose,  where  that  injured  person  simply  proves  the  damage,  the  defect  in  the  product  and  the 
causal link between that defect and the damage. 
306 2 respondents out of 4, 1 agrees and the other has not responded. 
307 65.22% agree. 
308 See, among others, HR and CY consumer organisations. 

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the additional cost of paid expertise. In addition, one stakeholder representative interviewed309 
has  suggested  addressing  the  issue  of  difficulties  involved  in  the  burden  of  proof  by 
establishing, at the procedural level, a second opinion option, under which consumers can ask 
for  a  second  opinion  (e.g.  referee).  The  burden  of  proof  should,  therefore,  be  partly  the 
responsibility  of  the  producers  as  well,  since  without  the  help  of  the  manufacturer  informing 
about the production process, the procedure of investigation is longer and more expensive for 
consumers.  According  to  an  Italian  expert,  the  problem  of  rejection  of  claims  relating  to  the 
difficulties inherent in the burden of proof is a general problem of the Directive and not specific 
to  new  technological  developments  and  is  relating  to  the  rules  of  procedures  of  each 
Member State which may vary significantly and have a relevant impact in terms of access to 
justice.  

When  the  burden  of  proof  regards  medical  liability,  event  for  experts,  gathering  irrefutable 
proof of a causal link between the damage and the defective  product/service is made difficult 
in  the  presence  of  uncertainties  relating  to  the  ethology  of  certain  pathologies  (Delforge, 
2014),  such  as  the  case  of  sufferers  of  multiple  sclerosis  developed  following  vaccination 
against hepatitis B (Rajneri, 2015).310 

Moreover,  as  scholars  noted  (Machnikowski,  2016),  the  application  of  new  technological 
developments will increase the “number of chains of events where a possible causal connection 
is  not  comprehensible  to  the  mind  of  an  average  person,  and  often  may  not  be  understood 
even by experts”. 

It  should  be  noted  that  procedural  rules  of  each  Member  State  can  provide  for  rules  of 
“presumptions”, according to which the proof of the link between the defect and the damage is 
inferred by the sole proof of the defect and the damage itself (see section 5.1.6). This means 
that the injured person can simply provide proof of the existence of a damage and of a defect, 
and  the  existence  of  the  link  can  be  inferred  by  the  existence  of  elements  of  proof,  or 
concurring evidence. 

Thus, the burden of proof upon the injured person is slightly simplified and easier due to these 
Member  State  rules.  This  helps  especially  when  dealing  with  the  technicalities  and  possible 
complexities  of  some  products,  such  as  pharmaceutical  products  and  medications  or  new 
technological developments. 

In this regard, the CJEU has released a significant judgment (C-621/2015) according to which 
Article  4  of  the  Directive  does  not  in  itself  preclude,  in  the  area  of  liability  of  pharmaceutical 
laboratories for the vaccines that they manufacture, a method by which the court ruling on the 
merits in the exercise of its  exclusive jurisdiction to appraise the facts may  consider that the 
facts  relied  on  by  the  applicant  constitute  serious,  specific  and  consistent  presumptions 
capable of proving the defect in the vaccine and the existence of a causal relationship between 
it  and  the  disease,  notwithstanding  the  finding  that  general  medical  research  does  not 
establish a relationship between the vaccine and the occurrence of the disease, provided that 
such  a  method  of  proof  does  not  effectively  result  in  a  reversal  of  the  burden  of  proof  of 
default, damage or causal link between those two. 

In particular, such a method of proof may only involve presumptions that: 

 

rely  on  evidence  which  is  both  relevant  and  sufficiently  rigorous  to  sustain  the  inferences 
drawn; 

  are rebuttable; 

  do  not  unduly  curtail  free  assessment  of  evidence  by  the  national  court,  in  particular  by 
preventing  the  national  judge,  without  prejudice  to  general  national  rules  on  admissibility 

309 CY consumer association.  
310  This  was  particularly  affirmed  by  AVIMEDI  which  reported  that  for  medicines  it  is  almost  impossible  to  prove 
imputation (see Box 2). 

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of  evidence,  from  taking  account  of  relevant  evidence,  or  requiring  that  specific  pieces  of 
evidence are treated as conclusive proof that one or more of the conditions of Article 4 are 
fulfilled, irrespective of what other evidence is presented; 

  do  not  prevent  the  national  judges  from  giving  due  consideration  to  any  relevant  medical 
research  presented  to  the  national  court,  without  prejudice  to  rules  on  admissibility  of 
evidence,  or  impose  as  an  absolute  requirement  that  medical  research  be  presented  in 
order to demonstrate defect or causal link. 

5.4.2.3.4  Exemptions from liability 

ARTICLE 7  
THE PRODUCER SHALL NOT BE LIABLE AS A RESULT OF THIS DIRECTIVE IF HE PROVES :  

a)  THAT HE DID NOT PUT THE PRODUCT INTO CIRCULATION; OR  
b)  THAT, HAVING REGARD TO THE CIRCUMSTANCES, IT IS PROBABLE THAT THE DEFECT WHICH CAUSED THE DAMAGE DID 
NOT EXIST AT THE TIME WHEN THE  PRODUCT WAS  PUT INTO CIRCULATION BY HIM  OR THAT THIS DEFECT  CAME INTO 
BEING AFTERWARDS; OR 

c)  THAT THE PRODUCT WAS NEITHER MANUFACTURED BY HIM FOR SALE OR ANY FORM OF DISTRIBUTION FOR ECONOMIC 

PURPOSE NOR MANUFACTURED OR DISTRIBUTED BY HIM IN THE COURSE OF HIS BUSINESS; OR 

d)  THAT THE DEFECT IS DUE TO COMPLIANCE OF  THE PRODUCT WITH MANDATORY  REGULATIONS  ISSUED BY THE PUBLIC 

AUTHORITIES; OR 

e)  THAT  THE  STATE  OF  SCIENTIFIC  AND  TECHNICAL  KNOWLEDGE  AT  THE  TIME  WHEN  HE  PUT  THE  PRODUCT  INTO 
CIRCULATION WAS NOT SUCH AS TO ENABLE THE EXISTENCE OF THE DEFECT TO BE DISCOVERED (DEVELOPMENT RISK 
CLAUSE CLAUSE); OR 
IN  THE  CASE  OF  A  MANUFACTURER  OF  A  COMPONENT,  THAT  THE  DEFECT  IS  ATTRIBUTABLE  TO  THE  DESIGN  OF  THE 
PRODUCT  IN  WHICH THE COMPONENT HAS BEEN  FITTED OR TO THE INSTRUCTIONS GIVEN BY THE MANUFACTURER OF 
THE PRODUCT. 

f) 

The exemptions from liability in favour of the  producer are listed in the Directive in  Article 7, 
which  mainly  spells  out  several  circumstances  that  render  the  producer  not  liable  under  the 
Directive in case he is able to prove them. 

In addition to the exemptions listed therein, the Directive provides for other limitations to the 
liability of the producer, and in particular: 

  The thresholds for the compensation of the damage: 

   A lower threshold of €500 (Article 9b); 
   An upper limit of €70 million (Article 16.1). 

  The limitation time period: 

   Of  three  years,  within  which  the  injured  person  can  bring  the  action  against  the 
producer,  starting  from  the  day  on  which  the  plaintiff  became  aware,  or  should 
reasonably have become aware, of the damage, the defect and the identity of the 
producer (Article 10.1); 

   Of  10  years,  starting  from  the  day  in  which  the  product  was  put  into  circulation, 
after  which  the  injured  person  cannot  institute  proceeding  against  the  producer 
anymore (Article 10 paragraph 2). 

The  findings  from  the  study  showed  the  above  listed  exemptions  and  limitations  to  be 
partially adequate when dealing with new technological developments.  

Indeed, the categories of exemptions are generally well accepted by businesses responding to 
the CATI survey irrespective of their size.311 

More  specifically,  the  CATI  survey  shows  that  on  average,  65%  of  the  respondents  to  the 
survey  think  that  the  definitions  and  categories  of  exceptions  are  adequate  for  their 
business  model  based  on  new  technological  developments.  This  positive  feedback  is 

311 35% (n=52) of small, 41% (n=62) of medium and 36% (n=58) of large enterprises declaring to be satisfied with 
this provision. Similar shares of respondents declared to be neutral to this aspect. 

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largely  due  to  the  views  of  medium-sized  firms,  with  85%  of  them  positively  assessing  the 
provisions.  However,  an  average  of  15%  of  respondents,  particularly  small  firms,  think  these 
provisions are not adequate. 

Figure 14: The definitions and the categories of exemptions are adequate for a firm business 
model building upon new technological developments312 

Source: CATI survey 

With regard to the time limit of 10 years, the respondents to the CATI survey are satisfied. 

Figure 15: The exemptions of producers from liability, e.g. the defect appeared after the 
product was put into circulation313 

Source: CATI survey 

Similarly,  on  average,  36%  of  businesses  declared  to  be  satisfied  with  the  three-year 
period for the recovery of damage. However, this provision seems to cause more concern 
to  small  enterprises  than  to  medium-sized  and  large  ones.  Indeed  33%  of  small  enterprises 
are  dissatisfied,  while  31%  are  satisfied.  On  the  contrary  the  majority  of  medium  and  large 
firms are satisfied. 

312  Small  n=24, medium  n=22, large  n=34.  The rate of  non-response  to  this  question  is  particularly  high  (i.e.  82%, 
n=377). 
313 Small n=147, medium n=151, large n=159. 

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Figure 16: The three-year period for the injured party to start the proceeding for the recovery 
of damage314 

Source: CATI survey 

With regard to the thresholds, businesses are overall satisfied with the lower threshold 
of €500 for damage compensation. Nonetheless, this provision is supported more strongly 
by medium-sized and large firms, as shown in the figure below. 

Figure 17: Compensation is granted only for damage to property of at least €500315 

Source: CATI survey 

At  the  same  time,  however,  the  majority  of  the  respondents  to  the  targeted  survey  believe 
that the definition of the exemptions to strict liability is not fully adequate.316 

This regards particularly the following exemptions vis-à-vis new technological developments: 

  The development risk clause and the exemption provided for in Article 7(b): these 
clauses  are  not  deemed  to  be  adequate,  specifically  when  dealing  with  AI  and  robotics. 
Some  literature  (Courtois,  2016)  as  well  as  an  interviewee  held  that  these  clauses  would 
not  be  apt  to  regulate  the  responsibility  of  the  producer  in  case  of  damages  caused  by 
robots, since the producer would always try to invoke the exemption under Article 7(b) of 
the  Directive.  Another  scholar  (Machnikowski  2016)  believes  that  “the  growing  rate  of 
technological  development  may  cause  increasing  difficulties  in  the  interpretation  of  the 
development risk clause. A broad application of this exception may significantly restrict the 
practical  significance  of  the  rules  in  question”.  This  has  also  been  supported  by  several 
stakeholders interviewed on the matter who believe that the clause cannot be applied to AI 
and  robotics.  More  generally,  contrasting  positions  are  held  by  businesses  responding  to 
the  CATI  survey  with  regard  to  removing  the  development  risk  clause:  this  possibility  is 
viewed  favourably  by  43%  of  large  firms,  while  the  largest  share  of  medium-sized  firms 

314 Small n=147, medium n=151, large n=159. 
315 Small n=147, medium n=151, large n=159. 
316 Four stakeholders out of five. 

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(38%)  thinks  this  removal  would  be  disadvantageous.  Small  firms  tend  to  think  that  this 
removal would be neutral (33%) or even disadvantageous (31%). 

  The threshold of €500: according to an Italian expert, the fixed threshold of €500 might 
even  be  low  when  dealing  with  new  technological  developments,  such  as  smartphones  or 
tablets, and he suggests to apply it as a relative rather than an absolute concept. In other 
words, the threshold shall be quantified as a percentage of the overall amount of damage 
and not just as a fixed amount. 

  More  in  general,  according  to  the  majority  of  the  164  respondents  to  the  Open  Public 
Consultation  Digital  Questionnaire,  there  should  be  a  liability  cap  (i.e.  an  upper  bound 
to  the  compensation  of  damages)  regardless  of  who  is  considered  liable.  In  particular 
20%  answered  that  this  should  apply  only  for  specific  products  abiding  by  strict  safety 
standards,  6%  answered  only  for  specific  products  in  the  experimentation/testing  phase, 
27%  answered  for  all  IoT  products.  The  remaining  share  of  respondents  answered  that 
there should not be a liability cap (47%). 

Another  provision  on  which  more  dissatisfaction  has  been  reported  is  the  10-year  period 
limitation:  on  average,  41%  of  businesses  declared  to  be  dissatisfied  with  the  10-year 
period  from  the  date  on  which  the  producer  put  the  defective  product  into 
circulation,  after  which  the  rights  conferred  upon  the  injured  person  shall  be 
extinguished.  However,  SMEs  are  more  dissatisfied  than  large  enterprises,  which  are  only 
marginally more satisfied than dissatisfied (38% satisfied vs 37% dissatisfied).  

Figure 18: 10-year period from the moment that the producer put the product into 
circulation after which the claimant’s rights expire317 

Source: CATI survey 

In conclusion, it is not possible to definitively state whether the list of exemptions provided for 
in the Directive are accepted and applicable to new technological developments: indeed, there 
are exceptions mainly relating to the AI technology and 3D printers where it is not considered 
adequate to maintain both the exemption as per Article 7(b) and the exemption as per Article 
7(e)  of  the  Directive.  Furthermore  the  concept  of  “put  into  circulation”,  the  liability  caps  and 
the  time  limit  of  10  years  can  cause  interpretative  problems  especially  regarding  3D  printing 
and cloud technologies.  

5.4.2.4  The term defective 
EQ  32  How  well  is  the  term  ‘defective’  as  defined  in  the  Directive  adapted  to  new  technological  or 
scientific  advances 
robots  and 
autonomous/intelligent systems?  For  example,  could software  vulnerability (for instance, a cyber-attack 
or a failure to update security software or a misuse of information) be considered as a defect? 

such  as  apps  and  non-embedded 

software,  advanced 

317 Small n=147, medium n=151, large n=159. 

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The  definition  of  “defect”  provided  in  the  Directive  does  not  provide  for  the  necessary  details 
that make it clearly applicable to new technological developments, in particular to robots and 
in general AI  

ARTICLE 6 
1. A PRODUCT IS DEFECTIVE WHEN IT DOES NOT PROVIDE THE SAFETY WHICH A PERSON IS ENTITLED TO EXPECT, TAKING ALL 
CIRCUMSTANCES  INTO  ACCOUNT,  INCLUDING  :  (A)  THE  PRESENTATION  OF  THE  PRODUCT;  (B)  THE  USE  TO  WHICH  IT  COULD 
REASONABLY BE EXPECTED THAT THE PRODUCT WOULD BE PUT; (C) THE TIME WHEN THE PRODUCT WAS PUT INTO CIRCULATION. 
2. A PRODUCT SHALL NOT BE CONSIDERED DEFECTIVE FOR THE SOLE REASON THAT A BETTER PRODUCT IS SUBSEQUENTLY PUT 
INTO CIRCULATION. 

The  central  concept  of  the  liability  regime  under  the  Directive  is  the  products’  defectiveness, 
which is strictly connected with the concept of safety. Article 6 of the Directive states that the 
defectiveness  must  be  assessed  on  the  basis  of  what  a  normal  person  is  entitled  to  expect. 
Using  only  this  one  criterion,  the  Directive  states  that  the  defectiveness  of  a  product  is  in 
principle  determined  only  on  the  basis  of  the  average  consumer  expectation  test  rather  than 
on a risk-utility test. But the defectiveness criterion is in the first place objective, because the 
defectiveness  must  be  assessed  on  the  basis  of  the  legitimate  expectations  of  the  public  and 
thus not be based on the subjective expectations of  an individual. The standard is in fact the 
safety  which  the  general  public  is  entitled  to  expect  and  this  shall  be  judged  on  the  basis  of 
what  normal,  prudent  persons  would  expect.  Except  for  the  essential  safety  requirements 
spelled out in safety legislation, it is impossible to determine in advance the standard of safety 
that  the  entire  range  of  consumers  is  entitled  to  expect  under  the  Directive,  and  thus  the 
defectiveness of a product must be assessed on a case-by-case basis. The courts have a wide 
range  of  appreciation  in  such  matters  and  can  take  into  account  the  dynamic  aspect  of  the 
safety assessment. 

In  the  second  place,  the  criterion  is  also  normative  as  it  takes  the  legitimate  expectations  of 
the general public as the basis for  the assessment. The normative character  of the  consumer 
expectation  test  works  in  two  ways:  on  the  one  hand,  it  prevents  the  public  from  having 
unrealistic  expectations.  But,  on  the  other  hand,  it  allows  the  public  to  expect  more  in  some 
circumstances than what is laid down in standards. 

The term “defective” has been interpreted and  discussed also by the courts. In particular, the 
English  blood  case  “A  v  National  Blood  Authority”  is  interesting.  In  this  case,  judges  firstly 
explicitly  stated  that  the  Directive  does  not  make  a  distinction  between  different  types  of 
defects, providing a single parameter in its assessment. And yet, in practice, courts in Member 
States  do  conduct  safety  assessments  based  on  the  nature  of  the  defect:  courts  distinguish 
between  manufacturing  defects  –  to  which  the  consumer  expectation  test  is  applied  –  and 
design and instruction defects  – in which, in addition to the consumer expectation test, other 
tests such as the risk-utility test and the reasonableness test play a role. 

Another  case  worth  noting,  both  for  the  interpretation  of  the  “defect”  and  the  nature  of  the 
products  considered,  is  the  “Boston  Scientific  Medizintechnik”  CJEU  C-503/13.  It  concerned 
pacemakers  and  cardioverter  defibrillators  implanted  in  patients.  The  preliminary  question 
referred to the CJEU was whether a product in the form  of a medical device implanted in the 
human  body  is  already  defective  if  it  is  found  that  products  belonging  to  the  same  product 
group of the same production series have a potential defect, without there being any need to 
establish that the product in question has such defect. The CJEU answered the question in the 
affirmative,  emphasising  the  preventive  function  of  the  Product  Liability  Directive.  Moreover, 
the CJEU emphasised the importance of the product’s nature: “in the light of their function and 
the particularly vulnerable situation of patients using such devices, the safety requirements for 
those  devices  which  such  patients  are  entitled  to  expect  are  particularly  high”.318  The  CJEU 

318 CJEU Joint Cases C-503/13 and C-504/13, Boston Scientific Medizintechnik v AOK Sachsen-Anhalt, recital 39. 

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thus placed the emphasis on the specific nature of the products concerned which may require a 
consumer-friendly approach. 

The  term  “defective”  as  defined  in  the  Directive  does  not  always  seem  to  adapt  to  new 
technological  developments,  because  it  is  not  always  clear  whether  new  technological 
developments  can  be  classified  as  “products”  under  the  Directive’s  provisions.  In  particular, 
software,  cloud  technologies  and  AI  are  difficult  to  categorise  in  this  context.  Annex  8 
summarises  some  possible 
issues  vis-à-vis  specific  new  technological 
developments. 

interpretative 

The main reasons that emerged from the findings of both the desk and the field research are 
the following. 

First, the new technologies do not always take the final form of a movable, so that it is 
difficult  to  clearly  identify  the  defect:  for  example,  taking  into  consideration  software,  some 
literature believes that it is still unanswered as to what extent software could potentially cause 
damage  (Armour  &  Humphrey,  1993).319  On  the  contrary,  other  literature  (Lewiatan,  2017) 
identified several cases of damages caused to consumers by “errors in software”.320 

Similarly, another author (Verbruggen, 2016) argues that software with security vulnerabilities 
should  be  considered  defective.  Producers  should  take  into  account  any  foreseeable 
irresponsible  use  of  software,  for  example  when  implementing  smart  solutions  concerning 
cybersecurity  based  on  security  by  design  (e.g.  no  default  passwords  and  the  automated 
implementation  of  crucial  security  updates  or  upgrades).  The  defect  does  not  need  to 
materialise in reality: the risk of a defect or ‘potential for failure’ has been considered sufficient 
to prove the defectiveness of the product (CJEU Joint Cases C-503/13 and C-504/13). 

Another  example  involves  the  Advanced  Driver  Assistance  Systems  (ADAS)  in  road  traffic 
which  have  led  to  many  complex  questions  relating  to  what  is  a  defect:  according  to  some 
literature  (Rob  van  der  Heijden,  R.,  &  van  Wees,  K.,  2001)  the  defect  in  ADAS  might  also 
consist of inadequate presentation of ADAS or instructions on its use.321  

Second,  it  could  sometimes  be  hard  to  prove  the  defect  of  new  technological  developments, 
which  appear  to  be  a  mix  of  several  intangible  components  interacting  with  each  other:  the 
lack  of  specific  technical  knowledge  would  prevent  the  consumer  from  identifying  and 
proving  the  defect  without  the  help  of  a  technical  expert.  As  stated  by  some  scholars 
(Machnikowski  2016),  even  experts  may  find  it  difficult  to  understand  defects  in  new 
technological developments, because of the increasing number of chain events where possible 
causal connections are not understandable. 

Third, there are specific fields where the term defect does not even seem to be applicable. In 
particular,  in  the  field  of  robotics  it  could  be  difficult  to  distinguish  between  a  defects  which 
was  present  at  the  moment  in  which  the  robot  was  put  into  circulation  from  a  defect  that 
appeared  after  that  moment,  given  the  characteristics  of  self-learning  systems.  As  also 
described in the scenarios in Annex 8, it is questionable whether the unintended autonomous 
behaviour of an advanced robot is a defect or not. Indeed, on one  hand, robots are meant to 
perform  autonomous  behaviours;  on  the  other  hand,  it  is  uncertain  whether  autonomous 

319  In  case  of  software  in  medical  devices  this  is  not  true  anymore:  indeed,  it  is  now  commonly  known  and  also 
expressed  in  the  related  regulations  on  medical  devices  (Regulation  (EU)  n°  2017/745)  and  Regulation  (EU) 
n°2017/746that software can be hazardous (see coherence paragraph in section 5.3). 
320 Such as “Incorrect match of patient and data; Incorrect readings in an auto analyser; Faulty programming provided 
false cardiac FVC values; Faulty programming caused pacer telemetry errors; Incorrect software design caused lockup 
of cardiac monitor; Incorrect calculations; Failure of central alarm in arrhythmia monitor; Table top moved without a 
command; Detector head could hit the patient; Algorithm error caused low blood pressure readings; Over infusion due 
to programming error” (Lewiatan, 2017). 
321  Same  authors  (van  der  Heijden  and  van  Wees  2001)  make  a  comparison  with  Cruise  Control  and  Anti-Block 
Systems  (ABS):  the  experience  with  ABS  indicate  that  in  a  number  of  cases  drivers  have  been  mistaken  in  their 
expectations  about  the  functionality  of  these  systems.  Drivers  expected  shortening  of  braking  distance  by  ABS, 
causing more accidents with cars equipped with ABS than with cars without the system. 

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behaviours  which  are  not  linked  to  the  producer  can  be  considered  defects  or  not.  The  term 
“defective”  could  be  difficult  to  apply  to  systems  with  autonomous  abilities  that  can 
define their  own path,  make their  own decisions and  set their  own priorities  (Iconoclast Tech 
LLC, 2017). 

Moreover,  in  the  field  of  medications  and  pharmaceutical  products  such  as  vaccines,  the 
inadequacy  of  the  definition  of  “defect”  is  evident  in  the  difficulties  arising  when  trying  to 
identify the causal link between defect and damage: from one side, the defect in the medical 
item  may  arise  from  non-compliance  with  the  general  medical  research  standards;  from  the 
other side, the general medical research does not represent the safer standard rule that helps 
avoid the risk of damages. Indeed, the CJEU recently intervened in this field with regard to the 
relationship  between  the  general  medical  research  findings  and  proof  of  the  link  between 
damages and defects of vaccines: in case 621/2015, the Court stated that the Directive does 
not  preclude,  in  the  area  of  liability  of  pharmaceutical  laboratories  for  the  vaccines  that  they 
manufacture, a method by which the court ruling on the merits  of the case  relies on serious, 
specific  and  consistent  presumptions  capable  of  proving  the  defect  in  the  vaccine  and  the 
existence  of a causal relationship between it and the disease,  notwithstanding the finding 
that general medical research does not establish a relationship between the vaccine 
and  the  occurrence  of  the  disease.  In  any  case,  the  relevance  of  the  Directive  to 
pharmaceutical  products  is  confirmed  also  by  the  desk  research  at  the  national  level,  which 
shows the tendency of pharmaceutical products and medical devices to be more frequently the 
matter of litigation and of judicial escalation, probably because of the fact that these products, 
when defective, are more likely to affect health and thus an essential part of one’s life. 

More generally, the partial adequacy  of the term  “defect” seems to match with the results  of 
the targeted survey as shown in the figure below. While the majority of consumer associations 
(4  out  of  6)  positively  assess  the  adequacy  of  the  definition  of  defect  (4  out  of  5  think  it  is 
adequate), the majority of PAs and civil society representatives think the definition of defect is 
not  adequate  (4  out  of  5).  In  particular,  a  Greek  national  association  suggests  that  the 
definition  of  defect  should  be  re-examined  in  light  of  the  increasing  importance  of  new 
technological developments in both volume and variety. It should be clarified to what extent a 
software embedded program is considered  as defective. Along the same line, two English law 
firms  observe  that  the  definition  of  defect  is  “too  vague  and  ambivalent”  to  cover  products 
relating to new technological developments, thus needing adjustment. 

Figure 19: Adequacy of the Directive to cover strict liability caused by defect in any of the 
following new technological developments 

In  particular,  according  to  the  limited  data  retrieved  through  the  targeted  survey  (i.e.one 
respondent),  it  appears  that  the  definition  of  defect  is  too  broad:  it  does  not  provide  any 

Source: targeted survey 

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certainty in the application of the law and hence it proves to be wholly inadequate in providing 
protection for consumers in the situations regarding new technological developments. In such 
situations, proving the defect could become impossible. 

Respondents to the targeted survey are rather aligned with respect to the Product Liability 
Directive’s adequacy and sufficiency to cover strict liability caused by defects in new 
technological  developments.  More  specifically,  all  new  technological  developments  seem 
not  to  be  adequately  covered  by  the  Product  Liability  Directive  according  to  the  majority  of 
respondents,  with  the  exception  of  devices  for  3D  printing/additive  manufacturing  and 
products manufactured with them. 

Indeed,  the  few  answers  to  the  targeted  survey  shows  that  five  consumer  organisations  see 
difficulties  in  obtaining  compensation  for  the  damages  suffered  in  case  of  defective  products 
based on new technological developments, and one consumer organisation from Malta reports 
that  in  less  than  25%  of  the  cases  relating  to  claims  for  damages  caused  by  a  defective 
product  linked  to  new  technological  developments  liability  was  allocated  to  actors  other  than 
the producer of the product.322 

More  generally,  some  scholars  consider  that  the  legal  term  “defect”  is  a  relative  concept 
(Delforge,  2014),  an  opinion  shared  by  some  of  the  lawyers  interviewed  who  believe  the 
definition of defect is imprecise and, thus, contributes to making it difficult to prove.  

Other authors go beyond considering that it relates to the requirements for the functionality of 
the product, on the one hand, and its safety, on the other hand, with defectiveness being seen 
as the  result of an unstable balance between an adequate level of  consumer protection in an 
advanced  industrial  society  and  the  need  to  promote  technological  innovation  while  avoiding 
burdening companies with excessive costs: in short, the concept of defectiveness expresses a 
political  choice  and  therefore  varies  according  to  ideologies  (Fourches  and  Guyot-
Sander 2001). Thus, in this perspective, despite the harmonising nature of the Directive, there 
is a risk of divergence between Member States  on key issues including the core concept  of 
defectiveness (Fairgrieve and Howells 2007). In addition, an English law firm responding to the 
targeted survey states that circumstances surrounding the definition of ‘defect’ should include 
benefits and risks. 

This overall perspective is supported by the results of the legal analysis (see Annex 8), where 
the  notion  of  defect  seems  to  cause  interpretative  problems  vis-à-vis  new  technological 
developments. 

In  conclusion,  the  definition  of  “defect”  provided  in  the  Directive  is  not  always  apt  and  clear 
with regard to new technological developments, and specifically, software, cloud technologies, 
and medical devices. A defect is difficult to detect in complex and intangible products and the 
notion of defect might be misleading when dealing with robotics. 

5.5  EU added value  

EQ 33. What is the EU added value of the Directive for stakeholders (manufacturers, including software 
developers and economic operators in the DSM, and consumers)? 

EQ 34 To what extent does the issue of strict liability, as addressed by the Directive continue to require 
action at EU level?  

Evidence  gathered  from  stakeholders  converges  on  the  Directive  providing  EU  added  value, 
although  with  some  important  differences  when  looking  at  the  EU  added  value  vis-à-vis  the 
different objectives of the Directive.  

322  The  desk  research  did  not  lead  to  identifying  any  published,  relevant  judgments  given  by  courts  in  Malta.  It  is 
possible that the judgments to which the organisation referred were actually given but not published. 

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The  EU  added  value  of  the  Directive  is  strongly  acknowledged  in  the  case  of 
consumer  protection.  The  large  majority  of  stakeholders323  who  responded  to  the  Open 
Public  Consultation  consider  it  to  be  a  strong  advantage  to  have  a  Directive  on  liability  for 
defective  products,  as  this  allows  consumers  to  enjoy  the  same  rights  for  compensation 
wherever they are in the EU. This could not have been achieved with national legislation 
only.  Indeed,  the  vast  majority  of  stakeholders  are  aware  of  the  fact  that  consumers  in  the 
European  Union  have  the  right  to  seek  compensation  for  damage  caused  by  a  defective 
product,324  and  that  producers  and/or  importers  into  the  European  Union  must  compensate 
for  damage  caused  by  their  defective  products,  regardless  of  whether 
consumers 
producers/importers  are  at  fault  or  negligent.325  The  EU  added  value  of  the  Directive  is 
confirmed  also  by  consumer  representatives  responding  to  this  question  in  the  targeted 
survey,  as  11  out  of  12  consumer  representatives  agree  that  the  protection  of  consumers 
achieved by the Directive could not be reached by means of individual Member State action. In 
the words of one stakeholder interviewed, “If the Directive was modified/changed, there will be 
a  change  in  the  consumer  protection  and  in  how  companies  do  business.  For  these  reasons 
there  could  be  problems  of  legal  clarity”.326  Yet,  not  all  PAs  and  civil  society  representatives 
responding  to  the  survey  confirmed  this  view,  as  only  one  respondent  made  a  positive 
assessment,  and  seven  did  not  express  any  opinion,  while  two  UK  law  firms  expressed  a 
negative opinion.  

Furthermore, when looking at the EU added value provided by the Directive with respect to the 
harmonisation  of  product  liability  rules,  the  percentage  of  stakeholders  acknowledging  this 
value remains high, but is lower when compared to consumer protection.327 In this case, there 
are  even  stakeholders  who  express  a  negative  opinion,328  although  the reasons  are  generally 
not expressed. 

As  a  matter  of  fact,  should  the  Directive  be  repealed,  it  is  the  shared  opinion  of  the  country 
correspondents involved in the study that either tort law or contract law or  both would apply, 
with  heterogeneous  rules  in  terms  of  protection  and  liability  (see  section  5.4.1  and  the 
following sections for further clarification). 

Also  findings  from  the  documentary  review  show  that  the  EU  added  value  of  the  Directive 
lies  in,  among  others,  achieving  the  right  balance  between  consumer  protection  and 
innovation  in  Europe,  not  only  with  regard  to  the  protection  that  consumers  may  find  in 
court, but also to the prevention measures taken by producers, who nonetheless do not refrain 
from innovation. In particular, it has been argued that one of the elements that contributes to 
EU added value  of the  Directive is  represented by the development risk  clause: as  confirmed 
by  the  desk  review  (Machnikowski,  2016;  Rosselli  Foundation,  2004;  European  Commission, 
COM(  547),  2011329),  the  development  risk  clause  is  a  satisfactory  compromise  between  the 
need  to  stimulate  innovation  and  consumers’  legitimate  expectations  for  safer  products,  and 
“removing this clause would stifle innovation”. In particular, in the frame of interviews, besides 

323 OPC feedback: 73% (n= 35 out of 48) of consumers, 80% (n=32 out of 40) of producers and 68% (n=17 out of 
25) of PAs and civil society. 
324 OPC feedback: 90% (n=43 out of 48) of consumers, 93% (n=37 out of 40) of producers and 100% (n=25) of PAs 
and civil society. 
325 OPC feedback: 79% (n=38 out of 51)  of consumers, 85% (n=34 out of 40) of producers, and 84% (n=21 out of 
25) of PAs and civil society. 
326  Interview  feedback:  one  producer  representative  (European  Committee  of  Domestic  Equipment  Manufacturers 
(CECED). 
327 OPC feedback: 71% (n=34 out 48) of consumers, 78% (n=31 out of 40) of producers and 68% (n=17 out of 25) of 
PAs and civil society. 
328 OPC feedback: 15% (n=7 out of 48) of consumers, 8% (n=3 out of 40) of producers and 16% (n=4 out of 25) of 
PAs and civil society. 
329 European Commission,  Report from The Commission To The European Parliament, The Council And The European 
Economic And Social Committee, Fourth Report On The Application of Product Liability Directive, COM (547), 2011. 

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the  limited  number  of  answers  collected,  one  stakeholder330  has  expressly  suggested  that  in 
case of revision of the Directive, the development risk clause should not be optional anymore.  

As  shown  in  the  figure  below,  stakeholders  generally  perceive  as  positive  various  potential 
changes in the Directive, regarding in particular (i) the reduction of the threshold of  €500 for 
damages  caused  to  property,  (ii)  the  enlargement  of  the  notion  of  damage  as  to  include  the 
economic  loss  and  the  notion  of  defect  as  to  include  fitness  for  use  of  the  product,  (iii)  the 
removal of the burden of proof relating to the defect, (iv) the extension of the strict liability to 
other  market  operators,  and  (v)  the  extension  of  the  scope,  covering  also  services. 
Consistently,  stakeholders  negatively  perceive  a  change  in  the  Directive  which  (i)  limits  the 
scope only to tangible products, (ii) reduces the types of damage, (iii) raises the threshold of 
€500 for damages caused to property, and (iv) removes the development risk clause.  

Figure 20: “What would be the effects of the following modifications of the Directive?” 

Sources: targeted survey  

Focusing on new technological developments,  as discussed in previous sections, the Directive 
might  not  be  fully  effective  and  relevant,  in  particular  in  addressing  some  emerging  issues 
(such  as  the  liability  of  self-learning  systems,  or  the  issues  regarding  the  data  privacy) 
requiring  action  at  the  EU  level  (in  particular  with  regard  to  robots,  cloud  computing  and  e-
services), as also highlighted in a Communication by the European Commission: “[…] there are 
concerns  over  how  liability  for  service  failures  such  as  downtime  or  loss  of  data  will  be 
compensated, user  rights in relation to system upgrades decided unilaterally by the provider, 
ownership of data created in cloud applications or how disputes will be resolved”.331 Evidence 
of this came from some stakeholders consulted through the targeted survey who are in favour 
of  a  revision  of  the  Directive’s  scope  to  address  the  specific  challenges  relating  to  new 
technological developments,332 although some drawbacks should be considered.333  

Furthermore, a modification of the Directive regarding in particular: 

 

the extension of the scope to services; 

330 Interview feedback: A FR lawyer. 
331 Brussels, 27.9.2012 COM (2012) 529 Final Communication from the Commission to the European Parliament, the 
Council, the European Economic and Social Committee and the Committee of the Regions. 
332  Source:  targeted  survey:  11  out  of  17  responding  to  this  question.  Interestingly,  the  two  industry  associations 
responding to the survey are not in favour of a revision of the Directive in this sense.  
333  In  some  stakeholder  opinions,  such  a  revision  would  lead  to  lower  investment  in  research  and  development,  an 
increase  in  insurance  costs  and  lower  exports  (according  to  an  EL  industry  association  and  two  UK  law  firms),  and 
costs for judicial claims, lower investments and exports. A BE academic thinks it would lead to an increase in costs for 
judicial  claims.  Another  UK  law  firm  states  that  this  modification  in  scope  would  result  in  an  increased  difficulty  in 
allocating  strict  liability  in  terms  of  identifying  the  right  subject.  An  IT  consumer  association  and  a  DE  law  firm 
supporting  the  inclusion  of  new  technological  development  in  the  Directive’s  scope  instead  think  this  would  lead  to 
adaptation  to  the  new  environment  and  a fair, reasonable  and  more  balanced  allocation  of risk  and  liability  between 
the supply side and customer/user side. 

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 

 

the enlargement of the notions of damage and defect; 

the decrease of the threshold of €500. 

Would create further  EU added value also for  new technological developments (such as  cloud 
technologies,  but  also  software  and  smartphone),  as  it  would  allow  a  clearer  common 
framework of rules. 

In  conclusion,  the  EU  added  value  of  the  Directive  seems  largely  to  be  recognised  for  the 
protection  of  consumers  and  the  balance  between  consumer  protection  and  innovation  in 
Europe.  There  still  are,  however,  some  concerns  especially  among  consumers  with  regard  to 
new technological developments.  

EQ  35)  What  would  be  the  most  likely  consequences  of  reducing  the  scope  of  the  existing  EU 
intervention? 

Support for reducing the scope of the Directive is rare among the stakeholders and limited to a 
few interviewees who underlined that:  

 

 

If the Directive is  considered to be inefficient with respect to some  sectors, this would be 
considered  a 
framework,  necessitating 
complementing it with sector-specific pieces of legislation 

the  scope  of 

limitation  of 

the  general 

It would be better to exclude medicines from the scope of the Directive, with the creation 
of  a  specific  EU  text  posing  the  problem  of  risk  mutualisation  and  compensation  of 
victims;334  

  Product liability should be restricted to damages of “absolute” legally protected rights such 
as  physical  integrity  (damages  to  life,  body  and  health)  and/or  (significant)  property 
damages.335 

Indeed stakeholders, as described in sections 5.1 and 5.4, usually either consider the Directive 
as future proof or call for a revision of the Directive in order to enlarge its scope.  

In  the  stakeholders’  opinion,  reducing  the  scope  (like  a  repeal)  of  the  existing  Directive  may 
undermine consumer protection, also leading to negative consequences for producers such as 
uncertainty  and  subsequent  difficulty  to  predict  (potentially  higher)  costs,  decrease  of 
harmonisation, and internal market fragmentation.336 

EQ 36) What would be the most likely consequences of repealing the Directive? 

The  most  likely  consequences  of  repealing  the  Directive  would  be  a  negative  impact  both  on 
consumer protection and on the uniformity of EU legislation. 

The consequences of repealing the Directive need to be assessed by considering the following: 

 

If only the Directive were repealed, other directives (such as the one on safety of products) 
and  the  corresponding  national  legislation  transposing  those  directives  would  remain  in 
force.  This  means  also  that  the  regulatory  framework  may  in  any  case  ensure  a  good 
protection of consumers. 

  The  national  courts  might  interpret  the  national  law  as  if  the  Directive  still  applied  (for 
instance, interpreting very strictly the concept of negligence under tort law), so ensuring in 
any case good protection of consumers. 

334 Interview feedback. The interviewee (a FR consumer association) imagines a kind of insurance, with for example 1 
cent  per  medicine  box  sent  to  a  compensation  fund,  paid  half  by  the  State  and  half  by  pharmaceutical  companies/ 
laboratories.  See  also  Bloch,  L.,  &  Le  Pallec,  S.  (2012).  Plaidoyer  pour  les  gueules  cassées  du  médicament.  Révue 
Génerale  de  Droites  Médicale,  42  and  Médecine  &  Droit  Volume  2006,  Issue  78,  May–June  2006,  Pages  103–109 
Responsabilité  civile–Droit  et  médicaments,  Les  fondements  juridiques  de  la  responsabilité  du  producteur  de 
spécialités  pharmaceutiques  :  vers  un  retour  à  la  raison  ?  Éric  Fouassier,  Professeur  de  droit  et  économie 
pharmaceutique.  
335 An EU association representing producers.  
336 An EU association representing producers, an EU industry association, an EE insurers’ association, a CY consumer 
association.  

