COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT Accompanying the Proposal for a Regulation of the European Parliament and of the Council on machinery products
Date: 2021-04-21
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, European standard, machinery, market approval, product design, product safety, safety standard, technical standard

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 21.4.2021  SWD(2021) 82 final  COMMISSION STAFF WORKING DOCUMENT  IMPACT ASSESSMENT  Accompanying the Proposal for a Regulation of the European Parliament and of the Council on machinery products {COM(2021) 202 final} - {SEC(2021) 165 final} - {SWD(2021) 83 final}  
 
 
Table of contents 

1. 

2. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT ............................................................... 3 

PROBLEM DEFINITION .................................................................................................................. 11 

3.  WHY SHOULD THE EU ACT? ........................................................................................................ 23 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? ............................................................................... 24 

5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? .................................................................... 26 

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? ........................................................... 35 

7.  HOW DO THE OPTIONS COMPARE? ............................................................................................ 68 

8. 

PREFERRED OPTION ...................................................................................................................... 71 

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? .................................. 72 

1. 

LEAD DG, DECIDE PLANNING/CWP REFERENCES .................................................................. 75 

2.  ORGANISATION AND TIMING ...................................................................................................... 75 

3. 

4. 

1. 

2. 

CONSULTATION OF THE RSB....................................................................................................... 75 

EVIDENCE, SOURCES AND QUALITY ......................................................................................... 77 

PRACTICAL IMPLICATIONS OF THE INITIATIVE..................................................................... 87 

SUMMARY OF COSTS AND BENEFITS ....................................................................................... 89 

1 

 
 
Glossary 

Term or acronym 

Meaning or definition 

AI 

CAGR 

CE 

CEN 

Cenelec 

DoC 

EC 

EEA  

EEC 

EFTA 

EHSRs 

EMCD 

EN 

ESO 

ETSI 

EU  

EU-28 

FTE 

GDP 

IIoT 

IoT 

ISO 

LD 

LVD 

MD  

ML 

MS 

MSA  

NACE  

NBs 

n.e.c. 

NGO 

NLF  

OEM 

OJEU 

OND 

OSHA  

PCM 

PED 

pp. 

RED 

REFIT  

SME 

TEU 

TFEU 

Artificial intelligence 

Compound average growth rate 

European conformity marking 

European Committee for Standardization 

European Committee for Electrotechnical Standardisation 

Declaration of conformity 

European Commission 

European Economic Area 

European Economic Community 

European Free Trade Association 

Essential health-and-safety requirements 

Electromagnetic Compatibility Directive 

European standards 

European standardisation organisation 

European Telecommunications Standards Institute 

European Union 

EU-28 Member States (as of 1/12/2019) 

Full-time equivalent 

Gross domestic product 

Industrial internet of things 

Internet of things 

International standards 

Lifts Directive 

Low-Voltage Directive 

Machinery Directive 

Machine learning 

Member State (of the EU) 

Market surveillance authority 

Statistical classification of economic activities in the EC 

Notified bodies  

Not elsewhere classified 

Non-governmental organisation 

New legislative framework 

Original equipment manufacturer  

Official Journal of the European Union 

Outdoor Noise Directive 

Occupational Safety and Health Administration 

Partly completed machinery 

Pressure Equipment Directive 

Percentage points 

Radio Equipment Directive 

Regulatory fitness and performance programme 

Small and medium-sized enterprises 

Treaty on European Union 

Treaty on the Functioning of the European Union 

2 

 
 
 
 
1. 

INTRODUCTION: POLITICAL AND LEGAL CONTEXT 

The  revision  of  the  Product  Safety  Directive  2006/42/EC  on  Machinery  (‘the  Machinery 
Directive’ or ‘the MD’)1 contributes to the digital transition and to the strengthening of the single 
market. It is part of the Commission’s 2020 work programme under the priority ‘A Europe fit for 
the  digital  age’.  The  Commission  has  been  active  in  studying  emerging  technologies  and  their 
impact on safety legislation. For example, the Commission published a white paper on artificial 
intelligence in February 2020. The white paper was accompanied by the Report on the safety and 
liability implications of Artificial Intelligence, the Internet of Things and robotics2. This report 
analysed  the  impact  of  emerging  technologies  and  the  challenges  they  pose  to  EU  safety 
legislation.  It  concluded  that  current  product-safety  legislation  contains  a  number  of  gaps 
that need to be addressed. One such piece of product-safety legislation that contains gaps is 
the MD. Addressing the gaps in this Directive is especially important for a sustainable recovery 
from the COVID-19 pandemic, since the machinery sector is an essential part of the engineering 
industry and one of the industrial mainstays of the EU economy.  

The MD is the main piece of legislation regulating products made by the mechanical engineering 
industry. The scope of the MD covers a wide range of products. Machinery is broadly defined as 
an assembly ‘of linked parts or components, at least one of which moves’. This definition applies 
to a great variety of products, from lawnmowers to 3D printers, and from powered hand-tools to 
robots or construction machinery. The MD applies across the whole value chain, from the design 
and  manufacturing  stages  until  the  machinery  is  placed  on  the  market  (or  put  into  service)  for 
consumer and professional use. The machinery manufacturers must take the appropriate measures 
to ensure safety risk throughout the foreseeable lifetime of the machinery before it is placed on 
the market. 

The MD lays down a regulatory framework for placing machinery on the single market, based on 
Article 114 of the TFEU (the approximation of laws). The MD was adopted on 17 May 2006 and 
implemented in 2009. It was the result of a comprehensive revision of previous legislation dating 
back to the first piece of legislation on this topic, Directive 89/392/EEC (which was reviewed in 
1991  and  1993),  replaced  by  a  subsequent  piece  of  legislation,  Directive  98/37/EC.  An 
amendment in 2009 to the current Directive 2006/42/EC added a ‘protection of the environment’ 
objective, although this amendment was limited to machinery used in pesticide applications. 

The MD is a piece of product-safety legislation that aims to ensure a high level of protection for 
workers, consumers and other exposed people. It seeks to achieve this by focusing on the safety 
of  machinery  itself,  and  thus  imposes  obligations  on  machinery  manufacturers  to  produce 
inherently safe machinery designs (safety by design). The general objectives of the MD are to: (i) 
ensure the free movement of machinery within the single market; and (ii) ensure a high level of 
protection  for  users  and  other  exposed  people.  The  MD  imposes  obligations  on  machinery 
manufacturers, but not on users. 

The  MD  follows  the  ‘new  approach’  principles  of  EU  legislation.  As  opposed  to  the  ‘Old 
approach’,  where  technical  specifications  are  embedded  in  the  legal  text,  the  ‘New  approach’ 
implies that the  legal text, the MD in this case, is intentionally written to be ‘technology neutral’ 
by 
‘safety 
the  essential  health-and-safety  requirements 
requirements’)  to  be  complied  with,  without  prescribing  any  specific  technical  solution  for 
complying  with  those  requirements.  The  choice  of  the  technical  solution  is  a  prerogative  of 
manufacturers, which leaves space for innovation and the development of new designs.  

laying  down 

(hereinafter 

1 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery. 
2 Available at: https://ec.europa.eu/info/publications/commission-report-safety-and-liability-implications-ai-internet-things-and-robotics-0_en  

3 

 
 
                                                           
The safety requirements are set out in Annex I of the MD. Some safety requirements are more 
general in nature, while others are specific to certain types of machinery. The manufacturers must 
make a risk assessment to determine what risks the machinery presents. Based on these risks, the 
manufacturers  must  identify  the  safety  requirements  with  which  the  machine  must  comply.  To 
help  manufacturers  prove  that  their  machinery  conforms  to  the  requirements,  and  to  allow 
inspection of conformity with the requirements, harmonised standards at EU level are commonly 
used (see Chapter 1.1 of this impact assessment). These standards are drawn up by private-law 
bodies and their use is voluntary. Manufacturers have the choice of implementing other technical 
solutions  as  long  as  they  can  prove  that  all  relevant  legal  requirements  are  complied  with. 
Compliant machinery is put on the market with a ‘CE marking’ affixed to it. This is a way for the 
manufacturer  to  declare  that  the  product  meets  all  the  legal  requirements  and  can  be  sold 
throughout the EU. 

During  the  REFIT  evaluation3  of  the  MD,  all  interested  parties  confirmed  that  the  MD  is  an 
essential piece of legislation necessary to guarantee: (i) the right level of safety for the wide range 
of products covered; and (ii) a level playing field in the machinery market. The evaluation was 
also positive about the MD’s flexibility and openness to innovation. Nevertheless, the evaluation 
also identified a necessity to improve, simplify, and adapt the MD to the needs of the market. In 
particular, the evaluation concluded that a revision should aim to:  

  address  the  risks  stemming  from  emerging  technologies  while  allowing  for  technical 

 

 

progress; 
improve the legal clarity of some major concepts and definitions in the current text of the 
MD;  
simplify the requirements for documentation by allowing digital formats, thus reducing 
administrative burden for businesses while also cutting environmental costs;  

  ensure  coherence  with  other  directives  and  regulations  for  products  and  improve 
enforcement  of  the legislation through  the alignment  to  the  new  legislative  framework; 
and  
reduce the costs of transposition by converting the MD into a regulation.  

 

Some  members  of  the  European  Parliament’s  IMCO  committee  European  Parliament’s 
Committee on Internal Market and Consumer Protection (IMCO) expressed their support for the 
revision of the MD. In particular, they supported the idea of ‘bringing the legislation into the 21st 
century’ and promoting innovation for the EU economy.  

1.1 The role of harmonised standards in the machinery sector 

As  indicated  above,  an  important  part  of  the  application  of  the  MD  is  the  role  of  harmonised 
standards.  These  harmonised  standards  are  developed  by  the  European  standardisation 
organisations (CEN/CENELEC and ETSI) following a standardisation request from the European 
Commission,  according  to  Regulation  (EU)  No  1025/20124.  Machinery  manufactured  in 
conformity  with  a  harmonised  standard,  the  references  to  which  have  been  published  in  the 
Official Journal of the European Union (OJEU), are presumed to comply with the requirements 
covered by such a harmonised standard. 

The  voluntary  nature  of  the  standards  makes  the  framework  flexible  enough  to:  (i)  enable 
innovation  and  technical  development;  and  (ii)  facilitate  the  placing  on  the  market  of  new 
products for which a harmonised standard does not yet exist. 

Under the MD, there are three types of standards: A, B and C. Type-A standards cover principles 
common to all machines. Type-B standards cover: (i) safety and ergonomic principles; (ii) safety 

3 Evaluation of the Machinery Directive: SWD (2018)160 
4 Regulation (EU) No 1025/2012 of 25 October 2012 on European standardisation, OJ L 316, 14.11.2012, pp. 12-33. 

4 

 
                                                           
components; and (iii) devices. Type-C standards cover specific types or groups of machines. The 
references of harmonised standards are published in the OJEU. The most recent list comprising 
all three types of standards5 includes a total of 1 112 standards relevant for the MD, of which 782 
will still apply after 2022, meaning that 330 have been withdrawn or will be withdrawn by then.  

The Commission may, within the limitations of the powers laid down in the Treaties, ask one or 
several European standardisation organisations (ESOs) to draft a European standard within a set 
deadline.  European  standards  and  European  standardisation  deliverables  must:  (i)  be  market-
driven; (ii) take into account the public interest as well as the policy objectives clearly stated in 
the Commission’s request; and (iii) be based on consensus. The Commission must determine the 
content requirements to be met by the requested document and set a deadline for its adoption6.  

1.2 The Machinery Directive in the broader EU legislative context 

The MD is a piece of EU, harmonised, sectoral, product-safety legislation. As such, it is also part 
of the EU’s body of law (‘the acquis’) dealing with product safety.  

There  are  more  general  EU  rules  dealing  with  safety  across  different  product  types  (i.e.  the 
General  Product  Safety  Directive7  and  the  new  legislative  framework8)  and  sectoral  rules  for 
specific  product  types.  The  General  Product  Safety  Directive  is  a  safety-net  legislation  that 
applies to consumer products if: (i) there are not more specific provisions in harmonised, sectoral, 
product-safety legislation; and (ii) there are aspects and risks (or categories of risks) not covered 
by that sectoral product-safety legislation. 

The  MD  covers  all  safety  risks  that  manufacturers  must  address  to  be  able  to  place  their 
machinery on the EU market. The specificities of the products covered and their risks confirm the 
need  for  sectoral  legislation.  Therefore,  because  the  safety  requirements  of  the  MD  are  more 
specific  than  the  general  safety  requirements  of  the  General  Product  Safety  Directive,  the  MD 
takes precedence.  

The  MD  ensures  a  high  level  of  protection  for  machinery  users  and  other  exposed  persons  by 
ensuring the safety of machinery. It applies at the moment the machine is placed on the market 
(or  put  into  service).  Another  directive,  EU  Directive  2009/104/EEC9  lays  down  minimum 
safety and health requirements for the  use of work equipment, after it has been placed on the 
market (or put into service). The two Directives are therefore complementary. 

In  some  cases,  depending  on  the  machinery’s  characteristics, the  MD  may  apply  together  with 
other  pieces  of  legislation,  such  as:  (i)  the  Outdoor  Noise  Directive  (OND);  (ii)  the  Radio 
Equipment Directive (RED); (iii) the Electromagnetic Compatibility Directive (EMCD); or (iv) 
Regulation  (EU)  2016/1628  on  requirements  relating  to  gaseous  and  particulate  pollutant 
emission  limits  and  type-approval  for  internal  combustion  engines  for  non-road  mobile 
machinery  (recently  amended  by  Regulation (EU)  2020/1040  in  order  to address  the impact  of 
the COVID-19 crisis). For instance, machinery with radio equipment may be subject to both the 
MD  and  the  RED,  while  machines  for  use  outdoors  (such  as  in  construction  sites,  road 
maintenance, gardening and forestry activities) may be subject to both the MD and the OND. 

In other cases, the MD applies alternatively to other product-safety legislation, such as the Low-
Voltage Directive (LVD), the Pressure Equipment Directive (PED), the Lifts Directive (LD) 
or  the  Medical  Devices  Directive.  In  such  cases,  some  categories  of  machinery  are  explicitly 

5 Available at: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/machinery_en. 
6 Regulation (EU) No 1025/2012 of 25 October 2012 on European standardisation, OJ L 316, 14.11.2012, pp. 12-33. 
7 Directive 2001/95/EC the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, pp. 4-

17).  

8 Regulation (EC) No. 2008/765 and Decision (EC) No. 2008/768.    
9 Directive 2009/104/EC of 16 September 2009 concerning the minimum safety and health requirements for the use of work equipment by 
workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC), OJ L 260, 3.10.2009, pp. 5-19. 

5 

 
                                                           
excluded from the scope of one of the legal acts, falling only under the scope of the other. For 
instance, certain machinery is excluded from the MD as listed in Article 1(2)(k) of the MD, and 
falls  instead  under  the  LVD.  Other  machinery  is  excluded  from  the  PED  (Category  I  products 
under  PED)  or  the  LD  (lifting  appliances  whose  speed  is  not  greater  than  0.15 m/s),  and  falls 
under the MD.  

The  Commission  is  also  active  in  assessing  artificial  intelligence  (AI),  the  internet  of  things 
(IoT), and other digital technologies and their implications for safety legislation. As mentioned in 
Introduction  1.1,  the  Commission  published  in  February  2020  its  Report  on  the  safety  and 
liability implications of Artificial Intelligence, the Internet of Things and robotics10. The report 
concluded  that  current  product-safety  legislation  contains  a  number  of  gaps  that  need  to  be 
addressed,  in  particular  in  the  MD.  The  revision  of  the  MD  is  taking  into  account  those 
recommendations. 

The  white  paper  on  AI  also  outlined  the  Commission’s  objective  to  propose  new  legislation 
covering  safety  and  fundamental  requirements  for  AI  systems.  A  new  AI  regulation  is  being 
drawn up in this area. The Commission intends to adopt proposals for both a new AI regulation 
and a revised MD in the second quarter of 2021. The link between a new AI regulation and the 
revised MD is further detailed in the policy options set out for AI. Coherence between this new 
AI regulation and the revised MD will be sought at the level of: (i) the safety requirements; (ii) 
the  concepts  and  definitions  used  (e.g.  the  ‘high-risk’  concept);  and  (iii)  the  conformity-
assessment  procedure.  This  coherence  is  essential  to  ensure  that  no  duplication  or  additional 
unnecessary burden is placed on businesses.  

On cybersecurity, the MD is focused on product safety, and addresses only those risks that may 
have  an  impact  on  safety.  This  means  that  the  revision  of  the  MD  should  be  limited  to  ‘cyber 
safety’  (related  to  the  machine),  rather  than  to  cybersecurity  in  broad  terms  (related  to  the 
network).  

On  cybersecurity  more  broadly,  the  Cybersecurity  Act11  represents  a  point  of  reference  as  an 
existing  market  initiative  on  network  security.  The  Cybersecurity  Act  is  a  voluntary,  EU-wide 
certification  framework  for  digital  products,  services  and  processes.  It  is  based  on  a 
comprehensive set of rules, technical requirements, standards and procedures. Manufacturers can 
choose to follow this voluntary certification framework if they wish. The Cybersecurity Act also 
has the potential to cover emerging cybersecurity risks for machinery products that use emerging 
technologies, but only to a certain extent due to its voluntary nature. In addition, under the RED, 
preparatory  work  is  under  way  for  possible  delegated  acts  addressing:  (i)  privacy;  (ii)  data 
protection; (iii) protection from fraud; and possibly (iv) protection to ensure that the equipment 
does  not  harm  the  network.  Those  delegated  acts  would  apply  to  connected  machines 
incorporating radio equipment. 

The Commission is also taking a broader look at the impacts of EU regulation, paying attention 
to other aspects, such as environmental or circular-economy effects. The MD is a piece of pure 
product-safety  legislation.  It  is  true  that  the  2009  amendment  added  a  ‘protection  of  the 
environment’  objective  limited  to  machinery  used  in  pesticide  applications.  Nevertheless, 
extending such an objective to the very wide range of machinery products would render the MD 
too  broad  and  unmanageable.  On  pollution  and  noise,  there  is  already  specific  legislation 
referred to above, namely  the OND and Regulation (EU) 2020/1040 on engine emissions from 
mobile  machinery.  Some  environmental  and  circular-economy  effects  are  being  taken  into 
account in the revision of the MD where possible. Indeed, one of the improvements sought by the 
revision  has  a  significant  environmental  benefit,  namely  to  allow  digital  documentation  which 

10 Available at: https://ec.europa.eu/info/publications/commission-report-safety-and-liability-implications-ai-internet-things-and-robotics-0_en.  
11 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for 
Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 
(Cybersecurity Act) (Text with EEA relevance), OJ L 151, 7.6.2019, pp. 15-69. 

6 

 
                                                           
would help save paper and decrease carbon emissions. In addition, some improvements proposed 
would favour the  circular economy, such as the clarification of what constitutes a ‘substantial 
modification’, subject to which substantially modified machinery can be put on the market again 
with a new CE marking. 

1.3 The machinery sector 

The  machinery  and  equipment  sector  is  one  of  the  major  sectors  of  the  EU’s  manufacturing 
industry.  Detailed  information  on  the  machinery  sector  can  be  found  in  the  Impact  assessment 
study  on  the  revision  of  Directive  2006/42/EC  on  machinery12.  A  snapshot  of  the  main  data13 
from that impact assessment study is set out in the following three bullet points. 

- 

- 

- 

In  2017,  the  machinery  sector  recorded  turnover  of  EUR  663  billion,  production  of 
EUR 609 billion, and a value added of EUR 191 billion.  

In  2017,  the  machinery  sector  employed  2.8  million  people  and  comprised  82 239 
enterprises. The machinery sector accounted for 9.4% of manufacturing turnover, 9.5% 
of manufacturing production, and 11.2% of value added in the EU. The machinery sector 
employed 9.9% of all people employed in manufacturing and accounted for 4.1% of all 
manufacturing enterprises.  

In  2017,  total  EU  machinery  and  equipment  exports  amounted  to  EUR  503  billion,  of 
which  49%  were  exported  to  EU  member  countries  (i.e.  intra-EU  exports),  while  51% 
were exported to countries outside the EU (extra-EU exports)14. 

Among  the  82 239  enterprises  registered  in  the  machinery  sector,  only  1 703  (2%)  are  large 
companies,  while  81 024  (98%)  are  SMEs.  Although  the  sector  has  important  large  players, 
SMEs  are  its  main  driving  force.  For  this  reason,  SMEs  were  extensively  consulted  for  this 
report, as detailed in Annex 5: SME TEST. Impacts on SMEs have also been carefully analysed. 

1.4 Digitalisation, robotics, the IoT and AI in the machinery sector  

The  uptake  of  emerging  technologies  in  machinery  depends  on  the  type  of  machinery  and  the 
sector it is used in. One of the most relevant sectors for the uptake of emerging technologies is 
the factory-automation market. In 2018, the EU had the second largest factory-automation market 
after Asia-Pacific, putting it ahead of North America. 

In  the  factory-automation  market,  we  can  distinguish  between  traditional  and  ‘smart’ 
manufacturing systems.  

The traditional manufacturing system is based on two parts: humans and physical systems. In a 
traditional  manufacturing  system,  machine-operation  controls  are  completely  manual.  This 
traditional  manufacturing  system  requires  humans  to  complete  tasks  (e.g.  information  sensing, 
decision-making,  operating  and  checking)  and  may  therefore  be  defined  as  a  human-physical 
system. 

In  comparison,  there  are  three  categories  of  smart-manufacturing  systems.  These  three 
categories are presented in the bullet points below15. 

12 Impact assessment study on the revision of Directive 2006/42/EC on machinery. Available at: https://data.europa.eu/doi/10.2873/423938. 
13 https://ec.europa.eu/eurostat/statistics-explained/index.php/Industrial_production_statistics#Overview 
14 UN COMTRADE. 
15 Ji, Z., Peigen, L., Yanhong, Z., Baicun, W., Jiyuan, Z., & Liu, M. (2018). ‘Toward new-generation intelligent manufacturing’. Engineering 

(4)2018, pp.11-20. Available at: https://www.sciencedirect.com/science/article/pii/S2095809917308652. 

7 

 
                                                           
i) 

ii) 

iii) 

Digital manufacturing: This is sometimes called ‘the third industrial revolution’.  In 
digital manufacturing, physical systems continue to act as the ‘executing body’, but 
humans  develop  the  underlying:  (i)  analysis;  and  (ii)  methods  and  rules  for 
computation  and  control  models.  The  operation  relies  on  the  knowledge  and 
experience  of  the  operator.  Industrial  robots  without  advanced  AI  applications  fall 
under this category.  

Digital-networked  manufacturing:  This  adds  the  internet  component  to  digital 
manufacturing.  For  instance,  machine-tool  manufacturers  can  engage  with  their 
suppliers in remote-operation maintenance of their products through networks.  

‘Next  generation’  smart  manufacturing:  This  is  sometimes  called  the  ‘fourth 
industrial  revolution’.  In  this type  of  system,  the  knowledge  in the cyber  system  is 
jointly built by humans and the self-learning/cognition module of the cyber system. 
Humans remain as the creators, managers and operators of intelligent machines. This 
stage is currently at the level of ‘weak’ or ‘narrow’ AI (used to accomplish a narrow 
set of goals).  

The broad definition of ‘smart manufacturing’ covers many different technologies. Some of the 
key  technologies  in  the  smart-manufacturing  movement  include  advanced  robotics,  industrial-
connectivity devices, and machine learning (ML). 

Robotics in the machinery sector 

Robots can be defined and classified as set out in the figure below16. 

A  robot  is  an  actuated  mechanism  programmable  in  two  or  more  axes  with  a  degree  of  autonomy,  and 
moving within its environment to perform intended tasks. 

Industrial  robots  are 
for  use  in  industrial-
automation 
(e.g. 
applications 
grinding, 
welding, 
assembling,  handling 
or packaging). 

Service  robots  perform  useful  tasks  for  humans  or  equipment,  excluding 
robotic 
(e.g. 
industrial-automation 
lawnmowers, and robots for entertainment). 

floor-cleaning 

applications 

robots, 

Personal-service 
robots  or  service 
robots  for  personal  use  are  used  for  a 
task,  usually  by 
non-commercial 
laypersons 
servant 
robots,  automated  wheelchairs,  robots 
to assist with personal mobility, or pet-
exercising robots). 

(e.g.  domestic 

robots 

Professional-service 
or 
service robots for professional use are 
service  robots  used  for  a  commercial 
task,  usually  operated  by  a  trained 
operator  (e.g.  cleaning  robots  for 
public  places,  delivery 
in 
offices or hospitals, etc.). 

robots 

Industrial robots can bring great benefits for health and safety by substituting for people working 
in unhealthy or dangerous environments, or in other highly repetitive, risky or unpleasant tasks. 
Europe  accounts  for  18.5%  of  total  global  sales  of  industrial  robots  and  is  the  leading 
continent for the number of robots per 10 000 employees. Germany ranks third globally for 
industrial robot density17, while four more European countries make it into the top 10 (Sweden, 
Denmark, Belgium and Italy)18. 

Collaborative  robots  are  a  growing  segment  of  the  market.  Also  known  as  ‘co-bots’,  these 
robots  are  intended  for  direct  human-robot  interaction  within  a  shared  space,  as  opposed  to 
traditional industrial robots which are isolated from human contact. A number of new robotics 

16  https://www.iso.org/obp/ui/#iso:std:iso:8373:ed-2:v1:en 
17  Industrial robots per 10 000 employees in the manufacturing industry. 
18  www.ifr.org 

8 

 
 
                                                           
companies have emerged in the EU in recent years, including Universal Robots, FerRobotics, 
Franka  Emika,  BioRob-Arm,  F&P  Robotics  and  MRK  Systeme.  Many  of  these  new  European 
players specialise in co-bots. The EU co-bots market was worth EUR 343 million in 2019 and is 
expected  to  grow  at  a  rate  of  41%  annually  between  2020  and  202619.  Indeed,  most 
established  European  robotics  manufacturers  have  co-bots  in  their  product  portfolios,  with  key 
players including Comau, Festo, ABB, Bosch, Stäubli, and Mabi Robotic. Of the key players in 
the global co-bots market, most are European companies20. 

The  global  market  for  non-industrial  robotics in  the  consumer  sector is  projected  to reach  an 
added  value  of  USD  286  billion  (EUR  260  billion)  by  2025.  Smaller  markets  will  include 
robotics for use in agriculture and logistics, among others. Of the service robots for domestic use, 
96%  of  sales  are  estimated  to  be  vacuum  and  floor-cleaning  robots,  while  70%  of  the 
entertainment robots are estimated to be toy and hobby robots21. The International Federation of 
Robotics  counts  700  registered  companies  that  make  service  robots.  Of  these,  43%  (300 
manufacturers) are based in Europe.  

The IoT in the machinery sector 

The IoT can be defined as a global infrastructure for the information society, enabling advanced 
services  by  interconnecting  (physical  and  virtual)  things  based  on  existing  and  evolving 
interoperable  information  and  communication  technologies22.  For  machinery,  the  IoT  opens  up 
the  possibility  of  improving  machine-to-machine  communications  in  complex  processes  and 
operating work equipment remotely. Increased interconnectivity requires embedding software in 
a machine, which entails using some form of network such as the internet.  

The industrial IoT (IIoT) is the use of smart sensors and actuators to enhance manufacturing and 
industrial processes. The IIoT leverages the power of smart machines and real-time analytics to 
take advantage of the data that machines have produced in industrial settings for years’23. While 
the IIoT is still in its infancy, manufacturing is considered the largest market that will be affected 
by developments in this area, considering that a ‘smart’ production unit could consist of a large 
connected industrial system of materials, parts, machines, tools, inventory and logistics that are 
connected to each other. 

‘Smart’ manufacturing ranked fourth in terms of growth potential after smart energy, smart health 
and smart transport. And ‘smart manufacturing’ also ranked third in terms of the EU’s industrial 
potential24.  The  IIoT  is  projected  to  increase  global  GDP  by  about  USD  15  trillion  (EUR  12 
trillion) by 203025. Although in 2014 only about 10% of industrial machines were connected, the 
projections  indicate  rapid  growth  in  uptake  of  connectivity  in  the  future.  In  comparison  to  the 
overall IoT, the number of IIoT connections is expected to increase by 70.5% from 2016 to 2025. 

AI in the machinery sector 

19 Research And Markets (2020). Europe Collaborative Robots Market to Grow with a CAGR of 40.73% During the Forecast Period, 2020-

2026. 

20 DG Research and Innovation (2020). Unlocking the potential of industrial human–robot collaboration. 
21  Statista.  Let  the  robot  do  the  cleaning.  Estimated  worldwide  unit  sales  of  robots  for  personal/domestic  use  (2017).  Available  at: 

https://www.statista.com/chart/9089/worldwide-personal-robot-sales-forecast/. 

22  The  definition  of  the  internet  of  things  provided  by  the  Recommendation  ITU-T  Y.2060  is  available  at  https://www.itu.int/ITU-

T/recommendations/rec.aspx?rec=y.2060. 

23  TechTarget  (n.d.).  Industrial  internet  of  things  (IIoT).  Available  at:  https://internetofthingsagenda.techtarget.com/definition/Industrial-

24 European Commission. Definition of a research and innovation policy leveraging cloud computing and IoT combination (2014). Available 
https://ec.europa.eu/digital-single-market/en/news/definition-research-and-innovation-policy-leveraging-cloud-computing-and-iot-

Internet-of-Things-IIoT. 

at: 
combination. 

25 Ibid. 

9 

 
                                                           
In the Commission’s White Paper on Artificial Intelligence - A European approach to excellence 
and trust26, AI systems are defined as follows.  

software (and possibly also hardware) systems designed by humans that, given a complex goal, 
act in the physical or digital dimension by perceiving their environment through data acquisition, 
interpreting  the  collected  structured  or  unstructured  data,  reasoning  on  the  knowledge,  or 
processing  the  information,  derived  from  this  data  and  deciding  the  best  action(s)  to  take  to 
achieve the given goal. AI systems can either use symbolic rules or learn a numeric model, and 
they  can  also  adapt  their  behaviour  by  analysing  how  the  environment  is  affected  by  their 
previous actions. 

AI can be categorised according to the following three stages of development27. 

i) 

ii) 

iii) 

Basic  AI,  or  artificial  narrow  intelligence,  is  limited  in  scope  and  restricted  to  just 
one functional area (e.g. AlphaGo, a computer programme that plays the board game 
Go).  

Advanced AI, or artificial general intelligence (AGI),  usually covers more than one 
field, such as the power of reasoning, abstract thinking, or problem solving on a par 
with human adults28. 

Autonomous AI, or artificial super intelligence (ASI), is where AI surpasses human 
intelligence across all fields. This stage of AI is not expected to be fully developed 
for several decades29. 

that 

algorithms 

Machine  learning  (ML)  is  the  study  of 
computer 
improve 
automatically  through  experience  and  by  the 
use  of  data.  It  is  seen  as  a  part  of  artificial 
intelligence. A traditional programmer would 
write computer code setting the rules needed 
to  process  data  inputs  to  get  an  answer  as 
output.  In  ML,  the  computer  receives  input 
data as well as the answers expected from the 
data, and the ML programme must then produce the rules itself. These rules can then be applied 
to new data to produce original answers. An ML-system is ‘trained’ rather than ‘programmed’30. 

To date, the manufacturing sector is using AI in only a few ways, and AI is not yet considered to 
have  come  close  to  its  full  potential.  The  main  applications  of  AI  in  the  market  are  in  ML.  In 
robotics, these applications include31: assembly (AI combined with advanced vision systems to 
help with real-time remedying of errors in assembly); packaging (AI for quicker, lower-cost and 
more accurate packaging); customer service (AI natural-language-processing abilities to interact 
with  customers);  and  open-source  robotics  (robotic systems  sold  as  open-source  systems  with 
AI  capability  that  enable  users  to  teach  their  robots  to  carry  out  tasks  based  on  their  specific 
application). 

26 EU White Paper on Artificial Intelligence - A European approach to excellence and trust. Available at:  
Second quarterhttps://ec.europa.eu/info/sites/info/files/commission-white-paper-artificial-intelligence-feb2020_en.pdf.   
27 IFC (2019, pp. 2-3). Artificial Intelligence: Investment trends and selected industry uses. Available at:  
https://www.ifc.org/wps/wcm/connect/7898d957-69b5-4727-9226-277e8ae28711/EMCompass-Note-71-AI-Investment-

Trends.pdf?MOD=AJPERES&CVID=mR5Jvd6. 

28 To date, AGI is not yet available and the focus lies on conducting research into developing the first AGI systems. See for example Montes, 
G.A,  &  Goertzel,  B.  Distributed,  decentralized,  and  democratized  artificial  intelligence  (2019).  In:  Technological  Forecasting  &  Social 
Change, 141(April 2019), pp. 354-358.  

29 Note: other classifications and research found do not distinguish between AGI and ASI. 
30 JRC. Artificial Intelligence: A European Perspective (2018), available at:  
https://publications.jrc.ec.europa.eu/repository/bitstream/JRC113826/ai-flagship-report-online.pdf 
31  Robotics  Industries  Association.  How artificial  intelligence  is used in today’s  robots  (2018).  Available at:  https://www.robotics.org/blog-

article.cfm/How-Artificial-Intelligence-is-Used-in-Today-s-Robots/117 

10 

 
                                                           
One  emerging  market  is  the  market  for  fully  automated  self-driving  robots,  also  known  as 
autonomous  mobile  robots  (AMRs).  AMRs  can  autonomously  navigate  in  an  uncontrolled 
environment by integrating sensors, 3D vision, and AI. They are often designed to interact and 
cooperate with humans. Due to the novelty of AMRs and the rapidly evolving market for these 
robots, there are no dependable figures on the market volume and adoption rate of self-driving 
robots. Despite this lack of data, analysts concur that the annual growth rate of the self-driving 
robot market will remain high over the next 5 years, ranging between 12.9% and 21.5% per 
year32,33. 

Another emerging market is driven by ML applications in service robots for professional use. 
The  International  Federation  of  Robotics  estimates  the  combined  value  of  the  market  for 
professional-service robots for the 2019-2021 period will be around EUR 34 billion34. Examples 
provided  by  the  French  Ministry  of  Agriculture  include  robots  with  ML  capabilities  to:  (i) 
distinguish  between  crop  plants  and  invasive  plants  (weeds);  (ii)  operate  spray  booms  (so 
spraying stops in areas not contaminated by weeds); (iii) sort lettuces from foreign objects before 
bagging; (iv) sort general waste on a conveyor; and (v) follow an operator in a warehouse and 
‘learn’ using smart sensors to memorise routes and obstacles while it transports loads.  

Additional  information  on  emerging  technologies  in  the  machinery  sector  is  available  in  the 
Impact assessment study on the revision of Directive 2006/42/EC on machinery35. 

2.  PROBLEM DEFINITION 

2.1.  What is/are the problems? 

Problem  1:  The  MD  does  not  sufficiently  cover  new  risks  originating  from  emerging 

technologies  

stakeholders  expressed 

The  evaluation  of  the  MD  found  that  most  stakeholders  believe  that  the  MD  takes  new 
innovations and technologies sufficiently into account either to a moderate or to a large extent. 
their  concern  about:  autonomous 
However,  a  number  of 
machines/systems,  AI,  collaborative  robotics,  mobile  robotics,  electrified  machines,  hybrid 
engines,  smart  appliances,  wireless  applications  and  cybersecurity.  If  accidents  occur  in  these 
areas, trust in emerging technologies would be undermined. And unless the MD provides legal 
clarity  about  those  technologies,  existing  gaps  (as  identified  in  the  Report  on  the  safety  and 
liability  implications  of  Artificial  Intelligence,  the  Internet  of  Things  and  robotics36)  could 
remove the level playing field for manufacturers. This would in turn impact the efficiency of the 
MD.  

1. A first source of potential risk is in human-robot collaboration. Accidents at work related 
to  industrial  robots  are  not  tracked  at  EU  level.  Some  of  these  incidents  may  occur  due  to  the 
robot  malfunctioning,  but  others  are  due  to  human  error,  such  as  entering  the  fenced-off  areas 
reserved  for  robots  while  the  robots  are  operating.  Industrial  robots  are  designed  to  work 
autonomously,  with  safety  ensured  by  isolation  from  human  contact.  However,  co-bots  are 
designed  to  work  alongside  human  employees.  Unlike  industrial  robots,  co-bots  are  often 
lightweight and portable, which makes them ideal to use for multiple tasks within a factory. The 
safety  of  collaborative  and  autonomous  robots  may  depend  on:  (i)  designing  them  with 
lightweight  construction  materials  and  rounded  edges;  (ii)  placing  inherent  limitations  on  their 
speed  and  force;  or  (iii)  adding  sensors  and  software  to  them  to  ensure  their  safe  behaviour. 

32 Allied Market Research. Mobile Robotics Market - Global Opportunity Analysis and Industry Forecast, 2019-2026 ((2019) 
33 Wilkins, J. (2019, October 23). The Challenges of Using Mobile Robots. Retrieved February 12, 2020, from 
https://www.ehstoday.com/safety-technology/article/21920421/the-challenges-of-using-mobile-robots.  
34 International Federation of Robotics. World Robotics 2018 Service Robots report  (2019). 
35 Impact assessment study on the revision of Directive 2006/42/EC on machinery. Available at: https://data.europa.eu/doi/10.2873/423938. 
36 Available at: https://ec.europa.eu/info/publications/commission-report-safety-and-liability-implications-ai-internet-things-and-robotics-0_en.  

11 

 
                                                           
Annex  6  illustrates  an  example  of  a  collaborative  robot  and  its  particularities,  as  well  as  the 
potential hazards of physical contact with co-bots.  

A stakeholder consultation gathered some information on how to adapt the requirements for co-
bots to better account for the risks of human-robot collaboration. Most stakeholders indicated that 
human-robot  collaboration  was  not  sufficiently  covered  by  the  MD.  In  particular,  some 
authorities  in  charge  of  market  surveillance  for  the  MD  considered  that  the  MD’s  Annex  I 
requirements  in  Section  1.3.7.  ‘Risks  related  to  moving  parts’  could  be  problematic.  For 
example, one of these requirements is that ‘the moving parts of machinery must be designed and 
constructed in such a way as to prevent risks of contact which could lead to accidents or must, 
where risks persist, be fitted with guards or protective devices’. Some authorities felt that these 
requirements may not be sufficient in cases of human-robot coexistence in a shared space, or 
in  cases  where  humans  and  robots  are  simultaneously  working  on  something,  or  in  cases 
where humans and robots are alternating in their work on something. 

Why  did  some  stakeholders  not  consider  that  the  current  requirements  sufficiently  covered 
human-robot  collaboration?  Most  industry  associations  and  manufacturers  cited  concern  over 
cybersecurity  and  the  lack  of  physical  separation  between  robots  and  humans.  Notified  bodies 
mostly said that the limits on force, speed, and energy in the current standards were not sufficient 
given the agility of interaction between humans and co-bots. Market-surveillance authorities also 
said that the current requirements did not sufficiently cover software traceability. 

2. A second source of potential risk comes from connected machinery. Connected machinery 
may  generate  new  risks  such  as:  (i)  a  permanent  loss  of  communication;  (ii)  intermittent 
connection; (iii) denial of service; or (iv) other situations when a sensor or camera capturing the 
physical  world  creates  erroneous  or  still/frozen  data.  If  data  from  the  physical  world  (or  the 
created  and  aggregated  data)  are  incorrect  or  delayed,  two  problems  are  possible.  Firstly,  the 
analysis  performed  may  not  be  correct  depending  on  the  extent  of  the  delay.  Secondly,  the 
decision  taken  (such  as  stopping  a  machine  to  prevent  overheating)  may  no  longer  be  valid 
depending  on  the  extent  of  the  delay.  The  severity  of  safety  issues  due  to  incorrect  control 
decisions  taken  based  on  erroneous  sensorial  data  was  highlighted  by  the  analysis  of  accidents 
from the industrial-automation study conducted by the French Ministry of Ecology, Sustainable 
Development  and  Energy37.  According  to  the  study,  sensor-related  accidents  were  observed 
mostly  in  operations  such  as  restarting,  stopping  and  shutting  down.  Unlike  standalone 
machinery, the safety of connected machinery requires consideration of all interactions between 
networked  machinery  assets.  Malfunction  accounted  for  more  than  50%  of  accidents related to 
sensors,  of  which  66%  were  caused  by  human  error,  a  lack  of  maintenance,  insufficient 
connectivity or lack of cleaning.  

Another cause for concern is the inclusion of communication devices to link the machine to the 
internet  (IoT).  This  allows  data  on  the  machine’s  use  and  operation  to  be  monitored  or  the 
machine  to  be  started  and  controlled  remotely.  If  an  unauthorised  third  party  managed  to 
upload  code  or  software  to  a  safety-critical  piece  of  machinery,  this  could  have  serious 
consequences  for  machinery  users.  For  example,  warning  systems  could  be  turned  off  or  the 
functionality of the machinery could be changed to sabotage operations. For robotics, one study 
found that  hackers could  access  co-bots,  allowing  them  to  stop  safety  programmes  designed  to 
protect the people working with the devices38.  

It  is  worth  distinguishing between cybersecurity,  related  to the  network,  and  cyber safety, 
related to the machine. It is also worth considering how and whether a machine enters into  a 
‘safe mode’ if it is subjected to a cyber attack. Although cybersecurity in broad terms does not 

37 French Ministry of Ecology, Sustainable Development and Energy (n.d.). Accident analysis of industrial automation (part 1/3). Available at: 

https://www.aria.developpement-durable.gouv.fr/wp-content/files_mf/Sensorsindustrialautomation_GB.pdf.  

38 Sciencing. The dangers of interactive home robots (2018). Available at:  https://sciencing.com/the-dangers-of-interactive-home-robots-

13711522.html. 

12 

 
                                                           
fall  under  the  scope  of  the  MD,  safety  is  well  within  its  scope.  For  example,  there  is  a 
requirement  in  the  current  MD’s  Annex  I  1.2.1  on  the  ‘Safety  and  reliability  of  control 
systems’. This requirement states that control systems ‘must be designed and constructed in such 
a  way  that  they  can  withstand  the  intended  operating  stresses  and  external  influences’.  An 
assessment should be made as to whether this requirement appropriately addresses cyber-safety 
risks. On this issue, several stakeholders and national authorities said it was unclear whether the 
notion of ‘external influences’ included cyber attacks. 

3.  A  third  area  of  concern  is  the  way  that  software  updates  affect  the  ‘behaviour’  of  the 
machinery after its placing on the market. Nowadays, the functionality of a machine can be 
updated using standalone software. On modern machinery fleets, machines are designed in such a 
way  that  updates  can  be  performed  either  on-site  or  remotely.  This  means  that  the  resulting 
updated software is not embedded in the original product, but provided separately, sometimes by 
a third party different from the machine manufacturer. Such situations raise questions about the 
risks  (and  the  management  of  these  risks)  emerging  from  software  updates  that  change  the 
functionality  and  operation  of  machinery  in  unintended  ways.  Some  market-surveillance 
authorities that  were  consulted  said they  found  it  necessary  to  ensure: (i)  that  requirements  are 
satisfied  after  the  integration  of  independent  software  to  any  (standalone  or  networked) 
machinery. They also said it was necessary to ensure that software updates not considered in the 
initial manufacturer’s risk assessment and that had an impact on safety should be considered as a 
substantial modification, thus requiring a new CE marking.  

In addition, software with a safety function that is placed independently on the market is not 
considered a safety component under the current MD (see Annex V of the MD for an indicative 
list of the safety components). Most stakeholders consulted saw this as a gap in the current MD. 

4. A fourth concern relates to the ability of original equipment manufacturers (OEMs) to conduct 
a  full  risk  assessment  of  ML  applications  before  the  product  is  placed  on  the  market. 
Chapter 1.4 of this report shows that narrow AI – and more specifically ML applications – are 
increasingly present in the machinery market. If the AI used for the machinery is set to learn and 
adapt as it is used, then its scope of operation could develop beyond what the designer took into 
account in their original risk assessment. With the development of collaborative robots that can 
move  around  and  work  closely  with  a  person,  these  risks  are  much  more  difficult  to  control. 
These risks depend almost entirely on the safety of the AI programme running them, such as the 
quality of the computer’s vision and image-recognition abilities.  

