Communication from the Commission to the Council and the European Parliament on medical devices
Date: 2003-07-02
Institutions: European Commission
Subjects: enlargement of the Union, health control, health costs, health legislation, health policy, health statistics, medical device, technical regulations

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 02.07.2003
COM(2003) 386 final

COMMUNICATION FROM THE COMMISSION
TO THE COUNCIL AND THE EUROPEAN PARLIAMENT

on medical devices

   
TABLE OF CONTENTS

COMMUNICATION FROM THE COMMISSION TO THE COUNCIL AND THE
EUROPEAN PARLIAMENT on medical devices .................................................................... 1

1.

2.

3.

4.

5.

5.1.

5.2.

5.3.

6.

Summary ...................................................................................................................... 4

Introduction.................................................................................................................. 5

Medical devices - an increasingly important sector..................................................... 6

Legal framework .......................................................................................................... 9

Reporting under Article 11(4) of Directive 93/42/EC ................................................. 9

Vigilance .................................................................................................................... 10

Clinical investigation ................................................................................................. 12

Pharmaceutical consultation ...................................................................................... 13

A need to improve overall the implementation of the Directives. ............................. 14

6.1.

Conformity assessment .............................................................................................. 15

6.1.1. Obligations under conformity assessment procedures............................................... 15

6.1.2. Reclassification of medical devices. .......................................................................... 16

6.1.3.

Improved designation and monitoring of Notified Bodies. ....................................... 17

6.2.

6.3.

6.4.

7.

7.1.

7.2.

7.3.

8.

Transparency and trust. .............................................................................................. 17

Market surveillance.................................................................................................... 19

Co-operation between Commission and Member States. .......................................... 19

Enlargement and the international dimension............................................................ 21

Enlargement. .............................................................................................................. 21

Mutual recognition agreements.................................................................................. 22

Global Harmonisation Task Force. ............................................................................ 22

Conclusions................................................................................................................ 23

Annex 1 - Summary of information - article 11 section 4 of 93/42/EC - Vigilance ................ 25

Annex 2 -Summary of information - article 11 section 4 of 93/42/EC –
Clinical investigations .............................................................................................................. 29

Annex 3 – Summary of information – article 11 section 4 of 93/42/EC – Pharmaceutical
consultations............................................................................................................................. 32

2

Annex 4 - Work programmes for working groups and task forces.......................................... 36

Annex 5 - Main areas identified for regulatory modification. ................................................. 38

Annex 6 - Other Measures ....................................................................................................... 40

Appendix 1 - Medical device product coverage....................................................................... 42

Appendix 2 - The Benefits of Medical Technology and Devices for EU Citizens.................. 45

Appendix 3 - Main features of regulatory framework ............................................................. 50

Appendix 4 - Working groups involved in the implementation of the Medical Devices
Directives. ................................................................................................................................ 51

3

1.

SUMMARY

This Communication presents the Commission’s policy conclusions on the functioning of
the medical  device  directives. They are based  on  the  issues  highlighted  in  the  report  of
the Medical Device Expert Group (MDEG), made available on the Commission ‘europa’
web-site in June 20021.

This  Communication  fulfils  in  the  first  place  the  requirements  of  the  medical  devices
directive 93/42/EEC  according to which  the  Commission has  to  present  a  report  on  the
operation  of  the  Directive’s  provisions  relating  to  vigilance,  clinical  investigations  and
consultation  of  the  competent  authorities  dealing  with  pharmaceutical  products.  Data
provided by Member States on these issues proved rather heterogeneous and it is difficult
to draw definitive conclusions. The Commission therefore proposes to step up the work
in order to complete the data collection. To the extent that the need has been identified for
a  more  co-ordinated  approach  between  Member  States,  the  Communication  announces
the elaboration of further guidance documents.

In  the  second  place,  it  gives  a  follow-up  to  the  initiative  undertaken  by  the  MDEG  to
carry out an overall assessment of the medical devices directive, going largely beyond the
reporting  requirements  mentioned  above.  The  Commission  endorses  the  MDEG
statement that the legal framework established by the medical device directives in itself -
even  though regulatory  changes  are  needed  in  certain areas  -  is  appropriate, but  that its
implementation  needs  to  be  improved.  From  the  various  issues  raised  in  the  MDEG
report,  the  Communication  highlights  in  particular  those  on  conformity  assessment,
transparency and trust, market surveillance, and co-operation between Member States and
Commission.

Improvements in implementation should be achieved by a comprehensive and ambitious
action programme, based on various means, involving all actors: implementing measures
at  national  level  (including  designation  of  notified  bodies  and  market  surveillance),  the
use of instruments  already  available under  the  directive  (re-classification,  precautionary
principle,  safeguard  clause,  formal  objection  to  standards),  guidance  documents  on
implementation,  regulatory  clarification  on  a  number  of  issues,  and  increased  co-
ordination and co-operation activities in different fora, including a new “high level group
on  medical  devices”.  A  great  number  of  initiatives  for  improvement  are  already  being
undertaken.

The Communication draws attention to the international dimension of the implementation
of the directive, including the challenge of the enlargement process. It refers to the impact
of  Mutual  Recognition  Agreements  and  the  work  of  the  Global  Harmonisation  Task
Force.

1

http://europa.eu.int/comm/enterprise/medical_devices/index.htm

4

                                                
The  Commission  takes  note  that  comprehensive  data  on  the  medical  devices  sector  are
lacking.  The  Communication  therefore  announces  a  study  to  be  carried  out  in  co-
operation  with  national  authorities  and  industry  in  order  to  improve  knowledge  of  the
sector,  of  its  impact  on  public  health  expenditure  and  of  the  conditions  for  increasing
competitiveness. Further studies covering key public health issues are foreseen under the
programme of Community action in the field of Public Health (2003-2008).

Finally,  the  Communication  contains  a  number  of  informative  appendices  providing
background  information  in  relation  to  the  vast  and  complex  sector  of  medical  devices.
These relate to medical devices product coverage, the benefits of medical technology and
devices for EU citizens, main features of the regulatory framework and details of working
groups involved in the implementation of the medical devices directives.

2.

INTRODUCTION

Article  11(4)  of  Directive  93/42/EC  on  medical  devices  requires  the  Commission  to
present  a  report  to  the  Council  on  the  Directive’s  functioning  in  relation  to  vigilance,
clinical investigation and pharmaceutical consultations.

In  preparing  this  report,  the  Commission  services,  national  authorities  and  stakeholders
working  in  the  framework  of  the  Commission’s  Medical  Devices  Experts  Groups
(MDEG)  decided  to  proceed  to  a  wider  review  of  the  functioning  of  the  regulatory
framework,  in  order  to  improve  both  the  regulatory  framework  and  its  implementation
where  possible.  The  consensus  view,  reflecting  the  outcome  of  discussions,  was
presented  as  a  report  made  available  by  the  Commission  on  its  web-site  in  June  2002,
hereafter referred to as the MDEG Report.2

The Commission welcomes the MDEG report on the functioning of the medical devices
Directive.  It  considers  the  MDEG  report  as  a  critical  analysis  that  will  allow  public
authorities and stakeholders to draw the appropriate policy conclusions against an agreed
statement of issues.

The present Communication should also be seen in the light of an overall review of the
New Approach to technical harmonisation and standardisation3, which is the subject of a
separate  Communication.  Elements  of  the  review  of  the  functioning  of  the  medical
devices directive have been fed into the overall review. Similarly, some issues identified
in the overall review are reflected in the present report, or may have an impact on solving
issues raised.

2

3

Report on the functioning of the Medical Devices Directive 93/42/EC of 14 June 1993; Medical
Devices Experts Group, 5 June 2002.
http://europa.eu.int/comm/enterprise/newapproach/index.htm
Council resolution of 7 May 1985 on a New Approach to technical harmonisation and standards;
OJEC C 136 of 4 June 1985. See appendix 3 for the main features of the New Approach regulatory
scheme.

5

                                                
The present Communication therefore contains the report required by article 11(4) as well
as the Commission’s conclusions based on the MDEG report.

3.

MEDICAL DEVICES - AN INCREASINGLY IMPORTANT SECTOR

Medical devices4 have become an increasingly important area in relation to their impact
on health and influence on health care expenditure. The Health Council5 recently adopted
a resolution on medical devices highlighting the sector’s importance, which has until now
been overshadowed by the other pillar of healthcare, pharmaceutical products.

Total Public Health Expenditure
Share Pharmaceuticals and Medical Devices
EU-15, Japan and USA

y
r
t
n
u
o
C

USA

JPN

EU-15

UK

SE

ES

PT

NL

LU

IT

IE

GR

DE

FR

FI

DK

BE

A

0

5

10

15

20

25

source EUCOMED , OECD

%

medical devices
 Pharmaceuticals

The term “medical device” 6 covers a wide range of products. Given the variations in the
features  of  each  of  these  device  families,  potentially  over  400,000  different  medical
devices could be on the market7.

The market for medical devices in Europe is the 2nd largest after the USA, and is followed
by Japan.

4

5

6

7

Figures advanced suggest that there are over 10,000 different families of medical device types.
Health Council, 26th June 2002
In this report the term ‘medical device’ (shortened to ‘device’) refers to products covered by the
definition in Directive 93/42/EC article 1 (2).
Appendix 1 contains some illustrative examples of the product coverage for medical devices.

6

                                                
Figures available are incomplete but suggest that public expenditure on medical devices
is increasing and in some countries already exceeds that for pharmaceutical products.

However, expenditure must be set off against benefits, both in terms of costs and quality
of life for patients and citizens. For instance, the development of new techniques such as
minimal  invasive  surgery  have  dramatically  reduced  the  treatment  time  and  cost  of
hospital stays.

Training of healthcare professionals has become a key issue. Authorities at national and
Community level  have  to  verify  whether  there  is  the  correct  balance  between  access  to
innovation and high protection of health. National authorities have to deal with the reality
of scarcity of expertise, particularly for high-risk devices where human resources are said
to be insufficient. Medical devices today are based on a variety of technologies, including
mechanical engineering, but  also  biomaterials,  electronics,  software, diagnostic  imaging
and  optics.  Medical  technology  is  characterised  by  a  high  speed  of  innovation  and  a
correspondingly high frequency of new models.

World Medical Devices Market Share in 2000

Others
22%

USA
37%

EU-15
26%

JPN
15%

source : EUCOMED 2000

In  many  of  the  health  areas  identified  by  the  European  Union  as  key  health  priorities
medical technology and medical devices provide a major contribution to the reduction of
disease and improvement of patient health in Europe8.

