Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE on in vitro diagnostic medical devices
Date: 1995-04-19
Institutions: European Commission
Subjects: dissemination of information, free movement of goods, medical device, medical diagnosis, technical regulations

COMMISSION  OF THE  EUROPEAN  COMMUNITIES 

Brussels,  19.04.1995 
COM(95)  130 final 

95/0013  (COD) 

Proposal  for a 
EUROPEAN PARLIAMENT  AND  COUNCIL DIRECTIVE 

on in vitro diagnostic  medical  devices 

Draft 
DECISION OF THE EEA JOINT COMMITTEE 

amending  Annex II, technical  regulations,  standards, testing  and  certification, 
to the Agreement on the European Economic Area 

Draft  common position  of the Community 

(presented by the  Commission) 

- 1-

EXPLANATOR Y MEMORANDUM 

I. 

GENERAL CONTEXT 

As part of the programme to complete the internal market, the rules for placing 
medical devices on the market are being harmonized throughout the Community 
to protect patients, users and third parties.  Most medical-devices are covered 
already by the Directives on active implantable medical devices (90/385/EEC)1 
and on medical devices (93/42/EEC).2 

In vitro diagnostic medical devices were defined  as medical devices in 
Directive 93/42/EEC but, in view of their special nature, were excluded  from 
the abovementioned  Directives.  They are covered by this proposal.  "In vitro 
diagnostic medical device" means, essentially, reagents, instruments and 
equipment for examining tissues or substances from  the human body for 
medical purposes. 

Unlike medicinal products, which are administered to the*human body, in vitro 
diagnostic devices are used outside the human body for medical examinations of 
samples taken from  the patient.  These devices are therefore important tools for 
diagnosing illnesses, monitoring patients'  state of health, checking the progress 
of courses of treatment and a whole series of other medical applications  (for 
example, AIDS, hepatitis and glucose tests, pregnancy tests, tests for congenital 
abnormalities, etc.).  Any malfunctioning  of these devices could lead to 
misdiagnosis, in some cases with grave consequences for the health and 
treatment of the patients or for third parties who could be infected  by contagious 
diseases. 

OJNoL  189,20.7.1990, p. 17. 
, OJNoL  169, 12.7.1993, p. 1. 

4 

2-

These devices are used mainly by medical laboratories, doctors and 
pathologists.  A growing proportion,  however, are intended to be used by the 
patients themselves (for example, glucose or pregnancy tests). 

The public interest covered by this proposal concerns the reliability, 
performance and precision of the devices in their medical application.  In 
addition,  the Directive provides protection for the health and safety of 
professional  or private users and third parties against the risks inherent in the 
devices. 

Unlike the other medical devices already covered by Directives 90/385/EEC 
and 93/42/EEC,  in vitro diagnostic devices do not usually enter into contact 
with the patient.  To take account of this unique feature and of the  different 
risks posed compared with other medical devices, this Directive covers such 
devices to complement the existing legislation in this sector. 

This proposal for a Directive is based on Article  100a of the Treaty. 
Furthermore,  it takes into account Article  129 of the Treaty which  stipulates 
that Community action shall be directed towards the prevention of diseases and 
that health protection requirements shall form one constituent part within other 
Community policies. 

It applies the principles of the new approach to technical harmonization.  The 
proposal lays down the essential requirements which devices placed on the 
market must meet and the conformity  assessment procedures with which 
manufacturers  must comply. 

Before drafting  this proposal, the Commission ordered a comparative study of 
the national legislation on such devices (cf.  Section III).  Its findings,  together 
with the broad-based consultations held since  1991 with experts from  the 
Member States, industrial circles and users, confirmed  the need for this 
Directive and paved the way for drafting  it. 

H. 

ECONOMIC IMPORTANCE OF THE SECTOR 

- 3-

Estimates put total worldwide production of medical devices, of which in vitro 
diagnostic devices are one subsector, at ECU 80 billion in  1993 (source: Health 
Industry Manufacturers'  Association, HIMA).  In  1993 the breakdown of 
production by country of origin was as follows:  USA 52%; EC  +  EFTA 28% 
(EC 26%); Japan  18%.  Since 1990 consumption has grown by 6% per year in 
the Community  (by 7% in the USA in  1993 and by 6% in Japan). 