In addition, some of the market-surveillance authorities interviewed said that the MD  lacks an 
explicit  requirement  for  the  manufacturer  to  provide  test  procedures/devices  to 
maintain/adjust  the  relevant  machinery.  Indeed,  while  there  is  such  a  requirement  for 
automated machinery (see MD Annex I 1.6.1 ‘a connecting device for mounting diagnostic fault-
finding  equipment  must  be  provided’),  it  is  not  clear  whether  the  MD’s  wording  sufficiently 
covers the specificities of the new generation of machines with learning capabilities. 

Another key area is that of the ‘control logic’. A control logic is a part of a computer programme 
that controls the operations of the programme. It can be highly complex, and is used to determine 
the learning process through which the machine uses the data sets to be trained on. The current 
MD  lacks  requirements  on  control  systems  to  prevent  unsafe,  unpredictable  outcomes 
during the ML phase and during the use phase. Combined with extensive and automated data 
collection,  it  can  become  very  complicated  to  identify  which  data  were  used  to  reach  certain 
decision  outcomes,  thus  hindering  the  correction  of  faulty  data  or  assumptions39.  Some  of  the 
market-surveillance  authorities  consulted  highlighted  that  the  current  MD  contains  no 

39  European  Parliament. 

framework 
https://www.europarl.europa.eu/RegData/etudes/STUD/2019/624262/EPRS_STU(2019)624262_EN.pdf. 

for  algorithmic  accountability  and 

‘A  governance 

transparency’ 

(2019).  Available  at: 

13 

 
                                                           
obligations for source codes or programmed logics to be made available to the authorities, 
and that this does not facilitate the product-safety inspections. 

5.  Finally,  there  is  the  issue  of  autonomous  machines  and  remote  supervisory  stations.  The 
current MD assumes there is a driver or an operator responsible for the movement of a machine. 
The driver may be transported by the machinery or may accompany the machinery, or may guide 
the machinery by remote control. However, the MD does not consider the possibility that there 
might be no driver, and it sets no requirements for autonomous machines.  

All the above problems may undermine the competitiveness of the machinery sector unless they 
are  properly  addressed.  Legal  uncertainty  on  the  requirements  that  machinery  with  emerging 
theologies  must  comply  would  cause  a  distortion  of  competition  in  the  market,  with  diligent 
manufacturers  taking  the  necessary  steps  whereas  other  companies  might  take  advance  of  this 
lack of precision in the legislation.   

Problem 2: (i) Legal uncertainty due to a lack of clarity on the scope and definitions; and 

(ii) possible safety gaps in traditional technologies 

The evaluation of the MD indicated the need for greater legal clarity in its scope and definitions. 
Both the scope and definitions generated some difficulties for manufacturers in understanding the 
correct legal framework they should apply.  

In addition there are a number of requirements in the MD not related to emerging technologies 
that  have  been  identified  as  either:  (i)  not  clear  or  safe  enough;  or  (ii)  too  prescriptive  and 
potentially hindering innovation. 

(i) Legal uncertainty due to a lack of clarity on the scope and definitions 

  The Low-Voltage Directive (LVD): The evaluation of the MD indicated that the lack of 
clarity  on  scope  was  most  common  in  the  relationship  between  the  LVD  and  the  MD. 
Within the current MD, Article 1(2)(k) lists the categories of low-voltage electrical and 
electronic machinery that are excluded from the scope of the MD. As an example, one of 
the  excluded  categories  is  ‘household  appliances  intended  for  domestic  use’,  such  as: 
refrigerators;  freezers;  ovens;  dishwashers;  washing  machines  and  dryers;  vacuum 
cleaners;  irons;  and  toasters.  These  appliances  thus  fall  under  the  LVD.  A  lack  of 
consistency arises from the fact that these products are no longer excluded from the MD 
if they  use  radio  equipment.  If  they  contain radio equipment,  these  products shift  from 
the LVD to the RED, which applies in addition to the MD. In 2018, the home-appliance 
industry  in  Europe  generated  EUR  53 billion  turnover  and  comprised  over  3 300 
enterprises and more than 200 000 direct employees40. 

  Exclusion of means of transport: Tractors and other vehicles primarily intended for the 
transport of persons are excluded from the MD, since they fall under an ad-hoc EU type-
approval legislation. Currently, the borderline is not clear enough, and allows that certain 
vehicles,  such  as  multipurpose  vehicles  of  the  type  All-Terrain  Vehicles  and  Side-By-
Side, can be considered as falling under the MD or under EU type-approval legislation, 
sometimes  by  the  same  manufacturer.  In  addition,  recently  proliferating  light  vehicles 
such as electrically power assisted cycles, hover boards or self-balancing scooters can be 
considered under the scope of the current MD, even if the MD is not meant and do not 
cover road circulation aspects. All this creates problematic distortions in the market. 

  Partly Completed Machinery (PCM): As defined in Article 2 of the MD, PCM means 
an  ‘assembly  which  is  almost  machinery  but  which  cannot  in  itself  perform  a  specific 

40 https://www.applia-europe.eu/statistical-report-2018-2019/introduction/index.html 

14 

 
                                                           
application. A drive system is partly completed machinery. Partly completed machinery 
is  only  intended  to  be  incorporated  into  or  assembled  with  other  machinery  or  other 
partly  completed  machinery  or  equipment,  thereby  forming  machinery  to  which  this 
Directive applies’. 

PCM  is  widely  considered  as  a  useful  concept  in  the  MD.  The  manufacturer  of  PCM 
determines with which health-and-safety requirements of Annex I of the MD it complies. 
According  to  the  MD,  the  manufacturer  only  needs  to  specify  in  the  declaration  of 
incorporation  those  requirements  that  are  actually  relevant  (in  terms  of  the  specified 
enabled  applications  of  the  machinery),  and  complied  with.  Buyers  of  such  PCM  thus 
often need to enter into specific private-law agreements to ensure the PCM’s compliance 
with applicable requirements before purchase41. This incurs additional costs to solve any 
potential  issues  between  supplier  and  customer  in  relation  to  PCM42.  However, 
stakeholders have often stated that a clearer definition and/or further clarification would 
help  buyers  and  sellers  of  PCM.  Sometimes  the  definition  is  applied  inconsistently  by 
manufacturers, leading to incorrect classifications (e.g. products that are partly completed 
machines are defined as components) and/or to the incorrect CE marking of PCMs. This 
may generate safety issues or create an unlevel playing field in the market. Companies, 
particularly SMEs manufacturing or buying PCM, incur compliance expenses to obtain 
clarifications and legal certainty, by hiring external consultants or lawyers. 

-  Substantial  modification:  This  problem  relates  to  machinery  that  has  undergone 
substantial  changes. The  Guide to  application  of  the Machinery  Directive  2006/42/EC-
Edition 2.243 (‘the Guide’), refers in paragraph 82 to: 

some  cases  [whereby]  machinery  is  sold  to  an  importer  or  a  distributor  who  then 
modifies machinery at the request of a customer before the machinery is put into service 
(…). If the modifications were foreseen or agreed by the manufacturer and covered by 
the  manufacturer’s  risk  assessment,  technical  documentation  and  EC  declaration  of 
conformity,  the  original  manufacturer’s  CE  marking  remains  valid.  (…)  If  the 
modification is substantial (for example, a change of function and/or performance of the 
machinery) and not foreseen or agreed by the manufacturer, the original manufacturer’s 
CE marking becomes invalid and has to be renewed. 

The  public  consultation  asked  stakeholders  about  the  potential  issues  resulting  from 
substantially modifying machines. Just over a half (53.1%) of the stakeholders said they 
had  modified  their  machines,  of  which  36.5%  were  companies.  The  large  majority  of 
respondents  (78.3%)  claimed  they  had  not  encountered  any  problems  with  the 
modification.  Despite  not encountering  many  problems,  most  of  the  respondents  to  the 
public  consultation  (61.2%)  claimed  that  the  MD  should  lay  down  the  criteria  for 
modifying machinery substantially. Otherwise, there a risk of different interpretations by 
market-surveillance authorities. This could potentially lead to uneven protection of safety 
across the EU and unequal terms for manufacturers, who may or may not be subject to 
costly  conformity-assessment  procedures,  depending  on  the  practices  of  the  different 
national authorities44. 

(ii) Possible safety gaps in traditional technologies 

41 Ostermann, H.J. Unvollständige  Maschinen Ein Teil vom Ganzen  – ‘A Never-Ending Story’ Im Europäischen Maschinen-Binnenmarkt. 

(2019). Available at:   

http://www.maschinenrichtlinie.de/fileadmin/veroeffentlichungen/Unvollstaendige_Maschinen_Maschinenrichtlinie_2006-42-EG.pdf.   
42 Assessment of the size of PCM market and number of companies affected was impossible due to lack of data. However, the problem was 

raised during the stakeholder consultations. 

43 Available at: https://ec.europa.eu/docsroom/documents/38022. 
44 Assessment of the size of the market for substantially modified machinery market was impossible due to lack of data. However, the problem 

was raised during the stakeholder consultations. 

15 

 
                                                           
For a few types of machinery, a number of requirements have been identified as: (i) insufficient 
to ensure safety; or (ii) too prescriptive and potentially hindering innovation. These requirements 
are set out in the paragraphs below. 

- 

Installation of lifting appliances: A lift under the Lifts Directive (LD) is considered to 
be  placed  on  the  market  only  after  its  installation,  when  it  can  be  inspected  and  CE-
marked.  Lifting  appliances  under  the  MD  (or  so-called  slow-speed  lifts,  the  speed  of 
which is not greater than 0.15 m/s) are often placed on the market and CE-marked by the 
manufacturer,  and  then  installed  by  a  third  party  following  the  manufacturer’s 
instructions  for  installation.  Issues  have  arisen  in  some  Member  States  where  installer 
and manufacturer consider the other party responsible for failures in installed lifts.  

The evaluation of the Lifts Directive in 2017 estimated the number of companies active 
in  the  lift  market  equal to 0.1%  of  all  manufacturing-sector companies in the  EU-2845. 
According to the European Lift & Lift Component Association, the estimated number of 
existing  lifts  in  2014  in  the  European  Economic  Area  (EEA)  was  5 361 896,  although 
most of these fall under the scope of the LD rather than the MD46.  

-  Slow-speed lifts: For slow-speed lifts, and the uncontrolled movement of objects in the 
carriers of slow-speed lifts, the MD states that ‘the control devices for these movements 
must be of the hold-to-run type except where the carrier itself is completely enclosed’. 
Hold-to-run  push  buttons  allow  the  platform  to  stop  immediately  once  the  button  is 
released.  Automatic  controls  may  be  used  when  the  carriage  is  fully  enclosed. 
Manufacturers claim this requirement limits innovative technologies such as light-barrier 
curtains.  Also,  some  authorities  consulted  find  it  an  anomaly  that  the  MD,  supposedly 
technologically neutral in its approach, prescribes a technical solution rather than a safety 
requirement.  

As indicated in the paragraph below, slow-speed lifts fall under the scope of the MD. In 
2005, the EU stair-lift industry was estimated to have sold about 100 000 units (62 000 
straight lifts and 38 000 curved lifts) and have turnover of EUR 188 million. The global 
market was also expected to grow. For example, the share of the US population owning a 
stair lift was expected to grow from 13% in 2005 to 19% in 203047. 

  Seating: For ‘ride-on’ mobile machinery, such as excavators or agricultural sprayers, the 
current  MD  includes  safety  requirements  for  seating  (Annex  I  3.2.2.)  that  are  seen  as 
insufficient  and  hindering  innovative  solutions  to  prevent  the  risk  of  falling  off.  All 
stakeholder groups (national authorities, notified bodies, market-surveillance authorities, 
and workers’ representatives), except for manufacturers agree that the health-and-safety 
requirements  for  seating  should  be  revised  and/or  updated.  According  to  these 
stakeholder  groups,  machines  should  be  constructed  in  such  a  way  as  to  prevent  the 
worker  from  becoming  unattached  to the  machinery.  The current  regulation  in the  MD 
requires a restraint system to be attached directly to the driver’s seat, but this system is 
sometimes  by-passed  by  users,  thus  increasing  the  risk  of  accidents.  This  requirement 
may also limit innovation, as there are other technological solutions on the market, such 
as restraint systems that keep operators within the framework of the protective structure 

45  European  Commission.  Evaluation  of  directive  95/16/EC  on  the  approximation  of  the  laws  relating  to  lifts  (2017).  Available  at: 

https://op.europa.eu/en/publication-detail/-/publication/9f1a5907-e539-11e7-9749-01aa75ed71a1/ 

46  European  Lift  &  Lift  Component  Association  (ELCA).  Main  figures  for  Europe  and  the  World  (2014).  Available  at:  http://www.elca-

eu.org/main-figure-for-europe-in-the-world.php 

47  Dolphin  Stair  Lifts  blog.  Stair  lift  sales  statistics  (2005).  Available  at:  http://sparedolphin.blogspot.com/2005/06/stair-lift-sales-

statistics.html. 

16 

 
                                                           
(e.g. doors or door-bar systems). The EU market for mobile machinery is estimated to be 
worth EUR 90 billion in annual turnover48. 

  Overhead  power  lines:  Overhead  power  lines  have  different  heights  in  EU  Member 
States. Accidents occur when vehicles or machinery make contact with overhead lines. If 
a vehicle or machine becomes ‘live’ by touching a power line then anyone touching the 
machine or vehicle is in mortal danger. Anyone in the cab of such a vehicle or machine 
may  be  in  less  danger,  but  they  may  still  be  threatened  by  the  vehicle  or  machine 
catching  fire. This  may  happen in a  number  of  different scenarios,  for example:  (i) the 
equipment is tall enough to reach the line while driving along in its normal configuration; 
(ii)  a trailer  is  tipped  up, making  contact  with  the  line  and rendering  the entire  vehicle 
‘live’; (iii) a hydraulic boom controlled from a cab makes contact with an overhead line, 
e.g.  a  crane  lifting  a  load,  etc.  Because  of  the  height of  equipment  used  in  agriculture, 
farmers and those using high agricultural equipment can be at risk if they hit an overhead 
line.  In  2019,  eight  serious  or  fatal  accidents  were  recorded  in  France  resulting  from 
contact  between  an  agricultural  machine  and  a  live  overhead  power  line.  One  of  these 
accidents resulted in two deaths. The machines involved were irrigators, mobile elevating 
work  platforms,  trailers,  grape  harvesters,  and combine  harvesters49.  In  the  former  EU-
28, the UK also reported several accidents of this nature. The French and other national 
authorities believe the requirements in the current MD to avoid or mitigate this risk are 
not sufficient. It was not possible to assess the more detailed market for other machinery 
which, because of its height, could potentially be impacted by this problem. 

to  protect  workers 

  Protection against hazardous substances: The current MD does not address the issue 
of  protecting  workers  from  exposure  to  hazardous  substances.  For  example,  many 
machines generate fine dust or metal micro parts, and these are considered very harmful 
to  workers’  lungs.  Workers’  associations  and  market-surveillance  authorities  believe  it 
necessary 
from  hazardous  substances,  whereas  consumer 
organisations  and  manufacturers  do  not  find  it  necessary.  According  to  workers’ 
associations, the emissions of hazardous substances from machinery should be assessed 
and mitigated at design stage. On the other hand, manufacturers argue that the exposure 
of  workers  to  hazardous  substances  is  handled  by  Directive  89/391/EEC  and  is  mainly 
the  responsibility  of  the  employer.  Manufacturers  also  argue  that  they  cannot  address 
safety  integration  on  their  own  in  cases  where  employers  often  select  machinery  from 
multiple manufacturers for a final application. Consumer organisations agreed that there 
is other legislation in place that ensures workers’ protection from hazardous substances50. 

  Vibration from portable handheld and hand-guided machinery:  It is estimated that 
around 400 000 employees every year are exposed to vibrations from portable handheld 
and hand-guided machinery in Sweden51. An occupational injury caused by vibration can 
lead  to  painful  and  disabling  conditions,  which  usually  involve  major  limitations  and 
inconveniences in everyday life for those affected. If the proportion of workers exposed 
to vibrations is the same in the rest of the EU, over 20 million workers in the EU could 
be  exposed  to  vibrations  from  handheld  and  hand-guided  machinery  every  year.  The 
Swedish authorities, supported by other Member States, propose to ask manufacturers to 
better specify in the instructions for these kinds of machines the vibrations to which the 
hand-arm system is subjected, including continuous vibrations and the peak amplitude of 
the acceleration from repeated shock vibrations. 

48  Cost-benefit  analysis  study 

for 

impact  assessment  on 

road  circulation  of  non 

road  mobile  machinery  available  at: 

https://op.europa.eu/en/publication-detail/-/publication/c0d598e2-17d8-11ea-8c1f-01aa75ed71a1/language-en.  

49 Machinery Working Group document:  
WG-2020.35 - MD Revision_Accidents machines contact with OPL in France (agriculture) Year2019_February 2020_FR+EN. 
50 Assessment of the size of the market and number of companies affected was impossible due to the great variety of  machines potentially 

involved and the lack of data availability. 

51 During at least 25% of an eight-hour working day. Machinery Working Group doc. WG-2020.46 - Swedish proposal on vibrations. 

17 

 
                                                           
Problem 3: Insufficient provisions for high risk machines 

The MD requires manufacturers to carry out a risk assessment for machinery they wish to place 
on the market. Manufacturers must determine which requirements are applicable, and therefore 
which  measures  must  be  taken  to  certify  compliance.  Compliance  with  the  MD  is  primarily 
assessed  through  internal  checks  by  the  manufacturer  and  without  the  involvement  of  a  third 
party.  Nevertheless,  there  is  an  exception  for  a  certain  sub-category  of  machines:  machines 
considered as presenting high risks that are listed in Annex IV. If these high-risk  machines are 
not manufactured in full accordance with all relevant harmonised standards listed under the MD, 
or if there are no harmonised standards listed under the MD covering all applicable requirements 
for that machinery, then conformity through internal checks is not allowed, and a third party must 
be involved instead.  

There is discussion about whether the internal-checks option leads to safety concerns. On this 
issue,  the  Rapid  Alert  System  for  Non-Food  Dangerous  Products  (Safety  Gate/RAPEX)  has 
shown over the years that some of the products falling under Annex IV of the MD were identified 
as not being compliant with the requirements of the MD and the relevant European standards52. 
The products identified in Safety Gate/RAPEX include circular saws and vehicle lifts, which are 
part of Annex IV53. Some of these products were manufactured outside the EU.  

Some market-surveillance authorities and notified bodies challenged the effectiveness of dealing 
with  high-risk  machines  using  a  procedure  that  does  not  systematically  impose  a  third-party 
conformity assessment. For these concerned stakeholders, third-party certification ensures higher 
quality and safer machinery, and minimises the need for surveillance authorities to intervene at 
later  stages.  However,  since  third  partly  involvement  is  costly,  manufacturers  of  Annex  IV 
machinery prefer to have the choice of involving or not a third party whenever they follow the 
relevant harmonised standards. 

Another problem is that the current list of high-risk machines in Annex IV was first drawn 
up 15 years ago, and the market has developed greatly since then. Several market-surveillance 
authorities believe it is necessary to: (i) remove from Annex IV machines no longer considered 
high  risk;  and/or  (ii)  introduce  new  machines  to  Annex  IV  (such  as  machinery  embedding  AI 
systems which fulfil a safety function); and/or (iii) even re-arrange the high-risk machine list in 
categories  of  risks  in  a  more  efficient  and  comprehensive  way.  Disagreeing  with  this  view, 
manufacturers of non-Annex IV machinery oppose any reclassification of their machines to the 
high-risk  category,  mainly  due  to  the  additional  costs  associated  with  third-party  conformity 
procedures. 

Problem 4: Monetary and environmental costs due to extensive paper-based documentation 

Article 5 of the MD details the requirements for documentation. Before placing machinery on the 
market and/or putting it into service, manufacturers must: 

  provide the necessary information, such as instructions;  
 

follow  the  appropriate  procedures  for  assessing  conformity  in  accordance  with  Article 
12; draw up the EC declaration of conformity (DoC) in accordance with Annex II, part 1, 
Section A; and ensure that this declaration is included with the machinery; and  
ensure that the technical file referred to in Annex VII, part A is available.  

 

Currently, the Guide clarifies that manufacturers must provide paper documentation for health-
and-safety-related  instructions  and  the  conformity  declaration.  This  is  largely  due  to  market 

52 It has not been possible to find out the percentage of non-compliant products, or the number of accidents caused. 
53 Non-compliant products in the high-risk machinery category reported in the Safety Gate/RAPEX system: since 2017, out of 138 machinery 

products in total, 43% belonged to Annex IV (37 brush cutters, 11 circular saws, 8 vehicle lifts and 4 log splitters). 

18 

 
 
 
  
                                                           
characteristics during the early years of the MD’s implementation, namely the lack of access to 
the internet and other digital formats. Thus, to ensure that every machine user had access to the 
instructions,  providing  a  printed  version  was  considered  as  the  most  viable  option.  Since  then, 
however, the use of the internet and digital technologies has increased. Manufacturers state that 
the  requirement  to  provide  printed  versions  increases  costs  and  administrative  burden  for 
economic  operators  and  has  a  negative  impact  on  the  environment.  On  the  other  hand,  some 
authorities  and  users  (workers  and  consumer  associations)  have  concerns  about  ending  this 
requirement  because  of:  (i)  users  that  are  less  digitally  savvy  and  that  may  prefer  paper 
documentation; (ii) a lack of internet access in certain environments; and (iii) changes or updates 
to an online manual that might not match the version of an already purchased product. 

The technical file and other information gathering foreseen in the MD other than the instructions 
and the DoC are already allowed in electronic formats. 

Problem 5: Inconsistencies with other pieces of Union product-safety legislation 

The  new  legislative  framework  (NLF)  is  a  package  of  measures  aimed  at  improving  market 
surveillance and the quality of conformity assessments. It consists of Regulation (EC) 765/2008, 
Decision  768/2008  and  Regulation  (EC)  764/2008.  A  main  objective  of  the  Commission  is  to 
bring  legislation  on  product-harmonisation  in  line  with  the  reference  provisions  of  Decision 
768/2008/EC. While the MD is already a ‘new approach’ directive (as explained in Chapter 1 of 
this report), it is not yet aligned to the NLF.  

One of the issues raised in the evaluation of the MD is the lack of appropriate enforcement. The 
evaluation  also  argued  that  aligning  the  MD  to  the  NLF  could  ‘help  to  increase  the  quality  of 
machinery and the confidence in products in the European market, as well as ensure good levels 
of safety and create a common framework for market surveillance’54.  

In  addition,  the  fact  that  the  MD  is  not  aligned  to  the  NLF  creates  inconsistencies  with  other 
pieces of Union product legislation. For instance, there are differences: 

 

 
 
 

in  the  definitions  of  the  economic  operators  and  their  obligations  (including  the 
conformity-assessment modules);  
in where the CE marking must be placed on the product; 
in the detailed information to be provided on the declaration of conformity (DoC)55;  
in  the  format  or  layout  required  of  the  DoC  and  whether  the  DoC  has  to  be  provided 
along with the product or product documentation.  

All  this  creates  confusion  for  manufacturers  and  other  economic  operators  whose  products  fall 
within the scope of more than one piece of product-safety legislation. 

Contributors to the evaluation of the MD would like to see an alignment in the MD to ensure the 
coherence of its horizontal provisions. In particular they would like to see: (i) a harmonisation of 
the compliance documents (with the same DoC model and technical-file requirements as in other 
pieces of NLF legislation); (ii) the obligations of economic operators extended to importers and 
distributors; and (iii) enforcement of the requirements and conformity-assessment procedures in 
the wider EU legal framework and other NLF-aligned pieces of legislation. 

In  addition,  the  current  MD  presents  a  burdensome  procedure  for  the  management  of  the 
safeguard  clauses,  where  the  Commission  needs  always  to  intervene  in  the  process,  which  is 
suboptimal. An alignment to the NLF would render the handling of safeguard clauses lighter and 

54  European  Commission.  Evaluation  of  the  Machinery  Directive  (2018).  Available  at:  https://op.europa.eu/en/publication-detail/-

/publication/2b213537-25a8-11e8-ac73-01aa75ed71a1/language-en/format-PDF/source-68663524. 

55 An EU declaration of conformity (DoC) is a mandatory document that a manufacturer must sign to declare that its products comply with the 

applicable EU law. 

19 

 
 
                                                           
more efficient as the Commission will have to intervene only when a MS objects to the safeguard 
measure taken by another MS.  

Currently,  there  are  23  pieces  of  product-safety  legislation  aligned  to  the  NLF56.  In  the 
engineering  and  manufacturing  sector,  the  MD  is  one  of  the  few  pieces  of  product-safety 
legislation  not  yet  aligned  to  the  NLF.  Indeed,  most  of  the  product-safety  legislation  on 
machinery  and  equipment  has  already  been  aligned  to  the  NLF,  including  the  Low  Voltage 
Directive,  the  Lifts  Directive,  the  Radio  Equipment  Directive  or  the  Pressure  Equipment 
Directive.  This  means  that  all  these  pieces  of  legislation  benefit  from  the  following  NLF 
improvements57: 

  better coherence and consistency across the range of directives and regulations;  
 

improved  market-surveillance  rules  to  provide  better  protection  for  consumers  and 
professionals from unsafe goods;  

  a clarified notification process for conformity-assessment bodies;  
 
improved accreditation of conformity-assessment bodies; 
  greater credibility and a clearer meaning for the CE mark;  
  clarified  obligations  for  importers  and  distributors  where  the  manufacturer  of  the  CE-

marked product is based outside Europe.  

Problem 6: Divergences in interpretation due to transposition 

Differences  in  interpretation  have  arisen  due  to  transposition.  For  instance  there  have  been 
different definitions of PCM and ‘safety component’, and whether to consider software a safety 
component.  Other  differences  occurred  when  one  or  several  Member  States  consider  that  a 
product placed on the market does not comply with the essential health-and-safety requirements, 
although  that  product  is  available  in  many  other  Member  States.  This  causes  additional  costs 
when the machine is traded in the single market, and thus poses an obstacle to the single market. 
These  differences  proved  difficult  to  eliminate  through  many  years  of  the  MD’s  history.  By 
the  essential  health-and-safety 
individual 
preventing  Member  States’ 
requirements, interpretation of technical solutions will also be prevented. 

interpretation  of 

Furthermore, there have been delays in the transposition of the MD in some Member States58. 

A  directive  leaves  Member  States  free  to  choose  the  means  to  comply  with  the  legislative 
objectives. There have been cases in the past where, following to accidents, Member States have 
taken national measures, in theory on the basis of the MD but in praxis going beyond the MD. 

Impact of the COVID-19 pandemic on the machinery sector 

The  COVID-19  pandemic  damaged  the  performance  of  the  engineering  industry,  including  the 
machinery  sector.  In  the  following  graph,  the  main  indicator  for  confidence  in  the  machinery 
sector (C28) is calculated (black line) as a combination of recent supply and demand factors and 
expected supply and demand in the months ahead. This confirms the picture of a slow but steady 
recovery from COVID-19 during 2020: 

56 https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en 
57 Conformance. The New Legislative Framework (NLF) for directives and regulations (2018).  
Available at: https://www.conformance.co.uk/adirectives/doku.php?id=new_legislative_framework_nlf. 
58 The Member State laws necessary to transpose and thus implement the MD were due to be passed by 29 June 2008, with application from 
29 December 2009. From June 2008 to the deadline for Member States to notify the Commission about their transposition measures, 12 non-
communication  cases  were  opened.  By  the  end  of  2008,  three  Member  States  (Greece,  Italy  and  Luxembourg)  had  still  not  notified  the 
Commission. The Italian case was closed in March 2010 following reasoned opinion, and Luxembourg and Greece both received a court 
referral,  which  was  subsequently  withdrawn  for  Luxembourg  and  closed  in  2010  for  Greece.  By  the  end  of  2010,  all  infringement 
proceedings for non-communication of national measures implementing Directive 2006/42/EC were closed following receipt of the national 
transposition  measures.  Fifteen  formal  infringement  procedures  were  opened  against  Member  States  for  reasons  other  than  ‘non-
communication’ (AT, BE, CY, CZ, FI, FR, DE, GR, HU, IT, LU, NL, SI, ES, UK). The specifics of these procedures are not explained in 
detail, but these cases were all closed after the first infringement stage (receipt of the letter of formal notice).     

20 

 
                                                           
Source:  GROW  elaborations  on  data  provided  by  the  Joint  Harmonised  EU  Programme  of  Business  and 
Consumer Surveys. 

An analysis of the situation of this sector at the beginning of 2021 showed that:  

 

 
 

the biggest shock took place in April 2020 amid concerns about disruptions in the supply 
chain (supply factors went down, driven by very pessimistic expectations about supply); 
expectations of demand were stable throughout the year 2020 and until now; 
excessively weak demand is holding back recovery in this sector. 

Just like  the  overall  economy,  this  sector  is suffering  from  the  prolonged  scarcity  of  aggregate 
demand, which is the lasting effect of the initial double shock (on both supply and demand). 

2.2.  What are the problem drivers? 

The problem drivers were explained above together with the problems. A summary is presented 
below. 

21 

 New risks originating from emerging technologies not sufficiently coveredExtensive paper-based documentation. Manuals used for certain machinery can be very long, and translated in several languagesLegal uncertainty due to lack of clarity of the scope and definitions and possible gaps on traditional technologiesInsufficient provisions for high risk machinesMonetary and environmental costs due to extensive paper-based documentationInconsistencies with other pieces of EU product-safety legislation’Divergences in interpretation due to transpositionNo digital documentation allowedExistence of improved framework to which MD has not yet been aligned (NLF)Acceleration of market uptake of those technologiesEmerging new technologies that create new risksLack of standardisedtechnical solutionsLack of clarity in some definitions used in the DirectiveAreas of overlap in the scope of different pieces of product-safety legislationNew types of ‘high risk’ machines have appeared on the marketConformity procedures based on internal checks are allowed also for high-risk machinesLack of coherence with other pieces of product-safety legislationDifferences in entry-into-force dates in each MSDifferences in interpretation in national transposing legislationRisks linked to traditional technologies could be better addressed, leading to possible safety problems 
 
 
 
 
2.3.  How will the problem evolve? 

On  the  risks  stemming  from  emerging  technologies,  the  lack  of  appropriate  requirements  will 
likely  lead  to  more  non-compliant  products  coming  onto  the  market,  including  imports  from 
outside  the  EU.  A  lack  of  EU  action  would  undermine  user  trust  in  machines  that  incorporate 
emerging technologies. Indeed, there is a danger that machines could be allowed onto the market 
that do not feature the necessary safety requirements. On the other hand, there is also a danger 
that  manufacturers  wanting  to  do  the  right  thing  might  find  their  machinery  development  is 
hindered by the lack of legal clarity and guidance on what product types can or cannot be placed 
on  the  market.  In  this  legal  vacuum,  Member  States  might  decide  to  issue  their  own  national 
rules. This could also create barriers in the single market, unfair competition, and a suboptimal 
level of safety.  

On  the  lack  of  clarity  in  some  areas  of  the  MD,  the  room  for  different  interpretations  could 
generate additional costs and burden for manufacturers and market-surveillance authorities due to 
the need for clarifications. This could also disrupt the level playing field. 

Without  a  reassessment  of  the  concept  of  high-risk  machines,  high-risk  machines  could 
potentially  be  placed  on  the  market  without  passing  the  appropriate  conformity-assessment 
procedures, diminishing the level of safety for those types of machinery. The current list of high-
risk  machines,  already  outdated  today,  will  become  even  more  outdated  with  future  market 
developments. 

On documentation, unless digital documentation is allowed to a certain extent, the industry will 
keep  incurring  economic  and  environmental  costs  for  the  printing  and  handling  of  extensive 
documentation.  This  would  mean  the  industry  would  lose  the  opportunity  for  greater 
digitalisation  and  fail  to  benefit  from  the  advantages  that  digital  formats  can  have  for  certain 
types  of  users  and/or  in  certain  environments  (such  as  speed  in  finding  information).  Paper 
consumption will keep increasing unnecessarily, with the accompanying environmental damage 
and additional costs for industry that this brings.  

On the lack of broader coherence with NLF legislation, the MD risks not taking advantage of the 
NLF’s improved framework for market surveillance and therefore not benefiting from the related 
improvement  in  safety.  Manufacturers  might  continue  to  be  obliged  to  deal  with  different 
approaches in the various product-safety rules applying to their products. This burden would be 
even  more  difficult  to  bear  for  SMEs.  Not  taking  action  would  also  contradict  the  European 
Commission’s commitment to aligning existing legislation to the NLF, where appropriate. 

Finally,  the  current  transpositions  in  the  Member  States  have  generated  certain  differences  of 
interpretation that will create additional costs and burden. This is particularly true in cases where 
manufacturers and users are based in different EU countries.  

Without further harmonisation of the market potentially brought by revising the MD, there is a 
risk that the opportunity to decrease the share of non-compliant products on the market might not 
be exploited. Moreover, not taking action would likely lead to Member States taking additional 
actions  at  national  level  (e.g.  issuing  additional  requirements  or  providing  clarifications  of 
concepts that might differ from those of other Member States). This would further undermine the 
functioning of the single market and its level playing field. It could also potentially undermine 
the safety and health of machinery users and others exposed to machines. 

22 

 
 
3.  WHY SHOULD THE EU ACT? 

3.1.  Legal basis 

The MD is a ‘total harmonisation’ directive based on Article 114 TFEU (ex-Article 95 TEC) and 
follows the ‘new approach’ legislative technique. As explained in Chapter 1 of this report, under 
the  ‘new  approach’  principles,  EU  product  legislation  sets  the  ‘essential  health-and-safety 
requirements’ (referred to in this report as ‘safety requirements’) which products must satisfy to 
benefit from the free movement of products across the internal market.   

3.2. 

Subsidiarity: Necessity of EU action 

This initiative addresses the issues identified in the evaluation of the MD, which was carried out 
as  part  of  the  Commission’s  regulatory  fitness  and  performance  (REFIT)  programme.  The 
evaluation concluded (see SWD (2018)160) that the MD is generally relevant, effective, efficient 
and coherent, and has EU added value, but that there was a need for specific improvements and 
simplification.  

The  machinery  sector  is  a  highly  important  part  of  the  engineering  industry  and  one  of  the 
industrial drivers of the EU’s economy, exporting more than half its production. The MD is a key 
driver of safety for machinery users in the EU. The main objective of the MD is to ensure a 
high  level  of  health-and-safety  protection  for  these  users,  and  to  allow  the  free  circulation  of 
machinery in the EU. In particular, the MD helps to reduce social costs by preventing accidents 
that may be caused by the use of machinery. A key rationale for an EU-level machinery directive 
is to provide harmonisation across Member States based on Article 114 TFEU. Any changes to 
the scope or requirements of such a directive must be made at EU level to avoid distorting the 
market,  creating  barriers  to  the  free  movement  of  products,  or  undermining  the  protection  of 
human health and well-being. 

Proportionality of approach is ensured by the MD being technologically neutral (i.e. the MD lays 
down  the  safety  requirements  to  be  complied  with,  without  prescribing  any  specific  technical 
solution  to  comply  with  those  requirements).  It  is  also  ensured  by  the  Member  States  being 
responsible for the enforcement of the MD in their countries. 

As  explained  in  Chapter  1  of  this  report,  the  technical  solutions  to  comply  with  the  safety 
requirements  set  out  in  the  MD  are  provided  in  European  standards.  These  standards  are 
developed  by  stakeholders,  and  the  standards:  (i)  ensure  interoperability  and  safety;  (ii)  reduce 
costs;  and  (iii)  facilitate  companies’  integration  into  trade  and  the  value  chain.  Further 
development  of  standards  might  pave  the  way  to  provide  solutions  to the  problems  outlined  in 
Chapter  2.  Given  the  widespread  nature  of  these  standardisation  activities,  any  changes  to  the 
scope or requirements of the MD must be made at EU level to avoid: (i) distorting the market; (ii) 
creating barriers to the free movement of products; and (iii) undermining the protection of human 
health and well-being. 

Without  an  EU-wide  regulation,  Member  States  could  impose  diverging  safety  requirements. 
This would lead to: (i) differences in the safety of products for users; (ii) inequalities in prices; 
and  (iii)  an  increase  in  adaptation  costs  for  manufacturers  when  trading  machinery  across 
different  countries.  For  instance,  some  market-surveillance  authorities  consulted  found  it 
necessary  to  ensure  that  software  updates  not  considered  in  the  initial  manufacturer’s  risk 
assessment  and  having  an  impact  on  safety  would  require  the  machine  to  go  through  a 
conformity-assessment  procedure  leading  to  a  new  CE  marking.  Unless  these  requirements  are 
regulated in the revised MD, there is a risk of divergent Member State interpretations, with some 
imposing such procedures and others not. 

A subsidiarity grid is provided in Annex 8 to this report. 

23 

 
3.3. 

Subsidiarity: Added value of EU action 

A regulatory action at EU level would ensure coherent implementation of the safety requirements 
for  machinery  and  thus  a  greater  level  of  safety.  It  would  also  allow  the  free  movement  of 
machines within the EU. But all this would only happen if the regulatory action at EU level laid 
down EU-wide requirements for ensuring the health and safety of machinery users, and allowing 
market enforcement at the national level according to the NLF principles. Regulatory action of 
this  sort  would:  (i)  help  develop  the  internal  (and  digital)  single  market;  (ii)  provide  legal 
certainty  and  a  level  playing  field  for  the  industry;  and  (iii)  build  a  high  level  of  trust  among 
machinery users. 

4.  OBJECTIVES: WHAT IS TO BE ACHIEVED? 

4.1.  General objectives 

There  are  two  general  policy  objectives  to  be  pursued  when  revising  the  MD  to  address  the 
problems  outlined  above.  These  two  general  policy  objectives  are  discussed  in  the  paragraphs 
below and follow those of the original MD. 

1.  General objective 1: Keep ensuring a high level of safety and protection for users of 
machinery and other people exposed to it, and build a high level of trust in innovative 
digital technologies for consumers and users. 

The EU has a competitive edge in world-leading industries such as manufacturing and robotics, 
producing more than a quarter of the world’s industrial and professional-service robots. With the 
emergence of new digital technologies such as AI and the IoT, the EU must remain competitive 
in  a  transforming  global  market.  Emerging  digital  technologies  are  increasingly  gaining  a 
foothold  not  only  in  consumer  applications  but  also  at  commercial/industrial  level,  where  they 
can bring new degrees of efficiency and productivity. With this general objective, the revision of 
the MD aims to ensure that the level of safety for traditional machinery is the same as that for 
machinery using emerging technologies which are being developed or will be developed in the 
future.  

2.  General  objective  2:  Keep  ensuring  the  good  functioning  of  the  single  market, 
including the digital single market. Create a level playing field for economic operators 
and preserve the competitiveness of the machinery sector in global digital markets. 

This objective is natural to the MD as it is a ‘total harmonisation’ directive. The MD is based on 
Article 114 TFEU and on the ‘new approach’ that sets the safety requirements that products must 
satisfy to benefit from the free movement of products across the single market. The single market 
has  brought  benefits  to  businesses  and  the  public  through  this  free  movement  of  products. 
Nevertheless,  administrative  obstacles  and  a  lack  of  appropriate  enforcement  leave  room  for 
further improvement59. This second general objective for the revision of the MD is to implement 
uniform rules across the EU so that: (i) manufacturers and other economic operators exploit the 
full potential of the single market; and (ii) consumers and the public benefit from the same level 
of high safety protection across the EU. 

4.2. 

Specific objectives 

There  are  six  specific  objectives  (SOs)  for  the  revision  of  the  MD,  and  they  are  set  out  in  the 
paragraphs below.  

  SO1: Cover new risks related to emerging digital technologies 

59 European Commission (n.d.) Single Market Act. Available at: https://ec.europa.eu/growth/single-market/smact_en.  

24 

 
                                                           
The aim of this objective is to ensure that the MD covers any potential new risks stemming from 
emerging technologies used in machinery to improve product safety for users and others exposed 
to machinery. This will help build a high level of trust in innovative digital technologies among 
consumers  and  users.  It  will  also  improve  the  functioning  of  the  single  market  and  the  digital 
single  market  by  ensuring  the  free  movement  of  machinery  within  the  EU.  A  revised  MD 
covering  potential  new  risks  will  create  a  level  playing  field  for  economic  operators  and  will 
preserve the competitiveness of the machinery sector in global digital markets. And addressing 
challenges stemming from the use of emerging technologies in machinery has another benefit: it 
can  ensure  the  desired  level  of  safety  in  both  current  market  developments  and  future  trends, 
making the MD conducive to technological progress in digitalisation.  

  SO2:  Ensure  coherent  interpretation  of  the  scope  and  definitions  and  improve 

safety for traditional technologies 

This specific objective aims at improving the legal clarity of some major concepts and definitions 
in the current text of the MD. This will: (i) guarantee that interpretations are consistent across the 
EU;  and  (ii)  help  create  a  level  playing  field  for  economic  operators.  It  will  also  ensure  the 
desired  level  of  safety  across  the  EU.  Adapting  certain  definitions  will  help  to  reduce 
uncertainties in the implementation of the Directive, thus reducing cross-border trade barriers and 
compliance costs, among other benefits. 

  SO3:  Reassess  machines  considered  as ‘high  risk’  and  reassess  related  conformity 

procedures 

This  specific  objective  relates  in  particular  to  the  general  objective  of  ensuring  a  high  level  of 
safety.  It  does  so  by  reassessing  the  machines  considered  as  high  risk,  and  the  conformity 
procedures that manufacturers of high-risk machines must follow. 

  SO4: Reduce paper-based requirements for documentation 

The  aim  of  this  objective  is  to  ensure  that  the  MD  is  as  efficient  as  possible,  minimising 
administrative  burden  where  feasible.  Revising  the  allowed  format  (from  paper  to  digital)  for 
manuals would entail economic benefits, such as savings on printing costs for manufacturers. It 
would also bring environmental benefits, such as reduced paper consumption and a decrease in 
carbon footprint.  

  SO5: Ensure coherence with other product-safety legislation 

Coherence with the wider EU legislative framework will improve enforcement of the legislation, 
thus  leading  to  safety  benefits.  In  addition,  it  will  help  economic  operators  to  manage  their 
activities more effectively and be more competitive in global markets. This improved coherence 
will provide further simplification, particularly for those machines that are covered by different 
NLF  legislative  acts.  Together  with  the  new  mechanisms  for  enforcement  and  compliance 
provided  for  in  the  Commission’s  ‘goods  package’60,  a  revised  MD  is  expected  to  provide  a 
clearer  legal  framework.  Further  simplification  of  the  MD  through  its  revision  would  decrease 
barriers  to  trade  and  cut  the  social  costs  of  accidents  by  strengthening  market-surveillance 
activities. It would also promote the removal of non-compliant machinery from the market. 

  SO6: Avoid divergences in interpretation derived from transposition 

This specific objective aims to reduce the shortcomings of different national transpositions of the 
MD in Member States, thus improving the legal clarity of the MD. 

60 https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2017:787:FIN  

25 

 
                                                           
5.  WHAT ARE THE AVAILABLE POLICY OPTIONS? 

Four policy options were considered. They are set out in the bullet points below. 

  Option 0 - Baseline: The baseline scenario is ‘no action’. This option would leave the 
standardisation  process  to  develop  as  usual,  without  any  particular  focus  on  risks 
stemming  from  emerging  technologies,  and  with  no  particular  focus  on  areas  for 
improvement  related  to  traditional  technologies.  It  would  also  include  revision  of  the 
Guide  following  the  ordinary  process  (discussions  among  stakeholders  and  decision 
taken only by consensus). 