At the same time the medical  devices  sector  is  increasingly  exposed  to  public  scrutiny.
Patients express a demand for information on medical treatment and medical devices and
are  sensitised  to  the  risks.  Whilst  it  is  generally  accepted  that  medical  technology  has
increased levels of public health and improved the quality of life of patients, recent events
such as those experienced with disinfectants, dialysers and breast implants, suggest  that
when problems do occur, the regulatory system itself can been challenged.

In  spite  of  the  quite  significant  evolution  of  the  medical  device  sector,  detailed
comprehensive,  reliable  and  recent  data  are  lacking,  both  at  national  and  Community

8

Examples  of  the  contribution  of  medical  devices  in  specific  disease  areas  are  included  in
Appendix 2.

7

                                                
level. The Commission therefore intends to launch a study in co-operation with National
Authorities and stakeholders, covering three aspects:

– 

– 

– 

The  first  objective  of  the  study  would  be  to  map  the  European  market  by
collecting  and  analysing  up-to-date  market  facts  and  figures.  The  study  will
thereby  have  to  overcome  the  currently  lacking  statistical  basis  for  such  data
collection.  It  should  make  appropriate  recommendations  that  will  allow
collecting  this  information  on  a  regular  basis  in  the  future.  This  will  be  of
particular importance in order to evaluate the  economic  relevance of the  sector
and its contribution to economic growth and employment.

Technological  progress  in  medical  care  is  often  quoted  as  one  of  the  reasons
behind increasing health care costs. However, the contribution of innovation in
health  care  to  actually  saving  health  care  resources  is  also  increasingly
documented (e.g. reduction in period of hospitalisation due to minimal invasive
surgery).  The  study  should  therefore  collect,  analyse  and  document  prominent
evidence  on  public  costs  and  savings.  It  will  also  identify  the  relative  share  of
public health expenditure for medical devices with respect to other components
of the health care system, such as pharmaceutical products.

Finally, the study will look at strengths, weaknesses, opportunities and threats of
the  medical  devices  sector  in  Europe.  It  will  look  at  the  current  state  of  the
industry in Europe, its competitiveness and its potential to innovate, in particular
in comparison with its current main competing regions, US and Japan. The study
should  in  this  way  allow  national  and  Community  authorities  to  determine
framework conditions allowing companies, whilst maintaining the highest level
of  protection  of  health,  to  increase  competitiveness  and  innovation,  so  as  to  –
eventually – benefit public health.

Similarly, further research will be required to gather more information concerning health
aspects, for instance in relation to the use of medical devices. A number of possibilities,
such  as  in  the  field  of  improving  information  in  medical  technology  related  areas,  are
offered under the Communities public health action programme (2003-2008)9.

9

Decision  1786/200/EC  of  the  European  Parliament  and  of  the  Council  of  23  September  2002,
OJEC L 271, 9 of October 2002

8

                                                
4.

LEGAL FRAMEWORK

Medical devices are covered by three Directives, dealing with active implantable medical
devices10, adopted in 1990, with in vitro diagnostic medical devices11, adopted in 1998,
and medical devices in general12, adopted in 1993. The 1993 directive was modified by
the  1998  in  vitro  diagnostic  devices  directive.  Special  provisions  covering  medical
devices incorporating substances derived from blood were introduced in 2000.13Together,
they  constitute  for  the  first  time  a  coherent  and  comprehensive  legal  framework  for
medical devices in the Community Member States14.

The major features of the regulatory framework are given in Appendix 3.

Whilst the legal framework itself is stable, it requires a careful - and resource-intensive -
management  and  implementation,  in  particular  at  the  national  level.  As  the  Directives
cover an enormous variety  of products and risks, there is a need  for wide  co-ordination
and consultation between authorities and Commission. Furthermore, there may be a need
to  adopt  specific  regulatory  measures  (such  as  reclassification  decision,  follow-up  to
the  availability  of  devices,  Common  Technical
national  measures 
Specifications  for  in  vitro  diagnostics  devices)  in  order  to  complement  the  legal
framework  created  by  the  Directives  on  specific  aspects,  or  to  elaborate  guidance
documents on implementation.

restricting 

In  order  to  ensure  a  coherent  implementation  of  the  Directives,  Commission,  national
authorities and stakeholders have created a number of instruments and working groups, in
addition to the – formal – Committee created by the Directives. Further details of these
instruments and working groups are given in Appendix 4.

5.

REPORTING UNDER ARTICLE 11(4) OF DIRECTIVE 93/42/EC

Article 11(4) of the 1993 medical devices directive requests the Commission to submit a
report to the Council;

10

11

12

13

14

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member
States relating to active implantable medical devices, OJEC L189 20 July 1990
Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on
in vitro diagnostic medical devices, OJEC L 331 7 December 1998
Council  Directive  93/42/EEC  of  14  June  1993  concerning  medical  devices,  OJEC  L  169
12 July 1993
Council  Directive  2000/70/EC  of  16  November  2000,  OJEC  L  313  of  13  December  2000,  as
modified by Directive 2001/104/EC of .7 December 2001, OJEC L 6 of 10 January 2002. See also:
Directive  2002/98/EC  of  the  European  Parliament  and  the  Council  of  27  January  2003  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/EC,  OJEC  L  033,
08.02.2003, p. 0030-0040
Medical  devices  containing  viable  animal  tissues  and  those  incorporating  human  tissues  are  not
regulated  at  Community  level.  The  Commission  is  currently  working  on  separate  proposals  to
cover the safety and performance of human tissue engineered products.

9

                                                
(i)

(ii)

(iii)

information  on  incidents  occurring  following  placing  of  devices  on  the  market
(vigilance);

clinical  investigation  carried  out  in  accordance  with  the  procedure  set  out  in
Annex VIII of the Directive; and

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  65/65/EEC  and
which is  liable to act  upon  the  body  with  action  ancillary  to  that  of  the  device
(pharmaceutical consultation).

In  order  to  collect  information,  Commission  and  national  authorities  prepared  a
questionnaire in order to allow a coherent  reporting. The information and data provided
by Member States are presented in Annexes 1, 2 and 3.

5.1.

Vigilance

Incidents can occur with medical devices where they do not perform as intended, leading
in the worst case to injury, additional medical procedure or death. The Directive therefore
imposes  timely  co-ordinated  action  and  provision  of  information  between  manufacturer
and national authority concerned and between national authorities in relation to incidents
that present a serious risk and that are related to the device15. Member States have to take
the  necessary  steps  to  ensure  that  any  information  brought  to  their  knowledge  in
accordance  with  the  provisions  of  the  Directive  regarding  specific  incidents  involving
medical  devices  (regardless  of  their  class)  is  recorded  and  evaluated  centrally:  These
provisions  relate  primarily  to  information  provided  by  the  manufacturer  to  national
authorities concerning medical devices. The Directive’s scheme does not relate to errors
in use, unless such errors can be explained by shortcomings in the design of the product
or  of  its  accompanying  labelling  or  instructions  for  use.  As  part  of  national  policy,  a
Member State can also require medical practitioners or the medical institutions to inform
the  competent  authorities  of  any  such  incidents.  In  that  case,  it  shall  ensure  that  the
manufacturer of the device concerned, or his authorised representative established in the
Community, is also informed of the incident.

Today,  vigilance  has  an  international  dimension  going  beyond  the  Union.  For  legal  or
political  reasons,  national  authorities  do  share  vigilance  reports  with  third  countries,  in
the  same  way  as  they  receive  information  from  third  countries.  Furthermore,  under  the

15

According  to  Article  10§1  “Member  States  shall  take  the  necessary  steps  to  ensure  that  any
information brought to their knowledge regarding the incidents mentioned below involving a Class
I, IIa, IIb or III device is recorded and evaluated centrally:
(a) 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;’.
(b)any technical or medical reason in relation to the characteristics or performance of a device for
the reasons referred to in subparagraph (a), leading to systematic recall of devices of the same type
by the manufacturer

10

                                                
Global  Harmonisation  Task  Force  for  Medical  devices  (GHTF)16,  a  global  vigilance
system  is  being  set  up,  in  which  all  Member  States  will  participate  and  this  is  open  to
participation by all other European countries.

Details of the number of incidents because of shortcomings of the device reported from
Member States, under the vigilance scheme of the Directive, are contained in Annex 1.

The following conclusions can be drawn:

– 

– 

– 

– 

Statistical data on reported cases received for the purpose of this communication
are  extremely  heterogeneous.  In  some  cases,  such  as  Belgium,  Finland,  the
Netherlands  and  the  United  Kingdom,  there  is  a  clear  trend  –  namely  a  steady
increase  –  in  the  number  of  vigilance  cases  reported,  but  for  some  other
countries  there  is  a  random  distribution.  It  has  been  suggested  that  the
information provided does not represent the same categories of vigilance reports,
which makes the analysis complicated.

The Commission  is  opposed  to  practices  where  safety  measures  are  limited  by
the manufacture or by national authorities to the sovereign territory of a Member
State or an EEA member country, without using the mechanisms foreseen by the
directive.  Under  such  measures,  products  remain  on  the  common  market,
obliging other Member States if they happen to have knowledge of the potential
risks to take individual actions. .

The  establishment  of  the  European  database  on  medical  devices  (EUDAMED)
recording incidents community wide will help to ensure a smooth functioning of
the Directive’s provisions on vigilance.

Perhaps  the  major  conclusion  to  be  draw  is  that  more  research  is  necessary  to
identify the causes and the uneven presentation of vigilance reports. It has been
suggested that lack of human  resources available for the implementation of the
directive might be a reason.

Against this background, the Commission will:

– 

– 

16

Reinforce,  in  the  framework  of  the  MDEG  Working  Group  on  vigilance,  co-
operate  with  national  authorities  on  the  improvement  of  national  practises  on
vigilance.

Make  available  periodically  on  its  web-site  summary  reports  on  statistics
regarding vigilance reports.

For the GHTF, see http://www.ghtf.org/ and section 5.3 of this report on GHTF.

11

                                                
– 

– 

Launch, under the IDA programme17, a pilot project from July-December 2003
on  EUDAMED,  the  EU  database  for  medical  devices  (EUDAMED)  that  the
Directive requires to be set up. On that basis the system will be made operational
in 2004.

Continue to promote participation of Europe in global vigilance schemes under
conditions  compatible  with  European  rules,  implemented  under  the  GHTF.
Whilst the  Community  and  other  European  countries  cannot  stay  out  of  global
developments, the Commission highlights that such global arrangements do not
replace  the  obligations  under  the  Directive.  On  the  other  hand,  practical
arrangements  for  European  and  global  vigilance  will  be  harmonised  as  far  as
possible.

