REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE on the implementation of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93
Date: 2022-12-05
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, EU financing, exchange of information, harmonisation of standards, international cooperation, market supervision, product safety, quality control of industrial products, single market

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 5.12.2022  COM(2022) 679 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE on the implementation of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93  
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE 
COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE 

on the implementation of Regulation (EC) No 765/2008 of the European Parliament and 
of the Council of 9 July 2008 setting out the requirements for accreditation and 
repealing Regulation (EEC) No 339/93 

1. 

INTRODUCTION 

This report provides an overview of how the provisions of Regulation (EC) No 765/2008 of 
the European Parliament and of the Council of 9 July 2008  setting out  the requirements for 
accreditation  (‘the  Regulation’)  were  implemented  between  2018  and  2022,  as  provided  for 
under Article 40 of the Regulation.  

This report does not constitute an evaluation of the up-to-date relevance and coherence of the 
framework  for  accreditation  and  CE  marking.  These  aspects  are  evaluated  under  the 
“Evaluation of the New Legislative Framework (NLF)”1, carried out by Commission in 2022.  

This  report  was  prepared  in  cooperation  with  the  Member  States  through  the  accreditation 
sub-group of the “Internal market for products” experts group. 

2.  ACCREDITATION 

2.1  The role of accreditation 

Products placed on the market (such as construction products, toys or machinery) must be safe 
and  comply  with  the  applicable  legislative  requirements.  While  manufacturers  must  ensure 
that  their  products  comply  with  the  requirements,  independent  bodies,  the  so-called 
“conformity  assessment  bodies”  or  “certification  bodies”  verify  if  the  products  meet  the 
applicable  legislative  requirements  before  they  are  sold.  These  bodies  are  also  used 
voluntarily by businesses to  demonstrate  compliance  with  standards or  market  requirements 
even where it is not a legislative requirement. 

Accreditation  is  the  attestation  by  a  National  Accreditation  Body  that  a  conformity 
assessment  body  has  the  technical  competence  to  perform  a  specific  conformity 
assessment activity.  

National Accreditation Bodies act as public authorities.  

National Accreditation Bodies monitor and reassess the conformity assessment bodies they 
have  accredited.  Where  a  National  Accreditation  Body  ascertains  that  a  conformity 
assessment body is no longer competent to carry out a specific conformity assessment activity 
or has committed a serious breach of its obligations, it takes appropriate measures to restrict, 
suspend or withdraw the accreditation. 

1   https://single-market-economy.ec.europa.eu/single-market/goods/new-legislative-framework_en    

1 

 
 
 
 
                                                           
For  products  regulated  at  EU  level  and  if  the  applicable  legislation  provides  for  the 
involvement  of  a  conformity  assessment  body,  nationally  designated  conformity 
assessment bodies — Notified Bodies — assess the product and issue an attestation of 
conformity before the product can be placed on the market.  

Accreditation is the preferred means of demonstrating the technical competence of the 
Notified Bodies. 

The Regulation establishes the legal  framework for accreditation.  The Regulation  applies to 
accreditation used on a compulsory or voluntary basis2. 

Moreover,  the  Regulation  recognises  a  body  known  as  the  European  co-operation  for 
accreditation  (the  EA)  of  which  national  accreditation  bodies  are  members  and  which 
cooperates with the Commission. 
By 2018, 35276 accreditations (initial accreditations and re-assessments) were delivered3. By 
the end of 2021 this number increased  to 367654. The number of “accreditations” is not the 
same as the number of accredited conformity assessment bodies. An “accreditation” refers to 
a  specific  conformity  assessment  activity  (e.g.  testing5,  certification6)  .  A  conformity 
assessment  body  may  be  accredited  in  more  than  one  conformity  assessment  activity  and 
related  sectors/scopes  (e.g.  toys,  machinery)  and  thus  may  have  more  than  one 
accreditation. 

2.2  The accreditation in the context of the EU policies  

2.2.1 Single Market and Industrial Strategy 

The  New  Industrial  Strategy  for  Europe7  and  its  2021  update8  stress  the  need  for  a  deeper 
Single  Market  that  empowers  European  companies  of  all  sizes  to  innovate,  scale-up  and 
employ more people.  