  Option 1 - Self regulation by industry and changes to the Guide: This option would 
make  no  changes  to  the  current  act.  Instead,  clarifications  would  be  introduced  in  the 
Guide.  The  Commission  would  push  for  consensus  on:  (i)  scope  and  definitions;  (ii) 
reducing paper-based documentation; (iii) clarifications on existing high-risk machinery; 
(iv) better coherence with other pieces of NLF product-safety legislation; and (v) fewer 
divergences  in  interpretations  in  the  various  Member  States.  On  this  last  point,  this 
option would also involve setting up dedicated sessions of the Machinery Expert Group. 
New risks stemming from emerging technologies (as well as certain risks from traditional 
technologies) would be addressed by issuing a new Commission standardisation request, 
within the boundaries of the current legal text.  

  Option 2 - Burden minimisation: This option would focus on clarifying the legal text 
and achieving simplification. To this end, this option would change the current MD to 
increase legal clarity in scope and definitions. It would also achieve simplification by: (i) 
allowing  digital  documentation  in  the  legal  text;  (ii)  aligning  the  MD  to  the  NLF;  and 
(iii)  avoiding  divergence  in  interpretations  by  converting  the  MD  into  a  regulation. 
Changes to the current act would also include an empowerment to the Commission for 
reviewing in the future the list of high-risk machines under certain criteria. However, all 
this would be done without adaptations of the safety requirements for products, and thus 
with no changes in the manufacturers’ obligations for designing and manufacturing the 
machinery. As a result, the following four annexes of the MD would remain unchanged: 
(i)  Annex  I:  safety  requirements;  (ii)  Annex  IV:  high-risk  machinery;  (iii)  Annex  V: 
indicative list of safety components; and (iv) Annex VII technical-file descriptions. The 
new risks stemming from emerging technologies (as well as certain risks from traditional 
technologies)  would  be  addressed  by  issuing  a  dedicated  Commission  standardisation 
request, within the boundaries of the current legal text. This would be complemented by 
the issuance of a new Commission standardisation request, within the boundaries of the 
current safety requirements in legal text. 

  Option  3  -  Burden  minimisation  and  enhanced  safety:  This  option  is  the  most 
ambitious  and  would  strive  for  a  better  safety  while  taking  advantage  of  all  burden 
reduction possibilities. To this end, this option would change the current MD to increase 
legal clarity in scope and definitions. It would also achieve simplification by: (i) allowing 
digital documentation; (ii) aligning the MD to the NLF; and (iii) avoiding divergences in 
interpretations by converting the MD into a regulation. This option would also include an 
empowerment  to the  Commission for  reviewing  the current  list  of  machines presenting 
high risks to new market developments in this area, remove the internal check option for 
the conformity assessment of the high risk machines, and make a first adaptation of the 
list  of  high  risk  machines.  In  addition,  it  would  also  adapt  the  safety  requirements  of 
Annex  I  with  which  manufacturers  must  comply  when  designing  and  manufacturing 
machinery,  to  address  risks  stemming  from  emerging  technologies,  as  well  as  specific 
risks  from  traditional  technologies.  This  would  be  complemented  by  the  issuance  of  a 
new  Commission  standardisation  request,  taking  into  account  any  new  and/or  revised 
safety requirements in the legal text. Changes to the current act would also include: (i) a 

26 

 
limited update of the list of high-risk  machines in Annex IV; (ii) making it possible to 
adopt a delegated act to further review the list in the future under certain criteria; and (iii) 
making  mandatory  the  involvement  of  a  third  party  in  the  conformity  assessment  for 
high-risk machines. Additional changes would be planned for Annex V: indicative list of 
safety components, and Annex VII: technical-file descriptions. 

5.1.  What is the baseline from which options are assessed? 

Policy  Option  0  is  the  current  baseline  scenario  for  the  revision,  against  which  the  potential 
impacts of the policy options are measured. It consists in no EU action, meaning no change to the 
current  regulatory  framework.  This  option  would  include  the  usual  standardisation  process, 
without any particular focus on the gaps identified. It would also include the normal process of 
revision  to  the  Guide,  which  requires  consensus  by  all  stakeholders  and  is  therefore  limited  to 
minimum  changes.  This  would  lead  to  the  continuation  and  consolidation  of  the  shortcomings 
identified  in  the  evaluation  of  the  MD,  and  the  effects  of  these  shortcomings,  as  described  in 
Chapter  2.3  of  this  report.  The  baseline  option  is  not  the  current  state  but  the  state  that  would 
develop without any additional EU action.  

5.2.  Description of the policy options 

Policy Options 0 to 3 address all specific objectives in ways that may gradually present higher 
compliance costs but that may also be more ambitious. These four options all tackle the problems 
to some extent. It could be said that they evolve from: (i) doing nothing (PO0); to (ii) purely ‘soft 
law’  (PO1);  to  (iii)  a  mix  of  ‘soft  law’  and  ‘hard  law’  (PO2)  that  would  revise  the  current  act 
without changes to the obligations of manufacturers; to (iv) a ‘hard law’ option (PO3) that would 
revise the current act with some clarifications and additions of new obligations for manufacturers 
when  designing  and  producing  machinery.  The  ‘hardest  law’  option  (complete  overhaul  of  the 
current act) was discarded from the beginning, as explained in Chapter 5.3.  

Following  this  logic,  each  specific  objective  can  be  addressed  from  a  ‘softer’  or  a  ‘harder’ 
approach.  However,  the  extent  to  which  these  approaches  meet  the  objectives  may  vary.  The 
bullet points below set out different policy options that could be taken for each specific objective.  

  SO1 – Cover new risks related to emerging digital technologies: 

o  by the usual standardisation process (PO0); 
o  by issuing a new Commission standardisation request (PO1, PO2); 
o  by adapting the safety requirements in the MD, followed by a new Commission 

standardisation request (PO3). 

  SO2 – Ensure coherent interpretation of the scope and definitions and improve safety for 

traditional technologies:* 

o  by revising the Guide following the normal process (PO0); 
o  by revising the Guide with a push for consensus (PO1); 
o  by adapting the legal text (PO2, PO3). 

` 

*Approaches for traditional technologies are the same as in SO1 

  SO3  –  Reassess  machines  considered  as  high  risk  and  reassess  related  conformity-

assessment procedures: 

o  by revising the Guide following the normal process (PO0); 
o  by revising the Guide with a push for consensus (PO1); 
o  by adapting the legal text to allow a delegated act for reviewing in the future the 

list of high-risk machines under certain criteria (PO2); 

27 

 
 
 
 
o  by updating the list of high-risk machines in Annex IV, allowing the adoption of 
a  delegated  act  for  future  updates  under  certain  criteria,  and  by  making  it 
mandatory to have third-party involvement in the conformity assessment (PO3). 

  SO4 – Reduce paper-based requirements for documentation: 

o  by revising the Guide following the normal process (PO0); 
o  by revising the Guide with a push for consensus (PO1); 
o  by adapting the legal text to allow digital documentation (PO2, PO3). 

  SO5 – Ensure coherence with other product-safety legislation: 

o  by revising the Guide following the normal process (PO0); 
o  by revising the Guide with a push for consensus (PO1); 
o  by adapting the legal text to align it to the NLF (PO2, PO3). 

  SO6 – Avoid differences in interpretation derived from transposition: 

o  by revising the Guide following the normal process (PO0); 
o  by  dedicated  sessions  of  the  Machinery  Expert  Group  and  the  revision  of  the 

Guide with a push for consensus (PO1); 

o  by adapting the legal text to convert it into a regulation (PO2, PO3). 

The policy options are further explained in the following table: 

28 

 
 
 
 
 
Specific objectives (SOs) 

PO0 – Baseline 

PO1 – Self regulation 
by industry and 
changes to the 
Guide  

PO2 – 
Burden 
minimisation 

PO3 – Burden minimisation and improved safety  

SO1 - Improve safety by covering 
new risks related to emerging 
digital technologies 

Address risks derived from human-
robot coexistence in a shared space 
with and without direct collaboration 

Address machine cyber safety, i.e. 
the machine should be designed to 
go into ‘safe mode’ in the event of 
cyber attacks 

Address risks derived from ML 
capabilities and software updates 
potentially altering the behaviour of 
the machine 

Explicitly cover software that has a 
safety function and is placed 
independently on the market  

Explicitly cover driverless machines 
(autonomous or remotely controlled)  

Standardisation as usual 

Standardisation with focus on 
emerging technologies 

Clarifications and targeted new provisions in Annex I 
safety requirements + standardisation 

Stakeholders tend to agree on 
narrower interpretations of the legal 
requirements. For this reason, 
whenever existing standards for 
different types of machinery are up 
for revision, such revised standards 
may or may not include the following 
areas depending on standardisers’ 
interpretation of the MD’s 
requirements on: 

 

 

 

risks derived from human-
robot coexistence 
threats to cyber safety as 
external hazards 
risks derived from ML 
capabilities. 
Bring for discussion a potential 
clarification in the Guide that: 
‘logic units’ include 
software 
driverless machines are 
covered. 

 

 

A Commission standardisation request 
would be issued. However, stakeholders 
tend to agree on narrower 
interpretations of the legal requirements. 
Hence the extent to which actual 
improvements are required depends on 
how stakeholders involved in 
standardisation interpret the MD’s 
current requirements on: 

 

 

 

risks derived from human-robot 
coexistence 
threats to cyber safety as 
external hazard 
risks derived from ML 
capabilities. 

Push for consensus on clarifying in the 
Guide that: 
 
 

‘logic units’ include software 
driverless machines are 
covered. 

Adapt Annex I requirements in the section on risks related to 
moving parts to specify that the prevention of risks of contact 
leading to hazardous situations must be also adapted to include 
human-robot coexistence. 
Clarify that ‘external hazards’ include cyber threats and add 
requirements in Annex I sections 1.1.9 and 1.2.1. on protection 
against corruption and safety and reliability. Machinery certified 
under the Cybersecurity Act will be presumed to be in 
conformity with the revised MD in so far as those requirements 
are covered by the cybersecurity certificate or statement of 
conformity. 
Clarify in Annex I that, for machines with ML capabilities, 
manufacturers must be able to plan out or at least frame in the 
initial risk assessment all potential future states of the machine. 
This will make it possible to ensure that safety is guaranteed at 
all times during the whole life cycle of the machine. 
Software with a safety function that is placed independently on 
the market would be added to the list of safety components in 
Annex V. 
To cover autonomous machines and remote supervisory 
stations, the definitions in Annex I are amended to consider the 
possibility of ‘no driver’. 

29 

 
 
 
 
 
 
Specific objectives (SOs) 

PO0 – Baseline 

PO1 – Self regulation by industry 
and changes to the Guide 

PO2 – Burden 
minimisation 

PO3 – Burden minimisation and 
improved safety  

SO2 – Ensure coherent 
interpretation of the scope and 
definitions and improve safety 
for traditional technologies 
Remove inconsistency in the 
exclusion of low-voltage products, 
specifically when such products are 
equipped with radio equipment 
Make more precise the exclusion of 
means of transport, currently 
limited only to means of transport 
by air, water and rail; and means of 
transport by road regulated in the 
EU type-approval legislation 

Harmonise interpretation of the 
concept of PCM 

Harmonise interpretation of 
responsibilities when installing lifts 
in some Member States 

Harmonise diverging approaches 
towards modifications of 
machinery during their use that are 
regarded as substantial, needing a 
new CE marking 

Clarifications in the Guide 
following the normal process 

Clarifications in the Guide with a 
push for consensus 

Clarifying the legal text to provide legal certainty 

Make it explicit that in the same way that certain products are 
excluded from the MD and fall under the LVD, equivalent products 
using radio equipment that fall under the RED would also be 
excluded from the MD. 
Clarify in the legal text that means of transport whose only 
objective is the transport of goods or persons (e.g. light vehicles 
such as electric-power-assisted cycles, hover boards, self-
balancing scooters and multipurpose vehicles such as all-terrain 
vehicles and side-by-sides) are out of scope, regardless of their 
speed limits. 

The legal text would clarify that those machines for which the 
specific applications are not activated until a piece of software is 
uploaded (e.g. non-pre-programmed robots) are not PCMs. 

Clarify in the legal text that that where the machinery cannot be 
assembled on the manufacturer’s premises, the appropriate 
measures must be taken at the place of use by the manufacturer 
‘or on the manufacturers’ behalf’. 

Add the definition of ‘substantial modification’ in the legal text.  

Bring for discussion a potential 
clarification in the Guide that: 

Push for consensus on these topics in 
the Guide that: 

 

in the same way that certain 
products are excluded from 
the MD and fall under LVD, 
equivalent products using 
radio equipment and falling 
under the RED would also be 
excluded; 
there would be a potential 
enlargement in the exclusion 
of means of transport; 
  machines for which the 

 

 

in the same way that certain 
products are excluded from 
the MD and fall under LVD, 
equivalent products using 
radio equipment and falling 
under RED would also be 
excluded; 
there would be a potential 
enlargement of the exclusion 
of means of transport; 
  machines for which the 

 

specific applications are not 
activated until a piece of 
software is uploaded (e.g. 
non-pre-programmed 
robots) are not PCM; 
new responsibilities when 
installing lifts are laid down; 
the concept of substantial 
modification is defined. 

 

 

specific applications are not 
activated until a piece of 
software is uploaded (e.g. 
non-pre-programmed robots) 
are not PCM; 
new responsibilities when 
installing lifts are laid down; 
the concept of substantial 
modification is defined. 

 

 

30 

 
 
 
 
Specific objectives (SOs) 

PO0 – Baseline 

PO1 – Self regulation 
by industry and 
changes to the Guide 

PO 2 – Burden 
minimisation 

PO3 – Burden minimisation and improved safety  

SO2 – Ensure coherent interpretation 
of the scope and definitions and 
improve safety for traditional 
technologies 

Standardisation as usual 

Standardisation with focus on 
identified gaps 

Clarifications and targeted new provisions in 
Annex I safety requirements + standardisation 

Allow alternative innovative solutions to 
the hold-to-run control devices obligatory 
for not completely enclosed carriers on 
slow-speed lifts 

Bring for discussion a clarification in 
the Guide that alternative solutions 
may be accepted if they provide an 
equivalent level of safety. 

Push for consensus on a clarification in the 
Guide that alternative solutions may be 
accepted if they provide an equivalent 
level of safety. 

Prevent serious or fatal accidents that 
happen when ride-on mobile machinery 
(e.g. ride-on lawn mowers) rolls or tips 
over (such as when cutting the grass on a 
hill) and the restraint systems are not 
attached by their operators 
Prevent serious or fatal accidents linked to 
mobile machinery hitting overhead power 
lines 

Improve protection against exposure of 
workers to hazardous substances starting 
in the initial design phase of machinery 

Prevent workers’ sicknesses and medical 
costs due to exposure to vibration peaks 
when using portable machinery 

Stakeholders tend to agree on 
narrower interpretations of the legal 
requirements. Therefore, whenever 
existing standards for different types 
of machinery are up for revision, 
revised standards may or may not 
include the following areas 
depending on standardisers’ 
interpretation of the MD’s 
requirements on: 

  warnings for the driver 

when the restraint system 
is not activated; 
avoiding overhead power 
lines; 
protection against 
exposure of workers to 
hazardous substances; 
vibration peaks. 

 

 

 

A Commission standardisation request 
would be issued. However, stakeholders 
tend to agree on narrower interpretations 
of the legal requirements. Hence the 
extent to which actual improvements are 
required depends on how stakeholders 
involved in standardisation interpret the 
MD’s current requirements on: 

 
 

  warnings for the driver when the 
restraint system is not activated; 
avoiding overhead power lines; 
protection against exposure of 
workers to hazardous 
substances; 
vibration peaks. 

 

Add the following to Annex I: if there is no risk to the 
people or the objects in the carrier of colliding or falling, 
and no other risks are added due to the upward and 
downward movements, then hold-to-run control devices 
may be replaced by other types authorising automatic 
stops at pre-selected positions. 
Add the following to Annex I: if the restraint system 
must keep the people in their seats and/or in the 
protective structure, and if such a system is not active, 
some kind of warning to the driver should be activated. 
Standards will be revised to provide for technical 
solutions to fulfil this requirement. 

Add a requirement in Annex I for mobile machinery to 
avoid overhead power lines. 

Add a requirement in Annex I to tackle chemical risks in 
Sections 1.7.4.2: Contents of the instructions; 2.2.1: 
Portable handheld and/or hand-guided machinery; and 
3.5.3: Emissions of hazardous substances. This 
requirement to tackle chemical risks only applies when 
hazardous substances are part of the intended use of the 
machinery. 
Add a requirement in Annex I for portable handheld and 
hand-guided machinery in Annex I 2.2.1.1 Portable fixing 
and other impact machinery – General principles. The 
requirement is to ensure better measuring and declare 
values for vibration peaks. 

31 

 
 
 
Specific objectives (SOs) 

PO0 – Baseline 

PO1 – Self regulation by industry 
and changes to the Guide 

SO3 – Reassess machines 
considered as high risk and 
reassess related conformity-
assessment procedures 

Clarifications in the Guide following 
the normal process. No changes to 
the conformity-assessment 
procedures 

Clarifications in the Guide with a 
push for consensus. No changes 
to the conformity-assessment 
procedures 

Clarify whether or not the 
concept of logic units includes all 
types of software including AI 
software.  
In addition, for types of 
machinery with a higher risk 
factor, a stricter certification 
procedure is desirable.  

Bring for discussion in the regular 
process for revising the Guide whether 
item 21 in the list of high-risk machines 
(‘logic units to ensure safety functions’) 
includes software, and what types of 
software. This may be debatable. 
Changes to the Guide must be agreed by 
consensus. Changes are potentially 
reversible in future changes to the Guide 
(limited improvement of legal certainty).  
Conformity assessment of such software 
will require the involvement of a third 
party unless relevant harmonised 
standards exist and are applied by the 
manufacturer. 

Push for consensus on revising the 
Guide, in particular to address 
whether item 21 in the list of high-
risk machines (‘logic units to ensure 
safety functions’) includes software, 
and what types of software. Changes 
to the Guide must be agreed by 
consensus. Changes are potentially 
reversible in future changes of the 
Guide (limited improvement of legal 
certainty). Conformity assessment of 
such software will require the 
involvement of a third party unless 
relevant harmonised standards exist 
and are applied by the manufacturer. 

PO2 – Burden minimisation 

Revision of the legal text to 
allow the adoption of a 
delegated act for reviewing 
the list of high-risk 
machines under certain 
criteria. No changes to the 
conformity-assessment 
procedures 

The addition or removal of 
items from the list is not done 
immediately but later, once the 
Commission is empowered to 
amend the list.  In the 
meantime, push for consensus 
on revising the Guide, in 
particular to address whether 
item 21 in the list of high-risk 
machines (‘logic units to ensure 
safety functions’) includes 
software, and what types of 
software. 

PO3 – Burden minimisation 
and improved safety  
Revision of the legal text to 
allow the adoption of a 
delegated act for reviewing 
the list of high-risk machines 
under certain criteria. 
Removal of the conformity-
assessment procedure based 
on internal-check options 
Add two new items in Annex IV: 
‘software to ensure safety 
functions including AI systems’ 
and ‘machinery embedding AI 
systems ensuring safety 
functions’. 
The conformity assessment of 
such software will require the 
involvement of a third party in all 
cases due to the high-risk nature 
of the machinery included in 
Annex IV. In addition, for all other 
products in Annex IV, an 
obligation is set that a third party 
checks conformity. 

Update the list of high-risk 
machines to keep up with market 
developments 

Clarifications are discussed in the regular 
process for revising the Guide. However, 
categories cannot be added or removed. 

Push for consensus on clarification in 
the Guide. However, categories 
cannot be added or removed. 

The Commission will be empowered to amend the list, including by 
adding a new category of machinery or withdrawing an existing 
category of machinery, through delegated acts. 

32 

 
 
 
 
 
 
 
Specific objectives (SOs) 

PO0 – Baseline 

SO4 – Reduce paper-based 
requirements for documentation 

Modernise the MD and minimise 
burden for manufacturers. 

Allow (to a certain extent) 
instruction manuals in digital 
format, by amending the Guide 
following the normal process 

The current MD requires 
instructions to be included with the 
machinery, without determining 
the format of such instructions. The 
Guide further specifies that 
instructions must be on paper. 
Bring the possibility of digital 
instructions for discussion into the 
regular process for revising the 
Guide. Changes to the Guide must 
be agreed by consensus. 

PO1 – Self regulation by industry 
and changes to the Guide 
Allow (to a certain extent) 
instruction manuals in digital 
format, by amending the Guide 
with a push for consensus 
The current MD requires instructions to 
be included with the machinery, 
without determining the format of 
such instructions. The current version 
of the Guide specifies that instructions 
must be on paper. Push for consensus 
on revising the Guide as regards the 
documentation formats. Changes to 
the Guide must be agreed by 
consensus. Changes are potentially 
reversible in future changes to the 
Guide. 

PO2 – Burden 
minimisation 

PO3 – Burden minimisation 
and improved safety  

Allow (to a certain extent) instruction manuals in digital 
format, by amending the current act 

Allow in the legal text that instructions and declarations of 
conformity can be provided in a digital format. However, upon 
request at the time of the purchase of the machine, the instructions 
must be provided in paper format and free of charge. How to access 
the digital instructions must be marked on the machinery and in an 
accompanying paper, clearly stating which version of the 
instructions corresponds to the machinery model. The format 
provided must make it possible for the end-user to download the 
instructions and save them on his/her electronic device, if he/she 
needs access to the instructions during a breakdown of the machine. 

33 

 
 
 
 
Specific objectives (SOs) 

PO0 – Baseline 

SO5 – Ensure coherence with other product-
safety legislation 

In alignment with the NLF, include definitions and 
obligations of economic operators, which do not exist 
in the current MD (e.g. importer, distributor) 

in alignment with the NLF, improve market-
surveillance rules and streamline management of 
safeguard clauses 

Clarifications in the Guide 
following the normal 
process 

Bring the definitions of 
economic operators into 
discussions in the regular 
process for revising the Guide. 

Bring the improvement of 
market-surveillance rules into 
discussions in the regular 
process for revising the Guide. 

PO1 – Self regulation by 
industry and changes to the 
Guide 

Clarifications in the Guide 
with a push for consensus 

Push for consensus on adopting 
the complete definitions of 
economic operators in the 
Guide. 

Push for consensus on 
improving market-surveillance 
rules in the Guide. 

Clarifications in the Guide 
following the normal 
process 

Dedicated Machinery 
Expert Group sessions and 
clarifications in the Guide 
with a push for consensus 

PO2 – Burden 
minimisation 

PO3 – Burden minimisation 
and improved safety  

Align the current act with the NLF 

 Add the NLF definitions/obligations on economic operators 
to the legal text. 

Aligning the MD to the NLF would bring the Information and 
Communication System for pan-European Market 
Surveillance (ICSMS) to the MD, enabling: (i) comprehensive 
exchange of information between all the market-
surveillance bodies that is fast and works across borders; 
and (ii) streamlined management of safeguard clauses. 

Convert current Directive into a Regulation 

SO6 – Avoid differences in interpretation 
derived from transposition 

Due to the nature of a directive, Member States have a 
margin of flexibility in transposing it. This sometimes 
leads to a different interpretations of key concepts 
such as the definition of PCM. This in turn implies that 
some Member States will issue national standards to 
indicate how manufacturers must comply with the 
MD. 

Bring the topic into discussion 
in the regular process for 
revising the Guide.  

Discussion of this topic at 
dedicated Machinery Expert 
Group sessions. Push for 
consensus on revising the 
Guide on this topic.  

Because regulations must be applied directly in Member 
States, this will prevent Member States from deviating from 
the legal text. This will in turn prevent the emergence of 
barriers to trade such as national standards. 

34 

 
 
 
5.3.  Options discarded at an early stage 

Two  other  potential  policy  options  or  sub-options  were  discarded  at  an  early  stage.  They  are 
discussed in the two bullet points below. 

  A complete overhaul of the current act, altering the current approach, which focusses 
on:  safety  requirements,  no  technical  specifications,  and  technology  neutrality.  The 
evaluation  of  the  MD,  carried  out  as  part  of  the  Commission’s  regulatory  fitness  and 
performance  (REFIT)  programme,  concluded  that  the  MD  was  mostly  fit  for  purpose. 
Large-scale  revisions  of  the  approach  and  requirements  in  the  MD  were  seen  as 
unnecessary.  In addition, larger-scale revisions would  lead to greater compliance costs 
for all stakeholder groups. The main expected costs would be one-off adaptation costs to 
deal with the changes. These costs would depend on the extent of the revision. A few 
manufacturers indicated in the public consultation that potential one-off costs could be 
up  to  8%  of  annual  turnover  on  average  for  major  changes  in  requirements  related  to 
emerging technologies. Stakeholders involved in standardisation, and in CEN/Cenelec in 
particular, indicated that major changes to existing requirements would require checking 
the 800 harmonised standards that currently exist for machinery. This might slow down 
the process of revising and drafting new standards. 

  Repeal of the MD. The evaluation of the MD also concluded that the MD is an essential 
driver for machinery safety in the market. All stakeholder groups agreed that the MD is 
generally relevant, effective, efficient and coherent. They also agreed that the MD has 
EU added value. In addition, repealing the MD would: (i) create a dramatic distortion of 
the single market for machinery; (ii) erect barriers to intra-EU trade; and (iii) undermine 
the  competitiveness  of  the  EU  machinery  industry  both  within  the  EU  and  globally. 
Most  likely,  Member  States  would  create  their  own  27  national  laws  on  machinery, 
since health-and-safety issues in machinery are too important to be left unregulated.  

6.  WHAT ARE THE IMPACTS OF THE POLICY OPTIONS? 

Economic,  social  and  environmental  impacts  were  considered  in  assessing  the  policy  options. 
The analysis in this chapter focuses on these three options. It is quantitative whenever possible. 
Where it is not possible to be quantitative the analysis is qualitative. A brief summary of the three 
impacts are set out in the bullet points below. 

Economic impacts (costs/benefits: one-off or recurrent, direct or indirect) 

  For manufacturers: 

o  savings (elimination of costs) due to improved legal clarity; 
o  costs  due  to  familiarisation  with  –  and  training  on  –  the  changes  made  to  the 

Directive; 

o  costs of conformity assessment (developing and updating technical files, internal 

testing activities, fees for notified bodies); 

o  costs due to modifications to the design of the product; 
o  savings of a share of the costs for printing, paper and shipping; 
o  costs to develop and maintain the database for online manuals; 
o  savings or costs due to innovation allowed or hindered; 
o 

improvement of industry competitiveness within the EU and globally. 

35 

 
 
 
 
 
 
  For national authorities: 

o  costs  due  to  familiarisation  with  –  and  training  on  –  the  changes  made  to  the 

Directive; 
time and burden to identify the correct digital manual and documentation;  

o 
o  savings (elimination of costs) for transposition. 

  For notified bodies: 

o 

familiarisation with – and training on – the changes made to the MD. 

  For standardisers: 

o  additional  work  to  review  standards  impacted  by  changes  or  draw  up  new 

standards. 

  For users (workers and/or consumers):  

o  potential  increased  costs  of  products  if  additional  costs  are  moved  down  the 

value chain; 

o  benefit of accessing innovative machinery in the market. 

Social impacts 

  For users (workers and/or consumers): 

improved product safety; 

reduction in number of non-compliant products in the market; 

o 
o  access to products of the same level of safety on the market; 
o 
o  advantages  of  e-manuals  (e.g.  non-paper  instruction  manuals,  or  manuals  that 
can  be  better adapted for blind  and  partially  sighted people)  and  disadvantages 
(e.g.  lack  of  access  to  digital  instructions  in  certain  environments;  changes  or 
updates of the manual might not match version of a product). 

  For national authorities 

o 

lower costs for the health system thanks to fewer accidents. 

Environmental impacts 

  For society: 

o  saving of paper and a decrease in carbon footprint. 

6.1. 

Policy Option 0 (PO0) – No change 

This policy option is the baseline option. It entails no change to the current regulatory framework 
or to ways of working.  

To  address  the  risk  stemming  from  emerging  technologies,  and  possible  gaps  identified  in 
traditional technologies, this option would rely on the usual standardisation process. It would not 
have  any  particular  focus  on  the  gaps  identified.  The  European  Standardisation  Organisations 
(ESOs) would remain obliged to keep the registry of harmonised standards up to date. Currently, 
the ESOs propose standards for revision if they become obsolete, particularly whenever: (i) the 
state-of-the-art advances in a certain area; or (ii) a shortcoming is identified in a given standard 
(formal  objection  by  a  Member  State61  or  other  reason).  Under  this  baseline  option  of  Policy 

61 When an EU Member State considers that a harmonised standard (see definition in Article 2(1)(c) of Regulation (EU) No 1025/2012) does 
not entirely satisfy the requirements which it aims to cover and which are set out in the relevant EU harmonisation legislation, it must inform 
the Commission thereof with a detailed explanation. This procedure is given in Article 11 of Regulation (EU) No 1025/2012. After such 

36 

 
 
 
 
 
 
 
 
 
 
 
                                                           
 
Option  0,  the  proposed  revisions  could  include  any  necessary  updates  covering  emerging 
technologies  applied 
to  machinery  such  as:  human-robot  collaboration,  AI,  IoT  and 
cybersecurity.  The  only  condition  is  that  stakeholders  involved  in  standardisation  (ESOs, 
industry, Member States, trade unions and consumer associations) must be of the view that the 
MD covers those areas. Indeed, stakeholders tend to agree on narrower interpretations of the legal 
requirements.  This  means  that  the  standardisation  process  typically  results  in  a  compromise 
among  stakeholders  and  provides  the  minimum  level  of  quality  necessary  to  comply  with  the 
requirements of the MD, without going beyond what the MD requires. 

To give an example, the MD does not cover cybersecurity per se but only covers cybersecurity if 
it has an impact on safety. In Annex I, the MD stipulates that ‘control systems must be designed 
and  constructed  in  such  a  way  that  they  can  withstand  the  intended  operating  stresses  and 
external influences’. Such ‘external influences’ may or may not be interpreted as including cyber 
attacks.  If  the  interpretation  of  the  standardisers  is  that  cyber  attacks  are  not  included,  then 
standards  will  not  propose  technical  solutions  to  address  them.  However,  if  the  legal  text 
specifically  states  that external influences  include  cyber  attacks,  then only  one  interpretation  is 
possible and standards will propose technical solutions so that the machine withstands such cyber 
attacks. Thus, Policy Option 0 addresses this problem, but only to a limited extent. 

Policy  Option  0  would  follow  the  normal  process  of revising  the  Guide  to:  (i) ensure coherent 
interpretation of the scope and definitions; (ii) reassess high-risk  machinery; (iii) reduce paper-
based  requirements  for  documentation;  (iv)  ensure  coherence  with  other  product-safety 
legislation;  and  (v)  avoid  differences  in  interpretation  derived  from  transposition.  However, 
Policy Option 0 has significant limitations in this area, for the following three reasons. 

 

It requires consensus from all stakeholders and is therefore generally limited to minimum 
changes.  As  an  example,  for  many  years  the  machinery  community  has  debated  the 
concept of substantial modification without reaching a consensus. 

  Changes to the Guide are potentially reversible in future revisions, and this means that 

manufacturers face the risk of limited legal certainty. 

  Changes  to  the  Guide  are  limited  to  what  the  legal  text  allows.  Changes  cannot  go 

beyond the legal text, otherwise they run the risk of being challenged in court. 

This baseline option of Policy Option 0 is not the current state but the state that would develop 
without any additional EU action. This would lead to the continuation and consolidation of the 
shortcomings  identified  in  the  evaluation  of  the  MD,  and  the  effects  of  these  shortcomings,  as 
described in Chapter 2.3 of this report.  

Under this baseline option of Policy Option 0, the problems identified will remain, and so will the 
costs  derived  from  the  existing  lack  of  clarity.  No  significant  impacts  are  expected.  The  vast 
majority of the respondents agreed that a revision of the MD is necessary, even if only a minor 
one. No stakeholder preferred this baseline option. 

6.2. 

 Policy Option 1 (PO1) – Self regulation by industry and changes to the 
Guide 

  PO1  –  Specific  objective  (SO)  1:  This  option  addresses  new  risks  related  to 
emerging  digital  technologies  by  self-regulation,  and  in  particular,  through 
standardisation activities.  

This policy option would include a new standardisation request issued by the Commission to the 
ESOs (CEN/Cenelec). The standardisation request would be focused on new standards covering 
emerging  technologies  applied  to  machinery  such  as:  human-robot  collaboration,  AI,  IoT  and 

objection, the Commission will, after consulting all EU members, adopt a decision which maintains, enables, restricts, or fully removes the 
references to the harmonised standards concerned in the Official Journal of the European Union (OJEU). 

37 

 
                                                                                                                                                                            
cybersecurity. The standardisation request would detail areas and deadlines for developing those 
standards. 

Standards are developed by the ESOs. The industry, Member States, consumer associations and 
trade union representatives also participate in the development of standards. The Commission’s 
role in the standardisation process consists of issuing standardisation requests to the ESOs. These 
standardisation requests detail the work areas, expected standards and delivery timeframes. When 
new standards (e.g. for a given type of machine) are proposed by ESOs to the Commission for 
publication  in  the  OJEU,  the  Commission  will  publish  those  standards  on  condition  that  the 
standards  address  the  relevant  requirements  of  the  legal  act  (Annex  I  of  the  MD)  and  the 
standardisation  request.  Only  harmonised  standards  that  are  published  in  the  OJEU  provide 
presumption of conformity with the MD’s relevant requirements.  

The  Commission  has  a  validation  role,  but  it  does  not  have  an  active  role  in  the  drafting  of 
standards. The Commission also does not have a voting right for approving new standards by the 
ESOs. In this respect, the Commission’s lever for a correct standardisation process is making the 
legislation requirements (to which harmonised standards make reference) as clear as possible, so 
that they are not subject to different interpretations by standardisers when developing standards. 

Harmonised  standards  provide  the  specifications  and  methods  for  testing  the  performance  of  a 
product for quality, safety or interoperability. For any machinery under the scope of the MD that 
is  placed  on  the  market  according  to  a  harmonised  standard  published  in  the  OJEU,  it  is 
presumed that the machinery complies with the requirements of the European legislation, in this 
case  the  MD.  Because  the  harmonised  standards  are  not  binding  legislation  and  their  use  is 
voluntary,  manufacturers  can  also  use  other  appropriate  technical  solutions  to  comply  with  the 
EU  legislation.  However,  if  manufacturers  choose  to  use  other  appropriate  technical  solutions 
they must demonstrate the legal compliance of these solutions. This gives harmonised standards 
an  important  double  role:  on  the  one  hand,  they  give  manufacturers  legal  certainty  that  their 
product conforms with EU requirements as long as they follow the harmonised standard. On the 
other hand, the voluntary nature of the standards makes the framework flexible enough to enable: 
(i) innovation and technical development; and (ii) the placing on the market of new products for 
which a harmonised standard does not yet exist. 

Industry  associations,  stakeholders  working  on  standardisation,  trade  unions,  and  the  European 
Economic  and  Social  Committee  (EESC)  all  agree  that  there  is  need  for  action  on  the  way 
machinery  safety  is  regulated.  However,  they  would  rather  take  action  at  the  standardisation 
level. They consider that, because the MD is – and should stay – technologically neutral, no new 
safety requirements need to be added to the current act to cover emerging technologies. Policy 
Option  1  would  take  action  only  at  the  standardisation  level,  and  thus  would  give  time  for 
emerging technologies to fully develop before further legal requirements are enacted. However, 
these groups that favoured only taking action at the standardisation level still found new safety 
requirements  necessary  in  some  areas.  As  an  example,  most  of  the  stakeholders  (56.8%)  that 
participated  in  the  public  consultation  (companies/business  associations  were  the  largest  group 
that  participated  in  the  consultation)  agreed  that  software  that  ensures  a  safety  function  and  is 
placed  independently  on  the  market  should  explicitly  be  covered  by  the  MD  and  therefore 
considered a safety component. 

Member  State  authorities disagreed  somewhat  with industry  associations,  stakeholders  working 
on standardisation, trade unions, and the EESC. This is because Member States believe that the 
MD must be the first area in which action is taken, and then the standards must follow. Member 
States  argue  that  unless  a  requirement  is  specified  in  the  legal  act,  it  will  not  be  properly 
developed in  the  standardisation  process.  Several  market-surveillance  authorities  and  consumer 
associations  also  believe  that  explicit  provisions  or  adaptations  to  existing  requirements  are 
necessary to provide legal certainty for these emerging technologies that pose risks that were not 
considered when drafting the original requirements.  

38 

 
Although  the  MD  is  ‘technology  neutral’  (which  means  that  the  wording  in  the  requirements 
should  not  mention  a  specific  technology)  it  must  still  ensure  that  the  risks  inherent  to  that 
technology are covered. In addition, harmonised European standards are drafted with the aim of 
providing presumption of conformity to certain requirements under EU acts. Therefore, it is the 
safety requirements included in those requirements (Annex I in the case of the MD) that drive the 
standardisation process. Moreover, many stakeholders with different perspectives and objectives 
are involved in this standardisation process (industry, consumers, public authorities, researchers 
and  other  interested  parties).  This  means  that  the  output  of  this  process  is  often  a  compromise 
reached by those stakeholders that fulfils the strict minimum requirements laid down by the EU 
act without going beyond it. For this reason, the real ‘lever’ that product-safety legislators have to 
determine the necessary level of required safety are the requirements in the EU act themselves. 
Because this policy option would not involve any substantive changes to the MD itself, it would 
not address the ‘gap’ identified in the Commission Report on the safety and liability implications 
of  Artificial  Intelligence,  the  Internet  of  Things  and  robotics.  This  report  stated  that  current 
product-safety legislation contains a number of gaps that need to be addressed, in particular in the 
MD. 

[+/-] Costs and Benefits: PO1 meeting specific objective 1 presents no significant impacts on 
stakeholders,  since  it  relies  on  the  usual  standardisation  process.  However  potential  costs  may 
emerge  due  to  the  need  for  compliance  with  new  standards.  These  costs  would  depend  on  the 
number and complexity of standards to be developed, and could not be quantified at this stage. 
However, it is worth noting that in case of absence of standards, there would be a cost of “not 
having a standard”, since each company would need to develop its own. 

  PO1  –  SOs  2,  3,  4  and  5:  The  Guide  would  bring  some  clarifications  to  the 
application  of  the  MD on:  (i) coherent interpretation  of the scope  and  definitions; 
(ii)  high-risk  machines;  (iii)  digital  documentation;  and  (iv)  coherence  with  other 
pieces of NLF legislation.  

The Guide is an informative document published on the MD’s Europa page in English only. It is 
a useful document, widely used by the machinery community, and quite extensive (450+ pages). 
Because  the  MD  covers  a  wide  range  of  machinery  types,  a  significant  amount  of  guidance  is 
necessary.  The  Guide  is  regularly  reviewed  in  concertation  with  all  stakeholders  involved. The 
current version was published in October 2019, and the previous version was published in July 
2017. 

Nevertheless,  making  clarifications  in  the  Guide  has its  limitations.  One  limitation  is  that  legal 
certainty will be limited, because it is a non-binding document that is regularly reviewed. Indeed, 
it should be stressed that only the MD and the texts implementing its provisions into national law 
are legally binding. Another limitation is that the Guide cannot go beyond what is written in the 
legal  text.  A  further  constraint  is  that  the  Guide  is  modified  by  consensus.  This  means  that  on 
many controversial issues it has not been possible to reach consensus, and it would take a very 
strong commitment by all interested parties to reach consensus on these issues. 

On the coherent interpretation of the scope and definitions, the Guide could include clarifications 
on the scope and definitions. This could include clarifications as to what is or is not considered a 
substantial  modification  requiring  a  new  CE  marking.  However,  substantial  modification  has 
been discussed for years among machinery stakeholders, without ever reaching an agreement. It 
would therefore require a strong commitment from stakeholders to make progress in this area. 

On  the  issue  of  high-risk  machines,  further  clarification  could  be  added  to  the  Guide.  The 
categories included or excluded in Annex IV could also be added to the Guide. As an example, 
Annex IV,  Item 1 covers only ‘circular saws for working with wood and analogous  materials’. 
The  Guide,  in  indent  §388,  states  that  ‘Materials  analogous  to  wood  include,  for  example, 
chipboard, fibreboard, plywood (and also these materials when they are covered with plastic or 

39 

 
light alloy laminates/edges), cork, bone, rigid rubber or plastic. On the other hand, stone, concrete 
and  similar  materials  requiring  an  abrasive  type  of  cutting  tool  are  not  considered  as  materials 
analogous to wood’. This is an example of what can be clarified in the Guide. However, broader 
clarifications  may  be  challenged  by  market-surveillance  authorities  if  they  go  beyond  what  is 
written  in  the  legal  text.  For  instance,  it  would  not  be  possible  to  use  the  Guide  alone  to  add 
circular saws for working with stone and concrete to the list. Adding circular saws for working 
with stone and concrete to the list would require adapting the legal text. 

On  the  issue  of  digital  documentation,  the  Commission  analysed  whether  the  choice  between 
digital  and  paper  documentation  might  be  product-related  and  not  generalisable.  However,  the 
range of products covered by the MD is very wide, and it would be difficult to draw up and agree 
on  criteria  for  allowing  the  use  of  e-manuals.  One  option  could  be  to  distinguish  between 
consumer use and professional use and allow digital documentation for one of these uses but not 
the other. However, here again it would be difficult to determine what constitutes consumer use 
and  what  constitutes  professional  use.  Therefore,  one  policy  option  would  be  to  allow  digital 
documentation  for  all  machinery  types.  This  policy  option  would  specify  in  the  Guide  that  the 
instruction manual and DoC62 can be provided in digital form. It would state that the digital form 
must  be  such  that  a  user  can  download  the  user  manual  to  his/her  own  laptop,  to  ensure 
availability in environments where the internet may not always be available. However, the Guide 
would also specify that a free-of-charge paper copy must be provided in all cases if the customer 
asks for it at the time of purchase. Allowing e-manuals through a change in the Guide could be 
challenged  in  the  future  as  not  being  in  line  with  the  legal  text  because  it  introduces  the 
possibility of a lack of legal certainty. 

Finally,  to  somewhat  improve  coherence  with  other  NLF  legislation,  in  this  policy  option, 
additional references to the ‘Blue Guide’ on the implementation of EU product rules63 would be 
included in the Guide. Those references would have a limited effect, since real alignment would 
need to be done in the legal text. 

On the gaps identified in the area of traditional technologies, the course of action and type and 
limited magnitude of the impacts are similar to those described for the emerging technologies in 
SO1.  Since  this  policy  option  relies  on  the  usual  standardisation  process  also  for  traditional 
technologies, no significant impacts on stakeholders would be expected. However potential costs 
may emerge due to the need for compliance with new standards. These costs would depend on 
the  number  and  complexity  of  standards  to  be  developed,  and  could  not  be  quantified  at  this 
stage. However, it is worth noting that in case of absence of standards, there would be a cost of 
“not having a standard”, since each company would need to develop its own. 

[+/-]  Costs  and  Benefits:  PO1  meeting  specific  objectives  2,  3  and  5  would  have  limited 
impacts on stakeholders. There would be additional costs for compliance with new standards on 
traditional  technologies,  and  in  relation  to  the  likelihood  that  consensus  is  not  reached  for  a 
change  in  the  Guide.  These  costs  could  not  be  quantified.  PO1  meeting  specific  objective  4 
brings  an  opportunity  to  simplify  and  reduce  net  costs,  mainly  for  manufacturers.  These 
benefits are quantified at the end of the PO1 section. 

  PO1  –  SO6:  On  reducing  possible  divergences  in  interpretation  derived  from 
transposition, this policy option would: (i) identify inconsistencies with transposition 
of  the  current  text  through  dedicated  Machinery  Expert  Group  sessions;  and  (ii) 
improve (to a certain extent) coherence in the Guide. 

The  Machinery  Working  Group  comprises:  Member  State  authorities;  the  Commission; 
stakeholders  from  industry;  standardisation  bodies;  notified  bodies;  consumer  associations;  and 

62  https://europa.eu/youreurope/business/product-requirements/compliance/technical-documentation-conformity/index_en.htm  
63  https://ec.europa.eu/growth/content/‘blue-guide’-implementation-eu-product-rules-0_en  

40 

 
                                                           
trade unions. It is used as a forum to the discuss problems in the practical application of the MD. 
The Machinery Working Group usually meets twice a year in Brussels. In 2021, this group will 
be  converted  into  an  expert  group64.  This  policy  option  would  identify  inconsistencies  with 
transpositions through a dedicated Machinery Expert Group workshop. 