5.2.

Clinical investigation

The  MDD  requires  conformity  assessment  of  characteristics  and  performances  to  be
carried under the normal conditions of use of the device and evaluation of the undesirable
side effects to be based “as a general rule”-on clinical data. The adequacy of the clinical
data must be based  on  either  a  compilation of the relevant  scientific literature currently
available  and  a  critical  evaluation  of  this  compilation,  or  the  results  of  clinical
investigation. The clinical data must be available for all medical devices, irrespective of
classification.  Clinical  investigation  programmes  must  be  notified  to  the  Competent
Authority of the Member State in which the investigation is to be conducted.

Member States  supplied information  on  clinical  investigations  conducted  between  1995
and 2000. Only about half of the Member States provided quantitative data on the number
of  clinical  investigations  reported.  Data,  randomly  distributed  and  thus  difficult  to
interpret, are presented in Annex 2.

More  important  are  the  comments  received  from  national  authorities,  that  can  be
summarised as follows:

– 

– 

– 

17

The current legal framework does not include a specific mechanism for Member
States  to  obtain  information  on  clinical  investigations  conducted  in  other
Member States.

The  wording  of  the  Directive  can  lead  to  doubts  on  interpretation.  The
Directive’s provisions need to be detailed and further explained through a series
of  guidance  documents  on  issues  including  procedures  and  assessment  of
clinical investigation results.

Variations  across  Member  States  in  the  requirements  for  reporting  adverse
incidents during clinical investigations may result in inconsistencies.

IDA,  Interchange  of  Data  between  Administrations,  Decisions  of  the  European  Parliament  and
Council 1719/1999/EC and 1720/1999/EC, OJEC L 203 of 3 August 1999

12

                                                
Discussions further indicated that manufacturers, in particular those of Class I devices, do
not  always  have  clinical  data  available.  Furthermore,  Notified  Bodies  do  not  verify
sufficiently  the  adequacy  of  clinical  data  provided  with  respect  to  characteristics  and
performances of the device.

Against this background, the Commission:

– 

– 

– 

– 

will continue to host, and within the limits of budgetary availability, support the
CETF,  the  Clinical  Evaluation  Task  Force  ,  comprising  representatives  from
reinforce
Member  States,  Notified  Bodies  and 
implementation of Annex X of the MDD on clinical data.

Industry,  created 

to 

highlights the need to develop guidance and policy documents18 as a compliment
to  harmonised  standards,  in  order  to  ensure  a  coherent  implementation  of  the
provisions of the Directive Community wide.

invites  Member  States  to  proceed  to  a  consistent  and  measured  exchange  of
information  on  refusals  of  clinical  investigations,  side  effects  and  adverse
incidents, as allowed under article 20 of the Medical Devices Directive.

urges Member States to provide the data in order to allow a more comprehensive
report to be drawn up before the end of 2003.

5.3.

Pharmaceutical consultation

A  device  which  contains  a  medicinal  product  and  which  is  liable  to  act  upon  the  body
with an action ancillary to the device must have the safety, quality and usefulness of that
substance  ascertained,  taking  into  account  the  intended  purpose  of  the  device.  The
Notified  Body  must  consult  with  one  of  the  competent  bodies  for  medicinal  products
established  in  the  Member  States  prior  to  taking  a  decision.  It  should  be  noted  that  a
similar  consultation  procedure,  involving  the  EMEA,  applies  for  medical  devices
substances derived from blood.19

Recently,  questions  of  interpretation  have  arisen  concerning  the  obligation  of  Notified
Bodies to consult EMEA and the respective competencies of the  Notified Body and the
EMEA.  Discussions  are  taking  place  between  Commission,  national  authorities  and
EMEA  to  establish  a  meaningful  and  operational  interpretation  of  the  Directive’s
provisions.

18

19

See annex 4.
Directive  2000/70/EC  amending  93/42/EEC  L313  13  Dec  2000,  as  last  amended  by  directive
2001/104/EC.

13

                                                
Only  a  few  isolated  data  have  been  provided  by  Member  States  on  the  number  of
pharmaceutical consultations reported, summarised in Annex 3. This makes interpretation
of the information very difficult.

The Commission therefore

– 

– 

– 

will, together with Member States, elaborate further guidance on pharmaceutical
consultation,  including  substances  to  be  submitted  for  consultation  and
procedures to be followed.

will  on  this  basis  pursue  data  collection  with  Member  States  and,  on  a  regular
basis, evaluate the functioning of the system.

will  propose  a  modification  of  part  7.4  of  Annex  I  of  the  Medical  Devices
Directive  clarifying  the  legislative  intent  when  the  discussions  between
Commission,  national  authorities  and  EMEA  do  not  lead  to  a  meaningful
accepted interpretation and mode of operation.

6.

A NEED TO IMPROVE OVERALL THE IMPLEMENTATION OF THE DIRECTIVES.

On  the  basis  of  the  MDEG  report  the  Commission  takes  the  view  that  the  legal
framework  created  by  the  medical  devices  directive  in  itself  is  appropriate,  but  that  its
implementation  should  be  improved  through  a  variety  of  instruments  involving  all
parties:

– 

– 

– 

– 

– 

Measures at national level implementing and managing the Directive;

Use of available instruments to address particular market occurrences;

Guidance in the form of consensus documents between stakeholders;

Co-ordination and co-operation activities in different fora;

Regulatory clarification on a number of issues.

Concerns  identified  in  the  MDEG  report  relate  in  particular  to  conformity  assessment
(including  clinical  investigation  and  post  market  surveillance  by  manufacturers),  to
market surveillance and to transparency.

A  number  of  these  issues  have  also  been  identified  during  the  review  of  the  New
Approach.  The  current  communication  only  raises  issues  as  far  as  they  are  specific  to
medical  devices  and  are  part  of  the  work  programme  of  the  working  groups  concerned
with the MDD.

The Commission takes note that the MDEG Report examines in detail a great number of
other  issues,  such  as  standardisation  and  a  more  precise  definition  of  the  scope  of  the
Directives.  However,  this  Communication  concentrates  on  those  issues  that  the

14

Commission  considers  as  the  major  ones.  he  Annexes  4,  5  and  6  to  the  present
Communication  -  detailing  respectively  the  issues  for  the  elaboration  of  guidance
documents  -  regulatory  change  and  other  measures,  also  cover  such  elements  of  the
MDEG Report not specifically highlighted in this Communication.

6.1.

Conformity assessment

Conformity  assessment  is  a  key  to  trust  and  confidence  in  the  regulatory  system’s
capacity to protect patients and citizens. All efforts must be made to ensure a high level
of  protection.  Failure  on  conformity  assessment,  even  if  related  to  a  small  number  of
specific devices,  will  jeopardise  the  credibility  of  the  existing  regulatory  system  and  of
the authorities’ capacity to effectively protect public health.

The Directive foresees a classification of medical devices in four classes based on risks
that determine the conformity assessment procedures to be followed by the manufacturer.
Classification  is  based  on  a  “classification  tree”.  The  directive  also  creates  various
mechanisms for authorities to rectify the outcome of these  classification rules, by up or
downgrading of devices or by imposing specific conformity assessment procedures.

Shortcomings  that  have  been  identified  in  the  MDEG  Report  relate  in  particular  to  the
designation and monitoring of notified bodies, insufficiencies in design evaluation under
the quality approach by notified bodies lack of clinical data available from manufacturers,
insufficient verification by notified bodies of post market surveillance arrangements and,
with  regard  to  specific  products,  the  need  to  impose  stricter  conformity  assessment
procedures than those resulting of the implementation of the provisions of the Directive.

Classification

Notified
Bodies
CAs

Modules
including
Clinicaldata,
PMS

The Commission considers that improvements in the field of conformity assessment must
be based on a combined action in the following three areas. Failure to act on one of these
elements will not produce the required improvements.

6.1.1. Obligations under conformity assessment procedures.

Where a manufacturer intends to declare conformity of Class IIA and IIB devices through
the implementation of a full quality assurance system, Notified Bodies have to verify not
only the presence of a complete technical file prepared by the manufacturer on a coherent

15

sample basis but also the correct application of the manufacturer’s quality system and the
veracity  and  appropriateness  of  the  data.  Furthermore  the  Directives  provisions  on
clinical  data  should  be  implemented  in  a  stricter  and  more  coherent  manner.  Finally
market surveillance should be reinforced. Against this background:

– 

– 

The  Commission  will  introduce  a  proposal  to  modify  Annex  II  of  the  Medical
Devices  Directive.  Subsequently,  appropriate  guidance  documents  will  be
elaborated  as  to  how  Annex  II  has  to  be  implemented  with  respect  to  groups,
families or categories of Class IIA and IIB devices20,

Whilst considering the principles of the Directive on clinical data in themselves
appropriate,  it  urges  the  CETF  to  develop  guidance  on  the  obligations  for
manufacturers,  Notified  Bodies  and  authorities  with  respect  to  implementation
regarding specific groups of devices21. The Commission stresses the need for the
Market  Surveillance  Operations  Group,  composed  of  national  authorities  in
charge of market surveillance, to finalise guidance documents, inter alia, on the
post  market  surveillance  obligations  of  the  manufacturer22.  It  will  continue  to
host and, within the limits of budgetary availability, to support the MSOG.

6.1.2.

Reclassification of medical devices.

– 

20

21

22

The  Directive  describes  mechanisms  in  order  to  achieve,  where  necessary,  a
reclassification  or  to  impose  specific  conformity  assessment  procedures  with
respect  to  particular  devices  or  categories  of  devices.  Until  now,  only  two
requests  have  been  introduced,  dealing  respectively  with  breast  implants  and
total joint replacements.

Approximate number of devices

Class III devices are always subject to a specific design evaluation by the Notified Body, leading
to a EC design examination certificate.
Annex 4
Annex  4  the  formal  terminology  is  ‘post  production  phase’  however,  it  has  become  common
practise  to  refer  to  it  as’  post  market  surveillance’  (PMS).  PMS  to  be  carried  out  by  the
manufacturer  should  not  be  confused  with  market  surveillance  to  be  carried  out  by  national
authorities.

16

                                                
– 

Member  States  should  make  use  of  the  existing  reclassification  mechanisms
where  they  identify  a  need  to  intervene  with  respect  to  conformity  assessment
procedures;  reclassification  requests  will  be  given  due  priority  by  the
Commission.

6.1.3.

Improved designation and monitoring of Notified Bodies.