In  this  context,  the  “Long  term  action  plan  for  better  implementation  and  enforcement  of 
single market rules”9 puts the Single Market at the core of Europe’s industrial transformation 
and provides for further facilitating the circulation of goods and services across the EU, while 
also protecting consumers. 

A  robust  accreditation  system  that  ensures  reliable  assessment  of  the  product  compliance 
and  safety  facilitates  the  free  circulation  of  goods,  deepens  the  single  market  and  is  thus  a 
pillar of the implementation of the EU industrial policy. 

2    See Article 3 of the Regulation. 
3   EA MLA report 2018,  

https://european-accreditation.org/wp-content/uploads/2019/04/EA-MLA-report-2018_9-April.pdf  

4   EA MLA report 2021,  

https://european-accreditation.org/wp-content/uploads/2022/04/EA-MLA-report-2021.pdf  

5   Testing  is  the  determination  of  technical  characteristics  of  a  product.      Testing  does  not  include  the 

examination of the product conformity against (legislative or non-legislative) requirements. 

6   Certification is the demonstration that specific requirements (legislative or non-legislative) are  fulfilled. 
7   COM(2020) 102 final, 10.03.2020,  

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020DC0102&from=EN 

8   COM(2021) 350 final, 05.05.2021,  

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021DC0350&from=EN  

9   COM(2020) 94 final, 10.03.2020,  

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52020DC0094&from=EN  

2 

 
 
  
                                                           
 
 
Furthermore,  the  Annual  Single  Market  Report  202210  underlines  the  importance  of 
development  of  certification  schemes  in  core  areas  of  the  EU  industrial  and  single  market 
policies. In this respect, accreditation confirms that  conformity assessment bodies providing 
certification have the technical capacity to perform their duties properly. 

2.2.2 European Green Deal 

Accreditation  is  an  enabler  for  the  successful  implementation  of  the  priorities  set  out  in  the 
European Green Deal11 and the “Fit for 55 package delivering the EU's 2030 climate target on 
the  way  to  climate  neutrality12”,  wherever  the  assessment  of  product  compliance  against 
climate related and sustainability milestones is necessary.   

2.2.3  Digital Transition 

In the State of the Union Address in September 202113, President von der Leyen underlined 
the need for Europe to shape its digital transformation and secure digital sovereignty.  

In this respect,  the  “2030 Digital  Compass” laying down “the European way for the Digital 
Decade”14 provides for the uptake of digital skills and the development of climate neutral and 
energy efficient digital infrastructures. 

Accreditation  ensures  the competence  of the entities in charge of  performing  assessments 
against the relevant requirements, i.e. related to energy and environmental efficiency. 

2.2.4  Fight against Covid-19 

The Commission Recommendation (EU) 2020/403 related to the Covid-19 threat15 considered 
the conformity assessment as a crucial tool in the fight against the pandemic.  

In  this  respect,  accreditation  ensured  the  reliability  and  the  objectivity  of  the  controls 
performed  by  conformity  assessment  bodies,  even  in  times  of  influx  into  the  market  of  a 
high number of new and unexperienced manufacturers as it is the case during the beginning 
of the Covid-19 pandemic.  

2.2.5  Sectoral policies 

Several pieces of EU  sectoral  legislation  have recourse to  accreditation in  order to  ensure  a 
reliable  assessment  of  the  conformity  of  products  and  services  against  the  applicable 
legislative requirements.  

These  pieces  of  legislation  are  covering  a  wide  range  of  sectors  such  as:  toys,  machinery, 
construction  products,  pressure  equipment,  lifts,  recreational  craft,  radio  equipment, 
explosives  for  civil  uses,  equipment  intended  for  use  in  potentially  explosive  atmospheres 

10   SWD(2022) 40 final, 22.02.2022  

https://ec.europa.eu/docsroom/documents/48877  

11   COM(2019) 640 final, 11.12.2019, 

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52019DC0640&from=EN   

12   COM(2021) 550 final, 14.07.2021,  

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021DC0550&from=EN  

13   https://ec.europa.eu/commission/presscorner/detail/en/SPEECH_21_4701  
14   COM(2021) 118 final, 09.03.2021, 

https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A52021DC0118  

15   Commission  Recommendation  (EU)  2020/403  of  13  March  2020  on  conformity  assessment  and  market 
surveillance procedures within the context of the COVID-19 threat, C/2020/1712,OJ L 79I , 16.3.2020,  p.  1–
5, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32020H0403 