The Commission does not currently provide translations of the Guide into other EU languages, 
although  a  few  Member  States  do  translate  the  Guide  into  their  language  to  benefit  their  own 
national machinery community. To better tackle specific objective 6, this policy option would see 
the  Commission  provide  translations  of  the  Guide  into  all  the  EU’s  languages.  Overall,  this 
policy  option  would  make  it  possible  to  see  if  changes  to  the  Guide  are  enough  to  solve  the 
existing problems, before further legal requirements are enacted. However, making clarifications 
in the Guide has its limitations. One limitation is that legal certainty will be limited, because the 
Guide  is  a  non-binding  document  that  is  regularly  reviewed.  Only  the  MD  and  the  texts 
implementing its provisions into national law are legally binding. Another limitation is that the 
Guide  cannot  go  beyond  what  is  written  in  the  legal  text.  And  a  further  constraint  is  that  the 
Guide  is  modified  by  consensus.  This  means  that  on  a  number  controversial  issues  (e.g. 
substantial  modification)  it  has  not  been  possible  to  align  positions  so  far,  and  it  would  take  a 
very strong commitment by all interested parties to make it work. 

[+/-] Costs and Benefits: PO1 meeting specific objective 6 presents no significant impacts on 
stakeholders.  Cost  savings  from  reducing  clarification  procedures  between  manufacturer  and 
Member  State  authorities  could  be  estimated  at  between  EUR  100  and  EUR 500  per  instance. 
The  number  of  instances  could  not  be  estimated.  Some  of  these  costs  could  be  avoided  if 
consensus is reached to make clarifications in the Guide. 

Therefore,  the  biggest  cost  and  benefits  of  PO1  are  linked  to  allowing  some  digital 
documentation  by  changing  the  Guide.  This  is  the  objective  that  this  option  is  most  likely  to 
achieve, despite the legal uncertainty it would create by the prospect of possible future changes to 
the  Guide.  To  estimate  the  potential  additional  costs  and  cost  savings  for  stakeholders  by 
switching to digital documentation, the following inputs have been assessed.  

Machinery  manuals  can  be  very  large,  depending  of  the  complexity  of  the  machine.  As  an 
example, an instruction handbook for a lawnmower can comprise 50 pages and up to 1 200 pages 
when translated. This would apply to about 3 billion manuals produced in a year in the machinery 
sector,  assuming  one  manual  per  sold  item  of  machinery.  Printing  manuals  imposes  costs  that 
include the paper itself, storage, printing and postage.  

For  manufacturers  (an  estimated  82 239  companies,  of  which  1 703  are  large  companies  and 
81 024 SMEs), the net effect is clearly a benefit. 

[-]  A  change  to  the  use  of  digital  documentation  could  imply  one-off  costs  for  economic 
operators to purchase and set up a server, in addition to the recurring costs of maintaining this 
database and keeping the information on it up to date (A lower cost alternative would be renting 
server space, but for a more conservative estimate the purchase of a server has been considered). 
There are also other costs that might be added to provide other digital tools (e.g. CD-ROMs or 
USB sticks). On average, the purchasing costs of a server can be estimated at EUR 1 84565 and 
the  setup  costs  at  EUR  115  per  month  server  (EUR  1,960  per  organisation).  The  costs  of 
maintaining a server of maximum complexity are on average of EUR 272 per month (EUR 3,264 
per  year)  for  small  businesses66.  Costs  for  large  manufacturers  are  likely  to  be  lower.  Some 

64  As per the Inter-Institutional Agreement on Better Regulation of 13 April 2016. 
65 Converted using European Commission’s InforEuro, baseline 2019. 
66 Average cost for the purchase of a server of USD 2 000 (EUR 1 845) for small businesses. This average is taken for all equally, although 
costs for large manufacturers might be lower. Setup costs were indicated to be on average about USD 125 (EUR 115). Cost for maintenance 
of  the  data  base  are  estimated  at  USD  295  (EUR  272)  per  month  for  systems  with  very  high  requirements.  Cost  estimates  taken  from 
https://www.servermania.com/kb/articles/how-much-does-a-server-cost-for-a-small-business/#Maintenance_Costs.   

41 

 
                                                           
manufacturers or large companies might already possess a website including such a database due 
to  their  e-commerce  activities.  For  these  companies,  the  costs  would  be  less  than  for  other 
companies  that  would  have  to  start  from  scratch.  Within  the  machinery  sector,  82%  of 
manufacturers  already  use  digital  formats  for  documentation  and/or  manuals.  Thus,  the  costs 
would apply to the remaining 18% in particular67. This would mean one-off costs of EUR 1 960 
and recurrent annual costs of EUR 3 264 per company, which multiplied by 18% of the total 
number  of  companies  (82  239)  would  lead  to  one-off  costs  for  the  whole  industry  of  EUR 
29 million  and recurrent annual  costs  of the whole  industry  of  EUR  48 million  across the 
EU-27. 

 [+] Printing costs for user  manuals have been estimated by different business associations and 
companies.  Depending  on  the  size  of  the  manual  and  the  number  of  products  manufactured, 
printing costs were reported during consultations to account for 1-4% of companies’ turnover per 
year.  Taking  into  account  the  EUR  663  billion  turnover  in  the  machinery  sector  in  2017,  this 
leads  to  an  annual  recurrent  cost  for  the  industry  of  between  EUR 6.63  billion  and  EUR 26.5 
billion. According to the answers to the public consultation, 62.7% of users would like to have 
the  manuals  only  in  digital  form.  This  brings  savings  on  printing  costs  for  the  industry  to 
between  EUR  4  billion  and  EUR  16.6  billion  annual  recurrent  cost  for  the  industry,  which 
divided by the number of companies (82 239) would lead to between EUR 48 000 and EUR 201 
000 per company)68. 

For market-surveillance authorities (71 or more) and notified bodies (137 or more) there would 
be: 
[-] one-off costs for adaptation to change, which are not quantifiable; 
[+] decreased storage costs for documentation, which are also not quantifiable. 

For  users,  i.e. workers (of  which there  are an  estimated  2 759 439)  and  consumers  (of  which 
there are an estimated 191 210 900), the benefits and costs would be as follows. 
[-] Average EUR 0.4 of printing costs per manual69(number of manuals not identified); a lack 
of internet access in certain environments; and changes or updates of the manual that might not 
match the version of a machine used by the user or worker.  
Indeed,  to  estimate  conservatively  the  costs  and  benefits,  it  should  be  considered  an  additional 
cost when users do not request the manual when purchasing the machinery, but decide to print it 
(or an extract of it) in one language subsequently.  
 [+]  Some  users  might  benefit  from  digital  documentation  (e.g.  increased  readability),  but  the 
number of such users is not quantifiable. 

In  addition,  there  are  environmental  costs  associated  with  the  paper  documentation,  ranging 
from  sourcing  through  manufacturing  to  disposal.  One  key  impact  of  printing  is  the  use  of 
primary material for papermaking: wood. Wood is critical for terrestrial carbon-dioxide storage. 
It  must  be  considered  that  more  than  40%  of  the  industrial  wood  harvest  is  used  for  paper 
manufacturing, and that the paper industry is Europe’s largest user of industrial-process water per 
tonne  of  end-product.  The  paper  industry  is  also  Europe’s  fourth-largest  contributor  to  water 
pollution, and a lot of energy is needed to produce one sheet of paper70.  

67 Results from consultations, n=22. 
68 EUR 4 billion (62.7% of 6.63 billion) and EUR 16.6 billion (62.7% of 26.5 billion). Divided by the number of companies (82 239) would 
lead to between EUR 48 000 and EUR 201 000 per company. (In the Impact assessment study on the revision of Directive 2006/42/EC on 
machinery, a more complex calculation method was used, based on the total number of machines sold, the average length of a machinery 
manual  and  the  average  costs  per  page.  This  method  led  to  higher  savings:  EUR  129  billion  across  the  industry  (EUR 1.6  billion  per 
organisation) in printing costs saved by switching to digital manuals and manuals printed on demand.) 

69 This cost is calculated from the total printing costs:  average between 1% and 4% =2.5%, multiplied by turnover EUR 663 billion = EUR 26 
520 000, divided then by 3.1 billion number of machinery units sold = EUR 8.5 per manual. The cost of printing  one translation only is 
estimated by taking 1/23 of a manual based on the assumption that this manual contains all 23 EU languages. Therefore, supposing a user 
would only print his own language, costs of an individual printing would reach about EUR 0.4 per manual. No difference could be made on 
the number of manuals used by professional users in comparison to consumers. 

70  Smith,  R.,  ‘The  Environmental  Sustainability  of  Paper’.  Graduate  Studies  Journal  of  Organizational  Dynamics,  (2011)  Available  at: 

https://repository.upenn.edu/cgi/viewcontent.cgi?article=1003&context=gsjod.  

42 

 
                                                           
The  table  below  shows  the  potential  costs  and  cost  savings  for  stakeholders  from  switching  to 
digital documentation. The result of the switch would be a  net benefit for the most impacted 
stakeholder group, the manufacturers. Nevertheless, the legal uncertainties of allowing digital 
documentation  only  through  the  Guide,  without  confirmation  in  the  legal  text,  may  lead  to 
additional costs that could not be quantified. In fact, the Guide could be changed again to cancel 
the digital e-manuals in the future, thus eliminating the net benefit. 

Potential costs and benefits of Policy Option 1 

Companies 

Large companies 

SMEs 

All 

Administratio
ns 

Market-
surveillance 
authorities 

Notified 
bodies 

ESOs 

Other organisations 

Citizens/users 

1 703 

81 024 

82 239 a) 

71 or more 

137 or more 

People 
employed in 
the sector 

2 759 439 

Consumers 

191 210 9
00f) 

Stakeholder 
description 

Allowing digital 
documentation  

Number of affected 
stakeholders (EU-
27) 

2.1 
Costs 
(total)  

One-off 

Recurrent 

2.2 
Costs 
per 
organisa
tion 

One-off 

Recurrent 

EUR 600 818b)               EUR 28 585 267b)                     

EUR 29 013 919b)  

(These are the costs for setting up and creating a new 
website for e-manual downloads 
and complying with new standards) (not quantifiable) 
EUR 1 000 547e)               EUR 47 603 220e)             

EUR 48 317 057e) 
(annually, for website maintenance) 
Costs due to limits and legal uncertainties related to the 
Guide not being binding, plus the risk of a lack of consensus 
to change the Guide (not quantifiable) 
EUR 1 960c) (setting up and creating new website for 
downloading e-manuals) 
EUR 3 264d) (annually, for website maintenance) 
and costs due to legal uncertainties related to the Guide 
being not binding, plus the risk of a lack of consensus to 
change the Guide (not quantifiable) 

3. 
Benefits 

Direct  

Between EUR 4 billion and EUR 16.6 billion 
(between EUR 48 000 and EUR 201 000 per company) 
savings on printing costs,  
excluding those who will keep using paper format 

Expected 
costs for 
adaptation to 
e-manuals 
(not 
quantifiable) 

One-off costs 
for adapting 
to expected 
change (not 
quantifiable) 

Compliance 
with new 
standards 
(not 
quantifiable) 

- 

- 

- 

- 

- 

- 

- 

- 

Some notified 
bodies might 
benefit from 
decreased 
storage costs 
for 
documentation 
(not 
quantifiable) 
- 

- 

- 

- 

-- 

EUR 0.4g) per manual if the 
user decides to print part 
of the manual (number of 
manuals not identified)  

- 

- 

- 

Some users might benefit 
from digital documentation 
e.g. because of increased 
readability, or because 
non-paper instruction 
manuals are better suited 
to the blind and partially 
sighted (not quantifiable) 

- 

- 

- 

- 

- 

- 

Indirect 

- 
a) Due to rounding differences in the Eurostat data, the total number of enterprises shown does not equal the sum of enterprises recorded per 
size class.  
b) Based on average costs of purchasing and setting up a server for small business (it is likely that costs for large manufacturers are lower) for the 
18% of enterprises that do not yet use digital formats in the sector multiplied by the number of companies in the sector. These one-off costs are 
expected to be the same irrespective of the sub-option because servers would need to be purchased and set up in all sub-options.  
c) Based on an average of EUR 1 845 to purchase a server plus an average of EUR 115 to set up a server (EUR 1 960 per organisation).  
d) Based on an average of EUR 272 per month (EUR 3 264 per year) in costs to maintain the server at maximum complexity of the system for small 
businesses. Costs for large manufacturers are likely to be lower. These are expected to be the same across sub-options.  
e)  Based  on  the  yearly  costs  of  maintaining  a  server  multiplied  by  the  number  of  enterprises,  large  manufacturers,  SMEs  and  the  18%  of 
enterprises not yet using digital formats. 
f) Proxy used: number of households, Eurostat EU-27, 2016.  
g) Based on the estimation of costs of one manual at EUR 8.50 (Printing costs of one manual calculated by dividing the total printing costs (2.5% of 
turnover)  by  the  total  number  of  manuals  (one  per  item  of  machinery  at  3.1  billion  machines).  The  cost  of  printing  translations  only  was 
estimated by taking 1/23 of a manual based on the assumption that this manual contains all 23 EU languages. Respondents to the consultation 
expected only the translations to be printed, in which case the cost would only be EUR 0.4 for printing the relevant parts of their language per 
manual. No difference could be found in the number of manuals used by professional users compared to consumers. 

6.3. 

Policy Option 2 (PO2) – Burden minimisation 

  PO2  –  SO1:  This  policy  option  addresses  new  risks  related  to  emerging  digital 
technologies  by  adapting the  current  act  to  some  extent  (to  make  reference to  the 

43 

 
 
 
  
 
 
availability  of  source  codes/programmed  logics  to  authorities),  although  without 
making  changes in  the  requirements.  This  adaptation  to  the  current  act would  be 
complemented with the usual standardisation process. 

As in PO1, PO2 would also include a new standardisation request issued by the Commission to 
the  ESOs  (for  machinery  CEN/Cenelec).  This  request  would  be  focused  on  emerging 
technologies, detailing areas and deadlines for development of standards. 

[+/-] The costs and benefits of PO2 meeting specific objective 1 consist of benefits for users 
thanks to a reduction in non-compliant products on the market. Potential costs may also emerge 
from  the  development  of  new  standards  as  asked  for  in  the  new  Commission  standardisation 
request. These costs would depend on the number and complexity of standards to be developed, 
and could not be quantified at this stage. 

  PO2 – SO2: This policy option would adapt the current act on scope and definitions, 
such as the borderlines with LVD-RED, the exclusion of the means of transport, the 
PCM,  the  substantial  modification,  and  the  installation  of  lifting  appliances,  and 
also include any necessary further clarifications in the Guide. 

Article 1(2)(k) lists the categories of low-voltage electrical and electronic machinery that are 
excluded from the scope of the MD. These categories are: (i) household appliances intended for 
domestic  use;  (ii)  audio  and  video  equipment;  (iii)  information  technology  equipment;  (iv) 
ordinary office machinery; (v) low-voltage switchgear and control gear; and (vi) electric motors. 
Electrical machinery that is not in any of the categories listed in Article 1(2)(k) and that is not 
affected by one of the other exclusions falls in the scope of the MD, and the electrical risks are 
covered  in  Annex  I  1.5.1  ‘Electricity  supply’.  When  such  machinery  has  an  electrical  supply 
within  the  voltage  limits  of  the  LVD  (between  50  V  and  1 000 V  for  alternating  current  or 
between 75 V and 1 500 V for direct current), it must fulfil the safety objectives of the LVD. As 
outlined in Chapter 2.1, the RED is not mentioned in this exclusion, which is not coherent. To 
tackle  the  inconsistency,  this  policy  option  would  make  it  explicit  that  in  the  same  way  that 
certain  products  are  excluded  from  the  MD  and  fall  under  LVD,  equivalent  products  using 
radio equipment and falling under RED would also be excluded. 

The MD already excluded means of transport by air, water, rail networks, and means of transport 
by  road  regulated  in  the  EU’s  type-approval  legislation.  By  default,  vehicles  that  were  not 
regulated  by  that  legislation  were  covered  by  the  MD.  Although  a  vehicle  may  fall  under  the 
definition of machinery, the purpose of the machinery legislation is to address the risks stemming 
from  the  machinery  performing  its  function  (such  as  excavator  in  a  construction  site),  not  the 
risks related to its circulation on the public roads. This option would make clear that the revised 
MD does not apply to means of transport, regardless of the speed limits, with the exception of 
machinery mounted on these means of transport. The means of transport includes all vehicles, the 
only  objective  of  which  is  the  transport  of  goods  or  persons.  The  following  vehicles  would 
therefore be excluded from the revised MD: (i) light vehicles, such as electrically power-assisted 
cycles, hover boards, or self-balancing scooters; and (ii) multipurpose vehicles such as all-terrain 
vehicles and side-by-sides. 

As  already  mentioned,  under  Policy  Option  2,  the  definition  of  PCM  would  be  adapted  to 
exclude those machines (e.g. non-pre-programmed robots) for which the specific applications 
are  not  activated  until  a  piece  of  software  is  uploaded.  In  addition,  the  definition  of  PCM 
would  also  clarify  that  ‘any  device  installed  after  the  machinery  on  which  it  is  assembled  has 
been put into service is not deemed partly completed machinery’. This would make it possible to 
clearly  distinguish  between  PCM  and  interchangeable  equipment.  The  results  from  the  public 
consultation  show  that  most  respondents  (52.4%)  support  the  changed  definition  of  PCM  and 
believe  that  further  clarification  would  be  beneficial.  These  respondents  were  not  in  favour  of 
removing  the  concept  of  PCM  from  the  MD.  Removing  this  concept  was  expected  to  lead  to 

44 

 
  
additional  costs,  including  costs  for:  (i)  negotiating  the  current  PCM  requirements  for  each 
delivery  contract  individually;  (ii)  filing  these  individual  contracts  and  linking  them  to  the 
technical file; (iii) court cases; and (iv) clarifications with market-surveillance authorities.  

This  policy  option  would  add  two  things  to  the  MD:  (i)  the  concept  of  ‘substantial 
modification’ as it exists in other NLF product-safety legislation; and (ii) the fact that a new CE 
marking  is  required  for  machinery  substantially  modified  that  is  made  available  again  on  the 
market71,  unless  it  is  meant  for  the  manufacturer’s  own  use.  This  addition  would  favour  the 
circular economy, since substantially modified machinery could be put on the market again with 
a new CE marking. 

To  address  the  issues  that  arise  where  installer  and  manufacturer  consider  the  other  party 
responsible  for  failures  in  installed  lifts  which  are  intended  to  be  installed  permanently,  a 
clarification  would  be  added  in  Annex  I.  This  clarification  would  specify  that  where  the 
machinery  cannot  be  assembled  in  the  manufacturer’s  premises  or  in  the  premises  of  their 
authorised  representative,  the  appropriate  measures  must  be  taken  at  the  place  of  use  by  the 
manufacturer  ‘or  on  its  behalf’.  For lifting  machinery  permanently  installed in a  building  or a 
structure,  the  address  where  the  machine  is  installed  will  be  added  in  Annex  II  Declaration  of 
Conformity. 

[+/-] The costs and benefits of PO2 meeting specific objective 2 are mainly linked to: (i) the 
addition of RED to the LVD exceptions in Article 1(2)(k); and (ii) the clarifications on the 
definition  of  PCM.  Clarifications  in  the  MD  allow  the  industry  to  save  on  guidance  for 
interpretation  or  additional  clarifications  via  commercial  contracts.  The  table  below  shows  the 
potential costs and benefits for stakeholders, although no quantification has been possible due to 
the lack of available data. 

Costs and benefits of changing Article 1(2)(k) 

Stakeholders’ 
description 

Companies 

Administrations 

Other 
organisations 

Citizens/users 

ADAPTING THE LIST OF 
LOW-VOLTAGE PRODUCTS 
EXCLUDED 

Large 
compan
ies 

SMEs 

All 

Market-surveillance 
authorities 

Notified 
bodies 

ESOs 
b) 

People 
employed 
in 
machinery 
sector 

Users/ 
consumers 

1. Number of affected 
stakeholders (EU-27) 

360 

17 645 

18 005a) 

71 or more 

137 or 
more 

1  

884 224c) 

191 210 900 
d) 

2.1 Costs 
(total) /  
2.2 Cost per 
organisation 

Recurrent 
(annual) 

One-off 

Some costs for adapting to the 
changes are likely but these 
could not be reliably quantified  

Some adaptation costs are 
likely but consultation 
participants expected these 
to be marginal 

Some recurrent costs expected 
by a few consultation 
participants but these recurrent 
costs could not be reliably 
quantified  
Some benefits are expected by a 
few consultation participants but 
these benefits could not be 
reliably quantified 

- 

Expected benefits from 
reducing legal uncertainty 
(not quantifiable) 

b. 

Benefits 

Direct 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

Reduction of unsafe 
products 
(not quantifiable) 

- 

Indirect 

- 
a) Based on Eurostat structural business statistics (EU-27) 2016, C28.23, C28.29, C28.95, C28.15. 
b) European standardisation organisations. 
c) Proxy used by looking into the home-appliances industry – number of direct employees 2016, APPLiA (2017). By the numbers: The home-appliance 
industry in Europe, 2017-2018. Available at: http://applia-europe.eu/statistical-report-2017-2018/documents/APPLiA_SR19.pdf. 
d) Proxy used: number of households in 2016 (EU-27), Eurostat. 

- 

- 

- 

- 

- 

- 

71 In NLF legislation: (i) ‘making available on the market’ means any supply of machinery for  distribution or use on the EU market in the 
course of a commercial activity, whether in return for payment or free of charge; and (ii) ‘placing on the market’ means the  first making 
available of machinery on the EU market. 

45 

 
  
  
                                                           
There are instances where data are quantified based on responses to consultations or interviews. When the number of replies is too low to present an 
estimate, the cost cannot be reliably quantified. Proxy values are used when direct information is not available. 

Potential costs and benefits of improving the definition of PCM 

Stakeholders’ description 

Companies  

Administrations 

Other organisations 

CHANGING THE 
DEFINITION OF PARTLY 
COMPLETED MACHINERY 

Large 
companies 

SMEs 

All 

Market-surveillance 
authorities 

Notified bodies 

ESOs 

1. Number of affected 
stakeholders (EU-27) 

1 703 

81 024 

82 239 a) 

71 or more 

137 or more 

2.1 Costs 
(total)/  
2.2 Costs 
per 
organisation 

One-off 

Costs for adapting to changes; these 
costs are not quantifiable but 
consultation participants expected 
them to be marginal  

Recurrent 

No costs were identified 

3. Benefits 

Direct 

Cost savings of roughly between 
EUR 5 000 and EUR 10 000 per 
instanceb) 
(Number of instances was not 
identified) 

Costs for adapting to 
changes; these costs 
are not quantifiable 
but consultation 
participants expected 
them to be marginal 
No costs were 
identified 

Expected benefits 
include greater legal 
clarity 
(not quantifiable) 

Costs for adapting to 
changes; these costs are 
not quantifiable but 
consultation participants 
expected them to be 
marginal 

No costs were identified 

Some cost savings could 
stem from decreased 
efforts in solving 
problems of uncertainty 
(not quantifiable) 

Indirect 

- 

- 

- 

- 

- 

- 

- 

- 

Citizens 
/users 
People 
employed in 
machinery 
sector/  
users or 
consumers 

- 

- 

- 

Cost savings 
of roughly 
between 
EUR 5 000 
and 
EUR 10 000 
per instance 
- 

a) Due to rounding differences in  the  Eurostat  data,  the total  number of enterprises shown  does  not equal  the sum of enterprises recorded per size 
class. 
b) Based on consultation answers. An instance refers to one product being placed on the market by one manufacturer. 
There are cases  where  data are  quantified  based on responses  to consultations or  interviews. When the  number of replies  is too low to  present an 
estimate, cost cannot be reliably quantified. Proxy values are used when direct information is not available. 

  PO2  – SO3: Like in PO1, clarifications on the list of high-risk machines would be 

added to the Guide.  

This option includes the possibility for the Commission to be empowered to amend the list in the 
future, including by adding a new category of machinery or withdrawing an existing category of 
machinery,  through  delegated  acts.  In  the  meantime,  as  explained  in  PO1,  clarification  would 
include specifications as to what categories of machinery are included or not included, provided 
that enough consensus is found, and without going beyond what the legal text prescribes. New 
categories of machines could not be added or removed by a change in the Guide alone. 

The conformity assessment of such software will require the involvement of a third 
party  in  all  cases  due  to the  high-risk  nature  of  the  machinery  included in  Annex 
IV. In addition, for all other products in Annex IV, an obligation is set that a third 
party checks conformity. 

[+/-]  Costs  and  benefits:  Like  in  PO1,  PO2  meeting  specific  objective  3  presents  no 
significant impacts to stakeholders.  

  PO2  –  SO4:  Like  in  PO1,  this  policy  option  would  specify  in  the  Guide  that  only 
‘safety’ information must be included with the machinery in paper form; all other 
parts of the manual instructions can be provided in digital form (plus on paper and 
free of charge upon customer request).  

One  of  the  results  of  the  evaluation  is  that  stakeholders,  particularly  the  industry,  thought  it 
would be a good idea to include the option to provide documentation and user manuals in digital 
formats  rather  than  on  paper  as  is  currently  indicated  in  the  Guide.  This  policy  option  would 

46 

 
 
 
require a change of the legal text in the MD, by specifying in the Annex I that the instruction can 
be provided either digitally or in paper, which would provide legal certainty, and would prevent 
this coming under question later on and being changed again in the Guide. 

Under this policy option, the digital declaration of conformity (digital DoC) would be part 
of  EU  digital  policy.  Other  pieces  of  EU  product-safety  legislation  such  as  the  Personal 
Protection  Equipment  Regulation72  have  already  integrated  this  possibility  of  providing 
documentation in digital format. Furthermore, aligning the MD to the NLF would oblige Member 
States  to  implement  the  ICSMS,  which  offers  fast  and  efficient  communication  for  market-
surveillance authorities to exchange information within a short space of time. The ICSMS allows 
information  on  non-compliant  products  (test  results,  product-identification  data,  photographs, 
economic-operator information, risk assessments, accident information, information on measures 
taken  by  surveillance  authorities, etc.) to be  quickly  and  efficiently  shared  between  authorities. 
This  means  that  Member  States  must  already  work  with  digital  documentation  on  product 
compliance including the digital DoC. 

[+/-] Costs and benefits: Like in PO1, PO2 meeting specific objective 4 brings an opportunity 
for  simplification  and  net-cost  reduction,  mainly  for  manufacturers.  See  table  reported  in 
PO1. 

  PO2 – SO5: By amending the legal text, this policy option would align the current 

act with the NLF.  

There  are  currently  23  pieces  of  product-safety  legislation  aligned  to  the  NLF73.  In  the 
engineering  and  manufacturing  sector,  the  MD  is  one  of  the  few  pieces  of  product-safety 
legislation not yet aligned to the NLF. 

As  mentioned  previously,  aligning  the  MD  to  the  NLF  would  bring  the  following 
improvements74.  

i) 

ii) 

iii) 
iv) 

v) 
vi) 

It  would  improve  coherence  and  consistency  across  the  range  of  directives 
and regulations. 
It  would  improve  market-surveillance  rules  to  provide  better  protection  for 
consumers and professionals from unsafe goods. 
It would clarify the notification process for conformity-assessment bodies. 
It  would  improve  the  accreditation  of  conformity-assessment  bodies  and 
improve the conformity-assessment procedures or modules. 
It would clarify the meaning of the CE mark and increase its credibility. 
It  would  clarify  the  obligations  of  importers  and  distributors  when  the 
manufacturer of the CE-marked product is based outside Europe. 

In  other  words,  such  an  alignment  would  ‘help  to  increase  the  quality  of  machinery  and  the 
confidence in products in the European market, as well as ensure good levels of safety and create 
a common framework for market surveillance’75. Aligning the MD to the NLF would bring the 
internet-supported ICSMS to the MD. The ICSMS creates the basis for effective and efficient 
cooperation between market-surveillance bodies in Europe. Supported by the internet, the ICSMS 
enables  the  rapid,  cross-border  and  comprehensive  exchange  of  information  between  all  the 
market-surveillance  bodies.  With  this  system,  it  is  possible  to  implement  efficient  safety 
measures and consumer protection, and to ensure fair competition throughout the EU. 

72 Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing 

Council Directive 89/686/EEC. 

73 https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en. 
74  Conformance 
(NLF) 

(2018).  The  New  Legislative  Framework 
https://www.conformance.co.uk/adirectives/doku.php?id=new_legislative_framework_nlf. 

for 

directives 

and 

regulations.  Available 

at: 

75  European  Commission.  Evaluation  of  the  Machinery  Directive,  p.  105.  (2018)  Available  at:  https://op.europa.eu/en/publication-detail/-

/publication/2b213537-25a8-11e8-ac73-01aa75ed71a1/language-en/format-PDF/source-68663524. 

47 

 
                                                           
On the effectiveness of the MD, an  alignment to the NLF would improve management of the 
safeguard clauses by using the ICSMS to involve all MS in the process  before the Commission 
intervenes. Aligning the MD to the NLF and the ‘goods package’76 adopted by the Commission 
in 2018 will improve market surveillance and enforcement. It will also improve the conditions for 
accreditation of notified bodies and the monitoring of the performance of notified bodies because 
Decision No 768/2008/EC on a common framework for the marketing of products will apply.  

There  was  broad  consensus  on  the  benefits  of  this  alignment.  Most  respondents  to  the  public 
consultation, across all stakeholder types, expressed support for this change. 

Would you be in favour of aligning MD to the NLF? 

Results (total) 
% 

Yes 
65.4% 

Source: Public-consultation results (n=523) 

No 
3.3% 

I do not know 
31.4% 

Industry stakeholders said that, because manufacturers sometimes work under the rules of more 
than  one  piece  of  legislation,  coherence  would  increase  if  all  directives  were  aligned.  Indeed, 
alignment is expected to ensure coherence of the horizontal provisions of the MD, especially in 
three areas: (i) compliance documents (there would be greater coherence as they would use the 
same DoC model and technical-file requirements as in other NLF legislation); (ii) the obligations 
of  economic  operators  (greater  coherence  because  these  obligations  would  be  extended  to 
importers and distributors); (iii) and requirements and conformity-assessment procedures (greater 
coherence because these requirements and procedures would be aligned with the wider EU legal 
framework  and  other  NLF-aligned  pieces  of  legislation).  This  would  result  in  significant 
simplification for the manufacturers. 

National authorities considered that the alignment would lead to: (i) easier market surveillance; 
(ii) common rules among different products and (iii) more clarity in certain terms, transversal to 
several  pieces  of  product-safety  legislation,  such  as  the  concept  of  substantial  modification. 
Similarly, notified bodies were of the view that the quality of the conformity assessment would 
increase through the alignment.  

[+/-]  Costs  and  benefits:  PO2  meeting  specific  objective  5  would  present  benefits  for  all 
stakeholders,  although  quantification  of  these  benefits  was  not  possible  due  to  the  lack  of 
available data. The table below shows the potential costs and benefits for stakeholders of aligning 
the MD to the NLF. 

Costs and benefits of aligning the MD to the NLF 

Stakeholders’ 
description 
ALIGNMENT TO THE NLF 

1. Number of affected 
stakeholders (EU-27) 

2.1 Costs 
(total) /  
2.2 Costs per 

One-off 

Companies 

Administrations 

Citizens/users 

Large 
companies 

SMEs 

All 

Market-surveillance 
authorities 

People employed in 
machinery sector 

Users/consumers 

1 703 

81 024 

82 239a) 

71 or more 

2 759 439 

446 000 000b) 

Some adaptation costs likely, but 
consultation participants expected 
these costs to be marginal 

Some adaptation costs 
likely but consultation 
participants expected 

- 

- 

76  See:  (i)  Regulation  (EC)  765/2008  setting  out  the  requirements  for  accreditation  and  the  market  surveillance  of  products;  (ii)  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,  Decision  768/2008 is  a template  for  future  product harmonisation  legislation;  and  (iii)  Regulation  (EU) 
2019/1020  on  market  surveillance  and  compliance  of  products  (available  at:  https://ec.europa.eu/growth/single-market/goods/new-
legislative-framework_en). In particular, the ‘goods package’: i) improves market surveillance rules to better protect both consumers and 
professionals  from  unsafe  products,  including  those  imported  from  outside  the  EU.  In  particular,  this  applies  to  procedures  for  products 
which  can  pose  danger  to  health  or  the  environment;  ii)  sets  clear  and  transparent  rules  for  the  accreditation  of  conformity  assessment 
bodies;  iii)  boosts  the  quality  of  and  confidence  in  the  conformity  assessment  of  products  through  stronger  and  clearer  rules  on  the 
requirements for the notification of conformity assessment bodies; iv) clarifies the meaning of CE marking and enhances its credibility; v) 
establishes  a  common  legal  framework  for  industrial  products  in  the  form  of  a  toolbox  of  measures  for  use  in  future  legislation.  This 
includes  definitions  of  terms  commonly  used  in  product  legislation,  and  procedures  to  allow  future  sectorial  legislation  to  become  more 
consistent and easier to implement. 

48 

 
 
                                                           
Stakeholders’ 
description 

organisation 

Companies 

Recurrent 

- 

Direct 

Benefits are expected through a 
harmonisation of ‘new approach’ 
directives under the same framework 
(not quantifiable) 

3. Benefits 

Administrations 

these costs to be 
marginal 
- 

Access to the ICSMS 
communication system 
for pan-European market 
surveillance is expected 
to facilitate the 
procedures 
(not quantifiable) 

Indirect 

- 

- 

Citizens/users 

- 
- 
Harmonisation of market-
Harmonisation of market-
surveillance procedures is 
surveillance procedures is 
expected to reduce the share 
expected to reduce the share 
of non-compliant products on 
of non-compliant products on 
the market (especially for 
the market (especially for 
consumer products that 
professional products that 
accounted for 88% of the 
accounted for 12% of the 
alerts registered in 2010-2019) 
alerts registered in 2010-2019) 
Harmonisation of market-surveillance procedures is expected to 
reduce the share of non-compliant products on the market (76% 
of products under the alert system are from non-EU countries) 
Access to the ICSMS communication system for pan-European 
market surveillance will also be available to consumers (not 
quantifiable) 

a) Due to rounding differences in the Eurostat data, the total number of enterprises shown does not equal the sum of enterprises recorded per size class. 
b) Proxy used: number of inhabitants living in the EU. 
There are instances where data are quantified based on responses to consultations or interviews. When the number of replies is too low to present an estimate, cost cannot 
be reliably quantified. Proxy values are used when direct information is not available. 

  PO2 – SO6: By amending the legal text, this policy option would convert the MD to 

a regulation.  

A directive leaves Member States to choose which means they will use to comply with the MD’s 
legislative  objectives.  This  has  led  to  different  interpretations  of  the  MD’s  provisions,  creating 
legal uncertainty and a lack of coherence throughout the single market. Furthermore, there have 
also been delays in the transposition of the MD in some Member States. 

Converting  the  MD  into  a  regulation  will  increase  the  uniformity  of  application.  It  will  also 
reduce the scope for differences in interpretation, thus ensuring greater legal certainty and a level 
playing field for economic operators. Furthermore, it will synchronise the timing of the entry into 
force of regulations across the single market. Finally, costs from transposition will be avoided.  

In addition, the MD is a ‘total harmonisation’ directive, which means that it requires a high level 
of safety, and does not allow the Member States to impose  more restrictive obligations. In this 
respect, a regulation – by its legal nature – would better ensure that Member States do not impose 
national technical requirements that: (i) go beyond the safety requirements laid down in Annex I 
of the current Directive; and/or (ii) contradict those safety requirements. Therefore, the legal text 
fits best with a regulation approach rather than with a directive approach. 

There was broad consensus across all stakeholder groups on the benefits of this conversion. A 
large majority of public-consultation respondents expressed support for this change.  

Would you be in favour of having exactly the same rules on machinery safety applicable at the same 
time across the EU (converting the MD into a regulation)? 

Results (total) 
% 

Yes 
79% 

Source: Public-consultation results (n=523) 

No 
5.4% 

I do not know 
15.7% 

[+/-]  Costs  and  benefits:  PO2  meeting  specific  objective  6  would  bring  benefits  to 
stakeholders.  Manufacturers  would  save  on  administrative  costs  for  clarifications  on 
interpretation differences between Member States. These administrative costs are estimated to be 

49 

 
 
 
between  EUR 100  and  EUR 500  per  instance77  to  write  letters,  print  papers  and  resolve 
differences. Member States would also save administrative costs by not having to transpose the 
MD to national legislation. Differences in interpretation could be reduced by converting the MD 
into a regulation. The table below shows the potential costs and benefits for stakeholders. 

Potential costs and benefits of converting the MD into a regulation 

Stakeholders’ description 

Companies 

Administrations 

Other organisations 

Citizens/users 

CONVERTING THE MD INTO 
A REGULATION 

Large 
companies 

SMEs 

All 

Market-surveillance 
authorities/Member States 

Notified bodies 

Users / 
consumers 

1. Number of affected 
stakeholders (EU-27) 

1 703 

81 024 

82 239a) 

2.1 Costs 
(total) 

One-off/ 
recurrent 

Some one-off adaptation costs are likely, but 
consultation participants expected these costs 
to be marginal. No expected recurrent costs. 

3. Benefits- 

Direct 

EUR 100-500 per instanceb) 
Cost savings in terms of clarification procedures 
between manufacturers and MSA authorities. 
Number of instances could not be estimated. 
- 

- 

27 EU Member States to 71 
market-surveillance 
authorities or more 
Some adaptation costs are 
likely but consultation 
participants expected these 
costs to be marginal. No 
expected recurrent costs. 
Benefits expected from 
avoiding transposition costs 
of the MD 
(not quantifiable) 
- 

137 or more 

Some adaptation costs are 
likely but consultation 
participants expected these 
costs to be marginal. No 
expected recurrent costs. 
Benefits expected through 
equal interpretation of the 
regulation across MS 
(not quantifiable) 
- 

- 

- 

Reduction of 
unsafe 
products 

Indirect 

- 
a) Due to rounding differences in the Eurostat data, the total number of enterprises shown does not equal the sum of enterprises recorded per size class. 
b) Based on consultation answers. An instance refers to one product being placed in the market by one manufacturer. 
There are instances where data are quantified based on responses to consultations or interviews. When the number of replies is too low to present an estimate,  
the cost cannot be reliably quantified. Proxy values are used when direct information is not available. 

- 

[+/-] Costs and benefits: The overall effects on stakeholders of PO2 include: (i) a net benefit 
to manufacturers thanks to the switch to e-manuals; (ii) light adaptation costs due to the exclusion 
of LVD products with embedded radio equipment and the clarifications on PCM; and (iii) net 
benefits  due  to  clarifications  in  the  MD  (thus  allowing  the  industry  to  save  on  guidance  for 
interpretation  or  the  need  for  commercial  contracts),  the  alignment  to  the  NLF,  and  no  longer 
needing  any  transposition.  National authorities  will also  benefit  from  clarifications in  the  MD 
and  avoiding  transposition  costs.  Benefits  for  users  and  consumers  derive  from  fewer  unsafe 
products. The  total  costs and  benefits  for  PO2  are  summarised  at the end  of  Chapter  6,  in  the 
table ‘Comparison of impacts on stakeholder groups (costs/benefits)’. 

6.4. 

Policy Option 3 (PO3) – Burden minimisation and improved safety 

  PO3  –  SO1:  This  policy  option  addresses  new  risks  related  to  emerging  digital 
technologies  by  adapting  the  current  act,  including  the  requirements  with  which 
manufacturers need to comply to place machinery on the market under the MD. In 
addition to the changes mentioned in PO2, it adapts the safety requirements in the 
legal  text  on:  (i)  standalone  software  with  a  safety  function;  (ii)  human-robot 
interaction;  (iii)  ML  test  procedures  and  equipment;  (iv)  lack  of  connection  or 
faulty connection; (v) cyber safety and external hazards; (vi) software updates; (vii) 
automated machines; and (viii) risk assessment. This adaptation to the current act 
would be complemented with the usual standardisation process. 

The  machinery  sector  is  developing  rapidly,  and  potential  risks  to  users  might  arise  from 
machinery with new technology applications. For these reasons, Policy Option 3 – in addition to 
the  changes  mentioned  in  Policy  Option  2  –  also  considers  also  some  adaptation  to  existing 
requirements to address these concerns.  

77 An instance refers to one product being placed in the market by one manufacturer. The number of instances requiring clarifications could not 

be quantified. 

50 

 
 
 
                                                           
The approach proposed in Policy Option 3 is coherent with the views of Member State authorities 
and other stakeholders active in implementation of the MD. The approach is also coherent with 
the  on-going  reflections  at  Commission  level,  which  see  advantages  in  combining  horizontal 
legislation  on  crosscutting  policy  areas  with  more  specific  requirements  that  only  sectoral 
legislation  can  accurately  lay  down  for  a  given  specific  sector.  As  outlined  in Chapter  1.4,  the 
Commission Report on the safety and liability implications of Artificial Intelligence, the Internet 
of Things and robotics78 reached two conclusions. The first conclusion was that the emergence 
of new digital technologies like AI, the IoT and robotics raises new challenges in terms of 
product safety and liability such as: (i) connectivity; (ii) autonomy; (iii) data dependency; 
(iv)  opacity;  (v)  the  complexity  of  products  and  systems;  (vi)  software  updates;  and  (vii) 
more  complex  safety  management  and  value  chains.  The  report’s  second  conclusion  was  that 
current product-safety legislation – including the MD – contains a number of gaps that need to 
be  addressed.  Addressing  the  concerns  in  the  report,  the  changes  planned  for  the  MD  will  be 
coherent and will not affect the horizontal requirements to be laid down in a future AI regulation. 
This  will  help  to  avoid  duplication  and  make  the  most  of  the  advantages  offered  by  the 
combination of horizontal and sectoral instruments. 

The machinery sector is an important part of the engineering industry. It covers a broad range of 
products of different complexities. To ensure health and safety, and in particular the health and 
safety  of  workers  and  consumers  (and  where  appropriate  the  health  and  safety  of  domestic 
animals and the safety of goods), machinery manufacturers must address the specific risks arising 
from  the  use  of their  machinery.  For this  purpose,  the  MD  lays  down the  essential  health-and-
safety requirements of general application, e.g. lighting, ergonomics, operating positions, control 
systems,  mechanical  risks,  hazardous  substances,  maintenance,  and  information.  The  MD  also 
lays  down  a  number  of  more  specific  requirements  for  certain  categories  of  machinery  e.g. 
foodstuff machinery, mobility machinery, and lifting machinery.  

On  AI,  the  future  AI  regulation  will  include  safety  requirements  for  high-risk  applications.  To 
assess  the  application  of  the  AI  regulation  to  products  covered  by  the  MD,  it  is  important  to 
consider  the  fact  that  machinery  manufacturers  must  perform  a  risk  assessment  to  ensure  the 
safety  of  the  machinery  as  a  whole,  including  all  parts  of  the  machinery.  This  means  that 
although  AI  developers  will  have  to  comply  with  the  AI  safety  requirements,  machinery 
manufacturers will have to assess the impact of AI systems on the safety of the whole machinery 
before it is placed on the market. Furthermore, the MD is ‘technology neutral’, which means that 
the risks stemming from emerging technologies must not be focused on one technology such as 
AI.  Finally,  the  AI  regulation  will  impose  requirements  only  for  high-risk  applications. 
Considering the above criteria, the revised MD will refer to the AI regulation requirements: (i) 
when  AI  systems/components  ensure  safety  functions;  and  (ii)  for  machinery  containing  AI 
systems with safety functions that are high-risk applications. 

The impact assessment of the future AI regulation proposes the following approach79. 