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However,  a  repeal  of  the  Directive  may  have  a  negative  impact  both  on  consumer 
protection and on the uniformity of EU legislation because: 

  The  general  tort  law  usually  requires  that  the  injured  party  demonstrates  at  least  the 
negligence  or  fault  of  the  producer  (in  some  cases,  this  means  a  very  heavy  burden  of 
proof for the consumer) and that the damage is unlawful; 

  The  general  contract  law  usually  requires  that  the  injured  party  demonstrates  the 
existence of a contract. This can be difficult in most of the cases, as generally there is no 
contract  between  the  producer  and  the  consumer,  but  between  the  consumer  and  one  of 
the intermediaries in the value chain. Furthermore, the consumer is the weaker party in the 
contract. Pure contractual liability would lead to a situation where the sellers and producers 
could  limit  their  liability  by  contract  and  consumers  end  up  facing  strict  and  potentially 
unfair contract clauses. 

It is also important to point out that in many Member States (BE, CZ, DK, IE, ES, HR, IT, CY, 
LV,  LU,  AT,  PL,  PT,  RO,  SE,  UK)337  the  national  legislation  does  not  provide  for  an  extra-
contractual liability to protect consumers from damages caused by defects of either intangibles 
(e.g.  software)  or  of  services.  In  other  words,  in  some  Member  States  where  repealing  the 
Directive leads to trying the product liability cases under tort law, the protection of consumers 
may be reduced, also with reference to new technological developments (e.g. in AT repealing 
the Directive means the applicability of tort rules, but national legislation does not provide for 
an  extra-contractual  liability  to  protect  consumers  from  damages  caused  by  defects  of  either 
intangibles or of services, so that there would be apparently no protection for consumers).338  

It  is  also  worth  noting  that  in  some  Member  States,  strict  liability  rules  used  to  be  only 
exceptionally  applied  and  the  principle  introduced  by  the  Directive  therefore  constituted  a 
novelty  for  these  legal  systems.  In  this  situation  one  would  assume  that  the  position  of  the 
injured person suing the producer of a defective product has improved.339 

In other words, a repeal of the Directive would mean that consumer protection would depend 
upon  the  courts’  interpretation  of  their  national  law  (contractual  and/or  tort  law),  leading  to 
varying levels of consumer protection in the different Member States, with potential impacts on 
the free movement of products and distortion of competition.  

To some extent, this conclusion finds an indirect confirmation in the very fact that some of the 
cases brought to court  invoking the Directive are then decided based  on tort  or  contract law. 
Indeed,  both  the  fact  that  in  some  cases  the  claimant  may  have  speciously  invoked  the 
Directive and the fact that the claimant has earnestly invoked it, show that the areas covered 
by the Directive, tort law and contract law can partially overlap. Thus, should the Directive be 
repealed,  tort  and  contract  laws  would  perhaps  partially  cover  the  area  left  unaddressed  by 
it.340 

337 Source: country fiches. 
338  This  is  further  confirmed  by  the  Second  report  from  the  Commission  on  the  application  of  Directive  85/374  on 
Liability  for  Defective  Products  COM(2000)  893  final  which  confirms  that  “In  Austria  nearly  all  product  liability  cases 
are solved on the sole basis of the system provided by the Directive”. Nonetheless, according to (Machnikowski 2016) 
“This does not mean, however, that the predecessor of product liability on the basis of a quasi-contractual theory, is 
no longer relevant  – it has been confirmed ever since, not only by the Austrian legislator when introducing the PHG, 
but also by the courts, that this cause of action remains valid alongside the delictual basis provided by the PHG.” 
339  Source:  Second  report  from  the  Commission  on  the  Application  of  Directive  85/374  on  Liability  for  Defective 
Products COM (2000) 893 final. 
340 This does not mean that the Directive is useless: the likely consequence of repealing would be that each Member 
State legal system would fall back to the rules and doctrines in place when the Directive was transposed. This would 
mean that in some Member States the direct liability of producers to injured persons for damages suffered because of 
defective  products  would  simply  disappear.  In  others,  some  doctrine  would  allow  for  some  protection  to  the  injured 
persons  against  producers,  with  more  conditions  than  those  required  under  the  Directive:  for  instance,  in  Italy  an 
injured  person  could  try  to  highlight  an  implied  manufacturer’s  fault  by  leveraging  general  tort  law  rules  or  could 
perhaps  invoke,  for  damages  deriving  from  pharmaceuticals,  producer’s  strict  liability  because  he  carries  out  a 
dangerous  activity;  in  any  case,  the  protection  would  be  limited  in  comparison  to  that  currently  offered  by  the 

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EQ  37)  According  to  the  case-law  and  the  experience  on  the  application  of  the  Directive,  could  it  be 
considered appropriate to enlarge the scope of the Directive, for instance so as to cover the services? 

According  to  the  case-law  and  the  experiences  on  the  application  of  the  Directive,  it  can  be 
appropriate to enlarge, to some extent, the scope of the Directive, for instance  so as to cover 
the services. 

As described in section 4.2 4.2, nine Member States (DE, EE, EL, FR, LT, MT, NL, SI, SK) have 
rules  ensuring  an  extra-contractual  liability  to  protect  consumers  from  damages  caused  by 
defects both of intangibles (e.g. software) and services (see finding 6). 

In  some  of  these  Member  States  (DE,  EE,  MT,  NL,  SI,  SK)  the  protection  of  consumers  from 
damages  caused  by  defects  either  of  intangibles  or  of  services  stems  from  general  rules, 
normally  tort  law:  in  these  cases,  protection  essentially  stems  from  the  interpretation  of 
general rules to include services or intangibles (see finding 7). 

In other Member States, specific pieces of legislation spell out the protection at stake: 

 

 

In Greece, Article 6 of Law 2251/1994 (the same transposing the Directive) is interpreted 
by  scholars  as  extending  the  liability  to  damages  caused  by  intangibles  or  services  (see 
section 4.2).  

In  Lithuania,  Articles  6.292–6.300  of  the  Civil  Code  regulates  not  only  the  liability  for 
compensation for damage caused by defective products, but also by defective services (see 
section 4.2). 

In addition, in France, liability depends both on the application of general rules on tort law, as 
is  the  case  for  the  Member  States  of  the  first  group,  and  on  specific  sectorial  rules:  for 
instance,  Article  L.1142-1  of  the  Public  Health  Code  provides  for  strict  liability  of  health 
professionals (see finding 9). 

Therefore, the state of the legislation concurring with the Directive shows that it is possible to 
extend the rules of the Directive so as to cover services or other intangibles, like software. 

This  opinion  is  supported  by  several  stakeholders  interviewed,  as  for  instance  an  Italian 
representative  from  industries  and  expert  who  believes  that  there  is  no  reason  anymore  to 
maintain  the  distinction.  In  addition,  some  literature  (Koziol  2013)  argued  that  there  is  no 
reason at all why strict liability should be imposed specifically for damage caused by defective 
products, but not in other cases where the damage is caused by entrepreneurs other than the 
manufacturers of goods, e.g. service providers, entrepreneurs erecting bridges and so on. This 
different  treatment  is  deemed  as  a  violation  of  the  principle  of  equal  treatment.  Another 
scholar  suggested  that  the  adoption  of  a  strict  liability  regime  for  software  failure  that 
produces physical injury is both necessary and sensible. It must be noted, however, that other 
opinions,  such  as  those  of  an  Italian  expert  and  a  French  expert  interviewed  on  the  topic, 
support the idea of not including services in the scope of the Directive, because its rules, and 
in  particular  the  strict  liability,  are  not  apt  to  regulate  services  as  well  as  cloud  technologies. 
Nonetheless, as discussed in section 5.4.2, the distinction between products and services does 
not  always  seem  to  be  suitable  to  dealing  with  new  technological  developments.  Several 
contributions  indicate  the  need  to  clarify  the  extension  of  the  scope  of  the  Directive  to  new 
technologies. 

In  conclusion,  based  on  the  evidence  gathered  from  the  implementation  of  the  Directive  in 
relation to those Member States where it is possible to extend the protection of the Directive 
also  to  services  and  intangibles,  on  the  finding  that  the  Directive  does  not  seem  to  be  no 
longer  relevant  when  dealing  with  the  distinction  between  products  and  services,  on  the 
stakeholders  interviewed  who  are  represented  also  by  producers,  it  is  possible  to  identify  a 

Directive (Rajneri, 2005). 

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European  added  value  in  enlarging  the  scope  of  the  Directive,  as  for  instance,  to  include 
services or specific new technological developments.  

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6  CONCLUSIONS 

This  section  of  the  document  summarises  the  main  conclusions  of  the  study,  which  has 
assessed the overall functioning and performance of the Product Liability Directive and whether 
it  is  effective,  efficient,  coherent,  relevant,  and  has  EU  added  value  in  achieving  its 
objectives.  The  findings  of  desk  and  field  research  were  analysed  in  terms  of  37  evaluation 
questions relating to the application of the Product Liability Directive between 2000 and 2016.  

6.1  Effectiveness 

Overall  the  Product  Liability  Directive  seems  to  be  an  effective  instrument  to  guarantee  the 
producer’s  liability  for  damage  caused  by  a  defective  product  and,  thus,  the  protection  of 
injured  persons.  For  this  purpose,  the  main  indicators  that  confirm  the  effectiveness  of  the 
Product  Liability  Directive  are  the  success  rate  of  the  claims  brought  to  court  based  on  the 
legislation  transposing  the  Product  Liability  Directive,  which  is  60%  of  the  cases,  and  the 
circumstance that most claims are settled out of court. The latter circumstance seems to show 
that  injured  persons  are  in  a  position  to  give  reasonable  evidence  for  their  claims  and,  faced 
with  such  evidence,  the  producers  prefer  to  avoid  court  cases  based  on  the  Product  Liability 
Directive.  It  is  true  that  the  number  of  court  cases  published  (roughly  800)  may  appear 
limited,  but  this  figure  should  be  considered  by  taking  into  account  that  the  Product  Liability 
Directive  operates  as  a  “safety  net”  in  the  framework  of  a  wider  European  legislation,  which 
prevents the spread of defective products in the internal market, ensures market surveillance 
and sets out precise contractual obligations. 

Evidence  on  the  effectiveness  of  the  Product  Liability  Directive  in  specifically  ensuring 
consumer  protection  is  divergent:  consumer  organisations  mainly  claim  that  the  Product 
Liability  Directive  is  not  effective  enough,  producers  and  insurers  consider  it  effective,  while 
PAs and civil society express more nuanced positions. 

In  addition,  the  Product  Liability  Directive  seems  to  have  met  its  objective  of  enhancing  an 
effectively  operating  internal  market  for  goods.  The  Product  Liability  Directive  has  reached  a 
reasonable  uniformity  in  its  implementation  and  the  set  its  rules  makes  it  effective,  even 
though  some  elements  may  limit its  effectiveness.  Namely,  it is  much  more  common  that  an 
injured person brings an action against a producer in  his/her own  Member State,  rather than 
against  a  producer  based  abroad.  Provided  that  rules  on  jurisdictional  competence  enable 
injured  persons  to  bring  action  in  their  own  Member  State,  probably  some  external  factor 
operates  in  restraining  consumers  from  suing  local  and  foreign  producers  at  an  equal  rate 
(such as, for instance, lack of knowledge of procedural rules and language barriers).  

As to new technological developments, just one case has been brought to and decided in court 
in  the  period  from  2000  to  2016,  and  stakeholders  participating  in  the  study  have  reported 
little  experience  with  damages  relating  to  them.  On  such  a  limited  basis,  it is  not  possible  to 
draw  conclusions  on  the  effectiveness  of  the  Directive  with  regard  to  the  new  technological 
developments. 

The main drivers to the effectiveness of the Product Liability Directive are relating to the level 
of  uniformity  in  its  implementation,  its  role  as  a  “safety  net”  within  a  broader  legislative 
framework  to  protect  consumers,  the  level  of  generality  of  some  provisions  that  allow  for 
flexibility and wide coverage, and the high level of awareness of stakeholders. 

6.2  Efficiency 

The limited data collected in relation to the costs entailed by the  Product Liability Directive do 
not  allow  for  the  application  of  any  standard  quantitative  methodology  for  a  cost  and  benefit 
evaluation. Hence, the analysis of the Product Liability Directive’s efficiency is mainly based on 
a qualitative evaluation of costs and beneficial outcomes.  

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The  main  costs  are  enforcement  costs  (e.g.  court  fees,  lawyers’  and  experts’  fees),  and  they 
fall on either consumers or producers, depending on the outcome of the decision. Their extent 
varies considerably according to whether the claim is settled in or out of court. 

Substantive compliance costs for producers are equal to the amount of the compensation to be 
paid – if the claim is successful. Producers also bear indirect  costs relating to the payment of 
insurance premiums. The analysis shows that these costs are not significant, also considering 
sectors characterised by new technological developments, where the Product Liability Directive 
may have distortive effects.  

Substantive  compliance  costs  for  consumers  are  mainly  due  to  the  burden  of  proof,  which  is 
deemed the heaviest requirement. The effort relating to the burden of proof varies from sector 
to  sector  and  seems  to  be  particularly  relevant  in  the  pharmaceutical  and  medical  sector. 
Considering  that  claims  for  defective  products  are  successful  in  60%  of  the  cases,  this  cost 
seems reasonable in comparison to the benefit achieved.  

With regard to producers’ benefits, the Product Liability Directive’s provisions – and particularly 
the €500 threshold ̶ increased market efficiency and legal certainty, as the threshold prevents 
many  claims  of  small  amount  to  be  raised.  As  for  consumers,  thanks  to  the  Product  Liability 
Directive they can obtain, since 1985, compensation for damage caused by a defective product 
– at least in principle.  

As  to  costs  and  benefits  for  producers,  the  Product  Liability  Directive  seems  an  efficient 
legislative instrument, achieving its objectives at a reasonable cost and ensuring a good cost-
benefit ratio for all sizes of companies. However, the analysis showed that the Product Liability 
Directive’s  cost-benefit  ratio  as  far  as  consumers  are  concerned  is  not  always  fair  and 
straightforward, mainly due to the (unavoidable) burden of proof, which implies costs that an 
injured person has to pay up front in order to bring a claim in court, and to external factors not 
relating to the Product Liability Directive such as the costs of proceedings.  

6.3  Coherence 

The coherence of the Product Liability Directive has been confirmed with respect to each piece 
of legislation it has been assessed against:  

  The  EU  rules  on  consumer  protection  in  the  area  of  contractual  liability  (i.e.  the  Directive 

on Consumer Rights and the Sales and Guarantee Directive);  

  The  ”Digital  contracts  proposals”  (i.e.  the  proposal  for  a  directive  on  contracts  for  the 
supply of digital content and the proposal for a directive on contracts for the distance sales 
of goods);  

  The  EU  product  safety  policies  and  in  particular  the  sectorial  safety  legislation  and  the 

General Product Safety Directive;  

  The EU rules on applicable law, litigation and alternative dispute resolution (i.e. the Rome 
II regulation, the Brussels IA regulation, and the Directive on consumer alternative dispute 
resolution). 

The  analysis  determined  the  coherence  of  the  Directive  on  Consumer  Rights  and  the  Product 
Liability Directive mainly on the basis of the fact that their scopes of application are mutually 
exclusive. The two Directives do not overlap ̶ rather they are complementary, as they concur in 
the overall protection of consumers by regulating different fields. 

Similar  conclusions  can  be  drawn  for  the  relationship  between  the  Sales  and  Guarantee 
Directive  and  the  Product  Liability  Directive,  which  are  complementary  and  coherent.  The 
minor terminology inconsistencies identified are due to the different scopes of the Directives. 

The  coherence  of  the  Product  Liability  Directive  with  both  the  proposal  for  a  directive  on 
contracts for the supply of digital content and the one for distance sales of goods is confirmed, 
besides some minor inconsistencies that seem justified by the different scopes of these pieces 

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of  legislation,  and  do  not  appear  to  be  significant  in  the  implementation  of  all  pieces  of 
legislation.  

The  Product  Liability  Directive  appears  to  be  overall  coherent  and  complementary  with  the 
sectorial  safety  legislation  and  the  General  Product  Safety  Directive,  aimed  at  ensuring  that 
only  safe  products  are  made  available  on  the  market.  This  Product  Liability  Directive  states 
that  its  provisions  should  not  affect  injured  party  rights  within  the  meaning  of  the  Product 
Liability Directive ̶ which remains an autonomous legal regime, with a scope different from the 
one of the General Product Safety Directive. 

Coherence and synergies have been confirmed also between the Product Liability Directive and 
the EU rules on applicable law and dispute resolution. These include the Rome II Regulation, 
which enhances consumer protection based on the possibility to “predict” the law applicable to 
the possible damage affecting consumers (first, the law of place of residence), while striking a 
balance with the defendant’s needs, taking into account where the product was marketed. 

The Brussels IA Regulation enables an injured person to sue the producer in the courts  of the 
place  where  the  harmful  event  occurred.  This  has  been  confirmed  by  a  European  Court  of 
Justice (C-45/13). This provision is coherent with the Product Liability Directive.  

As  to  dispute  resolution  methods,  since  the  Directive  on  consumer  Alternative  Dispute 
Resolution is limited to the resolution of contractual disputes and does not cover the disputes 
that  can  arise  from  damages  from  defective  products  according  to  the  Product  Liability 
Directive, it appears that there are currently no EU rules in place for the alternative resolution 
of claims relating to Product Liability Directive. Their scopes are mutually exclusive. 

6.4  Relevance 

The  Directive  entered  into  force  in  1985  to  ensure  a  high  degree  of  EU  consumer  protection 
against health and property damages caused by a defective product and the producers’ liability 
for  damages  caused  by  a  defective  product,  and  to  enhance  the  free  movement  of  products 
without distorting competition. 

The Product Liability Directive is relevant with regard to the abovementioned needs, which still 
correspond  to  current  needs.  In  particular,  the  trend  in  the  number  of  claims  relating  to 
defective products as well as the average EU litigation rate have not been decreasing 
over the last several years, demonstrating that consumer protection, producers’ strict liability 
and  ensuring  a  level  playing  field  are  still  relevant.  The  relevance  of  a  Product  Liability 
Directive  responding  to  these  needs  is  also  confirmed  by  the  results  of  the  field  research,  in 
which stakeholders expressed wide agreement on the usefulness of the Directive in responding 
to the abovementioned needs.  

The relevance of the Product Liability Directive in light of new technological developments 
is  more  uncertain.  Indeed,  even  if  the  core  needs  related  thereto  are  still  the  same,  new 
technological  developments  represent  an  issue  since  they  challenge  the  application  of  the 
Product  Liability  Directive,  as  they  challenge  the  relevance  of  the  distinctions  between 
services  and  products,  private  and  professional  use  of  products  and  some  definitions 
provided  for  in  the  Product  Liability  Directive.  Among  them,  the  definitions  of  product, 
damage, defect, and the list of exemptions of liability in favour of the producer, such as the 
development  risk  clause,  are  the  most  challenged  by  the  rise  of  new  technologies,  in 
particular Internet based technologies and artificial intelligence. 

The  existence  of  issues  due  to  new  technological  developments  is  confirmed  by  open  public 
consultation respondents, as 69% of them agree that there are products (mainly falling under 
the definition of new technological developments)  for which the application of the  Product 
Liability  Directive  is  or  might  become  uncertain  and/or  problematic,  and,  according  to 
62% of the open public consultation respondents, the Directive should be adapted accordingly.  

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In  addition,  the  uncertain  relevance  of  the  Product  Liability  Directive  to  new 
technological  developments  seems  confirmed  by  other  results  of  the  open  public 
consultation. 

Furthermore, there is limited awareness  of  stakeholders on the existence  of national rules on 
liability  in  this  area,  even  though  the  findings  of  the  desk  research  confirmed  that  in  some 
Member  States  legislation  provides  for  protection  from  damages  caused  by  software  and/or 
services on the basis of their general rules in civil law rather than on the basis of specific rules.  

The  findings  of  the  desk  research  confirmed  this  scenario  of  uncertainty  on  whether 
the  Directive  applies  to  new  technological  developments.  On  the  one  hand,  most  sources 
seem  to  favour  a  revision  of  the  Product  Liability  Directive  to  catch  up  with  new 
technological  developments.  Similar  views  were  also  expressed  by  the  European  Parliament. 
On  the  other  hand,  other  sources  deem  it  reasonable  to  resolve  the  issue  created  by  new 
technological developments by means of interpretation only, waiting for the future evolution 
of the technology.  

All  in  all,  to  date  there  was  only  one  successful  case  involving  a  new  technological 
developments product, suggesting that this issue – and its significance – may be limited. 

However, the issue of new technological developments is subject to a  vivid doctrinal debate 
and  stakeholders  consider  this  to  contribute  to  uncertainties  in  the  application  of  the 
legislation. 

To conclude, while the relevance of the  Product Liability Directive is confirmed with regard its 
initial  objectives  (partially  corresponding  also  to  the  current  needs),  such  relevance  is  not 
confirmed  with  regard  new  technological  developments  (e.g.  cloud  technologies,  artificial 
intelligence  and  robots,  3D  printers).  This  is  especially  the  case  with  regard  to  specific 
provisions  (e.g.  no  reference  to  the  concept  of  service  nor  distinction  between  products  and 
services)  and  definitions  of  the  Product  Liability  Directive  (such  as  Articles  2,  3,  6,  7  and  9), 
which seem no longer to be not apt in guaranteeing the same level of protection.  

6.5  EU added value 

Overall, the EU added value of the Product Liability Directive is acknowledged.  

In particular, stakeholders consider as a strong advantage the uniform consumer protection 
all  over  the  European  Union,  protection  which  could  not  be  reached  by  means  of  single 
Member State action. 

Stakeholders  are  aware  of  the  fact  that  consumers  in  the  European  Union  have  the  right  to 
seek compensation for damage caused by a defective product from producers and/or importers 
into the European Union, regardless of whether producers/importers are at fault or negligent.  

Beyond uniform consumer protection, the EU added value of the Product Liability Directive also 
lies  in  the  harmonisation  of  product  liability  rules  and  in  the  right  balance  between 
consumer protection and innovation in Europe, not only with regard to the protection that 
consumers may find in court, but also to the preventive measures taken by producers,.  

In the opinion of the majority of stakeholders participating in the study, reducing the scope (or 
repealing)  the  existing  Product  Liability  Directive  may  change  the  consumer  protection, 
leading  to  negative  consequences  also  for  producers  like  uncertainty  and  subsequent 
difficulty  to  predict  (potentially  higher)  costs,  decrease  of  harmonisation,  internal 
market  fragmentation.  Indeed  stakeholders  usually  either  consider  the  Product  Liability 
Directive  as  future  proof  or  call  for  a  revision  of  the  Product  Liability  Directive  in  order  to 
enlarge its scope.  

Furthermore,  should  the  Product  Liability  Directive  be  repealed,  consumer  protection  would 
depend on the courts’ interpretation of their national law (contractual and/or tort law), leading 
to  different  levels  of  consumer  protection  in  the  different  Member  States,  with  potential 
impacts on the free movement of products and distortion of competition. 

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Conclusively, the EU added value of the Product Liability Directive can be confirmed. 

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Annex 1 

Evaluation questions 

The  table  below  lists  all  final  evaluation  questions  and  how  they  have  been  finalised  in  the 
Inception  phase  of  the  Study.  The  symbol  ‘*’  identifies  implementation  questions  that  have 
been addressed in chapter  4. The other evaluation questions have been addressed in chapter 
5.  

EQ FINAL VERSION 

Changes to original questions 

EFFECTIVENESS 
EQ 1: To what extent the Directive meets its 
objective  of  guaranteeing  at  EU  level  the 
liability  of  the  producer  for  damage  caused 
by  a  defective  product  and 
turn, 
to  an  effectively  operating 
contributes 
internal  market 
for  goods  and  to  the 
protection of the consumer? 

in 

EQ  2/3:  Which  are  the  main  drivers  to  the 
objectives achieved? 

EQ 4: deleted  

Unchanged  

The final EQ aggregates the following previous EQs:  

2)  Which  are  the  main  elements  of  the  Directive  that 
would  have  contributed  to  meeting  the  objectives  of  the 
Directive? 

3) Are there any aspects/provisions/definitions that would 
render  certain  aspects  of  the  Directive  more  or  less 
effective  than  others,  and  if  there  are,  what  lessons  can 
be drawn? 

The  following  EQ  has  been  deleted  as  covered  under 
relevance: 

4) Have any gaps, uncertainties or inadequacies occurred 
in the application of the Directive, in particular during the 
last  five  years?  If  yes,  which  ones  and  with  which 
consequence? A particular attention should be paid to any 
potential 
the  new 
technological  developments  and  how  these  were  filled-in 
at national level? 

regulatory 

relating 

lacunas 

to 

EQ  5/6/13:  What  is  the  impact  of  the  new 
technological 
the 
effectiveness of the Directive? 

developments 

on 

EQ 4: deleted  

The final EQ aggregates the following previous EQs:  

5)  Have  technical  and  technological  progress  and,  in 
particular the development of digital software, robots and 
connected  objects,  affected  the  effectiveness  of  the 
Directive? Why and to what extent? 

6) Is the Directive fit for purpose in relation to the recent 
technological developments? What are the main obstacles 
(if  any)  in  the  application  of  the  Directive  to  these 
situations at national level?  

13)  How  does  the  Directive  impact  economic  actors 
operating  in  the  digital  economy  (including  sensors 
manufacturers,  software  developers  etc.)  which  propose 
IoT solutions and robotic technology? 

The  following  EQ  has  been  deleted  ad  treated  as  a 
judgement criterion under EQ1:  

7)  What  are,  if  any,  the  consequences  or  effects  (either 
positive or negative) that were not originally planned? 
The final EQ aggregates the following previous EQs:  

*EQ  8/12:  What  are  the  systems  used  to 
settle  the  claims  by  injured  persons  from 
damages caused by defective products? 

8) Is the strict liability litigation the first option chosen by 
the  consumers  that  have  been  injured  by  a  defective 
product? Why? 

12)  In  general,  which  system  (out-of-court  settlement  or 

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EQ FINAL VERSION 

Changes to original questions 

judicial  proceeding)  has  been  most  effective  for  the 
recovery  of  damages?  Why?  Is  there  a  trend  to  be 
observed in the last five years? 

*EQ  9:  Which  products  have  been  most 
frequently  at  cause  for  the  purpose  of 
recovery of damages? 

Unchanged 

*EQ  10:  Which  types  of  defects  have  been 
most frequently detected in those products? 

Unchanged 

*EQ  11:  Which  type  of  damages  (personal 
injuries  or  property)  have  been  more  often 
the object of recovery? 

*EQ  14:  How  many  cases  have  been 
brought  to  the  courts  on  the  applicability  of 
the  Directive?  Which  was  the  issue  in 
question and the ruling? 

EQ 15: In the judicial cases, what have been 
the most frequent difficulties encountered by 
consumers when obtaining compensation, in 
particular  during  the  last  five  years?  The 
identification 
The 
establishment  of  the  causal  link  between 
damage and defect? The threshold of  €500? 
The  allocation  of  the  liability  among  the 
economic players? Other? 

defect? 

the 

of 

*EQ 16: In general, have the claimants been 
successful  in  the  litigation?  Is  there  a  trend 
to be observed in the last five years?  

*EQ  17:  Have  cases  been  brought  to  the 
national  courts  relating  to  the  application  of 
the  Directive  to  damages  caused  by  a 
defect,  for  instance  the  malfunctioning,  in 
apps or in another non-embedded software? 
If it is the case, which was the issue at stake 
and what was the ruling?  

settlement 

*EQ  18:  Have  there  been  cases  brought  to 
the national courts or solved through an out-
of-court 
the 
application  of  the  Directive  to  damages 
caused  by  a  robot,  in  particular  in  an 
advanced  robot  or  an  autonomous  system? 
If it is the case, what was the issue at stake 
and the ruling?  

relating 

to 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

*EQ 19: Have there been cases in which the 
damage  was 
caused  by  a  product 
interconnected  with  other  products  or 
services,  for  instance  in  the  context  of  IoT 
and  automated  systems?  How  has  the 
liability been allocated in those cases? 

*EQ 20: In the context of new technological 
developments, 
been 
have 
discrepancies between the judgements made 
by  the  courts  on  similar  cases?  What  were 
the problems at stake? 

there 

Unchanged 

Unchanged 

EFFICIENCY 
EQ  21:  What  are  the  regulatory  (including 
relevant 
costs 
administrative) 
stakeholders stemming from the Directive? 

for 

EQ  22:  What  are  the  main  benefits  for 

Unchanged 

Unchanged 

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EQ FINAL VERSION 

Changes to original questions 

stakeholders  and  civil  society  that  derive 
from the Directive? 

EQ  23:  Are  the  benefits  achieved  at 
reasonable 
and 
for 
cost 
producers (with focus on SMEs)? 

consumers 

EQ  24:  Does  the  Directive  strike  the  right 
balance  between  the  costs  borne  by  the 
producers to cover the strict liability and the 
requirements  on  the  injured  party  to  obtain 
compensation? 

EQ  25:  What  aspects  of  the  Directive  are 
most  efficient  or  inefficient  to  reach  the 
objective of having a system of strict liability 
on the producer?  

COHERENCE 
EQ  26:  To  what  extent  is  the  intervention 
consistent and coherent with the EU rules on 
the  area  of 
consumer  protection 
(for  example,  new 
contractual 
Commission 
the  digital 
context)? 

initiatives 

liability 

in 

in 

EQ  27:  To  what  extent  is  the  Directive 
coherent  with  wider  EU  policy,  such  as  the 
free  movement  of  goods  and/or 
the 
protection  of  the  consumers,  including  EU 
product safety? 

RELEVANCE 
EQ  28:  To  what  extent  do  the  initial 
objectives  correspond  to  the  current  needs, 
including  new  needs  created  by  innovative 
products? 

EQ  29:  To  what  extent  does  the  distinction 
between products and services when dealing 
with  product  liability  continue  to  be  apt  for 
dealing  with 
technological 
developments?  

new 

the 

EQ 30: How well adapted is the intervention 
to  the  changing  market  environment:  often 
with  a  blurred  distinction  between  private 
and professional use of products?  

EQ  31:  To  what  extent  the  concepts  of 
product,  producer,  damage  or  the  category 
of exemptions as defined in the Directive are 
adequate to correspond to  the  technological 
and scientific developments? 

EQ  32:  How  well  is  the  term  'defective'  as 
defined  in  the  Directive  adapted  to  new 
technological  or  scientific  advances  such  as 
apps and non-embedded software, advanced 
robots  and  autonomous/intelligent  systems? 
For  example,  could  software  vulnerability 
(for  instance,  a  cyber-attack  or  a  failure  to 
update  security  software  or  a  misuse  of 
information) be considered as a defect? 

EU ADDED VALUE 
EQ  33:  What  is  the  EU  added  value  of  the 
Directive  for  stakeholders  (manufacturers, 
including  software  developers  and  economic 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

Unchanged 

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EQ FINAL VERSION 

Changes to original questions 

operators in the DSM, and consumers)? 

EQ  34:  To  what  extent  does  the  issue  of 
strict  liability, as addressed by the  Directive 
continue to require action at EU level? 

EQ  35:  What  would  be  the  most  likely 
consequences  of  reducing  the  scope  of  the 
existing EU intervention? 

Unchanged 

Unchanged 

EQ  36:  What  would  be  the  most  likely 
consequences of repealing the Directive? 

Unchanged 

EQ  37:  According  to  the  case  law  and  the 
experience  on 
the 
Directive, could it be considered appropriate 
to  enlarge  the  scope  of  the  Directive,  for 
instance so as to cover the services? 

the  application  of 

Unchanged 

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Annex 2 

Evaluation grids 

As discussed in section 3.2.23.2.2, the following tables present the evaluation grids used as a 
basis  for  this  evaluation.  The  grids  cross-reference  the  judgment  criteria,  the  analytical 
approach, the indicators and the sources of information. 

Legend: 

Q: Questions 

Questions assessing the evaluation of the Directive are in pink background. 

Questions concerning the Directive’s application are in yellow background. 

JC: Judgment Criteria 

TS: Targeted survey 

I: Interviews 

OPC: Open Public Consultation 

P: Industry associations, producers, importers and suppliers (including SMEs) as per Article 3 
of the Directive 

C: Consumer organisations 

IC: Insurance companies (including federations of insurers) 

PA/CS:  Public  administrations  and  European  Parliament  and  Commission  officials,  individual 
experts from academia, think tanks, law firms, judges residing in relevant courts and  others, 
e.g. the Product Liability Forum of the British Institute of International and Comparative Law 

T: 

Organisations 

of 

technical 

experts 

acting 

in 

courts

103 

 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Table 9 – Evaluation grids 

Question 

Judgment Criteria 

Analytical framework 

Indicators 

JC1 The Directive 
meets its objective in 
guaranteeing at EU 
level the strict liability 
of the producer for 
damage caused by a 
defective product 

Assessment of the extent to which the 
Directive has led to recognition of 
liability (in and out of courts). The 
analysis is based on stakeholders’ 
perception and other secondary sources. 

1. Level of 
satisfaction on the 
effectiveness of the 
Directive in 
guaranteeing the 
liability of 
producers for 
damages caused by 
defective products 

n
o
i
t
a
l
-
s
i
g
e

l

S
M

w
a

l

e
s
a
c

S
M

x 

w
a
l
-
e
s
a
c
U
E

x 

i

w
e
v
e
r

k
s
e
D

x 

C
P
O

P

C

C

I

S
C
/
A
P

T

)
3
2
Q
(

S
T

)
1
Q
(

I

)
3
Q
(

S
T

)
6
Q
–

1
Q
(

I

)
9
1
Q
A
P

,
0
2
Q
C
(

x

JC2 The Directive 
contributes to an 
effectively operating 
internal market for 
goods 

Assessment of the extent to which the 
Directive has led to a level playing field 
for producers 
The analysis is based on stakeholders’ 
perception and other secondary sources. 

1. Level of 
satisfaction on the 
effectiveness of the 
Directive on its 
contribution to a 
level playing field 

x   

)
2
1
Q
(

S
T

)
2
Q
(

S
T

JC3 The Directive 
contributes to the 
protection of the 
consumers 

Assessment of the extent to which the 
Directive contributes to a more effective 
protection of consumers. Analysis of the 
extent to which consumers have 
obtained compensation compared to 
what was requested  

1. Level of 
satisfaction on the 
effectiveness of the 
Directive for 
consumer 
protection 

x 

x 

x 

)
9
1
Q
A
P

,
0
2
Q
C
(

x

)
4
Q

)
,
3
0
Q
1
Q
(
S
T

I

,
)
1
1
Q
(

S
T

–

6
Q
–

1
Q
(

)
6
Q
–

1
Q
(

I

,
)
4
Q

,
3
Q
(

S
T

)
6
Q
–

1
Q
(

I

)
2
1
Q
(

S
T

)
6
Q

,
7
Q
(

S
T

)
0
1
Q

I

-

6
Q
-

1
Q
(

,
)
1
1
Q
(

S
T

104 

Q1. To what extent 
does the Directive 
meet its objective of 
guaranteeing at EU 
level the liability of 
the producer for 
damage caused by a 
defective product 
and in turn, 
contribute to an 
effectively operating 
internal market for 
goods and to the 
protection of the 
consumer? 
Q1. To what extent 
does the Directive 
meet its objective of 
guaranteeing at EU 
level the liability of 
the producer for 
damage caused by a 
defective product 
and in turn, 
contribute to an 
effectively operating 
internal market for 
goods and to the 
protection of the 
consumer? 
Q1. To what extent 
does the Directive 
meet its objective of 
guaranteeing at EU 
level the liability of 
the producer for 

s
s
e
n
e
v
i
t
c
e
f
f
E

s
s
e
n
e
v
i
t
c
e
f
f
E

n
e
v
i
t
c
e
f
f
E

s
s
e

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

n
o
i
t
a
l
-
s
i
g
e

l

S
M

w
a

l

e
s
a
c

S
M

w
a
l
-
e
s
a
c
U
E

i

w
e
v
e
r

k
s
e
D

C
P
O

P

C

C

I

S
C
/
A
P

T

damage caused by a 
defective product 
and in turn, 
contribute to an 
effectively operating 
internal market for 
goods and to the 
protection of the 
consumer? 
Q1. To what extent 
does the Directive 
meet its objective of 
guaranteeing at EU 
level the liability of 
the producer for 
damage caused by a 
defective product 
and in turn, 
contribute to an 
effectively operating 
internal market for 
goods and to the 
protection of the 
consumer? 
Q2/3. Which are the 
main drivers to the 
objectives achieved? 

s
s
e
n
e
v
i
t
c
e
f
f
E

s
s
e
n
e
v
i
t
c
e
f
f
E

The analysis is based on stakeholders’ 
perception, and other secondary 
sources. 

2. Ratio 
compensation 
requested/ 
compensation 
awarded 

JC4 The Directive 
contributes to other 
not originally planned 
consequences and 
effects 

Identification of aspects that go beyond 
the liability of producer for damages 
from defective products, through both 
desk and field research.  

x 

x 

x 

x   

)
2
Q
(

I

)
9
Q
-

4
Q

)
2
Q
(

I

)
2
Q
(

I

)
2
Q
(

I

-

3
Q
-

2
Q
-

1
Q
(

I

)
7
1
Q

,
6
1
Q
(

S
T

JC1 Some provisions 
have been 
implemented more 
consistently in MS  

Assessment of the extent to which the 
following terms have been implemented 
consistently in the MS:  
1. Producer 
2. Defective 
3. Damages 
4. Product (also including new 
technologies) 
5. Safety 
6. Material thresholds of €500 

1. Level of 
uniformity of 
implementation  
2. Number of case 
law references 
evidencing 
extension of the 
Directive by way of 
similarity  
3. Number of case 
law references 
evidencing 
exclusion of liability 
of the producer 
and/or other 
economic operators 

x 

x 

x 

x   

)
3
1
Q
(

I

)
4
Q
(

I

105 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
   
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

Assessment of the extent to which 
specific characteristics of Directive make 
it more effective: 
- application of the Directive to many 
products 
- strict liability of the producer 
- notion of "defective" 
- proof of defect 
- proof of damage 
- proof of the link between the defect 
and the damage 
- identification of the producer 
- material threshold of €500 
- private use 
- three-year period  
- expiry period of 10 years 
N/A  

s
s
e
n
e
v
i
t
c
e
f
f
E

s
s
e
n
e
v
i
t
c
e
f
f
E

Q2/3. Which are the 
main drivers to the 
objectives achieved? 

JC2 It is possible to 
identify specific 
aspects in the 
Directive that render 
it more or less 
effective 

Please consider that 
such question has 
been deleted because 
covered in terms of 
Relevance, below. 

Q4. Have any gaps, 
uncertainties or 
inadequacies 
occurred in the 
application of the 
Directive, in 
particular during the 
last five years? If 
yes, which ones and 
with which 
consequence? A 
particular attention 
should be paid to 
any potential 
regulatory lacunas 
relating to the new 
technological 
developments and 
how these were 
filled-in at national 
level? 

4. Rate of 
recurrence of 
specific factors  
Ranking of drivers 

n
o
i
t
a
l
-
s
i
g
e

l

S
M

w
a

l

e
s
a
c

S
M

w
a
l
-
e
s
a
c
U
E

i

w
e
v
e
r

k
s
e
D

x 

C
P
O

P

C

C

I

S
C
/
A
P

T

)
7
Q
(

I

)
4
Q
(

I

)
4
Q
(

I

)
7
Q
(

I

)
8
1
Q
A
P

,
9
1
Q
C
,
5
2
Q
P
(

x

N/A 

N/A  N/A  N/A  N/A   

A
/
N

A
/
N

A
/
N

A
/
N

A
/
N

106 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

Q5/6/13. What is 
the impact of the 
new technological 
developments on 
the effectiveness of 
the Directive? 

JC1 The Directive 
properly covers new 
technological 
developments new 
technological 
developments 

Q8/12. What are the 
systems used to 
settle the claims by 
injured persons from 
damages caused by 
defective products? 

