Proposal for a Directive of the European Parliament and of the Council amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the European Parliament and the Council as regards the review of the medical device directives {SEC(2005)1742}
Date: 2005-12-22
Institutions: European Commission
Subjects: chemical product, marketing, medical device, occupational safety, public health, radiobiology, standardisation

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 22.12.2005 
COM(2005) 681 final 

2005/0263 (COD) 

Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the 
European Parliament and the Council as regards the review of the medical device 
directives 

{SEC(2005)1742} 

(presented by the Commission) 

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

•  110Grounds for and objectives of the proposal 

Since its adoption in 1993, a great deal of experience has been gained on the implementation 
of  the  Directive  93/42/EEC  concerning  medical  devices.  Whilst  overall  the  experience  has 
been  extremely  positive,  some  experience  reveals  that  the  Directive  requires  improved 
implementation  by  all  parties  concerned.  Furthermore, 
improved 
implementation,  legislative  modification  is  necessary  both  to  clarify  certain  existing 
requirements  and  to  provide  a  legal  basis  for  planned  initiatives.  The  proposal  amends 
Directive  93/42/EEC  in  this  regard  and  also,  in  order  to  align  the  text  of  the  framework 
Directives on medical devices, it amends Directive 90/385/EEC relating to active implantable 
medical devices. 

to  support 

this 

•  120General context 

Directive 93/42/EEC itself requests the Commission to submit a report to the Council, no later 
than five years from the date of implementation of the Directive, concerning certain aspects of 
the  functioning  of  the  Directive.  It  was  the  view  of  various  Member  States  that  the  review 
called for under Article 11 (4) should be extended to cover not only those aspects referred to 
in the Article, but also to cover all elements of the Directive that have given rise to concern or 
where improvements can be made.  

Arising  from  this  review  process,  a  Report  on  the  functioning  of  the  Medical  Devices 
Directives  was  published  in  June  of  2002.  The  conclusions  of  this  Report  were  brought 
forward by the Commission in its Communication COM (2003)386 which was welcomed by 
the Council in its Conclusions of December 2003 and was received favourably at Parliament.  

The Communication highlighted that whilst the Devices Directives provide in themselves an 
appropriate legal framework, there is room for improvement. The most important areas where 
improvement should be made concern: 

conformity  assessment  -  where  questions  arose  as  to  the  absence  of  clear  rules  on  design 
examination by notified bodies, 

the sufficiency and adequacy of clinical data for all classes of devices, 

post  market  surveillance  -  where  better  coordination  of  activities  in  the  area  of  post  market 
surveillance are needed, 

Notified Bodies - in relation to their competence for the tasks for which they are designated, 
differences  in  interpretation  between  Notified  Bodies  and  lack  of  transparency  in  the 
performance, and control, of their activities,  

and increased transparency to the general public in relation to the approval of devices. 

modification of Directive 90/385/EEC relating to active implantable medical devices in order 
to align it with the other framework Directives on medical devices. 

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•  130Existing provisions in the area of the proposal 

This  proposal  aims  at  amending  the  already  existing  Directives  93/42/EEC  on  medical 
devices and 90/385/EEC on active implantable medical devices.  

2. 

141CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT 

•  Consultation of interested parties 

211Consultation methods, main sectors targeted and general profile of respondents 

Beginning in 2003, the primary method of consultation was through the Commission services’ 
Medical  Device  Experts  Group,  comprising  the  Commission,  Member  States,  Notified 
Bodies,  European  standards  bodies  and  industry.  The  bulk  of  all  comments  arose  from 
national authorities and industry. 

212Summary of responses and how they have been taken into account 

Authorities,  sought  clarification  on  certain  areas,  such  as 
the  appropriate  design 
documentation  and  design  review  for  particular  groups  of  medical  devices,  and  text  to  aid 
better  implementation  on  certain  aspects  of  the  Directives,  such  as  clinical  evaluation.  All 
substantial comments from authorities were considered and have resulted in either proposed 
legislative or non-legislative measures. 

Industry,  criticised  the  apparent  un-harmonised  interpretation  and  implementation  of  the 
Directives  by  Member  States,  and  welcomed  any  initiative,  either  legislative  or  non 
legislative,  that  brings  clarification  and  consistency  to  interpretation  and  implementation. 
They  also  highlighted:  clarification  of  the  role  of  a  national  authority  or  the  European 
Medicines  Agency  (EMEA)  when  consulted  for  devices  containing  a  medicinal  product  or 
human blood derivative, the provision of electronic labelling and the inclusion of reprocessors 
of ‘single use’ devices in the definition of ‘manufacturer’.  

Here text has been proposed in all areas except reprocessing. In examining the reprocessing 
issue in detail, including bilateral meetings involving the relevant trade federations, it became 
clear  that  it  goes  far  beyond  this  Directive,  and  a  simple  expansion  of  the  definition  of 
‘manufacturer’, and raises questions that would require further reflection by the Commission 
services, in consultation with a wider group of stakeholders, to explore possible development 
of appropriate legislation in this area.  

An  open  consultation  was  conducted  over  the  internet  from  11/05/2005  to  25/06/2005.  The 
Commission  received  80  response(s).  The  results  are  available  on  the  sectors  website: 
http://europa.eu.int/comm/enterprise/medical_devices/index_en.htm. 

•  Impact assessment 

In order to reach the objective of improved coherence and effectiveness of legislation, action 
was considered in key areas of the Directive namely: Simplification, Better Implementation, 
Better  Conformity  Assessment,  Legal  Certainty  (More  Binding  Rules)  in  the  Directive  and 
Improved Market Surveillance. 

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As  the  Directive  is  already  in  existence,  two  basic  options  are  open  in  order  to  achieve  the 
objective,  either  'legislative',  requiring  modification  of  the  current  legislation,  or  'non-
legislative', including co-ordination of national competencies to create transparency and foster 
harmonised implementation.  

Since the proposal is more regulatory clarification rather than regulatory change, there are no 
significant  economic  impacts  expected.  Similarly  there  were  no  environmental  impacts 
identified  by  the  current  proposal.  However,  three  principal  impacts,  health,  economic  and 
social impacts, can be singled out which arise not from any specific option chosen, but from 
the proposal in its entirety: 

- 

Increased clarity will continue to support a high level of public health protection. 

The proposal will provide more transparency and increase the certainty for all market 

- 
players and, in particular, the public.  

For enterprises and citizens alike, the improved regulatory framework will continue to 
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support  fast  technical  progress  to  benefit  citizens  under  better  clarified  conditions  for 
guaranteeing safety and increased trust. 

While, certainly, the regulatory clarification will lead to 'de facto' changes in implementation, 
for  those  manufacturers  who  are  correctly  implementing  the  Directive  there  will  be  no 
economic effect. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

•  305Summary of the proposed action 

This  proposal  amends  Directive  93/42/EEC  on  medical  devices  by  modifying  current 
provisions,  to  bring  about  clarity,  or  by  introducing  new  provisions,  seen  as  necessary  to 
continue  to  support  the  protection  of  human  health.  Also,  the  proposal  updates  Directive 
90/385/EEC  on  active  implantable  medical  devices  to  make  it  coherent  with  the  other 
Directives on medical devices. Finally, Directive 98/8/EC on biocides is amended to exclude 
in  vitro  diagnostic  medical  devices  from  its  scope,  this  removes  the  legal  ambiguity  that 
exists, in certain cases, as to which Directive should apply. 

•  310Legal basis 

The legal basis for the proposal is Article 95 EC Treaty (formerly Article 100A) upon which 
Directive 93/42/EEC is based.  

In order to achieve the objective of abolishing technical barriers to trade and clarification of 
existing provisions in Directives 93/42/EEC and 90/385/EEC, it is necessary and appropriate 
to  harmonise  the  laws,  regulations  and  administrative  provisions  in  the  Member  States  on 
certain  aspects  concerning  the  placing  on  the  market  or  putting  into  service  of  medical 
devices. 

•  320Subsidiarity principle 

The  subsidiarity  principle  applies  insofar  as  the  proposal  does  not  fall  under  the  exclusive 
competence of the Community. 

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The objectives of the proposal cannot be sufficiently achieved by the Member States for the 
following reason(s). 

The  proposal  aims  at  amending  existing  Community  legislation  that  harmonized  the  legal 
framework  for  medical  devices  on  Community  level  in  the  light  of  experiences  gained  by 
national authorities in its implementation over the past number of years.  

Any Member State legislative action would endanger the harmonized framework and present 
a potential breach of Directives 93/42/EEC and 90/385/EEC.  

Community  action  will  better  achieve  the  objectives  of  the  proposal  for  the  following 
reason(s). 

Such amendments to an existing harmonized framework can best be achieved on Community 
level.  

National authorities, through the Medical Device Expert Group Report of June 2002 into the 
functioning  of  the  medical  device  Directives,  have  called  for  the  Commission  to  propose 
necessary changes to the Directives on medical devices. 

The proposal relates to harmonised legislation for the placing on the market and putting into 
service  of  medical  devices  within  the  Community  and  thus  cannot  be  achieved  by  Member 
States alone. 

The proposal therefore complies with the subsidiarity principle. 

•  Proportionality principle 

The proposal complies with the proportionality principle for the following reason(s). 

The proposal is based on experiences gained with the existing framework, it concentrates on 
changes only where they were perceived by Member States and stakeholders to be necessary 
for its proper functioning.  

The  proposal  has  been  subject  to  an  impact  assessment  and  whilst,  certainly,  the  regulatory 
clarification  will  lead  to  'de  facto'  changes  in  implementation,  for  those  manufacturers  who 
are correctly implementing the Directive there will be no economic effect.  

•  Choice of instruments 

Proposed instruments: directive. 

Other means would not be adequate for the following reason(s). 

Given that the existing framework that is intended to be updated here has been adopted in the 
form  of  Directives,  a  Directive  is  the  most  appropriate  instrument  here  that  will  allow 
Member  States  to  incorporate  the  amendments  into  their  existing  transposing  laws  of 
Directive 93/42/EEC and 90/385/EEC.  

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4. 

BUDGETARY IMPLICATION 

4The proposal has no implication for the Community budget. 

5. 

ADDITIONAL INFORMATION 

•  Simulation, pilot phase and transitory period 

507There was or there will be a transitory period for the proposal. 

•  510Simplification 

The proposal provides for simplification of legislation. 

The proposal adapts the existing legislation in areas where the Commission, Member States 
and stakeholders saw a need to clarify the legislation to ensure better implementation.  

•  550Correlation table 

The  Member  States  are  required  to  communicate  to  the  Commission  the  text  of  national 
provisions  transposing  the  Directive  as  well  as  a  correlation  table  between  those  provisions 
and this Directive. 

•  560European Economic Area 

The  proposed  act  concerns  an  EEA  matter  and  should  therefore  extend  to  the  European 
Economic Area. 