Some 50% of the Community  market is supplied by the Community's own 
producers, 43% by US makers and 5% by Japanese manufacturers.  In  1993 the 
estimated number of jobs provided by this industry in the EC stood at over 
240 000. 

Research is particularly important to the performance  of this sector.  According 
to sources in the industry, an average of 5.9%  of its turnover is invested in 
research  (EC 5%; USA 6.7%; Japan 6%). 

The in vitro diagnostic medical device subsector covered by this proposal 
accounts for between  16% and  18% of the total medical device market.  This 
amounted to a total world market in these devices of some ECU  12.2 billion in 
1992 (source: European Diagnostics Manufacturers'  Association,  EDMA).  In 
1992 the EC/EFTA  took ECU 4.6 billion of this market, giving them a world 
market share of 38%  (USA 39%; Japan  12%). 

European  industry is highly developed  in this subsector.  It holds an extremely 
competitive position on the world market.  An estimated 400 or so businesses, 
most of them medium-sized,  are active in this field  in the EC and EFTA 
countries. . Germany is the largest producer in Europe.  France, the 
United Kingdom,  Italy, Belgium and the Netherlands also have major 
industries.. 

- 4-

In vitro diagnostic medical device technology has developed rapidly over the 
last thirty years. 

The success of the technology is due, in particular,  to the progress made with 
the development of scientific  methods of analysis in the fields of chemistry, 
biochemistry and immunology, to the increase in the biological parameters 
available and to the combination of these data and methods with 
microelectronics, automation and information  technology. Research activity in 
this industry is above average for the sector. Research accounts for between 15 
and 20% of the jobs in this subsector. 

m. 

LEGISLATION ON IN VITRO DIAGNOSTIC MEDICAL DEVICES AND 
EVALUATION OF THE NEED FOR LEGISLATION 

1. 

Existing legislation 

Before starting the harmonization work, in  1991 the Commission conducted a 
study to compare and analyse several Member States' national legislation on this 
subject.  This revealed that the Member States' legislation differed  not only in 
terms of the products covered but also on the detailed rules and the level of 
protection.  Moreover,  most of the legislation did not cover all the reagents, 
instruments, equipment and complete complex systems used for biomedicine, 
for which legislation is needed to provide an appropriate level of protection of 
health and  safety. 

Based on the abovementioned study,  the current situation as regards the 

Member States' legislation can be summed up as follows: 

* 

Some Member States have no legislation specifically on in vitro 

diagnostic devices,  except on selected products which are particularly 

sensitive from the public health point of view.  This is the case in the 

United Kingdom,  Spain, Italy and the Netherlands where,  in essence, 
tests to detect AIDS  (HIV),  tests on blood intended for transfusions  or a 
few  other specific  reagents are monitored by the public authorities or 

subjected to special regulatory procedures before they can be placed on 

the market. 

* 

France recently adopted new legislation  introducing a registration 

procedure to check the performance of reagents before  they are placed 

on the market.  Further inspections are required for certain categories  of 

devices  such as HIV tests,  tests to determine blood groups and 

radioimmunoassays. 

* 

Belgium applies some of the rules for medicinal products to in vitro 

reagents too. c 

* 

In Germany the devices in question are governed by various  regulations 

which call for stringent monitoring of some of them.  Reagents are 

classified  as medicinal products and are subject to controls calling  for the 

application of good  manufacturing practice.  Several other groups of tests 

(immunological  tests, particularly HIV tests, tests for hepatitis and tests 

for venereal diseases)  have to pass an authorization procedure  before 

they can be placed on the market.  In addition,  laboratory  instruments 

and equipment used in this field are covered by the legislation  on 

metrology and product safety. 

In conclusion,  the study revealed big differences  between  the requirements 

imposed on the devices by the national  regulatory  systems, particularly  with 

regard to labelling,  authorization or registration procedures and production 

control. 

- 6-

In the USA, the Community's leading trading partner and the biggest producer, 
in vitro diagnostic devices (reagents, laboratory instruments and equipment for 
biomedicine)  have been governed by the legislation on medical devices since 
1976. A series of special rules on, for example, labelling,  manufacturing,  etc. 
take account of the specific nature of these devices. The rules on good 
manufacturing  practice are compulsory. 

2. 