3 

 
 
                                                           
 
 
 
 
(ATEX),  pyrotechnic  articles,  gas  appliances,  personal  protective  equipment  including 
protective  masks  against  Covid-19,  medical  devices,  unmanned  aircraft  systems,  vehicles, 
railways,  fertilisers,  food  and  feed,  cybersecurity,  carbon  dioxide  emissions  from  maritime 
transport, verification of greenhouse gas emission reports.  

2.3 European Cooperation for Accreditation (EA) and Commission funding 

As  set  out  in  the  Regulation,  the  Commission  recognised  the  European  Cooperation  for 
Accreditation (EA) as the centre of the European accreditation infrastructure and is providing 
funding to EA16. 

In  December  2018,  the  Commission  and  the  EA  signed  the  third  framework  partnership 
agreement  for  a  four-year  period  (until  December  2022).  This  framework  partnership 
agreement allows financial support for the EA in fulfilling its tasks. At the time of writing this 
report, four annual operational grants amounting to EUR  722 900 each have been disbursed 
under this framework partnership agreement. This sum corresponds approximately to 45.73 % 
of the overall EA budget for 2022. 

The  Commission  and  the  EA  are  currently  discussing  the  fourth  framework  partnership 
agreement. 

The EA activities eligible for EU funding include the following : 

  carrying out technical work linked to the peer evaluation system; 

  providing technical expertise to different Commission services for the inclusion of 
accreditation  in  legislative  projects  or  in  terms  of  implementing  existing  sectoral 
legislation; 

  harmonising accreditation procedures; 

  participation in the international organisations such as the ILAC and the IAF  and 

international cooperation. 

In  addition,  the  EA  has  been  working  with  interested  stakeholders  through  its  Advisory 
Board. 

Besides the annual operational grant, the framework partnership agreement with the EA also 
stipulates  the  possibility  for  the  financing  of  specific  projects.  In  this  respect,  the  Joint 
Research Centre (JRC) awarded in 2020 to EA a contract of €410 000 for the continuation of 
the project “Support services regarding the accreditation/certification aspects of the project on 
a European voluntary Quality Assurance scheme for Breast Cancer Services”. The project is 
still  ongoing  at  the  time  of  writing  this  report  and  is  expected  to  be  concluded  in  the  first 
semester of 2023. 

The  cooperation  with  the  EA  has  been  very  fruitful  on  the  whole.  EA  is  recognised  as  the 
natural  "home"  of  the  European  accreditation  system.  Due  to  the  work  of  the  EA  and  its 
members,  it  is  recognised  that  accreditation  is  essential  for  the  enhancement  of  the 
competitiveness of the EU economy while protecting at the same time the public interest. 

16  See Article 14 of the Regulation. 

4 

 
 
                                                           
2.4 The peer evaluation system 

The  peer  evaluation  system17  of  national  accreditation  bodies  is  the  cornerstone  of  the 
European  accreditation  system.  National  accreditation  bodies  undergo  peer  evaluations  of 
their systems, procedures and structures at the latest every four years.  

The  aim  of  the  peer  evaluation  system  is  to  ensure  consistency  and  equivalence  of 
accreditation practices across Europe so that the national public authorities and  the 
wider  market  place,  mutually  recognise  the  services  delivered  by  the  accreditation 
bodies  that  have  successfully  passed  the  peer  evaluation,  and  therefore  accept  the 
accreditation  certificates  and  the  attestations  issued  by  the  conformity  assessment 
bodies accredited by them. 

The EA has the fundamental function of organising the peer evaluation18. EA is organising, 
managing and operating the peer evaluation system.  

Following the successful peer evaluation, national accreditation bodies became signatories to 
the  EA  Multilateral  Agreement  (MLA)19  for  the  mutual  recognition  of  accreditation 
certificates.  A  successful  peer  evaluation  is  the  prerequisite  for  the  mutual  recognition  of 
accreditation certificates. 