•  570Detailed explanation of the proposal 

The proposed legislative modification, developed to reflect the regulatory changes called for 
in the Commission Communication and subsequently welcomed by Council and Parliament, 
brings forth either additional or replacement text regarding, in particular: 

Conformity assessment modules 

Here it has been further clarified that, for the conformity assessment of class IIa and class IIb 
devices under Annex  II  notified bodies are required to assess,  on a representative basis, the 
design documentation for the device concerned. 

Clinical data and evaluation 

In order to clarify and enhance the provisions on clinical evaluation, significant modification 
was required of Annex X concerning clinical data and its evaluation and to various references 
to  clinical  data  within  the  provisions  of  the  Directive,  including  the  definition  of  clinical 
evaluation and provision for the possibility to centralise data on clinical investigations in the 
European databank. 

Legal certainty regarding scope 

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To provide a method to make binding decisions on issues arising at national level, in relation 
to  the  misinterpretation  of  a  product  as  being  or  not  being  a  medical  device,  a  procedure, 
based on comitology, has been added to Article 13. 

Also, in order to clarify that it is possible for both the Directive on medical devices and the 
Directive  on  personal  protective  equipment  to  simultaneously  apply  to  a  product,  such  as  a 
surgical glove, it is necessary to delete the reference in Article 1 to the Directive on personal 
protective equipment to allow both apply. 

Measures to increase transparency  

Article 20 on confidentiality, which previously maintained all information available under the 
Directive as being confidential, has been relaxed, to allow certain information on all devices 
to be publicly available and to allow, by comitology, a method of making other information 
non-confidential, such as summary information on the approval of high risk devices. 

Legal basis for better coordination and communication of market surveillance activities 

The market for medical devices is a global market, with a significant number of devices being 
imported into the European Union. This has led to an increasing need to coordinate activities 
of  national  authorities  when  applied  to  issues  related  to  the  directive  taking  place  across  a 
number  of  Member  States  and/or  third  countries.  Thus  it  is  necessary  to  introduce  a  new 
provision,  Article  20a,  on  cooperation  to  provide  a  legal  basis  for  this  coordination  and 
international activities. 

Clarification regarding medicinal products/medical device provisions 

Devices that incorporate as an integral part a medicinal product or blood plasma derivative are 
required  to  be  reviewed  by  a  notified  body  in  consultation  with  a  national  authority  for 
medicines  or  the  European  Medicines  Agency  (EMEA)  as  appropriate.  These  provisions, 
which are currently contained in Annex I Section 7.4 of the Directive needed modification to 
reflect the experience gained over the years in their implementation, clarifying both the role of 
the notified body and the relevant authority.  

Devices with an ancillary human tissue engineered product  

Provisions are made to include devices with an ancillary human tissue engineered product in 
the scope. This mirrors the proposed Community legislation on Advanced Therapies and fills 
a potential regulatory gap.  

Custom-made devices  

In order to better evidence the compliance of custom made device manufacturers there is now 
an explicit requirement for a post market vigilance system reporting to authorities, as already 
in place for other devices. In order to enhance patient information a requirement is introduced 
that  the  'Statement'  under  Annex  VIII  should  be  also  given  to  the  patient  and  that  it  must 
contain the name of the manufacturer. 

Amendment of other Directives: 

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Directive  90/385/EEC  on  the  approximation  of  the  laws  of  the  Member  States  relating  to 
active  implantable  medical  devices  -  Alignment  of  text  on  certain  aspects  across  all  three 
medical device directives. 

The Directive 90/385/EEC on active implantable medical devices, adopted in 1990, was the 
first in the series of directives on medical devices, however, it has not benefited to the same 
extent from the market experiences and developments as the Directive 93/42/EEC concerning 
medical  devices  and  the  Directive  98/79/EC  on  in  vitro  diagnostic  medical  devices,  which 
were adopted in later years. 

To ensure consistency of interpretation and implementation of the medical device Directives 
and  to  update  the  Directive  90/385/EEC  on  active  implantable  medical  devices  in  terms  of 
health  protection  measures,  certain  aspects,  such  as  authorised  representative,  the  European 
Databank,  health  protection  measures,  and  the  application  of  the  Directive  2000/70/EC  on 
medical devices incorporating stable derivates of human blood or human plasma have to be 
added to Directive 90/385/EC. The latter alignment, on human blood or plasma, results in a 
significant body of text being inserted into the Directive.  

Directive 98/8/EC concerning the placing of biocidal products on the market 

Under  this  regulatory  reform,  the  Directive  on  biocides  needs  to  be  modified  in  order  to 
clarify  that,  alongside  the  active  implantable  medical  devices  and  medical  devices,  also  in 
vitro diagnostic medical devices, now subject of a specific Directive, will be excluded from 
the scope of the biocides Directive. 

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2005/0263 (COD) 

33Proposal for a 

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the 
European Parliament and the Council as regards the review of the medical device 
directives 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
95 thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty3, 

Whereas: 

(1) 

Council  Directive  93/42/EEC  of  14  June  1993  concerning  medical  devices4  requests 
the  Commission  to  submit  a  report  to  the  Council,  no  later  than  five  years  from  the 
date  of  implementation  of  that  Directive,  concerning:  (i)  information  on  incidents 
occurring  following  the  placing  of  devices  on  the  market,  (ii)  clinical  investigation 
carried  out  in  accordance  with  the  procedure  set  out  in  Annex  VIII  to  Directive 
93/42/EEC, and (iii) design examination and EC type examination of medical devices 
that  incorporate,  as  an  integral  part,  a  substance  which,  if  used  separately,  may  be 
considered  to  be  a  medicinal  product  as  defined  in  Directive  2001/83/EC  of  the 
European Parliament and of the Council of 6 November 2001 on the Community code 
relating to medicinal products for human use5 and which is liable to act upon the body 
with action ancillary to that of the device. 

(2) 

The Commission brought forward the conclusions of this report in its Communication 
to the Council and the European Parliament on medical devices 6 which, upon request 

1 
2 
3 
4 

5 

6 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 169, 12.7.1993, p. 1, Directive as last amended by Regulation (EC) No 1882/2003 of the European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
OJ L 311 , 28.11.2001, p. 67 – 128, Directive as last amended by Directive 2004/27/EC of the European 
Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community 
code relating to medicinal products for human use (OJ L 136 , 30.4.2004, p. 34 – 57) 
COM (2003) 386 final, 02.07.2003, OJ C 96, 21.4.2004, p. 5. 

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of the Member States, was expanded to cover all aspects of the Community regulatory 
framework for medical devices. 

This  Communication  was  welcomed  by  the  Council  in  its  Conclusions  on  medical 
devices of 2 December 20037. It was also discussed by the European Parliament which 
adopted a resolution on health implications of Directive 93/42/EEC.8 

Following  from  the  conclusions  drawn  in  that  Communication  it  is  necessary  and 
appropriate  to  amend  Directive  93/42/EEC,  Council  Directive  90/385/EEC  of 
20 June 1990 on the approximation of the laws of the Member States relating to active 
implantable  medical  devices9  and  Council  Directive  98/8/EC  of  the  European 
Parliament and of the Council of 16 February 1998 concerning the placing of biocidal 
products on the market10. 

To  ensure  consistency  of  interpretation  and  implementation  between  Directives 
93/42/EEC and 90/385/EEC the legal framework related to issues such as authorised 
representative, the European databank, health protection measures, and the application 
of  Directive  93/42/EEC  as  regards  medical  devices  incorporating  stable  derivates  of 
human  blood  or  human  plasma11  should  be  extended  to  Directive  90/385/EEC.  The 
application  of  the  provisions  on  medical  devices  incorporating  stable  derivates  of 
human  blood  or  human  plasma  includes  application  of  Directive  2002/98/EC  of  the 
European Parliament and of the Council setting standards of quality and safety for the 
collection,  testing,  processing,  storage  and  distribution  of  human  blood  and  blood 
components and amending Directive 2001/83/EC12. 

It is necessary to  clarify that consideration  of a product having a  medical purpose is 
intrinsic to the definition of a medical device and that software in its own right can be 
defined as a medical device.  

In  the  light  of  technical  innovation  and  the  development  of  initiatives  at  the 
international  level  it  is  necessary  to  enhance  the  provisions  on  clinical  evaluation, 
including clarification that clinical data is generally required for all devices regardless 
of classification and the possibility to centralise data on clinical investigations in the 
European databank. 

In  the  light  of  the  development  of  a  Community  framework  on  human  tissue 
engineered products it is necessary to address medical devices that are combined with 
human tissue engineered products where they have a function ancillary to that of the 
device under Directives 93/42/EEC and 90/385/EEC.  

Council  Conclusions  on  2  December  2003  on  Medical  Devices 
OJ C 20, 24.1.2004, p. 1. 
European Parliament resolution on the health implications of Council Directive 93/42/EEC concerning 
medical devices (2001/2270(INI)). 
OJ L 189 , 20.7.1990, p. 17 – 36, Directive as last amended by Regulation (EC) No 1882/2003. 
OJ L 123 , 24.4.1998, p. 1 – 63, Directive as last amended by Regulation (EC) No 1882/2003. 
as  introduced  by  Directive  2000/70/EC  of  the  European  Parliament  and  of  the  Council  of 
16 November 2000  amending  Council  Directive  93/42/EEC  as  regards  medical  devices  incorporating 
stable derivates of human blood or human plasma, OJ L 313 , 13.12.2000, p. 22 – 24. 
OJ L 33, 8.2.2003, p. 30 – 40. 

(2004/C  20/01), 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

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(9) 

In  order  to  better  evidence  the  compliance  of  custom-made  device  manufacturers  an 
explicit  requirement  for  a  post  market  production  review  system  reporting  to 
authorities  should  be  introduced,  as  is  already  in  place  for  other  devices  and  to 
enhance  patient  information  a  requirement  should  be  introduced  that  the  ‘Statement’ 
under Annex VIII to Directive 93/42/EEC is also to be given to the patient and that it 
must contain the name of the manufacturer. 

(10) 

In  the  light  of  technical  progress  in  information  technology  and  medical  devices,  a 
process  should  be  provided  to  allow  information  supplied  by  the  manufacturer  to  be 
available by other means. 

(11)  Manufacturers of Class I sterile and/or measuring medical devices should be given the 
option  of  using  the  full  quality  assurance  conformity  assessment  module  in  order  to 
provide them with more flexibility in the choice of compliance modules. 

(12) 

In order to support market surveillance activities by Member States it is necessary and 
appropriate  to  link  the  retention  of  documents  for  administrative  purposes  to  the 
lifetime of the product as defined by the manufacturer. 

(13)  For  the  appropriate  and  efficient  functioning  of  Directive  93/42/EEC  as  regards 
regulatory  advice  on  classification  issues  arising  at  national  level,  in  particular  on 
whether  or  not  a  product  falls  under  the  definition  of  a  medical  device,  it  is  in  the 
interest  of  national  market  surveillance  and  the  health  and  safety  of  humans  to 
establish  a  procedure  for  decisions  on  whether  or  not  a  products  falls  under  the 
medical device definition. 