Regarding  high-risk  AI  systems  which  are  safety  components  of  machinery,  the  regulatory 
framework will integrate the enforcement of the new requirements into the revised MD so as to 
minimise  additional  burdens.  This  integration  will  take  place  following  an  appropriate 
transitional  period  before  the  new  AI  requirements  become  binding  for  operators  under  the 
revised MD. […] In particular: 

  Regarding  high-risk  AI  systems  covered  by  the  revised  MD,  existing  NLF  conformity 
assessment  systems  under  the  revised  MD  would  be  applicable  for  checking  the 
compliance of the AI system with the new requirements. The application of the horizontal 

78 Available at: https://ec.europa.eu/info/publications/commission-report-safety-and-liability-implications-ai-internet-things-and-robotics-0_en. 
79 Extract of impact assessment report on the AI regulation at the moment of finalisation of this impact assessment report on the revision of the 
MD. Where the original text mentions ‘relevant NLF product legislation’, this has been replaced by ‘revised MD’ to improve readability. 

51 

 
                                                           
framework  would  not  affect  the  logic,  methodology  or  general  structure  of  conformity 
assessment  under  the  revised  MD.  [...]  Obligations  of  economic  operators  and  ex-post 
enforcement provisions (as described later in this text) of the horizontal framework will 
also apply to the extent they are not already covered under the revised MD. 

To  further  clarify  the  interplay  between  the  requirements  of  the  revised  MD  and  the  AI 
regulation,  the  three  paragraphs  below  discuss  hypothetical  cases  where  the  two  pieces  of 
legislation could interact. 

  When  a  standalone  AI  system  fulfils  a  machinery-safety  function,  this  standalone  AI 
system  is  considered  high-risk  by  both  the  revised  MD  and  the  AI  regulation,  and 
becomes a safety component under Annex V of the revised MD. The standalone AI must 
comply  with  the  specific  requirements  of  the  AI  regulation,  and  with  any  additional 
requirements under the MD necessary to ensure the standalone AI’s proper integration in 
the machine for safe operation. The conformity assessment of the standalone AI system 
must be done under the revised MD.  

  When an AI system embedded in the machinery fulfils a safety function, the machinery 
is considered high-risk by both the revised MD and the AI regulation, and belongs to the 
high-risk categories under Annex IV of the revised MD. The embedded AI system must 
comply  with  the  specific  requirements  of  the  AI  regulation,  and  the  machinery  must 
comply with any additional requirements under the revised MD necessary to ensure the 
AI  system’s  proper  integration  in  the  machine  for  safe  operation.  The  conformity 
assessment of the machinery containing the embedded AI system must be done under the 
revised MD.  

  When  a  standalone  piece  of  non-AI  software  fulfils  a  machinery-safety  function,  this 
standalone  non-AI  software  does  not  fall  under  the  scope  of  the  AI  regulation.  The 
standalone non-AI software becomes a safety component under Annex V of the revised 
MD. In this case, only the revised MD applies. 

Hence, Policy Option 3 best addresses the relationship with a future AI regulation, maximising 
legal clarity for manufacturers.  

The following two paragraphs discuss the interplay between a revised MD and other directives. 

General  Product  Safety  Directive:  On  software  with  a  safety  function,  the  revision  of  the 
General  Product  Safety  Directive  intends  to  include  software  with  a  safety  function  under  its 
scope. However, as explained in Section 1.2, the General Product Safety Directive does not apply 
when  there  are  more  specific  provisions  in  harmonised,  sectoral,  product-safety  legislation.  As 
the MD will also cover software with a safety function addressing the specificities of the product, 
the safety requirements of the General Product Safety Directive will not apply.  

Radio  Equipment  Directive:  On  cybersecurity  requirements  to  secure  connected  products, 
delegated acts are being prepared under the RED to address data protection and privacy in some 
connected devices with Wi-Fi functions. These requirements will apply for machinery connected 
with  Wi-Fi  functions.  For  safety  aspects,  the  revised  MD  will  explicitly  refer,  in  its  essential 
health-and-safety requirements, to hazards caused by cyber attacks. This is to ensure the safety 
and  reliability  of  machinery-control  systems.  The  safety  and  reliability  of  machinery-control 
systems is discussed in more detail in this chapter, in the section on cyber safety. 

Cybersecurity Act: In view of addressing the risks stemming from malicious third party actions 
that  have  an  impact  on  the  safety  of  machinery  products,  this  policy  option  would  include 

52 

 
essential health and safety requirements for which a presumption of conformity may be given to 
the  appropriate  extent  by  a  certificate  or  statement  of  conformity  issued  under  a  relevant 
cybersecurity scheme adopted in accordance with Regulation (EU) 2019/88180.   

 

In this policy option, software with a safety function that is placed independently on 
the market would be added to the list of safety components in Annex V.  

Most stakeholders (56.8%) that participated in the public consultation agreed that software that 
ensures a safety function and is placed independently on the market should be explicitly covered 
by  the  MD  and  thus  considered  a  safety  component.  Companies  and  business  associations 
responding to the public consultation were mostly in favour of software to be considered a safety 
component.  Considering  software  as  a  safety  component  would  entail  additional  compliance 
costs for software companies specialising in safety, although this would be compensated by the 
increase in competitiveness that would come from being CE-marked under the MD. Because the 
AI software is used for wider purposes than just machinery, and software is transferable between 
domains,  stakeholders  consulted  did  not  consider  that  these  changes  would:  (i)  result  in 
consolidation of the software market; (ii) limit market access for smaller manufacturers; or (iii) 
lead the safety-software market to be absorbed by bigger manufacturers in AI.  

Three case studies were carefully selected and conducted to provide practical, issue-based, and 
detailed  insights  on  the  implications  and  the  developments  related  to  emerging  technologies  in 
the machinery sector and the MD. Full details of these case studies can be found in the Impact 
assessment study on the revision of Directive 2006/42/EC on machinery81. A summary of these 
case studies is provided in Annex 7 of this report. In particular, the second case study confirmed 
the need for the addition of the above requirement on standalone software with a safety function. 

  On human-robot collaboration, this option would adapt the requirements of Annex I in 
the section on risks related to moving parts. These adapted requirements would specify 
that preventing the risk of contact leading to hazardous situations must also be adapted to 
human-robot coexistence in shared spaces without direct collaboration and human-robot 
interaction  (simultaneous  or  alternating  work  on  a  piece).  Humans  should  always  have 
control of the machinery. The detailed technical solutions to comply with this additional 
provision would be left to the standardisation process. 

On  the  question  of  whether  the  existing  requirements  should  be  adapted  or  new  requirements 
should  be  added  to  account  for  humans  and  robots  in  shared  spaces,  responses  in  the 
consultations were diverse between stakeholder groups.  

Most manufacturers believed that the MD’s existing requirements in combination with existing 
standards82 already sufficiently cover robotic applications. The MD’s current text states that the 
movable  parts  of  machinery  must  be  designed  and  constructed  in  such  a  way  as  to  avoid  any 
contact risks which may cause an accident. And the existing standards already lay down a range 
of  security  controls  and  measures  (such  as  maximum  permitted  speeds,  minimum  separation 
levels, and the minimisation of sharp edges and projections) that reflect the state-of-the-art and 
the  requirements  of  the  MD.  However,  some  manufacturers  found  that  the  MD’s  focus  on 
blocking/stopping the machine as the main means of hazard prevention was insufficient. For co-
bots, the objective is precisely to let humans and robot work together in a potentially dangerous 
environment.  Technology  can  provide  solutions  here  if  the  rules  of  the  game  are  clear,  so  the 
requirements should be made clearer. 

80 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for 
Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 
(Cybersecurity Act) (Text with EEA relevance), OJ L 151, 7.6.2019, pp. 15-69. 

81 Impact assessment study on the revision of Directive 2006/42/EC on machinery. Available at: https://data.europa.eu/doi/10.2873/423938. 
82 E.g. ISO 10218 and ISO/TS 15066. 

53 

 
                                                           
Indeed,  given  co-bots’  higher  degree  of  agility  and  improved  interactions  with  humans,  both 
market-surveillance  authorities  and  notified  bodies  found  there  is  a  lack  of  coverage  of  the 
protection  objectives  in  the  standards.  For  example,  these  standards  do  not  refer  to  protection 
objectives in terms of force, speed, energy and interaction with people. The market-surveillance 
authorities  and  notified  bodies  believed  that  a  clarification  in  the  requirements  was  necessary. 
Generally, the groups in favour of adapting or adding new requirements were national authorities, 
consumer organisations, notified bodies, professional workers (including trade associations) and 
private  users.  Market-surveillance  authorities  found  that,  given  the  major  developments  in  the 
field  of  robotics,  the  EU  must  make  the  necessary  adjustments.  For  co-bots,  revised  safety 
requirement would trigger the revision/creation of standards which take into account the higher 
degree of agility in human/co-bot interactions mentioned above. 

Among  the  case  studies  conducted  and  summarised  in  Annex  7  of  this  report,  the  third  case 
study looked at the need to revise or add new requirements on human-robot collaboration. 

  On  connectivity  and  cyber  safety,  this  option  would  adapt  requirements  in  Annex  I 
‘1.2.1. Safety and reliability of control systems’ to specify that the ‘external influences’ 
include cyber threats, and that, for cable-less control, a failure of the connection or a 
faulty connection must not lead to a hazardous situation. It will also add requirements in 
Annex I section 1.1.9 on protection against corruption. Machinery certified under the 
Cybersecurity Act will be presumed to be in conformity with the revised MD in so far 
as those requirements are covered by the cybersecurity certificate. 

Connected machinery should be robust (the machinery should be able to withstand an attack) and 
resilient  (capacity  of  the  machinery  to  best  react  to  an  attack,  preventing  that  the  attack 
jeopardises the safety of the machinery). This means that when a machine receives signals from 
the outside world, it should be able to recognise and detect the authenticity of the input, and react 
to the input in a safe way. For example, air conditioning equipment should not be able to freeze 
an environment following a mischievous input.  

Stakeholders were consulted to obtain information on the issue of cybersecurity and the MD. All 
stakeholder  groups  recognised  a  growing  risk  of  malicious  interference  or  hacking.  On  the 
question of  whether the risk  of  cyber  threats  was  sufficiently  covered in the  current  MD,  most 
consultation  respondents  indicated  that  it  was  not.  A  workshop  on  this  issue  was  run  by  the 
German  Commission  for  Occupational  Health  and  Safety  and  Standardisation  (KAN).  The 
workshop concluded, after extensive discussions, that the MD covers cyber attacks (see Annex I, 
1.2.1 ‘external influences’, ‘fault’). However, the fact that it took a long debate among experts 
with  different  views  to  reach  this  conclusion  proves  that  the  MD  lacks  clarity.  Since  this  is  a 
clarification  of  an  already  existing  understanding  of  what  is  covered  by  the  provision,  no 
significant impacts are expected for manufacturers or market-surveillance authorities. However, 
clarification will ensure a level playing field in the market, for the benefit of manufacturers. 

  On  ML  capabilities  and  software  updates  potentially  altering  the  safety  of  the 
machine  after  it  is  placed  on  the  market/put  into  service,  Policy  Option  3  would 
clarify that for the machine to be allowed on the market, it must be technically feasible to 
foresee in the initial risk assessment all potential risks arising during the whole life cycle 
of the machine. 

This  means  the  manufacturer  must  be  able  to  appropriately  anticipate  or  somehow  limit  the 
potential consequences derived from ML capabilities during the machine’s whole life cycle. The 
manufacturer  must  also  be  able  to  do  this  for  those  machines  that  may  change  because  of  ML 
capabilities so they could place the machine on the market under the revised MD. Although this 
could be seen as hampering innovation, in reality it would guide innovation in the right direction 
so it is not detrimental to safety. Indeed, ML software can be safely tested in the research phases. 
There  is  also  typically  a  learning  phase,  which  should  be  done  under  the  supervision  of  the 

54 

 
manufacturer whenever the ML affects the safety of the machinery. The MD applies only for the 
placing  on  the  market  of  the  machinery  (hence  after  the  research  and  testing  phase  has  been 
completed),  and  at  that  moment  the  manufacturer  must  have taken  all  necessary  precautions  to 
ensure that the machine will not subsequently develop in a way that could harm users. 

Similarly, a software update that may alter the behaviour of the machinery in a way that affects 
the  compliance of the  machinery  would  require  a  new  conformity  assessment. In  this  instance, 
the concept of substantial modification would come into play. However, standard updates that do 
not change the behaviour of the machinery would not require a new conformity assessment. 

This  clarification  should  not  bring  additional  cost  to  manufacturers.  However,  it  would  bring 
benefits for users in the form of there being less non-compliant machinery on the market. 

Among the case studies conducted and summarised in Annex 7 of this report, the first case study 
discusses the need for the addition of the above requirement on software updates to be included 
in the initial risk assessment for machinery with ML capabilities. 

  On autonomous machines and remote supervisory stations, this option would amend the 

definition of ‘driver’ to consider the possibility of ‘no driver’. 

The proposed addition  of  a  ‘no  driver’  possibility  will  make  it  easier  for  new  autonomous  and 
remotely  controlled  machines  to  be put on  the  market in  a compliant  way.  This  clarification  is 
therefore an enabler, but it does not add any specific costs to manufacturers. Technical solutions 
would  be  detailed  in  the  relevant  standards.  As  a  result,  some  standards  might  need  to  be 
developed or revised  following  this  change,  or  manufacturers  might  need  to  develop  their  own 
technical  solutions  and  prove  they  are  safe.  A  French  manufacturer  of  autonomous  robots  for 
agricultural  applications  stated  that  their  company  was  unable  to  place  their  product  on  the 
market, because they did not know how to make it compliant. This was because there were no 
dedicated requirements and standards for autonomous robots. As a result, the manufacturer was 
limiting themselves to supplying only a few prototype units. 

The potential costs and benefits of covering new risks related to emerging digital technologies by 
adapting  the  safety  requirements  depend  on  the  level  of  changes  adopted.  According  to  the 
experts  consulted,  the  greater  the  changes,  the  higher  the  costs  for  industry  in:  design  and 
manufacturing  of  the  machinery;  training  for  technical  files;  documentation;  etc.  However, 
because the MD is ‘technology neutral’, the changes to the requirements would mainly consist of: 
(i) adaptations to add legal clarity in certain areas; and (ii) certain targeted additions. In addition, 
documentation costs could be mitigated by: (i) keeping the numbering of the safety requirements 
in  Annex  I  as  close  to  the  current  version  as  possible;  and  (ii)  providing  a  transposition  table 
between  the  numbering  of the revised  requirement  and  the original, as  was  provided for  in the 
last revision of the MD.  

Most of the changes will only add legal clarity. A change in the wording for better legal clarity 
would impose some adaptation costs on manufacturers, although the experts expected these costs 
to be low. For these changes that add legal clarity, diligent manufacturers who perform complete 
risk  assessments  will  not  need  to  incur  additional  costs,  other  than  the  costs  of  familiarising 
themselves with a new legal text. Besides, ensuring legal certainty for emerging technologies in 
the  MD  will  be  more  important  due  to  the  expected  increase  in  use  of  those  emerging 
technologies  in  the  machinery  sector,  and  the  corresponding  improvement  in  industry 
competitiveness. In addition, authorities will benefit from greater legal clarity when performing 
their  market-surveillance  activities,  and  users  will  benefit  from  greater  safety  in  the  market.  It 

55 

 
would also result in some costs for revising related standards borne by CEN/Cenelec to ensure 
that the list of harmonised standards is up to date and fits the revised requirements83. 

There  would  also  be  a  few  targeted  new  safety  requirements.  For  those,  certain  design, 
manufacturing  and  documentation  costs  will  be  incurred  by  manufacturers.  In  such  cases  the 
standard  revision  work  borne  by  CEN/Cenelec  will  be  more  important,  but  only  limited  to  the 
standards  related  to  the  affected  machinery.  The  effects  on  (i)  an  improvement  in  industry 
competitiveness  for  manufacturers  of  such  types  of  machinery  and  (ii)  a  greater  safety  in  the 
market for users will also apply. 

The new requirements and clarifications in the existing safety requirements set out in this policy 
option would be complemented by the usual standardisation process. Some harmonised standards 
exist today to cover some of these areas84, but others must be developed. The Commission would 
issue  a  standardisation  request  to  the  ESOs  (CEN/Cenelec  in  this  case)  to  formally  require  the 
revision  and  drafting  of  any  necessary  new  harmonised  standards. These  harmonised standards 
would detail the state-of-the-art technical solutions that ensure compliance with the MD. Priority 
should  be  given  to  carrying  out  this  work  at  international  level  (ISO/IEC)  to  support  the 
competitiveness of the EU industry. 

There  may  be  exceptional  cases  where:  (i)  no  harmonised  standards  exist;  and  (ii)  the 
Commission  has  asked  one  or  more  ESOs to  draft a  harmonised  standard.  In  these exceptional 
cases,  if  there  are  undue  delays  in  the  standardisation  procedure  or  if  the  request  has  not  been 
accepted  by  any  ESOs,  the  revised  MD  would  empower  the  Commission  to  adopt 
implementing  acts  laying  down  technical  specifications  that  meet  the  safety  requirements  of 
this regulation. However, this would only be a fall-back option. 

 [+/-]  The  costs  and  benefits  of  PO3  meeting  specific  objective  1  are  linked  to  standalone 
software with a safety function being added to the list of safety components. They are also linked 
to  adaptation  costs  for:  (i)  revising  the  text  on  human-robot  interaction;  (ii)  revised  ML  test 
procedures  and  equipment;  (iii)  addressing  a  lack  of  connection  or  a  faulty  connection;  (iv) 
addressing cyber safety and external hazards; (v) software updates; (vi) addressing the issue of 
automated  machines;  and  (vi)  risk  assessment.  The  table  below  shows  the  potential  costs  and 
benefits for stakeholders. 

Potential cost and benefits of Policy Option 3 meeting specific objective 1 

Stakeholders’ 
description 

Companies 

Net effect (+) 
NV not quantifiable 

Large 
companies 

SMEs 

All 

Administratio
ns 

Market-
surveillance 
authorities 

Other organisations 

Citizens/users 

Notified 
bodies 

ESOsg) 

People 
employed in 
machinery 
sector 

Users / 
consumers 

1. Number of 
affected 
stakeholders (EU-27) 

2.1 Costs 
(total) 

One-off 

1 703 

81 024 

82 239a) 

71 or more 

137 or 
more 

1 

2 759 439 

446 000 000b) 

One-off compliance costs and costs for 
adaptation to changes are likely  

- 

- 

Review of 
up to 800 

- 

Not 
quantifiable, 

83  Harmonised standards have  an  annex where it is  explained  what  requirements  of  the directive they  fulfil.  If  the  text  of  a  requirement  is 
redrafted to increase clarity, but the numbering and the scope/content stay the same, the related standard(s) do not need to be revised. If the 
text  of  a  requirement  is  redrafted  to  impose  a  new  obligation,  harmonised  standards  that  provide  presumption  of  conformity  to  that 
requirement  need  to  be  potentially  revised,  but  only  those.  Finally,  if  a  new  requirement  is  added,  existing  harmonised  standards  for 
machinery which is affected by the new requirement will need to be revised, but only those. 

84 EN ISO 10218-1:2011 Robots and robotic devices — Safety requirements for industrial robots — Part 1: Robots (ISO 10218-1:2011); EN 
ISO 10218-2:2011 Robots and robotic devices — Safety requirements for industrial robots — Part 2: Robot systems and integration (ISO 
10218-2:2011);  EN  ISO  13482:2014  Robots  and  robotic devices  —  Safety  requirements  for  personal  care  robots  (ISO  13482:2014);  EN 
50636-2-107:2015 Safety of household and similar appliances — Part 2-107: Particular requirements for robotic battery-powered electrical 
lawnmowers (IEC 60335-2-107:2012 Modified) EN 50636-2-107:2015/A1:2018; EN ISO 18497:2018 Agricultural machinery and tractors - 
Safety of highly automated agricultural machines - Principles for design (ISO 18497:2018). 

56 

 
                                                           
Users / 
consumers 

costs of 
changes 
could be 
pushed down 
the value 
chain 

- 

- 

- 

- 

Stakeholders’ 
description 

Companies 

Net effect (+) 
NV not quantifiable 

Large 
companies 

SMEs 

All 

Administratio
ns 

Market-
surveillance 
authorities 

Other organisations 

Citizens/users 

Notified 
bodies 

ESOsg) 

People 
employed in 
machinery 
sector 

(these include changes to: human-robot 
interaction; lack of connections or faulty 
connections; cyber safety and external 
hazards; software updates; automated 
machines; and risk assessment)c) (not 
quantifiable)  

Recurrent 
(annually) 

- 

One-off compliance costs and costs for 
adaptation to changes are likely (these 
include changes to: human-robot 
interaction; lack of connections or faulty 
connections; cyber safety and external 
hazards; software updates; automated 
machines; and risk assessment) (not 
quantifiable) 

- 

- 

One-off 

2.2 Costs 
per 
organisati
on 

Recurrent 
(annually) 

Direct 

Indirectf) 

3. 
Benefits 

- 

- 

- 

- 

standards; 
no further 
quantificati
on of 
efforts was 
possible c) 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

- 

Increased competitiveness in and outside 
the EU; 
level playing field 

Greater 
safety 

Less non-compliant machinery 
on the market; 
greater safety 

a) Due to rounding differences in the Eurostat data, the total number of enterprises shown does not equal the sum of enterprises recorded per 
size class. 
b) Proxy used: Number of inhabitants in the EU. 
c) Likely more time needed for larger revisions of the essential health-and-safety requirements. The revisions would entail an evaluation of 
the  existing  portfolio  of  harmonised  standards  and  their  applicability.  Revised  essential  health-and-safety  requirements  could  require 
adaptations.  
d) Estimates based on European Commission (2014), Study on evaluation of the internal market legislation for industrial products, indicating 
up to 10 FTEs for notified bodies to assess products’ conformity if all 137 notified bodies in the NANDO database used 10 FTEs. 
e) Based on up to 1% of turnover for compliance costs for additional products covered by the Directive. 
f)  Some  benefits  might  materialise  quicker  than  others.  For  instance,  benefits  from  legal  clarity  and  digital  documentation  are  likely  to 
materialise quicker than benefits from changes in the requirements. Due to the differences in products covered in the MD and the proposed 
changes, the life cycles of machinery could not be taken as a proxy to estimate the potential timeline for benefits. 
g) European standardisation organisations.  
There are instances where data are quantified based on responses to consultations or interviews. When the number of replies is too low to 
present an estimate, cost cannot be reliably quantified. Proxy values are used when direct information is not available. 

  PO3  –  SO2:  This  policy  option  would  adapt  (i)  the  current  act  in  scope  and 
definitions  such  as  the  borderlines  with  LVD-RED,  the  exclusion  of  means  of 
transport,  the  PCM,  the  substantial  modification,  and  the  installation  of  lifting 
appliances,  and  (ii)  safety  requirements  on  areas  not  related  to  emerging 
technologies,  such  as  requirements  for  slow-speed  lifts,  for  ride-on  machinery  on 
seating  and  avoidance  of  overhead  power  lines,  for  machinery  dealing  with 
hazardous  substances,  and  hand-held  machinery  producing  vibrations  potentially 
harmful for workers. This would be complemented by any necessary clarifications 
in the Guide. 

In addition to the changes mentioned in PO2, PO3 would include the following change to safety 
requirements not related to new digital technologies. 

  This  option  would  add  to  ‘1.1.2.  Principles  of  safety  integration’  an  obligation  for 
manufacturers to provide test procedures and specific test equipment, only when they 
are  essential  to  enable  the  machinery  to  be  adjusted,  maintained  and  used  safely.  This 
does not include ordinary test equipment. 

57 

 
 
Although  providing  test  procedures  and  specific  test  equipment  may  initially  seem  like  an 
additional  burden  for  manufacturers,  it is  not  particularly  burdensome.  This  is because  diligent 
manufacturers already provide this equipment when it is necessary to adjust, maintain, and safely 
use  machinery.  Additional  costs  for  those  diligent  manufacturers  are  therefore  negligible. 
Manufacturers who do not already provide specific test procedures and equipment will have to 
bear  a  cost.  This  will  improve  the  level  playing  field.  However,  some  adaptation  costs  or 
additional training may be necessary for market-surveillance authorities. 

  On  lifting  appliances,  a  clarification  would  be  made  for  only  those  lifting  appliances 
intended  to  be  permanently installed.  For these appliances,  it  would  be  clarified that 
the appropriate measures for correct installation must be taken at the place of use by the 
manufacturer or on his behalf, so that the manufacturer is responsible for the installation 
in all cases.  

To estimate the potential number of affected companies, NACE C33.2 ‘installation of industrial 
machinery  and  equipment’  was  used.  In  2018  in  the  EU-27,  around  40 000  companies  were 
registered,  although  this  number  includes  not  only  lifting  appliances,  but  also  other  industrial 
machinery  and  equipment  that  must  be  installed.  No  further  quantification  of  the  impact  was 
possible. 

  On slow-speed lifts, the obligation for hold-to-run control devices for carriers that are 
not  completely  enclosed  would  be  rephrased  to  make  it  technologically  neutral  and 
allow other innovative solutions. Given the trends in the area of slow-speed lifts and the 
expected  growth  in  their  use,  including  among  private  users,  it  is  essential  to  allow 
innovative  solutions  to  enable  products  to  be  more  efficient,  safe  and  accessible  to 
consumers.  It  is  therefore  crucial  that  the  MD  does  not  hinder  such  innovation  and 
remains  ‘technology  neutral’  while  ensuring  safety.  This  change  would  not  generate 
additional costs for manufacturers, since they could still use the current prescribed hold-
to-run  solution.  However, it  would  be  possible  to  innovate  and  propose other solutions 
with at least the same level of safety. 

EU statistics on the manufacture of lifting and handling equipment85 () provide information on the 
volume  and  value  of lifting  machinery  sold  in  Europe.  In  2018,  13  million  of  these  units  were 
sold at EU level. This accounted for about EUR 51 billion in revenues. However, not all these 
pieces  of  lifting  and  handling  equipment  fall  under  the  MD.  Based  on  Article  24  of  the  MD, 
slow-speed lifts are only included in the MD when the maximum speed does not exceed 0.15 m/s, 
otherwise the lifts fall under the scope of the Lifts Directive. 

Based  on  PRODCOM  data  from  2014,  the  number  of  companies  active  in  the  lift  market  was 
equal  to  0.1%  of  all  manufacturing-sector  companies  in  the  EU-28.  The  estimated  number  of 
existing  lifts  in  2014  in  the  EEA  was 5.4  million.  In  terms  of  market  development,  the overall 
turnover from the sales of new lifts and components was about EUR 5 billion in Europe in 2014, 
3% lower than in 2013. However, it is likely that not all those enterprises have slow-speed lifts in 
their product portfolio. It was not possible to assess the detailed market structure for slow-speed 
lifts. However in 2005, the EU stair-lift industry was estimated to sell about 100 000 units every 
year (62 000 straight lifts and 38 000 curved lifts) and be worth EUR 188 million in annual sales. 

  To  better  protect  machinery  drivers,  requirements  for  restraint  systems  would  be 
clarified  for  ride-on  mobile  machinery.  These  clarified  requirements  would  focus  on 
cases where there was a risk that operators or other persons transported by the machinery 
might be crushed between parts of the machinery and the ground if the machinery rolled 
or  tipped  over.  The  clarified  requirements  would  specify  that  for  such  cases:  (i) 
machinery  must  be  designed  or  equipped  with  a  restraint  system  so  as  to  keep  the 

85 Eurostat PRODCOM code 28.22 

58 

 
                                                           
persons in their seats and/or in the protective structure86; (ii) if such a system is not 
active, some kind of warning to the driver should be activated (visual, audible or other). 

According to national authorities, notified bodies, and workers’ representatives, machines should 
be  constructed in  such  a  way  as  to  prevent the  worker  from  becoming  unattached.  The  current 
regulation prescribes the need for a restraint system attached directly to the driver’s seat, and this 
restraint system is sometimes by-passed by users. Such a requirement may also limit innovation, 
as  there  are  other  technological  solutions  on  the  market,  such  as  restraint  systems  that  keep 
operators within the framework of the protective structure, e.g. doors or door-bar systems. 

Some  manufacturers  mentioned that,  depending  on  the  type of  mobile  machinery,  product-type 
specific harmonised standards are a very good tool for adding this or similar requirements, when 
these  features  become  common  for  this  type/these  types  of  machinery.  Indeed,  the  proposed 
revised requirement on restraint systems for ride-on machinery would leave the ESOs to draw up 
the  detailed  technical  solutions  to  comply  with  it.  This  would  ensure  that  innovation  could 
continue. Additional costs for this option are predicted only for manufacturers of ride-on mobile 
machinery, while the benefit would be an increase in safety for users. 

  A  requirement  would  be  added  in  Annex  I  to  reduce  the  risk  of  mobile  machinery 

contacting overhead power lines.  

According to the national authorities interviewed, the risk of contact with overhead power lines 
should  be  addressed  in  the  MD’s  requirements.  If  a  manufacturer  sells  a  product  across  all 
Member States, differences between Member States – such as the height of power lines – must be 
taken into account during the design stage. This requirement would apply mainly to agricultural 
mobile machinery, but also to: (i) machines used in construction such as excavators or diggers; or 
(ii)  other  machinery  such  as  self-propelled  cranes  or  grabs.  The  main  sector  impacted  by  this 
change would be the agricultural machinery sector, in particular manufacturers of high machines. 
According to CEMA, the association representing the European agricultural machinery industry, 
the  sector  comprises  about  7 000  manufacturers,  producing  more  than  450  different  types  of 
machines (covering any activity in the field from seeding to harvesting) with an annual turnover 
of  about  EUR 40  billion  (figures  for  the  EU-28  for  2016)  and  150 000  direct  employees87.  No 
further impact quantification was possible. 

  A requirement would be added in Annex I to tackle chemical risks in: 1.7.4.2 ‘Contents 
of the instructions’; 2.2.1 ‘Portable handheld and/or hand-guided machinery’; and 3.5.3 
‘Emissions of hazardous substances’.  

Stakeholders  were  asked  whether  the  MD  should  address  the  protection  of  workers  against 
exposure to hazardous substances starting in the initial design phase (through principles of safety 
integration). The stakeholders made the distinction between: (i) levels of exposure to hazardous 
substances, handled by Directive 89/391/EEC88 and by means of personal protective equipment 
and other actions, and mainly the employer’s responsibility; and (ii) the emissions of hazardous 
substances that can be addressed by the design of the machinery. If hazardous substances are a 
result of the intended use of the machinery (for example, where fine dust or metal micro parts are 
generated, both of which are considered very harmful for lungs), this is already a mandatory part 
of  the  risk  analysis  performed  by  the  manufacturer.  However,  the  revised  MD  would  make 
clearer that, for those kind of machines, emissions should be assessed during risk assessment and 
should be mitigated by design.  

86 A protective structure can be a cabin or any other structure from which the driver should not be expelled in order to safeguard his/her own 

safety. 

87 https://www.cema-agri.org 
88  Council  Directive  89/391/EEC  of  12  June  1989  on  the  introduction  of  measures  to  encourage  improvements  in  the  safety  and  health  of 

workers at work, OJ L 183, 29.6.1989, pp. 1-8. 

59 

 
                                                           
  A  requirement  for  portable  handheld  and  hand-guided  machinery  would  be  added  in 
Annex  I  2.2.1.1  ‘Portable  fixing  and  other  impact  machinery  –  General  principles,  for 
better measuring and declaring vibration peaks values’. 

The  MD  currently  requires  that  manufacturers  declare  the  vibration  values  in  the  instruction 
manuals of portable handheld and hand-guided machinery only when certain vibration limits are 
exceeded. Sweden, supported by other national authorities, proposes: (i) to remove those limits, 
so that that manufacturers declare the vibration values in all cases; and (ii) to add a requirement 
for  manufacturers  to  declare  in  the  instructions  the  machinery’s  peak  vibration  values,  since 
repeatedly high peak values can be very harmful. A cost and benefit analysis was provided in the 
Swedish proposal89 to the Machinery Working Group. The analysis estimated that, for declaring 
the mean peak value from repeated shock vibrations, manufacturers of handheld machines could 
expect  a  moderate  increase  in  initial  costs  due  to  new  measurement  methods  (e.g.  new 
instrumentation  and  a  slightly  expanded  test  report).  And  for  removing  the  limit  for  total 
continuous vibrations, there are no expected increased costs. Manufacturers today must already 
perform  measurements  to  establish  whether  their  machines  exceed  limits  for  total  continuous 
vibrations  or  not.  Therefore  the  costs  or  time  needed  for  these  more  comprehensive 
measurements should not significantly increase the total cost for vibration measurements. Costs 
for users include the need for new handheld tools with better vibration dampening and a reduced 
vibration level. However, handheld tools have a limited lifetime and typically need to be replaced 
regularly. The benefits include reduced social costs for sick leave, fewer occupational injuries, 
fewer  medical  examinations,  and  less  early  retirement.  These  benefits  would  all  be  due  to 
reduced vibration peaks in handheld machines, and have an estimated value of EUR 15 million 
yearly90. Low-vibration handheld and hand-guided machinery has a longer life span, and the tool 
accessories  also  last  longer.  This  reduces  costs  and  waste.  Since  vibration  injuries  are  also  a 
problem for countries outside the EU, the improved ability for employers and users to pinpoint 
dangerous vibrations with more reliable data will lead to an increased demand for handheld tools 
with  lower  vibration  values.  This  will  improve  the  competitiveness  of  EU  manufacturers  of 
handheld machinery, both within and outside the EU. 

 [+/-]  The  costs  and  benefits  of  PO3  meeting  specific  objective  2  (in  addition  to  the  RED 
clarification in the exceptions in Article 1(2)(k) and the clarifications on the definition of PCM 
presented in PO2) include: (i) compliance and adaptation costs for manufacturers (although 
these  are  not  quantifiable);  and (ii)  the  net  benefits for  users derived  from  the  declaration of 
vibration peak values. Machinery users will benefit from greater safety. 

  PO3  –  SO3:  On  Annex  IV,  this  policy  option  would  review  the  list  of  high-risk 
machines  in  Annex  IV  to  include  ‘AI  systems  with  a  safety  function’  and/or 
machinery embedding them.  It would  also  impose  in  Article  12  a requirement for 
manufacturers  to  systematically  involve  a  third  party  to  assess  the  conformity  of 
Annex IV machines.  

Certain types of machinery (listed in Annex IV to the MD) are considered to present higher risks, 
and  therefore  must  be  subject to  more  stringent  conformity-assessment  procedures, involving  a 
third party. Annex IV products currently include machines such as: (i) woodworking machinery; 
(ii)  chainsaws;  (iii)  presses  for  the  working  of  cold  metal;  (iv)  manually  loaded  and  unloaded 
compression moulding  machines for plastics and rubber; (v) certain types of lifting equipment; 
and (vi) various safety components, among others. 

Annex IV – list of machinery  

89 Machinery Working Group document ‘WG-2020.46rev Swedish proposal and effects of a revision of the legal requirements in Annex 1, 

2.2.1.1 on vibrations for handheld machinery’. 

90  Sweden  would  save  on  100  medical  examinations per  year,  at  a price  of  EUR 3 000  each,  which  would  mean  EUR 300 000 per  year  in 
savings.  These  savings,  extrapolated  to  the  EU-27  based  on  the  population  ratio  (ca.  50),  would  make  for  total  EU  savings  of  EUR  15 
million per year. 

60 

 
                                                           
Policy Option 3 would add two new types of machinery to the list of high-risk machines: (i) AI 
systems/components  ensuring  safety  functions;  and  (ii)  machinery  containing  AI  systems  with 
safety  functions,  in  line  with  the  categories  of  machinery  that  will  be  referred  to  in  the  AI 
regulation  under  preparation.  Although  AI  application  in  machinery  already  exist,  AI  systems 
fulfilling safety functions or machinery embedding such systems are not yet considered to be in 
the market. Hence one-off costs of such AI systems or machinery embedding them for third party 
involvement will be borne by manufacturers, but are difficult to estimate. Nevertheless they are 
considered to be much lower than the costs incurred for the development of such products.  

Without a reassessment of the high-risk machines, potentially high-risk machines could be placed 
on the market without the adequate conformity assessment procedures, diminishing the level of 
safety for those types of machinery. Furthermore, machines that are not high risk any more due to 
the  technological  progress  could  remain  submitted  to  disproportionate  conformity  assessment 
procedures. To be able to adapt to future market developments, this policy option would include 
the possibility of implementing changes at a later stage via a delegated or implementing act in 
the revised MD. Additional revisions of the list should be backed up by relevant data and further 
discussed.  Any  addition  of  new  categories  to  the  current  list  of  high-risk  machines  would 
potentially create additional costs for manufacturers. On the contrary, removal of categories from 
the current list would potentially diminish costs. These costs would need to be estimated for each 
type  of  machine  added.  Typically  one-off  costs  for  manufacturers  are  due  to  third  party 
involvement and can be are estimated at EUR 25 000 per new product type, or more, depending 
on the type of machinery. 

On  the  updating  of  Annex  IV  through  revising  the  high-risk  categories,  there  was  a  split  in 
opinion in the consultation responses. Importers, notified bodies and professional workers were 
generally in favour of revising the categories. However, industry associations were opposed. The 
opinions of market-surveillance authorities were divided.  

Annex IV – conformity assessment  

Another subject for discussion is whether the conformity procedure for internal checks for Annex 
IV  machines  should  stay  as  an  option  for  machines  that  are  put  on  the  market  according  to 
harmonised standards covering all risks of the machinery and cited in the OJEU under the MD.  

There is discussion about whether the internal-checks option leads to safety concerns. On this 
issue,  the  Rapid  Alert  System  for  Non-Food  Dangerous  Products  (Safety  Gate/RAPEX)  has 
shown over the years that some of the products falling under Annex IV of the MD were identified 
as not being compliant with the requirements of the MD and the relevant European standards91. 
The products identified in Safety Gate/RAPEX include circular saws and vehicle lifts, which are 
part of Annex IV92. Some of these products were manufactured outside the EU.  

Third-party  involvement  is  perceived  by  economic  operators  as  more  effective  in  ensuring 
protection  for  users.  However,  economic  operators  said  this  third-party  involvement  also  adds 
substantially to the costs and/or effort involved, when compared with the self-assessment option. 
By comparison, the main drawbacks to the self-assessment option are deemed to be: (i) the lack 
of  reassurance  and  protection  that  might  otherwise  be  provided  by  third-party  involvement 
(which  customers  might  expect/demand);  (ii)  the  effort  and  expertise  required  internally  to 
undertake the process; and (iii) the lack of relevant harmonised European standards to support the 
choice  of  self-assessment.  Some  stakeholders  were  concerned  about  an  (unintentionally) 
incorrect application of the process by manufacturers and the lack of involvement/checks from a 

91 It has not been possible to find out the percentage of non-compliant products, or the number of accidents caused. 
92 Non-compliant products in the high-risk machinery category reported in the Safety Gate/RAPEX system: since 2017, out of 138 machinery 

products in total, 43% belonged to Annex IV (37 brush cutters, 11 circular saws, 8 vehicle lifts and 4 log splitters). 

61 

 
                                                           
third party. For instance, manufacturers may just look to one harmonised standard, when in fact 
more than one standard has to be applied to properly assess a product. 

According  to  the  evaluation  of  the  MD,  the  conformity  assessments  undertaken  for  machinery 
might  be  split  approximately  into:  80%  self-assessment  (non-Annex  IV),  10%  self-assessment 
(Annex  IV),  8%  EC-type  examination,  and  2%  approval  of  full  quality-assurance  system.  This 
suggests  that  half  of  the  conformity  assessments  on Annex  IV  machines  are done  already  with 
third  party  involvement.  Purposes  for  this  are:  (i)  to  ensure  or  double  check  the  quality  of  the 
product (ii) to increase competitiveness inside the EU and globally and (iii) to improve the brand 
reputation and recognition.  

Given  the  nature  of  the  risks  involved  in  using  machinery,  procedures  are  often  laid  down  for 
assessing  the  machinery’s  conformity  to  the  essential  health-and-safety  requirements.  These 
procedures  should  be  devised  based  on  the  danger  inherent  in  such  machinery.  Manufacturers 
should retain full responsibility for certifying the conformity of their machinery to the provisions 
of  the  MD.  Nevertheless,  for  certain  types  of  machinery  with  a  higher  risk  factor,  a  stricter 
certification procedure is desirable.  

The NLF, to which the MD is to be aligned, determines the appropriate conformity-assessment 
processes  (these  modules  also  include  the  manufacturer’s  DoC)  to  be  applied.  For  products 
presenting  high  risks,  a  third  party  should  check  conformity,  regardless  of  whether  the 
manufacturer  applies  the  relevant  harmonised  standards  to  prove  conformity  with  the  essential 
health-and-safety  requirements.  This  is  the  case  in  other  pieces  of  product-safety  legislation 
aligned to the NLF, such as the Regulation on Personal Protective Equipment (PPE)93. 

 [+/-] The costs and benefits of PO3 meeting specific objective 3 would include the third-party 
conformity-assessment costs for manufacturers of products in categories added to Annex IV, or 
savings if these products were removed from the list. 

The  evaluation  of  the  MD  also  showed  that  obligatory  third-party  assessment  does  not  add 
significant costs to industry. During the Commission evaluation of the internal market legislation 
for  industrial  products94,  economic  operators  indicated  that,  even  though  the  obligation  for 
mandatory third-party conformity assessment had been removed in the current version of the MD 
(until the last revision, the MD had required mandatory third-party conformity assessment for the 
categories  of  machinery  in  Annex  IV),  this  had  not  necessarily  led  to  a  sudden  reduction  in 
demand  for  the  services  of  notified  bodies.  Many  manufacturers  have  continued  to  use  the 
services of third parties ‘voluntarily’ for reputational reasons and to reassure their customers that 
their products are safe. 

In the evaluation of the MD, industry provided estimates of the time and costs they incurred for 
their last conformity assessment relating to the MD. The average estimates were: (i) 1 393 days 
and EUR 105 000 in other costs for self-assessment; (ii) 33 days and EUR 275 000 for EC-type 
examination; and (iii) 4 days (no cost information given) for approval of full quality assurance 
(the last two needing the involvement of a third party). 

On  the  costs  of  removing  the  internal-checks  option,  these  costs  are  estimated  by  taking  the 
difference  between  the  compliance  costs  for  manufacturers  for  both  types  of  conformity 
assessments for the Annex IV products that are currently assessed via internal checks (10% of all 
machinery-conformity  assessments  currently  carried  out95).  The  total  costs  for  all  companies  is 

93 Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing 

Council Directive 89/686/EEC (Text with EEA relevance) OJ L 81, 31.3.2016, pp. 51-98. 

94 European Commission Staff Working Document part 1: Evaluation of the internal market legislation for industrial products (SWD/2014/023 

final) (2014).  Available at:  

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52014SC0023&from=SK&lang3=choose&lang2=choose&lang1=EN 
95 Evaluation of the Machinery Directive: SWD (2018)160. 

62 

 
 
                                                           
estimated at EUR 202 million in one-off costs (EUR 2 467 per company, and up to EUR 25 000 
or more for certain types of machinery). Some manufacturers argue that imposing a third-party 
assessment  procedure  for  Annex  IV  machines  will  reduce  manufacturers’  interest  in  investing 
time  and  efforts  to  participate  in  the  drafting  of  harmonised  standards  for  those  machines. 
However,  harmonised  standards  will  continue  to  provide  presumption  of  conformity  with  the 
MD, the only difference is that compliance will be not self-certified by the manufacturer, but by a 
third party.  

Removing  the  option  for  internal  checks  might  lead  to  a  higher  degree  of  safety  for  the 
machinery.  To  assess  the  potential  benefits  of  removing  the  option  for  internal  checks,  the 
evaluation of the MD is taken for a proxy. Here, the MD’s role in protecting the health and safety 
of users in the market when Annex IV machinery is assessed through internal checks and 83% 
consider it effective-to-very-effective. This is compared to 94% when an EC-type examination is 
followed. Thus, removing the option of internal checks on Annex IV machinery has the potential 
to  increase  the  effectiveness  of  the  MD  to  protect  health  and  safety  by  13%  for  the  10%  of 
assessments currently carried out through internal checks. 