The  peer  evaluation  system  has  demonstrated  its  strength  by  ensuring  that  national 
accreditation bodies have a high level of competence. 
The operation and management of the peer evaluation system in 2017-2021 included20: 

Year 

2017 

2018 

2019 
  202022 

2021 

Number of evaluations 
performed21 
18 

18 

16 

7 

25 

Total man-days of evaluation work 

1080 

1393 

935 

335 

1764 

For the period this report covers, the peer evaluation system reported the following numbers 
of  findings  where  corrective  action  was  required  by  national  accreditation  bodies.  The 
findings  are  either  proven  “non-conformities”  or  “comments”,  i.e.  suggestions  for  potential 
improvement.  Until  the  year  2020  (included),  the  findings  could  also  include  “concerns”  of 
the evaluators for possible non-conformities. These “concerns” are now covered under “non-
conformities”. National accreditation bodies are taking corrective action to remedy the “non-
conformities” and address the “comments”. The EA is monitoring how the corrective action is 
being implemented. 

17   See Article 10 of the Regulation. 
18   See Articles 10, 11 and 13 of the Regulation. 
19   The EA Multilateral Agreement (EA MLA) is a agreement whereby the signatories recognise and accept the 
equivalence  of  the  accreditation  systems  operated  by  the  signing  members,  and  also  the  reliability  of  the 
conformity assessment results provided by conformity assessment bodies accredited by the signing members. 

20   EA MLA report 2020, 

https://european-accreditation.org/wp-content/uploads/2021/04/EA-MLA-report-2020.pdf  
and EA MLA report 2021,  
https://european-accreditation.org/wp-content/uploads/2022/04/EA-MLA-report-2021.pdf  

21   Initial evaluations, re-evaluations with or without scope extensions and extraordinary evaluations. 
22   Due to the pandemic, several peer evaluations have been postponed to 2021. 

5 

 
 
 
                                                           
 
Year 
201723 
201824 
201925 
202026 
202127 

Non-conformities 

Concerns 

Comments 

116 

84 

71 

62 

239 

185 

139 

170 

94 

No longer applicable 

131 

81 

125 

56 

193 

2.5 Accreditation in support of notification 

Notification is the act of a Notifying Authority of a Member State informing the Commission 
and  the  other  Member  States  that  it  has  designated  a  conformity  assessment  body  under  an 
EU harmonisation act, and that the body fulfils the relevant requirements set out in that act. 
Member  States  have  to  ensure  the  competence  of  their  Notified  Bodies  towards  the  other 
Member States and the EU institutions. 

Accreditation is the most used instrument for verifying the competence of conformity 
assessment bodies wishing to be notified, for the following reasons.  

  The  existence  of  the  EA  peer  evaluation  system  ascertains  the  ability  and 
competence  of  the  National  Accreditation  Bodies  and  ensures  consistency  and 
equivalence of accreditation practices across the EU; 

  Accreditation  is  based  on  Harmonised  Standards  and  thus  ensures  EU-wide  the 

same stringency of the evaluation of the conformity assessment bodies; 

  Accreditation  provides  for  established  procedures  for  evaluation  and  regular 

surveillance of the accredited conformity assessment bodies; 

  Accreditation provides for transparent appeal procedures against the decision of a 

National Accreditation Body. 

Nevertheless,  besides  accreditation,  other  procedures  to  evaluate  the  competence  of 
conformity assessment bodies may be allowed as well. In such cases, evidence must be given 
to  the  Commission  and  other  Member  States  that  the  evaluated  body  complies  with  all  the 
applicable regulatory requirements28.  

The proportion of notifications of accredited conformity assessment bodies increased over the 
years.  This  demonstrates  the  confidence  of  the  economic  operators  to  the  merits  of 
accreditation.  