(14)  To ensure that, where a manufacturer does not have a registered place of business in 
the  Community,  authorities  have  a  single  individual  person  authorized  by  the 
manufacturer  whom  they  can  address  in  matters  relating  to  the  compliance  of  the 
devices  with  the  Directives  it  is  necessary  to  introduce  an  obligation  for  such 
manufacturers to designate an authorized representative for all classes of devices.  

(15)  To  further  ensure  public  health  and  safety  it  is  necessary  to  provide  for  a  more 

consistent application of the provisions on health protection measures. 

(16) 

In  support  of  transparency  in  Community  legislation,  certain  information  related  to 
medical  devices  and  their  conformity  with  Directive  93/42/EEC,  in  particular 
information  on  registration,  on  vigilance  reports  and  on  certificates,  should  be 
available to any interested party and the general public. 

(17)  To better coordinate the application and efficiency of national resources when applied 
to  issues  related  to  Directive  93/42/EEC  the  Member  States  should  cooperate  with 
each other and at international level. 

(18)  As design for patient safety initiatives play an increasing role in public health policy it 
is  necessary  to  expressively  set  out  the  need  to  consider  ergonomic  design  in  the 
essential  requirements.  In  addition  the  level  of  training  and  knowledge  of  the  user, 
such  as  in  the  case  of  a  lay  user,  is  further  emphasised  within  the  essential 
requirements. 

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(19) 

In the light of experience gained regarding activities of both, the notified body and the 
authorities, in the assessment of devices which require intervention of the appropriate 
authorities for medicines and human blood derivatives their duties and tasks should be 
clarified. 

(20)  Taking account of the growing importance of software in the field of medical devices, 
be it as stand alone or as software incorporated in a device, validation of software in 
accordance with the state of the art should be an essential requirement. 

(21) 

In the light of the increased use of third parties to carry out the design and manufacture 
of  devices  on  behalf  of  the  manufacturer,  it  is  important  that  the  manufacturer 
demonstrates that he applies adequate controls to the third party to continue to ensure 
the efficient operating of the quality system. 

(22)  The  classification  rules  are  based  on  the  vulnerability  of  the  human  body  taking 
account of the potential risks associated with the technical design and manufacture of 
the devices. For class III devices explicit prior authorization with regard to conformity, 
including an assessment of the design documentation, is required for them to be placed 
on  the  market.  In  performing  its  duties  under  the  quality  assurance  and  verification 
conformity  assessment  modules  for  all  other  classes  of  devices  it  is  essential  and 
necessary  for  a  notified  body,  in  order  to  be  assured  of  the  compliance  of  the 
manufacturer  with  Directive  93/42/EEC,  to  review  the  design  documentation  for  the 
medical device. The depth and extent of this review should be commensurate with the 
classification  of  the  device,  the  novelty  of  the  intended  treatment,  the  degree  of 
intervention,  the  novelty  of  the  technology  or  construction  materials,  and  the 
complexity of the design and/or technology. This review can be achieved by taking a 
representative  example  of  design  documentation  of  one  or  more  type(s)  of  devices 
from those being manufactured. Further review(s), and in particular the assessment of 
changes  to  the  design  that  could  affect  conformity  with  the  essential  requirements, 
should be part of the surveillance activities of the notified body. 

(23) 

(24) 

It  is  necessary  to  remove  the  incoherence  in  the  classification  rules  that  meant  that 
invasive  devices  with  respect  to  body  orifices  intended  for  connection  to  an  active 
class I medical device were not classified. 

It  should  be  clarified  that  alongside  Directives  90/385/EEC  and  93/42/EEC,  also  in 
vitro  diagnostic  medical  devices,  which  are  the  subject  of  Directive  98/79/EC  of  the 
European  Parliament  and  of  the  Council  of  27  October  1998  on  in  vitro  diagnostic 
medical devices13 should be excluded from the scope of Directive 98/8/EC. 

(25)  Directives  90/385/EEC,  93/42/EEC  and  98/8/EC  should  therefore  be  amended 

accordingly, 

13 

OJ L 331, 7.12.1998, p. 1. Directive as last amended by Regulation (EC) No 1882/2003. 

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HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Directive 90/385/EEC is amended as follows: 

(1) Article 1 is amended as follows: 

(a) Paragraph 2 is amended as follows:  

(i) point (a) shall be replaced by: 

“(a) ‘medical device’ means any instrument, apparatus, appliance, software, material 
or other article, whether used alone or in combination, together with any accessories, 
including  the  software  necessary  for  its  proper  application  intended  by  the 
manufacturer to be used for medical purposes for human beings for the purpose of: 

— diagnosis, prevention, monitoring, treatment or alleviation of disease, 

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or 
handicap, 

—  investigation,  replacement  or  modification  of  the  anatomy  or  of  a  physiological 
process, 

— control of conception, 

and which does not achieve its principal intended action in or on the human body by 
pharmacological, immunological or metabolic means, but which may be assisted in 
its function by such means;” 

(ii) in paragraph 2 points (d), (e) and (f) are replaced by the following: 

“(d) ‘custom-made device’ means any device specifically made in accordance with a 
duly  qualified  medical  practitioner's  written  prescription  which  gives,  under  his 
responsibility,  specific  design  characteristics  and  is  intended  for  the  sole  use  of  a 
particular patient. 

The  abovementioned  prescription  may  also  be  made  out  by  any  other  person 
authorized by virtue of his professional qualifications to do so. 

Mass-produced devices which need to be adapted to meet the specific requirements 
of  the  medical  practitioner  or  any  other  professional  user  are  not  considered  to  be 
custom-made devices; 

(e) ‘device intended for clinical investigation’ means any device intended for use by 
a duly qualified medical practitioner when conducting investigations as referred to in 
Section 2.1 of Annex 7 in an adequate human clinical environment.  

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For the purpose of conducting clinical investigation, any other person who, by virtue 
of his professional qualifications, is authorized to carry out such investigation shall 
be accepted as equivalent to a duly qualified medical practitioner; 

(f)  ‘intended  purpose’  means  the  use  for  which  the  device  is  intended  according  to 
the data supplied by the manufacturer on the labelling, in the instructions and/or in 
promotional materials;” 

(iii) the following point (j) is added: 

“(j) ‘authorised representative’ means any natural or legal person established in the 
Community  who,  explicitly  designated  by  the  manufacturer,  acts  and  may  be 
addressed  by  authorities  and  bodies  in  the  Community  instead  of  the  manufacturer 
with regard to the latter's obligations under this Directive;” 

(b) Paragraph 3 is replaced by the following: 

“3. Where an active implantable medical device is intended to administer a substance 
defined as a medicinal product within the meaning of Council Directive 2001/83/EC 
of the European Parliament and of the Council (*), that substance shall be subject to 
the system of marketing authorization provided for in that Directive. 

_________ 

(*) OJ L 311, 27.11.2001, p.67.” 

(c) In paragraph 4 the reference ‘65/65/EEC’ is replaced by ‘2001/83/EC’. 

(d) The following paragraphs 4a and 4b are inserted: 

“4a.  Where  a  device  incorporates,  as  an  integral  part,  a  substance  which,  if  used 
separately, may be considered to be a medicinal product constituent or a medicinal 
product derived from human blood or human plasma within the meaning of Article 1 
of Directive 2001/83/EC and which is liable to act upon the human body with action 
that  is  ancillary  to  that  of  the  device,  hereinafter  referred  to  as  a  “human  blood 
derivative”,  that  device  must  be  assessed  and  authorised  in  accordance  with  this 
Directive. 

4b.  Where  a  devices  incorporates,  as  an  integral  part,  a  substance,  which,  if  used 
separately,  may  be  considered  to  be  a  human  tissue  engineered  product  within  the 
meaning of [Article 2 (2) of the Regulation (EC) No […] of the European Parliament 
and of the Council (**) [on advanced Therapies and amending Regulation (EC) No 
726/2004]] and which is liable to act upon the body with action that is ancillary to 
that  of  the  device,  that  device  must  be  assessed  and  authorized  in  accordance  with 
this Directive. 

_________ 

(**) [OJ L …. of …, p…]” 

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(e) Paragraph 5 is replaced by the following: 

“5. This Directive constitutes a specific Directive within the meaning of Article 1(4) 
of Directive 2004/108/EC of the European Parliament and of the Council (***). 

_________ 

(***) OJ L 390, 31.12.2004, p. 24.” 

(f) The following paragraph 6 is added: 

“6. This Directive shall not apply to human blood, blood products, plasma or blood 
cells  of  human  origin,  or  to  human  tissue  engineered  products  or  to  devices  which 
incorporate at the time of placing on the market such blood products, plasma or cells, 
or  human  tissue  engineered  products  with  the  exception  of  devices  referred  to  in 
paragraphs 4a and 4b.” 

(2) Article 6 is amended as follows: 

(a) Paragraph 2 is amended as follows:  

(i) the second subparagraph is deleted.  

(ii) In the third subparagraph the words ‘Articles 3 and 7’ are replaced by ‘Articles 5 
and 7’.  

(b) The following paragraph 3 is added: 

“3. The Committee may examine any question connected with the implementation of 
this Directive.” 

(3) The following Articles 10a, 10b and 10c are inserted: 

“Article 10a 

1.  Any  manufacturer  who,  under  his  own  name,  places  devices  on  the  market  in 
accordance  with  the  procedures  referred  to  in  Article  9  (2)  and  Article  10  (1)  shall 
inform the competent authorities of the Member State in which he has his registered 
place  of  business  of  the  address  of  the  registered  place  of  business  and  the 
description of the devices concerned.  

2. Where a manufacturer who places devices on the market under his own name does 
not have a registered place of business in a Member State, he shall designate a single 
authorized representative established in the Community. 

For devices referred to in paragraph 1 the authorized representative shall inform the 
competent  authorities  of  the  Member  State  in  which  he  has  his  registered  place  of 
business of the address of the registered place of business and the category of devices 
concerned. 

3.  The  Member  States  shall  on  request  inform  the  other  Member  States  and  the 
Commission of the details referred to in paragraphs 1 and 2.  

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Article 10b 

1.  Regulatory  data  in  accordance  with  this  Directive  shall  be  stored  in  a  European 
databank  accessible  to  the  competent  authorities  to  enable  them  to  carry  out  their 
tasks relating to this Directive on a well-informed basis. 

The databank shall contain the following: 

(a) data relating to the registration of manufacturers and devices in accordance with 
Article 10a; 

(b)  data  relating  to  certificates  issued,  modified,  supplemented,  suspended, 
withdrawn or refused according to the procedures, as laid down in Annexes 2 to 5; 

(c) data obtained in accordance with the vigilance procedure as defined in Article 8;  

(d) data related to clinical investigations referred to in Article 10; 

2. Data shall be forwarded in a standardised format. 

3.  The  Commission  shall,  in  accordance  with  the  procedure  laid  down  in 
Article 6 (2), adopt the measures for the implementation of paragraph 1 and 2 of this 
Article  and  in  particular  the  scope  of  the  required  data  related  to  clinical 
investigations. 