European standardization 

Work already done by the European  standardization bodies 
CEN/CENELEC  will smooth the way for implementation  of the  future 
Community legislation. A number of  "horizontal"  standards on medical 
devices in general also apply to in vitro diagnostic devices and more 
specific work has been carried out on, for example, the information 
which must be supplied to users or on laboratory equipment.  Some of 
this work has already been started in anticipation of this Directive. 

3. 

Evaluation of the need for harmonization 

There is a danger that the current differences  between the national 
regulatory  systems could deepen in the future.  In particular,  several 
Member States have already begun to legislate on in vitro diagnostic 
devices, notably when reorganizing  their national legislation to 
implement Directives 90/385/EEC and 93/42/EEC on medical devices. 

- 7-

This has been confirmed  by the cases of application or non-application of 
Directive 83/189/EEC on the notification  of draft  technical regulations.3 
Under this procedure the Commission has received notification  of 
several national regulations concerning, in particular,  the introduction of 
monitoring arrangements for HIV and hepatitis tests or for other tests 
(immunological and cancer tests). In one case the Commission had to 
apply Directive 83/189/EEC to block a draft  national technical  -
regulation for one year pending this proposal. 

The current disparities between the national systems, plus those which would 
follow  with the adoption of further  national legislation in the absence of 
European harmonization,  create barriers to the free movement of these devices 
in the Community. The diverging requirements applied with regard to the 
devices covered and the monitoring procedures make it virtually impossible to 
establish any equivalence between the various national provisions in terms of 
health protection.  For this reason, application of the principles of mutual 
recognition based on Article 30 of the Treaty/will be insufficient  and 
inappropriate for removing and preventing barriers in this sector.  Establishment 
of European  standards by the CEN/CENELEC alone, without a regulatory 
framework,  will not be enough to remedy the situation described above, given 
the voluntary nature of the standards. Consequently, harmonization of the 
legislation is the most appropriate means of ensuring free trade, all the more so 
since such Community legislation already exists for most other medical devices. 

OJ No  L  109,  26.4.1983,  p.  8,  as  last  amended  by  Directive 94/10/EC  of  the 
European Parliament and the Council, OJ No L 100, 19.4.1994, p. 30. 

A 

- 8-

From the economic point of view,  there is a danger that the lack of harmonized 

legislation could hamper the development of this industry in the Community. 

The diverging regulations force manufacturers to adapt their products to the 

situation on the individual national markets.  They are therefore  unable to 
s  benefit  from the Community  market as their internal market.  By contrast, 

harmonized conditions for placing products on the market would enable them to 

achieve economies of  scale.  Also, once manufacturers have adapted their 

products and processes to the Community legislation,  they can expect the 

harmonization of legislation to cut the costs of complying with the regulations 

whicl\ are higher at the moment because of the need to comply with the varying 

national systems and procedures. 

The introduction of  Community legislation  taking account of the specific  nature 

of  the devices in question will generate added value for the development of the 

European industry and enable it to benefit  more fully  from the dimension of the 

internal  market..  In contrast to the current situation,  such legislation will  create 

stable,  foreseeable  regulatory conditions and at the same time encourage the 

industry  to proceed with research and make the necessary investments.  In this 

way,  it will  contribute towards making the European industry more competitive 

on the world market. 

Finally,  the Cqmmunity legislation will have an impact on trading relations with 

non-Community countries.  Once this proposed Directive has been adopted,  the 

Community  will be able to use it in its international negotiations to improve 

access for the European industry to markets in third countries. 

- 9-

Since 1991 the Commission has organized several meetings to consult experts 
from the Member States, the industry and users on the results of the 
comparative analysis of the legislative systems in a number of Member States 
and the evaluation of the need for harmonization of the legislation and the 
content thereof* The conclusions drawn confirmed  the Commission's view that, 
in view of the big differences  between the national systems, of the obstacles to 
free trade and of their negative impact on industrial activity on the European 
market, harmonization of the legislation is necessary and will provide added 
value, both for protecting health and for the activities of the European industry 
concerned.  In particular, all concerned have recognized the need for 
harmonization of the legislation.  The consultations also showed that, as far as 
possible, this harmonization  must complement and follow the same lines as the 
harmonization already completed for other medical devices. 

IV. 