A Notified Body may subcontract part of its work. However, it can only subcontract tasks for 
which it has the competence itself. It may not be the case, that a Notified Body subcontracts a 

23   EA MLA report 2017,  

https://european-accreditation.org/wp-content/uploads/2018/10/ea-mla-report-2017.pdf  

24   EA MLA report 2018, 

https://european-accreditation.org/wp-content/uploads/2019/04/EA-MLA-report-2018_9-April.pdf  

25   EA MLA report 2019,  

https://european-accreditation.org/wp-content/uploads/2020/04/EA-MLA-report-2019.pdf  

26   EA MLA report 2020, 

https://european-accreditation.org/wp-content/uploads/2021/04/EA-MLA-report-2020.pdf  

27   EA MLA report 2021, 

https://european-accreditation.org/wp-content/uploads/2022/04/EA-MLA-report-2021.pdf  

28   Article 5(2) of Regulation (EC) No 765/2008. 

6 

 
 
                                                           
 
 
 
part  of  the  work,  because  it  does  not  have  the  required  competence  and  knowledge. 
Subcontracting does not entail the delegation of powers or obligations to the subcontractor.  

In this respect, the National Accreditation Body and the Notifying Authority assess the extent 
to  which  the  conformity  assessment  body  intends  to  rely  on  subcontractors  and  they  may 
withdraw and limit the scope of the accreditation and notification. 

The  following  table  summarises  the  evolution  of  the  numbers  of  the  accredited  and  non-
accredited notifications29. 

Year 

200930 
201731  
202232 

Total number of 
notifications 
2249 

2708 

2507 

Unaccredited 

Accredited 

1089 

472 

420 

1118 

2236 

2087 

Accredited as % of 
all notifications 
48.4 

82.6 

83.2 

The fact that the UK had a high number of Notified Bodies (accredited and non-accredited) 
explains the drop by 7.9 percentage points in the total number of notifications between 2017 
and  2022.  Nevertheless  the  percentage  of  the  accredited  notifications  as  percentage  of  all 
notifications between 2017 and 2022 increased.  

The  following  tables  show  the  breakdown  of  notifications  per  Member  State  and  piece  of 
legislation at the time of the writing of this report33. 

29   As extracted from the information system for Notified Bodies (NANDO) 
30   Before the entry into force of the Regulation 
31   State of play is 3 November 2017 
32   State of play is 7 September 2022 
33   State of play is 7 September 2022 

7 

 
 
                                                           
Notifications per country (accredited vs non-accredited)

100%

3

1

1

1

0

1

6

1

1

1

0

1

6

6

2

2

4

2

6

30

1

2

8

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

6

80

140

47

1

6

56

86

67

48

100

12

69

27

49

108

90

2

45

2

29

39

282

215

20

13

0

0

Accredited

Non-accredited

8 

3

42

99

43

43

65

36

143

57 128

123

 
 
 
Legislation 

Accredited 

Non-accredited 

1 
2 
3 
4 
5 

90/385/EEC Active implantable medical devices34 
92/42/EEC Hot-water boilers 
93/42/EEC Medical devices35 
98/79/EC In vitro diagnostic medical devices36 
2000/14/EC Noise emission in the environment by equipment 
for use outdoors 
2006/42/EC Machinery 
2009/48/EC Safety of toys 
2010/35/EU Transportable pressure equipment 
2013/29/EU Pyrotechnic articles 

6 
7 
8 
9 
10  2013/53/EU Recreational craft and personal watercraft 
11  2014/28/EU Explosives for civil uses 
12  2014/29/EU Simple pressure vessels 
13  2014/30/EU Electromagnetic compatibility 
14  2014/31/EU Non-automatic weighing instruments 
15  2014/32/EU Measuring Instruments Directive 
16  2014/33/EU Lifts and safety components for lifts 
17  2014/34/EU Equipment and protective systems intended for 

use in potentially explosive atmospheres (recast) 

18  2014/53/EU Radio equipment 
19  2014/68/EU Pressure equipment 
20  2014/90/EU Marine equipment 
21  2016/797 on the interoperability of the rail system 
22  Regulation (EU) No 305/2011 Construction products 
23  Regulation (EU) 2016/424 Cableway installations 
24  Regulation (EU) 2016/425 Personal protective equipment 
25  Regulation (EU) 2016/426 Appliances burning gaseous fuels 
26  Regulation (EU) 2017/745 Medical devices 
27  Regulation (EU) 2017/746 In vitro diagnostic medical devices 
28  Regulation (EU) 2019/1009 Fertilising products 
29  Regulation (EU) 2019/945 Unmanned aircraft systems and on 

third-country operators of unmanned aircraft systems 
30  Regulation (EU) 2020/204 of 28 November 2019 on detailed 
obligations of European Electronic Toll Service providers 