Article 10c 

Where a Member State considers in relation to a given product or group of products, 
that,  in  order  to  ensure  protection  of  health  and  safety  and/or  to  ensure  that  public 
health  requirements  are  observed,  such  products  should  be  withdrawn  from  the 
market, or their placing on the market and putting into service should be prohibited 
or restricted, it may take any justified transitional measures.  

The Member State shall then inform the Commission and all other Member States of 
the transitional measures giving the reasons for its decision.  

The  Commission  shall,  whenever  possible,  consult  the  interested  parties  and  the 
Member States.  

Where the national measures are justified, the Commission shall adopt the necessary 
Community measures in accordance with the procedure referred to in Article 6(2). In 
case the national measures are unjustified, the Commission shall inform all Member 
States and the consulted interested parties.” 

(4) In Article 11 the following paragraphs 5, 6 and 7 are added:  

“5.  The  notified  body  shall  inform  the  other  notified  bodies  and  its  competent 
authority  about  all  certificates  refused,  suspended  or  withdrawn  and,  on  request, 
about  certificates  issued.  It  shall  also  make  available,  on  request,  all  additional 
relevant information. 

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6. Where a notified body finds that pertinent requirements of this Directive have not 
been  met  or  are  no  longer  met  by  the  manufacturer  or  that  a  certificate  should  not 
have been issued, it shall, taking account of the principle of proportionality, suspend 
or  withdraw  the  certificate  issued  or  place  any  restrictions  on  it  unless  compliance 
with  such  requirements  is  ensured  by  the  implementation  of  appropriate  corrective 
measures by the manufacturer.  

In the case of suspension or withdrawal of the certificate or of any restriction placed 
on  it  or  in  cases  where  an  intervention  of  the  competent  authority  may  become 
necessary, the notified body shall inform its competent authority thereof.  

The Member State shall inform the other Member States and the Commission. 

7.  The  notified  body  shall,  on  request,  supply  all  relevant  information  and 
documents, including budgetary documents, required to enable the Member State to 
verify compliance with the requirements laid down in Annex 8.” 

(5) Annexes 1 to 5 are amended in accordance with Annex I to this Directive. 

Article 2 

Directive 93/42/EEC is amended as follows: 

(1) Article 1 is amended as follows: 

(a) Paragraph 2 is amended as follows:  

(i) in point (a) the introductory phrase is replaced by the following: 

“‘medical device’ means any instrument, apparatus, appliance, software, material or 
other article, whether used alone or in combination, including the software necessary 
for  its  proper  application  intended  by  the  manufacturer  to  be  used  for  medical 
purposes for human beings for the purpose of:”  

(ii) the following point (k) is added: 

“(k) ‘clinical data’ means the safety and/or performance data that is generated from 
the clinical use of a device and must include data obtained from any of the following: 

— clinical investigation(s) of the device concerned; or 

—  clinical  investigation(s)  or  other  studies  reported  in  the  scientific  literature,  of  a 
similar device for which equivalence to the device in question can be demonstrated; 
or 

—  published  and/or  unpublished  data  on  clinical  experience  of  either  the  device  in 
question or a similar device for which equivalence to the device in qu estion can be 
demonstrated; or 

— any combination of the above.”  

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17 

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(b) Paragraph 3 is replaced by the following: 

“3. Where a device is intended to administer a medicinal product within the meaning 
of  Article  1  of  Directive  2001/83/EC  of  the  European  Parliament  and  of  the 
Council(*), that device shall be governed by this Directive, without prejudice to the 
provisions of Directive 2001/83/EC with regard to the medicinal product. 

If, however, such a device is placed on the market in such a way that the device and 
the  medicinal  product  form  a  single  integral  product  which  is  intended  exclusively 
for use in the given combination and which is not reusable, that single product shall 
be governed by Directive 2001/83/EC. The relevant essential requirements of Annex 
I to this Directive shall apply as far as safety and performance related device features 
are concerned. 

_________ 

(*) OJ L 311, 28.11.2001, p. 67.” 

(c) In paragraph 4 the reference ‘65/65/EEC’ is replaced by ‘2001/83/EC’. 

(d) In paragraph 4a the reference ‘89/381/EEC’ is replaced by ‘2001/83/EC’. 

(e) The following paragraph 4b is inserted:  

“4b.  Where  a  device  incorporates,  as  an  integral  part,  a  substance  which,  if  used 
separately,  may  be  considered  to  be  a  human  tissue  engineered  product  within  the 
meaning  of  [Article  2  (2)]  of  Regulation (EC)  No  […]  of  the  European  Parliament 
and of the Council(**)[Regulation on Advanced Therapies and amending Regulation 
(EC)  No  726/2004]  and  which  is  liable  to  act  upon  the  body  with  action  that  is 
ancillary  to  that  of  the  device,  that  device  must  be  assessed  and  authorized  in 
accordance with this Directive.” 

_________ 

(**) [OJ L …. of …, p…]” 

(f) Paragraph 5 is amended as follows: 

(i) point (c) is replaced by the following: 

“(c)  medicinal  products  covered  by  Directive  2001/83/EC.  In  deciding  whether  a 
product falls under that Directive or the present Directive, particular account shall be 
taken of the principal mode of action of the product;”  

(ii) point (f) is replaced by the following:  

“(f)  transplants  or  tissues  or  cells  of  human  origin  nor to  products  incorporating  or 
derived from tissues or cells of human origin, with the exception of devices referred 
to in paragraph 4b.” 

(g) Paragraph 6 is deleted. 

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(h) Paragraphs 7 and 8 are replaced by the following:  

“7.  This  Directive  is  a  specific  Directive  within  the  meaning  of  Article  1(4)  of 
Directive 2004/108/EC of the European Parliament and of the Council (***). 

8.  This  Directive  does  not  affect 
96/29/Euratom(****), nor of Council Directive 97/43/Euratom(*****). 

the  application  of  Council  Directive 

_________ 

(***) OJ L 390, 31.12.2004, p. 24 

(****) OJ L 159, 29.6.1996, p. 1 

(*****) OJ L 180, 9.7.1987, p. 22” 

(2) The second indent of Article 4 (2) is replaced by the following: 

“—  custom-made  devices  being  placed  on  the  market  and  put  into  service  if  they 
meet the conditions laid down in Article 11 in combination with Annex VIII; Class 
IIa, IIb and III devices shall be accompanied by the statement referred to in Annex 
VIII, which shall be provided to the named patient.” 

(3) In Article 9 paragraph (3) is replaced by the following: 

“3 Where a Member State considers that the classification rules set out in Annex IX 
require  adaptation  in  the  light  of  technical  progress  and  any  information  which 
becomes available under the information system provided for  in Article 10, it shall 
submit  a  duly  substantiated  request  to  the  Commission  and  ask  it  to  take  the 
necessary measures. The Commission shall adopt these measures in accordance with 
the procedure referred to in Article 7 (2).” 

(4) Article 11 is amended as follows: 

(a)  In  paragraph  11,  the  words  ‘Annexes  II  and  III’  are  replaced  by  ‘Annexes  II,  III, 
V and VI’. 

(b) The following paragraph is added: 

“14.  The  Commission  may,  in  accordance  with  the  procedure  referred  to  in 
Article 7 (2),  adopt  measures  allowing  instructions  for  use  to  be  provided  by  other 
means.” 

(5) Article 12 is amended as follows: 

(a) In paragraph 3, the words “Annex IV, V or VI” are replaced by “Annex II, IV, V or VI”. 

(b) in paragraph 4, the third sentence is replaced by the following: 

“The declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the 
competent  authorities  for  a  period  of  time  at  least  equivalent  to  the  lifetime  of  the 

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device as defined by the manufacturer but not less than five years from the date of 
manufacture.” 

(6) In Article 13(1) the following point (d) is inserted: 

”or 

(d) application of the classification rules set out in Annex IX requires a decision as to 
whether  a  product  falls  within  one  of  the  definitions  in  Article  1  paragraph  2, 
points (a) to (e),”; 

(7) Article 14 (2) is replaced by the following: 

“2.  Where  a  manufacturer  who  places  devices  on  the  market  under  his  own  name 
does not have a registered place of business in a Member State, he shall designate a 
single authorised representative.  

For  devices  referred  to  in  the  first  sentence  of  paragraph  1,  the  authorised 
representative shall notify the competent authorities of the Member State in which he 
has his registered place of business of all details as referred to in paragraph 1.” 

(8) Article 14a is amended as follows: 

(a) The second subparagraph of paragraph 1 is amended as follows: 

(i) point (a) is replaced by the following 

“(a) data relating to the registration of manufacturers and authorised representatives 
and devices in accordance with Article 14;” 

(ii) the following point (d) is added: 

“(d) data related to clinical investigations referred to in Article 15;” 

(b) Paragraph 3 is replaced by the following: 

“3.  The  Commission  shall,  in  accordance  with  the  procedure  referred  to  in 
Article 7 (2),  adopt  measures  for  the  implementation  of  paragraphs  1  and  2  of  this 
Article  and  in  particular  the  scope  of  the  required  data  related  to  clinical 
investigations.” 

(9) Article 14b is replaced by the following: 

“Article 14b 

Health Protection Measures 

Where a Member State considers, in relation to a given product or group of products, 
that,  in  order  to  ensure  protection  of  health  and  safety  and/or  to  ensure  that  public 
health  requirements  are  observed,  such  products  should  be  withdrawn  from  the 
market, or their placing on the market and putting into service should be prohibited 
or restricted, it may take any necessary and justified transitional measures. 

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The  Member  State  shall  then  inform  the  Commission  and  all  other  Member  States 
giving the reasons for its decision. 

The  Commission  shall,  whenever  possible,  consult  the  interested  parties  and  the 
Member States. 

Where the national measures are justified, the Commission shall adopt the necessary 
Community measures in accordance with the procedure referred to in Article 7(2). If 
the  national  measures  are  unjustified,  the  Commission  shall  inform  all  Member 
States and the consulted interested parties.” 

(10) Article 15(2) and (3) are replaced by the following: 

“2.  In  the  case  of  devices  falling  within  Class  III  and  implantable  and  long-term 
invasive devices falling within Class IIa or IIb, the manufacturer may commence the 
relevant  clinical  investigation  at  the  end  of  a  period  of  60  days  after  notification, 
unless the competent authorities have notified him within that period of a decision to 
the contrary based on considerations of public health or public policy. Such decisions 
shall be communicated by the competent authority to the other Member States. 

Member  States  may  however  authorize  manufacturers  to  commence  the  relevant 
clinical  investigations  before  the  expiry  of  the  period  of  60  days,  in  so  far  as  the 
relevant  ethics  committee  has  issued  a  favourable  opinion  on  the  programme  of 
investigation in question, including the reviewed clinical investigation plan. 

3. In the case of devices other than those referred to in paragraph 2, Member States 
may authorize manufacturers to commence clinical investigations immediately after 
the date of notification, provided that the ethics committee concerned has delivered a 
favourable opinion with regard to the reviewed clinical investigation plan.” 

(11) Article 16 (5) is replaced by the following: 

“5.  The  notified  body  shall  inform  the  other  notified  bodies  and  its  competent 
authority  about  all  certificates  refused,  suspended  or  withdrawn  and,  on  request, 
about certificates issued. The notified body shall also make available, on request, all 
additional relevant information.” 