JC1 There are 
different systems in 
place to settle the 
claims by injured 
persons 

s
s
e
n
e
v
i
t
c
e
f
f
E

s
s
e
n
e
v
i
t
c
e
f
f
E

n
e
v
i
t
c
e
f
f
E

v
i
t
c
e
f
f
E

s
s
e

s
s
e
n
e

Q9. Which products 
have been most 
frequently at cause 
for the purpose of 
recovery of 
damages? 
Q10. Which types of 
defects have been 
most frequently 
detected in those 
products? 

e
f
f
E

v
i
t
c

e
n
e

 Q11 Which type of 
s
damages (personal 
s
injuries or property) 

JC1 There are 
products whose 
defect caused 
damages object of 
recovery in claims 
from 2000 onward 
JC1 There are defects 
that have been 
frequently detected in 
products from 2000 
onward 
JC1 There are 
damages (personal 
injuries or property) 

Analysis of the extent to which new 
technological developments are covered 
or not, and why, by the Directive, by 
looking at  
- how new technological developments 
new technological developments are 
treated by national legislation.  
- there are new contractual 
arrangements covering the risks created 
by new technological developments 
(notably insurance contracts, in general, 
specific professional insurances).  
Analysis of the extent to which the 
Directive has impacts on economic 
operators in the digital economy, 
through interviews. 
Identification of the main systems used 
to settle claims by injured persons from 
damages caused by defective products 
through the analysis of case law and 
stakeholder consultation.  
The analysis shall focus on how many 
claims are settled in court and out of 
court with possible identification of any 
kind of trend in the use of these 
systems. 
Identification of the products most 
frequently subject to claims through the 
analysis of case law and stakeholder 
consultation 

Identification of the different types of 
defects most frequently subject to 
claims through the analysis of case law 
and stakeholder consultation 

Mapping and distribution of types of 
damages:  
- personal injuries 

1. Number of case 
law references 
relating to new 
technological 
developments  
2. Percentage of 
claims relating to 
new technological 
developments  

n
o
i
t
a
l
-
s
i
g
e

l

S
M

w
a

l

e
s
a
c

S
M

w
a
l
-
e
s
a
c
U
E

i

w
e
v
e
r

k
s
e
D

x 

x 

x 

x 

S
C
/
A
P

)
6
1
Q
(

I

,
)
5
Q
(

S
T

T

)
8
Q
(

I

,
)
3
Q
(

S
T

C
P
O

)
3
2
Q
A
P

,
2
2
Q
C
,
8
2
Q
P
(

x

P

C

C

I

)
4
1
Q
-

3
1
Q
(

I

,
)
5
Q

,
4
Q

,
3
Q
(

S
T

)
2
1
Q
-
1
1
Q
(

I

,
)
7
1
Q

,
6
1
Q

,
7
Q

,
6
Q

,
5
Q

,
4
Q
(

S
T

)
9
Q
-

5
Q

,
4
Q
(

I

,
)
4
1
Q

,
9
Q

,
8
Q

,
7
Q

,
6
Q

,
5
Q
(

S
T

1. Percentage of 
claims settled by 
each system 

x 

x 

1. Ranking of 
products 

x 

x 

1. Ranking of types 
of defects 

x 

x 

)
1
1
Q
A
P

)
2
2
Q
(

S
T

,
5
Q
C

)
9
Q
A
P

)
2
Q
(

I

)
9
Q
C

,
6
1
Q
C
,
5
1
Q
P
(

x

,
3
1
Q
P
(

x

,
7
1
Q
P
(

x

)
7
Q
(

I

1. Distribution of 
types of damages 

x 

x 

  x

Q
P
(

,
8
1

1
Q
C

,
0

Q
A
P

)
3
1

107 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
         
 
 
 
 
 
 
 
 
 
     
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

that are more often 
subject of recovery in 
the cases from 2000 
onward 
JC1 Cases brought to 
courts on the 
applicability of the 
Directive 

- property 
through the analysis of case law and 
stakeholder consultation 

Identification of claims brought to court 
from 2000 onward, with particular 
mention and details from 2011 onward, 
analysed by subject matter and ruling. 
Identification and mapping of the main 
issues behind the claim and final 
outcome of the judicial proceedings  

JC1 There are specific 
difficulties faced by 
consumers in 
obtaining 
compensation from 
2000 onward 

Identification of difficulties faced by 
consumers in obtaining compensation in 
judicial proceedings through the analysis 
of the reasons for rejecting the claim or 
reducing the compensation in case law 
from 2000, and particular mention and 
details from 2011 onward. 

1. Number of cases 
brought to court 
2. Number of cases 
per type of issue 
3. Number of cases 
per result of the 
ruling and per type 
of issue 

1. Number of case 
law references 
where the 
claimants did not 
receive the 
compensation or 
the claim was 
rejected.  

n
o
i
t
a
l
-
s
i
g
e

l

S
M

w
a

l

e
s
a
c

S
M

w
a
l
-
e
s
a
c
U
E

i

w
e
v
e
r

k
s
e
D

C
P
O

P

C

C

I

S
C
/
A
P

T

x 

x 

)
9
1
Q

,
8
1
Q

,
6
1
Q
(

S
T

s
s
e
n
e
v
i
t
c
e
f
f
E

s
s
e
n
e
v
i
t
c
e
f
f
E

have been more 
often the object of 
recovery? 

Q14 How many 
cases have been 
brought to the 
courts on the 
applicability of the 
Directive? Which 
was the issue in 
question and the 
ruling? 
Q15 In the judicial 
cases, what have 
been the most 
frequent difficulties 
encountered by 
consumers when 
obtaining 
compensation, in 
particular during the 
last five years? The 
identification of the 
defect? The 
establishment of the 
causal link between 
damage and defect? 
The threshold of 
€500? The allocation 
of the liability 
among the economic 
players? Other as for 
instance that the 
product was 
purchased as a 
bundle with a 
related service? 
Q15 In the judicial 
cases, what have 

E f

f e c t

i v e n e s s

JC2 There are specific 
difficulties faced by 

Analysis of the recurrence of the 
following types of difficulties faced by 

1.  Number  of  cases 
where  the  injured 

x 

x 

  x

( C Q 1

,
T S
7

C P 2

( Q 1
,
3

P A Q 1 4 )
,
6

( Q 2 )

Q 1 9 )

Q 1

T S

,
8

I

( Q 9 )

108 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

n
o
i
t
a
l
-
s
i
g
e

l

S
M

w
a

l

e
s
a
c

S
M

w
a
l
-
e
s
a
c
U
E

i

w
e
v
e
r

k
s
e
D

C
P
O

P

C

C

I

S
C
/
A
P

T

consumers in 
obtaining 
compensation from 
2000 onward 

consumers in obtaining compensation:  
- identification of the defect 
- establishment of the casual link 
between damage and defect 
- threshold of €500 
- allocation of liability among economic 
players 
The analysis is based on case law from 
2000, and particular mention and details 
from 2011 onward. 

did 

party 
receive 
compensation 
2. 
Ranking 
difficulties  

not 

of 

JC1 Success of 
claimants in the 
litigation 

Identification of the number of claims for 
damages of defective products that have 
been won by injured parties from 2000 
onward (in courts and out of courts) 

been the most 
frequent difficulties 
encountered by 
consumers when 
obtaining 
compensation, in 
particular during the 
last five years? The 
identification of the 
defect? The 
establishment of the 
causal link between 
damage and defect? 
The threshold of 
€500? The allocation 
of the liability 
among the economic 
players? Other? 
Q16 In general, 
have the claimants 
been successful in 
the litigation?  

s
s
e
n
e
v
i
t
c
e
f
f
E

  Q17 Have cases 
s
s
e
n
e
v
i
t
c
e
f
f
E

been brought to the 
national courts 
relating to the 
application of the 
Directive to 
damages caused by 
a defect, for 

JC1 Existence of 
claims relating to 
damages caused by 
malfunctions in apps 
or in another non-
embedded software 
which have been 
ruled: 

Identification and analysis of case law 
showing whether the Directive covers or 
does not cover claims relating to 
malfunctions in apps or in other non-
embedded software. 

1. Number of 
claims brought to 
court in relation to 
damages for 
defective products 
from 2000 onward 
2. Number of 
judicial cases in 
which the claimant 
has been successful 
in obtaining 
compensation in 
case law from 2000 
onward 
1. Number of cases 
brought to court for 
defects of apps or 
another non-
embedded software 
at national level 

x 

x 

)
0
1
Q

,
9
Q
(

S
T

x 

x 

x   

,
3
1
Q

,
2
1
Q
(

S
T

,
)
1
4
2
1
Q
Q

,
0
2
Q
(

S
T

,
4
2
Q

,
3
2
Q

,
2
2
Q

,
7
2
Q

,
6
2
Q

,
5
2
Q

I
)
8
,
2
)
9
Q
Q

)
0
1
Q
(

,
8
Q
(

S
T

109 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

n
o
i
t
a
l
-
s
i
g
e

l

S
M

w
a

l

e
s
a
c

S
M

w
a
l
-
e
s
a
c
U
E

i

w
e
v
e
r

k
s
e
D

C
P
O

P

C

C

I

S
C
/
A
P

T

i) based on 
application of the 
Directive; or 
ii) based on 
application of other 
legislation 

JC2 Existence of 
problematic questions 
arising out of the 
abovementioned 
cases 

1. Ranking of issues 

x 

x 

x   

Identification of main issues relating to 
the application of the Directive in case of 
damages caused by malfunctions in apps 
or in another non-embedded software, 
in terms of extra-contractual liability of 
the producer, considering the following:  
- definition of product 
- definition of defect 
- allocation of liability 

JC1 There are cases 
of claims relating to 
damages caused by 
robots which have 
been ruled based on 
the application of the 
Directive by way of 
similarity 

Identification and analysis of settlements 
showing whether the Directive covers or 
does not cover claims relating to 
damages caused by a robot/ automated 
or autonomous system.  

1. Number of cases 
relating to the 
application of the 
Directive to 
damages caused by 
a robot, by type of 
settlement system 

x 

x 

x   

instance the 
malfunctioning, in 
apps or in another 
non-embedded 
software? If it is the 
case, which was the 
issue at stake and 
what was the ruling? 
Q17 Have cases 
been brought to the 
national courts 
relating to the 
application of the 
Directive to 
damages caused by 
a defect, for 
instance the 
malfunctioning, in 
apps or in another 
non-embedded 
software? If it is the 
case, which was the 
issue at stake and 
what was the ruling? 
Q18 Have there 
been cases brought 
to the national 
courts or solved 
through an out of 
court settlement 
relating to the 
application of the 
Directive to 
damages caused by 
a robot, in particular 
in an advanced 
robot or an 
autonomous 
system? If it is the 
case, what was the 

s
s
e
n
e
v
i
t
c
e
f
f
E

s
s
e
n
e
v
i
t
c
e
f
f
E

)
8
Q
(

S
T

)
0
1
Q
(

I

,
)
9
Q
(

S
T

)
4
1
Q

,
3
1
Q

,
2
1
Q
(

S
T

)
9
1
Q

,
8
1
Q

,
7
1
Q

,
6
1
Q

,
5
1
Q
(

S
T

)
8
2
Q

,
7
2
Q

,
6
2
Q

,
5
2
Q

)
8
2
Q

,
7
2
Q

,
6
2
Q

,
5
2
Q

,
4
2
Q

,
3
2
Q

,
2
2
Q

,
1
2
Q

,
0
2
Q
(

S
T

,
4
2
Q

,
3
2
Q

,
2
2
Q

,
1
2
Q

,
0
2
Q
(

S
T

110 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

n
o
i
t
a
l
-
s
i
g
e

l

S
M

w
a

l

e
s
a
c

S
M

w
a
l
-
e
s
a
c
U
E

i

w
e
v
e
r

k
s
e
D

C
P
O

P

C

C

I

S
C
/
A
P

T

issue at stake and 
the ruling? 
Q18 Have there 
been cases brought 
to the national 
courts or solved 
through an out of 
court settlement 
relating to the 
application of the 
Directive to 
damages caused by 
a robot, in particular 
in an advanced 
robot or an 
autonomous 
system? If it is the 
case, what was the 
issue at stake and 
the ruling? 
Q19 Have there 
been cases in which 
the damage was 
caused by a product 
interconnected with 
other products or 
services, for 
instance in the 
context of IoT and 
automated systems? 
How has the liability 
been allocated in 
those cases? 
Q19 Have there 
been cases in which 
the damage was 
caused by a product 
interconnected with 
other products or 
services, for 

s
s
e
n
e
v
i
t
c
e
f
f
E

s
s
e
n
e
v
i
t
c
e
f
f
E

s
e
n
e
v
i
t
c
e
f
f
E

s

JC2 Existence of 
problematic questions 
arising out of the 
abovementioned 
cases 

Identification of main issues relating to 
the application of the Directive in case of 
damages caused by a robot/ automated 
or autonomous system, considering the 
following:  
- definition of product 
- definition of defect 
- allocation of liability 

1. Ranking of issues 

x 

x 

x   

)
0
1
Q
(

I

)
1
1
Q
(

I

,
)
1
1
Q

,
0
1
Q
(

S
T

)
9
1
Q

,
8
1
Q

,
7
1
Q

,
6
1
Q

,
5
1
Q
(

S
T

)
8
2
Q

,
7
2
Q

,
6
2
Q

,
5
2
Q

,
4
2
Q

,
3
2
Q

,
2
2
Q

,
1
2
Q

,
0
2
Q
(

S
T

Identification of cases in which the 
damage was caused by a "defect" of a 
product interconnected with other 
products or services, for instance in the 
context of IoT and automated systems. 

1. Number of cases 
on damages caused 
by a product 
interconnected with 
other products or 
services 

x 

x 

x 

x 

JC1 There are cases 
of claims relating to 
damages caused by 
interconnected 
products, services 
(for instance IoT 
items, automated and 
autonomous systems 
and other New 
Technological 
Developments).  

I

,
)
2
2
Q

,
1
2
Q

,
0
2
Q
(

S
T

)
9
-
8
Q
A
P

,
5
Q
C
,
3
1
-
2
1
Q
P
(

x

,
3
2
Q

)
5
1
Q
(

,
2
2
Q

,
1
2
Q

,
0
2
Q
(

S
T

JC2 Allocation of 
strict liability in case 
of damages caused 
by a defect in a 
product 
interconnected with 
other product or 

Identification of how the liability has 
been allocated in the context of IoT in 
case of damages due to defects of new 
technological developments products. 
Focus on those possible areas already 
covered and those not covered yet by a 
protection similar to the one granted by 

1. Number of cases 
where the liability 
was allocated to 
stakeholders other 
than the producer 

x 

x 

x 

x 

)
6
1
Q
(

I

)
2
Q
(

S
T

,
)
8
2
Q

,
7
2
Q

,
6
2
Q

,
5
2
Q

,
4
2
Q

)
5
1
Q
(

I

)
0
1
Q
(

)
4
1
Q
(

S
T

)
6
1
Q
(

S
T

)
4
1
Q
(

I

,
)
2
3
Q

I

,
3
1
Q

,
2
1
Q
(

S
T

)
2
1
Q
(

S
T

)
9
Q
(

I

111 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

n
o
i
t
a
l
-
s
i
g
e

l

S
M

w
a

l

e
s
a
c

S
M

w
a
l
-
e
s
a
c
U
E

i

w
e
v
e
r

k
s
e
D

C
P
O

P

C

C

I

S
C
/
A
P

T

service (for instance 
IoT items, automated 
and autonomous 
systems and other 
new technological 
developments).  
JC1 There are 
interpretative 
problems arising out 
of new technological 
developments  

instance in the 
context of IoT and 
automated systems? 
How has the liability 
been allocated in 
those cases? 
Q20 In the context 
of new technological 
developments, have 
there been 
discrepancies 
between the 
judgments made by 
the courts on similar 
cases? What were 
the problems at 
stake? 

the Directive. 

Identification of cases in which the 
courts of each MS might have applied 
other legislation and/or the principles of 
the Directive by way of similarity to 
claims relating to new technological 
developments to claims relating to new 
technological developments from 2000 
onward with reference to: 
- apps and other non-embedded 
software 
- robots/automated/autonomous 
systems 
- interconnected products  
Analysis of the reasons for discrepancies 
based on stakeholders perception 

Q21 What are the 
regulatory (including 
administrative) costs 
for relevant 
stakeholders 
stemming from the 
Directive? 

JC1 There are 
regulatory and 
administrative costs 
stemming from the 
Directive  

Mapping of costs distinguishing 
between:  
- direct (i.e. administrative) 
- enforcement  
- indirect  
based on the preliminary mapping 
provided in the inception report 
Quantification of costs 

s
s
e
n
e
v
i
t
c
e
f
f
E

y
c
n
e
i
c
i
f
f
E

i
f
f
E

e
i
c

  Q22 What are the 
y
main benefits for 
c
n
stakeholders and 

JC1 It is possible to 
identify some benefits 
that are deriving from 

Mapping of benefits distinguishing 
between:  
- direct (i.e. administrative) 

1. Number of cases 
in which legislation 
other than the 
Directive was 
applied to claims on 
damages caused by 
new technological 
products, directly or 
by the way of 
extension of its 
principles by type 
of "new 
technological 
developments" 
2. Number of cases 
in which other 
legislation was 
applied to damages 
caused by defects 
in new 
technological 
developments 
1. Costs on total 
production value for 
producers; 
2. Ranking on the 
level of burden for 
consumers; 
2. Costs for 
consumers (where 
available).  
Rating of identified 
benefits 

x 

x 

x 

x x

1
Q
(

)
8
2
Q

)
1
3
Q

,
7
2
Q

,
6
2
Q

,
5
2
Q

,
4
2
Q

,
3
2
Q

,
2
2
Q

,
1
2
Q

,
0
2
Q
(

S
T

-

0
3
Q
-

9
2
Q
(

S
T

)
9
Q

)
A
P
8
1
Q

,
P
5
2
Q

,
C
9
1
Q
(

x

,
8
Q

,
7
Q

,
6
Q
(

S
T

,
P

S
T

,
C
9

5
2
Q

2
Q
(

-
I

I
S
T
,
)
4

8
1
Q

3
4
Q
Q
(
(

)
A
P

,
)
5

) )
1
-
S
3
6
Q
Q
T
Q
(
(

3 )
9 )
4 )
,
I
I
8
1
2
Q
Q
Q
(

3 ,
Q
(

)
4
Q

112 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

civil society that 
derive from the 
Directive? 

the Directive that are 
particularly relevant 
for stakeholders 

Q23 Are the benefits 
achieved at 
reasonable cost for 
consumers and 
producers (with 
focus on SMEs)? 

JC1 The ratio 
between the benefits 
and the costs is 
perceived as 
reasonable by 
stakeholders 

Q24 Does the 
Directive strike the 
right balance 
between the costs 
borne by the 
producers to cover 
the strict liability 
and the 
requirements on the 
injured party to 
obtain 
compensation? 
Q25 What aspects of 
the Directive are 
most efficient or 
inefficient to reach 
the objective of 
having a system of 
strict liability on the 
producer? 

JC1 The ratio 
between the 
insurance costs of the 
producer and the 
compensation 
received by the 
consumers is 
appropriate 

JC1 There are some 
elements of the 
Directive that are 
more or less efficient 
than others.  

- enforcement 
- indirect  
based on the preliminary mapping 
provided in the inception report 
Quantification of benefits 
Analysis of the balance between costs 
and benefits based on the perception of 
consumers, distinguishing between 
"traditional products" and "products 
relating to New Technological 
Developments", overall and by type of 
stakeholder.  
Information will be gathered through the 
survey to consumers and producers and 
the results of the OPC 
Analysis of the ratio between insurance 
premiums and compensation costs (loss 
ratio) for damages caused by defective 
products compared to the overall 
average ratio, where possible 
distinguishing between "traditional 
products" and "products relating to new 
technological developments" 
Analysis of stakeholder perception  

Analysis of the level of efficiency of 
specific aspects of the Directive based 
on stakeholders' perception from OPC 
and interviews (specific elements: proof 
of defect, proof of damage, proof of link, 
attribution of liability to specific 
person/entity, threshold of €500, proof 
of private purposes, three year expiry 
period) 

y
c
n
e
i
c
i
f
f
E

y
c
n
e
i
c
i
f
f
E

y
c
n
e
i
c
i
f
f
E

1. Level of 
satisfaction of 
stakeholders on the 
balance between 
costs and benefits, 
by type of product 

1. Ratio between 
the specific and 
average loss ratio 
2. Ratio of loss ratio 
for traditional 
products and 
products relating to 
new technological 
developments  

Ranking of most 
efficient/inefficient 
aspects 

n
o
i
t
a
l
-
s
i
g
e

l

S
M

w
a

l

e
s
a
c

S
M

w
a
l
-
e
s
a
c
U
E

i

w
e
v
e
r

k
s
e
D

x 

x 

C
P
O

P

C

C

I

S
C
/
A
P

T

)
6
Q
(

I

)
7
Q
-

6
Q
(

I

,
)
5
1
Q
(

S
T

)
7
Q
-
6
Q
-
5
Q
(

I

,
)
9
3
Q

,
8
3
Q
(

S
T

)
7
Q
(

I

)
5
Q
(

I

,
)
5
3
Q
(

S
T

)
5
Q
-

4
Q
(

I

)
0
1
Q
(

I

)
7
Q
(

I

)
6
1
-
5
1
Q
A
P

,
9
Q
P
(

x

)
6
2
Q
P

,
2
2
Q
A
P

,
1
2
Q
C
(

x

)
9
1
Q
A
P

,
0
2
Q
C
(

x

)
8
Q
(

I

)
0
1
Q
-

9
Q
(

I

)
3
1
Q
-

6
Q
-

4
Q
(

I

h
o
C

e
r
e

  Q26 To what extent 
e
is the intervention 
c
n
consistent and 

JC1 The Directive is 
coherent with EU 
rules on consumer 

Analysis of the extent to which the 
Directive interacts with other EU rules 
on consumer protection in the area of 

1. Level of 
coherence (i.e. 
number of 

x   

I

)
1

1
Q
(

113 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

n
o
i
t
a
l
-
s
i
g
e

l

S
M

w
a

l

e
s
a
c

S
M

w
a
l
-
e
s
a
c
U
E

i

w
e
v
e
r

k
s
e
D

C
P
O

P

C

C

I

S
C
/
A
P

T

coherent with the EU 
rules on consumer 
protection in the 
area of contractual 
liability (for 
example, new 
Commission 
initiatives in the 
digital context)? 

protection in the area 
of contractual liability, 
in particular with 
regard to the EU 
initiatives in the 
digital content 

Q27 To what extent 
is the Directive 
coherent with wider 
EU policy, such as 
the free movement 
of goods and/or the 
protection of the 
consumers, 
including EU product 
safety? 
Q28 To what extent 
do the initial 
objectives 
correspond to the 
current needs, 

JC1 The Directive is 
coherent with EU 
policy, in particular 
the one relating to 
principle of free 
movement of goods, 
protection of the 
consumers and EU 
product safety 
policies.  
JC1 There are no 
additional needs 
besides those 
connected to the 
protection of 

e
c
n
e
r
e
h
o
C

n
a
v
e
l
e
R

e
c

contractual liability in terms of 
discrepancies, inconsistencies and 
applications, considering specifically the 
following: 
- Proposal for a Directive of the 
European Parliament and of the Council 
on certain aspects concerning contracts 
for the supply of digital content 
COM(2015) 634 final; 
- Proposal for a Directive of the 
European Parliament and of The Council 
on certain aspects concerning contracts 
for the online and other distance sales of 
goods COM(2015) 635 final; 
 - Regulation (EC) No 593/2008 of the 
European Parliament and of the Council 
of 17 June 2008 on the law applicable to 
contractual obligations (Rome I); 
- European Consumer Agenda 
Communication from the Commission to 
the European Parliament, the Council, 
the Economic And Social Committee and 
the Committee of the Regions A 
European Consumer Agenda - Boosting 
confidence and growth  
Analysis of the extent to which there are 
conflicts or gaps between the Directive 
and other EU policy, with regard to 
safety, free movement of goods and 
protection of the consumers, with 
specific reference to 2001/95 General 
Product Safety Directive, or Regulation 
765/2008 on accreditation and market 
surveillance relating to the marketing of 
products. 
Mapping of case law relating to new 
technological developments to 
understand to which extent the Directive 
applies. 
Analysis of the approximation of national 

discrepancies, 
inconsistencies, 
applications) with 
EU Rules  

1. Level of 
coherence with 
wider EU Policy  

x   

1. Proportion of 
case law relating to 
new technological 
developments on all 
case law under 

x 

x 

x 

-
0
2
Q
A
P

,
4
2
Q
C
(

x

,
1
2

)
7
2
Q
P

)
0
2
Q
(

I

)
6
1
Q
(

I

)
2
1
Q
(

I

114 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

including new needs 
created by 
innovative products? 

"consumers" and 
liability of "producers" 
for defective 
"products" 

law and case law. 
Analysis of stakeholders' perception on 
needs not covered by the Directive. 
Analysis of results from Q29, Q30, Q31, 
Q32. 

e
c
n
a
v
e
l
e
R

e
c
n
a
v
e
l
e
R

e
c
n
a
v
e
l
e
R

Q29 To what extent 
does the distinction 
between products 
and services when 
dealing with product 
liability continue to 
be apt for dealing 
with the new 
technological 
developments? 
Q30 How well 
adapted is the 
intervention to the 
changing market 
environment: often 
with a blurred 
distinction between 
private and 
professional use of 
products? 

Q31 To what extent 
are the concept of 
product, producer, 
damage or the 
category of 
exemptions as 
defined in the 
Directive adequate 
to correspond to the 
technological and 
scientific 

JC1 The distinction 
between products and 
services is still apt for 
new technological 
developments 
products 

Analysis of any difficulties encountered 
in distinguishing products from services 
due to new technological developments.  
Analysis of stakeholder perception  

JC1 The distinction 
between private and 
professional use is 
still apt to the 
changing market 
environment 

JC1 Existence of 
cases where claims 
are referred to terms 
different to the ones 
in the question 

Analysis of any difficulties encountered 
in distinguishing private and professional 
use of products, due to new 
technological developments. The 
analysis shall focus on case law and 
existing national legislation relating to 
damages caused by defects in products 
intended and used in the professional 
activity. 
Analysis of stakeholders' perception on 
the need to extend the Directive to 
professional use.  
Analysis of the extent to which the 
terms “product” (Art.2), “producer” 
(Art.3), “damage” (Art.9), “exemption of 
liability” (Art.7) of the Directive are fit 
for purpose vis-à-vis the new 
technological developments.  
Therefore it is important to understand 
whether the Directive is still apt to cover 
such developments. In order to verify it, 
desk research and stakeholders’ 
consultation shall be carried out. In 

relating to the 
Directive; 
2. Level of 
satisfaction of 
stakeholders of the 
relevance of the 
Directive; 
1. Number of cases 
ruling on the 
concept of products 
and services in the 
framework of new 
technological 
developments. 

Number of claims 
brought by 
consumers and 
professionals for 
damages caused by 
defective products. 

1. Number of case 
law references 
relating to the 
concepts in the 
question applying 
to new 
technological 
developments; 
2. Level of 
satisfaction of 
stakeholders on the 

n
o
i
t
a
l
-
s
i
g
e

l

S
M

w
a

l

e
s
a
c

S
M

w
a
l
-
e
s
a
c
U
E

i

w
e
v
e
r

k
s
e
D

C
P
O

P

C

C

I

S
C
/
A
P

T

x 

x 

x 

x 

x 

x 

x 

x 

)
8
Q
(

I

,
)
0
2
Q
(

S
T

)
5
Q
(

I

,
1
2
Q
(

S
T

)
5
1
Q

-

4
1
Q
(

I

,
)
6
Q
(

S
T

)
1
1
Q

-

7
Q
(

I

,
)
9
Q
(

S
T

)
5
Q
(

I

,
)
7
Q
(

S
T

)
5
Q
(

I

,
)
0
1
Q
(

S
T

)
6
2
Q
A
P

,
5
2
Q
C
,
0
3
Q
P
(

x

)
3
1
Q
(

)
8
1
Q
-

7
1
Q
(

I

,
)
6
2
Q

,
5
2
Q
(

S
T

I

,
)
0
4
Q

,
3
1
Q
(

S
T

)
1
1
Q
(

I

,
)
7
2
Q
(

S
T

)
8
Q
(

I

,
)
4
1
Q
(

S
T

)
6
2
Q
A
P

,
5
2
Q
C
,
0
3
Q
P
(

x

x 

x 

x 

x   

)
9
1
Q
–

8
1
Q
-
7
1
Q
(

)
3
1
Q
(

I

,
)
5
1
Q
(

S
T

I

,
)
9
2
Q

,
8
2
Q

,
6
2
Q
(

S
T

)
8
Q
(

I

,
)
3
2
Q

,
2
2
Q
(

S
T

)
5
1
Q
–

4
1
Q
(

I

,
)
8
Q
(

S
T

)
1
1
Q
(

I

,
)
1
1
Q
(

S
T

115 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

n
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developments? 

Q32 How well is the 
term ‘defective’ as 
defined in the 
Directive adapted to 
new technological or 
scientific advances 
such as apps and 
non-embedded 
software, advanced 
robots and 
autonomous/intellig
ent systems? For 
example, could 
software 
vulnerability (for 
instance, a cyber-
attack or a failure to 
update security 
software or a misuse 
of information) be 
considered as a 
defect? 
Q33 What is the EU 
added value of the 
Directive for 
stakeholders 
(manufacturers, 
including software 
developers and 
economic operators 

e
c
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v
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l
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R

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particular, the main points to take into 
consideration are: 
1. The importance of the role played by 
the individuals who are involved in trade 
chain;  
2. Uncertainties with the new 
technological developments;  
3. Existence of different kinds of damage 
caused by new technological 
developments. 
Analysis of cases relating to new 
technological developments where it was 
difficult to apply the term defective. 
Analysis of the perception of 
stakeholders on the difficulties to apply 
the term “defect” in case of specific new 
technological development. 

adequacy of the 
definitions 

1. Number of case 
law references 
relating to defects 
of new 
technological 
developments 
products  
2. Level of 
adequacy  

JC1 There are cases 
relating to new 
technological 
developments where 
it was difficult to 
apply the term 
defective 

x 

x 

x   

)
8
1
Q
(

S
T

)
0
2
Q

,
2
Q
(

S
T

)
2
1
Q
(

S
T

JC1 The objectives of 
the Directive could 
not be reached only 
with national 
legislation 

Analysis of the extent to which 
stakeholders consider that the Directive 
generates an EU added value for them, 
with particular focus on the new 
technological developments. 

1. Rating based on 
stakeholders’ 
perception 

,
6
2
-
4
2
Q
C
(

x

-
0
2
Q
A
P

,
7
2
Q
P

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1
2

)
4
3
Q

I

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)
5
2
Q
(

S
T

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3
2
Q
-

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0
3
Q

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4
2
Q

,
3
2
Q
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S
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,
4
2
Q

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1
2
Q
(

S
T

)
0
1
Q
(

S
T

)
6
Q

,
8
Q
(

S
T

116 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

n
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in the DSM, and 
consumers)? 
Q34 To what extent 
does the issue of 
strict liability, as 
addressed by the 
Directive continue to 
require action at EU 
level? 

JC1 The issue of 
strict liability 
continues to require 
action at EU level 

Q35 What would be 
the most likely 
consequences of 
reducing the scope 
of the existing EU 
intervention? 

JC1 Effects derive in 
case of reducing the 
scope of the Directive 

Q36 What would be 
the most likely 
consequences of 
repealing the 
Directive? 

JC1 Effects derive in 
case of repealing the 
Directive 

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x 

x 

x 

x   

x 

x   

x 

x   

Analysis of the extent to which the rule 
of strict liability on the producer in case 
of damages caused by a defective 
product is harmonised and MS may not 
adopt legislation jeopardising the 
application of the principle.  
Analysis of the extent to which national 
legislation of different MS interferes, 
overlaps and/or conflicts with the 
Directive, so as to require the 
intervention of the European institutions 
-i.e. European Court of Justice, with 
specific reference to  
i)contractual law, 
ii) extra-contractual based on fault on 
the producer 
Analysis of the extent to which reducing 
the scope of the Directive has impacts 
on the uniformity of legislation of MS, 
with regard to: 
1. the free movement of goods in terms 
of intra EU trade; 
2. different protection of injured persons 
according to national liability rules; 
3. liability of producers for damages 
caused by defective products. 
Analysis of the extent to which repealing 
the Directive has impacts on the 
uniformity of legislation of MS, with 
regard to benefits and obstacles that 
would arise in absence of the Directive, 
with regard to: 
1. the free movement of goods in terms 
of intra EU trade; 
2. differentiation of protection of 
consumers and other clients according 
to national rules on liability for damage; 
3. liability of producers for damages 

1. Number of cases 
for (contractual, 
fault and non-strict) 
liability of defective 
products 
2. Level of 
approximation of 
practices among MS 

1. Level of 
harmonisation of 
MS national 
legislation 
2. Rating based on 
stakeholders 
perception  

1. Level of 
uniformity of MS 
national legislation 
on civil liability for 
damages caused by 
defective products 
2. Rating on 
possible 
asymmetries across 
MS based on 
stakeholders' 
perception 

)
4
3
Q

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3
3
Q

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1
3
Q

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0
3
Q

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4
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Q
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7
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9
1
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3
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8
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117 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Question 

Judgment Criteria 

Analytical framework 

Indicators 

JC1 Opportunity to 
enlarge the scope of 
the Directive so as to 
cover, for instance, 
services 

caused by defective products. 
Analysis of the extent to which it would 
be appropriate to enlarge the scope of 
the Directive, in light of the spread of 
services and new technological 
developments, taking into account the 
EU safety rules. 

Q37 According to 
the case-law and the 
experience on the 
application of the 
Directive, could it be 
considered 
appropriate to 
enlarge the scope of 
the Directive, for 
instance so as to 
cover the services? 

e
u
l
a
V
d
e
d
d
A
U
E

1. Percentage of 
cases for producers' 
liability relating to 
new technological 
developments 
and/or services that 
are settled without 
application of the 
Directive 
2. Rating based on 
stakeholders' 
perception 

n
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-
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x 

x 

x 

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3
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7
2
Q
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6
2
Q
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6
2
Q

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9
2
Q

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8
2
Q
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2
Q
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7
3
Q

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7
3
Q

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6
3
Q
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Q

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5
3
Q

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4
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Q

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3
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Q
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1
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5
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1
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4
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3
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1
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118 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Annex 3 

Synopsis report 

1.  Introduction 

Directive  85/374/EEC  on  the  approximation  of  laws,  regulations  and  administrative 
provisions  of  the  Member  States  concerning  liability  for  defective  products  (the 
“Directive”)  aims  at  guaranteeing  the  protection  of  consumers’  health  and  property, 
the free movement of goods and undistorted competition among market operators in 
the Single Market. 

The Commission launched an evaluation to judge if the Directive meets its objectives 
and is fit for purpose vis-à-vis the new technological developments such as Internet of 
Things  or  autonomous  systems.  A  stakeholder  consultation  was  part  of  this 
evaluation. 

2.  Objectives of the consultation 

The  consultation  strategy  aimed  at  gathering  information  from  stakeholders  to  feed 
the  assessment  of  its  effectiveness,  efficiency,  relevance,  coherence  and  EU  added 
value. 

Relevant  stakeholders  include  producers,  importers,  suppliers  and  their  industry 
associations,  consumers  and  consumer  organisations,  insurers  and  federations  of 
insurers,  technical  experts,  and  public  authorities  and  civil  society  (e.g.  think-tanks, 
experts, law firms/legal experts).  

This document presents an overview of the consultation activities and their results. 

3.  Consultation methods and tools 

Overall, 657 stakeholders from all Member States (except for Latvia, Portugal, and 
Slovenia)  and  all  target  groups  (except  for  technical  experts)  contributed  to  the 
consultation. 

3.1.  Public Consultation 

An  open  public  consultation  was  launched  (10  January  –  26  April  2017)  in  23 
European  Union  languages,  consisting  of  three  online  questionnaires  addressed  to 
producers; consumers; public authorities and civil society representatives. 

113 stakeholders (40 producers, 48 consumers and 23 public authorities/civil society) 
from 16 Member States341 replied. 14 position papers were shared by consumers (1), 
business associations (9) and public authorities/civil society representatives (4).  

3.2.  Surveys 

A  targeted  survey  (3  April  –  20  May  2017)  was  carried  out  through  five 
questionnaires in English addressed to: 

  Producers and suppliers and related industry associations (4 responses); 

  Consumer associations (11); 

341 All except DK, EE, EL, HR, CY, LV, LU, HU, PL, PT, SI, SE. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 

Insurers and related associations (0); 

  Public authorities and civil society representatives (11); 

  Technical experts active in courts (0). 

Responses came from 14 Member States.342 

A Computer-assisted telephone (CATI) survey (29 May – 14 June 2017) covering 
11  Member  States343  was  addressed  to  producers,  importers,  and  suppliers.  457 
producers responded.344 

61  interviews  (3  May  –  end  of  July  2017)  were  held  with  stakeholders  with 
experience  with  the  Directive  (17  producers,  11  consumers,  9  insurers,  24  public 
authorities and civil society representatives).345 

The surveys encountered some limitations: 

 

Low  level  of  participation  in  the  targeted  survey:  more  than  400  stakeholders 
were contacted, but only 26 replied. 

  No representative from technical experts replied. 

3.3. Conference on the Evaluation of the Product Liability Directive 

The European Commission held a Conference on the evaluation of the Product Liability 
Directive346  in  Brussels  on  20  October  2017,  addressed  to  Member  State's 
representatives  and  different  categories  of  stakeholders  and  aimed  at  exchanging 
views on the preliminary results of the external study on the evaluation. 

4.  Main results of the consultation activities 

Several  stakeholders  had  experience  with  the  Directive.  Most  businesses  dealt  with 
claims brought by injured persons and paid for insurance; consumer associations were 
familiar  with  claims  by  injured  persons;  insurers  provided  specific  insurance  policies 
and paid compensations; public authorities and civil society representatives dealt with 
the needs of specific stakeholder categories, acted in litigation or carried out research 
on the Directive.  

4.1  Effectiveness 

The  consultation  aimed  at  understanding  whether  and  to  what  extent  the  Directive’s 
objectives  in  terms  of  protection  of  consumers,  undistorted  competition  and  free 
movement of goods have been achieved so far at both national and EU levels. 

Most  stakeholders  are  aware  of  the  Directive.  For  most  public  authorities  and  civil 
society representatives, the Directive is effective as consumers benefit from the strict 
liability of producers, and consumers’ and producers’ interests are fairly balanced. For 
these reasons, they also believe that the system of strict liability must be maintained. 

342 BE, BG, DK, EL, ES, FR, IT, LT, LU, MT, NL, SI, FI, UK.  
343  CZ, DE, ES, FR, IT, LT, NL, AT, PL, SE, UK. 
344 From CZ, DE, ES, FR, IT, LT, NL, AT, PL, SE, UK.  
345 From BE, DK, DE, EE, ES, FR, HR, IT, CY, LU, HU, MT, NL, FI, UK. 
346 See minutes of the Product Liability Conference at  https://ec.europa.eu/docsroom/documents/26661: 

120 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Most  producers  deem  the  Directive  to  be  effective,  as  it  creates  a  level  playing  field 
across  Europe  by  setting  the  same  liability  rules  in  all  Member  States  and  balances 
consumers’  and  producers’  interests,  setting  clear  rules  regardless  of  the  product 
type. 

Finally,  for  insurers  the  Directive  is  effective  overall,  as  it  balances  consumers’  and 
producers’ interests. 

However,  for  most  consumer  associations  the  Directive  is  not  fully  effective,  as  it 
protects producers’ interests more than those of consumers. 

In particular, some provisions of the Directive are seen as more effective than others: 

  Products, not services 

For some of the stakeholders (both producers and consumers) the distinction between 
products  and  services  is  not  clear  anymore  and  the  Directive  should  also  cover  the 
damages  caused  by  services;  other  producers  believe  that  the  Directive  should  not 
cover these damages. 

For more than half of the public authorities and civil society representatives consulted, 
the  distinction  between  products  and  services  is  not  adequate  and  the  Directive’s 
scope should be extended to services. 

The  vast  majority  of  consumers  and  their  associations  underline  that  it  may  be 
difficult  to  distinguish  a  product  from  a  service,  as  they  are  often  bundled  together, 
and they would favour a regime covering both products and services. 

On  the  contrary,  for  more  than  half  of  the  businesses,  the  distinction  between 
products  and  services  is  adequate  and  there  is  no  need  to  extend  the  Directive  to 
services. 

  What about new technological developments? 

The  application  of  the  Directive  to  new  technological  developments  is  not 
straightforward.   

The  feedback  from  stakeholders  on  new  technological  developments  is  quite 
divergent:  for  some  stakeholders  (including  many  producers,  some  consumers, 
insurers and public authorities/civil society representatives) there is no need to update 
the  Directive  vis-à-vis  new  technological  developments.  Others  from  all  consulted 
categories find  it difficult to apply the Directive to these items, given their  intangible 
nature and increasing complexity. 