3 
34 
21 
10 

37 

150 
35 
140 
10 
21 
6 
62 
56 
41 
58 
220 

67 

35 
283 
29 
46 
529 
14 
87 
38 
32 
7 
9 

5 

2 

7 
1 
28 
9 

8 

9 
7 
2 
0 
11 
4 
8 
16 
30 
31 
13 

6 

14 
32 
17 
13 
126 
4 
20 
4 
0 
0 
0 

0 

0 

34   As from 26 May 2021, the notified bodies designated under Directive 90/385/EEC are no longer able to issue 
new  certificates  under  that  Directive,  but  only  allowed  to  carry  out  surveillance  activities  for  certificates 
validly issued under that Directive  in the  transitional period, as established in Article 120 Regulation (EU) 
2017/745 on medical devices (line 26 of the table). 

35   As from 26 May 2021, the notified bodies designated under Directive 93/42/EEC are no longer able to   issue 
new  certificates  under  that  Directive,  but  only  allowed  to  carry  out  surveillance  activities  for  certificates 
validly issued under that Directive in the transitional period, as established in Article 120 of Regulation (EU) 
2017/745 on medical devices (line 26 of the table). 

36   As from 26 May 2022, the notified bodies designated under Directive 98/79/EC are no longer able to issue 
new  certificates  under  that  Directive,  but  only  allowed  to  carry  out  surveillance  activities  for  certificates 
validly issued under that Directive  in the  transitional period, as established in Article 110 Regulation (EU) 
2017/746 on in vitro diagnostic medical devices (line 27 of the table). 

9 

 
 
 
 
                                                           
2.6 Implementation of the agreement with Canada 

The EU-Canada Comprehensive Economic and Trade Agreement (CETA) contains a Protocol 
on  the  mutual  acceptance  of  the  results  of  conformity  assessment  (“the  Protocol”)37.  The 
Protocol relies on accreditation.  

Under the Protocol, once designated, a conformity assessment body in the EU can test 
products for export to Canada according to Canadian rules and vice versa. 

EA  and  Canada’s  national  accreditation  body,  the  Standards  Council  of  Canada  (SCC) 
signed in 2019 a cooperation agreement providing for exchange of information as well as of 
experts for on-site assessments and for establishing procedures for the implementation of the 
Protocol38. 

The  sectors  covered  by  the  Protocol  are:  Electrical  and  electronic  equipment,  Radio 
Equipment,  Electromagnetic  compatibility,  Toys,  Construction  products,  Machinery, 
Measuring Instruments, Hot-water boilers, Equipment and protective systems intended for use 
in  potentially  explosive  atmospheres,  Noise  emission  in  the  environment  by  equipment  for 
use outdoors, Recreational craft. 

During the CETA Joint Committee of 25 March 2021, Canada and the EU took stock of the 
positive outcomes regarding the ongoing implementation of the CETA Protocol.  

 A guidance document was adopted by the Commission and published in the Official Journal 
of the EU on 1 September 202139. The document addresses the following elements: 

  The scope of the Protocol; 

  The  conditions  for  the  recognition  (and  the  cessation  of  the  recognition)  of  the 

accreditation and conformity assessment bodies established in the other’s territory; 

  The acceptance of reports of recognised conformity assessment bodies;  

  The  ways  market  surveillance  or  enforcement  authorities  shall  verify  conformity  of  the  
products assessed by a recognised conformity assessment body established in the other’s 
territory. 

During the CETA Joint Committee of 8 March 2022, Canada and the EU acknowledged the 
positive  developments  in  the  implementation  of  the  CETA  Protocol  and  agreed  to  work 
towards  extending  the  scope  of  mutual  acceptance  of  results  of  conformity  assessment  to 
additional sectors. 

2.7 Remote assessment techniques 

Since the outbreak of the Covid-19 pandemic, remote methods are used more and more in the 
accreditation and conformity assessment processes. 