(12) In Article 18 (b) the word ‘Article 8’ is replaced by ‘Article 8(3)’. 

(13) Article 20 is replaced by the following: 

“Article 20 

Confidentiality 

1.  Without  prejudice  to  the  existing  national  provisions  and  practices  on  medical 
confidentiality,  Member  States  shall  ensure  that  all  the  parties  involved  in  the 
application  of  this  Directive  are  bound  to  observe  confidentiality  with  regard  to  all 
information obtained in carrying out their tasks.  

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This does not affect the obligation of Member States and notified bodies with regard 
to mutual information and the dissemination of warnings, nor the obligations of the 
persons concerned to provide information under criminal law. 

2. The following information shall not be treated as confidential: 

(a) information on the registration of persons responsible for placing devices on the 
market in accordance with Article 14; 

(b) competent authority vigilance reports in accordance with Article 10(3); 

(c)  data  relating  to  certificates  issued,  modified,  supplemented,  suspended, 
withdrawn or refused. 

3.  The  Commission  may,  in  accordance  with  the  procedure  referred  to  in 
Article 7 (2), determine the conditions under which other information may be made 
publicly available, and in particular for Class IIb and Class III devices an obligation 
for manufacturers to prepare and make available a summary of the information and 
data related to the device.” 

(14) The following Article 20a is inserted: 

“Article 20a 

Cooperation 

Member States shall take appropriate measures in order to encourage the authorities 
responsible for implementing this Directive to cooperate and provide each other and 
the Commission with information in order to assist the functioning of this Directive. 

Without prejudice to the provisions of this Directive, implementation may be part of 
initiatives developed at an international level.” 

(15) Annexes I to X are amended in accordance with Annex II to this Directive. 

In Article 1 (2) of Directive 98/8/EC the following point (s) is added: 

Article 3 

“(s)  Directive  98/79/EC  of  the  European  Parliament  and  of  the  Council  of 
27 October 1998 on in vitro diagnostic medical devices (*). 

_________ 

(*) OJ L 331, 7.12.1998, p. 1.” 

Article 4  

1.  Member  States  shall  adopt  and  publish  by  [12  months  after  publication]  the  laws, 
regulations and administrative provisions necessary to comply with this Directive. They shall 

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forthwith communicate to the Commission the text of those provisions and a correlation table 
between those provisions and this Directive. 

They shall apply those provisions from [12 months from the transposition]. 

When Member States adopt those provisions, they shall contain a reference to this Directive 
or be accompanied by such a reference on the occasion of their official publication. Member 
States shall determine how such reference is to be made. 

2.  Member  States  shall  communicate  to  the  Commission  the  text  of  the  main  provisions  of 
national law which they adopt in the field covered by this Directive. 

This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 5  

Article 6 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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ANNEX I 

Annexes 1 to 5 to Directive 90/385/EEC are amended as follows: 

(1) Annex 1 is amended as follows: 

(a) In Section 9, seventh indent, the following phrase is added:  

“For  devices  which  incorporate  software  or  which  are  medical  software  in 
themselves,  the  software  must  be  validated  according  to  the  state  of  the  art  taking 
into  account  the  principles  of  development  lifecycle,  risk  management,  validation 
and verification.” 

(b) Section 10 is replaced by the following:  

“10.  Where  a  device  incorporates,  as  an  integral  part,  a  substance  which,  if  used 
separately,  may  be  considered  to  be  a  medicinal  product  as  defined  in  Article  1  of 
Directive 2001/83/EC and which is liable to act upon the body with action ancillary 
to  that  of  the  device,  the  quality,  safety  and  usefulness  of  the  substance  must  be 
verified by analogy with the methods specified in Directive 2001/83/EC.  

For a substance which: 

—  has  already  been  granted,  as  a  medicinal  product,  a  Community  marketing 
authorisation  in  accordance  with  Council  Regulation  (EEC)  No  2309/93  (*)  or 
Regulation (EC) No 726/2004; or  

— falls within the scope of the Annex to Regulation (EC) No 726/2004; 

or 

— is a human blood derivative; 

the notified body shall, having verified the usefulness of the substance as part of the 
medical  device  and  taking  account  of  the  intended  purpose  of  the  device,  seek  a 
scientific opinion from the European Medicines Agency (EMEA) on the quality and 
safety of the substance. When issuing its opinion, the EMEA shall take into account 
the manufacturing process and the data related to the incorporation of the substance 
into the device. 

For  other  substances,  the  notified  body  shall,  having  verified  the  usefulness  of  the 
substance as part of the medical device and taking account of the intended purpose of 
the device, seek a scientific opinion from one of the competent authorities designated 
by the Member States in accordance with Directive 2001/83/EC, on the quality and 
safety of the substance. When issuing its opinion, the concerned competent authority 
shall  take  into  account  the  manufacturing  process  and  the  data  related  to  the 
incorporation of the substance into the device. 

Where changes are made to an ancillary substance incorporated in a medical device, 
in particular related to its manufacturing process, they shall be assessed by analogy 
with the procedures for the evaluation of variations to medicinal products laid down 
in Commission Regulations (EC) No. 1084/2003 (**)and EC No. 1085/2003 (***). 

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The  notified  body  shall  be  informed  of  the  changes  and  shall  consult  the  relevant 
medicines  competent  authority  (i.e.  the  one  involved  in  the  initial  consultation),  in 
order to confirm that the quality and safety of the ancillary substance are maintained, 
and to ensure that the changes have no negative impact on the established benefit/risk 
profile of the addition of the substance in the medical device. 

_________ 

(*) OJ L 214, 24.8.1993, p. 1. 

(**) OJ L 159, 27.6.2003 p. 1. 

(***) OJ L 159, 27.6.2003 p. 24.” 

(c) The following Section 10a is inserted: 

“10a.  Where  a  device  incorporates,  as  an  integral  part,  a  product  which,  if  used 
separately,  may  be  considered  to  be  a  human  tissue  engineered  product  within  the 
meaning  of  [Article  2  (2)  of  the  Regulation  on  Advanced  Therapies  and  amending 
Regulation (EC) No 726/2004] and which is liable to act upon the body with action 
that is ancillary to that of the device, the quality, safety and usefulness of the product 
must be verified by analogy with the methods specified in Regulation EC No. […] 
[on Advanced Therapies and amending Regulation (EC) No 726/2004]. 

The notified body shall, having verified the usefulness of the product as part of the 
medical  device  and  taking  account  of  the  intended  purpose  of  the  device,  seek  a 
scientific  opinion  from  the  [Committee  of  Advanced  Therapies]  on  the  quality  and 
safety  of  the  product.  When  issuing  its  opinion,  the  [Committee  of  Advanced 
Therapies] shall take into account the manufacturing process and the data related to 
the incorporation of the product into the device.” 

(d) The following indent is added to Section 14.2.: 

“— in the case of a device within the meaning of Article 1(4a), an indication that the 
device contains a human blood derivative or a human tissue engineered product.” 

(2) Annex 2 is amended as follows: 

(a) The following indent is added to Section 3.2(c): 

“— a statement indicating whether or not the device incorporates, as an integral part, 
a substance, a human blood derivative or a human tissue engineered product referred 
to  in  sections  10  and  10a  of  Annex  1  and  the  data  on  the  tests  conducted  in  this 
connection  required  to  assess  the  safety,  quality  and  usefulness  of  that  substance, 
human blood derivative or a human tissue engineered product, taking account of the 
intended purpose of the device.” 

EN 

25 

   EN 

 
(b) In Section 4.2 the first paragraph is replaced by the following:  

“The  application  shall  describe  the  design,  manufacture,  and  performances  of  the 
product in question and it must include the documents needed to assess whether the 
product  conforms  to  the  requirements  of  this  Directive,  and  in  particular  Annex  2, 
Section 3.2, third paragraph, points (c) and (d).” 

(c) In Section 4.3 the following subparagraphs are added: 

“In  the  case  of  devices  referred  to  in  Annex  1,  Section  10  third  paragraph,  the 
notified body shall, as regards the aspects referred to in that section, consult one of 
the competent bodies designated by the Member States in accordance with Directive 
2001/83/EC before taking a decision. The notified body will give due consideration 
to the views expressed in this consultation when making its decision. It will convey 
its final decision to the competent body concerned. 

In the case of devices referred to in Annex 1, Section 10a, second subparagraph, the 
scientific  opinion  of  the  EMEA  must  be  included  in  the  documentation  concerning 
the  device.  The  notified  body  will  give  due  consideration  to  the  opinion  of  the 
EMEA when making its decision. The notified body may not deliver the certificate if 
the EMEA's scientific opinion is unfavourable. It will convey its final decision to the 
EMEA.  

In the case of devices referred to in Annex 1, Section 10a, the scientific opinion of 
the  [Committee  of  Advanced  Therapies]  must  be  included  in  the  documentation 
concerning the device. The notified body will give due consideration to the opinion 
of  the  [Committee  of  Advanced  Therapies]  when  making  its  decision.  The  notified 
body  may  not  deliver  the  certificate  if  the  [Committee  of  Advanced  Therapies] 
scientific opinion is unfavourable. It will convey its final decision to the [Committee 
of Advanced Therapies].” 

(d) The following Section 7 is added: 

“7. Application to the devices referred to in Article 1(4a): 

Upon  completing  the  manufacture  of  each  batch  of  devices  referred  to  in  Article 
1(4a), the manufacturer shall inform the notified body of the release of the batch of 
devices  and  send  to  it  the  official  certificate  concerning  the  release  of  the  batch  of 
human  blood  derivative  used  in  the  device,  issued  by  a  State  laboratory  or  a 
laboratory designated for that purpose by a Member State in accordance with Article 
114(2) of Directive 2001/83/EC.” 

(3) Annex 3 is amended as follows: 

(a) The sixth indent of Section 3 is replaced by the following: 

“— a declaration stating whether or not the device incorporates, as an integral part, a 
substance,  a  human  blood  derivative  or  a  human  tissue  engineered  product  as 
referred to in Sections 10 and a of Annex 1 and the data on the tests conducted in this 
connection  required  to  assess  the  safety,  quality  and  usefulness  of  that  substance, 
human  blood  derivative  or  human  tissue  engineered  product,  taking  account  of  the 
intended purpose of the device.” 

EN 

26 

   EN 

 
(b) The following subparagraphs are added to Section 5: 

“In  the  case  of  devices  referred  to  in  Annex  1,  Section  10  third  paragraph,  the 
notified body shall, as regards the aspects referred to in that section, consult one of 
the competent bodies designated by the Member States in accordance with Directive 
2001/83/EC before taking a decision. The notified body will give due consideration 
to the views expressed in this consultation when making its decision. It will convey 
its final decision to the competent body concerned. 

In  the  case  of  devices  referred  to  in  Annex  1,  Section  10  second  paragraph,  the 
scientific  opinion  of  the  EMEA  must  be  included  in  the  documentation  concerning 
the  device.  The  notified  body  will  give  due  consideration  to  the  opinion  of  the 
EMEA when making its decision. The notified body may not deliver the certificate if 
the EMEA's scientific opinion is unfavourable. It will convey its final decision to the 
EMEA.  