JUSTIFICATION IN THE LIGHT OF THE SUBSIDIARITY PRINCIPLE 

1. 

What are the objectives of the proposed action in relation to the Community's 
obligations? 

As explained in Section III, the objective of this proposal for a Directive is: 

* 

* 

* 

to ensure free  movement of in vitro diagnostic medical devices by 
harmonizing the national legislation on protection of the health and  safety 
of patients, users and third parties; 

to complete the existing Community legislation provided by 
Directives 90/385/EEC and 93/42/EEC on medical devices and to apply the 
same principles to in vitro diagnostic devices; 

to create a favourable environment with uniform  conditions of competition 
to enable the industry to benefit  from  the scale of the European Economic 
Area and to help make European industry more competitive. 

-  10 -

2. 

Does competence for  the planned activity lie solely with the  Community? 

Exclusive competence, under Article  100a in conjunction  with Article 7a of the 
Treaty. 

What forms  of action are available to the  Community? 

In view of the objectives of removing the barriers created by the diverging 
regulatory  systems, of preventing new barriers and of establishing, a  uniform, 
stable and foreseeable legal framework  to protect the public interests concerned, 
the introduction of Community legislation is necessary.  It must cover the 
manufacturing  conditions,  the protection requirements imposed on the devices, 
the conformity  assessment procedures and the arrangements for  monitoring the 
market.  A Directive is the most appropriate instrument.  As far as possible, the 
Directive will have to follow  the principles already adopted for the rest of the 
industry  in Directives 90/385/EEC and 93/42/EEC. 

Is it necessary to have a uniform regulation or is a Directive setting out the 
general objectives sufficient,  leaving implementation at the level of the 
Member States ? 

A new approach Directive is proposed.  It is confined  to laying down the 
essential safety  and performance  requirements to be met by devices placed on 
the market and refers  to voluntary European standards to be established by the 
CEN/CENELEC  for technical formulation  of these requirements.  At the 
administrative level, implementation  is reserved for the Member States.  They 
will be responsible for  monitoring the market and cooperating with the 
authorities in the other Member States.  They will also appoint the certification 
bodies (notified  bodies), depending on the availability of suitably  qualified 
bodies, and monitor their activities. 

V. 

CONTENT OF THE PROPOSAL 

- 1 1-

1. 

Scope 

This proposal for a Directive governs the conditions for placing in vitro 
diagnostic medical devices on the market.  It lays down the essential 
requirements in terms of the reliability of the devices, bearing in mind their 
intended purpose as tools for diagnostics and medical monitoring, and in terms 
of protection of users and third parties.  The Directive also harmonizes the 
conformity  assessment procedures to be applied by manufacturers  before placing 
the devices on the market.  The CE marking must be affixed  to devices 
conforming  with the requirements, which will be allowed to move freely 
throughout the internal market. 

In vitro diagnostic medical devices are a subcategory of medical devices, as 
already defined  in Directive 93/42/EEC.  They are devices used in medicine for 
the in vitro analysis of specimens from  the human body.  The medical 
applications include analyses of state of health (cholesterol or pregnancy tests), 
of diseases or congenital abnormalities,  monitoring progress with a course of 
treatment (for example, dose and effect  of medicinal products) or the 
establishment of compatibility in cases of organ or blood donations (for 
example, HIV and hepatitis tests). 

The vast majority  of the products covered are intended for professional  users, 
i.e.  reagents, kits, instruments and equipment specifically  for  medical 
laboratories.  The Directive also includes devices for  self-testing  which are used 
by patients or consumers in the home environment,  for which it lays down 
special requirements to ensure that these devices can be easily used correctly by 
users with no particular knowledge of biological analysis. 

U 

- 1 2-

Control  material and calibrators intended for use in combination with the 

abovementioned reagents and equipment are also considered to be in vitro 

diagnostic devices. 

The Directive will cover laboratory equipment only where it is  Specifically 

intended for use in medical laboratories conducting in vitro examinations. 

The proposal  does not apply to devices,  in particular reagents,  manufactured  by 
laboratories  for their own needs without any transaction with other users.  It is 
left to the discretion of the Member States whether to require the appropriate 
monitoring  for such activities. 

2. 