37   OJ L 11, 14.1.2017, p. 567 
38   https://european-accreditation.org/implementation-of-ceta-ea-renewed-with-scc-the-bilateral-cooperation-

agreement/       

39   Commission Notice - Implementation Guide for the Protocol to the CETA Agreement between Canada, the 
European  Union  and  its  Member  States  regarding  the  mutual  acceptance  of  the  results  of  conformity 
assessment, OJ C 351, 1.9.2021, p. 1 

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A main task is thus the systematic integration of remote assessment methods into the 
accreditation  and  conformity  assessment  processes  while  ensuring  that  the 
assessments maintain their reliability and stringency. 

In this respect the following elements have to be taken into account: 

  As accreditation is based on Harmonised Standards, and many of them  do not provide 
explicitly  for  remote  assessment  techniques,  it  is  imperative  to  ensure  that  their 
application in the context of these techniques does not put at risk the health and safety of 
products in the EU and the role that Notified Bodies play in conformity assessment.  

  The  degree  of  use  of  remote  assessments  may  depend  on  the  specificities  of  the  sector 
concerned  such  as  the  complexity  of  the  product  and  the  technology  in  question,  the 
impact  on  the  public  interest,  the  size  of  the  operator  concerned  and  the  nature  of  the 
production process (e.g. mass production or small series production).  

Currently, accreditation and conformity assessment stakeholders are still gathering experience 
from  the  use  of  the  remote  assessment  techniques  and  are  debating  about  the  following 
elements: 

  The potential of the remote assessment techniques to complement on-site assessments; 

  Their benefits e.g. in terms of efficiency, cost reduction and pandemic-proofness; 

  Their effectiveness and reliability in comparison to the on-site evaluations; 

  Whether  they  can  be  used  also  during  the  initial  evaluation  of  a  conformity  assessment 

body or only for the monitoring of accredited bodies; 

  Whether  there  are  parts  of  the  accreditation  and  conformity  assessment  that  by  default 
cannot  be  carried  out  remotely  or  even  whether  there  are  whole  product  sectors  where 
evaluations have to be always on-site; 

  The  need  to  modify  the  existing  accreditation  and  conformity  assessment  processes  in 
order  to  facilitate  the  use  of  remote  assessment  techniques  without  endangering  the 
reliability and the objectivity of the processes. 

The experience gathered to date and the questions remaining open do not allow at the time of 
writing this report to predict the exact way the remote assessment techniques will be used in 
the future. It is expected that regulators and stakeholders will crystallise their opinions in the 
foreseeable future. In the meantime stakeholders consider the on-site methods as the regular 
ones.  

3.  CE MARKING 

3.1 The role of CE marking  

Once  the  product  conformity  against  the  applicable  EU  legislative  requirements  is 
demonstrated,  the  manufacturer  affixes,  on  its  sole  responsibility,  the  CE  marking  on  the 
product.   

11 

 
 
 
By  affixing  the  CE  marking  the  manufacturer  indicates,  under  its  sole  legal 
responsibility, that the product is in conformity with the applicable requirements set 
out in the EU legislation providing for its affixing. 

CE  marking  is  thus  a  key  indicator  of  a  product's  compliance  with  EU  legislation  and  the 
visible part of an assessment procedure laid down in EU legislation applying to the product in 
question. The applicable EU legislation lays down if such a product assessment is performed, 
either  only  by  the  manufacturer  itself  or  under  the  involvement  of  a  notified  conformity 
assessment body.  

The  manufacturer,  whether  established  inside  or  outside  the  Union,  is  the  entity 
ultimately legally responsible for the conformity of the product with the provisions of 
the  Union  harmonisation  legislation  and  for  the  affixing  of  the  CE  marking; 
independent of the fact whether a notified conformity assessment body was involved in 
the product checks or not. 

The Regulation establishes the legal framework for the CE marking. 

Several  pieces  of EU sectoral  legislation provide for the affixing of the  CE marking. These 
pieces of legislation are covering a wide range of products such as: toys, machinery, pressure 
equipment,  construction  products,  lifts,  recreational  craft,  radio  equipment,  explosives  for 
civil  uses,  equipment  intended  for  use  in  potentially  explosive  atmospheres  (ATEX), 
pyrotechnic articles, gas appliances, personal protective equipment, medical devices. 