In the case of devices referred to in Annex 1, Section 10a, the scientific opinion of 
the  [Committee  of  Advanced  Therapies]  must  be  included  in  the  documentation 
concerning the device. The notified body will give due consideration to the opinion 
of  the  [Committee  of  Advanced  Therapies]  when  making  its  decision.  The  notified 
body  may  not  deliver  the  certificate  if  the  [Committee  of  Advanced  Therapies] 
scientific opinion is unfavourable. It will convey its final decision to the [Committee 
of Advanced Therapies].” 

(4) The following Section 7 is added to Annex 4: 

“7. Application to the devices referred to in Article 1(4a): 

Upon  completing  the  manufacture  of  each  batch  of  devices  referred  to  in  Article 
1(4a), the manufacturer shall inform the notified body of the release of the batch of 
devices  and  send  to  it  the  official  certificate  concerning  the  release  of  the  batch  of 
human  blood  derivative  used  in  the  device,  issued  by  a  State  laboratory  or  a 
laboratory designated for that purpose by a Member State in accordance with Article 
114(2) of Directive 2001/83/EC.” 

(5) The following Section 6 is added to Annex 5: 

“6. Application to the devices referred to in Article 1(4a): 

Upon  completing  the  manufacture  of  each  batch  of  devices  referred  to  in  Article 
1(4a), the manufacturer shall inform the notified body of the release of the batch of 
devices  and  send  to  it  the  official  certificate  concerning  the  release  of  the  batch  of 
human  blood  derivative  used  in  the  device,  issued  by  a  State  laboratory  or  a 
laboratory designated for that purpose by a Member State in accordance with Article 
114(2) of Directive 2001/83/EC.” 

EN 

27 

   EN 

 
Annexes I to X to Directive 93/42/EEC are amended as follows: 

ANNEX II  

(1) Annex I is amended as follows: 

(a) Section 1. is replaced by the following: 

“1. The devices must be designed and manufactured in such a way that, when used 
under the conditions and for the purposes intended and, where applicable, by virtue 
of the technical knowledge, experience, education or training of intended users, they 
will not compromise the clinical condition or the safety of patients, or the safety and 
health  of  users  or,  where  applicable,  other  persons,  provided  that  any  risks  which 
may be associated with their intended use constitute acceptable risks when weighed 
against the benefits to the patient and are compatible with a high level of protection 
of  health  and  safety.  This  shall  include  reducing,  as  far  as  possible,  risks  posed  by 
user  error  due  to  the  ergonomic  features  of  the  device  and  its  intended  user 
environment.”  

(b) Section 7.4. is replaced by the following: 

“7.4.  Where  a  device  incorporates,  as  an  integral  part,  a  substance  which,  if  used 
separately,  may  be  considered  to  be  a  medicinal  product  as  defined  in  Article  1  of 
Directive 2001/83/EC and which is liable to act upon the body with action ancillary 
to  that  of  the  device,  the  quality,  safety  and  usefulness  of  the  substance  must  be 
verified by analogy with the methods specified in Directive 2001/83/EC.  

For a substance which: 

—  has  already  been  granted,  as  a  medicinal  product,  a  Community  marketing 
authorisation  in  accordance  with  Council  Regulation  (EEC)  No  2309/93  (*)  or 
Regulation (EC) No 726/2004; 

or 

— falls within the scope of the Annex to Regulation (EC) No 726/2004; 

or 

— is a human blood derivative; 

the notified body shall, having verified the usefulness of the substance as part of the 
medical  device  and  taking  account  of  the  intended  purpose  of  the  device,  seek  a 
scientific opinion from the European Medicines Agency (EMEA) on the quality and 
safety of the substance. When issuing its opinion, the EMEA shall take into account 
the manufacturing process and the data related to the incorporation of the substance 
into the device. 

For  other  substances,  the  notified  body  shall,  having  verified  the  usefulness  of  the 
substance as part of the medical device and taking account of the intended purpose of 
the device, seek a scientific opinion from one of the competent authorities designated 
by the Member States in accordance with Directive 2001/83/EC, on the quality and 

EN 

28 

   EN 

 
safety of the substance. When issuing its opinion, the concerned competent authority 
shall  take  into  account  the  manufacturing  process  and  the  data  related  to  the 
incorporation of the substance into the device. 

Where changes are made to an ancillary substance incorporated in a medical device, 
in particular related to its manufacturing process, they shall be assessed by analogy 
with the procedures for the evaluation of variations to medicinal products laid down 
in Commission Regulations (EC) No. 1084/2003 (**) and EC No.1085/2003 (***). 
The  notified  body  shall  be  informed  of  the  changes  and  shall  consult  the  relevant 
medicines  competent  authority  (i.e.  the  one  involved  in  the  initial  consultation),  in 
order to confirm that the quality and safety of the ancillary substance are maintained, 
and to ensure that the changes have no negative impact on the established benefit/risk 
profile of the addition of the substance in the medical device. 

_________ 

(*) OJ L214, 24.8.1993, p. 1. 

(**) OJ L 159, 27.6.2003, p. 1. 

(***) OJ L 159, 27.6.2003, p. 24.” 

(c) The following Section 7.4a is inserted:  

“7.4a.  Where  a  device  incorporates,  as  an  integral  part,  a  product  which,  if  used 
separately,  may  be  considered  to  be  a  human  tissue  engineered  product  within  the 
meaning  of  [Article  2  (2)  of  the  Regulation  on  Advanced  Therapies  and  amending 
Regulation (EC) No 726/2004] and which is liable to act upon the body with action 
that is ancillary to that of the device, the quality, safety and usefulness of the product 
must be verified by analogy with the methods specified in Regulation EC No. […] 
[on Advanced Therapies and amending Regulation (EC) No 726/2004]. 

The notified body shall, having verified the usefulness of the product as part of the 
medical  device  and  taking  account  of  the  intended  purpose  of  the  device,  seek  a 
scientific  opinion  from  the  [Committee  of  Advanced  Therapies]  on  the  quality  and 
safety  of  the  product.  When  issuing  its  opinion,  the  [Committee  of  Advanced 
Therapies] shall take into account the manufacturing process and the data related to 
the incorporation of the product into the device.” 

(d) In Section 8.2. the word ‘transferable’ is replaced by the word ‘transmissible’; 

(e) The following Section 12.1a is inserted: 

“12.1a  For  devices  which  incorporate  software  or  which  are  medical  software  in 
themselves,  the  software  must  be  validated  according  to  the  state  of  the  art  taking 
into  account  the  principles  of  development  lifecycle,  risk  management,  validation 
and verification.” 

EN 

29 

   EN 

 
(f) In Section 13.1. the first paragraph is replaced by the following: 

“13.1. Each device must be accompanied by the information needed to use it safely 
and properly, taking account of the training and knowledge of the potential users, and 
to identify the manufacturer.” 

(g) Section 13.3 is amended as follows: 

(i) point (a) is replaced by the following: 

“(a) the name or trade name and address of the manufacturer. For devices imported 
into the Community, in view of their distribution in the Community, the label, or the 
outer  packaging,  or  instructions  for  use,  shall  contain  in  addition  the  name  and 
address  of  the  authorized  representative  where  the  manufacturer  does  not  have  a 
registered place of business in the Community;”  

(ii) point (b) is replaced by the following:  

“(b) the details strictly necessary for the user to identify the device and the contents 
of  the  packaging  including  the  respective  code  of  an  internationally  recognized 
generic medical device nomenclature;”  

(iii) at the end of point (n) the following phrase is added:  

“and  in  case  of  devices  within  the  meaning  of  Article  1(4b)  an  indication  that  the 
device contains a human tissue engineered product”  

(h) Section 13.6 is amended as follows:  

(i) point (o) is replaced by the following: 

“(o)  medicinal  substances,  human  blood  derivatives  or  human  tissue  engineered 
products incorporated into the device as an integral part in accordance with Sections 
7.4a and 7.4b;” 

(i) Section 14 is deleted. 

(2) Annex II is amended as follows: 

(a) In Section 3.1, second paragraph, the first subparagraph of the seventh indent is replaced 
by the following: 

“— an undertaking by the manufacturer to institute and keep up to date a systematic 
procedure  to  review  experience  gained  from  devices  in  the  post-production  phase, 
including the provisions referred to in Annex X, and to implement appropriate means 
to apply any necessary corrective action. This undertaking must include an obligation 
for  the  manufacturer  to  notify  the  competent  authorities  of  the  following  incidents 
immediately on learning of them:” 

EN 

30 

   EN 

 
(b) Section 3.2. is amended as follows:  

(i) the following paragraph is inserted after the first paragraph:  

“It  shall  include  in  particular  the  corresponding  documentation,  data  and  records 
arising from the procedures referred to in Section 3.2(c).” 

(ii) in point (b) the following indent is added: 

“—  where  the  design,  manufacture  and/or  final  inspection  and  testing  of  the 
products,  or  elements  thereof,  is  carried  out  by  a  third  party,  the  methods  of 
monitoring the efficient operation of the quality system and in particular the type and 
extent of control applied to the third party;” 

(iii) point (c) is replaced by the following: 

“(c) the procedures for monitoring and verifying the design of the products, including 
the corresponding documentation, and in particular: 

—  a  general  description  of  the  product,  including  any  variants  planned,  and  its 
intended use(s), 

—  the  design  specifications,  including  the  standards  which  will  be  applied  and  the 
results of the risk analysis, and also a description of the solutions adopted to fulfil the 
essential  requirements  which  apply  to  the  products  if  the  standards  referred  to  in 
Article 5 are not applied in full, 

—  the  techniques  used  to  control  and  verify  the  design  and  the  processes  and 
systematic measures which will be used when the products are being designed, 

— if the device is to be connected to other device(s) in order to operate as intended, 
proof  must  be  provided  that  it  conforms  to  the  essential  requirements  when 
connected  to  any  such  device(s)  having  the  characteristics  specified  by  the 
manufacturer, 

— a statement indicating whether or not the device incorporates, as an integral part, a 
substance, a human blood derivative or a human tissue engineered product referred to 
in  sections  7.4  and  7.4a  of  Annex  I  and  the  data  on  the  tests  conducted  in  this 
connection  required  to  assess  the  safety,  quality  and  usefulness  of  that  substance, 
human  blood  derivative  or  human  tissue  engineered  product,  taking  account  of  the 
intended purpose of the device, 

— a statement indicating whether or not the device is manufactured utilising tissues 
of animal origin as referred to in Commission Directive 2003/32/EC (*), 

— the solutions adopted as referred to in Annex I Section I (2), 

— the preclinical evaluation, 

EN 

31 

   EN 

 
— the clinical evaluation referred to in Annex X, 

— the draft label and, where appropriate, instructions for use; 

_________ 

(*) OJ L 105, 26.4.2003, p. 18.” 