The Commission takes note that national authorities have identified the need to improve
processes  in  relation  to  the  designation  and  monitoring  of  Notified  Bodies23,  and  have
created  in  relation  to  medical  devices  a  specific  working  group  to  deal  with  it,  the
Notified  Bodies  Operations  Group.  Concrete  expression  of  increased  awareness  is  ‘de-
notification’ of Notified Bodies that has recently occurred.

– 

The  Commission  welcomes  the  creation  and  work  of  the  Notified  Bodies
Operations  Group  (NBOG)  composed  of  representatives  from  designating
authorities24.  It  will  carefully  monitor 
its  activities.  The
Commission  will  continue  to  host  and,  within  the  limits  of  budgetary
availability, financially support NBOG.

the  outcome 

6.2.

Transparency and trust.

It appears that there is no full transparency between authorities  and towards the  general
public  concerning  the  way  in  which  the  Directives  are  being  implemented.  Questions
have  been  raised  to  what  extent  national  authorities  and  Notified  Bodies  can  exchange
information  in  relation  to  the  implementation  of  the  directives  between  themselves.  In
addition, complaints have been registered as regards follow-up by national authorities to
requests for information by authorities from other countries.

In addition, whilst under Community law for pharmaceutical products and in the United
States of America for medical devices,25 summary reports on market approval are made
available to the general public, under the current Community legislation a similar practice
is not required for medical devices.

Furthermore  no  transparent  and  easily  accessible  data  exist  at  a  community  level  as  to
what  certificates  have  been  delivered  by  Notified  Bodies,  and  the  identification  of
manufacturers,  facilitating  the  identification  of  devices  on  the  Community  market.
Although the Directives impose the creation of a European Database for Medical Devices
(EUDAMED), insufficient progress has been made to date.

Similarly,  it  is  regrettable  that  not  all  Notified  Bodies  recommendations  and  consensus
views  have  been  endorsed  by  the  MDEG  and  made  available  to  manufacturers  and  the
general public.

23

24

25

Designation  and  monitoring  of  Notified  Bodies  is  also  a  key  issue  in  the  Commission
Communication on enhancing the implementation of the New Approach.
Annex 4
“Freedom of Information Act”

17

                                                
The Commission takes the view that transparency is a key element in order to ensure trust
between all stakeholders, and in particular to the general public. Transparency should be
increased, and the following measures should thereto be implemented.

– 

– 

– 

– 

– 

– 

The Commission will propose regulatory change in relation to the publication of
information  concerning  the  conformity  assessment  of  medical  devices.  In
particular  information  concerning medical devices presenting  high  risks  should
be made available to the general public. This can take the form of ‘EU Notified
Body  public  assessment  reports’.  Due  account  will  be  taken  of  legitimate
interests of manufacturers. Experience referred to above indicate that provision
of  selected  information  does  not  cause  harm  to  the  legitimate  interests  of
manufacturers, and is beneficial as it increases trust.

The Commission highlights the need to improve communication and welcomes
measures  already  taken  by  the  Notified  Bodies  Operations  Group  (NBOG),
Market  Surveillance  Operations  Group  (MSOG)  and  Clinical  Evaluation  Task
Force (CETF).

In  its  proposal  for  a  Directive  with  regard  to  detailed  specifications  relating  to
transmissible  spongiform  encephalopathies, 
the  Commission  proposes  a
mechanism  to  increase  transparency  between  Member  States  and  Notified
Bodies, with due respect to each others’ competencies. The Commission will, in
co-operation with national authorities, evaluate the outcome of this exercise and,
if appropriate, examine the need to extend it to other sensitive products.

The  Commission  will  put  to  the  MDEG  the  endorsement  of  recommendations
and  consensus  views  of  Notified  Bodies,  in  order  to  make  them  publicly
available on the Europa web-site.

The Commission will inform on a regular basis the Health Policy Forum, i.e. the
European platform representing consumers, patients and healthcare professionals
of developments in relation to medical devices.

On the basis of the activities currently undertaken under the IDA programme26,
the  Commission  will  present  in  the  course  of  2003  a  proposal  to  create
EUDAMED.  It will  submit Member States an implementation plan, ensuring  a
progressive and coherent implementation Community wide, using as a basis the
Global Medical Devices Nomenclature (GMDN). It will, if need be, clarify with
the  European  Committee  for  Standardisation  (CEN)  concerning  conditions  of
access to GMDN.

26

Interchange of Data between Administrations, Decisions of the European Parliament and Council
1719/1999/EC and 1720/1999/EC, OJEC L 203 of 3 August 1999.

18

                                                
6.3.

Market surveillance

Market  surveillance  is  an  essential  tool  for  the  enforcement  of  the  Medical  Devices
Directive,  in  particular  with  regard  to  Class  I  medical  devices,  placed  on  the  market
without the intervention of a Notified Body in the conformity assessment procedure.  Its
purpose  is  to  verify  that  the  provisions  of  the  Directive  are  complied  with  across  the
Community, to ensure a common level of safety and to eliminate unfair competition.

– 

– 

– 

It  is  a  case  of  serious  concern  that  levels  of  market  surveillance  vary  widely
between  Member  States  and  that  experiences  reported  by  some  national
authorities  indicate  that  the  provisions  of  the  Directives’  provisions  are  not
respected.  The  Commission  takes  note  that  Member  States  have  identified
market  surveillance  as  an  issue  and  started  co-operation  activities  under  the
Market  Surveillance  Operations  Group  (MSOG)27.  The  Commission  fully
supports this work. In the framework of the overall review of the New Approach
the  Commission  will  define  basic  rules  with  which  Member  States  will  be
obliged to comply, (e.g. sanctions, information exchange provisions), which may
require  a  revision  of  the  legal  framework  either  by  means  of  a  horizontal
directive  or  by  including  these  rules  in  the  individual  directives.  The
Commission  will  also  seek  to  introduce  a  legal  basis  for  administrative  co-
operation among Member States in the New Approach directives that do not yet
foresee this.

The Commission will further examine, in the light of the general product safety
directive28 and the current provisions of the Medical Devices Directive, whether
provisions  should  be  introduced  for  an  early  warning  exchange  between
authorities, as proposed in the Communication on the New Approach.

The  Commission  will  propose  regulatory  change  to  ensure  that  national
measures  that  restrict  the  placing  on  the  market  of  medical  devices  will  be
communicated to all Member States.

6.4.

Co-operation between Commission and Member States.

The  Directive  confers  a  number  of  important  tasks  to  the  Commission,  such  as,  the
evaluation  of  classification  requests,  national  health  measures  and  formal  objection  to
standards.

In most cases, the Directives foresee mechanisms by which Member States are consulted,
be  this  through  the  Committee  set  up  under  the  Medical  Devices  Directives,  or  the
Committee set up under Directive 98/34/CE laying down a procedure for the provision of

27

28

Annex 4
General Product Safety Directive 92/59/EEC of 29 June 1992 on general product safety OJ L 228,
11/8/92 p 24.

19

                                                
information in the field of technical standards and regulations and of rules of information
society services.29

However,  over  the  last  years  it  has  become  apparent  that  there  may  be  wider  need  for
consultation  between  Commission  and  Member  States.  Furthermore,  under  a  common
legal framework, action by one Member State can produce consequences for all. Bilateral
co-operation does already exist between some Member States, but should be extended to
all Member States. In reality, the technical complexity and political sensitivity of issues
in  relation  to  medical  devices  –  that  explain  to  a  large  extent  certain  slowness  in
Commission  follow-up  to  national  measures  -  can  require  reciprocal  “up-stream”
consultation  and  the creation of information  mechanisms  between  authorities,  including
the  Commission.  Such  consultations  and  information  mechanisms  can,  however,  not
interfere or determine the exercise of responsibilities incumbent on the Commission or on
national authorities.

In  some  way,  the  Notified  Bodies  Operations  Group  and  the  Market  Surveillance
Operations Group, chaired by national authorities and hosted by the Commission, already
reflect  the need  for co-operation and  consultation  mechanisms  in  specific,  critical  areas
where Member States bear specific responsibilities.

Beyond these specific areas, the need for pragmatic consultation mechanisms has recently
become  apparent  in  the  case  of  safeguard  clauses,  where  lack  of  expertise  Community
wide  requires  co-operation  between  all  authorities,  and  where  the  adoption  of  a
Commission opinion, which has a Community wide impact in a politically sensitive area
without  proper  consultation  of  all  Member  States  might  cause  serious  concerns  with
Member  States.  Similarly,  the  BSE  crisis  has  shown  that  in  relation  to  the  same  issue,
Member States have adopted widely divergent policies, using different instruments under
the Directive, whilst a prior consultation or mutual information might have been useful.
In  the  view  of  the  Commission,  it  is  also  important  that  national  authorities  formally
express  the  endorsement  of  Guidance  documents  elaborated  in  the  MDEG  or  its
subgroups.  Another  example  where  the  need  for  consultation  and  information  has  been
identified  concerns  European  standardisation:  for  instance,  key  standards  could  be
identified  where  one  national  authority  reports  on  progress  and  potential  issues  to  the
others.

Such consultation should be able to take place without the strict and formal rules that are
inherent to “comitology”, and that determine the exercise of regulatory tasks delegated by
the Directives to the Commission.

– 

29

Consequently,  the  Commission  foresees  the  creation  of  a  ‘high  level  group  on
medical  devices’,  composed  of  senior  officials  responsible  for  medical  devices
of  EU  Member  States,  Candidate  countries  and  EFTA,  that  would  allow,  as
appropriate,  for  co-operation  and  consultation  between  national  authorities  and
the  Commission  on  issues  related  to  medical  devices.  The  group  would  meet

OJEC L 204 of 21 July 1998; modified by Directive 98/48, OJEC L 217 of 5 August 1998.

20

                                                
only when necessary, or when written consultation procedures would appear to
be insufficient to allow for a proper consultation.

The  creation  of  such  a  group  would  not  in  any  way  jeopardise  the  functioning  of  the
MDEG  in  which  all  stakeholders,  National  Authorities,  standards  bodies  and  industry
take part. The proper functioning of the Directive needs indeed the input and feedback of
all  these  parties.  Furthermore,  it  would  not  interfere  with  the  tasks  incumbent  on  the
Commission or the formal procedures set out in the directives. The group would liase as
appropriate with the High level Committee on Health.

7.

ENLARGEMENT AND THE INTERNATIONAL DIMENSION

An  examination  of  the  functioning  of  the  Directives  on  medical  devices  cannot  be
complete  without  considering  enlargement  and  the  international  dimension.  There  is  an
interaction  between  the  regulatory  framework  and  third  countries  with  whom  the
Community  has  established  links,  sometimes  in  a  formal  way,  sometimes  more
informally.