3.2 Exchange with the stakeholders  

Replying to the questions from stakeholders on the CE Marking, the Commission stressed the 
following elements: 

  The CE marking is not a marking of origin and does not indicate that the product has 
been  manufactured  in  the  European  Union.  Economic  operators,  whether  established 
inside or outside the Union, must affix the marking when their products are intended for 
the EU market and therefore they must comply with the EU legislation. 

The CE marking is also not a sign that the products have been approved by a national or 
other authority. 

  Not all products  are  CE-marked.  Only if the applicable legislation provides for it, then 

the product in question has to be CE-marked. 

Thus, the CE marking does not refer to the manufacturer but to the product. This means 
that  one  company  can  produce  a  number  of  items,  some  of  which  will  be  CE-marked 
while the others will not.   

  There  is  neither  authority  “granting”  the  CE  marking  nor  any  CE  marking 
“representative”; the CE marking is a declaration of the manufacturer. Nevertheless, the 
EU legislation provides for a set of documents that need to accompany every product that 
is CE-marked: technical documentation and declaration of conformity. 

  Where  the  involvement  of  a  conformity  assessment  body  in  the  conformity  assessment 
procedure  is  mandatory  in  the  relevant  EU  legislation,  only  notified  conformity 
assessment bodies are allowed to be involved. 

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  The  CE  marking  provides  the  first  indication  that  the  necessary  assessment  can  be 
assumed to have been carried out, before the product in question is placed on the market, 
in order to ensure its compliance with the legislative requirements.  

Nevertheless,  market  surveillance  authorities  control  products  made  available  on  the 
market. Their aim is to ensure that products fulfil the applicable requirements providing a 
high level of protection of public interests such as health and safety, security, protection of 
consumers and protection of the environment. 

3.3 Enforcement  

National authorities detected the following number of cases of non-compliances related to the 
CE marking and/or its accompanying documentation40.  

Year 

2017 

2018 

2019 

2020 

2021 
202241 

Number of inspections 

Number of non-compliances 

9262 

11648 

13653 

13181 

15584 

12817 

1347 

1362 

1257 

2285 

1716 

1974 

4.  CONCLUSIONS  

The  Regulation  has  set  a  solid  legal  framework  for  accreditation  and  CE  marking.  In  this 
respect,  the  “Evaluation  of  the  New  Legislative  Framework  (NLF)”,  carried  out  by 
Commission services in 2022, acknowledges in line with this report the following: 

  The adoption and practical implementation of the EU legal framework for accreditation 
is  a  very  important  achievement  under  the  objective  of  strengthening  the  conformity 
assessment system in Europe; 

  The  provisions  on  CE  marking  are  clear,  enhance  its  clarity  and  credibility,  increase 
industry attention on CE marking requirements,  strengthen the visibility  of CE marking, 
and iron out minor inconsistencies between different pieces of legislation. 

As accreditation and CE marking underpin the implementation of several EU policies, a main 
challenge  is  to  reinforce  their  solidity  and  reliability.  In  this  respect,  the  “Evaluation  of  the 
New Legislative Framework (NLF)” concluded in line with this report that it is important to: 

  Ensure that the relevant Harmonised Standards are adopted through a quick and effective 
standardisation process and continue to be in line with the International Standards and to 
reflect the latest state of the art;  

  Explore ways in which remote assessment methods can facilitate the accreditation and 

conformity assessment processes, where appropriate; 

40   As registered by the market surveillance authorities into the Information and Communication System  

for 

Market  Surveillance  (ICSMS),  the  EU  wide  cooperation  mechanism  for  the  national  market  surveillance 
authorities 

41   State of play is 22 September 2022 

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  Ensure  that  the  National  Accreditation  Bodies  and  the  Notifying  Authorities  have  the  
resources  to  monitor  the  tasks  the  accredited  Notified  Bodies  subcontract,  especially 
when these tasks are performed in another Member State or a third country; 

  Explore  the  potential  of  digitalisation  for  simplification  of  administrative  obligations 

related to affixing of the CE marking. 

Moreover, it is essential that the EA continues to receive EU support to help it implement its 
tasks and to ensure the coordination of accreditation activities as well as the operation of the 
peer evaluation system.  

The  Commission  will  continue  to  promote  the  use  of  accreditation  and  CE  marking  in  any 
new proposals requiring conformity assessment. 

14