More  specifically,  for  almost  half  of  the  public  authorities  and  civil  society 
representatives  and  almost  all  consumers,  the  scope  of  the  Directive  should  be 
broadened  to  new  technological  developments  and  balance  consumers’  safety  and 
innovation, considering the distinction between products and services and the concept 
of “defect” as not adequate for these developments.  

Most  businesses  consider  apps,  non-embedded  software  and  IoT  components  to  be 
“products”  pursuant  to  the  Directive,  while  they  have  diverging  views  as  to  whether 
the  liability  is  adequately  allocated  among  the  different  operators.  Furthermore,  for 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

them defect is adequately defined as to damages caused by an advanced robot or an 
autonomous system.  

For  a  large  majority  of  businesses  the  exemptions  under  the  Directive  are  adequate 
for  new  technological  developments  and  the  Directive  already  applies  to  them;  they 
consider the Directive to be fit-for-purpose and neutral to different technologies. 

Similarly,  for  a  large  majority  of  insurer  associations  there  is  no  need  to  adapt  the 
Directive to new technological developments. 

  Burden of proof 

For a large majority of public authorities and civil society representatives the proof of 
defect and of the link between it and the damage is burdensome to consumers. 

Almost  all  consumer  associations  see  this  burden  as  the  most  frequent  obstacle  to 
obtaining  compensation,  especially  with  regard  to  new  technological  developments 
and increasing product complexity. 

However, only a few insurers view the burden of proof as onerous in practice. 

Most  businesses  think  that  removing  this  burden  would  be  disadvantageous:  indeed, 
the  burden  of  proof  upon  the  injured  person  is  essential  as  a  basis  for  the  claim; 
removing it would make the Directive unfair. 

  Damages to property 

For  a  slight  majority  of  public  authorities  and  civil  society  representatives,  the  €500 
threshold  should  be  removed  to  allow  compensation  of  smaller  damages.  Also,  the 
majority  of  consumer  associations  would  lower  the  threshold,  as  the  price  of  many 
products has decreased over the years.  

While  most  businesses  do  not  favour  a  modification  of  the  threshold,  a  significant 
share of small firms (24%) favour decreasing the threshold. 

For  the  majority  of  stakeholders,  except  for  insurers,  it  is  difficult  to  apply  the 
condition that the  item of property  is of a type ordinarily  intended for private use or 
consumption  and  was  used  by  the  injured  person  mainly  for  his  own  private  use  or 
consumption; they believe it should be removed. 

For half the public authorities and civil society representatives this provision should be 
removed,  as  it  is  increasingly  difficult  to  distinguish  when  an  item  of  property  is 
intended for professional or private use. 

Most businesses (63%) and more than half of the consumer associations consider the 
distinction between private and professional use as not adequate, since products can 
have both uses, and the removal of such distinction would not cause any problems. 

Almost  all  insurers  associations  consider  the  distinction  between  private  and 
professional use of products as clear enough and no change is needed. 

The  Conference  on  Product  Liability  gave  the  opportunity  to  further  elaborate  on  the 
views  obtained  through  the  use  of  other  consultation  tools.  On  effectiveness  of  the 
Directive,  the  majority  of  manufacturers  and  insurers  considered  that  the  Directive 
meets  its  objectives  and  that  it  is  future-proof  for  the  new  technological 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

developments.  In  their  opinion,  any  revision  at  this  stage  would  be  premature. 
However,  consumers  were  in  favour  of  a  revision  of  the  Directive  with  a  view  to 
facilitate the compensation of the injured party. 

4.2  Efficiency 

The consultation focused on the balance between the costs borne by the producers to 
cover the strict liability and the burdens on the injured party to obtain compensation, 
as well as on aspects making it more or less efficient in ensuring strict liability of the 
producer. 

Data on costs and benefits were expected from the targeted survey: however, the low 
rate  of  response  hampered  proper  quantification.  Data  retrieved  from  the  other 
consultation activities allowed carrying out only a qualitative analysis. 

In  particular,  for  more  than  half  of  the  businesses,  costs  and  benefits  deriving  from 
the Directive are well balanced. 

Yet more than two-thirds of consumer associations see costs as higher for consumers: 
proving the defect and its link to the damage is burdensome due to increasing product 
complexity. For almost half of the insurers, the burden of proof can be difficult to fulfil 
in practice. 

As  a  third  point  of  view,  for  two  thirds  of  the  public  authorities  and  civil  society 
representatives, although costs relating to the Directive are acceptable for traditional 
products, the new technological developments could bring new costs for producers to 
comply with it. 

4.3  Coherence 

The consultation focused also on questions relating to the coherence, complementarity 
and  consistency  between  the  Directive  and  other  Union  actions,  in  particular  product 
safety legislation and consumer protection.  

The Conference on Product Liability was the occasion for the stakeholders to confirm 
that the Directive is perceived as coherent and consistent with the EU product safety 
legislation  and  with  the  rules  on  consumer  protection.  It  was  recalled  that  products 
placed  on  the  European  market  must  comply  with  EU  safety  legislation.  In  case  that 
they  caused  damages  due  to  a  defect,  consumers  can  bring  legal  action  against  the 
producer  in  the  context  of  the  Directive  (extra-contractual  liability)  but  also  against 
the seller according to the contractual liability rules. 

4.4  Relevance 

The  consultation  activities  aimed  at  understanding  whether  the  initial  needs  still 
correspond  to  current  needs,  including  needs  created  by  innovative  products.  They 
also  aimed  at  investigating  whether  the  definitions  of  product,  producer,  defect  and 
damage or the exemptions under the Directive are adequate to the technological and 
scientific developments. 

Outcomes are quite fragmented: for most stakeholders there is a need to update the 
Directive  vis-à-vis  new  technological  developments,  even  though  they  have  not 
experienced any issues in applying the Directive. 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Overall,  for  the  majority  of  public  authorities  and  civil  society  representatives  the 
Directive is future-proof, and the harmonisation it brought across the EU confirms its 
current relevance; however, they suggest a revision of the Directive in relation to new 
technological  developments.  For  the  vast  majority  of  businesses  the  Directive  is 
future-proof and relevant due to the harmonisation it brought. 

For the vast majority of consumer associations the Directive has  harmonised product 
liability rules. However, they favour a revision of the Directive to take into account the 
new  technological  developments,  as  do  public  authorities  and  civil  society 
representatives,  because  of  the  lower  relevance  of  the  Directive  vis-à-vis  the  new 
needs  and  the  limited  applicability  of  the  concepts  of  the  Directive  to  new 
technological developments. 

4.5  EU added value 

The  consultation  aimed  at  gathering  feedback  on  whether  strict  liability  continues  to 
require  action  at  the  EU  level.  Moreover,  the  consultation  focused  on  understanding 
the most likely consequences in case of scope reduction or repeal of the Directive or 
extension of its scope. 

Overall,  all  stakeholders  acknowledge  the  EU  added  value  of  the  Directive  and  no 
stakeholder suggested to repeal it. 

A  majority  of  businesses  agree  that  the  level  playing  field  achieved  would  not  be 
possible  with  individual  Member  States  action.  In  addition,  for  almost  all  consumer 
associations  the  protection  of  consumers  achieved  would  not  be  feasible  with  only 
national action. 

The vast majority of public authorities and civil society representatives deem that the 
Directive added value to the EU legal framework and policies. 

The Conference on Product Liability confirmed the positions defended by the different 
categories  of  stakeholders.  In  addition,  many  participants  emphasised:  (i)  the  link 
between  product  safety  and  product  liability  rules,  (ii)  the  difficulty  for  victims  of 
undesirable effects of pharmaceutical products to prove the defect and the casual link 
between defect and damage in order to get compensation, (iii) the lack of evidence on 
the  application  of  the  Directive  to  the  new  technological  developments,  and  (iv)  the 
need to maintain a fair balance between the interests of the parties.. 

5.   Main conclusions  

Consultation  activities  allowed  to  gather  a  wide  range  of  views  on  the  Directive  in 
terms of what has worked well and what has not worked so well so far, as well as on 
expectations for the future.  

Overall  the  Directive  was  viewed  as  being  generally  effective  in  achieving  its 
objectives by public authorities, civil society, businesses and insurers representatives, 
though consumer organisations were more critical especially on obstacles to obtaining 
compensation. 

Most stakeholder categories recognised the efficiency of the Directive. In particular, 
all  categories,  except  for  consumer  associations,  think  the  costs  and  benefits  due  to 
the Directive for consumers and producers are balanced. 

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The  Directive  is  seen  as  coherent  with  the  EU  legislation  protecting  consumers, 
relevant  and  future-proof.  Nonetheless,  representatives  from  public  authorities, 
civil society and consumer associations agree there are issues not adequately covered 
by the Directive with regard to new technological developments, while businesses are 
more reluctant to amending the Directive. 

There  was  a  large  consensus  among  stakeholders  that  the  Directive  has  EU  added 
value. 

The Conference gave the opportunity to confirm the need to pursue the  reflection on 
the future of the Directive in order to ensure legal certainty, in particular in relation to 
its  application  to  new  technologies,  such  as  Artificial  Intelligence  systems  and 
advanced robots 

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Annex 4 

Targeted survey questionnaire 

As  discussed  in  section  3.3.2,  the  targeted  survey  consisted  of  five  questionnaires,  one  for 
each of the following categories of stakeholders: 

  Producers, distributors, retailers and related industry associations; 

  Consumer associations; 

 

Insurers and related associations; 

  Public Authorities and civil society representatives (e.g. think-tanks, experts, law firms); 

  Technical legal experts active in Courts. 

The  questions  were  customised  taking  into  account  the  different  levels  of  stakeholders’ 
engagement  and  experience  with  the  Directive.  The  questionnaires  consisted  mainly  of 
closed  questions  (i.e.  multiple  choice,  yes/no),  though  some  open-ended  questions  allowed 
participants  to  contribute  with  more  detailed  views,  opinions  or  advice.  Moreover,  each 
survey  had  a  “tree”  structure,  so  that  each  respondent  was  asked  only  questions  really 
relevant  to  his/her  own  experience.  The  questions  and  structure  of  the  questionnaires  have 
been  developed  in  close  collaboration  with  the  Steering  Group.  The  questionnaires  were 
piloted  with  one  representative  from  Insurance  Europe,  the  only  one  out  of  15  stakeholders 
contacted  for  the  pilot,  replying  in  the  time  given.  Finally,  the  questionnaires  have  been 
drafted  in  English,  although  stakeholders  were  allowed  to  submit  their  answers  in  any  EU 
languages, to ensure higher response rates.  

The following table presents the targeted survey questionnaires. 

Introduction:  This  targeted  survey  concerns  the  application  of  Directive  85/374/EEC  (as  modified 
by Directive 1999/34/EC) on liability for defective products (hereinafter the “Directive”). 

This survey is aimed at collecting information from various stakeholders, including businesses, insurance 
companies, consumer organisations, legal experts and technical experts acting in court, public authorities 
and  members  of  the  academic  community,  on  their  experiences  relating  to  the  application  of  the 
Directive,  also  in  light  of  new  technological  developments,  with  particular  focus  to  years  from  2010 
onward. 

The results of this survey will feed the evaluation study whose objectives are to analyse the effectiveness 
and efficiency of the Directive, as well as its coherence with other relevant EU initiatives, its relevance to 
stakeholders' needs and its added value. It will also assess if the Directive is fit for purpose with respect 
to new technological developments. For this reason, any input you may provide will be of a great value to 
us and we strongly encourage you to participate in light of the opportunity this represents for expressing 
your organisation’s view on the Directive. 

Replies  can  be  submitted  in  any  of  the  European  Union  official  languages.  Any  other  comment  or 
information is welcome, in particular other documents, reports, studies, etc. which may be relevant. The 
deadline  for  replies  is  21  April.  In  case  of  technical  issues  with  the  consultation  questionnaire,  please 
contact: survey.law@it.ey.com. 

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Background information 
The  Directive  provides  for  an  enhanced  protection  from  damages  caused  by  defective  products  to 
consumers, establishing the strict liability of producers (i.e. regardless the proof of their negligence or 
fraud).  The  injured  party  carries  the  burden  of  proof  of  the  defect,  of  the  damage  and  of  the  causal 
link  between  damage  and  defect.  The  Directive  also  provides  for  exemptions  from  strict  liability,  for 
instance in cases where the producer proves that he did not put the product into circulation or that the 
state of scientific and technical knowledge at the time when the product was put into circulation was 
insufficient  to  identify  the  defect.  Furthermore,  the  compensation  to  be  provided  by  producers  is 
limited  to  damage  to  property,  other  than  the  defective  product  itself,  exceeding  €500.  Similarly, 
liability for damage resulting from death or personal injury shall be limited to €70 million. However, no 
contractual  clause  may  allow  the  producer  to  limit  his  liability  to  the  injured  person,  who  has  three 
years to seek compensation, while the producer is no longer liable 10 years after the date the product 
was put into circulation. The Directive applies to any product marketed, including primary agricultural 
products and electricity, while it does not apply to services. However, there may be grey areas where 
its application can raise doubts: e.g. whether some new technological developments (such as apps and 
non-embedded  software)  are  products  within  the  meaning  of  the  Directive;  similarly,  robotics  and 
robotic  tools  raise  challenges  relating  to  the  building  of  a  data  economy  (Communication  from  the 
Commission on "Building A European Data Economy" {SWD(2017) 2 final}). 

a)  Name 

the 
Institution/organisation  your 
represent 

of 

b)  Location  of  the  institution/ 
organisation you work for 

c)  Please  select  your  relevant 
product  sector(s)  [only  for 
producers] 

d)  Please 

select 

the 
geographical area covered by 
your organisation 

[text] 

[single choice] [Belgium, Bulgaria, Czech Republic, Denmark, Germany, 
Estonia,  Ireland, Greece,  Spain, France, Croatia,  Italy,  Cyprus,  Latvia, 
Lithuania,  Luxemburg,  Hungary,  Malta,  Netherlands,  Austria,  Poland, 
Portugal,  Romania,  Slovenia,  Slovakia,  Finland,  Sweden,  United 
Kingdom, Other Country (please specify)] 

[multiple choice] [Agricultural products (primary products that have not 
undergone  initial  processing),  Products  of  the  soil,  Farming,  Fisheries, 
Game,  Cableways,  Chemical  substances,  Construction  products, 
Cosmetics,  Electricity,  Electrical  appliances  and  equipment,  Electronic 
communications,  Energy,  Explosives  for  civil  uses,  Gas  appliances, 
Lifts,  Machinery,  Marine  equipment,  Measuring  instruments,  Medical 
devices,  Motor  vehicles,  Noise  emissions  for  outdoor  equipment, 
Pharmaceutical  products,  Personal  protective  equipment,  Pressure 
equipment,  Pre-packaged  products,  Pyrotechnics,  Radio  and 
telecommunications  equipment,  Recreational  craft,  Robotics,  Smart 
devices,  Telecommunications,  Textile  and  Footwear,  Toys,  Software, 
Software  embedded  in  products,  Products  on  which  software  and 
applications from different sources can be installed after purchase and 
apps  and  other  non-embedded  software,  Products  connected  to  and 
through  the  Internet  (Internet  of  Things),  Products  shared  with  other 
users through collaborative platforms, Devices for 3D printing/additive 
manufacturing and products manufactured with them, Advanced robots 
and  autonomous  systems  empowered  by  artificial  intelligence,  i.e. 
physical  machines  perceiving  their  environment  processing  this 
information  correctly  and  then  carrying  out  a  complex  and  adequate 
actions  autonomously,  e.g.  advanced  driver  assistance  systems  or 
completely  self-driving  cars,  these  systems  can  also  learn  from  their 
actions  Software  –based  systems  empowered  by  artificial  intelligence, 
i.e.  software  processing 
information  correctly  and  then  acting 
appropriately,  e.g.  autonomous  trading  algorithms  or  any  other  big 
data algorithms + “other, please specify”] 

[multiple  choice]  [regional  level/  national  level  /  EU-EEA  level  / 
international level] 

PRODUCERS 

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1.  Is your organisation a Small-Medium Enterprise (i.e. employing less than 250 persons)? [yes/no] 
2.  Please  indicate  the  type  of  insurance  contract  your  organisation  has  to  cover  compensation 
costs in case of defective products [list with options 1. Specific insurance contract for strict liability 
2. General insurance contract covering different risks 3. No insurance contract] 

3.  Do  you  have  any  specific  insurance  for  products  relating  to  new  technological 
developments,  such  as  software  embedded  in  products,  products  on  which  software  and 
applications  from  different  sources  can  be  installed  after  purchase  such  as  apps  and  other  non-
embedded software, products connected to and through the Internet (Internet of Things), products 
shared  with  other  users  through  collaborative  platforms,  devices  for  3D  printing/additive 
manufacturing and products manufactured with them, advanced robots and autonomous systems 
empowered by artificial intelligence, software–based systems empowered by artificial intelligence? 
[yes/no/I do not know/my organisation does not deal with any of these product sectors] 

4.  [if yes] Could you please explain why? [text] 
5.  Have  the  costs  you  bear  relating  to  strict  liability347  changed  since  2000  (i.e.  after  the 
Directive entered into force)?  [yes they increased/yes, they decreased/no, they remained equal/I 
do not know] 

6.  Have the costs you bear relating to strict liability changed, particularly in the last five years 
due  to  new  technological  developments?  [yes  they  increased/yes,  they  decreased/no,  they 
remained equal/I do not know] 

7.  [only  for  those  who  have  answered  to  have  an  insurance  under  Q2  ]  Did  you  experience  any 
changes in insurance costs in the last five years due to new technological developments?  [yes 
they increased/ yes, they decreased/no, they remained equal/I do not know] 

8.  Are  the  benefits  provided  by  the  Directive  (e.g.  exemptions  from  strict  liability,  10-year  expiry 

period and lower and upper limit thresholds) useful? [yes/no/I do not know] 

9.  If yes, why? If not, what should be changed? [text] 
10. The  costs  (e.g.  for  compensation,  judicial  trials,  insurance)  and  benefits  (e.g.  limit  threshold) 
entailed  by  the  Directive  are  well-balanced  [options:  strongly  agree,  agree,  disagree,  strongly 
disagree] 

11. Do you perceive that the tendency to report claims for damages caused by defective products 
has changed since the entry into force of the Directive? [yes, it increased/yes, it decreased/no, it 
remained unchanged/I do not know] 

12. Have  you  ever  received  a  claim  relating  to  “traditional”  products  (i.e.  not  linked  with  new 
technological  developments)  have  you  received  over  the  period  2000-2016?  (please  indicate  the 
number of claims received, where 0 = no claim received) [number] 

13. [only  for  those  who  answered  to  have  received  a  claim  under  Q12]  How  many  of  these  cases 

decided in court were in your favour?  
[list with options] 
0% 
a) 
Less than 25% 
b) 
Between 26 and 50% 
c) 
d) 
Between 51 and 75% 
e)  More than 76% 
f) 
g) 

100% 
I do not know 

14. [only for n>0 under Q12] Please describe the most significant (in monetary terms) claim you have 

received: 
a) 
b) 

The issue at stake [text] 
The product [multiple choice] [Agricultural products (primary products that have not 
undergone initial processing), Products of the soil, Farming, Fisheries, Game, Cableways, 
Chemical substances, Construction products, Cosmetics, Electricity, Electrical appliances and 
equipment, Electronic communications, Energy, Explosives for civil uses, Gas appliances, 
Lifts, Machinery, Marine equipment, Measuring instruments, Medical devices, Motor vehicles, 
Noise emissions for outdoor equipment, Pharmaceutical products, Personal protective 
equipment, Pressure equipment, Pre-packaged products, Pyrotechnics, Radio and 
telecommunications equipment, Recreational craft, Telecommunications, Textile and 

347  “strict  liability”  within  the  meaning  of  the  Directive  is  liability  without  fault,  where,  based  on  Art.  4,  the  injured 
person shall be required to prove the damage, the defect and the causal relationship between defect and damage 

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Footwear, Toys] 

c)  Was it sold in bundle with a service? [yes/no/I do not know] 
d) 

The context [multiple choice] [household/ sport, leisure, other social activity/ professional 
activity/medical/ other (please specify)]  
The defect [text] 

e) 
f)  Was it easy to discover the root of the problem? [yes/no/I do not know] 
g) 
h)  Whether liability was difficult to allocate among the players (other producer, software 

The damage [multiple choice] [Physical well-being/ property damage/ other (please specify)] 

developer, network provider…) [yes/no/I do not know] 
If yes could you please explain why? [text] 

i) 
j)  Whether you were able to exempt your liability and, if yes, how. [text] 

15. [if yes] Was the claim settled in court or out of court? [in court / out of court/I do not know] 
16. [if out of court] Was it settled with an alternative dispute resolution (alternative dispute resolution) 
method  (e.g.  mediation)  or  by  direct  negotiation  between  the  parties?  [alternative  dispute 
resolution / negotiation/ I do not know] 

17. Have  you  ever  received  a  claim  relating  to  new  technological  developments,  such  as  software 
embedded in products, products on which software and applications from different sources can be 
installed  after  purchase  such  as  apps  and  other  non-embedded  software  in  the  last  five  years? 
(please indicate the number of claims received, where 0=no claim received) [number] 

18. [only  for  those  who  answered  to  have  received  a  claim  under  Q16]  How  many  of  these  cases 

0% 
Less than 25% 
Between 26 and 50% 
Between 51 and 75% 

decided in court were in your favour? [list with options] 
a) 
b) 
c) 
d) 
e)  More than 76% 
f) 
g) 

100% 
I do not know 

19. [only  for  those  who  answered  to  have  received  a  claim  under  Q16]  Please  describe  the  most 
significant  claim  (in  monetary  terms)  you  have  received  relating  to  new  technological 
developments,  such  as  software  embedded  in  products,  products  on  which  software  and 
applications  from  different  sources  can  be  installed  after  purchase  such  as  apps  and  other  non-
embedded software: 
a) 
b) 

The issue at stake [text] 
The product [multiple choice] [software embedded in products/ products on which software 
and applications from different sources can be installed after purchase such as apps and 
other non-embedded software] 

c)  Was it sold in bundle with a service? [yes/no/I do not know] 
d) 

The context [multiple choice] [household/ sport, leisure, other social activity/ professional 
activity/medical/ other (please specify)]  
The defect [text] 

e) 
f)  Was it easy to discover the root of the problem? [yes/no/I do not know] 
g) 
h)  Whether liability was difficult to allocate among the players (other producer, software 

The damage [multiple choice] [Physical well-being/ property damage/ other (please specify)] 

developer, network provider…) [yes/no/I do not know] 
If yes could you please explain why? [text] 

i) 
j)  Whether you were able to exempt your liability and, if yes, how. [text] 

20. [if yes] Was the claim settled in court or out of court? [in court / out of court/I do not know] 
21. [if out of court] Was it settled with an alternative dispute resolution (alternative dispute resolution) 
method  (e.g.  mediation)  or  by  direct  negotiation  between  the  parties?  [alternative  dispute 
resolutionADR / negotiation/ I do not know] 

22. Have  you  ever  received  a  claim  relating  to  devices  for  3D  printing/additive  manufacturing  and 
products  manufactured  with  them,  advanced  robots  and  autonomous  systems  empowered  by 
artificial  intelligence,  software–based  systems  empowered  by  artificial  intelligence  in  the  last  five 
years? [number] 

23. [only  for  those  who  answered  to  have  received  a  claim  under  Q22]  How  many  of  these  cases 

decided in court were in your favour? [list with options] 
a) 
b) 

0% 
Less than 25% 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Between 26 and 50% 
Between 51 and 75% 

c) 
d) 
e)  More than 76% 
f) 
g) 

100% 
I do not know 

24. [only  for  those  who  answered  to  have  received  a  claim  under  Q22]  Please  describe  the  most 

significant claim (in monetary terms) you have received: 
a) 
b) 

The issue at stake [text] 
The product [multiple choice] [devices for 3D printing/additive manufacturing and products 
manufactured with them/ Robotics/ Smart devices/ advanced robots and autonomous 
systems empowered by artificial intelligence/ software–based systems empowered by 
artificial intelligence] 

c)  Was it sold in bundle with a service? [yes/no/I do not know] 
d) 

The context [multiple choice] [household/ sport, leisure, other social activity/ professional 
activity/medical/ other (please specify)]  
The defect [text] 

e) 
f)  Was it easy to discover the root of the problem? [yes/no] 
g) 
h)  Whether liability was difficult to allocate among the players (other producer, software 

The damage [multiple choice] [Physical well-being/ property damage/ other (please specify)] 

developer, network provider…) [yes/no] 
If yes could you please explain why? [text] 

i) 
j)  Whether you were able to exempt your liability and, if yes, how. [text] 

25. [if yes] Was the claim settled in court or out of court? [in court / out of court/ I do not know] 
26. [if out of court] Was it settled with an alternative dispute resolution (alternative dispute resolution) 
method  (e.g.  mediation)  or  by  negotiation?  [alternative  dispute  resolution/  negotiation/  I  do  not 
know] 

27. Have  you  ever  received  a  claim  relating  to  products  connected  to  and  through  the  Internet 
(Internet of Things),  products shared with other  users  through collaborative platforms  in the  last 
five years? [number] 

28. [only  for  those  who  answered  to  have  received  a  claim  under  Q27]  How  many  of  these  cases 

0% 
Less than 25% 
Between 26 and 50% 
Between 51 and 75% 

decided in court were in your favour? [list with options] 
a) 
b) 
c) 
d) 
e)  More than 76% 
f) 
g) 

100% 
I do not know 

29. [only  for  those  who  answered  to  have  received  a  claim  under  Q27]  Please  describe  the  most 
significant  claim  (in  monetary  terms)  you  have  received  relating  to  products  connected  to  and 
through the Internet (Internet of Things), products shared with other users through collaborative 
platforms: 
a) 
b) 

The issue at stake [text] 
The product [multiple choice] [product connected to and through the Internet (Internet of 
Things)/ products shared with other users through collaborative platforms] 

c)  Was it sold in bundle with a service? [yes/no/I do not know] 
d) 

The context [multiple choice] [household/ sport, leisure, other social activity/ professional 
activity/medical/ other (please specify)]  
The defect [text] 

e) 
f)  Was it easy to discover the root of the problem? [yes/no] 
g) 
h)  Whether liability was difficult to allocate among the players (other producer, software 

The damage [multiple choice] [Physical well-being/ property damage/ other (please specify)] 

developer, network provider…) [yes/no] 
If yes could you please explain why? [text] 

i) 
j)  Whether you were able to exempt your liability and, if yes, how. [text] 

30. [if yes] Was the claim settled in court or out of court? [in court / out of court/ I do not know] 

31. [if out of court] Was it settled with an alternative dispute resolution (alternative dispute resolution) 
method (e.g. mediation) or by negotiation? [alternative dispute resolution / negotiation / I do not 
know] 

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32. Based  on  your  experience,  is  the  Directive  adequate  to  cover  strict  liability  relating  to defective 
products, as these are described as movables, even if incorporated into another movable or into an 
immovable, including electricity? [options: strongly agree, agree, disagree, strongly disagree, I do 
not know] 

33. Based on your experience and in particular within the context of new technological developments, 
the  distinction  between  private  and  professional  use  of  a  product  is  still  adequate  (e.g.  a 
smartphone  can  be  used  for  both  private  and  professional  use)  [options:  strongly  agree,  agree, 
disagree, strongly disagree, I do not know]  

34. Based on your experience, the Directive adequately defines: [for each definition: strongly agree, 

agree, disagree, strongly disagree/ I do not know]  
a)  Product,  consisting  of  all  movables,  even  if  incorporated  into  another  movable  or  into  an 

immovable, including electricity. 

b)  Producer, meaning the manufacturer of a finished product, the producer of any raw material or 
the manufacturer of a component part and any person who, by putting his name, trade mark 
or other distinguishing 
feature on the product presents himself as its producer 

c)  Defect,  meaning  the  lack  of  safety  which  the  public  is  entitled  to  expect,  taking  all 
circumstances  into  account,  including  the  presentation  of  the  product,  the  use  that  could 
reasonably be expected and the time when the product was put into circulation; 

d)  Damage,  caused  by  death  or  by  personal  injuries; damage  to,  or  destruction  of,  any  item  of 

property other than the defective product itself;  

e)  Exemptions  to  producer’s  liability:  the  product  was  not  put  into  circulation  by  the 
manufacturer;  the  defect  causing  the  damage  did  not  exist  when  the  product  was  put  into 
circulation;  the  product  was  not  manufactured  for  sale  or  distribution;  the  defect  is  due  to 
product compliance with mandatory regulations; the state of scientific and technical knowledge 
was  not  such  as  to  enable  the  existence  of  the  defect  to  be  discovered;  the  defect  is 
attributable  to  the  design  of  the  product  in  which  the  component  has  been  fitted  or  to  the 
instructions given by the manufacturer of the product. 

35. If any of the above definitions should be changed could you please explain why and how? [text] 
the 
36. What  would  be 

following  modifications  of 

effects  of 

the  Directive? 

the 

[positive/negative/none/No opinion]  
a)  Extending its scope to services. Please specify [text] 
b)  Limiting its scope, for instance to cover only tangible products. Please specify [text] 
c)  Expanding the strict liability to other market operators. Please specify [text] 
d)  Enlarging the concept of "defect" which is relating to the safety of the product to include the 

fitness for use of the product Please specify [text] 

e)  Removing the burden of proof of the defect from the injured party. Please specify [text] 
f)  Enlarging the types of material damages to cover also economic loss. Please specify [text] 
g)  Reducing the types of damages to which it applies. Please specify [text] 
h)  Raising the threshold of €500 for damages caused to property. Please specify [text] 
i)  Decreasing the threshold of €500 for damages caused to property. Please specify [text] 
j)  Removing the producer's exemption from liability as regards the state of scientific and 

technological development at the time of commercialisation of the product Please specify [text] 
k)  Reducing the three-year period for the injured party to start the proceedings for the recovery 

of damages. Please specify [text] 

l)  Reducing the expiry period of 10 years from when the producer put the product in circulation. 

Please specify [text] 

m)  Other. Please specify [text] 

37. [if  yes  to  any  of  the  above]  The  modification  of  the  Directive  as  described  in  the  options  above 

would bring the following effects: [multiple choice] 
a)  Lower investments in research and development Increase in insurance costs 
b)  Increase in costs for judicial claims 
c)  Lower exports 
d)  Other (please specify) 
e)  None of the above 
I do not know 
f) 

38. In your opinion, is the Directive adequate and sufficient to cover strict liability caused by defect in 

any of the following new technological developments? [multiple choice] 
a)  Software embedded in products: Yes/No/I Do not Know 
b)  Products  on  which  software  and  applications  from  different  sources  can  be  installed  after 

purchase such as apps and other non-embedded software; Yes/No/I Do not Know 

c)  Products connected to and through the Internet (Internet of Things); Yes/No/I Do not Know 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

d)  Products shared with other users through collaborative platforms; Yes/No/I Do not Know 
e)  Devices  for  3D  printing/additive  manufacturing  and  products  manufactured  with  them; 

Yes/No/I Do not Know 

f)  Advanced  robots  and  autonomous  systems  empowered  by  artificial  intelligence,  i.e.  physical 
machines perceiving their environment processing this information correctly and then carrying 
out a complex and adequate actions autonomously, e.g. advanced driver assistance systems or 
completely self-driving cars, these systems can also learn from their actions; Yes/No/I Do not 
Know 

g)  Software  –based  systems  empowered  by  artificial  intelligence,  i.e.  software  processing 
information correctly and then acting appropriately, e.g. autonomous trading algorithms or any 
other big data algorithms. Yes/No/I Do not Know 

h)  Other, please specify 

39. Could you please explain why? [text] 
40.  [if not] Are you in favour of a revision of the Directive’s scope to include the abovementioned 

new technological developments (strongly agree, agree, disagree, strongly disagree) 

41. The revision of the Directive’s scope to include the abovementioned new technological 

developments would bring the following effects: [multiple choice] 
Lower investment in research and development 

 

Increase in insurance costs 
Increase in costs for judicial claims 

 
 
  Lower exports 
  Other (please specify) [text] 
  None of the above 
I do not know 
 

42. The  Directive  applies  only  to  products.  Based  on  your  experience,  the  distinction  between 
products  and  services  is  appropriate, particularly in  light  of new technological developments, 
thanks  to  which  products  can  be  purchased  as  a  bundle  with  related  services  (such  as  software 
embedded in products; products on which software and applications from different sources can be 
installed  after  purchase  such  as  apps  and  other  non-embedded  software;  products  connected  to 
and  through  the  Internet  (Internet  of  Things);  products  shared  with  other  users  through 
collaborative platforms; devices for 3D printing/additive manufacturing and products manufactured 
with  them;  advanced  robots  and  autonomous  systems  empowered  by  artificial  intelligence; 
software–based  systems  empowered  by  artificial  intelligence)  [options:  strongly  agree,  agree, 
disagree, strongly disagree, I do not know] 

43. The scope of the Directive should be  extended to cover services, since they are often bundled 

with products [options: strongly agree, agree, disagree, strongly disagree] 

44. Could you please explain why? [text] 
[if  yes]  The  revision  of  the  Directive’s  scope  to  include  services  would  bring  the  following  effects: 
[multiple choice] 
 

Lower investment in research and development 

Increase in insurance costs 
Increase in costs for judicial claims 

 
 
  Lower exports 
  Other (please specify) [text] 
  None of the above 
I do not know 
 

45. Are products purchased as a bundle with related services typically considered as “products” 

within the meaning of the Directive in your country? [yes/no/I do not know] 

46. Do  you  think  that  there  is  a  need  of  an  EU  approach  for  dealing  with  liability  for  products 

interconnected with services? [yes/no/I do not know] 

47. Could you please explain why? [text] 
48. Do  you  think  there  is  need  to  cover  “pure  economic  loss”  (i.e.  a  pecuniary  loss  not 
consequential  upon  injury  or  damage)  amongst  the  damages  caused  by  a  defective  product  by 
design or as an add-on feature? [yes, by design/yes, as an add-on feature/no/I do not know] 
49. Which liability regime would be better? [the current system is ok/ I would prefer a comprehensive 
liability  regime  covering  both  products  and  services  /  I  would  prefer  different,  ad  hoc  regimes 
covering  different  fields  (i.e.  a  liability  regime  for  products,  a  regime  for  services,  and  another 
regime for products interconnected with services)/I do not know] 

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50. [If  different  regimes  for  different  things]  In  case  of  IoT,  robotics  applications  and  autonomous 
systems, which of the following do you think is the best liability regime? [the current strict liability 
regime as it is in the Directive (e.g. in case a bypass user suffers a damage caused by a defective 
bypass, the strict liability is placed on the producer  of the bypass)/ a risk-opening approach that 
would allocate the strict liability on the market actors using the technology (e.g. in case a bypass 
user suffers a damage caused by a defective bypass, the liability is placed on the hospital or any 
other  service  providers  besides  the  bypass  producer)/  a  risk-management  approach  putting  the 
strict liability on the market actor  best  placed to minimise  risks and costs (e.g. in case a bypass 
user  suffers  a  damage  caused  by  a  defective  bypass,  the  strict  liability  is  placed  on  the  hospital 
besides the bypass producer)] 

51. Could you please explain why? [text] 
52. Do you think that there is a need to provide for different liability caps for producers other than 

the ones already provided by the Directive (i.e. €500, €70 M)? [yes/no/I do not know] 

53. [if yes] Can you please specify? [text] 
54. Has the Directive been implemented in a uniform way across Member States? [yes/no/I do not 

know] 

55.  [if no]  Please  provide  specific examples, with specific reference  to the Member State and to the 

different ways of implementing the same provision [text] 

56. Based  on  your  experience,  the  Directive  has  been  capable  to  [options:  strongly  agree,  agree, 

disagree, strongly disagree/ I do not know] 
a)  Guarantee strict liability of producers for damages caused by defective products  
b)  Favour a level playing field among producers 
c)  Favour the export of products in other EU countries  
d)  Other (please specify) [text] 

57. Based on your experience, the Directive provides the following  benefits [options: strongly agree, 

agree, disagree, strongly disagree/ I do not know ] 
a)  Reduced probability to be recognised liable in case of exemptions 
b)  Reduced claims due to the existing thresholds for damage to property 
c)  Increased market sales in other EU countries  
d)  Other (please specify): [text] 

58. Please  rate to which extent do you agree with the  following statement:  The  level  playing  field 
achieved by the Directive could not be reached by means of single Member State action  [options: 
strongly agree, agree, disagree, strongly disagree, The Directive did not achieve level playing field, 
I do not know] 

59. Is there any other relevant issue you would like to bring to the Commission’s attention? [text]  

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1.  Do  you  perceive  that  the  tendency  to  report  claims  for  damages  caused  by  defective  products 
has  changed  since  the  entry  into  force  of  the  Directive?  [yes,  it  increased/yes,  it  decreased/no,  it 
remained unchanged/I do not know] 

2.  Have  you  ever  filed  a  claim  for  defects  or  malfunctioning  of  any  products  since  2000?  (please 

indicate the number of claims you have filed, where 0=no claim) [number] 

3. 

[if n>0 in Q2] Please describe the most significant claim (in monetary terms) you have filed: 

o  The issue at stake [text] 
o  The product [multiple choice] [list of products as per background information let. d)] 
o  Was it sold in bundle with a service? [yes/no/I do not know] 
o  The context [multiple choice] [household/ sport, leisure, other social activity/ professional 

activity/medical/ other (please specify)]  

o  The defect [text] 
o  Was it easy to discover the root of the problem? [yes/no/I do not know] 
o  The damage [multiple choice] [Physical well-being/ property damage/ other (please specify)] 
o  Whether liability was difficult to allocate among the players (other producer, software 

developer, network provider…) [yes/no/ I do not know] 

o  If yes could you please explain why? [text] 

4.  Based  on  your  experience,  proving  the  defect  and/or  the  casual  link  between  defect  and  damage 

was difficult [options: always/ often/seldom/ never/I cannot say] 

5. 

In general, did you obtain compensation? [options: always/ often/seldom/ never/I cannot say] 

6.  Based on your experience, receiving compensation for damages caused by “traditional” product (i.e. 
not  relating  to  new  technological  developments)  was  difficult  [options:  always/  often/seldom/ 
never/ I cannot say] 

7. 

[if always/ often] Could you please explain why? [text] 

8. 