7.1.

Enlargement.

As regards countries that  will  join the  Community,  it  is  of  utmost  importance  that  they
fully  participate  in  all  activities  and  working  groups  in  relation  to  the  medical  devices
directives. This is, unfortunately, not always the case. The level of safety and quality of
life for patients and citizens will depend on levels of safety and quality achieved in single
Member  States. The  challenge  of enlargement is not so  much a correct  transposition  of
Directives in national law, but a coherent and strict implementation and management with
sufficient  human  resources.  The  MDEG  Report  suggests  that  even  between  current
Member States this is not an easy task.

– 

– 

– 

The  Commission  considers  it  of  utmost  importance  that  countries  join  in  the
activities  of  the  various  working  groups.  Member  States  should  intensify  co-
operation  through  exchange  programmes,  study  visits,  trainee-ships,  twinning,
bilateral  consultation,  mentoring.  Similarly,  the  Commission  considers  that
European  trade  federations  have  a  similar  role  with  respect  to  training  and
information of industry associations in the candidate countries.

The  Commission  will  make  available  on  its  website  information  on  such
initiatives.

The Commission, together with Competent Authorities of the Member States, is
preparing the organisation of two workshops. One, scheduled for summer 2003,
will  deal  with  market  surveillance.  The  other;  scheduled  for  the  last  trimester
will cover best practice  on implementation of the  Directives.  These  workshops
should lead to the definition and implementation of further projects.

21

– 

The possibilities of a specific call for tender for a survey and an in depth analysis
on “Enlargement and Health Challenges” are being looked at in the framework
of  the  Programme  of  Community  action  in  the  field  of  public  health
(2003-2008).

7.2.

Mutual recognition agreements.

A  different  issue  is  the  Mutual  Recognition  Agreements  (MRAs)  covering  medical
devices, signed with the United States, Canada,  Australia and Switzerland and  foreseen
with Japan. Under the MRAs, conformity assessment bodies designated by and working
under  the  responsibility  of  authorities  of  the  third  country  will  assess  products  on  their
conformity  with  requirements  of  European  directives,  and  vice-versa.  Today,  only  the
MRA  with  Switzerland  (all  medical  devices)30  and  Australia31  is  operational  (with
exception for high-risk devices).

Experience  gained  during  the  confidence  building  activities  suggests  that  the  European
Directives  are not always fully understood  in  third  countries.  Whilst  being  in  favour  of
arrangements  facilitating  trade  and  increasing  the  competitiveness  of  industry,  the
Commission  considers  that  only  when  strict  guarantees  exist  as  to  the  capacity  of
designating  authorities  and  conformity  assessment  bodies  that  MRAs  should  enter  into
force.

– 

The Commission suggests that – and only in so far trading partners give concrete
signs  of  interest  -  activities  should  be  pursued  to  ensure  that  the  operation  of
MRAs  will  ensure  full  respect  of  health  considerations  as  defined  in  the
Directives on medical devices.

7.3.

Global Harmonisation Task Force.

Today, it has  become impossible  to  ignore  the  work  of  the  Global  Harmonisation  Task
Force (GHTF) on medical devices. The Global Harmonisation Task Force (GHTF) is an
informal platform for representatives from national medical device regulatory authorities
and the regulated industry from three geographical areas: Europe32, Asia-Pacific (Japan-
Australia) and North America (US, Canada).

The original objective of the GHTF, started in 1992, was to encourage convergence in the
implementation of common elements in regulation of participating countries, in particular
quality management systems. However, over time the activities of GHTF have expanded,
to cover guidance documents on best regulatory practice. The implementation of common
projects,  such  as  global  vigilance  and  a  Global  Medical  Devices  Nomenclature,  and
exchange of information and experience through “status reports” on new technologies or
new  risks.  The  GHTF  also  serves  as  an  information  exchange  forum  through  which

30

31

32

Switzerland is fully aligned on the Community Directives for medical devices.
Through alignment on GHTF guidance (see 5.3 below), Australian and Community law are since
recently de facto fully aligned.
Member States, EFTA states and candidate countries.

22

                                                
countries with medical device regulatory systems under development can benefit from the
experience  of  those  with  existing  systems  and/or  pattern  their  practices  upon  those  of
GHTF founding members.

GHTF documents are largely inspired by Community legislation.

The fact that Europe will take the Chair of GHTF for a period of three years from 2004
provides an opportunity to further promote a European role world-wide.

– 

It is important that Europe continues to play a leading role in the work of GHTF
and  that  Commission  and  European  countries,  including  the  Member  States,
continue  to  make  sufficient  resources  available  to  allow  for  an  efficient
European presence. The Commission is examining how,  at  the European  level,
such resources can best be made available.

8.

CONCLUSIONS

Medical devices have become a major sector in health care, both in terms of markets, of
public expenditure and of impact on health. However, it has remained a largely unknown
sector,  apparently  with  scarce  human  and  financial  resources  at  the  level  of  public
administration.  The  Commission  expects  that  the  vast  sector  study,  to  be  carried  out  in
co-operation  with  national  authorities  and  European  trade  federations,  will  increase
awareness.

The  Commission  accepts  the  view  expressed  in  the  MDEG  Report  that  the  medical
devices directives in themselves provide  an appropriate legal framework with a view  to
safety aspects and technological evolution, but that there is definitely a need to improve
implementation and to clarify particular aspects.

Improvement should be achieved through a combination of means, to be implemented by
all actors involved, be this Commission, national authorities, Notified Bodies, Standards
Bodies and manufacturers:

– 

– 

– 

– 

Implementing measures at national level including market surveillance and
designation of notified bodies, made possible through appropriate resources

Use of available instruments (re-classification, precautionary principle,
safeguard clause),

Guidance in the form of consensus documents between the stakeholders, detailed
in Annex 4

Co-ordination and co-operation activities in different fora, including a new “high
level committee for medical devices”

23

– 

– 

Regulatory clarification on a number of issues, detailed in Annex 5.

Implementation of other measures, detailed in Annex 6.

The Commission will carry out an impact assessment of this strategy within a period of
five years.

24

Annex 1 - Summary of information - article 11 section 4 of 93/42/EC - Vigilance

Vigilance data 1995- 2000 (not all years are complete)

Country

1995

1996 1997 1998 1999 2000

Comments

Problems encountered, suggestions for
changes and issues

Austria

119

163

231

140

166

169 - 1995-1997

counting of all protocoled vigilance
communications; one vigilance case
may  have  various  communications

seriousness: including incidents and
near incidents, user failures

It  would  be  advisable 
information  on  and  cooperation 
distribution chain

to  have  better
the

in 

- manufacturer > distributor > hospital

Belgium

18

24

68

120

176

246 Figures  only  include  manufacturers
and  users  reports.  Reports  received
from  other  Competent  Authorities
do  not  appear.  Sent  2  competent
authorities vigilance reports in 1997
3 in 1998, 3 in 1999, 4 in 2000 and
4 in 2001.

Belgium finds that more and more products that
are not medical devices are presented as such.

The  absence  of  a  European  database  makes
market  surveillance  activities  very  difficult.  It
is  necessary  that  incidents  be  notified  asap.  It
would be useful to have an effective European
database.

Denmark

74

98

82

223

The  first  vigilance  report  was  in
1996.Since  then,  only  1  report  is
is
transmitted.  No  clear 

trend 

It is suggested to have a better communication
among  MS  and  to  encourage  a  harmonized
and  manufacturers.
approach 

by  MS 

25

Finland

-

12

88

127

137

reports  are  not
observed.  Few 
the  criteria  of  serious
meeting 
incident.  They 
include  anything
from  near  indicent  to  death  of  a
patient

Manufacturers  should  be  made  aware  that  any
action related to a specific product must follow
the product to which the incident is linked, and
not the borders of MS.

from 

121 During  1999,  NAM  received  264
adverse  incident  reports:  54  from
users,  73  from  manufacturers  and
137 
Competent
other 
Authorities.  During  the  last  5  years
the  number  of  reports  from  users
stable.  The
quite 
has 
manufacturer  reports  have  shown  a
steady annual increase.

been 

It  is  suggested  that  MS  should  ensure  that
common  and  agreed  criteria  are  employed
when  determining  the  subject  af  a  competent
authority notification.

Finland is currently analyzing vigilance reports
from 1995 to the present, report June 2002

France

-

60

79

97

-

- Vigilance  reporting  is  done  on  two
levels:  locally  and  nationally.  The
information  gathered  comes  from
the  manufacturers  as  well  as  from
the users. No notification has led to
a safeguard clause

The  Commission  should  put  an  up-to-date
listing  of  CAs  at  the  disposal  of  each  MS.  It
would be advisable
-  to  have  a  more  precise  definition  of  the
reporting  criteria  in  order  to  have  harmonized
declarations
- to improve communication between MS,  and
-  to  apply  a  centralized  evaluation  method.

26

Germany

16

51

66

73

Ireland

204

196

Netherlands

87

134

248

282

434

467

the
There  still  exists  disharmonisation 
practical 
legal
the 
implementation 
provisions. The Netherlands still has a concern
about the :

of 

in 

Notified bodies

- Harmonization and establishment of European
opinions

- Carrying out of Annex II on Class IIa and IIb
devices

- supervision on Class I manufacturers

- keeping of product files

- adjustment of Annex IX

Portugal

2

-

19

53

60

86

Involved  19  cases  of  medical
devices  marketed  in  Portugal  and  a
total  of  3  serious  cases.  Infarmed
incident  report
the 
has  adopted 

Most  of  the  problems  are  common  to  other
Member States.

-  The absence of the European Database

27

Spain

20

73

157

219

321

formats suggested by the EC.

332 Competent 

vigilance
authority 
reports 1 in 1995and 1996 3 in 1997
and 1998 and 4 in 1999. During the
last  6  years  the  number  of  reports
from  users  has  been  quite  stable.
The  manufacturer 
reports  have
shown a steady annual increase.

-  The  need 

to 

improve  communication

between Member States

-  The  lack  of  information  regarding  the

distribution chain in Europe.

It would be advisable to have better knowledge
about  measures  adopted  by  other  Member
States after a first vigilance report is circulated
with national measures adopted

Sweden

12

52

167

269

397

375

UK

15

32

76

107

123

109 The  seriousness  of  the  incidents
involved 
and
both 
distributed by the MDA appeared to
be  consistent.  MDA  continues  to
receive  notifications related to  non-
CE marked devices.

received 

MS  should  ensure  that  common  and  agreed
criteria  are  employed  when  determining  the
subject of a competent authority notification.