Essential requirements 

Devices placed on the market must comply  with the essential  requirements  set 

out in Annex  1 to ensure a high level  of protection of health and safety.  They 

must be designed and manufactured  to achieve the performances  stated by the 

manufacturer and for use for the intended  medical purpose,  taking account of 
the generally  acknowledged  state of  the artvThe essential requirements are also 
designed  to protect users and third parties in particular against the risks posed 

by the physical and chemical properties of the devices and against the 

biological,  mechanical,  thermal,  electrical and radiation risks posed by any 

energy  source with which they are equipped.  Devices  for self-testing  must be 

designed  taking into account the skills and means available to users.  Particular 

* attention must be paid to the clarity of the information  and instructions 

accompanying  the devices. 

3. 

Conformity assessment procedures 

-  13 -

The conformity  assessment procedures are based on Council  Decision 
90/683/EEC,4 as amended by Council Decision 93/465/EEC.5 The proposal is 
aligned on the wording for these procedures in Directive 93/42/EEC,  taking 

account of the specific  nature of in vitro diagnostic medical devices and of 

manufacture thereof. 

(a) 

Devices placed on the market solely on the manufacturer's  responsibility 

For an extremely  large proportion of these devices,  Article 9 and Annex 
3 of the proposal provide for the design and manufacture  stages to be 
monitored on the manufacturer's  responsibility,  without the intervention 
of any third party.  In view of the requirements imposed in order to 
control production and obtain products of reliable quality,  manufacturers 
must follow  the principles of quality assurance as appropriate for the 
devices  manufactured.  In addition,  the technical documentation  provided 
by the manufacturer must contain,  inter alia,  proof of  the  manufacturer's 
evaluation of the performance. 

(b) 

Devices requiring the intervention of a notified  body 

Provision is made for the intervention of a notified  body before devices 

for self-testing  (Annex 3, point 6) and various categories of  devices 

specified  in Annex 2 are placed on the market. 

OJNoL380,  31.12.1990, p. 13. 
OJNo L 220, 30.8.1993, p. 23. 

14-

In the case of devices for self-testing,  the intervention of a notified  body 
is necessary as these devices are normally intended for persons with no 
experience of using them. For this reason, the notified  body must 
concentrate on verification  and on the performance of the devices under 
the conditions in which they would normally be used,  taking account of 
the intended users. 

For the categories specified  in Annex 2, i.e.  tests for blood grouping and 
for  the detection of HIV and hepatitis, Article 9 and Annexes 4, 5,  6 and 
7 provide for procedures requiring the intervention of a notified  body. 
The notified  bodies will certify  the design and manufacture of such 
devices. In accordance with Decision 90/683/EEC on the  certification 
modules,  manufacturers  may choose between product  certification 
(Annexes 5 and 6), evaluation of the full quality assurance system 
(Annex 4) or an approach combining a type examination  with a certified 
production quality assurance system (Annexes 5 and 7). 

These stringent procedures are-warranted by the fact that the tests in 
question are used particularly in the context of blood transfusions  or 
organ transplants. Consequently,  strict controls on these devices are 
essential to ensure reliable diagnosis. Moreover,  HIV tests are targeted 
on AIDS, which must be combated with the most appropriate,  effective 
means available in the interest of public health. 

-  15 -

(c) 

Classification  arid reclassification  of devices 

The proposal allows amendment of the list of devices in Annex 2, with 
the assistance of a regulatory committee (cf.  Article 12).  This 
reclassification  procedure could prove necessary, particularly where 
devices for new uses cannot provide sufficient  guarantees of the 
reliability of their performance.  In such cases, verification  by a third 
party could be necessary on health protection grounds. 

For this reason, depending on their intended medical use,  performance 
or characteristics, certain categories of device could, if necessary, be 
subjected  to the appropriate conformity  assessment procedures within the 
framework  of this proposal.  The rules on the conformity  assessment 
procedures are a balanced reflection  of the existing national legislation in 
this  field.  By reserving conformity  assessment for a large proportion of 
devices for the manufacturers,  the proposal takes account of the fact that 
these devices are intended for professional  users.  In addition, in most 
Member States-medical laboratories in turn are subject to outside quality 
assurance systems which will offer  added controls. 