[if  always/  often]  Based  on  your  experience,  what  is  the  most  frequent  obstacle  to  obtain 
compensation  for  damages  caused  by  “traditional”  product  (i.e.  not  relating  to  new  technological 
developments)?  [list  of  options,  single  choice:  1.Proving  that  the  product  was  defective  2.Proving 
the link between the defect and the damage 3. Attributing liability to a specific person or entity 4. 
Discovering  where  exactly  the  defect  occurred  5.  Proving  the  damage  6.The  requirement  that 
compensation  is  granted  only  for  property  damage  of  at  least  €500  7.  Having  to  prove  that  the 
defective  product  was  intended  and  used  for  private  purposes  8.  The  three  years  period  for  the 
injured party to start the proceeding for the recovery of damages 9. The expiry period of  10 years 
from the moment that the producer put the product into circulation 10. Other (please specify)] 

9.  Can  you  rate  the  burden  associated  to  each  type  of  cost  based  on  your  experience?  [rating  1-5 
(where 1= very low burden; 5=very high burden) for type of cost: 1. proof of the defect, 2. proof of 
the damage, 3. proof of the link, 4. Other costs (please specify)  

10.  Can  you  quantify  the  average  time  usually  dedicated  to  prove  the  right  to  be  compensated?  [0-1 

days; 2-5 days; 5-10 days; more than 10 days] 

11.  In case of legal assistance, how much does it cost on average? [euro] 

12.  In general, are cases relating to damages for defective products resolved judicially or out-of-court? 

[judicially/out-of-court/ I cannot say] 

13.  [if yes] Can you indicate the total number of judicial claims and the average percentage of 

successful judicial claims (over total number of claims) for compensation for damages caused by 
defective “traditional” products (i.e. not relating to new technological developments) over the period 
2000-2016? [list with options] 

o  Absolute number of claims: [text] 
o  0% 
o 

Less than 25% 

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o  Between 26 and 50% 
o  Between 51 and 75% 
o  More than 76% 
o  100% 
o 

I do not know  

14.  Can  you  indicate  the  average  percentage  of  successful  out-of-court  settlements  over  the 
total number of claims (i.e. both judicial and out-of-court) for obtaining compensation for damages 
caused by defective “traditional” products over the period 2000-2016? [list with options] 

Less than 25% 

o  0% 
o 
o  Between 26 and 50% 
o  Between 51 and 75% 
o  More than 76% 
o  100% 
o 

I do not know 

15.  Can  you  indicate  the  total  number  of  judicial  claims  and  the  average  percentage  of  successful 
judicial  claims  (over  total  number  of  claims)  for  compensation  for  damages  caused  by  defective 
products  connected  to  new  technological  developments  you  have  filed  in  the  last  five  years?  [list 
with options] 

Less than 10% 

o  Total number [text] 
o  0%  
o 
o  Between 10 and 20% 
o  Between 20 and 50% 
o  More than 50% 
o 
I do not know  

16.  Can  you  indicate  the  average  percentage  of  successful  out-of-court  settlements  over  the 
total number of claims (i.e. both judicial and out-of-court) for obtaining compensation for damages 
caused by defective products relating to new technological developments in the last five years? [list 
with options] 

Less than 25% 

o  0% 
o 
o  Between 26 and 50% 
o  Between 51 and 75% 
o  More than 76% 
o  100% 
o 

I do not know 

17.  Do  you  see  any  specific  difficulties in  obtaining  compensation  for  the damages  suffered  in  case  of 

defective products based on new technological developments? [yes/no/ I do not know] 

18.  [if yes] What is the most frequent obstacle in these cases? [list of options, single choice: 1.Proving 
that the product was defective 2.Proving the link between the defect and the damage 3. Attributing 
liability to a specific person or entity 4. Discovering where exactly the defect occurred 5. Proving the 
damage 6.The requirement that compensation is granted only for property damage of at least €500 
7.  Having  to  prove  that  the  defective  product  was  intended  and  used  for  private  purposes  8.  The 
three years period for the injured party to start the proceeding for the recovery of damages 9. The 
expiry  period  of  10  years  from  the  moment  that  the  producer  put  the  product  into  circulation  10. 
Other (please specify)] 

19.  In  how  many  cases  relating  to  claims  for  damages  caused  by  a  defective  product  linked  to  new 
technological developments was liability allocated to actors other than the producer of the product? 
(please provide the % calculated over the total number of claims filed relating to new technological 
developments products) 

o 

In 0% of cases 

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o 
o 
o 
o 
o 

In less than 25% of cases 
In between 26 and 50% of cases 
In between 51 and 75% of cases 
In more than 76% of cases 
I do not know 

20.  Can  you  indicate  the  total  number  of  judicial  claims  and  the  average  percentage  of  successful 
judicial  claims  (over  total  number  of  claims)  for  compensation  for  damages  caused  by  defective 
products such as software embedded in products, products on which software and applications from 
different sources can be installed after purchase such as apps and other non-embedded software in 
the last five years? [list with options] 

Less than 10% 

o  Total number [text] 
o  0%  
o 
o  Between 10 and 20% 
o  Between 20 and 50% 
o  More than 50% 
o 
I do not know  

21.  What is usually the legal basis for the claim? [text] 

22.  Can  you  indicate  the  average  percentage  of  successful  out-of-court  settlements  over  the 
total number of claims (i.e. both judicial and out-of-court) for obtaining compensation for damages 
caused by defective products  such as software embedded in products, products on which software 
and applications from different sources can be installed after purchase such as apps and other non-
embedded software in the last five years? [list with options] 

Less than 25% 

o  Total number [text] 
o  0% 
o 
o  Between 26 and 50% 
o  Between 51 and 75% 
o  More than 76% 
o  100% 
o 

I do not know 

23.  Can  you  indicate  the  total  number  of  judicial  claims  and  the  average  percentage  of  successful 
judicial  claims  (over  total  number  of  claims)  for  compensation  for  damages  caused  by  defective 
devices  for  3D  printing/additive  manufacturing  and  products  manufactured  with  them,  advanced 
robots  and  autonomous  systems  empowered  by  artificial  intelligence,  software–based  systems 
empowered by artificial intelligence in the last five years? [list with options] 

Less than 10% 

o  Total number [text] 
o  0%  
o 
o  Between 10 and 20% 
o  Between 20 and 50% 
o  More than 50% 
o 
I do not know  

24.  What was the legal basis for the claim? [text] 

25.  Can  you  indicate  the  average  percentage  of  successful  out-of-court  settlements  over  the 
total number of claims (i.e. both judicial and out-of-court) for obtaining compensation for damages 
caused by defective products such as  devices  for  3D  printing/additive manufacturing  and  products 
manufactured  with  them,  advanced  robots  and  autonomous  systems  empowered  by  artificial 
intelligence, software–based systems empowered by artificial intelligence in the last five years?  

o  Total number [text] 
o  0% 
o 

Less than 25% 

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o  Between 26 and 50% 
o  Between 51 and 75% 
o  More than 76% 
o  100% 
o  I do not know 

26.  Can  you  indicate  the  total  number  of  judicial  claims  and  the  average  percentage  of  successful 
judicial  claims  (over  total  number  of  claims)  for  compensation  for  damages  caused  by  defective 
products  connected  to  and  through  the  Internet  (Internet  of  Things),  products  shared  with  other 
users  through collaborative platforms  (e.g. smart watches,  smart  cars)  in the last  five  years?  [list 
with options] 

Less than 10% 

o  Total number [text] 
o  0%  
o 
o  Between 10 and 20% 
o  Between 20 and 50% 
o  More than 50% 
o 
I do not know  

27.  What was the legal basis for the claim? [text] 

28.  Can  you  indicate  the  average  percentage  of  successful  out-of-court  settlements  over  the 
total number of claims (i.e. both judicial and out-of-court) for obtaining compensation for damages 
caused by defective products such as products connected to and through the Internet (Internet of 
Things),  products  shared  with  other  users  through  collaborative  platforms  (e.g.  smart  watches, 
smart cars) in the last five years?  

Less than 25% 

o  Total number [text] 
o  0% 
o 
o  Between 26 and 50% 
o  Between 51 and 75% 
o  More than 76% 
o  100% 
o 

I do not know 

29.  The  Directive  applies  only  to  products.  Based  on  your  experience,  the  distinction  between 
products  and  services  is  appropriate,  in  particular  in  light  of  new  technological  developments, 
thanks  to  which  products  can  be  purchased  as  a  bundle  with  related  services  (such  as  software 
embedded in products; products on which software  and applications from different sources can be 
installed after purchase such as apps and other non-embedded software; products connected to and 
through  the  Internet  (Internet  of  Things);  products  shared  with  other  users  through  collaborative 
platforms;  devices  for  3D  printing/additive  manufacturing  and  products  manufactured  with  them; 
advanced  robots  and  autonomous  systems  empowered  by  artificial  intelligence;  software–based 
systems  empowered  by  artificial  intelligence)  [options:  strongly  agree,  agree,  disagree,  strongly 
disagree, I do not know] 

30.  The  scope  of  the  Directive  should  be  extended  to  cover  services,  since  they  are  often  bundled 

with products [options: strongly agree, agree, disagree, strongly disagree] 

31.  Could you please explain why? [text] 

32.  [if  yes]  The  revision  of  the  Directive’s  scope  to  include  services  would  bring  the  following 

effects: [multiple choice] 

 
 
 
 
 

Lower investment in research and development 
Increase in insurance costs 
Increase in costs for judicial claims 
Lower exports 
Increased difficulty in allocating strict liability in terms of identifying the right subject 

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  Other (please specify) [text] 
  None of the above 
I do not know 
 

33.  Are  products  purchased  as  a  bundle  with  related  services  typically  considered  as  “products” 

within the meaning of the Directive in your country? [yes/no/I do not know] 

34.  Do you think there is a need for an EU approach for dealing with liability for products interconnected 

with services? [yes/no/I do not know] 

35.  Based on your experience and, in particular within the context of new technological developments, 
the  distinction  between  private  and  professional  use  of  a  product  is  still  adequate  (e.g.  a 
smartphone  can  be  used  for  both  private  and  professional  use  [options:  strongly  agree,  agree, 
disagree, strongly disagree, I do not know] 

36.  Based  on  your  experience,  the  Directive  adequately  defines:  [for  each  definition:  strongly  agree, 

agree, disagree, strongly disagree/ I do not know]  

o  Product,  consisting  of  all  movables,  even  if  incorporated  into  another  movable  or  into  an 

immovable, including electricity. 

o  Producer, meaning the manufacturer of a finished product, the producer of any raw material 
or  the  manufacturer  of  a  component  part  and  any  person  who,  by  putting  his  name,  trade 
mark or other distinguishing feature on the product presents himself as its producer 

o  Defect,  meaning  the  lack  of  safety  which  the  public  is  entitled  to  expect,  taking  all 
circumstances  into  account,  including  the  presentation  of  the  product  the  use  that  could 
reasonably be expected and the time when the product was put into circulation; 

o  Damage, caused by death or by personal injuries; damage to, or destruction of, any item of 

property other than the defective product itself;  

o  Exemptions  to  producer’s  liability:  the  product  was  not  put  into  circulation  by  the 
manufacturer;  the  defect  causing  the  damage  did  not  exist  when  the  product  was  put  into 
circulation;  the  product  was  not  manufactured  for  sale  or  distribution;  the  defect  is  due  to 
product  compliance  with  mandatory  regulations;  the  state  of  scientific  and  technical 
knowledge was not such as to enable the existence of the defect to be discovered; the defect 
is attributable to the design of the product in which the component has been fitted or to the 
instructions given by the manufacturer of the product. 

37.  What  would 

effects 
be 
[positive/negative/none/No opinion]  

the 

of 

the 

following  modifications 

of 

the  Directive? 

o  Extending its scope to services. Please specify [text] 
o  Limiting its scope, for instance to cover only tangible products. Please specify [text] 
o  Expanding the strict liability to other market operators. Please specify [text 
o  Enlarging the concept of "defect" which is relating to the safety of the product to include the 

fitness for use of the product Please specify [text] 

o  Removing the burden of proof of the defect from the injured party. Please specify [text] 
o  Enlarging the types of material damages to cover also economic loss. Please specify [text] 
o  Reducing the types of damages to which it applies. Please specify [text] 
o  Raising the threshold of €500 for damages caused to property. Please specify [text] 
o  Decreasing the threshold of €500 for damages caused to property. Please specify [text] 
o  Removing the producer's exemption from liability as regards the state of scientific and 

technological development at the time of commercialisation of the product Please specify 
[text] 

o  Reducing the three-year period for the injured party to start the proceedings for the recovery 

of damages. Please specify [text] 

o  Reducing the expiry period of 10 years from when the producer put the product in circulation. 

Please specify [text] 

o  Other. Please specify [text] 

38. Do  you  think  that  there  is  a  need  to  provide  for  different  liability  cap  for  producers  other 

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than the ones already provided by the Directive (i.e. €500, €70 M)? [yes/no/I do not know] 

39.  [if yes] Can you please specify? [text] 

40.  In  your  opinion,  is  the  Directive  adequate  and  sufficient  to  cover  strict  liability  for  damages 

caused by defect in any of the following new technological developments? [multiple choice] 

o  Software embedded in products [Yes/No/I do not know] 
o  Products  on  which  software  and  applications  from  different  sources  can  be  installed  after 

purchase such as apps and other non-embedded software; Yes/No/I do not know 

o  Products connected to and through the Internet (Internet of Things) [Yes/No/I do not know] 
o  Products shared with other users through collaborative platforms[Yes/No/I do not know] 
o  Devices  for  3D  printing/additive  manufacturing  and  products  manufactured  with  them; 

[Yes/No/I do not know] 

o  Advanced  robots  and  autonomous  systems  empowered  by  artificial  intelligence,  i.e.  physical 
machines perceiving their environment processing this information correctly and then carrying 
out a complex and adequate actions autonomously, e.g. advanced driver assistance systems 
or completely self-driving cars, these systems can also learn from their actions; [Yes/No/I do 
not know] 

o  Software  –based  systems  empowered  by  artificial  intelligence,  i.e.  software  processing 
information  correctly  and  then  acting  appropriately,  e.g.  autonomous  trading  algorithms  or 
any other big data algorithms[Yes/No/I do not know] 

o  Other, please specify] 
41.  Could you please explain why? [text] 

42.  [if not] Are you in favour of a revision of the Directive’s scope to include the abovementioned new 
technological developments (strongly agree, agree, disagree, strongly disagree/I do not know) 

43.  The revision of the Directive’s scope to include the abovementioned new technological 

developments would bring the following effects: [multiple choice] 

Lower investment in research and development 
Increase in insurance costs 
Increase in costs for judicial claims 
Lower exports 
Increased difficulty in allocating strict liability in terms of identifying the right subject 

 
 
 
 
 
  Other (please specify) [text] 
  None of the above 
I do not know 
 

44.  Do you think there is need to cover “pure economic loss” (i.e. a pecuniary loss not consequential 
upon  injury  or  damage)  amongst  the  damages  caused  by  a  defective  product  by  design  or  as  an 
add-on feature? [yes, by design/ yes, as an add-on feature /no/I do not know] 

45.  Which liability regime would be better? [the current system is ok/ I would prefer a comprehensive 
liability  regime  covering  both  products  and  services  /  I  would  prefer  different,  ad  hoc  regimes 
covering  different  fields  (i.e.  a  liability  regime  for  products,  a  regime  for  services,  and  another 
regime for products interconnected with services)//I do not know] 

46.  [If  different  regimes  for  different  things]  In  case  of  IoT,  robotics  applications  and  autonomous 
systems, which of the following do you think is the best liability regime?  [the current strict liability 
regime as it is in the Directive (e.g. in case a bypass user suffers a damage caused by a defective 
bypass,  the  strict  liability  is  placed  on  the  producer  of  the  bypass)/  a  risk-opening  approach  that 
would allocate the strict liability  on  the  market  actors using the  technology  (e.g. in  case a  bypass 
user  suffers  a  damage  caused  by  a  defective  bypass,  the  liability  is  placed  on  the  hospital  or  any 
other  service  providers  besides  the  bypass  producer)/  a  risk-management  approach  putting  the 
strict  liability  on  the  market  actor  best  placed  to  minimise  risks  and  costs  (e.g.  in  case  a  bypass 
user  suffers  a  damage  caused  by  a  defective  bypass,  the  strict  liability  is  placed  on  the  hospital 
besides the bypass producer)] 

47.  Could you please explain why? [text] 

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48.  Based  on  your  experience,  do  you  think  that  the  strict  liability  regime  as  per  the  Product  Liability 

Directive offers enough protection to consumers? [yes/no/I do not know] 

49.  Please rate to which extent do you agree with the following statement: The protection of consumers 
achieved by the  Directive could  not be  reached  by means of single Member State action  [options: 
strongly  agree,  agree,  disagree,  strongly  disagree/  The  Directive  did  not  achieve  protection  of 
consumers/ I do not know] 

50.  Based on your experience, do consumers feel protected for damages caused by defective products 

imported by other EU countries? [yes/no/I do not know] 

51.  Please rate your level of satisfaction about the following benefits possibly deriving by the Directive 

[rating 1-5 for each option, where 1=no satisfaction; 5= maximum satisfaction]: 

o  1. Right to compensation harmonised across Member States,  
o  2.  Increased  protection  if  compared  to  the  situation  previous  to  the  entry  into  force  of  the 

Directive,  

o  3. Reduced legal costs for the proof of fault/negligence of the producer,  
o  4. Other benefits (please specify)] 

52.  Has  the  Directive  been  implemented  in  a  uniform  way  across  Member  States?  [yes/no/I  do  not 

know] 

53.   [if  no]  Please  provide  specific  examples,  with  specific  reference  to  the  Member  State  and  to  the 

different ways of implementing the same provision [text] 

54.  Is there any other relevant issue you would like to bring to the Commission’s attention? [text] 

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1.  Do you perceive that the tendency to report claims for damages caused by defective products has 
changed  since  the  entry  into  force  of  the  Directive?  [yes,  it  increased/yes,  it  decreased/no,  it 
remained unchanged/I do not know] 

2.  Which are the defective products that have been object most frequently of claims for compensation in 
the last five years? (ADD LIST of both traditional and new technological developments products) 

3.  In your opinion, have consumers more frequently been awarded with the claimed compensation since 

the entry into force of the Directive? [yes/no/I do not know] 

4.  From  2000  on,  have  you  ever  dealt  with  cases  concerning  damages  caused  by  a  malfunctioning 
“traditional”  product  (i.e.  not  relating  to  new  technological  developments)?  (please  indicate  the 
number of cases you have dealt with, where 0=no cases) [number] 

5.  [if n>0 in Q4] Please describe the most significant case (in monetary terms) you have dealt with: 

a)  The issue at stake [text] 
b)  The product [multiple choice] [list] 
c)  Was it sold in bundle with a service? [yes/no/I do not know] 
d)  The context [multiple choice] [household/ sport, leisure, other social activity/ professional 

activity/medical/ other (please specify)]  

e)  The defect [text] 
f)  Was it easy to discover the root of the problem? [yes/no/ I do not know] 
g)  The damage [multiple choice] [Physical well-being/ property damage/ other (please specify)] 
h)  Whether liability was difficult to allocate among the players (other producer, software developer, 

network provider…) [yes/no/ I do not know] 
If yes could you please explain why? [text] 

i) 

6.  In  the  last  five  years,  have  you  ever  dealt  with  cases  concerning  damages  caused  by  a 
malfunctioning in products such as software embedded in products, products on which software and 
applications  from  different  sources  can  be  installed  after  purchase  such  as  apps  and  other  non-
embedded software?  (please  indicate the  number of cases you  have dealt  with,  where 0=no  cases) 
[number]  

7.  [if n>0 in Q6] Please describe the most significant case (in monetary terms) you have dealt with: 

a)  The issue at stake [text] 
b)  The product [multiple choice] [software embedded in products/ products on which software and 

applications from different sources can be installed after purchase such as apps and other non-
embedded software] 

c)  Was it sold in bundle with a service? [yes/no/I do not know] 
d)  The context [multiple choice] [household/ sport, leisure, other social activity/ professional 

activity/medical/ other (please specify)]  

e)  The defect [text] 
f)  Was it easy to discover the root of the problem? [yes/no/ I do not know] 
g)  The damage [multiple choice] [Physical well-being/ property damage/ other (please specify)] 
h)  Whether liability was difficult to allocate among the players (other producer, software developer, 

network provider…) [yes/no/ I do not know] 
If yes could you please explain why? [text] 

i) 

8.  In the last five years, have you ever dealt with cases concerning damages caused by  devices for 3D 
printing/additive  manufacturing  and  products  manufactured  with  them,  advanced  robots  and 
autonomous  systems  empowered  by  artificial  intelligence,  software–based  systems  empowered  by 
artificial intelligence?  (please  indicate the number  of cases you have dealt  with, where 0=no cases) 
[number] 

9.  [if n>0 in Q8] Please describe the most significant case (in monetary terms) you have dealt with: 

a)  The issue at stake [text] 
b)  The product [multiple choice] [devices for 3D printing/additive manufacturing and products 

manufactured with them/ advanced robots and autonomous systems empowered by artificial 

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intelligence/ software–based systems empowered by artificial intelligence] 

c)  Was it sold in bundle with a service? [yes/no/I do not know] 
d)  The context [multiple choice] [household/ sport, leisure, other social activity/ professional 

activity/medical/ other (please specify)]  

e)  The defect [text] 
f)  Was it easy to discover the root of the problem? [yes/no/I do not know] 
g)  The damage [multiple choice] [Physical well-being/ property damage/ other (please specify)] 
h)  Whether liability was difficult to allocate among the players (other producer, software developer, 

network provider…) [yes/no/I do not know] 
If yes could you please explain why? [text] 

i) 

10. Have you ever dealt with cases concerning damages caused by  a product connected to and through 
the  Internet  (Internet  of  Things),  products  shared  with  other  users  through  collaborative  platforms 
(e.g. smart watches, smart cars)? (please indicate the number of cases you have dealt with, where 
0=no cases) [number] 

11. [if n>0 in Q10] Please describe the most significant case (in monetary terms) you have dealt with: 

a)  The issue at stake [text] 
b)  The product [multiple choice] [product connected to and through the Internet (Internet of 

Things)/ products shared with other users through collaborative platforms] 

c)  Was it sold in bundle with a service? [yes/no/I do not know] 
d)  The context [multiple choice] [household/ sport, leisure, other social activity/ professional 

activity/medical/ other (please specify)]  

e)  The defect [text] 
f)  Was it easy to discover the root of the problem? [yes/no/I do not know] 
g)  The damage [multiple choice] [Physical well-being/ property damage/ other (please specify)] 
h)  Whether liability was difficult to allocate among the players (other producer, software developer, 

network provider…) [yes/no/I do not know] 
If yes could you please explain why? [text] 

i) 

12. Have  there  been  any  increases  in  the  claims  for  compensations  with  reference  to  damages 
linked to new technological developments products348 in the last five years? [yes/no/I do not know] 

13. Did  you  adapt,  or  plan  to  adapt  in  the  near  future,  your  contractual  arrangements  to  cover 
liability  for  defective  products  to  New  Technological  Developments  (i.e.  Software  embedded  in 
products;  Products  on  which  software  and  applications  from  different  sources  can  be  installed  after 
purchase  such  as  apps  and  other  non-embedded  software;  Products  connected  to  and  through  the 
Internet  (Internet  of  Things);  Products  shared  with  other  users  through  collaborative  platforms; 
Devices  for  3D  printing/additive  manufacturing  and  products  manufactured  with  them;  Advanced 
robots  and  autonomous  systems  empowered  by  artificial  intelligence,  i.e.  physical  machines 
perceiving  their  environment  processing  this  information  correctly  and  then  carrying  out  a  complex 
and  adequate  actions  autonomously,  e.g.  advanced  driver  assistance  systems  or  completely  self-
driving cars, these systems can also learn from their actions; Software–based systems empowered by 
artificial intelligence, i.e. software processing information correctly and then acting appropriately, e.g. 
autonomous trading algorithms or any other big data algorithms)? [yes/no/ I do not know]  

14. If yes, how? [text] 

348  i.e.:  Software  embedded  in  products;  products  on  which  software  and  applications  from  different  sources  can  be 
installed  after  purchase  such  as  apps  and  other  non-embedded  software;  Products  connected  to  and  through  the 
Internet  (Internet  of  Things);  Products  shared  with  other  users  through  collaborative  platforms;  Devices  for  3D 
printing/additive  manufacturing  and  products  manufactured  with  them;  Advanced  robots  and  autonomous  systems 
empowered  by  artificial  intelligence,  i.e.  physical  machines  perceiving  their  environment  processing  this  information 
correctly  and  then  carrying  out  a  complex  and  adequate  actions  autonomously,  e.g.  advanced  driver  assistance 
systems  or  completely  self-driving  cars,  these  systems  can  also  learn  from  their  actions;  Software  –based  systems 
empowered by artificial intelligence, i.e. software processing information correctly and then acting appropriately, e.g. 
autonomous trading algorithms or any other big data algorithms. 

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15. Could the introduction of a risk and/or of an unintended autonomous behaviour be considered as a 

"defect" for the purposes of the Directive? [yes/no/I do not know] 

16. How should the Directive work in case the role of the human being decreases or stops having any 

influence? [text] 

17. Can  you  please  rank  the  level  of  profitability  of  insurance  contracts  covering  product  liability 
compared to other business lines in your organisation? [more profitable / equal / less profitable/not 
applicable to my organisation/I do not know] 

18. With regard to the level of profitability of insurance  contracts covering product liability, is there any 
difference  when  considering  new  technological  developments  with  respect  to  “traditional”  products? 
[yes/no/I do not know] 

19. Do you think there is need to cover “pure  economic loss” (i.e. a pecuniary  loss not consequential 
upon injury or damage) amongst the damages caused by a defective product by design or as an add-
on feature? [yes, by design/yes, as an add-on feature/no/I do not know] 

20. Which  liability  regime  would  be  better?  [the  current  system  is  ok/  I  would  prefer  a  comprehensive 
liability  regime  covering  both  products  and  services  /  I  would  prefer  different,  ad  hoc  regimes 
covering different fields (i.e. a liability regime for products, a regime for services, and another regime 
for products interconnected with services)/I do not know] 

21. [If  different  regimes  for  different  things]  In  case  of  IoT,  robotics  applications  and  autonomous 
systems,  which  of  the  following  do  you  think  is  the  best  liability  regime?  [the  current  strict  liability 
regime as it is in  the Directive (e.g. in case a  bypass  user  suffers a damage  caused by a defective 
bypass,  the  strict  liability  is  placed  on  the  producer  of  the  bypass)/  a  risk-opening  approach  that 
would  allocate  the  strict  liability  on  the  market  actors  using  the  technology  (e.g.  in  case  a  bypass 
user  suffers  a  damage  caused  by  a  defective  bypass,  the  liability  is  placed  on  the  hospital  or  any 
other service providers besides the bypass producer)/ a risk-management approach putting the strict 
liability  on  the  market  actor  best  placed  to  minimise  risks  and  costs  (e.g.  in  case  a  bypass  user 
suffers  a  damage  caused  by  a  defective  bypass,  the  strict  liability  is  placed on  the  hospital  besides 
the bypass producer)] 

22. Could you please explain why? [text] 

23. The  Directive  applies  only  to  products.  Based  on  your  experience,  the  distinction  between 
products  and  services  is  appropriate  in  particular  in  light  of  new  technological  developments, 
thanks  to  which  products  can  be  purchased  as  a  bundle  with  related  services  (such  as  software 
embedded  in  products;  products  on  which  software  and  applications  from  different  sources  can  be 
installed after purchase such as apps and other non-embedded software; products connected to and 
through  the  Internet  (Internet  of  Things);  products  shared  with  other  users  through  collaborative 
platforms;  devices  for  3D  printing/additive  manufacturing  and  products  manufactured  with  them; 
advanced  robots  and  autonomous  systems  empowered  by  artificial  intelligence;  software–based 
systems  empowered  by  artificial  intelligence)  [options:  strongly  agree,  agree,  disagree,  strongly 
disagree, I do not know] 

24. The scope of the Directive should be extended to cover services, since they are often bundled with 

products [options: strongly agree, agree, disagree, strongly disagree] 

25. Could you please explain why? [text] 

26. [if yes] The revision of the Directive’s scope  to include  services would bring the following effects: 

[multiple choice] 
Lower investment in research and development 

 

  Increase in insurance costs 
  Increase in costs for judicial claims 
  Lower exports 
  Increased difficulty in allocating strict liability in terms of identifying the right subject 
  Other (please specify) [text] 
  None of the above 
  I do not know 

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27. Are products purchased as a bundle with related services typically considered as “products” 

within the meaning of the Directive in your country? [yes/no/I do not know] 

28.  Do you think that there is a need of an EU approach for dealing with liability for products 

interconnected with services? [yes/no/I do not know] 

29. Do  you  think  that  there  is  a  need  to  provide  for  different  liability  cap  for  producers  other  than  the 

ones already provided by the Directive (i.e. €500, €70 M)? [yes/no/I do not know] 

30. Can you explain why? [text] 

31. Based  on  your  experience  and  in  particular  within  the  context  of  new  technological  developments, 
the  distinction  between  private  and  professional  use  of  a  product  is  still  adequate  (e.g.  a 
smartphone  can  be  used  for  both  private  and  professional  use)  [options:  strongly  agree,  agree, 
disagree, strongly disagree, I do not know]  

32. Based on your experience, and in light of new technological developments, the Directive adequately 
defines: [for each definition: strongly agree, agree, disagree, strongly disagree/ I do not know]  
a)  Product,  consisting  of  all  movables,  even  if  incorporated  into  another  movable  or  into  an 

immovable, including electricity. 

b)  Producer,  meaning the manufacturer  of a  finished  product, the producer  of  any raw material or 
the manufacturer of a component part and any person who, by putting his name, trade mark or 
other distinguishing 
feature on the product presents himself as its producer 

c)  Defect, meaning the lack of safety which the public is entitled to expect, taking all circumstances 
into  account,  including  the  presentation  of  the  product,  the  use  that  could  reasonably  be 
expected and the time when the product was put into circulation; 

d)  Damage,  caused  by  death  or  by  personal  injuries;  damage  to,  or  destruction  of,  any  item  of 

property other than the defective product itself;  

e)  Exemptions to producer’s liability: the product was not put into circulation by the manufacturer; 
the  defect  causing  the  damage  did  not  exist  when  the  product  was  put  into  circulation;  the 
product  was  not  manufactured  for  sale  or  distribution;  the  defect  is  due  to  product  compliance 
with  mandatory  regulations;  the  state  of  scientific  and  technical  knowledge  was  not  such  as  to 
enable the existence of the defect to be discovered; the defect is attributable to the design of the 
product in which the component has been fitted or to the instructions given by the manufacturer 
of the product. 

33. If any of the above definitions should be changed could you please explain why and how? [text] 

34. The  Directive  has  been  capable  to  guarantee  strict  liability  of  producers  for  damages  caused  by 
defective products (“strict liability” within the meaning of the Directive is liability without fault, where, 
based on Art.4, the injured person shall be required to prove the damage, the defect and the  causal 
relationship  between  defect  and  damage)?  [options:  strongly  agree,  agree,  disagree,  strongly 
disagree/ I do not know].  

35. Please explain why: [text] 

36. In your opinion, is the Directive adequate and sufficient to cover strict liability for damages caused by 

defect in any of the following new technological developments? [multiple choice] 
a)  Software embedded in products: [Yes/No/I do not know] 
b)  Products  on  which  software  and  applications  from  different  sources  can  be  installed  after 

purchase such as apps and other non-embedded software; [Yes/No/I do not know] 

c)  Products connected to and through the Internet (Internet of Things); [Yes/No/I do not know] 
d)  Products shared with other users through collaborative platforms; [Yes/No/I do not know] 
e)  Devices for 3D printing/additive manufacturing and products manufactured with them; [Yes/No/I 

do not know] 

f)  Advanced  robots  and  autonomous  systems  empowered  by  artificial  intelligence,  i.e.  physical 
machines  perceiving  their  environment  processing  this  information  correctly  and  then  carrying 

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out  a  complex  and  adequate  actions  autonomously,  e.g.  advanced  driver  assistance  systems  or 
completely  self-driving  cars,  these  systems  can  also  learn  from  their  actions;  [Yes/No/I  do  not 
know] 

g)  Software  –based  systems  empowered  by  artificial  intelligence,  i.e.  software  processing 
information  correctly  and  then  acting  appropriately,  e.g.  autonomous  trading  algorithms  or  any 
other big data algorithms. [Yes/No/I do not know] 

h)  Other, please specify 
37. Could you please explain why? 

38. [if  not]  Are  you  in  favour  of  a  revision  of  the  Directive’s  scope  to  include  the  abovementioned 
new  technological  developments  (strongly  agree,  agree,  disagree,  strongly  disagree,  I  do  not 
know) 

39. The revision of the Directive’s scope to include the abovementioned new technological developments 

would bring the following effects: [multiple choice] 
Lower investment in research and development 

 

 
 
 
 
 
 
 

Increase in insurance costs 
Increase in costs for judicial claims 
Lower exports 
Increased difficulty in allocating strict liability in terms of identifying the right subject 
Other (please specify) [text] 
None of the above 
I do not know 

40. The  Directive  is  effective  in  protecting  consumers  from  damages  caused  by  defective  products 

[options: strongly agree, agree, disagree, strongly disagree/ I do not know] 

41. Please  rate  to  which  extent  do  you  agree  with  the  following  statement:  The  protection  of 
consumers achieved by the Directive could not be reached by actions at national level or by means 
of single Member State action [options: strongly agree, agree, disagree, strongly disagree + option: 
“The Directive did not achieve protection of consumers”] 

42. The Directive is  effective  in  guaranteeing  a  level-playing  field  for  businesses  across  the  EU 
with respect to liability from damages caused by defective products  [options: strongly agree, agree, 
disagree, strongly disagree/ I do not know] 

43. Please  rate to which  extent do you agree  with the following statement:  The  level  playing  field  or 
the  balance  between  the  interest  of  producers  and  the  interest  of  consumers  achieved  by  the 
Directive could not be reached by actions at national level or by means of single Member State action 
[options: strongly agree, agree, disagree, strongly disagree + option: “The Directive did not achieve 
level playing field”] 

44. Has the Directive been implemented in a uniform way across Member States? [yes/no/I do not 

know] 

45.  [if no] Please provide specific examples, with specific reference to the Member State and to the 

different ways of implementing the same provision [text] 

46. Is there any other relevant issue you would like to bring to the Commission’s attention? [text]  

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1.  Could you please describe an experience you had relating to the application of the Directive? 

2.  How often have injured parties been compensated:  

a.  Through an out of court arrangement [always/often/rarely/never/I do not know] 
b.  Through a judicial decision [always/often/rarely/never/I do not know] 

3.  Based on your experience, the Directive is capable to cover strict liability in case of damages 
caused by defective products [options: strongly agree, agree, disagree, strongly disagree, I do not 
know] 

4.  In  your  opinion,  is  the  Directive  adequate  and  sufficient  to  cover  strict  liability  for  damages 

caused by defect in any of the following new technological developments? [multiple choice] 

a.  Software embedded in products: [Yes/No/I do not know] 
b.  Products on which software  and applications from  different sources  can be installed after 

purchase such as apps and other non-embedded software; [Yes/No/I do not know] 

c.  Products  connected  to  and  through  the  Internet  (Internet  of  Things);  [Yes/No/I  do  not 

know] 

d.  Products shared with other users through collaborative platforms; [Yes/No/I do not know] 
e.  Devices  for  3D  printing/additive  manufacturing  and  products  manufactured  with  them; 

[Yes/No/I do not know] 

f.  Advanced  robots  and  autonomous  systems  empowered  by  artificial  intelligence,  i.e. 
physical  machines  perceiving  their  environment  processing  this  information  correctly  and 
then  carrying  out  a  complex  and  adequate  actions  autonomously,  e.g.  advanced  driver 
assistance systems or completely self-driving cars, these systems can also learn from their 
actions; [Yes/No/I do not know] 

g.  Software  –based  systems  empowered  by  artificial  intelligence,  i.e.  software  processing 
information correctly and then acting appropriately, e.g. autonomous trading algorithms or 
any other big data algorithms. [Yes/No/I do not know] 

h.  Other, please specify 
5.  Could you please explain why? [text] 

6.  [if not] Are you in favour of a revision of the Directive’s scope to include the abovementioned 
new technological developments (strongly agree, agree, disagree, strongly disagree, I do not 
know) 

7.  The revision of the Directive’s scope to include the abovementioned new technological 

Lower investment in research and development Increase in insurance costs 
Increase in costs for judicial claims 
Lower exports 
Increased difficulty in allocating strict liability in terms of identifying the right subject 

developments would bring the following effects: [multiple choice] 
 
 
 
 
  Other (please specify) [text] 
  None of the above 

 

I do not know 

8.  The  Directive  applies  only  to  products.  Based  on  your  experience,  the  distinction  between 
products and services is appropriate in particular in light of new technological developments, 
thanks  to  which  products  can  be  purchased  as  a  bundle  with  related  services  (such  as  software 
embedded in products; products on which software and applications from different sources can be 
installed  after  purchase  such  as  apps  and  other  non-embedded  software;  products  connected  to 
and  through  the  Internet  (Internet  of  Things);  products  shared  with  other  users  through 
collaborative  platforms;  devices 
for  3D  printing/additive  manufacturing  and  products 
manufactured  with  them;  advanced  robots  and  autonomous  systems  empowered  by  artificial 
intelligence;  software–based  systems  empowered  by  artificial  intelligence)  [options:  strongly 
agree, agree, disagree, strongly disagree, I do not know] 

9.  The scope of the Directive should be extended to cover services, since they are often bundled 

with products [options: strongly agree, agree, disagree, strongly disagree] 

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10. Could you please explain why? [text] 

11. [if  yes]  The  revision  of  the  Directive’s  scope  to  include  services  would  bring  the  following 

effects: [multiple choice] 

 

Lower investment in research and development 

 

 

 

Increase in insurance costs 

Increase in costs for judicial claims 

Lower exports 

Increased difficulty in allocating strict liability in terms of identifying the right subject 

 
  Other (please specify) [text] 

  None of the above 

 

I do not know 

12. Are products purchased as a bundle with related services typically considered as “products” 

within the meaning of the Directive in your country? [yes/no/I do not know] 

13. Do  you  think  there  is  a  need  for  an  EU  approach  for  dealing  with  liability  for  products 

interconnected with services? 

14. Could you please explain why? [text] 

15. Which liability regime would be better? [the current system is ok/ I would prefer a comprehensive 
liability  regime  covering  both  products  and  services  /  I  would  prefer  different,  ad  hoc  regimes 
covering  different  fields  (i.e.  a  liability  regime  for  products,  a  regime  for  services,  and  another 
regime for products interconnected with services)/I do not know] 

16. [If  different  regimes  for  different  things]  In  case  of  IoT,  robotics  applications  and  autonomous 
systems, which of the following do you think is the best liability regime? [the current strict liability 
regime as it is in the Directive (e.g. in case a bypass user suffers a damage caused by a defective 
bypass, the strict liability is placed on the producer of the bypass)/ a risk-opening approach that 
would allocate the strict liability on the market actors using the technology (e.g. in case a bypass 
user suffers a damage caused by a defective bypass, the liability is placed on the hospital or any 
other  service  providers  besides  the  bypass  producer)/  a  risk-management  approach  putting  the 
strict liability on  the market  actor  best  placed  to minimise  risks and costs (e.g. in case a bypass 
user  suffers  a  damage  caused  by  a  defective  bypass,  the  strict  liability  is  placed  on  the  hospital 
besides the bypass producer)] 

17. Could you please explain why? [text] 

18. Do you think there is need to cover “pure economic loss” (i.e. a pecuniary loss not consequential 
upon injury or damage) amongst the damages caused by a defective product by design or as an 
add-on feature? [yes, by design/ yes, as an add-on feature /no/I do not know] 

19. Do you think that there is a need to provide for different liability cap for producers other than the 

ones already provided by the Directive (i.e. €500, €70 M)? [yes/no/I do not know] 

20. [if yes] Can you please specify? [text] 
21. Based on your experience and in particular within the context of new technological developments, 
the  distinction  between  private  and  professional  use  of  a  product  is  still  adequate  (e.g.  a 
smartphone  can  be  used  for  both  private  and  professional  use)  [options:  strongly  agree,  agree, 
disagree, strongly disagree, I do not know]  

22. Based on your experience, and also in light of new technological developments, the Directive 

adequately defines: [for each definition: strongly agree, agree, disagree, strongly disagree/ I do 
not know]  
a.  Product,  consisting  of  all  movables,  even  if  incorporated  into  another  movable  or  into  an 

immovable, including electricity. 

b.  Producer, meaning the manufacturer of a finished product, the producer of any raw material or 
the manufacturer of a component part and any person who, by putting his name, trade mark or 
other distinguishing feature on the product presents himself as its producer 

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c.  Defect,  meaning  the  lack  of  safety  which  the  public  is  entitled  to  expect,  taking  all 
circumstances  into  account,  including  the  presentation  of  the  product,  the  use  that  could 
reasonably be expected and the time when the product was put into circulation; 

d.  Damage,  caused  by  death  or  by  personal  injuries;  damage  to,  or  destruction  of,  any  item  of 

property other than the defective product itself;  

e.  Exemptions  to  producer’s  liability:  the  product  was  not  put  into  circulation  by  the 
manufacturer;  the  defect  causing  the  damage  did  not  exist  when  the  product  was  put  into 
circulation;  the  product  was  not  manufactured  for  sale  or  distribution;  the  defect  is  due  to 
product compliance with mandatory regulations; the state of scientific and technical knowledge 
was  not  such  as  to  enable  the  existence  of  the  defect  to  be  discovered;  the  defect  is 
attributable  to  the  design  of  the  product  in  which  the  component  has  been  fitted  or  to  the 
instructions given by the manufacturer of the product. 

23. Based on your experience, the Directive is effective in favouring a level playing field among 

producers [options: strongly agree, agree, disagree, strongly disagree] 

24. Please  rate  to  which  extent  do  you  agree  with  the  following  statement:  The  level  playing  field 
achieved by the Directive could not be reached by means of single Member State action  [options: 
strongly  agree,  agree,  disagree,  strongly  disagree +  option:  “The  Directive  did  not  achieve  level 
playing field”] 

25. Based on your experience, the Directive is effective in favouring the protection of 

consumers [options: strongly agree, agree, disagree, strongly disagree] 

26. Please  rate  to  which  extent  do  you  agree  with  the  following  statement:  The  protection  of 
consumers  achieved  by  the  Directive  could  not  be  reached  by  means  of  single  Member  State 
action [options: strongly agree, agree, disagree, strongly disagree + option: “The Directive did not 
achieve protection of consumers”] 

27. Has the Directive been implemented in a uniform way across Member States? [yes/no/I do not 

know] 

28.  [if no]  Please  provide specific examples,  with  specific reference  to the Member State and  to the 

different ways of implementing the same provision [text] 

29. Is there any other relevant issue you would like to bring to the Commission’s attention? [text] 

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1.  Could you please describe an experience you had relating to the application of the Directive? 