28

Annex 2 -Summary of information - article 11 section 4 of 93/42/EC – Clinical investigations

Clinical investigations 1995-2000

Country

1995 1996 1997 1998 1999 2000

Comments

Problems encountered, suggestions for changes
and issues

Austria

2

12

17

21

28 Numbers  apply  to  all  classes  of  medical

devices

It  is  suggested  to  establish  a  system  of  clinical
guidance documents.

Belgium

Denmark

Finland

-

-

-

-

-

-

24

26

30

It  is  suggested  to  notify  the  investigations  on  a
European  level  to  obtain  comparability.  It  should
be  required  to  submit  the  file  to  all  countries
where one wishes to conduct a study.

-

-

-

-

This  competence 
Scientific Ethical Committee

is  delegated 

to 

the

No suggestions have been made

4

5

5

8

9

For  assessment  purposes  all  classes  of
devices are treated equally under the Finnish
Act.  The  number  of  notifications  have  been
relatively small as there  are  few  class  IIb  or
III manufacturers in Finland.

The present system does not include a mechanism
where other Member States could get information
from 
for
investigations.  National 
assessment are not sufficiently transparent.

schemes 

29

France

On  national  level,  it  is  noted  that  there  is  a  large
non-notification  of  undesirable  serious  incidents.
It  is  envisaged  to  launch  a  procedure  to  improve
this  situation.  On  European  level,  it  would  be
advisable to improve the communication between
CA, the authorities and NBs.

France did not  give any specific number per
year.  They  indicate  an  average  of  200  per
year. Clinical  investigations are  done on  CE
and  non-CE  marked  products.  Clinical
evaluation  is  very  often  based  on  literature
and  not  actually  on  investigations  even  for
AIMD  and  devices  with  high  risk.  80%  of
the notifications are incomplete in  particular
the  technical  file  and  the  declaration  of
conformity to the essential requirements. The
manufacturers  are  sometimes  reluctant  to
deliver the certificate.

Ireland

1

1

2

Netherlands

-

Portugal

-

-

-

44

27

31

41

-

-

-

5 Detected  difficulties  in  the  instruction  of

technical documentation

It 
is  suggested 
through a Guideline

to  harmonize 

the  procedure

30

Spain

14

16

21

17

9

-

Testing Class I and Ila products are very rare
and  do  not  appear  to  be  on  the  increase.
Testing class III and class Ilb products with a
view to new  identifications  of products with
the EC mark is now being carried out.

It is thought that the system is working adequately
and does not need to be changed.

Sweden

25

25

26

39

34

34

UK

83

51

47

50

29

54 MDA sees a downward trend in notifications
concerning  lower  risk  devices  that  may
reflect  a  tendency  on  the  part  of  these
manufacturers  to  rely  more  heavily  upon
existing literature as a source of clinical data.

31

20% 

around 

objecting 

The  government  of  the  United  Kingdom  is
currently 
of
to 
notifications,  of  which  2/3  are  due  to  the  failure
by manufacturers to demonstrate compliance with
the  essential  requirements.  The  present  system
would appear to give rise to some inconsistency in
the assessment of clinical investigations across the
Community.  The  UK  is  also  concerned  that  the
present  system  does  not  make  provision  for
investigations.  The
monitoring  of 
requirements  for  reporting  of  adverse  incidents
that  occur  during  a  clinical  investigation  would
not appear to be consistent across the MS.

clinical 

Annex 3 – Summary of information – article 11 section 4 of 93/42/EC – Pharmaceutical consultations

Pharmaceutical consultations 1995-2000

Country

1995 1996 1997 1998 1999 2000

Comments

Problems encountered, suggestions
for changes and issues

Austria

Belgium

Denmark

-

-

-

-

-

-

-

-

-

2

-

-

-

-

-

- No 

specific 
pharmaceutical cases

problems 

encountered  with

-

Presently,  no  notified  bodies  are  established  in
Belgium

2

Figures are not given per year.

Denmark  lacks  experience  to  present
suggestions in this area.

Received about 10 requests for information

The  few  consultations  did  not  give  indication  of
main difficulties connected to the system.

32

Finland

-

-

-

-

-

-

-  Finland  received  no  consultation  requests  from
NB based in Finland

-  NAM  issued  a  guidance  note  based  on  MedDev
2.1/3 Rev 5

France

-

-

-

-

-

38 Only  the  French  authority  was  consulted;  No

negative opinion was given

Ireland

Netherlands

Portugal

-

-

-

-

-

-

2

-

5

-

1

3

-

Infarmed  did  not  have  any  consultation  as
mentioned

33

for 

Add  to  the  documentation  protocol
that  the  manufacturer  must  state  the
following 
of
consultation  of  the  competent  body:
"Certificate from the health authorities
on  the  guarantees  of  the  manufacturer
of the medicinal substance".

purpose 

the 

Spain

-

-

-

-

-

8

Figures are not given per year.

It it suggested to:

-  State  more  clearly  which  medicinal  substances
should be submitted for consultation.

Exclude cases meeting the following criteria:

a)  combination  of  health  product  +  medicinal
substance well known for the intended uses

b)  medicinal  substance  frequently  used  and  with
quality  specifications 
the
European Pharmacopoeia monograph

fully  described 

in 

c)  origin  of  medicinal  substance  guaranteed  by  a
certificate  from  the  health  authorities  in  the
country of origin concerning the guarantees of the
supplier of the substance

d)  specifications  of 
the  medicinal  substance
guaranteed by a supplier's certificate of compliance
with  the  specifications  laid  down  in  the  relevant
European Pharmacopoeia monograph

34

UK

-

-

-

-

-

- MCA  received  several  consultation  requests  from

NBs based in UK and abroad

MCA  understands  from  discussions
that  more  detailed
held  with  NB 
guidance  on  data  requirements  for  the
medicinal 
be
required.  MCA  includes  a  statement
on which the NB can indicate whether
the  data  submitted  was  sufficient  or
not.

substance  would 

issued  guidance  documents  based  on

MCA 
MEDDEV 2.1/3 rev. 5

The  nature  and  data  submitted  is  variable  but  has
improved since companies have gained experience
in compiling files for combination products

 MCA  feels  that  there  are  still  3  areas  requiring
further discussion:

-  Quantitative  declaration  of  content  of  medicinal
substance availability

- Stability

- Claims

35

Annex 4 - Work programmes for working groups and task forces.

Clinical Evaluation Task Force

– 

– 

– 

– 

Evaluation of Clinical data: A Guide for Notified Bodies

Guidelines for Post-Market Clinical Follow-up (PMCF)

Specific guidelines for certain categories of implantable medical devices namely
coronary stents and hip implants

Transparency of the clinical evaluation reports

Notified Body Operations Group

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

Production and completion of a checklist on the designation and monitoring of
notified bodies

Production  of  a  Best  Practice  Guide  (BPG)  for  Member  States  and  notified
bodies

Production  of  a  Communication  Strategy  on  the  exchange  of  information
between Member States

Production of Annual Reports by Notified Bodies

Observing Member States Auditing Notified Bodies

Training Events

Guidance  on  Possible  Notified  Body  remedial  action(s)  to  rectify  non
compliance

Notified Body Competence requirements

Guidance on minimum data set for Certificates of Conformity

Sharing Audit Experiences

Vigilance Reporting clarification of the notified bodies role

Change  of  Notified  Body  by  the  manufacturer  actions  by  Member  State  and
notified body

Market Surveillance Operations Group

– 

Communication  strategy  to  cover  exchange  of  information  about  individual
inspections

36

– 

– 

– 

– 

– 

– 

– 

– 

– 

Guidance Notes for manufacturers of class I medical devices

Guidelines to elaborate the technical documentation related to the annex VII of
MDD

Guidelines to elaborate the EC declaration of conformity

Compliance  check-list  for  regulatory  authority 
documentation conformity

to  verify 

the 

technical

Inspection of class I manufacturers

Guidance notes for importers and distributors

Protocol  for  a  possible  inspection  programme  for  shadow  audits,  where  one
Member  State  is  doing  the  audit  together  with  other  one  to  develop  better
understanding of procedures

Criteria for acceptance and assessment “miracle” and other borderline products

European Inspector’s Hand Book for Best Practice

Medical Devices Expert Group

– 

Endorsement of Notified Body Recommendations and Consensus statements

37

Annex 5 - Main areas identified for regulatory modification.

Scope

– 

– 

Exclusion of in vitro diagnostic medical devices from the scope of the Directive
covering Biocides.

Clarify  the  situation  in  regard  to  Personal  protective  equipment  to  allow  both
Directives to apply.

Conformity assessment and classification.

– 

– 

– 

– 

– 

Modification  of  the  classification  criteria  in  annex  IX  to  eliminate  certain
classification anomalies.

Annex  II:  clarification  of  obligation  of  design  evaluation  under  quality
assurance.

Redefine period of validity of conformity assessment certificates

Definition for the period of retention of product files.

Clarification of the text of Annex X on clinical evaluation.

Essential requirements.

– 

Introduce expiry dating for sterile medical devices

Transparency

– 

Make  possible  the  publication  of  information  concerning  the  assessment  of
medical devices. Review the Directive provision for confidentiality (article20)

Post production phase

– 

Propose  regulatory  change  to  ensure  that  national  measures  that  restrict  the
placing on the market of medical devices will be communicated to all Member
States.

Alignment  of  the  Active  Implantable  Medical  Devices  Directive  with  the  Medical
Devices Directive.

– 

– 

– 

– 

Inclusion of provision on particular health monitoring measures

Extension of database EUDAMED to active implantable devices

Addendum for EC type-examination certificates

Requirements regarding new devices

38

– 

– 

– 

– 

One  single  person  (manufacturer  or  authorised  representative)  responsible  for
placing on the market in the Community

Reference to the importer

Requirement to designate an authorised representative

Documentation of the quality system in the technical documentation

39

Annex 6 - Other Measures

Study on medical devices sector.

The  Commission  will  launch  a  study  in  2003  concerning  the  medical  devices
sector,  its  impact  on  health  and  health  expenditure,  and  framework  conditions
for increasing competitiveness.

Creation of a High Level Group for medical devices

The Commission  will create a High  Level Group for medical devices allowing
for  consultation  and  mutual  information  between  Commission  and  national
authorities on issues in relation to medical devices.

Complete and publish data

The  Commission  will  ask  national  authorities  to  complete  data  on  vigilance,
clinical investigation and pharmaceutical  consultation,  to  be  made  available  on
the Commission’s web-site for medical devices.