The total potential costs and benefits related to removing the internal-checks option under Annex 
IV are summarised in the table below. 

Costs and benefits of removing the internal-checks option for Annex IV machinery 

Stakeholders’ 
description 

REMOVING THE OPTION 
FOR INTERNAL CHECKS FOR 
ANNEX IV MACHINERY 

1. Number of affected 
stakeholders (EU-27) 

Companies 

Large 
companies 

SMEs 

All 

1 703 

81 024 

82 239a) 

2.1 Costs 
(total) 

One-off 

EUR 202 895 485c) 

2.2 Costs per 
organisation 

One-off 

Average 2 467c) (can be up to EUR 
25 000 or more for certain types of 
machineryg)) 

3. Benefits 

Direct 

Indirect 

A few consultation participants 
expected there to be some benefits 
from the changes but these benefits 
could not be reliably quantified (not 
quantifiable) 

MD’s effectiveness in facilitating the 
functioning of the internal market is 
expected to increase by 1% f) 
(not quantifiable) 

Administratio
ns 

Market-
surveillance 
authorities 

- 

- 

- 

- 

- 

Other organisations 

Citizens/users 

Notified bodies 

ESOs 

137 or more 

Increased turnover 
EUR 202 895 485c) 

One-off costs for 
adaptation are expected 
to require an average of 
10 FTEse) (not 
quantifiable) 

- 

Increased product 
portfolio among the 10% 
of machinery under 
Annex IV currently 
assessed through internal 
checks 

- 

- 

- 

- 

- 

People employed 
in machinery 
sector 

Users / 
consumers 

2 759 439 

446 000 000b) 

Not quantifiable, costs of changes could 
be pushed down the value chain 

- 

MD’s effectiveness in protecting the 
health and safety of users is expected to 
increase 13% for the 10%d) of machinery 
that currently undergoes internal checks  
(not quantifiable) 

- 

a) Due to rounding differences in the Eurostat data, the total number of enterprises shown does not equal the sum of enterprises recorded per size class. 
b) Proxy used: Number of inhabitants in the EU. 
c) Based on the difference in cost for conformity assessment of third-party assessments compared to internal checks for the 10% of products that currently undergo internal checks 
under Annex IV. 
e) Estimates based on European Commission (2014), Study on evaluation of the internal market legislation for industrial products indicating up to 10 FTEs for notified bodies to assess 
products’ conformity. 
f) Based on the 2018 evaluation of the MD and the difference in the MD’s effectiveness in facilitating the functioning of the single market by type of conformity assessment. 
g) From stakeholder interviews. 
There are  instances  where data are quantified  based on  responses to consultations  or interviews. When the  number of  replies is too low to  present an estimate, cost  cannot  be 
reliably quantified. Proxy values are used when direct information is not available. 

  PO3  –  SO4:  On  digital  documentation,  this  policy  option  would  provide  full  legal 
clarity  by  amending  requirement  1.7.4.  (Instructions)  to  clarify  that  manual 
instructions can be provided in digital form (plus on paper and free of charge upon 
customer request).  

63 

 
 
 
 
Similarly  to  PO2,  this  policy  option  would  require  a  change  of  the  legal  text  in  the  MD,  by 
specifying  in  the  Annex  I  that  the  instruction  and  declaration  of  conformity  can  be  provided 
either digitally or in paper, which would provide legal certainty, and would prevent this coming 
under question later on and being changed again in the Guide. 

 [+/-] Costs and Benefits: Like in PO1 and PO2, PO3 meeting specific objective 4  brings an 
opportunity to simplify and reduce net costs, mainly for manufacturers. See table reported in 
PO1. 

  PO3 – SO5: Like in PO2, by amending the legal text, this policy option would align 

the current MD with the NLF.  

As  mentioned  previously,  aligning  the  MD  to  the  NLF  would  ‘help  to  increase  the  quality  of 
machinery and the confidence in products in the European market, as well as ensure good levels 
of  safety  and  create  a  common  framework  for  market  surveillance’96.  Aligning  the  MD  to  the 
NLF would bring the ICSMS to the MD. The ICSMS is the internet-supported information and 
communication  system  for  pan-European  market  surveillance.  As  detailed  in  PO2,  there  was 
wide  consensus  on the  benefits  of this  alignment;  most respondents  to the  public  consultation, 
across all stakeholder types, expressed support for this change. 

 [+/-]  Costs  and  Benefits:  PO3  meeting  specific  objective  5  would  benefit  all  stakeholders, 
although quantification of these benefits was not possible due to the lack of available data. The 
table in  PO2  shows  the  potential  costs  and  benefits  for  stakeholders  of aligning  the MD  to  the 
NLF. 

  PO3  –  SO6:  Like  in  PO2,  by  amending  the  legal  text,  this  policy  option  would 

convert the MD to a regulation.  

As detailed in PO2, there was wide consensus on the benefits of this conversion. Most public-
consultation respondents, across all stakeholder types, expressed support for this change.  

[+/-]  Costs  and  benefits:  PO3  meeting  specific  objective  6  would  benefit  stakeholders. 
Manufacturers  would  save  on  administration  for  clarifications  on  interpretation  differences 
between Member States, which is estimated at between EUR 100 and EUR 500 to write letters, 
print papers and resolve differences97. The table in PO2 shows the potential costs and benefits for 
stakeholders. 

Impacts of the policy option 3 on SMEs 

As already mentioned, 98% of companies in the machinery sector are SMEs. Legal certainty will 
particularly favour SMEs since they have fewer resources to assess and interpret the legal text. 
For  instance,  legal  certainty  on  the  safety  requirements  will  result  on  clearer  harmonised 
standards, which will also be beneficial for SMEs that rely on harmonised standards to comply 
with  the  safety  requirements.  Standardisation  on  new  technologies  happens  in  alignment  and 
reciprocal  feedback  with  ISO/IEC  (International  Organization  for  Standardization/International 
Electrotechnical  Commission)  so  that competitiveness  in and  outside  the  EU  is  maximised  and 
export  is  facilitated  (key  aspect  of  the  EU  machinery  sector,  which  exports  51%  of  their 
production to countries outside the EU, and this is the case for SMEs too).  

Manufacturer  of  Annex  IV  high-risk  machines  are  often  SMEs.  However,  SMEs  often  prefer 
third  party  conformity  assessment,  due  to  lack  of  means  e.g.  laboratories/expertise  or  for 

96 Available at: https://ec.europa.eu/info/publications/commission-report-safety-and-liability-implications-ai-internet-things-and-robotics-0_en.  
96 Evaluation of the Machinery Directive: SWD (2018)160. 
97 An instance refers to one product being placed in the market by one manufacturer. The number of instances requiring clarifications could not 

be quantified. 

64 

 
                                                           
competitiveness  reasons,  as  a  guarantee  of  quality,  and  in  case  of  lack  of  brand  recognition. 
According  to  the  evaluation  of  the  directive,  50%  of  the  conformity  assessment  for  Annex  IV 
machines is already done with third party involvement. 

On the burden reduction side, the following opportunities are favouring SMEs: 

-   Cost savings for manufacturers and favourable environmental impact by allowing digital 
instructions and digital declaration of conformity, applying to all machinery. 

- 
 The  preferred  option  includes  a definition  of  substantial  modification  in  the  legal text, 
and clarifies that the obligations of the company performing the substantial modification are 
limited  to  the  part  of  the  machinery  affected  by  the  modification  (unless  the  substantial 
modification  has  an  impact  on  the  safety  of  the  entire  machinery).  Companies  modifying 
machinery are often SMEs. 

-  The  alignment  to  the  NLF  means  a  better  functioning  of  the  directive  and  its 
enforcement,  but  also  a  burden  simplification  for  manufacturers  dealing  with  several 
product safety acts applying to their products (e.g. machinery to which both the machinery 
directive  and  the radio equipment  directive  apply).  It  streamlines  the process  of safeguard 
procedures,  by  involving  manufacturers  and  Member  States  before  the  Commission  is 
notified  and  triggers  a  Commission  decision  only  in  cases  where  there  is  disagreement 
between Member States. 

-  The  complementarity  between  AI  and  machinery  legal  texts,  where  the  AI  regulation 
delegates  the  conformity  assessment  to  the  machinery,  so  that  the  risk  assessment  for 
machinery with AI systems is done only through the machinery directive. 

The fact that the directive includes technology neutral requirements for new technologies drives 
the standardisation, which allows safe innovative solutions in the market. The objective is not to 
hinder innovation but to allow safe innovation. As far as high risk machines are concerned, the 
empowerment for a revision of the high risk categories in line with the market development will 
allow the directive to keep up to date in that sense. 

As regards AI, research and development happen at an earlier stage. The MD applies when the 
machinery is put on the market, i.e. once the technology has become state of the art. Leaving the 
regulation of machine learning to the sole AI regulation would not ensure machinery safety. AI 
systems used in machinery need a risk assessment for the specific application of that machinery. 
This  approach  is  coherent  with  the  future  AI  regulation  for  continuously  learning  AI  systems, 
which delegates the conformity assessment of the AI systems used in machinery to the machinery 
directive rules. In addition, it must be considered that development of AI software is more costly 
than  other  types  of  software.  Costs  derived  from  compliance  to  the  directive  would  not  be 
significant as compared to development costs. 

Impacts of policy option 3 on innovation 

The fact that the MD includes technology-neutral requirements for emerging technologies drives 
standardisation, which allows safe innovative solutions to come onto the market. The objective of 
standardisation is not to hinder innovation but to allow safe innovation. On the subject of high-
risk machines, allowing a revision of the high-risk categories in line with market developments 
will allow the MD to keep up to date. 

On AI, research and development happen at an early stage. The MD applies when the machinery 
is put on the market, i.e. once the technology has become commercialised. Leaving the regulation 
of  ML  solely  to  the  AI  regulation  would  not  ensure  machinery  safety.  AI  systems  used  in 
machinery need a risk assessment for the specific application of that machinery. This approach is 
coherent with the future AI regulation for continuously learning AI systems, which will delegate 

65 

 
the conformity assessment of the AI systems used in machinery to the MD’s rules. In addition, it 
must be considered that development of AI software is more costly than other types of software. 
Costs  derived  from  ensuring  AI  software  complies  with  the  MD  would  not  be  significant 
compared to the costs of developing the software. 

The following table summarises and compares the impacts (economic, social and environmental) 
of each policy option per stakeholder group. 

[+/-] Costs and Benefits: The overall effects of PO3 on stakeholders include: (i) benefits for 
manufacturers thanks to the switch to e-manuals; (ii) benefits for society and users thanks to less 
exposure to peak vibrations; and (iii) net benefits generated by aligning the MD to the NLF and 
the  legal  clarity  derived  from  a  lack  of  transposition.  Costs  are  predicted  for  manufacturers 
following  the  adaptation  or  introduction  of  new  requirements.  These  costs  are  limited  as  there 
would only be a few cases where completely new requirements requiring re-design of products 
would  be  added.  In  most  cases,  new  requirements  would  be  applicable  only  to  some  types  of 
machinery.  Diligent  manufacturers  that  already  correctly  perform  the  risk  assessment  may  see 
cost savings from increased legal certainty. Greater legal clarity ensures a level playing field and 
would allow manufacturers to introduce emerging technologies. 

On compliance costs, it must be stressed that the scope of the MD is very wide, and not all safety 
requirements in Annex I of the MD apply to all types of machinery. Manufacturers must make a 
risk  assessment  to  determine  the  risks  involved  and  the  safety  requirements  relevant  for  their 
machinery.  They  need  to  ensure  compliance  only  to  those  requirements  relevant  for  their 
machinery.  New  or  revised  requirements  proposed  in  this  policy  option  are  proportional  and 
targeted, since they would be limited to certain types of machinery. For instance; (i) requirements 
on  overhead  power  lines  are  relevant  only  to  certain  types  of  high  mobile  machinery;  the  (ii) 
declaration of peak vibration values is requested only for portable handheld and/or hand-guided 
machinery; and (iii) requirements on hazardous substances apply only to those machines whose 
operation implies emissions of those substances. 

As  outlined  in  Chapter  1.3  of  this  report,  many  machinery  manufacturers  are  SMEs.  Users 
(workers and consumers) will expect a similar level of product safety, regardless of the size of 
the  company  producing  the  machinery.  The  impacts  of  Policy  Option  3  on  SMEs  include 
additional costs in a few cases where SMEs may need to adapt the design of their machinery to 
comply with new requirements. However, these additional costs would be targeted, and limited to 
certain machine types. Moreover, diligent manufacturers will be already implementing some of 
the revised requirements, and would thus already have a competitive advantage once the revised 
MD  is  in  force.  SMEs  will  particularly  benefit  from  the  legal  clarity  that  the  revised  MD  will 
bring.  This  legal  clarity  is  important  for  them  since  SMEs  typically  have  fewer  resources  to 
follow up and seek advice on legislation. 

It must be also considered that, after the Commission adopts the regulation, negotiations with the 
European  Parliament  and  Council  take  2  years  on  average.  After  the  new  regulation  on 
machinery products has entered into force, an additional transition period of 30 months will be 
given for the new provisions to be effective. This transitional period would allow manufacturers 
to prepare themselves for compliance with the new requirements. Often, manufacturers already 
take  account  of  the  new  requirements  while  developing  new  models.  For  models  already  in 
production,  if  manufacturers  want  to  keep  putting  them  on  the  market  after  the  end  of  the 
transitional period, they must modify those products so that they comply with the new regulation, 
where  necessary.  Market-surveillance  authorities  will  face  some  adaptation  costs  for  enforcing 
requirements linked to emerging technologies, but will benefit from an NLF alignment and the 
avoidance of transposition costs. 

The following table summarises and compares the impacts (economic, social and environmental) 
of each of the policy options on every stakeholder group: 

66 

 
Comparison of impacts on stakeholder groups (costs/benefits/environmental benefits against baseline PO0) 

Policy option 
Affected 
stakeholders 

PO1: Self 
regulation by 
industry and 
changes to 
the Guide 

PO2: Burden 
minimisation 

PO3: Burden 
minimisation 
and 
improved 
safety 

Companies 
Up to 82 239 (EU-27); Up to 81 024 SMEs (EU-27);  
Up to 1 703 large companies (EU-27) 

P1: Costs for compliance with new standards. 
P4: Costs for setting up and maintaining a server: one-off EUR 29 million 
(EUR 2 000 per company), annual EUR 48 million (EUR 3 000 per 
company); Reduction in printing costs of up to EUR 16.6 billion 
(EUR 201 000 per company). 
P2, 3, 5, 6: Legal uncertainty and lack of consensus for changes to the Guide. 
P1: Costs for compliance with new standards. 
P2: Some costs for adapting to changes on RED-LVD and PCM; Cost 
savings on PCM of about EUR 5 000 - EUR 10 000 per instance. 
P4:  Costs  for  setting  up  and  maintaining  a  server:  one-off  EUR 29 million 
(EUR  2 000  per  company),  annual  EUR  48  million  (EUR  3 000  per 
company);  Reduction 
to  EUR 16.6  billion 
in  printing  costs  of  up 
(EUR 201 000 per company). 
P5: Simplification thanks to Directives under the same framework. 
P6: Cost savings from fewer clarifications EUR 100 - EUR 500 per instance. 
P1: One-off costs for adaptation to changes on: (i) human-robot interaction; 
(ii) ML test procedures and equipment; (iii) a lack of connection or faulty 
connections; (iv) cyber safety and external hazards; (v) software updates; (vi) 
automated machines; (vii) risk assessment; and (viii) costs for compliance 
with new standards; Improved competitiveness and level playing field; Fewer 
barriers to market. 
P2: Some compliance costs and costs for adapting to changes (slow-speed 
lifts, seating, hazardous substances, overhead power lines, vibrations); Cost 
savings on PCM of EUR 5 000 – EUR 10 000 per instance. 
P3: EUR 202 million one-off overall costs (EUR 2 500 per company, EUR 
25 000 or more for certain machine types) for removal of internal checks. 
P4: Costs for setting up and maintaining a server: one-off costs of EUR 29 
million (EUR 2 000 per company), annual costs of EUR 48 million (EUR 
3 000 per company); Savings on printing costs of up to EUR 16.6 billion 
(EUR 201 000 per company). 
P5: Simplification thanks to directives coming under the same framework. 
P6: Cost savings for fewer clarifications EUR 100 - EUR 500 per instance. 

Notified bodies 

137 or more 

P4: One-off costs for 
adaptation to change 
expected; Decreased 
storage costs for 
manuals. 

P4: One-off costs for 
adaptation to change 
expected; Decreased 
storage costs for 
manuals 
P6: Benefits from 
equal interpretation 
across Member States. 

P3: Turnover 
increase: 
EUR 202 million for 
product portfolio of 
the 10% of machinery 
under Annex IV that 
is currently assessed 
through internal 
checks;  
P4: One-off costs 
expected for adapting 
to change; Decreased 
storage costs for 
manuals 
P6: Benefits through 
equal interpretation 
across Member States. 

ESOs 
CEN/ 
Cenelec 

P1: 
Compliance 
with new 
standards. 

P6: Benefits 
through 
equal 
interpretatio
n of 
regulation 
across 
Member 
States. 
P1: 
Compliance 
with – and 
revision of – 
new 
harmonised 
standards 
P6: Benefits 
expected 
through 
equal 
interpretatio
n of 
regulation 
across 
Member 
States. 

Member States 
27 EU Member States 
(or more incl. EEA) 
P4: One-off costs for 
adaptation to changes. 

P2: Costs for 
adaptation to changes; 
increased legal clarity. 
P4: One-off costs for 
adaptation to changes. 
P5: Access to ICSMS  
P6: Saving on 
transposition costs. 

P2: Costs from 
adapting to changes; 
increased legal 
clarity; reduced social 
costs for sick leave 
and occupational 
injuries (e.g. costs 
from vibrations are 
currently EUR 15 
million annually). 
P4: One-off costs for 
adapting to changes. 
P5: Access to ICSMS. 
P6: Saving on 
transposition costs. 

Citizens/Users (workers and consumers) 

2 759 439 employees in the 
sector (EU-27)  

Up to 446 000 000 
EU citizens  

P4: EUR 0.4 per manual if user decides to print part 
of the manual after purchase; Increased readability, 
non-paper instructions manual more adapted for 
blind/partially sighted; Decreased use of paper and 
smaller carbon footprint. 

P4: EUR 0.4 per manual if user decides to print part 
of the manual after purchase; increased readability, 
non-paper instructions manual more adapted for 
blind/partially sighted; Decreased use of paper and 
smaller carbon footprint. 
P5: Access to ICSMS. 
P6: Fewer unsafe products in the market. 

P1: Costs of changes pushed down the value chain;  
Less non-compliant machinery in the market; 
increased safety for workers and consumers; fewer 
occupational injuries for workers. 
P2: Increased safety thanks to clarifications; fewer 
occupational injuries for workers. 
P3: Costs pushed down the value chain; MD’s; 
Higher effectiveness in protecting the health and 
safety of users expected to increase for machinery 
currently following internal checks. 
P4: EUR 0.4 per manual if user decides to print part 
of the manual after purchase; increased readability, 
non-paper instructions manual more adapted for 
blind and partially sighted; Decrease of use of 
paper and smaller carbon footprint. 
P5: Access to ICSMS. 
P6: Increased safety. 

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7.  HOW DO THE OPTIONS COMPARE? 

The following tables provide information comparing the policy options in terms of effectiveness 
(how  each  option  achieves  the  specific  objectives),  efficiency  (cost-benefit  analysis)  and 
coherence with other pieces of EU law. 

Comparison of policy options against the effectiveness criterion 

Cover new risks 
related to 
emerging digital 
technologies 

Ensure coherent 
interpretation of 
the scope and 
definitions, and 
improve safety 
for traditional 
technologies 

Reassess 
machines 
considered as 
high risk and 
reassess 
related 
conformity 
procedures 

Reduce 
paper-based 
requirement
s for 
documentati
on 

Ensure 
coherence 
with other 
product-
safety 
legislation 

Avoid 
divergences in 
interpretation 
derived from 
transposition 

PO0 

It does not address any of the identified problems and does not fulfil any of the objectives 

+ 

+ 

+ 

+ 

PO1 

It will rely on 
standards 

PO2 

PO3 

+/++ 
It will add clarity 
to the scope and 
definitions in the 
current act, 
including the part 
of the current act 
related to risks 
stemming from 
emerging 
technologies, but 
with no changes 
to requirements 

+++ 
It will add clarity 
to the scope and 
definitions in the 
current act 
including the part 
of the current act 
related to risks 
stemming from 
emerging 
technologies, and 
will adapt the 
requirements 

Net 
effect 

0 
+ 

++ 

It will add some 
clarity to the 
scope and 
definitions 
through the 
Guide, however 
to a very limited 
extent since not 
binding 

It will add 
some clarity 
to high-risk 
machines 
through the 
Guide, 
however to a 
very limited 
extent since 
not binding 

Digital 
instructions 
and DoC 
will be 
allowed 
through the 
Guide 

+/++ 

+/++ 

+++ 

It will add 
clarity to the 
scope and 
definitions in 
the current act, 
but with no 
changes to 
requirements  

It will add 
some clarity 
to the concept 
of high-risk 
machines 
through the 
Guide, 
however to a 
very limited 
extent since 
not binding 

Digital 
instructions 
and DoC 
will be 
allowed in 
the legal 
text (full 
legal 
certainty) 

+ 
It will add 
some 
coherence 
with the 
NLF 
through the 
Guide, 
however to 
a very 
limited 
extent since 
not binding 
+++ 

+ 
Workshops 
will be 
organised to 
clarify 
differences in 
interpretation 
due to 
transpositions, 
and 
clarifications 
will be added 
to the Guide 
+++ 

Full 
alignment to 
NLF will be 
achieved 

Reduction of 
costs and 
delays from 
transposition 
will be 
achieved 

+++ 

+++ 

+++ 

+++ 

+++ 

+++ 

It will add 
clarity to the 
scope and 
definitions in 
the current act, 
and will adapt 
the 
requirements 

It will reassess 
and revise the 
list of high-
risk machines 
in the legal 
text  

Digital 
instructions 
and DoC 
will be 
allowed in 
the legal 
text (full 
legal 
certainty) 

Full 
alignment to 
NLF will be 
achieved 

Reduction of 
costs and 
delays from 
transposition 
will be 
achieved 

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Impact assessment study on the revision of the Machinery Directive 

Comparison of policy options against the efficiency criterion 

See  table  comparing  the  impacts  on  stakeholder  groups  (costs/benefits/environmental  benefits 
against baseline PO0) at the end of Chapter 6.  

In addition, the table below compares policy options against types of impacts. 

Options 
Policy Option 0 
Policy Option 1 

Social impacts 
No change 
No change 

Policy Option 2 

Fewer non-compliant products 
on the market 

Policy Option 3 

Fewer non-compliant products 
on the market  
Increased safety 

Environmental impacts 
No change 
Saving of paper  
Decrease of carbon footprint 
(with limited certainty) 
Saving of paper  
Decrease of carbon footprint 
(with full certainty) 
Saving of paper  
Decrease of carbon footprint 
(with full certainty) 

Comparison of policy options against the coherence criterion 

Policy Options 

PO0 

PO1 

PO2 

PO3 

No coherence. 
Very limited coherence in the implementation of the EU law for three reasons. 
Firstly, there would be no clarification on the exceptions due to borderline areas 
with LVD and RED. Secondly, there would not be any alignment to the NLF. 
Thirdly, the interplay with the AI regulation would not be ensured. 
This option would allow a more coherent implementation of the EU law, by 
clarifying the borderline area with the LVD and RED and aligning the MD to the 
NLF but without covering the interplay with the future AI regulation. 
This option would allow the most coherent implementation of the EU law, by: (i) 
clarifying the borderline area with the LVD and RED; (ii) aligning the MD to the 
NLF; and (iii) allowing full complementarity and interplay between the MR and 
the future AI regulation on high-risk machines with AI systems. 

Net effect 
0 

0 

+ 

++ 

Overall comparison of policy options 

Effectiveness  

Efficiency 

PO0 

PO0 would not address any of 
the identified problems and 
would not fulfil any of the 
objectives. The standardisation 
process and revisions of the 
Guide would develop as usual, 
with limited ambition.  

PO0 would have negative effects on 
industry competitiveness, the level playing 
field. Compliance, and safety in the market 
would decrease over time as a 
consequence of no action. 

Coherence 
PO0 would not 
improve coherence 
with existing 
legislation and 
would not provide 
coherence with the 
new AI legislation 
nor with the 
Cybersecurity Act. 

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Impact assessment study on the revision of the Machinery Directive 

PO1 

PO2 

PO3 

PO1 would obtain limited 
results in reaching the 
objectives. 
Emerging technologies would 
be covered to some extent 
through: (i) the issuance of a 
new standardisation request; 
and (ii) covering gaps in 
traditional technologies. Other 
objectives would be pursued by 
a push for consensus in the 
Guide. 

PO1 would obtain limited results, and only 
mainly of the following areas: net benefits 
from the allowance of digital 
documentation in the Guide, although with 
limited certainty; but no avoidance of 
existing costs due to clarification of 
differences in interpretation. This option 
implies few costs for companies incurred 
for compliance with new standards, but 
less than if requirements were changed.  
There would be no significant benefits for 
users or other stakeholders. 

PO2 would address to a large 
extent all the identified 
problems through: (i) changes 
in the MD’s scope and 
definitions; (ii) alignment to 
the NLF; (iii) conversion into a 
regulation; and (iv) allowance 
of digital documentation.  
The only identified problem it 
would not address is the level 
of safety. 

PO3 would address to a large 
extent all the identified 
problems through: (i) changes 
in the MD’s scope and 
definitions; (ii) alignment to 
the NLF; (iii) conversion into a 
regulation; and (iv) allowance 
of digital documentation. It 
would also improve the level of 
safety in the market. As a 
result, it would increase trust in 
emerging technologies, 
improve competitiveness, and 
ensure a level playing field.    

PO2 would fully achieve some of the 
objectives, such as the allowance of digital 
documentation and related large savings 
on printing costs for companies, and the 
clarifications in scope definition and the 
avoidance of transposition, which would 
avoid costs for manufacturers due to 
clarification of differences in 
interpretation. One area where only limited 
results would be achieved is in the safety 
of new and traditional technologies and of 
high-risk machines.  

PO3 would fully achieve all the objectives 
(with correspondingly greater impacts), 
including the improvement of safety. As a 
result, companies would bear costs for 
adapting to changes in requirements and 
complying with new standards. However, 
they would still make large savings from 
the allowance of digital documentation 
with full certainty and would avoid costs 
derived from differences in interpretation. 
Companies would also benefit from a 
better legal clarity, greater competitiveness 
and a more level playing field in the 
machinery market. 
- Users would benefit from safer machines 
in the market and lower cost of injuries 
and sickness at work. 

PO1 would slightly 
improve coherence 
with existing 
legislation by 
clarifications in the 
Guide, but would 
not provide 
coherence with the 
new AI legislation 
nor with the 
Cybersecurity Act. 

PO2 would ensure 
full coherence with 
existing legislation 
by: (i) revising the 
current act in scope 
and definitions; (ii) 
aligning to the 
NLF. However, it 
would not provide 
coherence with the 
new AI legislation 
nor with the 
Cybersecurity Act. 

PO3 would ensure 
full coherence with 
existing legislation 
by: (i) revising the 
current act in scope 
and definitions; and 
(ii) aligning to the 
NLF. PO3 would 
also ensure full 
coherence with the 
new AI legislation 
and with the 
Cybersecurity Act. 

In a nutshell, the options could be summarised as follows.  

Option 0: No action. 

Option 1: Unambitious option that achieves limited results and does not prepare the MD 
for either the short-term or the medium/long term. 

Option 2: This option boosts competitiveness by minimising burden for manufacturers. 
It  brings  economic  benefits  for  industry  by  allowing  digital  documentation  for  all 
machinery. It also modernises the legislation by aligning it to the NLF. However, by not 
adapting the safety requirements on emerging technologies, it misses the opportunity to 
render the legislation future proof.  

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Impact assessment study on the revision of the Machinery Directive 

Option  3:  This  option  boosts  competitiveness  by  minimising 
the  burden  for 
manufacturers. It also improves safety by clarifying or adding requirements on emerging 
(and traditional) technologies. These additional or clarified requirements bring additional 
costs  for  compliance.  Nevertheless,  despite  these  extra  costs,  the  additional  or  clarified 
requirements bring longer term benefits such as: (i) fewer unsafe products in the market; 
(ii) greater legal certainty (reducing private litigation); and (iii) a more level playing field 
for economic operators on the global market. This option also brings economic benefits 
for industry because it allows digital documentation. In addition, this option has benefits 
for the public and national healthcare systems, because it would lead to safer products on 
the  market.  As  a  result,  there  would  be  fewer  injuries,  less  sick  leave,  and  lower 
rehabilitation costs. This is also the most future-proof option. 

8.  PREFERRED OPTION 

8.1. 

Preferred policy option: Option 3  

In light of the data and the considerations in the previous chapters, the preferred policy option is 
Policy  Option  3. This  policy  option  addresses  all  identified  problems  in the  most effective  and 
efficient way, proposing a revised MD that is not only fit for purpose now, but also in the years to 
come. Policy Option 3 also ensures coherence with existing product-safety legislation and with 
the future AI regulation.  

Policy  Option  3  adds  new  requirements  and  clarifies  existing  ones:  (i)  in  a  targeted  and 
proportional  way;  and  (ii)  only  when  necessary.  These  new  requirements  and  clarifications  are 
often applicable only to certain types of machinery. It adds legal clarity to the current act in its 
scope, definitions and requirements, including those requirements covering risk stemming from 
emerging  technologies.  In  addition,  this  option  will  drive  the  standardisation  activities  in  the 
machinery area, which will increase safety and ensure a higher level of trust and competitiveness 
in  the  market  for  machinery  and  digital  machinery.  This  option  also:  (i)  adapts  high-risk 
machines to new market developments in this area; (ii) removes the internal-check option for the 
conformity  assessment  of high-risk  machines; and  (iii)  ensures  full  coherence with the  new  AI 
regulation.  This  option  proposes  a  burden-reduction  measure  that  was  widely  requested  by 
industry, and which partially allows digital documentation, while at the same time ensuring that 
end-users and consumers can have a printed version free of charge if they so request. Finally, the 
revised MD will gain in coherence and legal certainty by being aligned to the NLF and becoming 
a regulation. To ensure proportionality, this policy option includes: (i) the standardisation process 
with a new standardisation request issued by the Commission for detailed technical solutions; and 
(ii) the Guide for detailed clarification examples. 

The preferred policy option complies with the principle of proportionality. The proposed changes 
to the safety requirements are targeted, and limited to the following machinery types: machinery 
including  emerging  technologies,  specific  machinery,  and  high-risk  machinery.  The  burden-
reduction measures are aimed at all machinery types. These burden-reduction measures include: 
(i)  clarifications  on  what  constitutes  a  substantial  modification;  (ii)  digital  documentation;  (iii) 
alignment  to  the  NLF;  and  (iv)  conversion  of  the  MD  to  a  regulation.  Proportionality  is  also 
ensured by the MD being technologically neutral. The proposed clarifications or additions to the 
safety requirements are kept to the strict minimum in the proposal. They will be complemented 
by  a  new  standardisation  request  issued  by  the  Commission  to  empower  the  standardisation 
bodies to develop voluntary technical solutions. 

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Impact assessment study on the revision of the Machinery Directive 

This  policy  option  is  coherent  with  the  new  regulation  on  artificial  intelligence,  which  will 
address the risks having an impact on safety for high-risk AI systems embedded in a machinery 
or that are safety components under the machinery regulation. In addition, this option is coherent 
with the Union policy on cybersecurity, making the link with the future cybersecurity schemes 
pursuant to the Cybersecurity Act. Furthermore it contributes to simplification of the regulatory 
environment. 

8.2.  REFIT (simplification and improved efficiency) 

Description 

REFIT cost savings – Preferred option – Option 3 
Amount 

Comments 

Allowing digital instructions 
generates considerable economic 
benefits (printing and paper cost 
savings, etc.) that greatly 
outweigh the costs generated 
(purchasing, setting up and 
maintaining a server, etc.) 

Reduced social costs for sick 
leave and fewer occupational 
injuries thanks to reduced 
vibration peaks in handheld 
machines 

Clarifications where there had 
previously been a lack of legal 
clarity or differences in 
interpretation between Member 
States 

Printing saving costs up to EUR 16.6 billion 
(EUR 201 000 per company) in printing costs 
saved with digital instructions and DoC. 

EUR 15 million yearly 

Benefits are mainly for 
manufacturers. End-users might 
benefit from price decreases if 
these price decreases are passed 
on to them. National authorities 
and notified bodies might benefit 
from decreased storage costs for 
documentation 

Benefits are mainly for 
consumers  

EUR 5 000 - EUR 10 000 per instance for 
clarifications of differences in interpretation 
between Member States 

Benefits are for manufacturers 
and national authorities 

Alignment to NLF 

Not quantifiable 

Beneficial to all stakeholders 

Conversion to a regulation 

Cost savings in terms of clarification 
procedures EUR 100 to EUR 500 per instance 

Benefits are mainly for 
manufacturers 

Impact calculation methodology is described in Annex 4: Analytical methods. 

9.  HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED? 

This  chapter  proposes  several  indicators  to  monitor  and  evaluate  the  implementation  of  the 
changes.  After  the  entry  into  force  of  the  preferred  option,  the  Commission  will  monitor  the 
implementation, application and compliance of these new provisions to assess their effectiveness. 

On unsafe products and accident data, monitoring would be based on: (i) the information that 
is made available by Member States in the ICSMS on safeguard clauses; (ii) the information that 
is made available by Member States in the RAPEX systems about unsafe products found on the 
market;  and  (iii)  the  safety  concerns  and  related  accident  data  regularly  reported  at  both  the 
Machinery  Administrative  Cooperation  Group’s  (AdCo)  twice  yearly  meetings  (market-
surveillance  authorities  and  the  Commission  as  observer)  and  the  Machinery  Expert  Group 
(MEG) twice-yearly meetings (with all interested stakeholders: industry, trade unions, consumer 
associations,  standardisation  organisations,  notified  bodies,  market-surveillance  authorities  and 
the Commission). Following the alignment of the revised MD to the NLF, the use of the ICSMS 
on defective products will facilitate and improve this reporting. 

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Impact assessment study on the revision of the Machinery Directive 

The capacity of the revised MD to deal with new innovations and emerging technologies could 
be  monitored  by  the  many  new  and  revised  harmonised  standards  positively  assessed  and 
cited by the Commission. These new and revised standards provide presumption of conformity 
with  the  new  and  revised  safety  requirements.  In  addition,  the  Commission  could  consult 
competent authorities and stakeholders for evaluation98. 

The removal of the current uncertainties and lack of clarity in the application of the MD will 
lead  to  lower  compliance  costs,  especially  in  the  administrative  burden  related  to  additional 
paperwork  for  clarifications  and  paper  documentation.  By  three  years  after  the  regulation 
becomes applicable and every four years thereafter, the Commission shall submit a report on the 
evaluation and review of this Regulation to the European Parliament and to the Council. These 
evaluation reports will analyse the effective and efficiency of the legislation. 

On the reassessment of high-risk machines, one indicator of success would be the greater safety 
of  high-risk  products.  To  monitor  this,  there  would  be  targeted  new  reporting  obligations  on 
Member  States  limited  to  high-risk  machinery  as  criteria  to  determine  whether  the  list  needs 
modification,  such  as  (i)  an  assessment  of  the  risks;  (ii)  a  cost-effectiveness  analysis;  (iii)  
machinery accident analysis; (iv) statistics on accidents caused by the machinery product during 
the preceding four years, based on information from the Information and Communication System 
for  Market  Surveillance  (ICSMS),  safeguard  clauses,  Rapid  Alert  System  (RAPEX)  and  the 
Machinery Administrative Cooperation Group reporting. This obligation would be proportionate, 
since it would be limited to high-risk products. 

The  expected  objectives  and  impacts  of  allowing  digital  documentation  could  be  evaluated 
through stakeholder consultations. 

On the effectiveness of the MD, aligning the MD to the NLF would improve the management 
of safeguard clauses through the ICSMS. Fewer safeguard clauses handled by the Commission99 
would be an indicator of success with respect to greater safety and legal clarity. The alignment to 
the  NLF  and  the  ‘goods  package’100  adopted  by  the  Commission  in  2018  will  improve  market 
surveillance  and  enforcement.  It  will  also  improve  the  accreditation  and  monitoring  of  the 
performance of notified bodies because Decision No 768/2008/EC on a common framework for 
the marketing of products will apply. 

The  Commission  will  monitor  the  implementation,  the  application  and  the  compliance  to  the 
revised  MD  to  assess  its  effectiveness.  The  revised  MD  will  request  a  regular  Commission’s 
evaluation and review and the submission of a public report to the European Parliament and to 
the Council. 

98 Current developments in digitalisation, IoT and AI could allow data collection relevant to the monitoring and evaluation of the MD. Such 
data gathering mechanisms could possibly be outlined in new requirements in the MD at EU level (e.g. on the adoption of digital identifiers 
of machines and automatic digital collection of data from machines of certain types). After reflection, such mechanisms were considered too 
burdensome and thus not proposed. 

98 The alignment to the NLF will entail a reduction of the Commission decisions whether to justify a measure taken by a Member State to 
withdraw a product from the market. Under the current MD provisions, when a Member State notifies such a measure to the Commission, 
there is an obligation on the Commission to issue a decision in all cases. Under the NLF, the Commission will be subject to that obligation 
only when another Member State objects to the national measure, or where the Commission considers a national measure to be contrary to 
EU legislation. 

99 Current developments in digitalisation, IoT and AI could allow data collection relevant to the monitoring and evaluation of the MD. Such 
data gathering mechanisms could possibly be outlined in new requirements in the MD at EU level (e.g. on the adoption of digital identifiers 
of machines and automatic digital collection of data from machines of certain types). After reflection, such mechanisms were considered too 
burdensome and thus not proposed. 

100  See:  (i)  Regulation  (EC)  765/2008  setting  out  the  requirements  for  accreditation  and  the  market  surveillance  of  products;  (ii)  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 future product-harmonisation legislation); and (iii) Regulation (EU) 2019/1020 on market 
surveillance and compliance of products. Available at: https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en. 

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Impact assessment study on the revision of the Machinery Directive 

A summary is included in the table below. 

Indicator 

Stage 
Implementation  Evolution of 
harmonised 
standards 

Implementation  Assessment of 

high-risk 
machines 

Definition 
As in the 
Standardisation 
Regulation 
1025/2012 
Reports 

Implementation  Reassessment of 

high-risk 
machines 

New reporting 
obligations on 
Member States 

Unit of measurement 
Number of harmonised 
standards positively 
assessed by the 
Commission 
Number of positive third-
party inspections out of 
total inspections on 
newly added high-risk 
machine categories  
statistics on accidents 
caused by the machinery 
product during the 
preceding four years 

Data source 
ESOs, internal 
Commission 
databases 

Notified 
bodies 

ICSMS, 
safeguard 
clauses, 
RAPEX and the 
Machinery 
Administrative 
Cooperation 
Group  
Stakeholder 
consultations 

Implementation  Simplification 
through digital 
instructions 
Alignment to the 
NLF 

Enforcement 

Enforcement 

Enforcement 

Statistics of 
market-
surveillance or 
other EU 
authorities 
Reports from 
market-
surveillance 
authorities or 
other EU 
authorities 

Reports 

Annual cost savings from 
digital documentation  

Safeguard clauses 
needing 
Commission 
intervention 
Reports 

Number of safeguard 
clauses needing 
Commission intervention 

ICSMS  

Number of pieces of non-
compliant machinery 

RAPEX 

Reports from 
market-
surveillance 
authorities at AdCo 
and MEG meetings 

Accidents, ad hoc 
reporting when concerns 
arise. Shared twice a year 
(at twice-yearly AdCo or 
MEG meetings). 

Member 
States 

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Impact assessment study on the revision of the Machinery Directive 

Annex 1: Procedural information 

1.  LEAD DG, DeCIDE PLANNING/CWP REFERENCES 

The  ‘Revision  of  the Machinery  Directive  2006/42/EC’  is  part  of the  2020  CWP  as  one  of  the 
REFIT  initiatives  the  Commission  in  taking  within  the  “A  Europe  fit  for  the  Digital  Age” 
priority. 

The lead DG for this initiative is the DG for Single market, Industry, Entrepreneurship and SMEs 
(DG GROW). The Directorate in charge is Directorate H - Construction & Machinery.  

The initiative is coded in Decide Planning with the reference PLAN/2018/2979. 

2.  ORGANISATION AND TIMING 

The timing for adoption of the new act by the Commission is April 2021.  

The Inter-service consultation took place in March/April 2021. 

3.  CONSULTATION OF THE RSB 

This impact assessment was sent to the RSB on 18/11/2020. 

A meeting with the RSB took place on 3/02/2021. 

The RSB issued its opinion on 5/02/2021, following which this impact assessment was revised as 
follows:  

RSB recommendations 

Revisions introduced 

(B) Summary of findings 

(1) The report does not provide sufficient evidence 
on the scope and magnitude of the problems (e.g. 
regarding safety requirements, legal instrument). It 
does not explain which the most affected segments 
of the machinery sector are. 

Further evidence on the scope and magnitude of 
the problems and additional explanations on types 
of machinery most affected by changes have been 
added in section 2 of the report: 

-  The  type  of  machinery  affected  by  each 
types  of 

problem,  when  only  some 
machinery are affected; 

-  Market data whenever available; 
-  Examples  of  issues  reported  by  Member 

States; 

-  RAPEX  data  on  non-compliant  products 
(high-risk) 
to  Annex 

IV 

belonging 
machinery. 

(2) The report is not sufficiently transparent on the 
content and foreseen functioning of the policy 
options. It does not bring out clearly enough the key 
differences between the options, and where the main 
decisions lie for the political level. It does not 
sufficiently explore alternatives to deal with specific 
issues, such as on machine learning. 

The following have been added in section 5:  

-  More  detailed  explanation  of  the  policy 

options; 

-  Tables  detailing  how  and  to  what  extent 
every  policy  option  meets  each  specific 
objective. 

The following have been added in section 6:  

-  A  chapter  on  innovation  has  been  added 
at the end of the impacts section in policy 

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Impact assessment study on the revision of the Machinery Directive 

(3) The report lacks sufficient clarity on the role of 
the standardisation process and how future-proofness 
would be ensured, given the evolving safety risk and 
technology landscape. 

(4) The report does not compare the efficiency of 
options in a clear and informative manner. Trade-
offs between the options in terms of efficiency and 
effectiveness are not sufficiently explained. 
C) What to improve 
(1) The report should be more specific on the scope 
and magnitude of the problems, for instance by 
differentiating between problems that affect specific 
segments of manufacturers or users, and problems 
that affect the overall sector. It should better 
substantiate the identified key issues and be 
transparent where there is a lack of, or only limited 
evidence available. 

(2) The report should provide more information on 
divergent transposition and interpretations across 
Member States, and the related problems that might 
justify a change in legal instrument. It should explain 
to what extent the reliance on harmonised standards 
can help mitigate such divergences.   
(3) The report should provide a comprehensive 
description of the content and functioning of the 
options in its options chapter. It should bring out 
more clearly their key differences, including by 
better justifying why certain provisions feature in 
certain policy options and not in others. It should 
explain if any alternative measures, or combinations 
thereof, were considered and, if so, why they were 
discarded. Where relevant, the report should further 
explore such alternative options. This should be the 
case for machine learning throughout the product life 
cycle, where alternative measures should be 
considered that might hamper innovation to a lesser 
extent while adequately ensuring safety. 
(4) The report should clarify how some of the 
options would function. It should better explain why 
and for which types of machinery or new 
technologies the safety requirements or components 
(including in the annexes) would be changed under 
the preferred option. It should describe how this 
would affect current and future standardisation work. 
The report should better assess the future proofness 
of options, including the implications of dealing with 
upcoming new risks through standardisation. 
(5) Overall, the quantitative analysis should be 
complemented by a qualitative explanation and 
assessment. The report should elaborate further the 
analysis of economic impacts, including on SMEs 

76 

option 3. 