Finally,  the proposal provides for  mechanisms to monitor the market, 
notably via vigilance procedures.  If application of these mechanisms 
indicates a need to tighten up the controls before certain devices are 
placed on the market, reclassification  may be decided following  the 
committee procedures. 

- 1 6-

4. 

Registration of manufacturers and vigilance procedure 

Article  10 of the proposal requires all manufacturers  to inform  the 
competent authorities of the Member State where they have their 
registered place of business of the categories of devices which they 
market.  Manufacturers  not established in the Community must designate 
an authorized representative to carry out the abovementioned 
notification.  Notification  is also required for new devices, as  specified 
in the proposal.  These rules enable the authorities to monitor the market 
and to take any measures necessary to protect the public interest.  A 
network linking the authorities will therefore  have to be established to 
make it easier to exchange data.  Just as for the other medical devices 
covered by Directives 90/385/EEC and 93/42/EEC, this proposal 
introduces a vigilance procedure (Article  11).  Under these rules, 
manufacturers  will have to give notification  of any malfunction  of the 
devices which could affect  patients' and users' health.  The objective of 
this vigilance system is to prevent devices from  remaining in circulation 
on the Community market if they display faults which could lead to the 
wrong medical decisions.  This system reinforces  the monitoring 
methods at the disposal of the competent authorities and encourages 
manufacturers  to conduct the requisite investigations and make the 
necessary corrections to the devices concerned.  Close cooperation 
between the national administrations will be essential in this system. 

Special arrangements for  devices for performance evaluation 

Article 9(3) of the proposal makes special arrangements for in vitro 
diagnostic medical devices for performance evaluation.  These apply to 

17-

devices intended  for medical  use of which the precise performance  has 

yet to be verified  and confirmed.  In view of the objective of the 

evaluations,  there is no need for such devices to comply with all the 

essential requirements.  The status of these devices must be indicated on 

the label and the manufacturer must follow  a special  conformity 

procedure. 

Amendments to Directive  93/42/EEC  concerning medical  devices 

These amendments (Article  19(1)) concern the definition  of  "in vitro 

diagnostic  medical device" in Directive 93/42/EEC.  They would also 

extend the scope of Directive 93/42/EEC by adding devices 
incorporating  tissues of human origin.  At the time of the adoption of the 

Directive concerning  medical devices,  the Council asked the 

Commission  to reexamine the situation with these devices and to propose 

the measures to be taken.  Preparatory  work on this subject has revealed 

that,  at national level,  either there is no legal cover for such devices or 

that they are governed by diverging classifications  which could impair 

free movement.  In view of the current legal uncertainty and of the 

inherent health hazards posed by these devices,  the majority of the 

national experts recognize the need to make such devices subject to 

Directive 93/42/EEC.  However,  Directive 93/42/EEC  will apply only 

to devices incorporating  tissues which have been rendered non viable. 

The proposal will apply without prejudice to the national regulations 

relating  to the ethics of collecting and using tissues of human origin, 

thereby taking account of the concerns expressed during the consultation 

phase. 

- 1 8-

Similar problems with the inclusion of devices incorporating  tissues of 
human origin also arise in the case of in vitro diagnostic devices 
(including in the form of control materials in kits).  Consequently,  the 
proposed amendment to Directive 93/42/EEC will result in uniform  rules 
for the entire sector. 

VI.  RELEVANCE TO THE EUROPEAN ECONOMIC AREA 

This proposal falls into the field covered by the Agreement on the European 
Economic Area.  The consultations included experts from  the EFTA countries 
in the EEA.  The proposal for a decision by the EEA Joint Committee 
extending the proposal for a Directive to the EEA is included in this dossier. 

12 

PROPOSAL FOR A DIRECTIVE OF THE EUROPEAN PARLIAMENT 
AND THE COUNCIL 

ON IN VITRO DIAGNOSTIC MEDICAL DEVICES 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

-2 

Having  regard  to  the  Treaty  establishing  the  European  Community, 
and in particular Article 100a thereof, 

Having regard to the proposal from the Commission1, 

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

Acting  in  accordance  with  the  procedure  referred  to  in  Article 
189B of the Treaty establishing the^. European Community, 

Whereas  measures  should  be  adopted  for  the  progressive 
establishment  of  the  internal market; whereas  the  internal market 
is  an  area  without  internal  frontiers  in which  the  free movement 
of goods, persons, services and capital is ensured; 