2.  Do you perceive that the tendency to report claims for damages caused by defective products 
has changed since the entry into force of the Directive? [yes, it increased/yes, it decreased/no, it 
remained unchanged/I do not know] 

3.  Have you ever dealt with cases concerning damages caused by new technological developments in 

the last five years (e.g. software embedded in products, products on which software and 
applications from different sources can be installed after purchase such as apps and other non-
embedded software, products connected to and through the Internet (Internet of Things), products 
shared with other users through collaborative platforms, devices for 3D printing/additive 
manufacturing and products manufactured with them, advanced robots and autonomous systems 
empowered by artificial intelligence, software–based systems empowered by artificial intelligence)? 
[yes/no/ I do not know] 

4.  If yes, what were the main issues at stake? [multiple choice] 

  Proving that the product was defective  
  Proving the link between the defect and the damage  
  Attributing liability to a specific person or entity  
  Discovering where exactly the defect occurred  
  Proving the damage  
  The requirement that compensation is granted only for property damage of at least €500  
  Having to prove that the defective product was intended and used for private purposes  
  The  three  years  period  for  the  injured  party  to  start  the  proceeding  for  the  recovery  of 

damages  

  The  expiry  period  of  10  years  from  the  moment  that  the  producer  put  the  product  into 

circulation  

  Other (please specify)]  

5.  The  Directive  applies  only  to  products.  Based  on  your  experience,  the  distinction  between 
products  and  services  is  appropriate,  particularly  in light  of  new technological  developments, 
thanks  to  which  products  can  be  purchased  as  a  bundle  with  related  services  (such  as  software 
embedded in products; products on which software and applications from different sources can be 
installed  after  purchase  such  as  apps  and  other  non-embedded  software;  products  connected  to 
and  through  the  Internet  (Internet  of  Things);  products  shared  with  other  users  through 
collaborative platforms; devices for 3D printing/additive manufacturing and products manufactured 
with  them;  advanced  robots  and  autonomous  systems  empowered  by  artificial  intelligence; 
software–based  systems  empowered  by  artificial  intelligence)  [options:  strongly  agree,  agree, 
disagree, strongly disagree, I do not know] 

6.  Are products purchased as a bundle with related services typically considered as “products” 

within the meaning of the Directive in your country? [yes/no/I do not know] 

7.  The scope of the Directive should be  extended to  cover services, since they are often bundled 

with products [options: strongly agree, agree, disagree, strongly disagree] 

8.  Could you please explain why? [text] 

9.  [if  yes]  The  revision  of  the  Directive’s  scope  to  include  services  would  bring  the  following 

effects: [multiple choice] 
Lower investment in research and development 

 

 

 

 

Increase in insurance costs 

Increase in costs for judicial claims 

Lower exports 

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  Other (please specify) [text] 

  None of the above 

 

I do not know 

10. Do  you  think  there  is  a  need  for  an  EU  approach  for  dealing  with  liability  for  products 

interconnected with services? [yes/no/I do not know] 

11. Could you please explain why? [text] 

12. Based on your experience and particularly in the context of new technological  developments, the 
distinction  between  private  and  professional  use  of  a  product  is  still  adequate  (e.g.  a 
smartphone  can  be  used  for  both  private  and  professional  use)  [options:  strongly  agree,  agree, 
disagree, strongly disagree, I do not know]  

13. Based on your experience, the Directive adequately defines: [for each definition: strongly agree, 

agree, disagree, strongly disagree/ I do not know]  

a.  Product,  consisting  of  all  movables,  even  if  incorporated  into  another  movable  or  into  an 

immovable, including electricity. 

b.  Producer,  meaning  the  manufacturer  of  a  finished  product,  the  producer  of  any  raw 
material  or  the  manufacturer  of  a  component  part  and  any  person  who,  by  putting  his 
name,  trade  mark  or  other  distinguishing  feature  on  the  product  presents  himself  as  its 
producer 

c.  Defect,  meaning  the  lack  of  safety  which  the  public  is  entitled  to  expect,  taking  all 
circumstances  into  account,  including  the  presentation  of  the  product,  the  use  that  could 
reasonably be expected and the time when the product was put into circulation; 

d.  Damage, caused by death or by personal injuries; damage to, or destruction of, any item 

of property other than the defective product itself;  

e.  Exemptions  to  producer’s  liability:  the  product  was  not  put  into  circulation  by  the 
manufacturer; the defect causing the damage did not exist when the product was put into 
circulation; the product was not manufactured for sale or distribution; the defect is due to 
product  compliance  with  mandatory  regulations;  the  state  of  scientific  and  technical 
knowledge  was  not  such  as  to  enable  the  existence  of  the  defect  to  be  discovered;  the 
defect is attributable to the design of the product in which the component has been fitted 
or to the instructions given by the manufacturer of the product. 

14. In your opinion, is the Directive adequate and sufficient to cover strict liability for damages caused 

by defect in any of the following new technological developments? [multiple choice] 

a.  Software embedded in products: [Yes/No/I do not know] 
b.  Products  on  which  software  and  applications  from  different  sources  can  be  installed  after 

purchase such as apps and other non-embedded software; [Yes/No/I do not know] 

c.  Products  connected  to  and  through  the  Internet  (Internet  of  Things);  [Yes/No/I  do  not 

know] 

d.  Products shared with other users through collaborative platforms; [Yes/No/I do not know] 
e.  Devices  for  3D  printing/additive  manufacturing  and  products  manufactured  with  them; 

[Yes/No/I do not know] 

f.  Advanced  robots  and  autonomous  systems  empowered  by  artificial  intelligence,  i.e. 
physical  machines  perceiving  their  environment  processing  this  information  correctly  and 
then  carrying  out  a  complex  and  adequate  actions  autonomously,  e.g.  advanced  driver 
assistance systems or completely self-driving cars, these systems can also learn from their 
actions; [Yes/No/I do not know] 

g.  Software  –based  systems  empowered  by  artificial  intelligence,  i.e.  software  processing 
information correctly and then acting appropriately, e.g. autonomous trading algorithms or 
any other big data algorithms. [Yes/No/I do not know] 

h.  Other, please specify 

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15. Could you please explain why? [text] 

16. [if not] Are you in favour of a revision of the Directive’s scope to include the abovementioned 
new technological developments (strongly agree, agree, disagree, strongly disagree, I do not 
know) 

17. The revision of the Directive’s scope to include the abovementioned new technological 

developments would bring the following effects: [multiple choice] 
Lower investment in research and development 

 

Increase in insurance costs 
Increase in costs for judicial claims 
Lower exports 

 
 
 
  Other (please specify) [text] 
  None of the above 
I do not know 
 

18. Could the introduction of a risk and/or of an unintended autonomous behaviour be considered as a 

"defect" for the purposes of the Directive? [yes/no/I do not know] 

19. How should the Directive work in case the role of the human being decreases or stops having any 

influence? [text] 

20. Which liability regime would be better? [the current system is ok/ I would prefer a comprehensive 
liability  regime  covering  both  products  and  services  /  I  would  prefer  different,  ad  hoc  regimes 
covering  different  fields  (i.e.  a  liability  regime  for  products,  a  regime  for  services,  and  another 
regime for products interconnected with services)/I do not know] 

21. [If  different  regimes  for  different  things]  In  case  of  IoT,  robotics  applications  and  autonomous 
systems, which of the following do you think is the best liability regime? [the current strict liability 
regime as it is in the Directive (e.g. in case a bypass user suffers a damage caused by a defective 
bypass, the strict liability is placed on  the  producer of the bypass)/ a risk-opening approach that 
would allocate the strict liability on the market actors using the technology (e.g. in case a bypass 
user suffers a damage caused by a defective bypass,  the liability is placed on the hospital or any 
other  service  providers  besides  the  bypass  producer)/  a  risk-management  approach  putting  the 
strict liability on the market  actor best placed  to minimise  risks and costs (e.g. in case a bypass 
user  suffers  a  damage  caused  by  a  defective  bypass,  the  strict  liability  is  placed  on  the  hospital 
besides the bypass producer)] 

22. Could you please explain why? [text] 

23. Do you think there is need to cover “pure economic loss” (i.e. a pecuniary loss not consequential 
upon injury or damage) amongst the  damages caused by a defective product by design or as an 
add-on feature? [yes, by design/yes, as an add-on feature /no/I do not know] 

24. Do  you  perceive  any  differences  in  the  level  of  complexity  of  the  technical  activity  if  a 
“traditional” product rather than a product relating to new Technological Development is involved? 
[yes/no/ I do not know] 

25. The Directive has been capable  to guarantee strict liability of producers for damages caused by 
defective  products  (“strict  liability”  within  the  meaning  of  the  Directive  is  liability  without  fault, 
where, based on Art.4, the injured person shall be required to prove the damage, the defect and 
the  causal  relationship  between  defect  and  damage)?  [options:  strongly  agree,  agree,  disagree, 
strongly disagree/ I do not know].  

26. Please rate to which extent do you agree with the following statement: The level playing field 

achieved by the Directive could not be reached by means of single Member State action [options: 
strongly agree, agree, disagree, strongly disagree, The Directive did not achieve level playing field, 

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TECHNICAL EXPERTS 

I do not know] 

27. Please rate to which extent do you agree with the following statement: The protection of 

consumers achieved by the Directive could not be reached by means of single Member State 
action [options: strongly agree, agree, disagree, strongly disagree, The Directive did not achieve 
the protection of consumers, I do not know] 

28. Is there any other issues you would like to bring to the Commission’s attention? [text] 

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Annex 5 

CATI survey questionnaire 

The CATI survey consists of one questionnaire lasting 12.5 minutes targeted to businesses. 
The questions have been customised to cover issues specifically relevant for them in relation 
with  the  Directive.  The  questionnaires  consist  mainly  of  closed  questions  (i.e.  multiple 
choice, yes/no). The questions and structure  of the questionnaires have been developed in 
close collaboration with the Steering Group. Finally, the questionnaire is translated into 
national languages of Member States to interview stakeholders in their own language. 

Introduction: The sponsor of this survey is the EC and carried out by EY and its partners. 
The  EC is  evaluating the Directive on the liability for defective products. In the  subsequent 
questions,  we  will  ask  you  about  the  practices  of  your  company  or  your  business  line,  and 
your opinion about this topic, which will feed directly (anonymous) into the evaluation. The 
feedback from companies like yours will be very important for the European Commission to 
assess how well the Directive works, and possibly to propose amendments to it. Thank you 
in advance for your participation. 

60. Please select the geographical area covered by your company  
[READ the list] 

□  national level 
□  EU-EEA level 
□ 

international level 

61. Please  indicate  the  type  of  insurance  contract  your  company  has  to  cover  compensation  costs  in 

case of damages caused by defective products  

[READ the list] 

□  Specific insurance contract for strict liability (i.e. an extra-contractual liability without fault 

on the producer)  

□  General insurance contract covering different risks  
□  No insurance contract 

62. How  many  claims  for  damages  caused  by  defects  or  malfunctioning  of  any  of  your  products  has 

your company received last year? (Please give your best estimate.) [enter number]  

(If the answer is “zero”, go to Q5. If the answer is different than “zero”, go to Q6) 

63. Has your company received at least one claim since 2000?  
[READ the list]  

□  Yes 
□  No 
□ 

I do not know 

64. How many of these claims were settled out of court? (please give your best estimate) 
[READ the list]  

□  0% 
Less than 25% 
□ 
□  Between 26-50% 
□  Between 51-75% 
□  More than 76% 
□  100% 
□ 

I do not know 

65. How many of the cases decided in court were in your favour?  

[READ the list] 

□  0% 

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Less than 25% 
□ 
□  Between 26-50% 
□  Between 51-75% 
□  More than 76% 
□  100% 
□ 

I do not know 

66. To  what  extent  are  you  satisfied  with  the  following  legislative  provisions  on  the  liability  for 

defective products, considering their impact on your business?  

Dissatisfied 

Neutral  

Satisfied 

No Opinion 

[READ the list] 

The  producer  is  considered  liable 
independently  of  his 
fault  or 
negligence 

The  injured  party  has  to  prove  the 
defect,  the  damage  caused,  and  the 
casual link between them 

The  exemptions  of  producers  from 
liability,  e.g.  the  defect  appeared 
after  the  product  was  put 
into 
circulation 

The  expiry  period  of  10  years  from 
the  moment  that  the  producer  put 
the product into circulation  

The three year period for the injured 
party  to  start  the  proceeding  for  the 
recovery of damages  

The  requirement  that  only  damage 
caused  by  defective  items  intended 
and  used  for  private  purpose  can  be 
compensated  

Compensation  is  granted  only  for 
damage to property of at least €500  

67. In general, do the provisions of the Directive have an impact on the following costs or outcomes?  
[READ the list] 

Increasing 

No Impact 

Decreasing 

No Opinion 

The  propensity  of  private  end-users 
to report claims 

The  probability  to  be  subjected  to 
pay compensation  

The  amount  of  compensation  per 
case 

The  likelihood  to  settle  claims  out  of 
court 

The costs of legal settlement 

The cost of liability insurance 

68. In  general,  are  the  costs  (e.g.  for  compensation,  judicial  trials,  insurance)  and  benefits  (e.g. 

limited threshold) of the Directive well-balanced?  

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[READ the list]  

□  Yes 
□  No 
□ 

I do not know 

69. What impact, if any, would the following possible modifications of the Directive have on businesses 

like yours? 

 [READ the list] 

Advantageou

Neutra

Disadvantageou

No Opinion 

s 

l 

s 

Extending its scope to services 

Limiting  its  scope  only  to  tangible  products, 
excluding for instance software 

Expanding 
the  strict 
operators who are not the producers 

liability 

to  market 

Enlarging  the  concept  of  "defect"  from  safety 
of use to also fitness for use 

Removing  the  burden  of  proof  of  the  defect 
from the injured party 

Enlarging  the  types  of  damages  to  also  cover 
economic loss 

Reducing the types of damages  

Removing  the  producer's  exemption  from 
liability on grounds of the inadequate state of 
scientific  and  technological  knowledge  at  the 
time of commercialisation of the product  

Reducing the three-year period for the injured 
party to start the proceedings for the recovery 
of damages 

Reducing  the  expiry  period  of  10  years  from 
when 
in 
circulation 

the  producer  put 

the  product 

70. Do you think that the lower threshold of €500os for liability of producers should be changed?  

[READ the list]  

□  Yes, raised 
□  Yes, decreased 
□  No 
□ 

I do not know 

71. If yes, at approximately how many euros should the threshold lie in your view? [enter number] 

72. Should the upper threshold of 70 million euros for liability of producers be changed?  

[READ the list]  

□  yes, raised 
□  yes, decreased 
□  no 
□ 

I do not know 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

73. At approximately how many euros should the threshold lie in your view? [enter number] 

New technological developments subsection 

74. Does your company make or sell consumer products based on new technologies, such as products 
with  embedded  software,  applications,  artificial  intelligence,  products  communicating  through  the 
Internet,  3D  printing  tools?  (If  respondent  asks  examples:  smartphones,  intelligent  refrigerators, 
autonomous cars, robotic vacuum cleaners) 

[READ the list] 

□  Yes 
□  No (If “no”, close the interview) 

75. To  what  extent  do  you  agree  with  the  following  statements  on  the  current  rules  for  these  new 

technologies?  

[READ the list] 

Agree  Neithe

Disagre

No 

r 

e 

Opinion 

Apps and non-embedded software or components of Internet of 
Things  can  be  considered  “products”  with  regard  to  product 
liability rules 

The  allocation  of  liability  between  the  different  actors  in  the 
case of interconnected products is adequately regulated  

The  definition  of  defect  in  the  case  of  damages  caused  by  an 
advanced robot or an autonomous system is adequate  

The distinction between product and services is adequate 

76. Do  you  think  that  the  definitions  of:  product,  producer  and  defect,  together  with  the  category  of 
exceptions  are  adequate  for  your  business  model  building  upon  these  new  technological 
developments? 

[READ the list]  

□  Yes 
□  No 
□ 

I do not know 

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Annex 6 

Interview questionnaire 

The  following  section  presents  the  list  of  questions  used  during  the  interviews,  divided  per 
stakeholder  category.  Each  question  refers  (in  square  brackets)  to  the  evaluation  criterion 
and question it has feed for the analysis.  

Interviews  have  been  used  to  further  investigate,  clarify  or  triangulate  data  collected 
through the desk research, surveys and OPC. Therefore, these guidelines should be consider 
as non-exhaustive. 

Industry associations, producers, importers and suppliers (including SMEs) 

Results of the Directive 

1.  What  is  your  overall  assessment  of  the  results  achieved  by  the  Product  Liability 

Directive with reference to its specific objectives of  
a.  Guaranteeing  at  EU  level  the  liability  of  the  producer  for  damage  caused  by  a 

defective product?  

b.  Contributing to an effectively operating internal market? [Effectiveness-Q1] 

2.  Has the Directive impacted the volumes and the types of products imported from third 

countries? [Effectiveness-Q1] 

3.  Are there any unexpected results? [Effectiveness-Q1] 

4.  What are the most important benefits for producers stemming from the Directive? Is it 
possible to quantify and qualify them? Can they be further increased?  How?  Is there a 
role that could be played by industry associations? [Efficiency – Q22] 

5.  What are the main costs for producers? [Efficiency – Q 23]  

6.  Are  there  specificities  in  terms  of  costs  and  benefits  for  SMEs?  Can  you  specify? 

[Efficiency – Q22; Q23] 

7.  What  is  your  overall  assessment  about  the  relationship  between  costs  and  benefits  for 
producers?  Are  benefits  achieved  at  a  reasonable  cost?  Do  you  think  there  is  a  fair 
balance  between  the  costs  borne  by  producers  to  cover  strict  liability  and  the 
requirements on the injured party to obtain compensation? [Efficiency – Q23; Q24] 

8.  Are  there  differences  in  terms  of  benefits  across  sectors?  Why?  Are  there  sectors  with 

more cases of claims for defective products? [Effectiveness- Q1] 

9.  Do you see any negative effects stemming from the Directive? [Effectiveness-Q1] 
10.  Which aspects of the Directive are more important in determining these results? Which 
are less important (proof of defect, proof of damage, proof of link, attribution of liability 
to  specific  person/  entity,  threshold  of  €500  ,  proof  of  private  use,  three-year-expiry 
period)? [Effectiveness-Q2, Q3] Which are the most efficient and inefficient? [Efficiency 
– Q25] 

11.  What is your opinion about the application of the Directive in cases where there is not a 
clear distinction between private and professional use of products, particularly in light of 
new technological developments? [Relevance – Q30] 

12.  Are  there  specific  issues  you  want  to  highlight  in  terms  of  implementation  of  the 
Directive  in  your  Member  State?  Do  you  know  any  cases  of  Gold-Plating  (i.e.  national 
practices  incorporating  additional/  costly/  unnecessary  requirements)?  [Effectiveness-
Q2, Q3] 

New technological developments 

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13.  As  for  the  benefits  of  the  Directive,  are  there  any  differences  when  considering  cases 
relating  to  new  technological  products?  (e.g.  apps  and  other  non-embedded  software, 
interconnected devices in the context of Internet of Things, advanced robots, automated 
and autonomous systems) [Effectiveness- Q5, Q6, Q13] 

14.  Are  there  specific  needs  connected  to  new  technological  developments  (i.e.  apps  and 
other non-embedded software, interconnected  devices linked to the  Internet of Things, 
advanced  robots  and  autonomous  systems)  that  are  not  covered  by  the  Directive? 
[Effectiveness - Q5, Q6, Q13] [Relevance – Q28] 

15.  Which  are  the  typical  damages  caused  by  products  relating  to  new  technological 
products?  [Effectiveness-  Q1]  Are  there  any  specificities  in  the  different  types  of 
technological  developments  that  impact  on  the  implementation  of  the  Directive?  (i.e. 
apps and other non-embedded software vs interconnected devices linked to the Internet 
of  Things  vs  advanced  robots/automated/autonomous  systems)  [Effectiveness  –  Q19, 
Relevance – Q31] 

16.  Do  you  see  any  problems  in  the  allocation  of  liability  between  the  different  actors 

involved? [Effectiveness – Q19] 

17.  More in general, do you think the  definitions of: product, producer, damage and defect 
together  with  the  categories  of  exceptions  are  adequate  when  considering  changes  in 
business  models  stemming  from  these  technological  developments?  Is  the  distinction 
between product and services suitable for new technological developments?  [Relevance 
– Q29; Q31]  

18.  Can  you  provide  any  examples  of  specific  difficulties  encountered  when  applying  these 
definitions?  Do  you  have  any  suggestions  on  how  these  definitions  should  be 
changed/modified? [Relevance – Q29; Q31]  

Future perspectives 

19.  Are there any needs that are not currently addressed by the Directive? Is there anything 

specific relating to new technological developments? [Relevance – Q28] 

20.  Do  you  have  any  opinions  about  reducing  or  widening  the  scope  of  the  Directive,  for 
instance  in  terms  of:  explicitly  including/excluding  services,  products  in  bundle  with 
services, new technological development products, expanding the strict liability to other 
market operators, enlarging the concept of "defect"? And about repealing it? What would 
be the consequences? [EU Added Value– Q35, Q36] 

Consumer organisations 

Results of the Directive 

1.  What  is  your  overall  assessment  of  the  results  achieved  by  the  Product  Liability 
Directive  with  reference  to  its  specific  objective  of  contributing  to  the  protection  of 
consumers? [Effectiveness-Q1] 

2.  Are there other unexpected results? [Effectiveness-Q1] 

3.  What  are  the  most  important  benefits  for  consumers?  Is  it  possible  to  quantify  and 
qualify them? Can they be further increased? How? Is there a role that could be played 
by consumer associations? [Efficiency – Q22] 

4.  What  are  the  main  costs  for  consumers?  What  is  the  opinion  of  European  consumers 
with respect to the necessary requirements to obtain compensation in cases of defective 
products? [Efficiency – Q24] 

5.  What  is  your  overall  assessment  about  the  relationship  between  costs  and  benefits  for 
consumers? Are benefits achieved at a reasonable cost? Do you think overall there is a 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

fair balance between the costs borne by the producers to cover the strict liability and the 
requirements on the injured party to obtain compensation? [Efficiency – Q23-24] 

6. 

Is  your  assessment  based  on  any  monitoring  tools  on  consumer  satisfaction  on  the 
implementation  of  the  Directive  when  dealing  with  claims  for  damages  relating  to 
defective products? [Effectiveness-Q1] 

7.  Which  aspects  of  the  Directive  are  more  important  in  determining  consumers’ 
protection?  Which  are  less  important  (proof  of  defect,  proof  of  damage,  proof  of  link, 
attribution  of  liability  to  specific  person/entity,  threshold  of  500  €,  proof  of  private 
purposes,  three-year-expiry  period)?  [Effectiveness-Q2,  Q3];  Which  are  the  most 
efficient and inefficient [Efficiency – Q25] 

8.  What is your opinion about the application of the Directive in cases where there is not a 
clear  distinction  between  private  and  professional  use  of  the  products?  [Relevance  – 
Q30] 

9.  What are, if any, the main difficulties for consumers in proving the defect of the product 

and the casual link between the defect and the damage? [Effectiveness-Q15]  

10.  Under what circumstances and with what type of products are there more difficulties in 
obtaining  compensation  for  the  damages,  once  proved  the  casual  link  between  the 
product and the damage? [Effectiveness- Q1] 

New technological developments 

11.  Are  there  cases  of  damages  caused  to  consumers  by  products  relating  to  new 
software, 
technological  developments 
interconnected devices in the context of Internet of Things, advanced robots, automated 
and autonomous systems)? [Effectiveness- Q5, Q6, Q13] 

(e.g.  apps  and  other  non-embedded 

12.  Are  there  specific  obstacles  consumers  face  in  these  cases  in  the  context  of  product 
liability  (e.g.  identifying  the  liable  subject)?  What  are  the  possible  solutions  to  face 
them? [Effectiveness- Q5, Q6, Q13, Q19] 

13.  Are there specific difficulties relating to the definition of product, producer, damage and 
defect provided in the Directive? Is the distinction between product and services suitable 
for new technological developments? [Relevance – Q29; Q31] 

14.  Are  there  any  specificities  in  the  different  types  of  technological  developments  that 
impact on the application of the Directive? (i.e. apps and other non-embedded software 
vs  interconnected  devices  linked  to  the  Internet  of  Things  vs  advanced  robots/ 
automated/autonomous systems) [Effectiveness – Q19] 

Future perspectives  

15.  Are there any needs that are not currently addressed by the Directive? Anything specific 

relating to new technological developments? [Relevance – Q28] 

16.  Do  you  have  any  opinions  about  reducing  or  widening  the  scope  of  the  Directive  for 
instance  in  terms  of:  explicitly  including/excluding  services,  products  in  bundle  with 
services, new technological development products, expanding the strict liability to other 
market operators, enlarging the concept of "defect"? And about repealing it? What would 
be the consequences? [EU Added Value– Q35, Q36] 

PAs, individual experts from academia, think tanks, law firms, and others 

Results of the Directive 

1.  What  is  your  overall  assessment  of  the  results  achieved  by  the  Product  Liability 

Directive with reference to its specific objectives of  

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

a.  Guaranteeing at EU level the liability of the producer for damage caused by a 

defective product?  

b.  Contributing to an effective operating internal market?  
c.  Contributing to the protection of consumers? [Effectiveness-Q1] 

2.  Are there other unexpected results? [Effectiveness-Q1] 

3.  What are the main benefits for producers and consumers? [Efficiency - Q22] 

4.  Which aspects of the Directive are more important in determining these results (proof of 
defect,  proof  of  damage,  proof  of  link,  attribution  of  liability  to  specific  person/entity, 
threshold of €500, proof of private purposes, three-year-expiry period)? [Effectiveness-
Q2, Q3] Which are the most efficient and inefficient [Efficiency – Q25] 

5.  What is your opinion about the application of product liability legislation in cases where 
there  is  not  a  clear  distinction  between  private  and  professional  use  of  the  products? 
[Relevance – Q30] 

6.  What is the percentage of claims settled out-of-courts? [Effectiveness Q1] 

7.  Are  there  specific  products  for  which  it  is  more  difficult  to  obtain  compensation?  Why? 

[Effectiveness Q9] 

8.  Do you think there is a fair balance between the costs borne by producers to cover strict 
liability and the requirements on the injured party to obtain compensation? [Efficiency – 
Q24] 

9.  Based  on  your  experience,  what  are  the  aspects  of  the  legislation  on  product  liability 

that should be revised? [Efficiency – Q25] 

10.  Are there elements in the legislation on product liability that are not efficient and should 

be changed? Can you elaborate? [Efficiency – Q25] 

11.  Do  you  see  any  inconsistencies  between  the  Directive  and  other  pieces  of  legislation, 

including those on consumer protection? [Coherence – Q26] 

12.  Do  you  see  any  inconsistencies/overlapping  of  the  Directive  with  legislation  on 
contractual  liability  and  other  legislation  on  extra-contractual  liability  based  on  fault? 
[EU added value – Q34] 

13.  Are  there  specific  issues  you  want  to  highlight  in  terms  of  implementation  of  the 

Directive in Member States?  

New technological developments 

14.  Do you think the definitions of: product, producer, damage and defect together with the 
category  of  exceptions  are  adequate  when  considering  changes  in  business  models 
stemming from these technological developments?  

15.  Is  the  distinction  between  product  and  services  suitable  for  new  technological 

developments? [Relevance – Q29; Q31] 

16.  Can  you  highlight  any  specificities  in  the  different  types  of  technological  developments 
and  how  they  impact  on  the  application  of  the  Directive?  (i.e.  apps  and  other  non-
embedded  software  vs  interconnected  devices  linked  to  the  Internet  of  Things  vs 
advanced  robots/automated/autonomous  systems)  [Effectiveness  –  Q19;  Relevance  – 
Q31] 

Future perspectives  

17.  Are there specific needs/issues connected to new technological developments (i.e. apps 
and  other  non-embedded  software,  interconnected  devices  linked  to  the  Internet  of 
Things,  advanced  robots  and  autonomous  systems)  that  are  not  covered  by  the 
Directive? [Effectiveness - Q5, Q6, Q13] [Relevance – Q28] 

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18.  Do  you  have  any  opinions  about  reducing  or  widening  the  scope  of  the  Directive  for 
instance  in  terms  of:  explicitly  including/excluding  services,  products  in  bundle  with 
services, new technological development products, expanding the strict liability to other 
market operators, enlarging the concept of "defect"? And about repealing it? What would 
be the consequences [EU Added Value– Q35, Q36] 

Insurance companies (including federations) 

Results of the Directive 

1.  What  is  your  overall  assessment  of  the  results  achieved  by  the  Product  Liability 

Directive with reference to its specific objectives of  

a.  Guaranteeing at EU level the liability of the producer for damage caused by a 

defective product?  

b.  Contributing to the protection of consumers? [Effectiveness-Q1] 
2.  Are there unexpected impacts on the insurance sector? [Effectiveness-Q1] 

3.  What is the percentage of claims settled out-of-courts? [Effectiveness Q1] 

4.  What are the cases where the producer supplier is liable for a defective product but the 

consumer cannot receive compensation by the insurance? [Effectiveness-Q1] 

5.  Do  you  think  the  distinction  between  private  and  professional  use  of  the  products  is 

always clear to apply the Directive? [Relevance – Q30] 

6.  What  is  your  assessment  of  the  relationship  between  costs  and  benefits  for  producers 
and  consumers?  Do  you  think  there  is  a  fair  balance  between  the  costs  borne  by  the 
producers to cover the strict liability and the requirements on the injured party to obtain 
compensation? [Efficiency – Q23; Q24] 

7. 

If the balance has any distortions, how is it possible to correct them? [Efficiency – Q24] 

New technological developments 

8.  Are there specific difficulties relating to the definition of product, producer, damage and 
defect  provided  in  the  Directive  especially  considering  new  technological  developments 
and 
relating 
robot/automated/autonomous systems? Is the distinction between product and services 
suitable for new technological developments? [Relevance – Q29; Q31] 

interconnected  products, 

to  non-embedded 

software, 

apps/ 

9.  Are there specific contractual arrangements to cover cases relating to new technological 
developments  (e.g.  apps  and  other  non-embedded  software,  interconnected  devices  in 
the  context  of  Internet  of  Things,  advanced  robots,  automated  and  autonomous 
systems)? If yes, can you clarify why do you need to have them?[Effectiveness-Q1, Q5, 
Q6, Q13]  

10.  What  it  the  percentage  of  claims  over  total  number  of  claims  for  defective  products 

relating to new technological developments? [Effectiveness – Q17; Q18; Q19]  

11.  Have there been cases brought to the national courts or solved through an out of court 
settlement relating to the application of the Directive to damages caused by a robot, in 
particular  in  an  advanced  robot  or  an  autonomous  system?  If  it  is  the  case,  what  was 
the issue at stake and the ruling? [Effectiveness – Q18] 

Future perspectives  

12.  Do  you  have  any  opinions  about  reducing  or  widening  the  scope  of  the  Directive  for 
instance  in  terms  of:  explicitly  including/excluding  services,  products  in  bundle  with 
services, new technological development products, expanding the strict liability to other 
market operators, enlarging the concept of "defect"? And about repealing it? What would 
be the consequences [EU Added Value– Q35, Q36] 

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Technical experts 

Results of the Directive 

1.  What  is  your  overall  assessment  of  the  results  achieved  by  the  Product  Liability 

Directive with reference to its specific objectives of  

a.  Guaranteeing at EU level the liability of the producer for damage caused by a 

defective product?  

b.  Contributing to an effective operating internal market?  
c.  Contributing to the protection of consumers? [Effectiveness-Q1] 

2.  Are there other unexpected results? [Effectiveness-Q1] 

3.  What  are  the  most  important  benefits  for  consumers  and  producers?  Is  it  possible  to 
quantify and qualify these? Can they be further increased? How? [Efficiency – Q22] 

4.  Which aspects of the Directive are more important in determining these results? Which 
are least important (proof of defect, proof of damage, proof of link, attribution of liability 
to specific person/entity, threshold of €500, proof of private purposes, three-year-expiry 
period)? [Effectiveness-Q2, Q3] Which are the most efficient and inefficient [Efficiency – 
Q25] 

5.  What is your opinion about the application of product liability legislation in cases where 
there  is  not  a  clear  distinction  between  private  and  professional  use  of  the  products 
[Relevance – Q30] 

6. 

If  we  compare  the  legislation  on  product  liability  in  the  EU,  with  the  same  type  of 
legislation outside Europe, what are the elements of differentiation? And which one can 
be considered more or less efficient to in reaching its objectives? [Efficiency – Q25] 

New Technological Developments 

7. 

In  your  opinion,  to  what  extent  do  the  initial  objectives  of  the  legislation  on  product 
liability  correspond  to  the  current  needs  of  consumers  and  producers  in  view  of  new 
technological developments [Relevance – Q28], and to what extent does the distinction 
between  products  and  services  when  dealing  with  product  liability  continue  to  be 
suitable for new technological products? [Relevance – Q29] 

8. 

Is it possible to consider apps and non-embedded software or components of Internet of 
Things  as  “products”  for  the  purpose  of  the  current  legislation  on  the  product  liability? 
[Effectiveness – Q5, Q6, Q13] 

9.  Do  you  see  any  problems  in  the  allocation  of  liability  between  the  different  actors 
involved  in  the  case  of  interconnected  products  linked  to  New  Technological 
Developments? [Effectiveness – Q19] 

10.  Do you see any issues relating to the definition of defect in the case of damages caused 
by  a  robot,  in  particular  in  an  advanced  robot  or  an  autonomous  system?  If  it  is  the 
case, what was the issue at stake and the ruling? [Effectiveness – Q18] 

11.  More in general, do you think the  definitions of: product, producer, damage and defect 
together  with  the  category  of  exceptions  are  adequate  when  considering  changes  in 
business models stemming from these technological developments?  

12.  Is  the  distinction  between  product  and  services  suitable  for  new  technological 

developments? [Relevance – Q29; Q31] 

13.  Is  it  possible  to  identify  the  needs/issues  which  are  not  covered  by  the  current 

legislation and that should be satisfied? [Relevance – Q28] 

Future perspectives 

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EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

14.  Based  on  your  knowledge,  what  are  the  points  in  the  context  of  the  legislation  on 

product liability that should be revised (removed/modified)? [Efficiency – Q25] 

15.  Do  you  have  any  opinions  about  reducing  or  widening  the  scope  of  the  Directive  for 
instance  in  terms  of:  explicitly  including/excluding  services,  products  in  bundle  with 
services, new technological development products, expanding the strict liability to other 
market operators, enlarging the concept of "defect"? And about repealing it? What would 
be the consequences [EU Added Value– Q35, Q36] 

163 

 
 
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Annex 7 

Template of the Country fiches 

The following tables presents a draft of the country fiche for the legal mapping. 

Survey question 

Type of question 

BACKGROUND INFORMATION 

1.  Please select your Member State 

[dropdown menu] 

2.  Please 

indicate 

the  national 

legislation 

transposing 

[reference of the law] 

Directive 85/374/EEC 

3.  Does your MS adopt the derogation under Article 15 of the 
Directive, 1(b) (by which the producer shall be liable even 
if  he  proves  that  the  state  of  scientific  and  technical 
knowledge  at  the  time  when  he  put  the  product  into 
circulation  was  not  such  as  to  enable  the  existence  of  a 
defect to be discovered)? 

4.  Has  your  MS 

introduced  any  additional  measures, 
procedures  or  burdens  regarding  the  application  of  the 
Directive,  which  are  not  expressly  provided  for  in  the 
Directive?  

[yes/no] 

[yes/no/I do not know] 

5.  [if A to Q4 = yes] Please specify  

[text] 

CASE LAW RELATING TO THE DIRECTIVE 

Please answer based on the cases retrieved through the main legal databases (either public or private) 
and law reviews used by legal professionals in your MS. If a case was appealed, please count it in the 
year of first-instance  decision and  report information  and  data based on the last judgment published 
(be it appeal or third-grade decision). 

6.  Please fill in the table below with the requested information 

EQ: 1, 14, 16, 14, 15 

Year 

200

200

200

200

200

200

200

200

200

200

201

201

201

201

201

201

201

0 

1 

2 

3 

4 

5 

6 

7 

8 

9 

0 

1 

2 

3 

4 

5 

6 

No. of claims 

Country 
origin 

of 

Your MS 

No.  of  times 
which, 
in 
overall, 
producers 
have 
brought 
court 

been 
to 

Another MS 

A  non  EU-
country 

Information 
not available 

The 
manufacture
r 
of 
finished 
product 

a 

The 
producer  of 
any 
raw 
material 

The 
manufacture
r 
of 
component 
part 

a 

The  person 
who, 
by 
putting  his 

164 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Year 

200

200

200

200

200

200

200

200

200

200

201

201

201

201

201

201

201

0 

1 

2 

3 

4 

5 

6 

7 

8 

9 

0 

1 

2 

3 

4 

5 

6 

other 

name, 
trademark, 
or 
distinguishin
g  feature  on 
the  product, 
presents 
himself 
as 
the producer 

The importer   

The supplier 

Information 
not available 

%  %  %  %  %  %  %  %  %  %  %  %  %  %  %  %  % 

%  %  %  %  %  %  %  %  %  %  %  %  %  %  %  %  % 

%  %  %  %  %  %  %  %  %  %  %  %  %  %  %  %  % 

%  %  %  %  %  %  %  %  %  %  %  %  %  %  %  %  % 

%  %  %  %  %  %  %  %  %  %  %  %  %  %  %  %  % 

Overall, 
which 
context 
where 
claimed 
damages 
suffered? 
(%) 

in 

Within 
household 

an 

the 

Sport, 
leisure, 
or 
other  social 
activity 

Professional 
activity 

Medical (e.g. 
in hospital) 

Other 
(please 
specify) 

Information 
not available 

Object  of  the 
damage (%) 

Physical 
well-being 

Damage 
property 

%  %  %  %  %  %  %  %  %  %  %  %  %  %  %  %  % 

to 

%  %  %  %  %  %  %  %  %  %  %  %  %  %  %  %  % 

Both 

%  %  %  %  %  %  %  %  %  %  %  %  %  %  %  %  % 

%  %  %  %  %  %  %  %  %  %  %  %  %  %  %  %  % 

Other 
(please 
specify) 

Information 
not available 

Requested 
compensatio
n 

Awarded 
compensatio
n 

What  is  the 
ratio between 
the 
requested 
compensatio
n  and 
awarded 
compensatio
n, overall? 

the 

7.  Please fill in the table below with the requested information:  

Classification of products subject to claims, based on Combined Nomenclature. Please 
use the search engine you can find at this URL https://eurostat.prod.3ceonline.com/ 

EQ:  11, 
14 

165 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Year 

Combined Nomenclature code 

New technological development349 

2000 

2001 

2002 

2003 

2004 

2005 

2006 

2007 

2008 

2009 

2010 

2011 

2012 

2013 

2014 

2015 

2016 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

[yes/no] 

8.  Please fill in the table below with the requested information in relation to the claims rejected from 

2000 on:  

349 Please consider as a new technological development, amongst others: 

- 
- 

Software embedded in products; 
Products on which software and applications from different sources can be installed after purchase such as 
apps and other non-embedded software; 
Products connected to and through the Internet (Internet of Things); 
Products shared with other users through collaborative platforms; 

- 
- 
-  Devices for 3D printing/additive manufacturing and products manufactured with them; 
- 

Advanced  robots  and  autonomous  systems  empowered  by  artificial  intelligence,  i.e.  physical  machines 
perceiving  their  environment  processing  this  information  correctly  and  then  carrying  out  a  complex  and 
adequate  actions  autonomously,  e.g.  advanced driver  assistance  systems  or  completely self-driving  cars, 
these systems can also learn from their actions; 
Software  –based  systems  empowered  by  artificial  intelligence,  i.e.  software  processing  information 
correctly  and  then  acting  appropriately,  e.g.  autonomous  trading  algorithms  or  any  other  big  data 
algorithms. 