The role of the standardisation process has been 
better developed in sections 5 and 6, particularly in 
the description and impacts of policy option 1.  
How future-proofness would be ensured has been 
developed in sections 5 and 6, particularly in the 
description and impacts of policy option 3, which 
is the most future-proof option. 
The efficiency and effectiveness table in section 7 
has been clarified. 

The following have been added in section 2: 

-  The  type  of  machinery  affected  by  each 
types  of 

problem,  when  only  some 
machinery are affected; 

-  Market data whenever available; 
-  Examples  of  issues  reported  by  Member 

States; 

-  RAPEX  data  on  non-compliant  products 
(high-risk) 
to  Annex 

IV 

belonging 
machinery. 

Divergent transposition and interpretations across 
Member States have been better explained in 
section 2 (problem 6) and in section 6 (policy 
option 2 dealing with specific objective 9). 

The following have been added in section 5:  

-  More  detailed  explanation  of  the  policy 

options; 

-  Tables  detailing  how  and  to  what  extent 
every  policy  option  meets  each  specific 
objective. 

The following have been added in section 6: 

-  A  chapter  on  innovation  has  been  added 
at the end of the impacts section in policy 
option 3. 

The following have been added in section 5:  

-  More  detailed  explanation  of  the  policy 

options; 

-  Tables  detailing  how  and  to  what  extent 
every  policy  option  meets  each  specific 
objective. 

The following have been added in section 6: 

-  A  chapter  on  innovation  has  been  added 
at the end of the impacts section in policy 
option 3. 

The following have been added in section 6:  
reference 

-  More 

complete 

to 

competitiveness; 

-  A 

section  on  burden  minimisation, 

 
 
 
 
 
 
 
Impact assessment study on the revision of the Machinery Directive 

and competitiveness. It should present more clearly 
which provisions would contribute to simplifying the 
Machinery Directive. 
(6) The comparison of the efficiency of options 
should be improved to provide a more transparent 
overview of the expected costs and benefits. This 
should also help to better explain trade-offs between 
options in terms of efficiency and effectiveness. 

particularly  for  SMEs,  has  been  added  at 
the  end  of  the  impacts  section  in  policy 
option 3. 

The following have been added in section 5:  

-  Tables  detailing  how  and  to  what  extent 
every  policy  option  meets  each  specific 
objective. 

The following have been added in section 6: 

-  A 

clearer 

and  more 
comparison of the options. 

transparent 

(7) The report should discuss possible solutions to 
solve data limitations in the future monitoring 
framework. 
Other changes as suggested in the check list received 
from the RSB on 29/01/2021 have been incorporated 
to the report. 

In section 9, the report proposes ways for future 
monitoring, but avoids imposing burdensome 
obligations to companies on data gathering.  
The following impacts have been recalculated and 
better explained in section 6:  

- 

Savings  for  companies  of  printing  costs 
linked to digital documentation;  

-  Costs  for  companies  for  buying,  setting 

up and maintaining a server; 

-  Costs  for  users  to  print  parts  of  the 

- 

instructions; 
Savings  of  medical  costs  due  to  workers 
exposure  to  vibration  peaks  when  using 
hand held machinery. 

4.  EVIDENCE, SOURCES AND QUALITY 

The Evaluation101 of the directive identified the key areas for the revision. A study102 supporting 
this impact assessment was carried out by an external contractor. The Commission’s consultants 
carried  out  a  number  of  interviews,  analysed  the  data  from  the  public  and  the  targeted 
consultations, complementing them through desk research and three targeted case studies.  

Evidence was also gathered in the Machinery Working Group, interviews with stakeholders and 
through public or targeted consultations. Another contribution to this impact assessment comes 
from  the  European  Economic  and  Social  Committee  (EESC),  which  issued  an  Information 
Report103  on this initiative. 

Sources  have  been  chosen  as  reliable  as  possible.  Whenever  quantitative  information  has  been 
found,  EU  sources  were  preferred.  When  not  available,  other  sources  were  also  considered. 
Similar  data  were  cross-checked  whenever  possible.  It  is  acknowledged  that  some  data  are 
estimates;  in  order  to  compensate  for  possible  inaccuracies,  throughout  this  document  benefits 
have been estimated in a conservative manner. 

It  has  been  consistently  attempted  to  quantify  impacts,  but  sometimes  limitations  of  data  have 
made possible only a qualitative analysis: 

  As regards emerging technologies, accident data are not available because of the lack 
of penetration in the machinery market of emerging technologies performing safety 
functions.  

101 SWD (2018) 160 final, Evaluation of the Machinery Directive.  
102 Impact assessment study on the revision of Directive 2006/42/EC on machinery. Available at: https://data.europa.eu/doi/10.2873/423938 
103 https://www.eesc.europa.eu/en/our-work/opinions-information-reports/information-reports/revision-machinery-directive  

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Impact assessment study on the revision of the Machinery Directive 

  Limitations on accidents data: Safety incidents on a consumer level are not recorded. 
On occupational safety, Eurostat European Statistics on Accidents at Work (ESAW) 
general data are compulsory, but recording the causes and circumstances, which are 
the  most  interesting  for  an  in-depth  analysis,  is  not  compulsory  and  hence  not 
consistently  reported.  This  has  been  mitigated  by  the  reports  from  Member  States, 
which have a good overview of the risks in their markets. 

  A  lack  of  granularity  in  the  categorisation  of  the  machinery  sub-sectors  in  the 
structural  business  statistics,  where  NACE  codes  do  not  allow  a  high  degree  of 
accuracy. In such cases, proxy were used when possible. 

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Impact assessment study on the revision of the Machinery Directive 

Annex 2: Stakeholder consultation  

Annex 2.1 Introduction 

In the context of the impact assessment on the revision of the MD various consultation activities 
were conducted between March and December 2019. The aim was to assess the potential areas of 
revision  and  the  impacts  of  the  suggested  policy  options  on  different  stakeholder  groups.  The 
consultation  activities  included  semi-structured  interviews,  a  public  consultation  and  a  targeted 
online survey.  

Annex 2.2 Overview of participants 

For all consultation activities, the main stakeholder groups addressed were:  

Industry associations;  

  CEN/CENELEC and other stakeholders involved in standardisation; 
  Companies/manufacturers, importers and distributors;  
  Consumer associations;  
  Experts on AI, AI High Level Expert Group;  
 
  Market Surveillance Authorities;  
  National authorities;  
  Notified bodies;  
  Others, such as citizens and other NGOs; 
  Workers/professionals’ associations. 

Over the course of the impact assessment, 98 stakeholders were interviewed. The majority of the 
interviewees  were  representatives  from  the  industry,  such  as  manufacturers  and  industry 
associations. The graphs below summarise the participation of the different stakeholder groups in 
the  semi-structured  interviews  and  the  country  of  origin.  The  majority  of  the  interviewed 
stakeholders were EU-level based associations, followed by Germany. 

Participants in the semi-structured interviews 

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Impact assessment study on the revision of the Machinery Directive 

The  Public  Consultation  ran  from  June  to  end  of  August  2019  for  12  weeks.  A  total  of  523 
responses  were  recorded,  5  additional  responses  were  submitted  digitally  afterwards.  The 
majority  of  respondents  were  companies,  followed  by  industry  associations.  Indeed,  most 
respondents  were  manufacturers,  followed  by  machinery  safety  consultants  and  industry 
associations.  The  majority  of  respondents  were  from  Germany,  followed  by  France,  the 
Netherlands, Belgium and Italy. Most companies that participated in the public consultation were 
large companies (61%). To account for the differences between large companies and SMEs, the 
results have also been compared along this category to identify potential differences in positions. 
The graphs below indicate the distribution of stakeholder groups that participated in the Public 
Consultation and their country of origin.  

Participants in the Public Consultation 

The targeted online survey was conducted during November 2019. The aim was to close certain 
information  gaps  identified.  A  total  of  24  stakeholders  participated  in  the  survey:  i) 
companies/manufacturers (22); ii) notified bodies (1); and Experts on emerging technologies (1). 

Annex 2.3 Summary of results 

  Specific Objective 1: Cover new risks related to digital emerging technologies 

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Impact assessment study on the revision of the Machinery Directive 

The consultation activities asked stakeholders whether they have experienced or are aware of any 
safety  incidents  with  machinery  using  emerging  technologies,  which  types  of  emerging 
technologies they own and for manufacturers, what the expected trend for employing emerging 
technologies is. 

In general, most stakeholders of all groups participating in the 98 semi-structured interviews did 
not  report  any  instances  of  health  and/or  safety  incidents  resulting  from  the  use  of  machinery 
with AI or IoT implementations. Of the respondents to the public consultation, the majority had 
not encountered (or heard about) situations in which the safety of users (or domestic animals or 
property) was at risk as a result of the internet connection of the machinery (71%), 14% said they 
had. Of those 14%, a few mentioned having heard of the cyberattacks on nuclear power plants 
and  weak  security  or  insufficient  application  of  a  firewall  of  the  software  especially  for  older 
machinery.  Some  stakeholders  were  also  concerned  by  remote  maintenance  or  updates 
conducted,  potentially  while  a  machine  operator  being  at  work.  Most  of  them  indicated.  The 
majority  did  not  own  an  autonomous  domestic  robot  (n=417).  Of  those  that  did  own  a  device, 
most indicated to possess a robot vacuum cleaner (n=66), a robot lawn mower (n=19), a drone 
(n=19) or a robotic toy (physical robot intended for entertainment purposes only) (n=19). Most of 
these devices are not connected to the internet (59%), compared to about 30% that are connected 
to the internet. Again, the majority of domestic robot owners had not encountered situations in 
which  the  safety  of  the  user  was  at  risk  (81%).  Of  those  14  that  had  encountered  problems 
mentioned  “  near  fly-into  incidents  or  animals  trying  to  catch  the  drone”,  “tripping  hazard  of 
robot vacuum cleaners” or “robotic vacuum cleaner pushing a loudspeaker towards the edge of a 
staircase, causing the fall of the loudspeaker” and dangers of electric shocks or static electricity. 
When it comes to the use of emerging technologies, six of the manufacturers that responded to 
the  online  survey  indicated  a  use  of  these  in  their  products,  whereas  more  than  half  of  the 
respondents  indicated  none  or  almost  no  application  of  these  technologies  in  their  products. 
However,  most  foresee  an  increase  in  uptake  of  these  technologies  in  the  future  (n=11),  either 
strongly (n=3) or to a limited extent (n=8). 

Whether  the  risks  of  emerging  technologies  should  be  addressed  in  the  MD  led  to  different 
results across stakeholder groups and type of application. Most respondents to the online survey 
showed preference to an overarching directive or horizontal legislation to cover risks of emerging 
technologies  across  sectors  and  directives  (n=10),  followed  by  those  indicating  that  the  risks 
should be specifically addressed in the MD (n=9). The results of the public consultation showed 
that  most  importers  are  in  favour  of  voluntary  certification.  In  comparison,  consumer 
organisations,  machinery  safety  consultants  and  manufacturers  rather  preferred  sectorial 
legislation  with  regards  to  implementing  cybersecurity  requirements  in  the  EU.  Cross-cutting 
legislation  to  all  products  was  selected  by  most  stakeholders  involved  in  standardisation. 
Authorities,  private  users  and  professional  workers  indicated  preference  towards  cross-cutting 
legislation  with  specific  requirements.  Finally,  other  ways  of  implementation  were  selected  by 
most distributors, industry associations and notified bodies. 

On the question as to whether the current requirements sufficiently covers the safety of human-
robot collaboration, the majority of public consultation respondents answered negatively (36%), 
compared  to  29%  positive  responses.  The  only  stakeholder  group  that  considered  the  current 
requirements  to  suffice  were  industry  associations.  Again,  more  respondents  indicated  a 
preference  towards  adapting  the  current  requirements  to  take  into  account  humans  and  robots 
sharing  a  space  (32%)  than  those  answering  negatively  (27%).  Slightly  more  respondents 
indicated  a  preference  on adding  new  requirements (29%) than  not (27%). With  regards to  the 
interview responses, many stakeholders, in particular manufacturers, referred to the limitations of 
the current requirements in 1.3.7. (risks related to moving parts). These are said to represent the 
most  commonly  used  approaches  of  physically  separating  robots  from  persons  through  fences 

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Impact assessment study on the revision of the Machinery Directive 

and  guards,  and  therefore  no  longer  successfully  cover  the  inherent  nature  of  human-robot 
collaboration. 

Does the MD sufficiently cover human-robot collaboration? 

Opinions on adapting or adding new requirements on human-robot collaboration 

On risks of AI and ML, the responses are varied across stakeholder groups and specific aspects 
on AI and ML. First, on transparency of algorithms and datasets, more respondents to the public 
consultation  negated  that  this  should  be  addressed  in  the  MD  (30%),  compared  to  those  that 
agreed it should (27%). Second, on software updates,  more stakeholders indicated a preference 
towards  addressing  software  updates  in  the  Directive  (41%)  than  those  against it  (26%).  Many 
interviewed industry representatives (manufacturers and industry associations) and some notified 
bodies pointed out that differences of degrees in updates exists, referring to either maintenance 
with regards to minor updates or machinery substantially modified with major updates. Third, the 
vast  majority  of  public  consultation  respondents  indicated  a  preference  towards  covering 
software which ensures a safety function and is placed independently on the market  within the 
MD as a safety component (57%). 

The MD should explicitly address transparency of algorithms and datasets 

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Impact assessment study on the revision of the Machinery Directive 

The MD should specifically address software updates 

Finally,  with  regards  to  cybersecurity,  the  vast  majority  of  stakeholders  recognised  the  risks 
stemming  from  (malicious)  interference  across  all  groups  and  consultation  activities.  Most 
respondents  to  the  public  consultation  indicated  that  the  current  Directive  does  not  sufficiently 
cover cyber threats (47%), with the exception of importers and industry associations. Most of the 
online  survey  respondents indicated  a  preference  towards  pursuing  an  overarching  Directive  or 
horizontal  legislation  to  cover  cyber-security  across  the  board  (n=7).  The  public  consultation 
showed that if requirements on cybersecurity were to be added, these should focus on safety and 
security  requirements  (46%)  or  no  obligatory  requirements  (31%).  Many 
interviewed 
stakeholders, in particular industry representatives but also notified bodies, referred to the already 
existing  requirements  set  out  in  requirements  1.2.1  on  control  systems  under  “external 
influences”. In this regard, cyberattacks were considered to fall under such “external influences”. 
However, a clearer demarcation of this relation in the current legal text was mentioned as option 
to provide additional legal clarity. 

Public Consultation Results on whether MD covers cyber threats affecting safety

  Specific objective 2: Ensure coherent interpretation of the scope and definitions and 

improve safety for traditional technologies 

On  the  question  whether  the  current  exclusion  of  low  voltage  products  covered  by  the  Low-
Voltage  Directive  (LVD)  in  Art.  1.2(k)  of  the  MD  caused  any  problems,  the  majority  of  the 
respondents  to  the  public  consultation  answered  that  it  did  not  (58%).  Most  of  the  offered 
alternatives  were  not preferred  by  most  industry  respondents to the  public  consultation, though 
with differences in opinion across stakeholder groups.  

Manufacturers,  machinery  safety  consultants,  notified  bodies  and  researchers,  for  example,  did 
agree that explicitly differentiating between consumer and commercial/professional products, so 
that  low  voltage  machinery  for  consumer  use  is  excluded,  whereas  the  products  for 
commercial/professional  use  are  not,  could  facilitate  the  application  of  the  Directive. 

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Impact assessment study on the revision of the Machinery Directive 

Interviewees and open questions, however, often mention the risk that certain products or product 
categories could be used in both consumer and professional contexts.  

Respondents' opinion on differentiating between consumer and professional products for Art. 1.2(k), 
by stakeholder group 

Importers  of  machinery  (50%)  and  manufacturers  (27%)  could  also  imagine  a  removal  of  the 
exclusion of low voltage machinery in Art. 1.2(k), so that the machinery whose risks are mainly 
of electrical origin are covered exclusively by the LVD. Most stakeholder groups, however, were 
not in favour of a removal of the exclusion. 

Finally, on the definition of partly completed machinery, the majority of stakeholders did not 
experience any problems with the definition, according to the public consultation results (43.6%). 
In  particular  distributors  (67%),  industry  associations  (55%)  and  manufacturers  (50%)  did  not 
indicate any problems. In comparison, authorities (42%), importers (50%), notified bodies (52%) 
and  private  users  (40%)  mentioned  that  it  had  led  to  the  wrong  classification  of  the  product. 
Machinery  safety  consultants  (57%),  professional  workers  (50%)  and  stakeholders  involved  in 
standardisation  (57%)  indicated  that  it  had  led  to  problems  with  the  CE  marking.  Most  of  the 
interviewed  stakeholders  that  gave  a  response  to  this  question  did  not  prefer  a  removal  of  the 
concept of partly completed machinery.  

On the changing of requirements on carrier and run-control for slow-speed lifts, the majority 
of the stakeholders  indicated  in  the  public  consultation  that  the  requirements  should  be revised 
(45%). Against a revision were only industry associations (23%), if the responses of ‘no opinion’ 
are excluded. Lifts manufacturers were also largely against a revision of the requirements (64%). 
Within the open questions and the interviews, stakeholders were in favour of allowing alternative 
solutions but stressed the importance of keeping the same level or reaching higher levels of safety 
in  comparison  to  the  current  requirements.  They  also  stressed  the  differences  between  product 
categories,  as  alternative  solutions  could  not  be  as  effective  in  limiting  the  risk  of  falling  of 
persons or objects as well as a physical barrier.  

The requirements for carriers or run-controls for slow-speed lifts should be revised 

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Impact assessment study on the revision of the Machinery Directive 

  Specific objective 3: Reassess machines considered as high risk and reassess related 

conformity procedures 

Annex IV covers a list of high-risk machinery and includes other requirements for the conformity 
assessment procedure of these products. 

The  question  to  whether  the  internal  checks  option  in  Annex  IV  of  the  MD  leads  to  safety 
concerns  received  mixed  responses  in  the  public  consultation,  with  40%  indicating  it  does  and 
39%  indicating  it  does  not.  In  particular  the  majority  of  authorities  (63%),  consumer 
organisations (33%), distributors and importers (both 50%), notified bodies (80%), private users 
(80%),  professional  workers  (72%)  indicated  that  it  does  lead  to  safety  concerns.  In  contrast, 
most  industry  associations  (64%),  machinery  safety  consultants  (42%),  manufacturers  (43%), 
researchers  (67%)  and  stakeholders  involved  in  standardisation  (43%)  negated  higher  safety 
concerns due to internal checks.  

Removing  the  option  for  internal  checks  of  Annex  IV  machinery  was  expected  to  lead  to 
increased costs by more than half of the respondents (55%). On the question whether other high-
risk categories of machinery should be added to the Annex yielded mixed results. Most did not 
indicate  any  preference  (39%),  followed  by  respondents  negating  that  they  should  be  included 
(31%). The  respondents  with  a  preference  for  either  option  are importers  (3  out  of  6),  notified 
bodies (75%) and professional workers (11 out of 18) that prefer an inclusion of other high-risk 
categories,  compared  to  industry  associations  (55%)  rather  not  preferring  an  inclusion  of  other 
categories. The interview responses, on the other hand often referred to an adaptation and regular 
updates of the Annex IV as potential to bring benefits.  

  Specific objective 4: Reduce paper-based requirements for documentation  

On allowing digital formats for documentation, the public consultation asked a few questions on 
the  experiences  with  user  manuals.  The  majority  of  the  stakeholders  across  groups  (with  the 
exception  of consumer  organisations and industry  associations) indicated  that the  user  manuals 
were  difficult  to  understand  (59%).  The  most  common  mentioned  difficulties  were  related  to 
‘manuals being badly written’ (47%), followed by other reasons (29%) and the manual being too 
complex (10%). The stakeholder groups representing the industry in majority indicated that they 
have had the need to update their manuals (87%) and almost all of them answered that electronic 
manuals  would  have  facilitated the  process (98%). With regards to  the  preferences  on the  way 
user manuals should be provided, the majority of stakeholders indicated ‘always digital’ (63%), 
followed  by  ‘short  printed  Quick  Start  Guide  (QSG)  and  in-depth  online  manual’  (51%). 
Stakeholder  groups  showed  different  opinions.  While  the  option  of  always  having  a  digital 
manual  was  preferred  by  importers  (67%),  industry  associations  (63%),  machinery  safety 
consultants  (57%), notified  bodies  (55%),  private  users (all),  professional  workers (72%),  most 
authorities (58%) preferred always having a printed version. A combination of a QSG and a more 
in-depth  online  version  of  the  manual  was  preferred  by  most  distributors  (67%),  consumer 
organisations (67%) and a potential alternative for authorities (46%).  

Preferences on the delivery of user manuals by stakeholder group 

Q32.1: Delivery 
user manual - 
always printed 

Authority enforcing MD 
Consumer organisation 
Distributor 
Importer 
Industry association 

58.3% 
0.0% 
16.7% 
16.7% 
12.5% 

Q32.2: Delivery 
user manual - 
printed on 
demand 
12.5% 
0.0% 
66.7% 
16.7% 
25.0% 

Q32.3: 
Delivery user 
manual - 
digital 
33.3% 
33.3% 
33.3% 
66.7% 
62.5% 

Q32.4: Delivery 
user manual - 
external device 
(DVD/USB) 
20.8% 
0.0% 
16.7% 
16.7% 
14.1% 

Q32.5: 
Delivery user 
manual - QSG 

45.8% 
66.7% 
66.7% 
16.7% 
57.8% 

Q32.6: 
Delivery user 
manual - 
other 
25.0% 
33.3% 
0.0% 
16.7% 
51.6% 

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Impact assessment study on the revision of the Machinery Directive 

Q32.5: 
Delivery user 
manual - QSG 

Q32.1: Delivery 
user manual - 
always printed 

Q32.2: Delivery 
user manual - 
printed on 
demand 
16.5% 
27.4% 
11.4% 
20.0% 
22.2% 
0.0% 
14.3% 
2.2% 

Q32.3: 
Delivery user 
manual - 
digital 
56.5% 
69.3% 
54.5% 
100.0% 
72.2% 
33.3% 
57.1% 
67.4% 

Q32.4: Delivery 
user manual - 
external device 
(DVD/USB) 
22.4% 
21.7% 
15.9% 
20.0% 
11.1% 
33.3% 
0.0% 
15.2% 

45.9% 
19.3% 
38.6% 
40.0% 
50.0% 
0.0% 
14.3% 
52.2% 

Machinery safety consultant 
Manufacturer 
Notified body 
Private user 
Professional worker 
Researcher/academic 
Stakeholders i in standardisation 
Other 
If a combination of an in-depth online manual with a printed QSG was selected, most mentioned 
information that should be included in the Guide was ‘basic handling information’ (40 mentions), 
followed by ‘details of safety control systems’ (34 mentions). The expected effects of moving to 
online manuals only was ‘access to manual would be difficult without internet’ (55%) and ‘users 
would  only  print  the  relevant  parts’  (44%).  Within  the  open  questions  and  the  interview 
responses, the majority of industry stakeholders expected high cost savings of switching to digital 
documentation. 

50.6% 
49.5% 
52.3% 
60.0% 
44.4% 
33.3% 
71.4% 
47.8% 

Q32.6: 
Delivery user 
manual - 
other 
12.9% 
13.2% 
31.8% 
0.0% 
11.1% 
33.3% 
28.6% 
30.4% 

  Specific objective 5: Ensure coherence with other NLF legislation 

Alignment to the New Legislative Framework received nearly universal support, despite the fact 
that  stakeholders  did  not  report  any  major  problems  resulting  from  the  lack  of  alignment.  An 
alignment to the NLF would affect all stakeholder groups in the machinery sector, in particular 
manufacturers  and  market  surveillance  authorities.  For  the  industry  stakeholders  that  as 
manufacturers must apply other Directives that are aligned, more coherence would be beneficial. 
In particular, it was considered useful to have all Directives under one regulatory framework, as 
with  different  products,  different  Directives  have  to  be  complied  with.  National  authorities 
considered  that  the  alignment  would  lead  to  easier  market  surveillance,  better  explanation  of 
certain  terms  and  common  rules  between  technologies.  Market  surveillance  authorities  cited 
clarity  of  responsibilities  of  the  economic  actors  and  focus  on  market  surveillance.  Notified 
bodies  and  machinery  safety  consultants  on  the  other  hand  noted  that  the  quality  of  the 
conformity assessment would increase through the alignment.  

  Specific  objective  6:  Reduce  possible  divergences  in  interpretation  derived  from 

transposition 

This objective focuses on the potential of converting the Directive into a Regulation. Most of the 
stakeholders  that  participated  in  the  public  consultation  did  not  indicate  any  problems 
experienced through delays of transposition (44%) or due to differences in transposition across 
the Member States (MS) (38%), with the exception of stakeholders involved in standardisation. 
Nevertheless,  even  though  no  problems  arose  from  potential  differences  in  transposition,  most 
stakeholders  mentioned  potential  benefits  of  converting  the  Directive  into  a  Regulation.  For 
manufacturers, a conversion could lead to a decrease of additional costs related to differences in 
interpretation across MS. Indeed, the vast majority of stakeholders across groups showed a clear 
preference of converting the Directive into a regulation (79%).  

Further  information  on  all consultation  activities  performed  can  be  found  in  the  in  the ‘Impact 
assessment study on the revision of Directive 2006/42/EC on machinery’104.  

104 Impact assessment study on the revision of Directive 2006/42/EC on machinery. Available at: https://data.europa.eu/doi/10.2873/423938 

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Annex 3: Who is affected and how? 

1.  PRACTICAL IMPLICATIONS OF THE INITIATIVE 

First,  changes  to  the  requirements  will  lead  to  additional  direct  compliance  costs  borne  by 
manufacturers in terms of adaptation to the changes, training and familiarity with the new text. 
Standardisation bodies will also be affected by the necessity to review the transferability of the 
revised requirements to the list of harmonised standards in the OJEU. Other stakeholder groups, 
including notified bodies and market surveillance authorities are also likely to be affected by a 
need to familiarise with the new legal requirements. However, the impacts generated by a change 
of requirements can be mitigated by keeping the numbering of the new or adapted requirements 
close to the existing list or by providing a reference table between the current requirements and 
the new ones. Machinery users and consumers will benefit from safer products in the market, at a 
potentially higher price if manufacturers pass the higher costs on. Machinery users will benefit 
from safer products in the market, at a potentially higher price if manufacturers pass the higher 
costs on to them. Society will benefit from a significant reduction of public health systems costs 
across the EU. 

In relation to the compliance costs, it must be stressed that the scope of the MD is very wide, and 
not  all  safety  requirements  in  Annex  I  of  the  MD  are  applicable  for  all  types  of  machinery. 
Manufacturers  need  to  make  a  risk  assessment,  to  determine  the  risks  involved  and  the  safety 
requirements  relevant  for  their  machinery,  and  they  need  to  ensure  compliance  only  to  those. 
New or revised requirements proposed in this policy option are proportional and targeted, since 
limited  to  certain  types  of  machinery.  For  instance,  requirements  on  overhead  power  lines  are 
relevant  only  to  certain  high  mobile  machinery  types,  declaration  of  peak  vibration  values  is 
requested for portable hand-held and/or hand-guided machinery, and requirements on hazardous 
substances are applicable only to machines whose operation implies emissions of those. 

As  outlined  in  chapter  1.3  of  this  report,  many  machinery  manufacturers  belong  to  the  SME 
category.  Users  (workers  and  consumers)  will  expect  a  same  level  of  product  safety, 
independently  of  the  size  of  the  company  producing  it.  Impacts  of  policy  option  3  on  SMEs 
include additional costs in few cases where they may need to adapt the design of their machinery 
to  comply  with  new  requirements,  although  those  would  be  targeted,  and  limited  to  certain 
machine types. On the other hand, diligent manufacturers will be already implementing some of 
the  revised  requirements  and  in  such  cases  they  would  have  a  competitive  advantage  once  the 
revised MD is in force.  

Secondly, clarifications in scope and definitions may be beneficial for manufacturers who will 
not  need  to  seek  advice  or  resort  to  private  contracts  for  clarification.  SMEs  will  particularly 
benefit from the legal clarity that the revised MD will bring, important for them since SMEs have 
typically less resources to follow up and seek advice on legislation. Further legal clarity will have 
an  effect  on  the  reduction of  uncompliant  products  in  the  market,  for  the  benefit  of  machinery 
users (workers and consumers). 

Thirdly,  a  revised  list  of  high-risk  machinery  (Annex  IV  of  the  MD)  will  lead  to  additional 
direct  compliance  costs  for  third  party  involvement  borne  by  manufacturers  of  products  newly 
added  to  it,  and  potential  savings  for  products  removed.  Other  stakeholder  groups,  including 
notified  bodies  and  market  surveillance  authorities  are  also  likely  to  be  affected  by  a  need  to 
familiarise with the new legal requirements, although notified bodies will increase their turnover 
and market surveillance authorities will be backed by the notified bodies work. Machinery users 
and  consumers  will  benefit  from  safer  products  in  the  market,  although  at  a  potentially  higher 

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Impact assessment study on the revision of the Machinery Directive 

price if manufacturers pass the higher costs on to them. A removal of the internal checks option 
for conformity assessments of Annex IV machinery would bring additional costs for third party 
involvement  to  manufacturers,  but  is  expected  to  increase  the  effectiveness  of  the  Directive  to 
ensure the protection of health and safety of users. 

Fourthly, allowing digital documentation will bring cost savings to manufacturers, as well as 
an environmental benefit derived from the reduction in paper consumption and waste. Additional 
costs for manufacturers derived from the setting up of proper digital traceability systems will be 
offset by far by the economic benefits. In some cases, market surveillance authorities will need to 
adapt  and  put  in  place  new  market  surveillance  procedures  related  to  digital  documentations. 
Under  the  existing  NLF  product  legislation,  market  surveillance  authorities  have  already  been 
adapted to digital documentation e.g. ICSMS.  Machinery users and consumers will benefit from 
a free of charge paper version of the manual instructions should they require it. 

Finally, an alignment to the NLF and a conversion of the directive to a regulation represents 
an  opportunity  to  harmonise  the  market  surveillance  process,  clarify  the  economic  operators’ 
obligations  and  decrease  costs  of  compliance  borne  by  manufacturers  through  a  reduction  of 
differences  in  interpretation  across  Member  States.  The  work  of  the  market  surveillance 
authorities will be likewise facilitated. Machinery users and consumers will benefit from a lower 
number of uncompliant machinery in the market. 

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2.  SUMMARY OF COSTS AND BENEFITS 

This table summarises the potential costs and benefits of all the potential changes. The majority 
of the costs are expected to be one-off, as the compliance costs currently at place will continue to 
apply. 

I. Overview of Benefits (total for all provisions) – Preferred Option (Policy Option 3) 

Description 

Amount 

Comments 

Direct benefits 

Administrative 
cost reductions 

Printing saving costs up to EUR 
16.6 billion (EUR 201 000 per 
company) 

printing costs saved with digital instructions and 
DoC 

Social benefits  EUR 15 million yearly 

Reduced social costs for sick leave and occupational 
injuries, medical examinations and early retirement, 
by reduced vibration peaks in handheld machines 

Compliance 
cost reductions 

Increased legal 
certainty 

Safety of 
products on the 
market 

EUR 5 000 to 10 000 per instance  These cost reductions for economic operators could 

be achieved through clarifications in scope and 
definitions resulting from lowering the costs related 
to resolving unclarities 

EUR 100 to EUR 500 per instance  A change of the requirements in terms of emerging 

technologies can lead to improved legal certainty 
and maintain a level playing field, particularly for 
manufacturers 

Indirect benefits 

Reduction of non-compliant 
products 
(The removal of the internal checks 
option for conformity assessments 
of Annex IV machinery is expected 
to increase the effectiveness of the 
Directive to ensure the protection 
of health and safety of users) 

Machinery users would indirectly benefit from a 
clarification of the scope and definitions, as well as 
from new/revised targeted safety requirements 
through a reduction of non-compliant products on 
the market and increased safety. This benefit will be 
reinforced by the alignment of the MD to the NLF 

Estimates are relative to the baseline for the preferred option as a whole (i.e. the impact of individual 
actions/obligations of the preferred option are aggregated together). Stakeholder group main recipient of the benefit in 
the comment section is indicated. For reductions in regulatory costs, details as to how the saving arises (e.g. reductions 
in compliance costs, administrative costs, regulatory charges, enforcement costs, etc.) are provided. 

II. Overview of costs – Preferred option (Policy Option 3) 

Citizens/Consumers  

Businesses 

Administrations 

One-off  Recurrent 

One-off 

Recurrent 

One-off 

Recurrent 

Specific 
Objective 
1 

Direct costs 

Compliance 
and 
adaptation 
to changes 

Compliance 
and 
adaptation 
to changes 

Higher 
prices in the 
market if 
passed on 
by 
companies 

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Impact assessment study on the revision of the Machinery Directive 

II. Overview of costs – Preferred option (Policy Option 3) 

Citizens/Consumers  

Businesses 

Administrations 

One-off  Recurrent 

One-off 

Recurrent 

One-off 

Recurrent 

Indirect 
costs 

Specific 
Objective 
2 

Direct costs 

Indirect 
costs 

Specific 
Objective 
3 

Direct costs 

Specific 
Objective 
4 

Indirect 
costs 

Direct costs 

Indirect 
costs 

Specific 
Objective 
5 and 6 

Direct costs 

Indirect 
costs 

Compliance 
and 
adaptation 
to changes 

Compliance 
and 
adaptation 
to changes  

Higher 
prices in the 
market if 
passed on 
by 
companies 

Familiarisati
on with new 
legal text 
(one-off). 

Increased 
costs of 
products if 
additional 
costs are 
moved 
down the 
value chain 

If the internal 
checks 
procedure is 
removed: 
Increased costs 
for third parties 
conformity 
assessment 
/Annual EUR 
202 million 
overall 

EUR 29 
million 
(EUR 1 960 
in average 
per 
company) 

EUR 48 million  
(EUR 3 264 in 
average per 
company) 

Increased 
costs of 
adaptation 
to new 
procedure. 

EUR 0.4 per 
manual if 
user decides 
to print part 
of the 
manual 
(number of 
manuals not 
identified) 

Some 
adaptation 
costs likely 
but expected 
to be 
marginal 

Some 
adaptation 
costs likely 
but expected 
to be 
marginal 

Estimates are provided with respect to the baseline. Costs are provided for each identifiable action/obligation of the 
preferred option otherwise for all retained options when no preferred option is specified. If relevant and available, 
information on costs according to the standard typology of costs (compliance costs, regulatory charges, hassle costs, 
administrative costs, enforcement costs, indirect costs) is provided. 

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Impact assessment study on the revision of the Machinery Directive 

Annex 4: Analytical methods 

This Annex presents a general overview of the methodological approach taken during this impact 
assessment. In order to provide an exhaustive and systematic answer to all evaluation questions, 
data and information from a wide range of sources have been collected. 

This impact assessment is supported by a study  105 carried out through a range of data collection 
methods. A desk research and literature review from statistical databases, reports and studies, 
a  stakeholder  consultation  comprising  semi-structured  interviews  (68  interviews),  a  public 
consultation  (528  replies),  follow-up  interviews  (30)  and  three  use  cases  on  emerging 
technologies  (digital  transformation,  product  optimisation  and  self-driving  robots)  were 
performed. 

In addition, regular Machinery Working Group meetings have been held with all stakeholders has 
allowing  all  stakeholder  groups  to  express  their  views,  also  when  evolving  in  light  of  deeper 
discussions.  A  contribution  was  also  received  from  the  European  Economic  and  Social 
Committee  (EESC),  by  means  of  an  Information  Report  issued  on  this  initiative  106.  Finally, 
constant  exchanges  with  all  stakeholders  by  the  Commission  services  has  allowed  a  wide  and 
extensive consultation process at all levels which has left no voice unheard. 

Overview of the assessment tools and methods 

Firstly, key existing documentation and information were reviewed in a desk research exercise 
and literature review with the objective of providing an accurate description of the state of play 
regarding the current market developments and characteristics. 

In addition, an assessment of the likely impacts of the policy options for the main target groups 
(consumers,  businesses,  Member  States,  notified  bodies,  and  standardisation  organisations)  has 
been  conducted.  For  that  purpose,  several  assessment  tools  were  employed:  firstly,  desk 
research  and  literature  review  gathered  all  data  and  information  available  from  statistical 
databases,  reports  and  studies.  Subsequently,  a  stakeholder  consultation  comprising  semi-
structured  interviews  was  organised  to  refine  the  assessment  and  gather  input  on  potential 
impacts  regarding  the  effectiveness  and  efficiency  of  the  policy  options.  Moreover,  a  public 
consultation  targeting  a  wider  range  of  stakeholders  has  been  organised  to  complement  the 
inputs  received  from  the  interviews.  Following  these  consultation  tools,  follow-up  interviews 
were  conducted  to  close  the  data  and  information  gaps  identified.  Lastly,  following  the  same 
incentive,  an  online  survey  targeted  at  those  stakeholders  that  provided  the  fewest  input  in  the 
previous consultation phases was conducted. 

The  results  and  input  from  the  data  collection  tools  have  been  assessed  using  a  multi-criteria 
analysis  consisting  of  a  quantitative  assessment  based  on  available  data,  and  a  qualitative 
dimension  based  on  the  interviews  with  relevant  stakeholders.  Lastly,  public  consultation  and 
survey results have been used to assess benefits of stakeholders that cannot be monetised. 

Robustness of the results 

The diversity of methodologies used to collect data described above ensures a broad coverage of 
different  sources  of  information.  In  order  to  ensure  the  robustness  of  the  results  of  this  impact 

105 Impact assessment study on the revision of Directive 2006/42/EC on machinery. Available at: https://data.europa.eu/doi/10.2873/423938 
106 https://www.eesc.europa.eu/en/our-work/opinions-information-reports/information-reports/revision-machinery-directive  

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Impact assessment study on the revision of the Machinery Directive 

assessment,  the  key  method  of  triangulation  of  findings  has  been  employed  during  the  data 
analysis phase to verify the findings increasing the validity of the overall analysis.  

Triangulation of findings means cross-checking and validating information collected through one 
method  by  comparing  it  with  the  information  collected  through  other  methods.  In  this  way,  it 
tests  the  consistency  of  findings  collected  across  the  different  methods  and  enables  to  assess 
some of the threats influencing analysis results. By doing so, some of the biases that come with 
the different data collection tools can be mitigated. For instance, this is case with the statistical 
biases  that  come  with  quantitative  targeted  consultations  such  as  the  surveys  that  have  been 
conducted (sampling bias, non-response bias and response bias). 

Triangulation is also useful to combine quantitative and qualitative data and to ensure the overall 
coherence  of the  analysis. This approach,  using  multi-level  and  multi-stakeholder  dimension in 
the  data  collection,  ensured  the  robustness  and  reliability  of  the  data  and  information  used  to 
draw up conclusions. 

There are instances where data are quantified based on responses to consultations or interviews. 
When the number of replies is too low to present an estimate, cost cannot be reliably quantified. 
Proxy values are used when direct information is not available. 

Methodology for calculation of impacts 

Methodology  for  calculation  of  reduced  social  costs  of  EUR  15  Million  for  sick  leave  and 
occupational injuries medical examinations thanks to changes in requirements for declaration of 
peak vibration in hand held machinery: 

- 

In Sweden, there are 400 000 exposed vibrations from hand held machinery. The medical 
examinations  of  vibration  injuries  cost  around  EUR  3  000.  It  is  reported  that  the 
requirement proposed would improve the situation and avoid 100 medical visits per year. 
This  means  that  a  reduction  of  the  number  of  performed  medical  examinations  by  100 
per year would lessen the costs in Sweden by EUR 300 000 every year.  These savings, 
extrapolated to the EU27 based on the population ratio (ca. 50), would make a total EU 
saving  of  EUR  15  Million.  (Source:  Machinery  Working  Group  document  ‘WG-
2020.46rev Swedish proposal and effects of a revision of the legal requirements in annex 
1, 2.2.1.1 on vibrations for handheld machinery’.) 

Methodology for calculation of impacts for manufacturers of Annex IV machines if the internal 
checks procedure is removed:  

- 

Increased  costs  for third  parties  hired for  the  conformity  assessment  /Annual EUR  202 
895 485 (recurring):  Based on the difference in cost for conformity assessment of third-
party assessments compared to internal checks, for the 10% of products that currently fall 
under internal checks under Annex IV. (Source: ‘Impact assessment study on the revision 
of Directive 2006/42/EC on machinery’.)  

Methodology for calculation of impacts on digital documentation: 

Savings in printing costs by companies: 

-  Printing costs are reported to reach 1-4% of companies’ turnover per year. Taking in to 
account EUR 663 billion turnover in the machinery sector in 2017, this leads to an annual 
recurrent cost for the industry of up to between EUR 6.63 billion and EUR 26.5 billion. 
According  to  the  public  consultation  on  the  preferences  of  the  form  of  documentation, 

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62.7% would like to have it always digital, bringing the estimate of the annual recurrent 
savings for the industry to between EUR 4 billion and EUR 16.6 billion. Dividing these 
amounts by the number of companies 82 239, this savings can be estimated at between 
48 000 and 201 000 per company. 

Costs for developing and maintaining the database for online manuals by companies: 

-  EUR  1  960:  Based  on  average  of  EUR  1  845  for  purchasing  a  server  plus  average  of 

EUR 115 to set up a server (EUR 1 960 per organisation) 

-  EUR 29 013 919: Based on average costs of purchasing and setting up a server for small 
business od EUR 1 960, multiplied by the number of companies 82 239 and multiplied 
by 18% of companies not yet using digital formats. 

-  EUR  3  264:  Based  on  average  of  EUR  272  per  month  (EUR  3  264  per  year)  costs  of 
maintaining the server at maximum complexity of the system for small businesses. Costs 
for large manufacturers are likely to be lower. 

-  EUR 48 317 057: Based on the yearly costs of maintaining a server times EUR 3 264 the 
number of companies 82 239 and multiplied by 18% of enterprises not yet using digital 
formats. 

User costs for printing digital manuals by users of EUR 0.4 per manual is calculated as follows:  

-  Total  printing  costs:  average  between  1%  and  4%  =2.5%,  multiplied  by  turnover  EUR 

663 billion = EUR 26 520 000  

-  EUR 26 520 000 divided by 3.1 billion number of machinery units sold = EUR 8.5 per 

manual 

-  The cost of printing translation only was estimated by taking 1/23 of a manual based on 
the  assumption  that  this  manual  contains  all  23  EU  languages.  Therefore,  supposing  a 
user  would  only  print  his  own  language,  costs  of  an  individual  printing  would  reach 
about EUR 0.4 per manual. No difference could be made on the number of manuals used 
by professional users in comparison to consumers. 

Methodology for calculation of impacts from transposition 

-  Cost  savings  in  terms  of  clarification  procedures  between  manufacturer  and  Member 
State authorities. EUR 100 to EUR 500 per instance. Based on consultation answers. The 
number of instance could not be estimated. 

Data limitations and mitigation 

As regards accidents data, key data limitations should be considered. First, safety incidents on a 
consumer level are not recorded. Second, availability of data differs depending on the variable of 
Eurostat  European  Statistics  on  Accidents  at  Work  (ESAW).  The  main  characteristics  of  the 
accident and of the employer, so called ‘Phase I’ and ‘Phase II’ variables of ESAW, are based on 
compulsory data provided by individual companies and reported by countries with a more or less 
coherent method. Variables on causes and circumstances, so called ESAW ‘Phase III’ variables, 
are the most interesting for an in-depth analysis due to their level of detail. However, reporting is 
not compulsory for all Phase III variables by Member State authorities; as such, availability and 
reliability varies strongly between countries. This has been mitigated by the information that is 

93 

 
 
 
 
 
 
Impact assessment study on the revision of the Machinery Directive 

made  available  by  Member  states  in  the  ICSMS  and  RAPEX  systems  about  unsafe  products 
found in the market, and the safety concerns and related accident data regularly reported at the at 
the  Machinery  Administrative  Cooperation  Group  (AdCo)  biannual  meetings  (market 
surveillance  authorities  and  the  Commission  as  observer)  and  also  at  the  Machinery  Working 
Group  biannual  meetings  (with  all  interested  stakeholders:  industry,  trade  unions,  consumer 
associations, standardisations organisations, notified bodies, market surveillance authorities and 
Commission). 