Whereas  the  content  and  scope  of  the  laws,  regulations  and 
administrative  provisions  in  force  in  the  Member  States  with 
regard  to  the  safety,  health  protection  and  performance 
characteristics  and  authorization  procedures  for  in  vitro 
diagnostic medical devices are different; whereas  the existence of 
such  disparities  constitute  barriers  to  trade  and  the  need  to 
establish  harmonised  rules  was  confirmed  by  a  comparative  survey 
of national legislations carried out on behalf of the Commission; 

Whereas  the  harmonization  of  national  legislations  is  the  only 
means of removing  these barriers  to  free trade  and preventing  new 
barriers;  whereas " this  objective  cannot  be  achieved  in  a 
satisfactory  manner  at  another  level  by  the  individual  Member 
States;  whereas  this  Directive  only  lays  down  necessary  and 
sufficient  requirements  for  the  free  circulation  of  the  in vitro 
diagnostic medical devices to which it is applicable; 

tl\e  harmonized  provisions  must  be  distinguished  from  the 
Whereas 
measures  adopted  by  the 'Member  States  to  manage  the  funding  of 
public health  and  sickness  insurance  schemes  relating  directly  or 
indirectly  to  such devices; whereas, therefore,  the provisions  do 
not  affect  the  ability  of  the  Member  States  to  implement  the 
abovementioned measures provided Community law is complied with; 

Whereas  in  vitro  diagnostic  medical  devices  should  provide 
patients, users  and third parties with  a high  level of protection 
and  attain  the  performance  levels  attributed  to  them  by  the 
manufacturer;  whereas,' /therefore,  the  maintenance  or  improvement 
of the level of protection attained in the Member States is one of 
the essential objectives of this Directive; 

-4-

Whereas,  in  accordance  with  the  principles  set  out  in  the  Council 

resolution  of  7  May  1985  concerning  a  new  approach  to  technical 
harmonization  and  standardization3,  rules  regarding  the  design  and 

manufacture  of  relevant  products  must  be  confined  to  the 

provisions  required  to  meet  the  essential  requirements;  whereas, 

because  they  are  essential,  such  requirements  should  replace  the 

corresponding 

national 

provisions; 

whereas 

the 

essential 

requirements,  including  requirements  to  minimize  and  reduce  risks, 

should  be  applied  with  discretion,  taking  into  account  the 

technology  and  practice  at  the  time  of  design  and  of'technical  and 

economic  considerations  compatible  with  a  high  level  of  protection 

of  health  and  safety; 

Whereas  the  major  part  of  medical  devices  are  covered  by  Council 

90/385/EEC  relating  to  active 

medical 
Directive 
devices4  and  Council  Directive  93/42/EEC  relating  to  all  other 
medical  devices-"1  with  the  exclusion  of  in  vitro  diagnostic  medical 

implantable 

devices;  the  present  Directive  shall  extend  the  harmonization  to 

in  vitro  diagnostic  medical  devices;  whereas,  in  the  interest  of 

uniform  Community  rules,  this  Directive  is  based  largely  on  the 

provisions  of  Directives  90/385/EEC  and  93/42/EEC; 

Whereas  certified  international  reference  materials  and  materials 

used  for  external  quality  assessment  schemes  are  not  covered  by 

this  Directive,  calibrators  and  control  materials  needed  by  the 

user  to  establish  or  verify  performances  of  devices  are  in  vitro 

diagnostic  medical  devices; 

OJNo.C 136.4.6.1985. p. I 

OJ NoL 189. 20.7.1990. p. I 7 

OJNo. L 169, 12.7.1993. p. 1 

D -

Whereas  reagents  produced  within  user  laboratories  and  which  are 
not  subject  to  commercial  transactions,  taking  account  of  the 
principle of subsidiarity, are not included in this Directive; 

Whereas the electromagnetic  compatibility  aspects  form an integral 
part of.the essential  requirements  of  this- Directive,  the Council 
Directive* 89/336/EEC  of  3  May  1989  relating  to  electromagnetic 
compatibility  6 shall not apply; 