- 

166 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Letter 

Reasons for rejection 

No. 

of 

Year(s) 

of 

rejected cases  

reference  (from 

2000) 

A 

B 

C 

D 

E 

F 

G 

H 

I 

J 

K 

L 

M 

N 

   

  The consumer gave up trying to achieve compensation before 

the claim was launched 

  The consumer was not able to prove the defect 

  The  consumer  was  not  able  to  prove  the  link  between  the 

defect and the damage 

  The  producer  was  found  not  liable  since  he  had  not  put  the 

product into circulation 

  The  producer  was  found  not  liable  since  the  defect  did  not 

exist at the time when the product was marketed 

  The producer  was  found not liable since  the  product  was  not 

for sale or for distribution for economic purposes 

  The producer was found not liable since the defect was due to 

compliance of the product with mandatory regulations 

  The producer was found not liable since the state of scientific 
or  technical  knowledge  at  the  time  when  the  product  was 
marketed did not enable the defect to be discovered 

  The producer was found not liable since he manufactured only 
a  component  of  the  product,  following  the  instructions  given 
by the producer of the product 

  The  damage  was  caused  also  by  the  fault  of  the  injured 
person  or  any  person  for  whom  the  injured  person  is 
responsible 

  The injured person did not use the product mainly for his own 

private use or consumption 

  Expiration  of  the  three  year  period  for  the  injured  party  to 

start the proceedings for the recovery of damages 

  Expiration  of  the  10  year  period  from  the  moment  the 

producer put the product in circulation 

  Other. Please specify [text] 

Survey question 

9.  [if  A  to  Q8  =  E]  the  producer  was 
found not liable since the defect was 
due  to  product  compliance  with 
mandatory  regulations,  which  were 
the relevant mandatory regulations? 

10. In  how  many  cases  did  the  court 
allow  the  compensation  even  if  the 
product  was  subject  to  professional 
use? 

Question type 

[text] 

[figure] 

11. Are  there  claims  relating  to  new 
technological  developments  within 
your national case law? 

[yes/no] 

12. [if  A  to  Q11  =  yes],  which  kind  of 

[multiple choice] 

EQ 

Q27 

Q30 

Q17-

167 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Survey question 

Question type 

new  technological  development  was 
it? 

  Software embedded in products; 
  Products  on  which  software  and  applications  from 
different sources can be installed after purchase such 
as apps and other non-embedded software; 

  Products  connected  to  and  through  the  Internet 

(Internet of Things); 

  Products 

shared  with 

other  users 

through 

collaborative platforms; 

  Devices  for  3D  printing/additive  manufacturing  and 

products manufactured with them; 

  Advanced 

and 

robots 

autonomous 

systems 
empowered  by  artificial  intelligence,  i.e.  physical 
machines  perceiving  their  environment  processing 
this  information  correctly  and  then  carrying  out  a 
complex  and  adequate  actions  autonomously,  e.g. 
advanced  driver  assistance  systems  or  completely 
self-driving  cars,  these  systems  can  also  learn  from 
their actions; 

  Software  –based  systems  empowered  by  artificial 
intelligence,  i.e.  software  processing  information 
then  acting  appropriately,  e.g. 
correctly  and 
autonomous trading algorithms or any other big data 
algorithms. 

  Other 
Please specify what was the new technological development at 
stake [text] 

13. [if  A  to  Q11  =  yes]  Did  the  court 

accept or reject the claim? 

[radio button] 
  Accepted 
  Rejected 

14. [if  A  to  Q13  =  accepted]  What  was 

[text] 

the defect alleged and proved? 

15. [if A to Q13 = rejected] Why did the 

court reject the claim? 

[multiple choice] 
  The 

consumer  gave  up 

trying 

to  achieve 

compensation after he brought the claim to court 

  The  court  did  not  consider  the  new  technological 
development  as  a  product  or  a  component  or  a  raw 
material 

  The consumer was not able to prove the defect 
  The consumer was not able to prove the link between 

the defect and the damage 

  The  producer  was  found  not  liable  since  he  had  not 

put the product into circulation 

  The  producer  was  found  not  liable  since  the  defect 
did  not  exist  at  the  time  when  the  product  was 
marketed 

  The  producer  was  found  not  liable  since  the  product 
was  not  for  sale  or  for  distribution  for  economic 
purposes 

  The  producer  was  found  not  liable  since  the  defect 
was due to compliance of the product with mandatory 
regulations 

  The  producer  was  found  not  liable  since  the  state  of 
scientific or technical knowledge at the time when the 
product was marketed did not enable the defect to be 
discovered 

EQ 

Q19-
Q29 

Q17-
Q19-
Q29 

Q2-
Q3-
Q32 

Q17-
Q20, 
Q31 

168 

 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Survey question 

Question type 

EQ 

  The  producer  was 

liable  since  he 
manufactured  only  a  component  of  the  product, 
following  the  instructions  given  by  the  producer  of 
the product 

found  not 

  The  damage  was  caused  also  by  the  fault  of  the 
injured  person  or  any  person  for  whom  the  injured 
person is responsible 

  The injured person did not us  the product mainly for 

his own private use or consumption 

  Expiration  of  the  three-year  period  for  the  injured 
party  to  start  the  proceedings  for  the  recovery  of 
damages 

  Expiration of the 10 year period from the moment the 

producer put the product in circulation 

  Other. Please specify [text] 

16. [if A to Q13 = rejected and A to Q15 
≠  The  consumer  was  not  able  to 
prove  the  defect]  What  was  the 
defect alleged and proved? 

[text] 

17. [if  A  to  Q13  =  The  court  did  not 
consider 
technological 
the  new 
development  as  a  product  or  a 
component  or  a  raw  material]  How 
did  the  court  consider  the  new 
technological development? 

[multiple choice] 
  As the matter of an industrial or intellectual property 
right.  Please  specify  (e.g.,  an  invention,  a  utility 
model, software, a design) [text] 
  As a service. Please specify [text] 
  Other. Please specify [text] 

18. [if  A  to  Q15  =  The  producer  was 
found not liable since the defect was 
due  to  compliance  of  the  product 
with  mandatory  regulations]  Which 
were  the  mandatory  regulation  with 
which the product complied? 

[text] 

Q2-
Q3-
Q32 

Q29, 
Q31, 
Q37 

Q37 

invoking 

to  court 

implementing 

19. Were  there  claims  that  a  consumer 
the 
brought 
legislation 
the 
Directive,  while  the  court  allowed 
the  compensation  based  on  another 
piece  of  legislation?  Please  indicate 
the  number  of  cases 
for  each 
different  grounds  for  compensation. 
If  a  claim  was  never  allowed  on  a 
given ground, please write “0”. 

General tort law 

No. of claims 

Q20 

Contract law 

No. of claims 

Year  

Specific  legislation.  Please 
specify [text] 

By  way  of  similarity  with 
the legislation implementing 
the Directive 

Other 

Year  

No. of claims 

Year  

No. of claims 

Year 

No. of claims 

Year  

ADDITIONAL INFORMATION AS TO THE APPLICATION OF THE DIRECTIVE 

20. In  your  experience,  how  are  claims 
normally 
the  Directive 
a 

indicate 

Please 

under 
settled? 
percentage. 

21. Could 

you 

provide 
documentation / statistics about out 
of  court  settlements  for  the  period 

please 

In court 

With  an  alternative  dispute 
resolution method 

[figure] percent 

[figure] percent 

With direct negotiation 

[figure] percent 

Other. Please specify [text] 

[figure] percent 

[upload] 

Q1-
Q8-
Q12-
Q16-
Q18 

Q1-
Q8-
Q12-

169 

 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Survey question 

Question type 

from 2000 to 2016? 

[text] 

22. If  the  strict  liability  rule  (i.e.  the 
exclusion  of  any  requirement  to 
prove  negligence  or  fault  of  the 
producer 
to  obtain  a 
compensation)  were  repealed,  what 
rule  would  apply  in  your  Member 
State? 

in  order 

LEGISLATION CONCURRING WITH THE DIRECTIVE 

EQ 

Q16-
Q18 

Q34-
Q36 

than 

23. Does 

your  national 

legislation 
for  an  extra-contractual 
provide 
liability 
the  strict 
(other 
liability)  in  order  to  compensate  or 
protect  consumers  from  a  damage 
(a)  caused  by  death  or  by  personal 
injuries  or  (b)  to  any  items  of 
property, because of defects, either: 
  of  intangibles  (e.g.  software  – 
such  as  operating 
systems, 
executables,  apps  –  technical 
drawings), or  

[radio button] 
  Yes, for new technological developments only. 
  Yes, for goods that may  fall beyond  the  definition of 

Q17-
Q18Q1
9-Q37 

“product” only. 

  Yes, for both. 
  No. 

  of services?  

24. [if  A  to  Q23  =  Yes,  for  both.]  Does 
the  compensation  or  protection 
stem from the same rules? 

[yes/no] 

25. [if  A  to  Q23  =  Yes, 

for  new 
technological  developments  only.; 
or if A to Q23 = Yes, for goods that 
may  fall  beyond  the  definition  of 
“products”  only.;  or  if  A  to  Q24  = 
yes] Does this protection stem from 
general  product  liability  rules  or 
from  sectorial  rules  for  the  specific 
good? 

[radio button] 
  General rules. Please specify [text] 
  Sectorial rules. Please specify [text] 
  Other. Please specify [text] 

26. [if  A  to  Q25  =  Sectorial  rules,  or 
Other] What is the sector or area to 
which these rules apply? 

[text] 

Q17-
Q18Q1
9-Q37 

Q17-
Q18Q1
9-Q37 

Q17-
Q18Q1
9-Q37 

Q11 

27. [if  A  to  Q23  =  Yes, 

for  new 
technological  developments  only.; 
or if A to Q23 = Yes, for goods that 
may  fall  beyond  the  definition  of 
“products”  only.;  or  if  A  to  Q24  = 
yes]  What  is  the  damage  for  which 
one  may  claim  for  compensation  or 
protection? 

28. [if  A  to  Q23  =  Yes, 

for  new 
technological  developments  only.; 
or if A to Q23 = Yes, for goods that 
may  fall  beyond  the  definition  of 
“products”  only.;  or  if  A  to  Q24  = 
yes] Who is liable for the damages? 

[multiple choice] 
  Damage caused by death or by personal injuries 
  Damage to, or destruction of, any item of property 

[multiple choice] 
  The manufacturer of a finished product 
  The producer of any raw material 
  The manufacturer of a component part 
  The person who, by putting his name, trade mark or 
other  distinguishing  feature  on  the  product  presents 
himself as its producer  

Q15-
Q17-
Q18-
19 

  The importer 
  The supplier 
  The software developer 
  The software owner 
  The software license distributor 

170 

 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Survey question 

Question type 

EQ 

29. [if  A  to  Q23  =  Yes, 

for  new 
technological  developments  only.; 
or if A to Q23 = Yes, for goods that 
may  fall  beyond  the  definition  of 
“products”  only.;  or  if  A  to  Q24  = 
yes] What must the claimant prove? 

30. [if  A  to  Q23  =  Yes, 

for  new 
technological  developments  only.; 
or if A to Q23 = Yes, for goods that 
may  fall  beyond  the  definition  of 
“products”  only.;  or  if  A  to  Q24  = 
yes]  Are  there  exemptions  from 
liability? 

  The service provider 
  The subcontractor of the service provider 
  Other. Please specify [text] 

[multiple choice] 
  The damage 
  The defect 
  The causal link between defect and damage 
  The fault or negligence of the person liable 
  A contract with the defendant 
  Other. Please specify [text] 

Q25 

[multiple choice] 
  The defendant did not put the product into circulation 
  Having  regard  to  the  circumstances,  it  is  probable 
that  the  defect  which  caused  the  damage  did  not 
exist  at  the  time  when  the  item  was  put  into 
circulation by him or that this defect came into being 
afterwards 

  The  item  was  neither  created  by  the  defendant  for 
sale or any form of distribution for economic purpose 
nor manufactured or distributed by him in the course 
of his business 

  The  defect  is  due  to  compliance  of  the  product  with 
the  public 

issued  by 

regulations 

mandatory 
authorities 

  The state of scientific and technical knowledge at the 
time when the defendant put the item into circulation 
was not such as to enable the existence of the defect 
to be discovered 

  In the case of a component, the defect is attributable 
to  the  design  of  the  product  or  other  item  in  which 
the  component has been  fitted  or  to the instructions 
given by the manufacturer of the product or item 

  Other. Please specify [text] 

[radio button] 
  General rules. Please specify [text] 
  Sectorial rules. Please specify [text] 
  Other. Please specify [text] 

[if A to Q24 = no, Q31-Q44 to be asked] 

31. As 

to 

new 

technological 
developments,  does  this  protection 
stem from general  rules or  sectorial 
rules for the specific good? 

32. [if  A  to  Q31  =  Sectorial  rules,  or 
Other] What is the sector or area to 
which the rules apply? 

[text] 

33. As 

to 

new 

technological 
developments,  what  is  the  damage 
for  which  one  may  claim 
for 
compensation or protection? 

34. As 

to 

technological 
developments,  what  remedy  can 
one claim for? 

new 

35. As 

to 

technological 
developments,  who  is  liable  for  the 
damages? 

new 

[multiple choice] 
  Damage caused by death or by personal injuries 
  Damage to, or destruction of, any item of property 

[multiple choice] 
  Compensation 
  Other. Please specify [text] 

[multiple choice] 
  The manufacturer of a finished product 
  The producer of any raw material 
  The manufacturer of a component part 
  The person who, by putting his name, trade mark or 

Q31 

Q31-
Q37 

Q31-
Q37 

Q31-
Q37 

Q31-
Q37 

171 

 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Survey question 

Question type 

EQ 

other  distinguishing  feature  on  the  product  presents 
himself as its producer  

36. As 

to 

technological 
developments,  who  may  claim  for 
damages? 

new 

37. As 

to 

new 

developments,  what  must 
claimant prove? 

technological 
the 

  The importer 
  The supplier 
  The software developer 
  The software owner 
  The software license distributor 
  The service provider 
  The subcontractor of the service provider 
  Other. Please specify [text] 

[multiple choice] 
  Consumers 
  Professional users 
  Others. Please specify [text] 

[multiple choice] 
  The damage 
  The defect 
  The causal relationship between defect and damage 
  The fault or negligence of the person liable 
  A contract with the defendant 
  Other. Please specify [text] 

Q31-
Q37 

Q31-
Q37 

38. As  to  goods  that  may  fall  beyond 
the  definition  of  products,  does  this 
protection  stem  from  general  rules 
or  sectorial  rules  for  the  specific 
good? 

[radio button] 
  General rules. Please specify [text] 
  Sectorial rules. Please specify [text] 
  Other. Please specify [text] 

39. As  to  goods  that  may  fall  beyond 
the  definition  of  products,  what  is 
the  damage  for  which  one  may 
claim 
or 
protection? 

compensation 

for 

[multiple choice] 
  Damage caused by death or by personal injuries 
  Damage to, or destruction of, any item of property 

40. As  to  goods  that  may  fall  beyond 
the  definition  of  products,  what 
remedy can one claim for? 

[multiple choice] 
  Compensation 
  Other. Please specify [text] 

41. As  to  goods  that  may  fall  beyond 
the  definition  of  products,  who  is 
liable for the damages? 

[multiple choice] 
  The manufacturer of a finished product 
  The producer of any raw material 
  The manufacturer of a component part 
  The person who, by putting his name, trade mark or 
other  distinguishing  feature  on  the  product  presents 
himself as its producer  

  The importer 
  The supplier 
  The software developer 
  The software owner 
  The software license distributor 
  The service provider 
  The subcontractor of the service provider 
  Other. Please specify [text] 

42. As  to  goods  that  may  fall  beyond 
the  definition  of  products,  who  may 
claim for damages? 

[multiple choice] 
  Consumers 
  Traders 
  Workers 

172 

 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Survey question 

Question type 

EQ 

43. As  to  goods  that  may  fall  beyond 
the  definition  of  products,  what 
must the claimant prove? 

44. As  to  goods  that  may  fall  beyond 
the  definition  of  products,  are  there 
exemptions from liability? 

  Others. Please specify [text] 

[multiple choice] 
  The damage 
  The defect 
  The causal relationship between defect and damage 
  The fault or negligence of the person liable 
  A contract with the defendant 
  Other. Please specify [text] 

[multiple choice] 
  The defendant did not put the product into circulation 
  Having  regard  to  the  circumstances,  it  is  probable 
that  the  defect  which  caused  the  damage  did  not 
exist  at  the  time  when  the  item  was  put  into 
circulation by him or that this defect came into being 
afterwards 

  The  item  was  neither  created  by  the  defendant  for 
sale or any form of distribution for economic purpose 
nor manufactured or distributed by him in the course 
of his business 

  The  defect  is  due  to  compliance  of  the  product  with 
the  public 

issued  by 

regulations 

mandatory 
authorities 

  The state of scientific and technical knowledge at the 
time when the defendant put the item into circulation 
was not such as to enable the existence of the defect 
to be discovered 

  In the case of a component, the defect is attributable 
to  the  design  of  the  product  or  other  item  in  which 
the  component has been  fitted  or  to the instructions 
given by the manufacturer of the product or item 

  Other. Please specify [text] 

173 

 
 
 
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Annex 8 

Legal issues in the context of emerging technologies 

(“Legal analysis”) 

The  following  table  highlights  some  issues  that  the  application  of  the  Directive  to  new 
technological  developments  could  raise  and  possible  solutions.  In  particular,  given  the  lack 
of  actual  cases  relating  to  the  application  of  the  Directive  to  new  technological 
developments, both issues and solutions are hypothesised by cross-referencing five different 
new technological developments with the key provisions of the Directive. 

Namely the five new technological developments considered are: 

  The  smartphone,  i.e.  a  mobile  phone  that  performs  many  of  the  functions  of  a 
computer, typically having a touchscreen interface, Internet access, and an operating 
system capable of running downloaded apps.350 

  The 3D printer, i.e. a machine allowing the creation of a physical object from a three-
dimensional digital model, typically by laying down many thin layers of a material in 
succession.351 

  Cloud computing, i.e. the practice of using a network of remote servers hosted on the 
Internet to store, manage, and process data, rather than a local server or a personal 
computer.352 

  The  robot,  i.e.  a  machine  capable  of  carrying  out  a  complex  series  of  actions 

automatically, especially one programmable by a computer.353  

  The  self-driving  vehicle,  i.e.  a  vehicle  capable  of  travelling  without  input  from  a 
human  operator,  by  means  of  computer  systems  working  in  conjunction  with  on-
board sensors.354 

In  all  of  these  new  technological  developments  software  plays  a  key  role  as  a  component. 
Thus, assessing whether software is a product or not is key to solving many, if not all, issues 
that new technological developments raise. In this respect, the starting point is the definition 
of software: software consists of the programmes and other operating information used by a 
computer.355 

Based  on  this  definition,  software  can  be  regarded  as  “information”,  i.e.  an  intangible  by 
definition,  and  thus  something  far  from  being  a  product.  Also,  the  technical  possibility  to 
duplicate  a  software  programme  infinitely  seems  to  corroborate  the  nature  of  intangibility, 
just like a work of literature or a movie or a song. 

Yet  software  also  has  a  physical  (even  if  not  immediately  tangible)  dimension:  indeed, 
software  always  requires  an  electronic  medium,  be  it  the  hardware  it  operates  or  the  data 
storage medium where it lies when idle. Also, under Article 2 electricity is a product for the 
purposes  of  the  Directive  and  a  copy  of  a  software  programme  consists  of  electrons,  thus 
software  could  be  a  product.  Furthermore,  such  an  interpretation  also  seems  to  be 
consistent  with  the  system  of  EU  product  safety  legislation:  indeed,  several  pieces  of 
legislation in that area expressly refer to software as a product (see section5.3.3.1). 

350 Definition retrieved from https://en.oxforddictionaries.com/definition/smartphone on 25/11/2017. 
351 Definition retrieved from https://en.oxforddictionaries.com/definition/3d_printer on 25/11/2017. 
352 Definition retrieved from https://en.oxforddictionaries.com/definition/cloud_computing on 25/11/2017. 
353 Definition retrieved from https://en.oxforddictionaries.com/definition/robot on 25/11/2017. 
354 Definition retrieved from https://en.oxforddictionaries.com/definition/self-driving on 25/11/2017. 
355 Definition retrieved from https://en.oxforddictionaries.com/definition/software on 25/11/2017. 

174 

 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Whether  software  can  be  regarded  as  a  product  or  not  has  of  course  concrete  immediate 
importance  regarding  the  possibility  to  consider  its  developer  as  a  manufacturer  of  a 
product:  this  turns  out  to  be  central  when  dealing,  for  instance,  with  non-embedded  apps 
and similar items. Moreover, this also has an impact on how a developer is regarded when 
the  software  is  one  component  of  another  product,  such  as  3D  printer,  a  robot  or  a  self-
driving vehicle. This has an implication for those who are to be regarded as suppliers. 

The lack of actual data to analyse regarding these technologies makes the outcome of the exercise 
just conjecture. 

l

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r
A

SMARTPHONE 

3D PRINTER 

CLOUD COMPUTING 

ROBOTS 

SELF-DRIVING VEHICLE 

Is a cloud platform a 
product? 

it  a 

Is 
product? 

robot  a 

Is  it  a  self-driving 
vehicle a product? 

-
2

  Is an embedded 
T
C
application a 
U
D
movable embedded 
O
R
into another 
P
movable, i.e. the 
smartphone? 
Is a non-embedded 
application or 
software a product? 
issues, 
For  both 
the 
whether 
application 
a 
not, 
product 
the 
depends 
answer 
the 
question  of  whether 
software 
a 
is 
product or not. 

or 
on 
to 

is 

the  3D  digital 

Is 
model a product? 
Is 
product? 

the  output  a 

3D 
Whether 
the 
is  a 
digital  model 
not, 
or 
product 
the 
on 
depends 
the 
to 
answer 
question  of  whether 
software  is  a  product 
or not. 
The  output  of  a  3D 
printer  is  a  product, 
as it is a tangible and 
movable object. 

  Is  the  developer  of 
R
E
the 
software 
C
U
manufacturer  of  a 
D
O
product  or  of  a 
R
P
component  part  of 
–
it? 
3

Is  the  developer  of 
the  3D  digital  model 
the  manufacturer  of 
a component? 
Is the user of the 3D 
printer 
the 
manufacturer? 

as 

cloud 

A 
platform 
does  not  seem  to  be 
a  product,  not  even 
considering 
when 
a 
software 
product.  Indeed,  the 
activity 
is  run  on 
remote  servers  and, 
even  assuming  that 
software is a product, 
it would be difficult to 
the  service 
regard 
provided 
a 
as 
product. 
Furthermore,  unless 
the service requires a 
client  application  to 
be  installed  on  the 
user’s  device,  it  does 
not  seem  possible  to 
identify a product.  
Is  the  owner  of  the 
cloud 
computing 
platform a producer? 

is 

the 
Whether 
a 
developer 
manufacturer or not 
the 
depends 
answer 
the 
question  of  whether 
a 
is 
software 
product or not. 

on 
to 

is 

on 
to 

the 
Whether 
a 
developer 
manufacturer  or  not 
the 
depends 
answer 
the 
question  of  whether 
software  is  a  product 
or not. 
The  user  of  the  3D 
printer  appears  as 
the  manufacturer  of 
the output. 

be 

The  owner  of 
the 
platform  does  not 
seem 
a 
to 
manufacturer,  unless 
the service requires a 
client  application  to 
be  installed  on  the 
user’s device  and the 
same 
application 
provokes a damage. 

A  robot  is  a  product, 
as it is a tangible and 
movable object. 

A  self-driving  vehicle 
is a product, as it is a 
tangible and movable 
object. 

the 

robot 

Is  the  manufacturer 
of 
a 
producer? 
Is  the  developer  of 
software 
the 
operating the robot a 
manufacturer  of  a 
component? 

Is  the  manufacturer 
of 
the  self-driving 
vehicle a producer? 
Is  the  developer  of 
software 
the 
operating  the  vehicle 
a  manufacturer  of  a 
component? 

175 

 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

l

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r
A

SMARTPHONE 

3D PRINTER 

CLOUD COMPUTING 

ROBOTS 

SELF-DRIVING VEHICLE 

  Is  the  burden  of 
F
O
proof  harder  than 
O
R
for 
“traditional” 
P
–
products? 
4
This  would  depend 
on  specific  factual 
circumstances. 

  Could 

to 

the 
manufacturer  of  the 
smartphone and the 
the 
developer  of 
software  share  a 
liability 
the 
injured person? 
Whether 
the 
developer can share 
the  liability  or  not, 
the 
depends 
answer 
the 
question  of  whether 
a 
is 
software 
product or not. 

on 
to 

Y
T
I
L
I
B
A
I
L

T
N
I
O
J
–
5

there 
specific 

  Apparently, 
T
C
E
F
E
D
–
6

are 
issues. 

no 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

N/A 

the  burden  of 
Is 
proof  harder  than  for 
“traditional” 
products? 
This  would  depend 
factual 
on  specific 
circumstances. 
Could the user of the 
3D  printer  and  the 
developer  of  the  3D 
digital  model  share  a 
liability to the injured 
person? 

on 
to 

Whether 
the 
developer  can  share 
the  liability  or  not, 
the 
depends 
answer 
the 
question  of  whether 
software  is  a  product 
or not. 
What  is  the  safety 
level  to  be  expected 
from  a  3D-printer 
output? 
of 
The 
possible 
outputs 
makes  it  depend  on 
the  type  of  output  to 
fix the safety level to 
be expected. 

variety 

and 

of 
share 

the  burden  of 
Is 
proof  harder  than  for 
“traditional” 
products? 
This  would  depend 
factual 
on  specific 
circumstances. 
Could 
the 
manufacturer  of  the 
the 
robot 
the 
developer 
software 
a 
liability to the injured 
person? 
Whether 
the 
developer  can  share 
the  liability  or  not, 
the 
depends 
answer 
the 
question  of  whether 
software  is  a  product 
or not. 
What  is  the  safety 
level  to  be  expected 
from a robot? 

on 
to 

The level of safety to 
likely 
be  expected 
depends 
the 
on 
possible  uses  of  the 
robot. 

and 
of 
share 

the  burden  of 
Is 
proof  harder  than  for 
“traditional” 
products? 
This  would  depend 
factual 
on  specific 
circumstances. 
Could 
the 
manufacturer  of  the 
the 
vehicle 
the 
developer 
software 
a 
liability to the injured 
person? 
Whether 
the 
developer  can  share 
the  liability  or  not, 
the 
depends 
answer 
the 
question  of  whether 
software  is  a  product 
or not. 
What  is  the  safety 
level  to  be  expected 
from  a  self-driving 
car? 
The level of safety to 
be  expected  could 
depend 
the 
technical 
requirements 
set 
vehicle 
the 
upon 
manufacturer, as well 
as  on  the  range  of 
the 
freedom 
vehicle 
to 
determine its use. 

for 
user 

on 
to 

on 

176 

 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Annex 9 

EU legislation on safety: the sectorial safety legislation 

and the General Product Safety Directive  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

Article 9 - 
'Damage' 
means:(a) 
damage caused 
by death or by 
personal injuries; 
(b) damage to, or 
destruction of, 
any item of 
property other 
than the 
defective product 
itself, with a 
lower threshold 
of 500 ECU, 
provided that the 
item of property: 
(i) is of a type 
ordinarily 
intended for 
private use or 
consumption, and 
(ii) was used by 
the injured 
person mainly for 
his own private 
use or 
consumption. 
This Article shall 
be without 
prejudice to 
national 
provisions 
relating to non-
material damage. 

  Damages 
)
C
caused by 
E
E
defective 
/
4
products 
7
3
/
5
8
(

Article 2 - 'product' means 
all movables (including 
electricity), with the 
exception of games, even 
though incorporated into 
another movable or into an 
immovable, and nuclear 
accidents. Electricity is a 
product. 

Article 6 - A product 
is defective when it 
does not provide the 
safety which a person 
is entitled to expect, 
taking all 
circumstances into 
account, including: 
(a) the presentation 
of the product; (b) 
the use to which it 
could reasonably be 
expected that the 
product would be put; 
(c) the time when the 
product was put into 
circulation.  

No. Reference 
is made only to 
"Electricity" 

N/A 

Cosmetics 

Article 2 - "‘cosmetic 
product’ means any 
substance or mixture 
intended to be placed in 
contact with the external 
parts of the human body 
(epidermis, hair system, 
nails, lips and external 
genital organs) or with the 
teeth and the mucous 
membranes of the oral 
cavity with a view 
exclusively or mainly to 
cleaning them, perfuming 
them, changing their 
appearance, protecting 
them, keeping them in 
good condition or 
correcting body odours" 

Article 3 - "A 
cosmetic product 
made available on the 
market shall be safe 
for human health 
when used under 
normal or reasonably 
foreseeable 
conditions of use, 
taking account, in 
particular, of the 
following:(a) 
presentation including 
conformity with 
Directive 
87/357/EEC; (b) 
labelling; (c) 
instructions for use 
and disposal; (d) any 
other indication or 
information provided 
by the responsible 
person defined in 
Article 4. 

Lack of 
compliance with 
EHSR (Art.4.2) 

NO 

NO 

i

g
n
n
r
e
c
n
o
c

s
e
t
a
t
S

r
e
b
m
e
M
e
h
t

f
o

s
n
o
i
s
i
v
o
r
p

e
v
i
t
a
r
t
s
i
n
m
d
a

i

d
n
a

s
n
o
i
t
a
u
g
e
r

l

r
e
b
m
e
v
o
N
0
3

f
o

L
I
C
N
U
O
C

E
H
T

F
O
D
N
A

T
N
E
M
A
I
L
R
A
P

,
s
w
a

l

e
h
t

f
o

n
o
i
t
a
m
x
o
r
p
p
a

i

e
h
t

n
o

5
8
9
1

l

y
u
J

5
2

f
o

E
V
I
T
C
E
R
I
D
L
I
C
N
U
O
C

N
A
E
P
O
R
U
E

E
H
T

F
O
9
0
0
2
/
3
2
2
1

o
N
)
C
E
(

l

n
o
i
t
a
u
g
e
R

1. 

2. 

s
t
c
u
d
o
r
p

e
v
i
t
c
e
f
e
d

r
o
f

y
t
i
l
i

b
a

i
l

6
5
3
s
t
c
u
d
o
r
p

c
i
t
e
m
s
o
c

n
o

9
0
0
2

356 http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF  

177 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

y
a
M
0
2

f
o

C
E
E
/
4
2
3
/
5
7

3. 

e
v
i
t
c
e
r
i
D

l
i
c
n
u
o
C

s
w
a

l

e
h
t

f
o

n
o
i
t
a
m
x
o
r
p
p
a

i

e
h
t

n
o

5
7
9
1

o
t

g
n
i
t
a
e
r

l

s
e
t
a
t
S

r
e
b
m
e
M
e
h
t

f
o

4. 

i

8
5
3
y
r
e
n
h
c
a
m
n
o

6
0
0
2

y
a
M
7
1

f
o

l
i
c
n
u
o
C

e
h
t

f
o

d
n
a

t
n
e
m
a

i
l
r
a
P

n
a
e
p
o
r
u
E

e
h
t

f
o

C
E
/
2
4
/
6
0
0
2

e
v
i
t
c
e
r
i
D

Article 2 - "For the purpose 
of this Directive, the term 
"aerosol dispenser" shall 
mean any non-reusable 
container made of metal, 
glass or plastic and 
containing a gas 
compressed, liquefied or 
dissolved under pressure, 
with or without a liquid, 
paste or powder, and fitted 
with a release device 
allowing the contents to be 
ejected as solid or liquid 
particles in suspension in a 
gas, as a foam, paste or 
powder or in a liquid 
state." 

Article 3 -"The person 
responsible for the 
marketing of aerosol 
dispensers shall affix 
the symbol '3 ' 
(inverted epsilon) to 
aerosol dispensers, as 
proof that they satisfy 
the requirements of 
this Directive and the 
Annex thereto" 

Lack of 
compliance with 
EHSR (Art.3) 

NO 

NO SPECIFC 
REFERENCE. 
However, Art.8 
provides this 
safeguard clause: 
"Without prejudice 
to other Community 
Directives, in 
particular to 
Directives on 
dangerous 
substances and 
preparations" 

  Aeresol 

dispensers 

7
5
3
s
r
e
s
n
e
p
s
i
d

l

o
s
o
r
e
a

Machinery 

Article 1 - "This Directive 
applies to the following 
products: (a) machinery; 
(b) interchangeable 
equipment; (c) safety 
components; (d) lifting 
accessories; (e) chains, 
ropes and webbing; (f) 
removable mechanical 
transmission devices; (g) 
partly completed 
machinery. 2. The 
following are excluded 
from the scope of this 
Directive: […]". 

Article 5 - “Before 
placing machinery on 
the market and/or 
putting it into service, 
the manufacturer or 
his authorised 
representative shall: 
(a) ensure that it 
satisfies the relevant 
essential health and 
safety requirements 
set out in Annex I; 
(b) ensure that the 
technical file referred 
to in Annex VII, part 
A is available; (c) 
provide, in particular, 
the necessary 
information, such as 
instructions; (d) carry 
out the appropriate 
procedures for 
assessing conformity 
in accordance with 
Article 12; (e) draw 
up the EC declaration 
of conformity in 
accordance with 
Annex II, part 1, 
section A and ensure 
that it accompanies 
the machinery; (f) 
affix the CE marking 
in accordance with 
Article 16. 2. Before 
placing partly 
completed machinery 
on the market, the 
manufacturer or his 
authorised 
representative shall 
ensure that the 
procedure referred to 
in Article 13 has been 
completed. 3. […]”. 

Lack of 
compliance with 
EHSR (Art.4) 

Article 1.2.1. 
Safety and 
reliability of 
control 
systems - 
"Control 
systems must 
be designed 
and 
constructed in 
such a way as 
to prevent 
hazardous 
situations from 
arising. Above 
all, they must 
be designed 
and 
constructed in 
such a way 
that: (...) a 
fault in the 
hardware or 
the software of 
the control 
system does 
not lead to 
hazardous 
situations 
(...)". 

Software and 
hardware are 
components 
within the 
machinery and 
shall be non-
faulty for the 
purpose of the 
EHSR. 

NO 

357 http://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A31975L0324 
358 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006L0042&from=IT  

178 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

t
n
e
m
a

i
l
r
a
P

n
a
e
p
o
r
u
E

e
h
t

5. 

f
o
U
E
/
3
5
/
3
1
0
2

e
v
i
t
c
e
r
i
D

d
n
a

t
f
a
r
c
r
e
t
a
w

l

a
n
o
s
r
e
p

d
n
a

t
f
a
r
c

l

a
n
o
i
t
a
e
r
c
e
r

n
o

3
1
0
2

r
e
b
m
e
v
o
N
0
2

f
o

l
i
c
n
u
o
C

e
h
t

f
o

d
n
a

9
5
3
C
E
/
5
2
/
4
9

e
v
i
t
c
e
r
i
D
g
n

i
l

a
e
p
e
r

Recreational 
craft and 
personal 
watercraft 

Article 2 - "This Directive 
shall apply to the following 
products:(a) recreational 
craft and partly completed 
recreational craft;(b) 
personal watercraft and 
partly completed personal 
watercraft;(c) components 
listed in Annex II when 
placed on the Union 
market separately, 
hereinafter referred to as 
‘components’;(d)propulsion 
engines which are installed 
or specifically intended for 
installation on or in 
watercraft;(e)propulsion 
engines installed on or in 
watercraft that are subject 
to a major engine 
modification;(f)watercraft 
that are subject to major 
craft conversion." 

Article 4: " The 
products referred to 
in Article 2(1) may be 
made available or put 
into service only if 
they do not endanger 
the health and safety 
of persons, property 
or the environment 
when correctly 
maintained and used 
in accordance with 
their intended 
purpose, and only on 
the condition that 
they meet the 
applicable essential 
requirements set out 
in Annex I." 

Lack of 
compliance with 
EHSR (Art.4) 

NO 

NO 

359 http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32013L0053  

179 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

o
t

g
n
i
t
a
e
r

l

s
e
t
a
t
S

r
e
b
m
e
M
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t

f
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a

l

e
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t

f
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n
o
i
t
a
s
i
n
o
m
r
a
h

e
h
t

n
o

4
1
0
2

y
r
a
u
r
b
e
F

6
2

f
o
U
E
/
9
2
/
4
1
0
2

e
v
i
t
c
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r
i
D

e
h
t

f
o

s
w
a

l

e
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t

f
o

n
o
i
t
a
s
i
n
o
m
r
a
h

0
6
3
s
l
e
s
s
e
v

e
r
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s
s
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r
p

l

e
p
m
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s

f
o

t
e
k
r
a
m
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h
t

n
o

l

e
b
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l
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a
v
a

i

g
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a
m
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t

s
t
f
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l

o
t

g
n
i
t
a
e
r

l

s
e
t
a
t
S

r
e
b
m
e
M

Simple 
pressure 
vessels  

r
o
f

s
t
n
e
n
o
p
m
o
c

y
t
e
f
a
s

d
n
a

Lifts and safety 
components 

1
6
3
s
t
f
i
l

6. 

6
2

f
o
U
E
/
3
7. 
3
/
4
1
0
2

e
h
t

n
o

4
1
0
2

e
v
i
t
c
e
r
i
D

y
r
a
u
r
b
e
F

Article 1 - This Directive 
shall apply to simple 
pressure vessels (‘vessels’) 
manufactured in series 
with the following 
characteristics:(a) the 
vessels are welded, 
intended to be subjected to 
an internal gauge pressure 
greater than 0.5 bar and to 
contain air or nitrogen, and 
are not intended to be 
fired;(b) the parts and 
assemblies contributing to 
the strength of the vessel 
under pressure are made 
either of non-alloy quality 
steel or of non-alloy 
aluminum or non-age 
hardening aluminum 
alloys;(c) the vessel is 
made of either of the 
following elements:(i) a 
cylindrical part of circular 
cross-section closed by 
outwardly dished and/or 
flat ends which revolve 
around the same axis as 
the cylindrical part;(ii)two 
dished ends revolving 
around the same axis;(d) 
the maximum working 
pressure of the vessel does 
not exceed 30 bar and the 
product of that pressure 
and the capacity of the 
vessel (PS × V) does not 
exceed 10 000 
bar.L;(e)the minimum 
working temperature is no 
lower than – 50 °C and the 
maximum working 
temperature is not higher 
than 300 °C for steel and 
100 °C for aluminum or 
aluminum alloy vessels.2. 
[…]”. 
Article 2 - This Directive 
shall apply to lifts 
permanently serving 
buildings and constructions 
and intended for the 
transport of persons, 
persons and goods, goods 
alone if the carrier is 
accessible, that is to say a 
person may enter it 
without difficulty, and 
fitted with controls situated 
inside the carrier or within 
reach of a person inside 
the carrier […]”. 

Article 4 : "Vessels of 
which the product of 
PS × V exceeds 50 
bar.L shall satisfy the 
essential safety 
requirements set out 
in Annex I." 

Article 5 - " Lifts 
covered by this 
Directive shall satisfy 
the essential health 
and safety 
requirements set out 
in Annex I." 