Another  limitation  is  the  categorisation  of  the  machinery  sector  in  the  structural  business 
statistics, where NACE codes do not allow the market sector and potential affected or involved 
actors  to  be  identified  to  a  high  degree  of  accuracy.  This  is  the  case,  for  example,  with  the 
product group low-voltage products. In such cases, a proxy was used.  

94 

 
 
 
 
 
 
Annex 5: SME TEST 

Preliminary assessment of businesses likely to be affected 

According to the stakeholder consultations, no specific business sector were mentioned as being 
particularly or disproportionally affected by the policy options.  

Consultation with SMEs representatives 

SMEs  taking  part  in  the  public  consultation  did  not  report  any  difficulties  in  buying/selling 
machinery  from/to  EU/EFTA/CH/TK  (42%,  n=119).  Similarly,  a  majority  of  SMEs  did  not 
report  any  difficulties  in  identifying  the  relevant  risks  (59%,  n=67).  SMEs  in  majority  also 
reported  no  difficulties in identifying  Requirements (55.2%)  or  finding  right  standards  (41.8%, 
n=67). A majority of SMEs experienced no difficulties in doing conformity assessment (46.3%), 
no  difficulties  in  preparing  the  documentation  (41.8%),  no  difficulties  in  receiving  correct 
declaration of conformity (44.8%), no difficulties in receiving correct instructions (44.85) and no 
difficulties understanding responsibility for CE marking (41.8%) (n=67). SMEs did report some 
difficulties in translating documentation in other EU languages (37.3%, n=67).  

A majority of SMEs (57.1%) reported experiencing situations in which safety of users was at risk 
for  using  machinery  (n=119).  For  majority  of  SMEs  (75.6%),  internet  connection  was  not  the 
main  cause  of  safety  risks  for  the  users  (n=119).    SMEs  reported  in  large  majority  (75%) 
experienced  problems  were  caused  by  machines  from  EU/EFTA/CH/TK  (n=68).  On  the  other 
hand,  a  majority  of  SMEs  (80%)  experience  problems  when  ensuring  compliance  for  product 
(n=5),  however  the  results  for  this  observation  can  be  distorted  due  to  the  small  number  of 
participant SMEs.  

Public  consultation  with  SME  representatives  produced  the following  results  about the  specific 
objectives:   

  Specific Objective 1: Cover new risks related to digital emerging technologies 

SMEs remained rather non-informative when asked about future technical developments and its 
impacts, as most of the times SMEs responded with “no opinion”.  

A majority of SMEs participating in the public consultation do not have an opinion (40.9%) on 
whether  the  MD  sufficiently  covers  human-robot  collaboration  (n=115).  36.5%  of  participant 
SMEs  responded  that  the  MD  does  not  sufficiently  covers  the  human-robot  collaboration, 
compared  to  22.6%  of  SMEs  who  believe  that  MD  covers  sufficiently  the  human-robot 
collaboration  (n=115).  Almost  half  of  the  participant  SMEs  (49.6%)  in  the  public  consultation 
also do not have an opinion on whether requirements should be adapted to cover the human-robot 
collaboration (n=115). 30.4% of SMEs on the hand believes that requirements should be adapted 
in  order  to  account  human  and  robots  in  shared  space.  26.1%  of  SMEs  believe  that  new 
requirements  should  be  added  to  cover  human-robot  collaboration  (n=115).  According  to  the 
45%  of  the  consulted  SMEs  in  the  public  consultation  report  that  changes  made  to  the  
requirements  in  order  to  take  into  account  human-robots  collaboration  will  results  in  the 
production costs (n=20).  

SMEs responded in majority with “no opinion” on the possible MD addressing transparency of 
algorithms (53.9%) and software updates (45.2%) (n=115). On the other hand, SMEs believe in 
majority (60.9%) that the MD should cover independent software as safety component (48.7%) 
(n=115). More than half of the SMEs (55.7%) believe that concept of foreseeable misuse is still 
relevant (n=115). 

 
 
 
Regarding  cybersecurity,  a  majority  of  SMEs  (45.2%)  believe  that  MD  does  not  cover 
cybersecurity  well  (n=115)  and  47.8%  of  SMEs  believe  that  safety  and  security  requirements 
should be added to specifically address the issue of cybersecurity. However, on the question on 
how the cybersecurity requirements should be implemented in the EU, majority of SMEs (29.6%) 
believes that the best approach to do so is via sectoral legislation (n=115).  

  Specific objective 2: Ensure coherent interpretation of the scope and definitions and 

improve safety for traditional technologies 

When  discussing  clarifications  about  the  scope  and  definitions,  47%  of  SMEs  reported  facing 
problems with partly completed machinery due to its wrong classification. More than half of the 
SMEs (52.2%) agree with the change of the definition - partly completed machinery.  

Majority  of  SMEs  (48.7%)  does  not  have  an  opinion  whether  the  changes  to  the  safety 
requirements covering speed lifts should be made. 34.8% of SMEs however believes that safety 
requirements  should  be  changed  (n-115).  Large  majority  of  SMEs  (88.1%)  believes  that  if 
changes  to  the  safety  requirements  covering  speed  lifts  were  to  be  made,  there  would  be  no 
changes in costs (neither increase nor decrease of costs) (n=67).  

  Specific objective 3: Reassess machines considered as high risk and reassess related 

conformity procedures 

44.3% of SMEs believe that internal checks conducted by manufacturers themselves can lead to 
safety concerns (n=115). On the other hand. 33.9% of SMEs believe there are no safety concerns 
associated with the internal checks. Removing internal checks option would in the opinion of a 
majority of SMEs (47.8%) lead to an increase of costs (n=67). Removing internal checks option 
would  for  39.8%  of  SMEs  mostly  affect  the  production  cost  (39.8%  of  SMEs)  and  turnover 
(39.8% of SMEs). A majority of SMEs participating in the public consultation does not have an 
opinion  on  the  possibility  of  updating  the  Annex  IV by  adding  higher risk  category  machinery 
(45.2%). From those SMEs that answered the question, 29.6% of SMEs would support adding the 
higher risk categories of machinery to the Annex IV compared to 25.2% of SMEs that are against 
this update (n=115). Updating the Annex IV by adding high risk categories of machinery would 
according to most SMEs (47.1%) affect the production costs. 

  Specific objective 4: Reduce paper-based requirements for documentation 

61.3%  of  users  which  are  SMEs  reported  having  difficulty  in  understanding  user  manual.  For 
majority of SMEs (45.3%), the main reason are badly written manuals (n=115). Large majority of 
SMEs  (85.7%)  reported  to  have  the  need  to  update  manuals  and  93.8%  of  SMEs  believes  that 
electronic manuals would make updating easier (n=115). More than half of the SMEs believe that 
digital manuals would create cost savings due to the paper savings (n=115).  

  Specific objective 5: Ensure coherence with other NLF legislation 

53.9% of SMEs agree with the alignment of MD to the New Legislative Framework (n=115).   

  Specific  objective  6:  Reduce  possible  divergences  in  interpretation  derived  from 

transposition 

Majority of SMEs participating in the public consultation (78.3%) would support the conversion 
of the Directive into regulation (n=115). 

 
 
Annex 6: Example of a collaborative robot  

The  collaborative  robot  AURA  is  a  relevant  example  from  a  regulatory  perspective.  Aura  is 
marketed as Partly Completed Machinery. 

Aura as advertised on Comau’s website107 

AURA can automatic switch from a collaborative mode  or a non-collaborative high-speed 
mode as needed. In the speed and separation monitoring mode, the AURA’s automatic motion 
discontinues  when  a  human  comes  closer  to  the  co-bot  than  the  pre-programmed  minimum 
separation  distance  allows.  During  the  non-collaborative  high-speed  mode,  the  AURA  exerts 
kinetic forces that could cause serious injury to human collaborators. While a sophisticated laser 
sensor enables emergency interruptions in case a moving object is detected close to the AURA, 
and the frame of the co-bot is fitted with soft foam108, a potential failure of the sensor input could 
still lead to a severe workplace injury. As noted by a stakeholder, the MD’s clause according to 
which  “the  moving  parts  of  machinery  must  be  designed  and  constructed  in  such  a  way  as  to 
prevent risks of contact which could lead to accidents or must, where risks persist, be fitted with 
guards  or  protective  devices”  may  be  considered  limiting  with  regards  to  human-robot 
collaboration. In addition, operators can stop the AURA at any time. While the MD requires that 
machinery needs to be able to be overruled by humans, overruling a co-bot can also pose a risk. 
In practice, some co-bots should not be able to be overruled by all users. A situation could occur, 
for  example,  in  which  an  AURA  shuts  down  during  an  emergency  in  a  complex  collaborative 
workflow  and  overruling  the  co-bot  could  pose  a  risk  to  humans  or  equipment  at  subsequent 
stages of the workflow.109 

In  addition,  AURA  is  intended  to  work  in  the  proximity  of  human  co-workers  and  can  be 
manually  or  autonomously  switched  between  collaborative  and  non-collaborative  mode, 
during which the co-bot performs high-velocity movements110. Human operators on the factory 
floor need to be aware of the operational mode that the AURA is currently functioning in order 
not to involuntarily shut down operations by getting too close to the co-bot111. This heightened 
degree of required vigilance – from a workflow efficiency perspective – can create an additional 
cognitive  burden  on  human  collaborators  that  might  cause  mental  distress  in  the  long  run.  In 
addition, human collaborators are exposed to the additional stress factor of being in the vicinity 
of  a  co-bot  that  is  at  times  collaborative,  and  at  other  times  not.  This  may  induce  fear  of 
dangerous  contact  itself,  although  the  AURA  has  passed  all  required  risk  assessments  before 
being deployed on the factory floor112.  

107 https://www.comau.com/en/our-competences/robotics/automation-products/collaborativerobotsaura 
108 COMAU (n.d.) AURA: Advanced use robotic arm. Available at: https://www.comau.com/Download/our-
competences/robotics/Automation_Products/Folder_Aura%20Doppie.pdf 
109  TNO 
risks 

the 
https://repository.tudelft.nl/view/tno/uuid%3A6dc7b018-e77f-4bc2-8988-63a96a510f11  

(2018).  Emergent 

safety:  working 

to  workplace 

space 

same 

in 

as 

a 

co-bot.  Available 

at: 

110 COMAU (n.d.) AURA: Advanced use robotic arm. Available at: https://www.comau.com/Download/our-
competences/robotics/Automation_Products/Folder_Aura%20Doppie.pdf  
111 Although the specific mode in which the AURA currently operates is signalled through a bright LED lamp 
112 DG Research and Innovation (2020). Unlocking the potential of industrial human–robot collaboration 

 
 
 
 
                                                           
Hazards for Physical Contacts with Crowdbot113 

Hazard 

Collision:  a 
robot 
hits  a  standing  or 
moving  person  or 
vice versa. 

the 

Squash: 
robot 
presses  a  person  or 
part of his/her body 

Potential physical 
consequences for humans 
Impact  injuries:  the  person 
falls  down  and 
sustains 
injury;  the  robot  falls  down 
and  crushes  another  person 
or objects. 
Impact and crush injuries 

Push: 
robot 
the 
pushes  a  standing  or 
moving person 

the 
against 

robot 
Swipe: 
swipes 
a 
standing  or  moving 
person 

The person falls and sustains 
injury;  the  person  collides 
with 
another  person  or 
object  and  sustains  impact 
injuries 
Cutting;  pinching;  dragging; 
trapping 

Drag:  the  robot  pulls 
a standing or moving 
person 

The  person  can  fall  and 
sustain  injury;  stumble  on 
something/someone,  loosing 
balance;  collide  against  a 
sustaining 
person/object 
impact injuries 
While  in  contact  with  a  part 
of  the  robot  body,  harmful 
movements  or  events  may 
happen:  pinch,  cut,  burn, 
electric shocks, etc. 

Touch/contact: 
the 
robot  body  and  the 
are 
human 
physically 
touching 
each other 
Source: Crowdbot project, 2018, p.16 

body 

Notes from the author 

Collisions  may  be  caused  by  a  failure  in  the 
detection  system;  the  robot  suddenly  stops;  lack 
of awareness of robot operation (lack of noise  or 
localisation  and  navigation 
silent  operation); 
errors. 
Squashes can happen during robot navigation for 
the same reasons as collisions. Different types of 
squashes  can  happen,  e.g.  the  robot  crushes  a 
person  against  a  wall,  a  robot  wheel  rolls  over  a 
person’s  foot.  Squashes  can  be  the  result  of  a 
robot loss of stability, e.g. the robot falling due to 
a collision or while navigating an uneven surface. 
Pushes  can  happen  during  robot  navigation 
mainly due to a failure in the detection system. 

Although  light,  swipe  contacts  may  involve 
harmful  parts  of  the  robots  (e.g.  sharp  edges, 
burning  parts  and  hook  parts)  causing  serious 
injuries.  Swipes  can  be  due  to  a  failure  in  the 
detection  system;  the  robot  suddenly  stopping; 
lack  of  awareness  of  robot  operation  (lack  of 
noise  or  silent  operation); 
localisation  and 
navigation errors. 
This  may  be  due  to  presence  of  external  parts  in 
the  robot  (e.g.  hooks)  or  gaps  between  moving 
parts where clothes can be trapped. 

Involuntary  continuous  or  single  contacts  or 
touches  can  be  the  result  of  situations  in  which 
robot and people are forced to be physically close 
to each other. 

113 A crowdbot is a robot operating in a public environment 

 
 
 
 
                                                           
Annex 7: Case studies on emerging technologies 

Three case studies were conducted in order to provide practical, issue-based, and detailed insights 
on  the  implications  and  the  developments  related  to  emerging  technologies  in  the  machinery 
sector and the Directive. Full details on these case studies can be found in the Impact assessment 
study  on  the  revision  of  Directive  2006/42/EC  on  machinery114.  The  conclusions  are  reported 
here below. 

  1. Digital transformation of machinery: The world of machinery software development 
has  evolved  rapidly,  now  covering  the  whole  process  from  single  initial  installation  to 
continuous updates. Devices and machinery used to be updated only a few times (if any) 
in  their  lifetime,  mostly  through  a  manual  process.  Wireless  technologies  now  allow 
control systems to be updated remotely over the internet in an autonomous manner and 
on a continuous basis. Post-deployment updates of software can change the functionality 
and  operations  of  machinery.  This  creates  challenges  from  a  regulatory  perspective, 
notably  in  terms  of  ensuring  that  safety  requirements  are  satisfied  following  software 
updates  and  that  the  relevance  and  accuracy  of  required  documentation  (manuals,  
requirements  instructions  etc.)  is  safeguarded  and  accessible  to  users.  This  case  study 
examines  the  impact  of  digital  transformation  of  machinery  and  associated  control 
systems on the safety of human supervisors and operators. It describes the challenges that 
arise from the upload of software in machinery and the resulting safety implications with 
regards to functional changes and cybersecurity. 

  2.  Production  optimisation:  With  the  sophistication  of  machine  learning  (ML), 
ubiquitous  interconnectivity  through  IoT  and  the  development  of  increasingly  accurate 
sensors  at  ever  smaller  scale,  the  manufacturing  industry  has  witnessed  technology 
advances  at  an  unprecedented  speed.  The  combination  of  ML,  sensor-based  inputs  and 
IoT  can  unlock  a  dramatic  leap  in  efficiency  and  productivity  gains,  but  also  pose 
complex  regulatory  challenges.  IoT  is  a  technology  enabler  that  allows  connecting 
several  machinery  products  -  covered  by  the  current  MD  -  in  a  connected  multi-agent 
interoperable  system.  By  integrating  machinery  in  IoT  network,  the  ex-standalone 
machinery  (subject  to  risk  assessment)  becomes  far  more  complex  to  assess.  Machine 
Learning-enabled  control  systems  embedded  in  an  IoT  network  can  control  groups  of 
assets and can adapt the functions of the machinery over time. Currently, software as a 
safety control component that is placed independently on the market is not considered as 
a safety component under the MD. This case study focuses on the consequences of the 
emergence of ML techniques and on the implications of ML-enabled applications for the 
safety of human supervisors. The technical focus of this case study lies on ML models, 
sensor-based data, IoT and business driven code. 

  3.  Self-driving  robots:  Moving  robots  have  been  part  of  the  machinery  industry  for  a 
long  time.  In  the  past,  they  were  characterised  by  the  use  on  fixed  paths  and  human-
operated controls. By contrast, recent generations of robots are increasingly able to react 
to  external  stimuli  based  on  autonomous  data  processing.  Self-driving  robots  have  two 
new characteristics that challenge the current regulatory framework: mobility and direct 
human interaction. The interaction between humans and self-driving robots in dynamic, 
partially  unknown  environments  introduces  complex  health  and  safety  risks  for 
regulators  to  consider.  Challenges  for  regulators  arise  in  terms  of  defining  appropriate 
guidelines for robot control, stipulating criteria for adequate situation assessment skills, 
and ensuring required levels of adaptation to the emotional needs of users.  

114 Impact assessment study on the revision of Directive 2006/42/EC on machinery. Available at: https://data.europa.eu/doi/10.2873/423938 

 
 
 
                                                           
Case Study 1 - Digital transformation of machinery 

The agile nature of the digital market along with decreasing costs of application deployment and 
constant  innovation  have  shortened  the  time  to  market  for  machinery  with  emerging 
technologies.  The  MD  should  be  adapted  to  remain  relevant  and  to  facilitate  this  pace  of 
digitalisation  in  a  safe  manner.  As  this  case  study  scenarios  have  shown,  adapting  to  digital 
technologies can result in improved safety (e.g. re-assessment of risk in case of a major update 
and updating the requirements instructions along with the update).  

The  extent  to  which  challenges  arising  from  these  technologies  should  be  addressed,  however, 
were seen controversially by stakeholders, some of them invoking the technology-neutral aspects 
of  the  MD.  While  some  reform  scenarios  to  the  MD  were  widely  supported  by  stakeholders, 
others were more controversially discussed, e.g. whether the challenges coming from the digital 
technologies should be addressed by domain experts via standardisation or through a change in 
the MD. 

Possible reforms of the MD to ensure machinery safety include: i) specifying requirements  and 
related  harmonised  standards  for  software  updates;  ii)  specifying  responsibility  for  safety-
relevant software updates in case they are developed and/or delivered by a party other than the 
OEM  and  involving  a  substantial  modification  requiring  a  renewed  risk  assessment;  and  iii) 
making it mandatory for OEMs to provide software updates that ensure the safety of machinery 
throughout  its  lifetime.  However,  no  overwhelming  support  in  favour  or  against  these  options 
could  be  identified.  On  the  other  hand,  providing  technical  clarifications  of  what  constitutes  a 
machine substantially modified, also in relation to major software updates that might render the 
initial risk assessment invalid, and to cover software that ensures a safety function and is placed 
independently on the market as safety component yielded positive responses by the majority of 
respondents. 

Summary of challenges and potential changes to the Directive – Case study 1 

Focus 
Upload of 
software in 
machines 

Challenges 
  Potential  changes  to  functionality  of  the 
machinery  can  have  a  significant  impact 
on  safety  risks,  which  raises  questions 
with  regards  to  the  conformity  of  the 
functionality 
the 
changes 
requirements. 

with 

Expectation of change of the MD 

  Defining  requirements  and  related  harmonised 
standards  for  software  updates.  A  revision  of 
the MD could specify the EHRS and economic 
operators’  obligations  that  need  to  be  in  place 
in order for software updates to be safe. 

  Specifying 

the 
for 

operator’s 
responsibility 
software 
updates  in  case  they  are  developed  and/or 
delivered by a party other than the OEM. 

economic 
safety-relevant 

  Making  it  mandatory  for  OEMs  to  provide 
software  updates  that  ensure  the  safety  of 
machinery throughout its lifetime. 

 

emerge 

Issues of responsibility on the machinery 
standalone 
in 
safety 
software  or 
are 
developed by service providers other than 
the OEM. 

case 
software  updates 

  New  risks  emerge  during  the  lifetime  of 
the  machine  in  case  the  manufacturer 
stops 
for  updates  on 
functionality. 

support 

the 

  The  possibility  of  externally  uploading 
software 
the  control  system  of 
machinery raises issues of cybersecurity. 

to 

 
 
 
 
 
 
 
 
 
 
 
 
Case Study 2 - Production optimisation 

The scope of this case study was to assess the challenges limited to existing technologies related 
to sensor-based control, ML and IoT. In combination with ML-enabled applications, IoT brings 
forth  several  challenges  including  ensuring  accuracy  of  data  inputs  (sensors  and  others), 
facilitating  for  safe  communication  and  high-integrity  aggregation  of  data,  and  ultimately 
ensuring safe outputs of ML-enabled control systems. 

The MD should facilitate the innovation of emerging technologies and help in strengthening the 
position  of  EU  as  the  leader  in  ML  and  IoT.    There  are  several  challenges  that  need  to  be 
addressed  on  a  broader  level.  These  include  the  wider  incorporation  of  independent  software 
when  it  comes  to  control  and  enhancing  the  requirements  to  incorporate  safety  risks  that  arise 
from connectivity and machine centric control.  

Other challenges include the continuous updating of the control software changing the operations 
of machines. The risks that arise from ML such as machine taking control over human beings, 
ethical  dilemmas,  designing  the  autonomous  systems  such  that  humans  stay  in  control  and  the 
risks are  minimised. These  challenges  are respectively  covered  in  the  Digital transformation  of 
machinery and the Self-driving robots case studies. 

Summary of challenges and potential changes to the Directive – Case study 2 

Focus 
Sensor input-
related safety 
issues 

Machine 
Learning 

Challenges 
 

The  MD  does  not  explicitly  cover  input  sources 
(sensor  data,  input  data,  training  data)  that  feed  into 
ML-enabled  applications  (robots  or  other).  The 
reliability,  accuracy  and  timeliness  of  data  captured 
and  transmitted  by  sensors  and  other  input  sources  is 
crucial to the safe operation and effective optimisation 
of  ML-enabled  applications,  irrespective  of  whether 
they are embedded in an IoT. 
Independent  software  is  not  included  in  the  MD 
definition of control systems.  

The MD does not provide minimum standards for the 
display  of  safety-critical  information  of  ML-enabled 
processes.  

The  MD  does  not  provide  minimum  standards  for 
data  logging  and  storage  of  ML-driven  data  and 
decision-making processes.  

 

 

 

 

The MD’s clause on cable-less control in case of loss 
of communication can be dangerous.  

Internet of 
Things 

  Control  systems  are  not  defined  in  the  MD  as 

physically or logically connected entities.   

 

The  MD  does  not 
for 
communication  processes  and  channels  for  IoT-
embedded machinery.  

requirements 

specify 

Expectation of change of the MD 
  Regulating  safety  requirements 
for  data 
(training, 
streams 
sensor  or  input  data)  that  feed 
into ML-enabled applications 

 

Independent  software  could  be 
included in the MD definition of 
control systems.  

  A  revised  MD  could  provide 
minimum standards regarding the 
safety-critical 
display 
information 
of  ML-enabled 
processes.    

of 

  A  revised  MD  could  provide 
for  data 
minimum  standards 
logging  and  storage  of  ML-
driven  data  and  decision-making 
processes.  

  A  revised  MD  could  include 
physically or logically connected 
entities 
the  definition  of 
control systems.  

in 

  A  revised  MD  could  specify 
requirements  for  communication 
processes  and  channels  for  IoT-
embedded machinery. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Case Study 3 - Self-driving robots 

AI-enabled  robotics  create  a  plethora  of  new  opportunities  and  use  cases  but  are  also  highly 
challenging for regulators. These challenges did not exist when the MD was first implemented. 
The  objective  of this  case study  was to  identify  and assess these  challenges  and  to  explore the 
extent to which current and emerging challenges should be covered by the MD. A key take-away 
of  the  case  study  is  that  establishing  and  maintaining  human  safety  and  trust  in  self-driving 
robotics in the sine qua non for the proliferation of this technology.   

This  case  study  showcased  the  importance  of  transparency  and  ensured  responsibility  for 
autonomous functionality, as well as the importance of designing autonomous systems in a way 
that is human centric. The systems should be taught not only by using data but also by certified 
experts  to  be  able  to  counter  biases.  The  data  sets  used  for  learning  and  the  decision-making 
process  should  be  transparent  and  traceable.  Autonomous  robots  should  be  tested  in  real-life 
environments to better attune their behaviour to the real world and asses if there are un-intended 
consequences or flaws in the underlying algorithmic model.  

It is clear from the market research that the EU is one of the global leaders in the development of 
these  emerging  technologies.  The  MD  should  stay  relevant  and  facilitate  these  technologies  to 
promote safety in the usage of these technologies.  

Summary of challenges and potential changes to the Directive – Case study 3 

Focus 
Self-driving 
robots 

Challenges 
 

The MD makes no explicit mention of the 
required  testing  environment  of  self-
driving robots. 

Expectation of change of the MD 

  Requiring 

testing  parameters  and 
testing  environment  for  self-driving 
robots. 

 

 

 

 

 

 

 

Partly 
Completed 
Machinery 

There  is  currently  no  regulation  on  the 
safety  impact  of  the  governance  and 
usage of social robots. 

  Regulating  relevant  aspects  of  data 
privacy of social robotics if having an 
impact on safety and mental health. 

The  MD  does  not  sufficiently  cover 
potential physical and mental health risks 
arising from human-robot collaboration. 

The  MD  does  not  cover  relevant  aspects 
of  data  privacy  of  social  robotics  having 
an impact on safety. 

The  MD  does  not  specify  situations  in 
which  robots’  autonomy  needs  to  be 
curtailed in favour of human control. 

The  MD  does  not  specify  requirements 
requiring  that  specific  safety  relevant 
information should be made visible to the 
human user on a HMI system. 

The  MD  does  not  explicitly  specify  the 
concept of partly completed machinery in 
all relevant aspects.    

The  MD  does  not  require  manufacturers 
of PCM to disclose relevant aspects of the 
PCM’s  technical  file  that  do  not  fall 
under IP for review. 

  Defining  obligations  for  OEMs  of 
collaborative  robots  to  avoid  physical 
and  mental  health  risks  for  human 
collaborators. 

  Requiring  that  robots’  autonomy  need 
to  be  curtailed  in  favour  of  human 
control depending on the risk. 

  Requiring that specific safety- or trust-
relevant 
robots’ 
information 
decision-making and behaviour should 
be made visible to human operators on 
a HMI system. 

on 

information 
could 

  Requiring  manufacturers  of  PCM  to 
to 
provide  additional 
buyers.  Manufacturers 
be 
required to specify which requirements 
the  PCM  has  not  met,  which  is  an 
essential  information  for  buyers  of 
PCM.  However,  such  an  approach 
needs 
the 
manufacturers’  legitimate  interest  to 
safeguard IP with the buyers’ interests 
to know not only the functions but also 
the limitations of PCM.   

carefully  balance 

to 

 
 
 
 
 
Annex 8: Subsidiarity Grid 

1.  Can the Union act? What is the legal basis and competence of the Unions’ intended 

action? 

1.1 Which article(s) of the Treaty are used to support the legislative proposal or policy 
initiative? 

Article 114 TFEU, according to which the EU may adopt measures for the approximation 
of the provisions laid down by law, regulation or administrative action in Member States 
which have as their object the establishment and functioning of the single market 

1.2 Is the Union competence represented by this Treaty article exclusive, shared or 
supporting in nature? 

In the case of product safety legislation for the single market, the Union’s competence is 
shared (Article 4 of the TFEU) 

Subsidiarity does not apply for policy areas where the Union has exclusive competence as 
defined in Article 3 TFEU115. It is the specific legal basis which determines whether the proposal 
falls under the subsidiarity control mechanism. Article 4 TFEU116 sets out the areas where 
competence is shared between the Union and the Member States. Article 6 TFEU117 sets out the 
areas for which the Unions has competence only to support the actions of the Member States. 

2.  Subsidiarity Principle: Why should the EU act? 

2.1  Does the proposal fulfil the procedural requirements of Protocol No. 2118: 

-  Has there been a wide consultation before proposing the act? 
- 

Is there a detailed statement with qualitative and, where possible, quantitative indicators 
allowing an appraisal of whether the action can best be achieved at Union level? 

The consultation activities performed include an inception impact assessment over a four 
week period, a 12-week public consultation in 23 languages on the Commission’s central 
public consultation webpage, targeted consultations to follow and build on the results of the 
public consultation, and regular consultations with stakeholders, experts, workers/users 
and other interested parties at EU level. In particular, the following entities were consulted: 

 
 

the Machinery Committee (Member states authorities and Commission) 
the Machinery Working/Expert Group  (all interested stakeholders: industry, trade 
unions, consumer associations, standardisations organisations, notified bodies,  
market surveillance authorities and Commission) – biannual meetings 

  The Machinery Administrative Cooperation (AdCo) group (market surveillance 

authorities) - biannual meetings 

  The European Economic and Social Committee issued an information report 
  The Advisory Committee on Safety and Health at Work (ACSH) Working party 
  The EP Internal Market Committee (IMCO) 

The explanatory memorandum and the impact assessment (chapter 3) contain a section on 
the principle of subsidiarity. In addition, chapter 9 of the IAR proposes several indicators 
to monitor and evaluate the implementation of the changes.   

115 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12008E003&from=EN  
116 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12008E004&from=EN  
117 https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12008E006:EN:HTML  
118 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:12016E/PRO/02&from=EN  

 
 
                                                           
2.2  Does the explanatory memorandum (and any impact assessment) accompanying the 

Commission’s proposal contain an adequate justification regarding the conformity with 
the principle of subsidiarity? 

A regulatory action at the EU level, laying down EU-wide requirements for 
ensuring the health and safety of machinery users, and allowing market 
enforcement at the national level according to the New Legislative Framework 
(NLF) principles, ensures a coherent implementation of the safety requirements for 
machinery, thus an improved level of safety, and allows the free movement of 
machines within the EU. This contributes to the development of the Internal (and 
Digital) Single Market, provides legal certainty and a level playing field for the 
industry, and establishes a high level of trust among machinery users. 

2.3  Based on the answers to the questions below, can the objectives of the proposed action 
be achieved sufficiently by the Member States acting alone (necessity for EU action)? 

The proposed action cannot be achieved by the Member States acting alone as this 
would likely lead to different health and safety requirements in each Member State. 
This would create barriers in the single market, additional administrative burden 
on manufacturers, and a loss of competitiveness of the European mechanical 
industry also outside the EU. The Machinery Directive is a full harmonisation 
directive that ensures a same level of essential health and safety requirements and 
the free circulation of machinery across the EU, impacting manufacturers that 
place machinery in the EU market and protecting users of machinery in all Member 
States. The Machinery Directive is enforced by each Member State following 
common market surveillance rules. 

(a)  Are there significant/appreciable transnational/cross-border aspects to the problems being 

tackled? Have these been quantified? 

The Machinery Directive is a full harmonisation directive and play a fundamental role in 
ensuring  the  free  circulation  of  machinery  intra  EU.  In  2017,  the  machinery  sector 
recorded  a  turnover  of  EUR  663  billion,  production  of  EUR  609  billion  and  a  value 
added  of  EUR  191  billion.  In  that  same  year,  the  total  EU  machinery  and  equipment 
exports  amounted  to  EUR  503  billion,  of  which  49%  were  exported  to  EU  member 
countries (i.e. intra-EU  exports),  while  51%  were  exported to countries  outside  the  EU 
(extra-EU exports). 119 

(b)  Would national action or the absence of the EU level action conflict with core objectives 

of the Treaty120 or significantly damage the interests of other Member States? 

National action or the absence of the EU level action would create an  important gap in 
the single market.  
As regards the risks stemming from emerging technologies, a lack of EU action would 
undermine  the  users  trust  on  machines  incorporating  emerging  technologies.  Machines 
could  be  allowed  on  the  market  without  being  imposed  the  necessary  safety 
requirements.  Manufactures  might  find  their  machinery  development  hindered  by  the 
lack  of  legal  clarity  and  guidance  on  what  products  types  can  or  not  be  placed  on  the 
market. In this legal vacuum Member States may decide to issue their own national rules. 
All  that  could  also  create  barriers  in  the  single  market,  unfair  competition  and  a 
suboptimal level of safety. In relation to the lack of clarity in some areas of the directive, 
the  room  for  different  interpretations  by  different  manufacturers  would  generate 

119 UN COMTRADE 
120 https://europa.eu/european-union/about-eu/eu-in-brief_en  

 
 
                                                           
additional costs and burden for manufacturers and market surveillance authorities due to 
the  need  for  clarifications,  and  would  prevent  a  level  playing  field.  Without  a  further 
harmonisation of the market potentially brought by the MD revision, the opportunity of 
decreasing the share of non-compliant products on the market might not be exploited.  
The Evaluation of the Machinery Directive showed that all stakeholder groups value the 
Machinery  Directive  and  were  in  agreement  with  a  revision,  maintaining  its  current 
architecture and technological neutrality approach. 

(c)  To what extent do Member States have the ability or possibility to enact appropriate 

measures? 

The  Machinery  Directive  has  been  transposed  into  all  EU  Member  States  legislation. 
Member  States  are  responsible  for  its  enforcement,  following  common  market 
surveillance rules. Without clear requirements for emerging technologies, Member States 
could try to fill the gap, or allow machinery in the market without the necessary  safety 
level.  The  level  of  safety  could  become  different  from  one  EU  country  to  another, 
altering the functioning of the single market and the level of trust of machinery users. 

(d)  How does the problem and its causes (e.g. negative externalities, spill-over effects) vary 

across the national, regional and local levels of the EU? 

The Machinery Directive is a product safety legislation whose implications are the same 
at all levels of the EU and is enforced by each Member State following common market 
surveillance  rules.  Each Member  State  applies these common  market  surveillance rules 
according  to  their  own  national  allocation  of  competencies.  Germany,  the  biggest 
machinery  producer  in  the  EU,  registered  about  280  billion  of  turnover  in  2017, 
representing  42%  of  total  EU  turnover,  followed  by  Italy  and  France.  Together  these 
three  countries  accounted  for  69%  of  EU  turnover;  they  are  further  followed  by  the 
Netherlands,  Sweden,  Austria,  Denmark  and  Spain.  All  EU  countries  are  users  of 
machinery. 

(e)  Is the problem widespread across the EU or limited to a few Member States? 

The  Machinery  Directive  is  a  product  safety  legislation  that  tackles  machinery 
manufactured  and  placed  on  the  market/put  into  service  across  the  EU.  The  share  of 
machinery within total manufacturing was 9.4% in 2017 for the EU-average. Countries 
most specialist on the machinery sector were Denmark (19%), Germany and Italy (about 
13%), Finland, Sweden and Austria (about 12%). As outlined in (d), all EU countries are 
users of machinery. 

(f)  Are Member States overstretched in achieving the objectives of the planned measure? 

The  revision  of  the  Machinery  Directive  all  introduce  some  simplification  for  Member 
States, namely the alignment to the NLF will improve and bring the market surveillance 
activities  in  line  with  those  existing  under  other  product  safety  legislation  already 
aligned,  including  the  ICSMS  (Information  and  Communication  System  for  the  pan-
European Market Surveillance). Member States authorities have been active participants 
to the consultation and have made concrete proposals for the revision of the Machinery 
Directive.  They  are  supportive  of  the  changes  proposed,  which  in  some  cases  are 
clarifications that will facilitate their market surveillance and enforcement work. 

(g)  How do the views/preferred courses of action of national, regional and local authorities 

differ across the EU? 

The Market Surveillance Authorities may be national or regional depending on political 
systems  and  competencies  allocation  in  each  Member  State.  Authorities  enforcing  the 

 
 
Machinery  Directive  agree  in  that  the  Machinery  Directive  need  revision.  The  new 
Regulation on machinery products proposed by the commission has overall the support 
of  a  majority  of  the  Member  States,  as  demonstrated  through  the  several  consultations 
held  (public  consultation,  targeted  interviews,  dedicated  committee  meeting  with 
Member  States  authorities,  and  dedicated  working  group  sessions  with  the  wider 
machinery stakeholder group. Diverging views were found on few proposals, for which a 
minimum compromise has been made. 

2.4  Based on the answer to the questions below, can the objectives of the proposed action be 
better achieved at Union level by reason of scale or effects of that action (EU added 
value)? 

The Machinery Directive is a harmonised product safety piece of legislation, already 
acting at EU level, which ensures a high level of safety and protection for users of 
machinery and other people exposed to it, as well as the well-functioning of the 
digital single market, which allows economies of scale at the manufacturer’s level. 
The revised Directive will add clarity to the current act in its scope, definitions and 
requirements, including those covering risk stemming from emerging technologies 
(such as e.g. artificial intelligence and autonomous robots). 

(a)  Are there clear benefits from EU level action?  

The Machinery Directive is a harmonised product safety piece of legislation, thus acting 
at  EU  level  already.  The  Evaluation  of  the  Machinery  Directive  (SWD  (2018)160) 
concluded that the Directive is generally relevant, effective, efficient and coherent, and 
has  EU  added  value,  but  that  there  was  a  need  for  specific  improvements  and 
simplification.  As  a  result  from  the  revision,  new  risks  related  to  digital  emerging 
technologies  (AI,  IoT,  robotics)  will  be  adequately  covered,  ensuring  the  well-
functioning of the (digital) single market and establishing a high level of trust in digital 
innovative  technologies  for  consumers  and  users.  The  revision  will  also  ensure  a 
coherent interpretation of the scope throughout the EU; reassess machines considered as 
high risk and their related conformity procedures and increase coherence with other NLF 
legislation,  ensuring  a  high  level  of  safety  and  protection  for  users  of  machinery  and 
other people exposed to it. It will also bring a reduction of paper-based requirements for 
documentation leading to environmental and economic benefits (recurrent EUR 79 m net 
savings for manufacturers annually). 

(b)  Are there economies of scale? Can the objectives be met more efficiently at EU level 

(larger benefits per unit cost)? Will the functioning of the internal market be improved? 

There  are  economies  of  scale  at  the  manufacturer’s  level,  since  they  can  sell  their 
machinery in all EU countries, as long as it complies with the Machinery Directive. 

(c)  What are the benefits in replacing different national policies and rules with a more 

homogenous policy approach? 

This  was  already  done  when  the  first  Machinery  Directive  was  adopted  (Directive 
89/392/EEC). Since then, this and any subsequent directives have played an essential role 
in ensuring a harmonised set of safety requirements to protect machinery users and other 
exposed  persons  and  has  ensured  a  proper  functioning  of  the  single  market  for 
machinery.  Both  the  Evaluation  and  the  Impact  Assessment  consultations  have 
confirmed  the  benefit  of  the  Machinery  Directive  for  all  stakeholders  and  most 
particularly for manufacturers and users of machinery (workers and consumers). 

(d)  Do the benefits of EU-level action outweigh the loss of competence of the Member 

States and the local and regional authorities (beyond the costs and benefits of acting at 

 
 
national, regional and local levels)? 

An  EU-level  action  is  the  most  efficient  way  to  ensure  the  objectives  sought  by  the 
revised directive:   

  Keep ensuring a high and the same level of safety and protection for users of 

machinery and other people exposed to it in the EU, and establish a high level of 
trust in digital innovative technologies for consumers and users; and 

  Keep ensuring the well functioning of the (digital) single market. Create a level 
playing field for economic operators and preserve the competitiveness of the 
machinery sector in global digital markets. 

(e)  Will there be improved legal clarity for those having to implement the legislation? 

The proposed revised Machinery Directive will add legal clarity to the current act in its 
scope,  definitions  and  requirements,  including  those  covering  risk  stemming  from 
emerging  technologies.  In  addition,  the  revised  Machinery  Directive  will  gain  in 
coherence by aligning to the NLF and becoming a Regulation. 

3.  Proportionality: How the EU should act 

3.1   Does the explanatory memorandum (and any impact assessment) accompanying the 

Commission’s proposal contain an adequate justification regarding the proportionality 
of the proposal and a statement allowing appraisal of the compliance of the proposal 
with the principle of proportionality? 

Several policy options were considered for the revision of the Machinery Directive. 
A complete overhaul of the Directive imposing major new requirements to address 
the risk stemming from emerging technologies was considered not proportional and 
discarded from the beginning. The non-revision of the Directive, or the revision only 
in scope and definition was considered insufficient. The revision of the directive 
including clarifications to scope, definitions and minor necessary adaptation to the 
essential health and safety requirements was considered proportionate and not 
exceeding what it necessary to achieve the objectives. 

3.2  Based on the answers to the questions below and information available from any impact 
assessment, the explanatory memorandum or other sources, is the proposed action an 
appropriate way to achieve the intended objectives? 

The initiative is limited to the setting of product safety requirements, that are better 
dealt with at EU level to ensure a harmonised product safety and the free 
circulation of machinery, leaving the enforcement to the Member States. Those 
requirements are formulated in a technologically neutral way, so that innovation is 
allowed to adopt the best technical solutions according to the state of the art for 
each type of machinery. The revised text takes the form of a regulation to minimise 
differences in interpretation and avoid costs and delays of transposition. The 
benefits of this initiative offset the costs incurred. 

(a)  Is the initiative limited to those aspects that Member States cannot achieve satisfactorily 

on their own, and where the Union can do better? 

The initiative sets out the essential health and safety requirements the manufacturers of 
machinery need to comply with when designing and manufacturing their machines for 
the EU market. Only taken at EU level can this action create a harmonised product safety 
and allow the free circulation of machinery within the EU. Member States are 
responsible for the enforcement of the Directive, which is better dealt with at national 
level. 

 
 
(b)  Is the form of Union action (choice of instrument) justified, as simple as possible, and 
coherent with the satisfactory achievement of, and ensuring compliance with the 
objectives pursued (e.g. choice between regulation, (framework) directive, 
recommendation, or alternative regulatory methods such as co-legislation, etc.)? 

The instrument proposed for the revision of the Machinery Directive is a regulation, 
since it is seen as the most effective and efficient solution, for it minimises the potential 
differences in interpretation and avoids costs and delays of transposition.  There is a wide 
consensus on the benefits of the conversion of the directive to a regulation. 79% of 523 
public consultation respondents, across all stakeholder types, expressed support for this 
change, and also all Member States authorities supported this choice of instrument. 

(c)  Does the Union action leave as much scope for national decision as possible while 

achieving satisfactorily the objectives set? (e.g. is it possible to limit the European action 
to minimum standards or use a less stringent policy instrument or approach?) 

The Machinery Directive is a fully harmonised piece of legislation; hence, Member 
States cannot alter the requirements laid down in the directive. However, this is the basis 
for achieving an EU wide level of safety for machinery users and the free circulation of 
machinery across EU countries. However, since the Machinery Directive is 
technologically neutral, it leaves space for manufacturers to meet the safety requirements 
via harmonised standards cited in the OJEU, or to propose alternative solutions as long as 
they demonstrate conformity to the requirements of the directive. 

(d)  Does the initiative create financial or administrative cost for the Union, national 

governments, regional or local authorities, economic operators or citizens? Are these 
costs commensurate with the objective to be achieved? 

The initiative create additional costs in some areas (costs for manufacturers of software 
with a safety function that is put independently in the market) and other adaptation costs 
for manufactures and authorities, but bring overall more benefits (e-manuals brings 
saving of printing costs for manufacturers, vibration requirements allow savings of social 
costs for reduced sick leave and occupational injuries). In addition, clarifications in the 
directive allow the industry to save on guidance for interpretation or additional 
clarifications via commercial contracts, and ensure fair competition in the EU market. 
The changes to the Machinery Directive in this revision are the minimum necessary to 
achieve the objectives, and are commensurate with those objectives, complemented with 
clarifications in the Guide to application of the Machinery Directive and with the 
standardisation process. 

(e)  While respecting the Union law, have special circumstances applying in individual 

Member States been taken into account? 

No special circumstances apply to any individual Member State in the frame of this 
initiative have been identified.