Support MSOG, NBOG and CETF

The  Commission  will  continue  to  host  and,  within  the  limits  of  budgetary
availability, financially support the work of NBOG, MSOG and CETF.

Health policy Forum

The  Commission  will  inform  on  a  regular  basis  the  Health  Policy  Forum  of
developments in relation to medical devices.

Eudamed

The  Commission  will  launch  a  pilot  project  on  Eudamed  in  mid  2003,  under
which national authorities will start to load data, to be implemented throughout
the second half of 2003.

Vigilance

MDEG Vigilance group to verify and improve national practise on vigilance.

Pharmaceutical consultation.

Guidance  to  be  developed  by  MDEG  to  ensure  coherent  implementation  of
relevant provisions in Directive.

40

Standardisation.

MDEG to monitor and verify on a regular basis issues and progress in relation to
European standardisation for medical devices.

Intervention mechanisms

Commission to propose guidance document on the implementation of the
Directive’s provisions on national health monitoring measures and their relation
with safeguard clauses.

41

Appendix 1 - Medical device product coverage

The  medical  devices  sector  is  covered  by  three  Directives,  covering  some  10,000  products.
Medical  devices  are  instruments,  apparatus,  appliances,  materials  or  other  articles,  whether
used  alone  or  in  combination,  together  with  any  accessories  or  software  for  its  proper
functioning, intended by the manufacturer to be used for human beings in the:

– 

– 

– 

– 

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

that  do  not  achieve  their  principal  intended  action  by  pharmacological,  chemical,
immunological or metabolic means, but which may be assisted in its function by such means.

A.

The 1990 Directive on Active Implantable Medical Devices (AIMDD)

This Directive covers medical devices  relying for their  functioning  on a  source of  electrical
energy  or  any  source  of  power  other  than  that  directly  generated  by  the  human  body  or
gravity, and which are intended to be totally or partially introduced, surgically or medically,
into the human body or by medical intervention into a natural orifice, and which is intended to
remain after the procedure.

Typical products covered are

– 

– 

– 

B.

Pacemakers

Diffusion pumps for oncological applications

Cochlear implants

The 1998 Directive on In Vitro Diagnostic Medical Devices. (IVDD)

This  Directive  covers  any  medical  device  which  is  a  (i)  reagent,  reagent  product,  (ii)
calibrator,  control  material,  kit,  (iii)  instrument,  apparatus,  equipment,  or  system,  whether
used  alone  or  in  combination,  intended  by  the  manufacturer  to  be  used  in  vitro  for  the
examination  of  specimens,  including  blood  and  tissue  donations,  derived  from  the  human
body, solely or principally for the purpose of providing information:

– 

– 

– 

– 

concerning a physiological or pathological state, or

concerning a congenital abnormality, or

to determine the safety and compatibility with potential recipients, or

to monitor therapeutic measures

42

Typical products covered are IVDs for

– 

– 

– 

– 

– 

Reagents for determining pregnancy

Reagents for determining Aids

Reagents for determining blood grouping

Reagents for determining Hepatitis

Specimen receptacles for the containment and preservation of human specimens

C.

The 1993 Directive on Medical Devices (MDD)

This Directive covers medical devices not subject to the AIMDD or to the IVDD.

Hospital equipment , such as

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

– 

Anaesthetic equipment and workstations; respiration and inhalation equipment (lung
ventilators)

Tomographic equipment

Magnetic resonance equipment

Sterilizers

Operating theatre

Diagnostic  equipment,  such  as  X-ray,  laser  applications,  electro-cardiography,
stethoscopes

Hemodialysis

Nuclear therapeutic equipment

Infusion and transfusion equipment

Incubators

Surgery equipment

Catheters

Medical disposables

Dentistry, such as

– 

– 

– 

Equipment, including drills, chairs, UV lighting for hardening of materials

Dental material, including amalgams, plastics, porcelain

Dental implants

43

Audio-metric devices, such as

– 

– 

Measuring instruments

Audative prostheses, hearing aids

Ophthalmic devices, such as

– 

– 

Measurement and diagnostic devices

Spectacles, glasses, contact lenses

Protheses, implantable and non-implantable; Internal and external orthopaedics, such as

– 

– 

– 

– 

– 

Walking aids

Artificial limbs

Hips implants

Cardiac valves

Corsets

Aids for disabled, such as

– 

– 

– 

Wheelchairs

Portable ventilators

Rehabilitation equipment

Disposable

– 

– 

– 

Barrier contraceptives, Condoms

Dressings

Surgical drapes

44

Appendix 2 - The Benefits of Medical Technology and Devices for EU Citizens33

Approximately  80%  of  healthcare  costs  are  spent  on  the  management  of  chronic  disease,
much of it on hospitalisation and medical intervention. The bulk of these costs are being spent
on  cardiovascular  disease,  cancer,  diabetes,  AIDS,  orthopaedic  and  spinal  diseases,  arthritis
and the full range of neurological diseases. As the population ages, the prevalence of chronic
disease  will  increase  dramatically,  further  accentuating  the  need  for  better  chronic  care.  An
important  opportunity,  in  the  near  future,  is  to  improve  the  quality  of  life  for  people  with
chronic  disease.  Also  with  regard  to  rare  diseases  is  the  devices  and  technology  industry
making a strong contribution and it is looking how the environment in Europe can encourage
companies to do even more in this field.

The  medical  technologies  and  devices  industry  believes  the  opportunity  to  improve  the
management  of  chronic  disease  will  be  greatly  facilitated  by  the  integration  of  information
technology with medical technology.

Some examples of areas where medical technologies and devices and the industry are playing
a significant role are described below in more detail.

Cardiovascular Disease

In  the  area  of  cardiovascular  disease  interventional  cardiology,  including  coronary
angiography  and  coronary  stents,  arrhythmia  management  and  stroke  management
provide excellent examples of the contribution of medical technologies and devices
to patient care. There has been a continuous trend of innovation in the development
of procedures in these areas.

According to the third monitoring report of the WHO, cardiovascular diseases cause
12  million  deaths  in  the  world  each  year.  They  cause  half  of  all  deaths  in  major
developed  countries,  and  are  one  of  the  main  causes  of  death  in  many  developing
countries — and the major cause of death in adults.

The  utilisation  of  devices  has  contributed  to  the  decline  in  mortality  rate  through
appropriate diagnosis and treatment.

Interventional Cardiology

Interventional cardiology has really come into its own since the 1970's. Technologies
have provided much less invasive alternatives for patients who were typically treated
by  bypass  surgery  in  the  60's  and  70's.  These  modalities  include  coronary
angioplasty, stenting and debulking. However, several new pioneering techniques are
underway to  further  the  advancement  of  coronary  care  and  to  address  restenosis,
often referred to as the Achilles' heel of coronary interventions.

Coronary Angioplasty

In  1977,  Dr.  Andreas  Gruentzig  revolutionised  interventional  cardiology  when  he
performed  the  first  Percutaneous  Transluminal  Coronary  Angioplasty  (PTCA).
PTCA has now become a widespread and relatively simple procedure, involving the

33

Extract from the MDEG Report; information supplied by EUCOMED

45

                                                
use  of  a  balloon  catheter  to  open  blocked,  or  narrowed,  coronary  arteries.  It  is
estimated that approximately 1.5 million PTCA procedures are performed each year,
with approximately 400-500 thousand of them being performed in Europe.

Coronary Stents

Coronary stents have revolutionised interventional medicine. The worldwide market
for these devices was forecast at € 2.1 billion in 1999, up from € 1.9 billion in 1998.
This  young  market  is  forecast  to  reach  €  4.8  billion  by  2002,  driven  by  increasing
competition in both the United States and Europe.

Forces that continue to provide momentum in the coronary stent market include the
development of smaller stents (permitting a larger group of patients to be treated) and
new  adjunctive  therapies,  such  as  radiation  and  statin  drugs,  that  are  showing
promising results in reducing the plaguing problem of restenosis.

The Challenge of Restenosis

While these less invasive technologies have greatly enhanced cardiac care and have
proved  successful  in  huge  numbers  of  patients,  continued  enhancements  and
developments are occurring to address  some of the continued challenges facing the
interventional  cardiologist.  These  advancements  include  vascular  brachytherapy,
pharmacological  agents  and  PTMR.  The  most  significant  challenge  to  the
interventional cardiologist is restenosis.

Vascular Brachytherapy (VBT) an Emerging Technology

One of the most significant advancements in the treatment of restenosis involves the
use  of  radiation  to  treat  the  balloon  injury  site,  thereby  reducing  the  amount  of
neointimal  cell  proliferation.  This  application 
to  as  vascular
brachytherapy.  There  are  a  variety  of  different  projects,  trials  and  marketing
registries under development involving the use of Beta and Gamma isotopes. Recent
clinical  results  from  a  number  of  trials  have  confirmed  significant  reductions  in
restenosis rates.

referred 

is 

Arrhythmia Management

One  device  used  for  arrhythmia  management  is  the  implantable  pacemaker.  A
pacemaker is an electronic device that stimulates the heartbeat. A slow heart rate is
called  bradycardia.  It  can  occur  in  various  types  of  heart  blocks  or  arrhythmias
(rhythm disturbance). The pacemaker may be needed temporarily or on a permanent
basis.  Sometimes  myocardial  infarction  (heart  attack)  causes  transient  heart  block
requiring  a  temporary  pacemaker.  Most  of  the  time,  the  need  for  pacing  is
permanent.

The  global  arrhythmia  management  device  market  is  also  growing  rapidly,  as  the
world's  population  ages  and  the  cost-effective  diagnosis  and  management  of  heart
rhythm disorders grows in importance. The total market for these devices (valued at
about  €  4.5  billion  in  1998)  includes  external  manual  and  automated  defibrillators,
traditional  bradycardia  pacemakers  and  implantable  cardioverter  defibrillators  to
treat  tachycardias  and  various  forms  of  fibrillation.  Electrophysiology  and  catheter
ablation products represent a market growing at 12–15% per year.

46

Stroke Management

Stroke diagnosis and treatment is a field in dire need of cost-effective technology, as
the incidence of this disorder and treatment costs continue to grow. Worldwide, total
stroke management costs are estimated at more than € 100 billion. Stroke is the third
leading cause of death in the United States (after heart disease and cancer) and is the
leading  cause  of  long-term  disability  and  nursing  home  admissions.  The  direct
clinical and indirect economic costs of stroke are estimated at about € 43 billion.