Lack of 
compliance with 
EHSR (Art.3) 

NO 

NO 

Lack of 
compliance with 
EHSR (Art.4) 

NO 

NO 

360http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32014L0029  
361http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014L0033  

180 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

n

i

e
s
u

r
o
f

d
e
d
n
e
t
n

i

s
m
e
t
s
y
s

e
v
i
t
c
e
t
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p

d
n
a

t
n
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m
p
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q
e

i

o
t

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n
i
t
a
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r

l

S
M
e
h
t

f
o

s
w
a

l

e
h
t

f
o

n
o
i
t
a
s
i
n
o
m
r
a
h

2
6
3
s
e
r
e
h
p
s
o
m
t
a

e
v
i
s
o
p
x
e

l

y

l
l

a
i
t
n
e
t
o
p

Equipment and 
protective 
systems 
intended for 
use in 
potentially 
explosive 
atmospheres 

8. 

e
h
t

n
o

4
1
0
2

y
r
a
u
r
b
e
F

6
2

f
o
U
E
/
4
3
/
4
1
0
2

e
v
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t
c
e
r
i
D

e
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t

n
o

4
1
0
2

y
r
a
u
r
b
e
F

6
2
9. 
f
o
U
E
/
5
3
/
4
1
0
2

e
v
i
t
c
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r
i
D

o
t

g
n
i
t
a
e
r

l

S
M
e
h
t

f
o

s
w
a

l

e
h
t

f
o

n
o
i
t
a
s
i
n
o
m
r
a
h

l

a
c
i
r
t
c
e
e

l

f
o

t
e
k
r
a
m
e
h
t

n
o

l

e
b
a

l
i

a
v
a

i

g
n
k
a
m
e
h
t

Electrical 
equipment 

i

n
a
t
r
e
c

i

n
h
t
i

w
e
s
u

r
o
f

d
e
n
g
i
s
e
d

t
n
e
m
p
u
q
e

i

3
6
3
s
t
i

m

i
l

e
g
a
t
l
o
v

Article 1 - This Directive 
shall apply to the 
following, hereinafter 
referred to as ‘products’: 
(a) equipment and 
protective systems 
intended for use in 
potentially explosive 
atmospheres; (b) safety 
devices, controlling devices 
and regulating devices 
intended for use outside 
potentially explosive 
atmospheres but required 
for or contributing to the 
safe functioning of 
equipment and protective 
systems with respect to 
the risks of explosion; (c) 
components intended to be 
incorporated into 
equipment and protective 
systems referred to in 
point (a). […]”. 
Article 1 - The purpose of 
this Directive is to ensure 
that electrical equipment 
on the market fulfils the 
requirements providing for 
a high level of protection of 
health and safety of 
persons, and of domestic 
animals and property, 
while guaranteeing the 
functioning of the internal 
market. This Directive shall 
apply to electrical 
equipment designed for 
use with a voltage rating of 
between 50 and 1 000 V 
for alternating current and 
between 75 and 1 500 V 
for direct current, other 
than the equipment and 
phenomena listed in Annex 
II. 

Article 4 - "Products 
shall meet the 
essential health and 
safety requirements 
set out in Annex II 
which apply to them, 
account being taken 
of their intended 
use." 

Lack of 
compliance with 
EHSR (Art.3) 

Article 1.5.8. - 
Risks arising 
from software: 
In the design 
of software-
controlled 
equipment, 
protective 
systems and 
safety devices, 
special account 
must be taken 
of the risks 
arising from 
faults in the 
program. 

NO 

Article 6 - "When 
placing their electrical 
equipment on the 
market, 
manufacturers shall 
ensure that it has 
been designed and 
manufactured in 
accordance with the 
safety objectives 
referred to in Article 3 
and set out in Annex 
I." 

Lack of 
compliance with 
EHSR (Art.3) 

NO 

NO 

362http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32014L0034  
363http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2014.096.01.0357.01.ENG  

181 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

Reference to the 
Directive 

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

n
o

4
1
0
2

l
i
r
p
A

6
1

f
o

l
i
c
n
u
o
C

e
h
t

f
o

d
n
a

t
n
e
m
a

10. 

i
l
r
a
P

n
a
e
p
o
r
u
E

e
h
t

f
o
U
E
/
3
5
/
4
1
0
2

e
v
i
t
c
e
r
i
D

n
o

l

e
b
a

l
i

a
v
a

i

g
n
k
a
m
e
h
t

o
t

g
n
i
t
a
e
r

l

s
e
t
a
t
S

r
e
b
m
e
M
e
h
t

f
o

s
w
a

l

e
h
t

f
o

n
o
i
t
a
s
i
n
o
m
r
a
h

e
h
t

4
6
3
C
E
/
5
/
9
9
9
1

e
v
i
t
c
e
r
i
D
g
n

i
l

a
e
p
e
r

d
n
a

t
n
e
m
p
u
q
e

i

i

o
d
a
r

f
o

t
e
k
r
a
m
e
h
t

Radio 
equipment  

Article 1 - This Directive 
establishes a regulatory 
framework for the making 
available on the market 
and putting into service in 
the Union of radio 
equipment. This Directive 
shall not apply to 
equipment listed in Annex 
I [..]”. 

Article 3 - "1.Radio 
equipment shall be 
constructed so as to 
ensure: (a) the 
protection of health 
and safety of persons 
and of domestic 
animals and the 
protection of 
property, including 
the objectives with 
respect to safety 
requirements set out 
in Directive 
2014/35/EU, but with 
no voltage limit 
applying; (b) an 
adequate level of 
electromagnetic 
compatibility as set 
out in Directive 
2014/30/EU. 2. Radio 
equipment shall be so 
constructed that it 
both effectively uses 
and supports the 
efficient use of radio 
spectrum in order to 
avoid harmful 
interference. 3. Radio 
equipment within 
certain categories or 
classes shall be so 
constructed that it 
complies with the 
following essential 
requirements: […]." 

Lack of 
compliance with 
EHSR (Art.4) 

Reference to 
new 
technological 
developments 
Article 10 - 
Obligations of 
manufacturers 
- 
"Manufacturers 
shall ensure 
that the radio 
equipment is 
accompanied 
by instructions 
and safety 
information in 
a language 
which can be 
easily 
understood by 
consumers and 
other end-
users, as 
determined by 
the Member 
State 
concerned. […] 
Such 
information 
shall include, 
where 
applicable, a 
description of 
accessories 
and 
components, 
including 
software, 
which allow the 
radio 
equipment to 
operate as 
intended. […]." 

NO 

t
n
e
m
a

i
l
r
a
P

n
a
e
p
o
r
u
E

e
h
t

f
o
U
E
/
8
6
/
4
1
0
2

e
v
i
t
c
e
r
i
D

f
o

e
h
t

n
o

l
i
c
n
u
o
4
C
1
11. 
0
e
2
h
t

y
a
M
5
1

f
o

d
n
a

e
h
t

f
o

n
o
i
t
a
s
i
n
o
m
r
a
h

r
e
b
m
e
M
e
h
t

f
o

s
w
a

l

o
t

g
n
i
t
a
e
r

l

s
e
t
a
t
S

l

e
b
a

l
i

f
o

i

t
e
k
r
a
m
e
h
t

a
v
a
5
Pressure 
6
3
g
t
equipment  
n
n
e
e
k
r
m
a
u
m
p
s
s
u
e
e
q
r
h
p
e
t

n
o

i

Article 1 - This Directive 
shall apply to the design, 
manufacture and 
conformity assessment of 
pressure equipment and 
assemblies with a 
maximum allowable 
pressure PS greater than 
0.5 bar. This Directive shall 
not apply to: […]”.  

Article 4 - The 
pressure equipment 
listed in Article 4 shall 
satisfy the essential 
safety requirements 
set out in Annex I 

Lack of 
compliance with 
EHSR (Art.3) 

NO 

NO 

364 http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32014L005  
365http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0068&from=IT  

182 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

12. 

e
v
i
t
c
e
r
i
D
g
n

i
l

a
e
p
e
r

d
n
a

s
n
o
i
t
a

l
l

a
t
s
n

i

y
a
w
e
b
a
c

l

n
o

6
1
0
2

h
c
r
a
M
9

f
o

4
2
4
/
6
1
0
2

)
U
E
(

l

n
o
i
t
a
u
g
e
R

-
8
3
1
5
3
5
7
a
/
n
o
i
t
a
c
i
l

b
u
p
/
-
/
l
i

a
t
e
d
-
n
o
i
t
a
c
i
l

b
u
p
/
n
e
/
u
e
.
a
p
o
r
u
e
.
s
n
o
i
t
a
c
i
l

b
u
p
/
/
:
s
p
t
t
h
(

C
E
/
9
/
0
0
0
2

Cableway 
installations 

)
n
e
-
e
g
a
u
g
n
a
l
/
1
a
1
7
d
e
5
7
a
a
1
0
-
1
b
b
a
-
5
e
1
1
-
4
1
7
f

n
a
e
p
o
r
u
E

e
h
t

f
o

13. 

5
2
4
/
6
1
0
2

)
U
E
(

l

n
o
i
t
a
u
g
e
R

d
n
a

t
n
e
m
p
u
q
e

i

e
v
i
t
c
e
t
o
r
p

l

a
n
o
s
r
e
p

n
o

6
1
0
2

6
6
3
C
E
E
/
6
8
6
/
9
8

e
v
i
t
c
e
r
i
D

l
i
c
n
u
o
C
g
n

i
l

a
e
p
e
r

h
c
r
a
M
9

f
o

l
i
c
n
u
o
C
e
h
t

f
o

d
n
a

t
n
e
m
a

i
l
r
a
P

Personal 
protective 
equipment 
(ppp) 

Article 2 - This Regulation 
does not apply to the 
following: (a) lifts covered 
by Directive 2014/33/EU; 
(b) cableway installations 
that are categorised by 
Member States as historic, 
cultural or heritage 
installations, that entered 
into service before 1 
January 1986 and that are 
still in operation, and that 
have not had any 
significant changes in 
design or construction, 
including subsystems and 
safety components 
specifically designed for 
them;(c) installations 
intended for agricultural or 
forestry purposes; (d) 
cableway installations for 
the service of mountain 
shelters and huts intended 
only for the transport of 
goods and specifically 
designated persons; (e) 
on-site or mobile 
equipment exclusively 
designed for leisure and 
amusement purposes and 
not as a means for 
transporting persons; (f) 
mining installations or 
other industrial on-site 
installations used for 
industrial 
activities;(g)installations in 
which the users or their 
carriers are waterborne. 
Article 2 - This Regulation 
applies to personal 
protective equipment 
(PPE). This Regulation 
does not apply to 
PPE:(a)specifically 
designed for use by the 
armed forces or in the 
maintenance of law and 
order;(b)designed to be 
used for self-defence, with 
the exception of PPE 
intended for sporting 
activities;(c)designed for 
private use […]. 

Article 6 - "The 
cableway installations 
and their 
infrastructure, 
subsystems and 
safety components 
shall meet the 
essential 
requirements set out 
in Annex II which 
apply to them." 

Lack of 
compliance with 
EHSR (Art.6) 

NO 

NO 

Article 5 - "PPE shall 
meet the essential 
health and safety 
requirements set out 
in Annex II which 
apply to it." 

Lack of 
compliance with 
EHSR (Art.4) 

NO 

NO 

366http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32016R0425  

183 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

Burning 
gaseous fuels 

Article 1 - This Regulation 
applies to appliances and 
fittings. For the purposes 
of this Regulation, an 
appliance is considered to 
be ‘normally used’ where 
the following conditions are 
met: (a)it is correctly 
installed and regularly 
serviced in accordance 
with the manufacturer's 
instructions; (b) it is used 
with a normal variation in 
the gas quality and a 
normal fluctuation in the 
supply pressure as set out 
by Member States in their 
communication pursuant to 
Article 4(1); (c) it is used 
in accordance with its 
intended purpose or in a 
way which can be 
reasonably foreseen. […]. 

Article 5 - "Appliances 
and fittings shall 
meet the essential 
requirements set out 
in Annex I which 
apply to them." 

Lack of 
compliance with 
EHSR (Art.5) 

Toys 

Article 2 - This Directive 
shall apply to products 
designed or intended, 
whether or not exclusively, 
for use in play by children 
under 14 years of age 
(hereinafter referred to as 
toys). 

Article 10 - "Member 
States shall take all 
measures necessary 
to ensure that toys 
may not be placed on 
the market unless 
they comply with the 
essential safety 
requirements set out, 
as far as the general 
safety requirement is 
concerned, in 
paragraph 2, and, as 
far as the particular 
safety requirements 
are concerned, in 
Annex II" 

Lack of 
compliance with 
EHSR (Art.4) 

n
o

6
1
0
2

h
c
r
a
M
9

f
o

l
i
c
n
u
o
C

e
h
t

f
o

d
n
a

t
n
e
m
a

i
l
r
a
P

n
a
e
p
o
r
u
E

e
h
t

f
o
14. 
6
2
4
/
6
1
0
2

)
U
E
(

l

n
o
i
t
a
u
g
e
R

s
y
o
t

n
o

y
t
e
f
a
s

e
h
t
15. 
n
o

C
E
/
8
4
/
9
0
0
2

e
v
i
t
c
e
r
i
D

-
r
u
e
/
/
:
p
t
t
h
(

g
n

i
l

a
e
p
e
r

d
n
a

s
l
e
u
f

s
u
o
e
s
a
g

i

g
n
n
r
u
b

s
e
c
n
a

i
l

p
p
a

:
J
O
=
i
r
u
?
o
d
.
v
r
e
S
i
r
U
x
e
L
/
v
r
e
S
i
r
U
x
e
L
/
u
e
.
a
p
o
r
u
e
.
x
e

l

7
6
3
C
E
/
2
4
1
/
9
0
0
2

e
v
i
t
c
e
r
i
D

)
F
D
P
:
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:
7
3
0
0
:
1
0
0
0
:
0
7
1
:
9
0
0
2
:
L

NO 

NO 

Annex I (as 
referred to in 
Article 2(1)) - 
List of 
products that, 
in particular, 
are not 
considered as 
toys within the 
meaning of this 
Directive: 
Interactive 
software, 
intended for 
leisure and 
entertainment, 
such as 
computer 
games, and 
their storage 
media, such as 
CDs 

Whereas 45 - 
"Council Directive 
85/374/EEC […] 
applies, inter alia, 
to toys which are 
not in conformity 
with Community 
harmonisation 
legislation. 
Manufacturers and 
importers who have 
placed non-
compliant toys on 
the Community 
market are liable 
for damages under 
that Directive." 
Article 52 - "This 
Directive is without 
prejudice to 
Directive 
85/374/EEC." 

367 
01aa75ed71a1/language-en  

https://publications.europa.eu/en/publication-detail/-/publication/bcbb34d4-f714-11e5-abb1-

184 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

16. 

17. 

8
6
3
s
e
c
i
v
e
d

l

a
c
i
d
e
m
n
o

7
1
0
2

l
i
r
p
A

5

f
o

5
4
7
/
7
1
0
2

)
U
E
(

l

n
o
i
t
a
u
g
e
R

c
i
t
s
o
n
g
a
d

i

o
r
t
i
v

n

i

n
o

7
1
0
2

l
i
r
p
A

5

f
o

6
4
7
/
7
1
0
2

)
U
E
(

l

n
o
i
t
a
u
g
e
R

9
6
3
s
e
c
i
v
e
d

l

a
c
i
d
e
m

Medical devices 

Article 1 - This Regulation 
lays down rules concerning 
the placing on the market, 
making available on the 
market or putting into 
service of medical devices 
for human use and 
accessories for such 
devices in the Union. This 
Regulation also applies to 
clinical investigations 
concerning such medical 
devices and accessories 
conducted in the Union. 
[…]”. 

Article 5 - "A device 
shall meet the 
general safety and 
performance 
requirements set out 
in Annex I which 
apply to it, taking 
into account its 
intended purpose" 

In vitro 
diagnostic 
medical devices 

Article 1 - "This Regulation 
lays down rules concerning 
the placing on the market, 
making available on the 
market or putting into 
service of in vitro 
diagnostic medical devices 
for human use and 
accessories for such 
devices in the Union. This 
Regulation also applies to 
performance studies 
concerning such in vitro 
diagnostic medical devices 
and accessories conducted 
in the Union. 2. For the 
purposes of this 
Regulation, in vitro 
diagnostic medical devices 
and accessories for in vitro 
diagnostic medical devices 
shall hereinafter be 
referred to as ‘devices’. 
[…]”. 

Article 5 - "A device 
shall meet the 
general safety and 
performance 
requirements set out 
in Annex I which 
apply to it, taking 
into account its 
intended purpose" 

Lack of 
compliance with 
EHSR (Art.5) 

Lack of 
compliance with 
EHSR (Art.5) 

Whereas 35 - "The 
liability of the 
authorised 
representative 
provided for in this 
Regulation is 
without prejudice to 
the provisions of 
Directive 
85/374/EEC, […]". 
Article 10 - 
"Manufacturers 
shall […] have 
measures in place 
to provide sufficient 
financial coverage 
in respect of their 
potential liability 
under Directive 
85/374/EEC, […]". 
Article 17 - "[…] 
The reprocessor of 
the device shall be 
considered to be a 
producer for the 
purpose of Article 
3(1) of Directive 
85/374/EEC" 
Article 10 - General 
obligations of 
manufacturers - 
"Manufacturers 
shall […] have 
measures in place 
to provide sufficient 
financial coverage 
in respect of their 
potential liability 
under Directive 
85/374/EEC, […]."  
Whereas 34 - "The 
liability of the 
authorised 
representative 
provided for in this 
Regulation is 
without prejudice to 
the provisions of 
Directive 
85/374/EEC, and 
accordingly the 
authorised 
representative 
should be jointly 
and severally liable 
with the importer 
and the 
manufacturer." 

Article 2 - "For 
the purposes of 
this Regulation 
(…) medical 
device means 
(...) software 
(…)" 

Article 2 - "For 
the purposes of 
this Regulation, 
the following 
definitions 
apply: (1) 
‘medical 
device’ means 
‘medical 
device’ as 
defined in point 
(1) of Article 2 
of Regulation 
(EU) 
2017/745; (2) 
‘in vitro 
diagnostic 
medical device’ 
means any 
medical device 
which is (...) 
software or 
system, 
whether used 
alone or in 
combination, 
(...)." 

368 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN  
369http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN  

185 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

4
1
0
2

y
r
a
u
r
b
e
F

6
2

f
o
18. 
U
E
/
0
3
/
4
1
0
2

e
v
i
t
c
e
r
i
D

c
i
t
e
n
g
a
m
o
r
t
c
e
e

l

o
t

g
n
i
t
a
e
r

l

s
e
t
a
t
S

r
e
b
m
e
M

e
h
t

f
o

s
w
a

l

e
h
t

f
o

n
o
i
t
a
s
i
n
o
m
r
a
h

e
h
t

n
o

0
7
3
)
t
s
a
c
e
r
(

y
t
i
l
i

b
i
t
a
p
m
o
c

or 

appliance 

Article  2.1:  “This  Directive 
shall  apply  to  equipment 
as defined in Article 3 
Article 3:  
(1) ‘equipment’ means any 
apparatus 
fixed 
installation; 
(2)  ‘apparatus’  means  any 
finished 
or 
combination 
thereof  made  available  on 
the  market  as  a  single 
functional 
unit,  intended  for  the  end-
user and liable to generate 
electromagnetic 
disturbance, 
performance of which is 
liable  to  be  affected  by 
such disturbance; […]” 

the 

or 

  Electromagnetic 
compatibility 

Article 6 - "The 
equipment shall meet 
the essential 
requirements set out 
in Annex I." 

Lack of 
compliance with 
EHSR (Art.6) 

NO 

NO 

n
o
i
t
a
s
i
n
o
m
r
a
h

e
h
t

n
o

3
1
0
2

19. 

e
n
u
J

2
1

f
o
U
E
/
9
2
/
3
1
0
2

e
v
i
t
c
e
r
i
D

i

g
n
k
a
m
e
h
t

o
t

g
n
i
t
a
e
r

l

s
e
t
a
t
S

r
e
b
m
e
M
e
h
t

f
o

s
w
a

l

e
h
t

f
o

1
7
3
s
e
l
c
i
t
r
a

c
i
n
h
c
e
t
o
r
y
p

f
o

t
e
k
r
a
m
e
h
t

n
o

l

e
b
a

l
i

a
v
a

Pyrotechnic 
articles 

Article 2 – 1. "This 
Directive shall apply to 
pyrotechnic articles […] " 

Article 1 - "This 
Directive establishes 
the essential safety 
requirements which 
pyrotechnic articles 
are to fulfil with a 
view to their being 
made available on the 
market. Those 
requirements are set 
out in Annex I" 

Lack of 
compliance with 
EHSR (Art.1) 

NO 

Whereas 49 - "It is 
in the interests of 
the manufacturer 
and the importer to 
supply safe 
pyrotechnic articles 
in order to avoid 
liability costs for 
defective products 
causing damage to 
individuals and 
private property. In 
this regard, Council 
Directive 
85/374/EEC […] 
complements this 
Directive, […]. 
Furthermore, 
Directive 
85/374/EEC 
provides that 
notified bodies 
should be 
adequately insured 
in respect of their 
professional 
activities, […].” 

370http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0030  
371http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32013L0029&from=IT  

186 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

d
n
a

t
n
e
m
p
u
q
e

i

e
n
i
r
a
m
n
o

4
1
0
2

l

y
u
J

3
2

f
o
U
E
/
0
9
/
4
1
0
2

e
v
i
t
c
e
r
i
D

o
t

g
n
i
t
a
e
r

l

s
e
t
a
t
S

r
e
b
m
e
M
e
h
t

f
o

s
w
a

l

e
h
t

f
o

n
o
i
t
a
s
i
n
o
m
r
a
h

2
7
3
C
E
/
8
9
/
6
9

e
v
i
t
c
e
r
i
D

l
i
c
n
u
o
C
g
n

i
l

a
e
p
e
r

g
n
i
r
u
s
a
e
m

f
o

t
e
k
r
a
m
e
h
t

n
o

l

e
b
a

l
i

a
v
a

i

g
n
k
a
m
e
h
t

20. 

e
h
t

n
o

4
1
0
2

y
r
a
u
r
b
21. 
e
F

6
2

f
o
U
E
/
2
3
/
4
1
0
2

e
v
i
t
c
e
r
i
D

3
7
3
s
t
n
e
m
u
r
t
s
n

i

Marine 
equipment  

Measuring 
instruments  

Article 3 - "This Directive 
shall apply to equipment 
placed or to be placed on 
board an EU ship and for 
which the approval of the 
flag State administration is 
required by the 
international instruments, 
regardless of whether the 
ship is situated in the 
Union at the time when it 
is fitted with the 
equipment" 

Lack of 
compliance with 
EHSR (Art.4) 

Article 4 - "Marine 
equipment that is 
placed on board an 
EU ship on or after 
the date referred to 
in the second 
subparagraph of 
Article 39(1) shall 
meet the design, 
construction and 
performance 
requirements of the 
international 
instruments as 
applicable at the time 
when that equipment 
is placed on board. 
Compliance of marine 
equipment with the 
requirements referred 
to in paragraph 1 
shall be 
demonstrated solely 
in accordance with 
the testing standards 
and by means of the 
conformity 
assessment 
procedures referred 
to in Article 15.3. 
[…]" 

Article 2 - "This Directive 
applies to the measuring 
instruments defined in the 
instrument-specific 
Annexes III to XII 
(hereinafter ‘instrument-
specific Annexes’) 
concerning water meters 
(MI- 001), gas meters and 
volume conversion devices 
(MI-002), active electrical 
energy meters (MI-003), 
thermal energy meters 
(MI-004), measuring 
systems for continuous 
and dynamic measurement 
of quantities of liquids 
other than water (MI-005), 
automatic weighing 
instruments (MI-006), 
taximeters (MI-007), 
material measures (MI-
008), dimensional 
measuring instruments 
(MI-009) and exhaust gas 
analysers (MI-010)" 

Article 6 - "A 
measuring instrument 
shall meet the 
essential 
requirements set out 
in Annex I and in the 
relevant instrument-
specific Annex" 

Lack of 
compliance with 
EHSR (Art.6) 

NO 

NO 

Article 7.6 - 
"When a 
measuring 
instrument has 
associated 
software which 
provides other 
functions 
besides the 
measuring 
function, the 
software that is 
critical for the 
metrological 
characteristics 
shall be 
identifiable and 
shall not be 
inadmissibly 
influenced by 
the associated 
software" 

NO 

372http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0090&from=EN  
373 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0032&from=IT  

187 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

o
t

g
n
i
t
a
e
r

l

0
0
0
2

h
c
r
M
0
2

22. 

f
o

C
E
/
9
/
0
0
0
2

e
v
i
t
c
e
r
i
D

y
r
r
a
c

o
t

d
e
n
g
i
s
e
d

s
n
o
i
t
a

l
l

a
t
s
n

i

y
a
w
e
b
a
c

l

4
7
3
s
n
o
s
r
e
p

Cabley 
installations 
desgned to 
carry persons 

Article 1 - "The Directive 
shall apply to cableway 
installations designed to 
carry persons" 

23. 

n
o

4
1
0
2

y
r
a
u
r
b
e
F

6
2

f
o
U
E
/
1
3
/
4
1
0
2

e
v
i
t
c
e
r
i
D

r
e
b
m
e
M
e
h
t

f
o

s
w
a

l

e
h
t

f
o

n
o
i
t
a
s
i
n
o
m
r
a
h

e
h
t

e
h
t

n
o

l

e
b
a

l
i

a
v
a

i

g
n
k
a
m
e
h
t

o
t

g
n
i
t
a
e
r

l

s
e
t
a
t
S

i

i

g
n
h
g
e
w
c
i
t
a
m
o
t
u
a
-
n
o
n

f
o

t
e
k
r
a
m

Non-automatic 
wighing 
instruments 

Article 1 - "This Directive 
shall apply to all non-
automatic weighing 
instruments. 

5
7
3
s
t
n
e
m
u
r
t
s
n

i

Lack of 
compliance with 
EHSR (Art.3) 

Whereas 18 - 
"The concept of 
safety 
component 
applies not 
only to physical 
objects but 
also to 
intangible 
objects such as 
software" 

NO SPECIFC 
REFERENCE. 
However, Art.2 
provides this 
safeguard clause: 
"This Directive shall 
apply without 
prejudice to other 
Community 
Directives, although 
compliance with the 
essential 
requirements laid 
down in this 
Directive may call 
for the application 
of special European 
specifications 
established for that 
purpose."  

Lack of 
compliance with 
EHSR (Art.4) 

NO 

NO 

Article 3 - "The 
installations and their 
infrastructure, 
subsystems and 
safety components of 
an installation must 
comply with the 
essential 
requirements which 
are laid down in 
Annex II and are 
applicable to them." 

Article 4 - 
"Instruments used or 
intended to be used 
for the applications 
listed in points (a) to 
(f) of Article 1(2) 
shall satisfy the 
essential 
requirements set out 
in Annex I." 

e
h
t

f
o

s
w
a

l

e
h
t

f
o

i

n
o
i
t
a
m
x
o
r
p
p
a

24. 

e
h
t

n
o

0
9
9
1

e
n
u
J

9
2

f
o

e
v
i
t
c
e
r
i
d

l
i
c
n
u
o
C

Burning 
gaseous fuels 

s
l
e
u
f

s
u
o
e
s
a
g

i

g
n
n
r
u
b

s
e
c
n
a

i
l

p
p
a

o
t

g
n
i
t
a
e
r

l

s
e
t
a
t
S

r
e
b
m
e
M

6
7
3
)
C
E
E
/
6
9
3
/
0
9
(

Article 1 - "This Directive 
shall apply to: appliances 
burning gaseous fuels used 
for cooking, heating, hot 
water production, 
refrigeration, lighting or 
washing and having, where 
applicable, a normal water 
temperature not exceeding 
105 °C, hereinafter 
referred to as 'appliances'. 
Forced draught burners 
and heating bodies to be 
equipped with such 
burners will also be 
considered as appliances, 
safety devices, controlling 
devices or regulating 
devices and sub-
assemblies, other than 
forced draught burners and 
heating bodies to be 
equipped with such 
burners separately 
marketed for trade use and 
designed to be 
incorporated into an 
appliance burning gaseous 
fuel or assembled to 
constitute such an 
appliance, hereinafter 
referred to as 'fittings'. 

Article 3 - "Appliances 
and fittings as 
referred to in Article 1 
shall satisfy the 
essential 
requirements 
applicable to them 
set out in Annex I." 

Lack of 
compliance with 
EHSR (Art.3) 

NO 

NO 

374http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32000L0009&from=EN  
375http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0031&from=EN  
376http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31990L0396&from=EN  

188 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

e
h
t

f
o

s
w
a

l

e
h
t

f
o

n
o
i
t
a
s
i
n
o
m
r
a
h

6
2

f
o
U
E
/
8
2
/
4
1
0
2

e
h
t

n
25. 
o
4
1
0
2

e
v
i
t
c
e
r
i
D

y
r
a
u
r
b
e
F

t
e
k
r
a
m
e
h
t

n
o

l

e
b
a

l
i

a
v
a

i

g
n
k
a
m

e
h
t

o
t

g
n
i
t
a
e
r

l

s
e
t
a
t
S

r
e
b
m
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M

r
o
f

s
e
v
i
s
o
p
x
e

l

f
o

n
o
i
s
i
v
r
e
p
u
s

d
n
a

7
7
Explosives for 
3
)
t
civil uses 
s
a
c
e
r
(

s
e
s
u

l
i

v
i
c

Article 1 - "This Directive 
shall apply to explosives 
for civil uses. This Directive 
shall not apply to: (a) 
explosives, including 
ammunition, intended for 
use, in accordance with 
national law, by the armed 
forces or the police; (b) 
pyrotechnic articles falling 
within the scope of 
Directive 2013/29/EU; (c) 
ammunition, save as 
provided for in Articles 12, 
13 and 14 

Article 5 - "When 
placing their 
explosives on the 
market or when using 
them for their own 
purposes, 
manufacturers shall 
ensure that they have 
been designed and 
manufactured in 
accordance with the 
essential safety 
requirements set out 
in Annex II." 

Lack of 
compliance with 
EHSR (Art.5) 

n
o
i
t
a
m
x
o
r
p
p
a

i

e
h
t

n
o

C
E
E
/
5
8
3
/
0
9

e
v
i
t
c
e
r
i
D

l
i
c
n
u
o
C
26. 
g
n
d
n
e
m
a

i

7
0
0
2

r
e
b
m
e
t
p
e
S

5

f
o

C
E
/
7
4
/
7
0
0
2

e
v
i
t
c
e
r
i
D

e
v
i
t
c
e
r
i
D

l
i
c
n
u
o
C

,
s
e
c
i
v
e
d

l

l

a
c
i
d
e
m
e
b
a
t
n
a
p
m

l

i

e
v
i
t
c
a

o
t

g
n
i
t
a
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r

l

s
e
t
a
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S

r
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b
m
e
M
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t

f
o

s
w
a

l

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t

f
o

s
t
c
u
d
o
r
p

l

a
d
i
c
o
b

i

f
o

g
n
i
c
a
p

l

e
h
t

i

g
n
n
r
e
c
n
o
c

C
E
/
8
/
8
9

e
v
i
t
c
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r
i
D
d
n
a

s
e
c
i
v
e
d

l

a
c
i
d
e
m
g
n
n
r
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c
n
o
c

i

C
E
E
/
2
4
/
3
9

8
7
3
t
e
k
r
a
m
e
h
t

n
o

Active 
implantable 
medica devices  

Lack of 
compliance with 
EHSR (Art.3) 

Article 1 - "“medical 
device” means any 
instrument, apparatus, 
appliance, software, 
material or other article, 
whether used alone or in 
combination, together with 
any accessories, including 
the software intended by 
its manufacturer to be 
used specifically for 
diagnostic and/or 
therapeutic purposes and 
necessary for its proper 
application". 

Article 3 - "The active 
implantable medical 
devices referred to in 
Article 1(2)(c), (d) 
and (e), hereinafter 
referred to as 
“devices”, shall 
satisfy the essential 
requirements set out 
in Annex 1 which 
apply to them, 
account being taken 
of the intended 
purpose of the 
devices concerned." 

NO 

NO 

Whereas 6, 20: 
"It is necessary 
to clarify that 
software in its 
own right, 
when 
specifically 
intended by 
the 
manufacturer 
to be used for 
one or more of 
the medical 
purposes set 
out in the 
definition of a 
medical device, 
is a medical 
device. 
Software for 
general 
purposes when 
used in a 
healthcare 
setting is not a 
medical 
device"; 
"Taking 
account of the 
growing 
importance of 
software in the 
field of medical 
devices, be it 
as stand-alone 
or as software 
incorporated in 
a device, 
validation of 
software in 
accordance 
with the state 
of the art 
should be an 
essential 
requirement" 

NO 

377 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri(=CELEX:32014L0028&from=EN)  
378http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32007L0047&from=EN  

189 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

Article 1 - "This Regulation 
lays down requirements for 
the construction and 
functioning of motor 
vehicles and frontal 
protection systems in order 
to reduce the number and 
severity of injuries to 
pedestrians and other 
vulnerable road users who 
are hit by the fronts of 
vehicles and in order to 
avoid such collisions". 

d
Motor vehicles 
n
a
with regard to 
C
E
the protection 
/
2
of pedestrians 
0
1
and other 
/
3
vulnerable road 
9
0
7
0
3
users 
C
2
E
s
/
e
6
v
6
i
/
t
c
5
e
0
r
0
i
D
2

d
Motor vehicles  
n
A

r
o
F

d
e
d
n
e
t
n
I

s
t
i
n
U

l

a
c
i
n
h
c
e
T

e
t
a
r
a
p
e
S

s
t
n
e
n
o
p
m
o
C

0
8
3
s
e
l
c
i
h
e
V

h
c
u
S

Article 1 - "This Directive 
applies to the type-
approval of vehicles 
designed and constructed 
in one or more stages for 
use on the road, and of 
systems, components and 
separate technical units 
designed and constructed 
for such vehicles […].” 

Noise emission 
in the 
environment by 
equipment  

Article 2 - "This Directive 
applies to equipment for 
use outdoors listed in 
Articles 12 and 13 and 
defined in Annex I. This 
Directive only covers 
equipment that is placed 
on the market or put into 
service as an entire unit 
suitable for the intended 
use. Non-powered 
attachments that are 
separately placed on the 
market or put into service 
shall be excluded, except 
for hand-held concrete-
breakers and picks and for 
hydraulic hammers" 

4
1

f
o

9
0
0
2
/
8
7

o
N
)
C
E
(

l

n
o
i
t
a
u
g
e
R

f

O
d
n
A

t
n
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m
a

i
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r
a
P

n
a
e
p
o
r
u
E

e
h
T

f

O
C
E
/
6
4
/
7
0
0
2

e
v
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t
c
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r
i
D

e
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o
t

d
r
a
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l

a
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p
p
a
-
e
p
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t

h
t
i

n
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e
27. 
w
h
t
s
e
l
c
i
h
e
v

9
0
0
2

i

g
5
n
28. 
h
O
s
i
l

f

y
r
a
u
n
a
J

r
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b
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t
p
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S

l
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C

e
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T

r
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m

f
o

A

b
a
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s
E

7
0
0
2

E
H
T

F
O
D
N
A

T
N
E
M
A
I
L
R
A
P
N
A
E
P
29. 
O
R
U
E

E
H
T

F
O
C
E
/
4
1
/
0
0
0
2

e
v
i
t
c
e
r
i
D

r
e
h
t
o

d
n
a

s
n
a
i
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t
s
e
d
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p

f
o

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i
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l

a
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p
p
A

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h
T

r
o
F

k
r
o
w
e
m
a
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F

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w
a

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f
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o
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t
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Article 4 - "In 
accordance with 
Article 9, 
manufacturers shall 
ensure that vehicles 
placed on the market 
are equipped with a 
type approved brake 
assist system in 
accordance with the 
requirements of 
section 4 of Annex I 
and that such 
vehicles comply with 
the requirements of 
sections 2 or 3 of 
Annex I." 
Article 4 - "Member 
States shall ensure 
that manufacturers 
applying for approval 
comply with their 
obligations under this 
Directive. 2. Member 
States shall approve 
only such vehicles, 
systems, components 
or separate technical 
units as satisfy the 
requirements of this 
Directive" 
Article 4 - "Equipment 
referred to in Article 
2(1) shall not be 
placed on the market 
or put into service 
until the 
manufacturer, or his 
authorised 
representative 
established in the 
Community, ensures 
that: — the 
equipment satisfies 
the requirements 
concerning the noise 
emission in the 
environment of this 
Directive, — the 
conformity 
assessment 
procedures referred 
to in Article 14 have 
been completed, — 
the equipment bears 
CE marking and the 
indication of the 
guaranteed sound 
power level and is 
accompanied by an 
EC declaration of 
conformity. […]" 

Lack of 
compliance with 
TECHNICAL 
REQUIREMENTS 
(Art.3) 

Lack of 
compliance with 
TECHNICAL 
REQUIREMENTS 
(Art.4) 

Lack of 
compliance with 
TECHNICAL 
REQUIREMENTS 
(Art.4) 

NO 

NO 

NO 

NO 

NO 

NO 

379 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32009R0078&from=EN 
380http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32007L0046&from=EN  
381 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02000L0014-20090420&from=EN  

190 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Definition of 
damage/ 
compliance 
with EHSR 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

i

f
o

8
2

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7
7
9
1

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2
8
Safety belts 
3
s
e
and restraint 
l
c
systems of 
i
h
e
mothor vehicle  
v

ANNEX I - "This Directive 
applies to safety belts and 
restraint systems which 
are designed for 
installation in vehicles 
conforming to the 
definition in Article 9 and 
are intended for separate 
use, i.e. as individual 
fittings, by adults 
occupying forward-facing 
seats" 

Article 1 - " Each 
Member State shall 
grant EEC component 
type-approval for any 
type of three-point or 
lap safety belt and 
any type of restraint 
system which 
satisfies the design 
and test requirements 
laid down in 2 of 
Annex I and in 
Annexes IV to XIV" 

Lack of 
compliance with 
EHSR (Art.1) 

NO 

NO 

382 http://eur-lex.europa.eu/legal content/EN/ALL/?uri=celex:31977L0541  

191 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

 Legislation 

Scope 

Definition of product 

Definition of defect 
or definition of 
safety (EHSR) 

Reference to 
new 
technological 
developments 

Reference to the 
Directive 

Definition of 
damage/ 
compliance 
with EHSR 
Article 3 "[…] A 
product shall be 
deemed safe, as 
far as the aspects 
covered by the 
relevant national 
legislation are 
concerned, when 
[…], it conforms 
to the specific 
rules of national 
law of the 
Member State 
[…]. A product 
shall be 
presumed safe as 
far as the risks 
and risk 
categories 
covered by 
relevant national 
standards are 
concerned when 
it conforms to 
voluntary 
national 
standards 
transposing 
European 
standards […]. In 
circumstances 
other than those 
referred to in 
paragraph 2, the 
conformity of a 
product to the 
general safety 
requirement shall 
be assessed by 
taking into 
account […]: (a) 
voluntary 
national 
standards 
transposing 
relevant 
European 
standards […]; 
(b) the standards 
drawn up in the 
Member State in 
which the 
product is 
marketed; (c) 
Commission 
recommendations 
setting guidelines 
on product safety 
assessment; (d) 
product safety 
codes of good 
practice in force 
in the sector 
concerned; (e) 
the state of the 
art and 
technology; (f) 
reasonable 
consumer 
expectations 
concerning 
safety. […]” 

NO 

Article 2 - ‘safe 
product’ shall mean 
any product which, 
under normal or 
reasonably 
foreseeable 
conditions of use 
including duration 
and, where 
applicable, putting 
into service, 
installation and 
maintenance 
requirements, does 
not present any risk 
or only the minimum 
risks compatible with 
the product's use, 
considered to be 
acceptable and 
consistent with a high 
level of protection for 
the safety and health 
of persons, taking 
into account the 
following points in 
particular: (i) the 
characteristics of the 
product, including its 
composition, 
packaging, 
instructions for 
assembly and, where 
applicable, for 
installation and 
maintenance; (ii) the 
effect on other 
products, where it is 
reasonably 
foreseeable that it 
will be used with 
other products; (iii) 
the presentation of 
the product, the 
labelling, any 
warnings and 
instructions for its 
use and disposal and 
any other indication 
or information 
regarding the 
product;(iv) the 
categories of 
consumers at risk 
when using the 
product, in particular 
children and the 
elderly. 

Article 2 - ‘Product’ shall 
mean any product — 
including in the context of 
providing a service — 
which is intended for 
consumers or likely, under 
reasonably foreseeable 
conditions, to be used by 
consumers even if not 
intended for them, and is 
supplied or made available, 
whether for consideration 
or not, in the course of a 
commercial activity, and 
whether new, used or 
reconditioned. This 
definition shall not apply to 
second-hand products 
supplied as antiques or as 
products to be repaired or 
reconditioned prior to 
being used, provided that 
the supplier clearly informs 
the person to whom he 
supplies the product to 
that effect; 

Hazardous, 
unsafe 
consumer 
products 

31. 

)
"
D
S
P
G
"
(

y
t
e
f
a
s

t
c
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d
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p

l

a
r
e
n
e
g

n
o

1
0
0
2

r
e
b
m
e
c
e
D
3

f
o

L
I
C
N
U
O
C

E
H
T

F
O
D
N
A

T
N
E
M
A
I
L
R
A
P
N
A
E
P
O
R
U
E

E
H
T

F
O
C
E
/
5
9
/
1
0
0
2

E
V
I
T
C
E
R
I
D

Article 17 - "This 
Directive shall be 
without prejudice to 
the application of 
Directive 
85/374/EEC". 

192 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EVALUATION OF COUNCIL DIRECTIVE 85/374/EEC  

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