(c) the second paragraph of Section 3.3. is replaced by the following: 

“The  assessment  team  must  include  at  least  one  member  with  past  experience  of 
assessments of the technology concerned. The assessment procedure must include an 
assessment,  on  a  representative  basis,  of  the  documentation  of  the  design  of  the 
product(s)  concerned,  an  inspection  on  the  manufacturer's  premises  and,  in  duly 
substantiated  cases,  on  the  premises  of  the  manufacturer's  suppliers  and/or 
subcontractors to inspect the manufacturing processes.” 

(d) In Section 4.3. the second and third paragraphs are replaced by the following:  

“In  the  case  of  devices  referred  to  in  Annex  I,  Section  7.4a,  second  paragraph,  the 
scientific  opinion  of  the  EMEA  must  be  included  in  the  documentation  concerning 
the  device.  The  notified  body  will  give  due  consideration  to  the  opinion  of  the 
EMEA when making its decision. The notified body may not deliver the certificate if 
the EMEA's scientific opinion is unfavourable. It will convey its final decision to the 
EMEA. 

In  the  case  of  devices  referred  to  in  Annex  I,  Section  7.4a,  third  paragraph,  the 
notified body shall, as regards the aspects referred to in that section, consult one of 
the competent bodies designated by the Member States in accordance with Directive 
2001/83/EC before taking a decision. The notified body will give due consideration 
to the views expressed in this consultation when making its decision. It will convey 
its final decision to the competent body concerned. 

In the case of devices referred to in Annex I, Section 7.4a, the scientific opinion of 
the  [Committee  of  Advanced  Therapies]  must  be  included  in  the  documentation 
concerning the device. The notified body will give due consideration to the opinion 
of  the  [Committee  of  Advanced  Therapies]  when  making  its  decision.  The  notified 
body  may  not  deliver  the  certificate  if  the  [Committee  of  Advanced  Therapies] 
scientific opinion is unfavourable. It will convey its final decision to the [Committee 
of Advanced Therapies]. 

In the case of devices manufactured utilising tissues of animal origin as referred to in 
Directive  2003/32/EC,  the  notified  body  must  follow  the  procedures  referred  to  in 
that  Directive.  The  notified  body  shall  give  due  consideration  to  any  comments 
received when making its decision.” 

(e) In Section 5.2, the second indent is replaced by the following: 

“ — the data stipulated in the part of the quality system relating to design, such as the 
results of analyses, calculation tests, the solutions adopted as referred to in Annex I 
Section I (2), preclinical and clinical evaluation, post-market clinical follow-up plan 
and the results of the post-market clinical follow-up, if applicable etc.,” 

EN 

32 

   EN 

 
(f) In Section 6.1 is amended as follows: 

(i) the first sentence is replaced by the following: 

“The manufacturer must, for a period at least equivalent to the intended lifetime of 
the product as defined by the manufacturer but not less than five years from the date 
of manufacture, keep at the disposal of the national authorities:” 

(ii) in the second indent the following phrase is added: 

“and  in  particular  the  documentation,  data  and  records  referred  to  in  the  second 
paragraph of Section 3.2,”; 

(g) Section 6.3 is deleted; 

(h) In Section 8 the words “Article 4 (3) of Directive 89/381EEC” are replaced by the words 
“Article 114(2) of Directive 2001/83/EC”. 

(3) Annex III is amended as follows: 

(a) Section 3 is replaced by the following: 

“3. The documentation must allow an understanding of the design, the manufacture 
and  the  performances  of  the  product  and  must  contain  the  following  items  in 
particular: 

— a general description of the type, including any variants planned, and its intended 
use(s), 

—  design  drawings,  methods  of  manufacture  envisaged,  in  particular  as  regards 
sterilization, and diagrams of components, sub-assemblies, circuits, etc., 

—  the  descriptions  and  explanations  necessary  to  understand  the  abovementioned 
drawings and diagrams and the operation of the product, 

—  a  list  of  the  standards  referred  to  in  Article  5,  applied  in  full  or  in  part,  and 
descriptions  of  the  solutions  adopted  to  meet  the  essential  requirements  if  the 
standards referred to in Article 5 have not been applied in full, 

— the results of the design calculations, risk analysis, investigations, technical tests, 
etc. carried out, 

— a declaration stating whether or not the device incorporates, as an integral part, a 
substance, human blood derivative or a human tissue engineered product, referred to 
in  Sections  7.4  and  7.4a  of  Annex  I,  and  the  data  on  the  tests  conducted  in  this 
connection  which  are  required  to  assess  the  safety,  quality  and  usefulness  of  that 
substance,  human  blood  derivative  or  human  tissue  engineered  product,  taking 
account of the intended purpose of the device, 

— a statement indicating whether or not the device is manufactured utilising tissues 
of animal origin as referred to in Directive 2003/32/EC, 

EN 

33 

   EN 

 
— the solutions adopted as referred to Annex I, Section I(2), 

— the preclinical evaluation, 

— the clinical evaluation referred to in Annex X, 

— the draft label and, where appropriate, instructions for use.” 

(b) In Section 5 the second and third paragraphs are replaced by the following:  

“In  the  case  of  devices  referred  to  in  Annex  I,  Section  7.4,  second  paragraph,  the 
scientific  opinion  of  the  EMEA  must  be  included  in  the  documentation  concerning 
the  device.  The  notified  body  will  give  due  consideration  to  the  opinion  of  the 
EMEA when making its decision. The notified body may not deliver the certificate if 
the EMEA's scientific opinion is unfavourable. It will convey its final decision to the 
EMEA. 

In  the  case  of  devices  referred  to  in  Annex  I,  Section  7.4a,  third  paragraph,  the 
notified body shall, as regards the aspects referred to in that section, consult one of 
the competent bodies designated by the Member States in accordance with Directive 
2001/83/EC before taking a decision. The notified body will give due consideration 
to the views expressed in this consultation when making its decision. It will convey 
its final decision to the competent body concerned. 

In the case of devices referred to in Annex I, Section 7.4a, the scientific opinion of 
the  [Committee  of  Advanced  Therapies]  must  be  included  in  the  documentation 
concerning the device. The notified body will give due consideration to the opinion 
of  the  [Committee  of  Advanced  Therapies]  when  making  its  decision.  The  notified 
body  may  not  deliver  the  certificate  if  the  [Committee  of  Advanced  Therapies] 
scientific opinion is unfavourable. It will convey its final decision to the [Committee 
of Advanced Therapies]. 

In the case of devices manufactured utilising tissues of animal origin as referred to in 
Directive  2003/32/EC,  the  notified  body  must  follow  the  procedures  referred  to  in 
that  Directive.  The  notified  body  shall  give  due  consideration  to  any  comments 
received when making its decision.” 

(c) Section 7.3 is replaced by the following: 

“7.3. The manufacturer or his authorized representative must keep with the technical 
documentation  copies  of  EC  type-examination  certificates  and  their  additions  for  a 
period  at  least  equivalent  to  the  intended  lifetime  of  the  product  as  defined  by  the 
manufacturer but not less than five years from the date of manufacture.” 

(d) Section 7.4 is deleted. 

(4) Annex IV is amended as follows: 

(a) In Section 3 the first paragraph is replaced by the following: 

“3.  The  manufacturer  must  undertake  to  institute  and  keep  up  to  date  a  systematic 
procedure  to  review  experience  gained  from  devices  in  the  post-production  phase, 

EN 

34 

   EN 

 
including the provisions referred to in Annex X, and to implement appropriate means 
to apply any necessary corrective action. This undertaking must include an obligation 
for  the  manufacturer  to  notify  the  competent  authorities  of  the  following  incidents 
immediately on learning of them:” 

(b) Section 6.3 is replaced by the following: 

“6.3.  Statistical  control  of  products  will  be  based  on  attributes  and/or  variables, 
entailing  sampling  schemes  with  operational  characteristics  which  ensure  a  high 
level  of  safety  and  performance  according  to  the  state  of  the  art.  The  sampling 
schemes  will  be  established  by  the  harmonised  standards  referred  to  in  Article  5, 
taking account of the specific nature of the product categories in question.” 

(c) In Section 7 the first paragraph is replaced by the following: 

“The  manufacturer  or  his  authorized  representative  must,  for  a  period  at  least 
equivalent to the intended lifetime of the product as defined by the manufacturer but 
not less than five years from the date of manufacture, make available to the national 
authorities:” 

(d) In the first paragraph of Section 8 the word ‘exemptions’ is deleted. 

(e)  In  Section  9  the  words  ‘Article  4(3)  of  Directive  89/381EEC’  are  replaced  by  ‘Article 
114(2) of Directive 2001/83/EC’. 

(5) Annex V is amended as follows: 

(a) In Section 3.1. the eighth indent is replaced by the following: 

“— an undertaking by the manufacturer to institute and keep up to date a systematic 
procedure  to  review  experience  gained  from  devices  in  the  post-production  phase, 
including the provisions referred to in Annex X, and to implement appropriate means 
to apply any necessary corrective action. This undertaking must include an obligation 
for  the  manufacturer  to  notify  the  competent  authorities  of  the  following  incidents 
immediately on learning of them:” 

(b) In Section 3.2.(b) the following indent is added: 

“—  where  the  manufacture  and/or  final  inspection  and  testing  of  the  products,  or 
elements  thereof,  are  carried  out  by  a  third  party,  the  methods  of  monitoring  the 
efficient  operation  of  the  quality  system  and  in  particular  the  type  and  extent  of 
control applied to the third party;” 

(c) In Section 4.2, the following indent is inserted after the first indent: 

“— the technical documentation,” 

(d) In Section 5.1 the first sentence is replaced by the following: 

“The manufacturer must, for a period at least equivalent to the intended lifetime of 
the product as defined by the manufacturer but not less than five years from the date 
of manufacture, make available to the national authorities:” 

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(e) In Section 6, first paragraph, the word ‘exemptions’ is deleted.  

(f)  In  Section  7  the  words  ‘Article  4(3)  of  Directive  89/381EEC’  are  replaced  by  ‘Article 
114(2) of Directive 2001/83/EC’. 

(6) Annex VI is amended as follows: 

(a) In the eight indent of Section 3.1 the first paragraph is replaced by the following: 

“— an undertaking by the manufacturer to institute and keep up to date a systematic 
procedure  to  review  experience  gained  from  devices  in  the  post-production  phase, 
including the provisions referred to in Annex X, and to implement appropriate means 
to apply any necessary corrective action. This undertaking must include an obligation 
for  the  manufacturer  to  notify  the  competent  authorities  of  the  following  incidents 
immediately on learning of them:”  

(b) In Section 3.2. the following indent is added: 

“—  where  the  final  inspection  and  testing  of  the  products,  or  elements  thereof,  are 
carried out by a third party, the methods of monitoring the efficient operation of the 
quality  system  and  in  particular  the  type  and  extent  of  control  applied  to  the  third 
party;” 

(c) In Section 5.1. the first sentence is replaced by the following: 

“The manufacturer must, for a period at least equivalent to the intended lifetime of 
the product as defined by the manufacturer but not less than five years from the date 
of manufacture, make available to the national authorities:” 

(7) Annex VII is amended as follows: 

(a) Section 2 is replaced by the following: 

“2. The manufacturer must prepare the technical documentation described in Section 
3.  The  manufacturer  or  his  authorized  representative  established  in  the  Community 
must make this documentation, including the declaration of conformity, available to 
the national authorities for inspection purposes for a period at least equivalent to the 
intended lifetime of the product as defined by the manufacturer but not less than five 
years from the date of manufacture.” 