Devices that fall into the stroke prevention and acute-treatment categories—such as
implantable  atrial  pacemakers  and  defibrillators,  carotid  stents,  least-invasive  clot
removal/dissolution  devices  (for  ischemic  stroke),  and  novel  embolisation  products
(for haemorrhagic stroke)—are likely to have the greatest long-term potential.

Cancer

After  heart  disease,  cancer  is  the  second  leading  cause  of  death  in  Europe  and  the
world.  Medical  technologies  and  devices  are  used  in  many  ways  to  assist  and
improve  the  quality  of  life  of  cancer  patients.  These  include  breast  cancer  patients
and colon/rectal cancer patients.

Breast  cancer  is  the  most  common  cancer  among  women,  excluding  skin  cancer.
Breast cancer is the leading cause of cancer death in women between the ages of 40
and  55.  A  very  high  percentage  of  mastectomies  are  followed  by  reconstructive
surgery utilising a surgical implant or tissue expander.

More than 300,000 colostomies, mainly  caused by colorectal cancer, are  performed
each year in Europe. Part of the colon is removed and the intestine is re-routed to an
outlet  (the  stoma)  in  the  abdominal  wall  where  waste  is  then  collected  in  an
externally worn pouch. Medical devices  are  used by  these patients to  provide  them
with  security  and  peace  of  mind  to  continue  their  lives  in  a  productive  and  quality
manner.

Diabetes

Diabetes,  a  glucose  metabolism  disorder  that  can  cause  a  variety  of  severe
complications involving virtually every major organ system, is one of the most costly
and debilitating diseases. Worldwide, more than 154 million people are afflicted with
diabetes this figure is expected to double by 2025.

Diabetes is an important area where medical technologies play a vital role in patient
care  and  demonstrate  a  significant  potential  for  increased  patient  safety,  improved
quality of life and reduction in healthcare costs. These devices include insulin deliver
products  (syringes,  pens,  automatic  injectors  and  external/implantable  pumps),
glucose monitoring devices and wound care products.

Delivery Systems

Today,  most  people  who  take  insulin  to  manage  diabetes  inject  the  insulin  with  a
needle and syringe that delivers insulin just under the skin. Several other devices for
taking insulin are available, and New Approaches are under development.

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Wound Care

Diabetic foot is  a  general term that describes a  variety of foot  problems in  patients
with diabetes mellitus. These diabetic feet problems range from small breaks in the
skin  to  large, non-healing  ulcers that  may  ultimately  require  amputation  of  the  toe,
foot or leg. Remarkable strides have been made in the treatment of diabetic ulcers. A
number of treatments are currently available from several medical technologies and
device manufacturers that stimulate new cell growth and help heal skin ulcers or use
cultures  of  human  skin  cells.  Recent  advances  in  biotechnology,  biomaterials,  and
tissue  engineering  are  driving  the  development  of  a  new  generation  of  advanced
products that may dominate wound management early in the next century.

Dialysis

– 

– 

There are currently about 250.000 patients in Europe who suffer from Kidney Failure
or End Stage Renal Disease (ESRD). A patient is diagnosed with ESRD when 80%
of their kidney function is lost.

Transplantation  is  one  option  for  these  patients  but  less  than  50%  can  expect  to
receive a kidney transplant, due to a shortage of donor organs.

The  alternative  option  is  dialysis.  Close  to  200,000  patients  regularly  undergo  this
treatment  to  replace  some  of  their  kidney  function.  There  are  two  dialysis  options
available:

– 

– 

Haemodialysis  (HD)  is  the  most  common  form  of  treatment  with  close  to
175,000 patients in Europe. HD is usually a hospital-based treatment.

The other modality, Peritoneal Dialysis (PD) is a treatment performed at home.
Approximately 25,000 patients in Europe currently benefit from this homecare
treatment.

Musculoskeletal Disorders

Musculoskeletal  disorders  are  on  the  rise.  Osteoarthritis  is  the  most  prevalent  joint
disorder,  characterised  by  joint  pain,  tenderness,  and  functional  disability.  The
percentage of individuals over 65 years of age is the fastest growing segment of the
population,  and  is  expected  to  exceed  80  million  people  by  the  year  2010.
Osteoarthritis  will  affect  at  least  70%  of  this  population.  Other  important  areas
include  work  and  sport  related  injuries.  Work-related  Musculoskeletal  Disorders
(WMSDs) account for a major component of the cost of work-related illness.

Orthopaedic surgery is a large medical technologies and device area. Ripe with new
developments in bone, cartilage, and soft-tissue regeneration that may offset single-
digit  growth  rates  in  the  market  for  total  joint  implants.  In  Europe  approximately
450,000  hip  joints  and  150,000  knee-joints  are  replaced  each  year.  Recently,
companies have turned their attention to one of the most exciting areas in the MSK
industry: biologically attuned implants that can mimic the body's own natural repair
processes,  potentially  expedite  the  healing  process,  and  overcome  many  of  the
problems  associated  with  metallic  devices.  Because  biomaterials  may  be  used  to
repair  or  regenerate  most  MSK  tissues,  including  bone,  cartilage,  meniscus,
ligaments, tendons, and even spinal disks, their applications cross the boundaries of
traditional orthopaedic segments.

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Neurostimulation Therapy for Pain Management

It  is  clear  that  there  is  an  epidemic  in  Europe:  6%  of  the  population  has  persistent
pain  resulting in a  reduced quality of life.  Spinal  cord  stimulation  (SCS)  uses  low-
voltage  electrical  stimulation  to  generate  parasthesia  in  the  area(s)  of  pain.  The
system consists of three major devices: the lead, the extension and the power source,
all fully implanted.

Information Technologies

Healthcare information systems (HIS) represent another growing medical technology
market  for  the  future.  The  U.S.  market  for  these  products—including  patient  care,
clinical  data,  financial,  laboratory,  radiology,  pharmacy,  and  other  segments—is
valued at more  than €  4  billion.  Issues such  as the increasing  demand  for point-of-
care  (POC)  information,  and  the  proliferation  of  Internet  use  represent  new
challenges as well as opportunities for the medical products industry.

The  increased  reliance  on  information  technology  (IT)  from  a  clinical  perspective  is  being
driven, first and foremost, by the need to provide remote access to diagnostic information and
patient records.

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Appendix 3 - Main features of regulatory framework

The Directives are based on the concept of the New Approach to technical harmonisation and
standardisation, defined by the Council in 198534. Directives define the essential requirements
that products have to meet when they are put on the market or put into service. Products can
only be placed on the market or put into service, if they were subject of a risk assessment, a
risk management process and a risk/benefit analysis. In this approach, risks to be taken into
consideration relate to issues  such  as  chemical,  physical  and  biological  properties,  infection
and microbiological contamination, construction and environmental properties and protection
against  radiation.  Furthermore,  medical  devices  must  achieve  the  performances  intended  by
the manufacturer.

In order to allow technological progress and to ensure that new products placed on the market
reflect the current state of the art, the directives do not specify technological solutions to be
adopted  by  manufacturers.  Instead,  manufacturers  have  to  substantiate  how  risks  have  been
taken into consideration and dealt with, both at the level of the design and the manufacture of
the device.  Use  of  European  “harmonized  standards”  provides  a  presumption  of  conformity
with the essential requirements to which such standards specifically relate.

The  Directives  contain  a  number  of  conformity  assessment  procedures,  the  use  of  which
depends on the type of products and type of risks involved. Except for low risk devices, these
risk-based  procedures  always  involve  independent  conformity  assessment  bodies,  so-called
Notified Bodies, designated and monitored by national authorities.

The Directives foresee a number of mechanisms for authorities by which they can intervene in
order to ensure the proper functioning of the directives. Such mechanisms relate for instance
to the designation and monitoring of notified bodies, reclassification of devices, mandates for
standards, formal objections to standards, safeguard clauses,  actions under the precautionary
principle,  market  surveillance,  administrative  co-operation  and  the  creation  of  guidance
documents. A proper implementation and management of the Directives is therefore resource
intensive.

This  legal  framework  is  stable  and  does  not  require  regular  updating.  However,  in  order  to
meet its requirements, manufacturers must follow the state of the art. Devices placed on the
market today will not be deemed to respect the directives’ requirements if they do not evolve
over time with technological evolution.

34

Council resolution of 7 May 1985 on a New Approach to technical harmonisation and standards; OJEC
C 136 of 4 June 1985.

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Appendix 4 - Working groups involved in the implementation of the Medical Devices
Directives.

In  order  to  ensure  a  coherent  implementation  of  the  Directives,  the  Commission,  national
authorities  and  stakeholders  have  created  a  number  of  instruments  and  working  groups,  in
addition to the – formal - Committee created by the Directives.

– 

– 

– 

– 

– 

The  main  platform  for  discussion  on  implementation  issues  is  the  MDEG,  the
Medical Devices Experts Group. MDEG is chaired by the Commission. Participants
are 
the  national  competent  authorities  (including  candidate  countries)  and
stakeholders  such  as  representatives  of  industry,  European  standards  bodies  and  of
Notified Bodies. MDEG has set up a number of specific Working Groups that report
to MDEG, dealing with issues such as BSE/TSE, vigilance. Of particular interest is
the recently created clinical evaluation task force.

MDEG  can  adopt  guidelines,  “MedDevs”,  that  reflect  the  consensus  view  of
authorities and stakeholders on issues of interpretation or implementation. MedDevs
are published on the Commission’s web-site.

More recently, national authorities have come together to co-ordinate policies under
the  Notified  Bodies  Operations  Group  (NBOG)  and  the  Market  Surveillance
Operations Group (MSOG). Meetings are chaired by a national authority, and hosted
by the Commission. NBOG and MSOG inform MDEG of their activities.

Notified  Bodies  meet  on  a  regular  basis  in  the  framework  of  the  Co-ordination  of
Notified  Bodies  Medical  Devices  (NB-MED)  The  aim  is  to  co-ordinate  the
assessment  of  technical  issues.  The  Commission  funds  the  organisation  of  these
meetings and all Notified Bodies are encouraged to attend. The NB-MED lays down
its conclusions in recommendations and consensus statements. These documents are
currently not publicly available.

Scientific  advice  on  particular  issues  is  obtained  from  the  Scientific  Committee  on
Medicinal  Products  and  Medical  Devices,  created  by  Committee’s  Decision  N°
97/579/EC of 23 July 199735. The list of the Committee’s Opinions adopted so far is
available on the web-site of the Commission36.

35

36

OJEC L 237 of 28.8.97
http://europa.eu.int/comm/food/fs/sc/scmp/index_en.html

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