(b) Section 3 is amended as follows: 

(i) the first indent is replaced by the following: 

“—  a  general  description  of  the  product,  including  any  variants  planned  and  its 
intended use(s),” 

(ii) the seventh indent is replaced by the following indent: 

“ — the test reports,” 

(iii) the following indent is inserted after the seventh indent: 

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“— the clinical evaluation in accordance with Annex X,”  

(c) In Section 4 the first paragraph is replaced by the following: 

“4.  The  manufacturer  shall  institute  and  keep  up  to  date  a  systematic  procedure  to 
review  experience  gained  from  devices  in  the  post-production  phase,  including  the 
provisions referred to in Annex X, and to implement appropriate means to apply any 
necessary corrective actions, taking account of the nature and risks in relation to the 
product.  He  shall  notify  the  competent  authorities  of  the  following  incidents 
immediately on learning of them:” 

(d) In Section 5 and Section 6.1. the words ‘Annex IV, V or VI’ are replaced by ‘Annex II, 
IV, V or VI’. 

(8) Annex VIII is amended as follows: 

(a) In Section 2.1. the following indent is inserted after the introductory phrase: 

“—  the  name  and  address  of  the  manufacturer  and  any  additional  manufacturing 
site,” 

(b) Section 2.2. is amended as follows:  

(i) the second indent is replaced by the following: 

“— the clinical investigation plan,” 

(ii) the following indents are inserted as third, fourth and fifth indents:  

“— the investigator’s brochure,  

— the confirmation of insurance of subjects, 

— the documents used to obtain informed consent,” 

(c) Section 3.2. is replaced by the following: 

“3.2.  for  devices  intended  for  clinical  investigations,  the  documentation  must 
contain: 

— a general description of the product and its intended use, 

—  design  drawings,  methods  of  manufacture  envisaged,  in  particular  as  regards 
sterilization, and diagrams of components, sub-assemblies, circuits, etc., 

—  the  descriptions  and  explanations  necessary  to  understand  the  abovementioned 
drawings and diagrams and the operation of the product, 

— the results of the risk analysis and a list of the standards referred to in Article 5, 
applied in full or in part, and descriptions of the solutions adopted to meet the 
essential requirements of this Directive if the standards referred to in Article 5 have 
not been applied, 

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— a declaration stating whether or not the device incorporates, as an integral part, a 
substance, human blood derivative or human tissue engineered product, referred to in 
sections 7.4 and 7.4a of Annex I, and the data on the tests conducted in this connection 
which are required to assess the safety, quality and usefulness of that substance or human 
blood derivative, taking account of the intended purpose of the device, 

— a statement indicating whether or not the device is manufactured utilising tissues 
of  animal  origin  as  referred  to  in  Directive  2003/32/EC  and  the  risk  management 
measures in this connection which have been applied to reduce the risk of infection , 

—  the  results  of  the  design  calculations,  and  of  the  inspections  and  technical  tests 
carried out, etc. 

The  manufacturer  must  take  all  the  measures  necessary  to  ensure  that  the 
manufacturing  process  produces  products  which  are  manufactured  in  accordance 
with the documentation referred to in the first paragraph of this Section. 

The  manufacturer  must  authorize  the  assessment,  or  audit  where  necessary,  of  the 
effectiveness of these measures.” 

(d) Section 4 is replaced by the following: 

“4. The information contained in the declarations concerned by this Annex should be 
kept for a period at least equivalent to the intended lifetime of the product as defined 
by the manufacturer but not less than five years from the date of manufacture.” 

(e) The following Section 5 is added: 

“5. For custom-made devices, the manufacturer must undertake to institute and keep 
up  to  date  a  systematic  procedure  to  review  experience  gained  from  devices  in  the 
post-production  phase,  including  the  provisions  referred  to  in  Annex  X,  and  to 
implement  appropriate  means  to  apply  any  necessary  corrective  action.  This 
undertaking must include an obligation for the manufacturer to notify the competent 
authorities of the following incidents immediately on learning of them: 

i)  any  malfunction  or  deterioration  in  the  characteristics  and/or  performance  of  a 
device, as well as any inadequacy in the labelling or the instructions for use which 
might  lead  to  or  might  have  led  to  the  death  of  a  patient  or  user  or  to  a  serious 
deterioration in his state of health; 

ii) any technical or medical reason connected with the characteristics or performance 
of a device for the reasons referred to in subparagraph (i) leading to systematic recall 
of devices of the same type by the manufacturer.” 

(9) Annex IX is amended as follows: 

(a) Chapter I is amended as follows: 

(i) in Section 1.4. the following sentence is added: 

“Stand alone software is considered to be an active medical device.” 

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(ii) Section 1.7. is replaced by the following: 

“1.7 Central circulatory system 

For the purposes of this Directive, ‘central circulatory system’ means the following 
vessels: 

arteriae  pulmonales,  aorta  ascendens,  aorta  arcus,  aorta  descendens  to  the 
bifurcatio  aortae,  arteriae  coronariae,  arteria  carotis  communis,  arteria  carotis 
externa,  arteria  carotis  interna,  arteriae  cerebrales,  truncus  brachiocephalicus, 
venae cordis, venae pulmonales, vena cava superior, vena cava inferior.” 

(b) In Chapter II, Section 2 the following Section 2.6 is added: 

“2.6 In calculating the duration referred to in Section 1.1 of chapter I, continuous use 
means an uninterrupted actual use of the device for the intended purpose. However 
where  usage  of  a  device  is  discontinued  in  order  for  the  device  to  be  replaced 
immediately by the same or an identical device this shall be considered an extension 
of the continuous use of the device.” 

(c) Chapter III is amended as follows: 

(i)  the  introductory  phrase  of  the  first  sentence  of  Section  2.1  is  replaced  by  the 
following: 

“All  invasive  devices  with  respect  to  body  orifices,  other  than  surgically  invasive 
devices  and  which  are  not  intended  for  connection  to  an  active  medical  device  or 
which are intended for connection to an active medical device in Class I:” 

(ii) Section 2.2 is replaced by the following: 

“2.2. Rule 6 

All surgically invasive devices intended for transient use are in Class IIa unless they 
are: 

— intended specifically to control, diagnose, monitor or correct a defect of the heart 
or  of  the  central  circulatory  system  through  direct  contact  with  these  parts  of  the 
body, in which case they are in Class III, 

— reusable surgical instruments, in which case they are in Class I, 

— intended specifically for use in direct contact with the central nervous system, in 
which case they are in Class III, 

— intended to supply energy in the form of ionizing radiation in which case they are 
in Class IIb, 

— intended to have a biological effect or to be wholly or mainly absorbed in which 
case they are in Class IIb, 

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— intended to administer medicines by means of a delivery system, if this is done in 
a manner that is potentially hazardous taking account of the mode of application, in 
which case they are in Class IIb.” 

(iii) in Section 2.3 the first indent is replaced by the following: 

“— either specifically to control, diagnose, monitor or correct a defect of the heart or 
of the central circulatory system through direct contact with these parts of the body, 
in which case they are in Class III,” 

(iv)  in  Section  4.1.,  first  paragraph,  the  reference  ‘65/65/EEC’  is  replaced  by  the 
reference ‘2001/83/EC’. 

(v) in Section 4.1. the second paragraph is replaced by the following: 

“All devices incorporating, as an integral part, a human blood derivative or a human 
tissue engineered product, are in Class III.” 

(vi) in Section 4.3. second paragraph the following phrase is added: 

“unless  they  are  specifically  to  be  used  for  disinfecting  invasive  devices  in  which 
case they are in Class IIb.” 

(vii)  in  Section  4.4.  the  words  ‘Non  active  devices’  are  replaced  by  the  word 
‘Devices’ 

(10) Annex X is amended as follows: 

(a) Section 1.1 is replaced by the following: 

“1.1. As a general rule, confirmation of conformity with the requirements concerning 
the characteristics and performances referred to in Sections 1 and 3 of Annex I, under 
the normal conditions of use of the device, and the evaluation of the side-effects and 
of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must 
be based on clinical data. The evaluation of this data, hereafter referred to as clinical 
evaluation, where appropriate taking account of any relevant harmonized standards, 
must follow a defined and methodologically sound procedure based on: 

1.1.1.  either  a  critical  evaluation  of  the  relevant  scientific  literature  currently 
available  relating  to  the  safety,  performance,  design  characteristics  and  intended 
purpose of the device, where: 

— there is demonstration of equivalence of the device to the device to which the data 
relates and, 

—  the  data  adequately  demonstrate  compliance  with  the  relevant  essential 
requirements; 

1.1.2. or a critical evaluation of the results of all clinical investigations made;  

1.1.3.  or  a  critical  evaluation  of  the  combined  clinical  data  provided  in  1.1.1  and 
1.1.2 .” 

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(b) The following Sections 1.1a, 1.1b, 1.1c and 1.1d are inserted: 

“1.1a  In  the  case  of  implantable  devices  and  devices  in  class  III  clinical 
investigations shall be performed unless it is duly justified to rely on existing clinical 
data. 

1.1b  The  clinical  evaluation  and 
documentation  shall  be 
documentation of the device. 

included  and/or  fully  referenced 

its  outcome  shall  be  documented.  This 
technical 

the 

in 

1.1c  The  clinical  evaluation  and  its  documentation  have  to  be  actively  updated. 
Where post market clinical follow up as part of the postmarket surveillance plan for 
the device is not deemed necessary, this must be duly justified and documented.  

1.1d  Where  demonstration  of  conformity  with  essential  requirements  based  on 
clinical data is not deemed appropriate, adequate justification for any such exclusion 
has  to  be  given  based  on  risk  management  output  and  under  consideration  of  the 
specifics  of  the  device-body  interaction,  the  clinical  performances  intended  and  the 
claims  of  the  manufacturer.  Adequacy  of  demonstration  of  conformity  with  the 
essential  requirements  by  performance  evaluation,  bench  testing  and  preclinical 
evaluation alone has to be duly substantiated.” 

(c)  In  Section  2.2.  the  words  ‘41st  World  Medical  Assembly  in  Hong  Kong  in  1989’  are 
replaced by the words ‘World Medical Assembly.’; 

(d) Section 2.3.5 is replaced by the following: 

“2.3.5.  All  serious  adverse  events,  whether  device  related  or  not,  must  be  fully 
recorded and immediately notified to the competent authority of the Member State in 
which the event occurred. 

A  summary  of  the  events  referred  to  in  the  first  paragraph,  shall  be  provided,  on  a 
periodic basis, to all competent authorities of the Member States in which the clinical 
investigation is being performed.” 

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