Whereas,  in order  to ease the task of proving  conformity  with the 
essential requirements  and to enable conformity to be verified, it 
is  desirable  to  have  harmonized  standards  in  respect  of  the 
prevention  of  risks  associated  with  the  design,  manufacture  and 
packaging  of  medical  devices;  whereas  such  harmonized  standards 
are drawn up by private-law  bodies  and  should  retain  their  status 
as  non-mandatory  texts;  whereas,  to  this  end,  the  European 
Committee  for Standardization  (CEN) anpl the European Committee for 
Electrotechnical  Standardization  (CENELEC)  are  recognized  as  the 
competent  bodies  for  the  adoption  of  harmonized  standards  in 
accordance, with  the  general  guidelines  on cooperation between  the 
Commission and these two bodies signed on 13 November 1984; 

Whereas,  for  the purpose  of  this Directive,  a harmonized  standard 
is  a  technical  specification  (European  standard  or  Harmonization 
Document)  adopted,  on a mandate  from  the Commission, by  either or 
both  .of  these  bodies  in  accordance  with  Council ^ Directive 
83/189/EEC  of  28  March  1983  laying  down  a  procedure  for  the 
provision  of  information  in  the  field  of  technical  standards  and 
regulations7,  and  pursuant  to  the  abovementioned  general 
guidelines; 

6 

7 

OJ  No.  L  139,  23.5.1989.  p.  19.  Directive  last  amended  by  Directive  93/68/EEC  (OJ  No.  L  220, 
30.8.1993, p.  1) 

OJ  No.  L  109,  26.4.1983,  p.  8.  Directive  last  amended  by  Directive  94/10/EC  of  the  European 
Parliament and the Council  (OJ No.  L  100,  19.4.1994. p. 30) 

which 

Whereas,  in- Decision  90/683/EEC of 13 December  1990 concerning the 
modules  for  the  various  phases  of  the  conformity  assessment 
procedures 
are  intended  to  be  used  in  the  technical 
harmonization  directives8,  the  Council  has  laid  down  harmonized 
conformity  assessment  procedures;  whereas  the  details  added  to 
these  modules  are  justified  by  the  nature  of  the  verification 
required  for  in vitro  diagnostic  medical  devices  and  by  the need 
for consistency with the previous directives on medical devices; 

Whereas  it  is  necessary,  essentially  v for  the  purpose  of  the 
conformity  assessment  procedures,  to  group  in  vitro  diagnostid. 
medical devices  into two product classes; whereas, since the large 
majority  of  such  devices  do  not  constitute  a  direct  risk  to 
patients  and  are  used  by  competently  trained  professionals,  and 
the  results  obtained  can  often  be  confirmed  by  other  means,  the 
conformity  assessment  procedures  can be  carried  out, as a general, 
rule,  under  the  sole  responsibility  of  the manufacturer; whereas, 
taking  account  of  existing  national  regulations  and  of 
notifications  received  following  the  procedure  of  Directive 
83/189/EEC, the intervention of->•• natifled bodies is needed only for 
defined  devices,, t'he correct performance  of which  is essential to 
medical practice and the failure of which can cause a serious risk 
to health; 

OJ No.  L 380,  31.12.1990,  p.  13, as  last amended  by Decision  93/465/EEC,  OJ No.  L 220,  30.8.1993, 
p. 23 

- 7 -

Whereas  the  list  of  in  vitro  diagnostic  medical  devices  to  be 

subjected  to  third  party  conformity  assessment  needs  updating,, 

taking  account  of  technological  progress  and  of  evolution  in  the 

domain  of  protection  of  health;  whereas  such  updating  measures 

must  be  taken  in  line  with  the procedure  Ilia  as  laid  down  in  the 
Council  Decision  87/373/EEC9;  whereas  a  system  of  adverse  incident 
for  the 
(vigilance)  constitutes  a  useful  tool 
reporting 

surveillance  of  the  market,  including  the  performance  of  new 

devices;  whereas  information  obtained  from  vigilance  as  Well  as 

from  external  quality  assessment  schemes  becomes  useful  for 

decision-making  on classification of devices; 

Whereas  medical  devices  should,  as  a  general  rule,  bear  the  CE 

marking  to  indicate  their  conformity  with  the  provisions  of  this 

Directive  to  enable  them  to  move  freely  within  the  Community  and 

to be put  into  service  in accordance with their  intended purpose; 

Whereas  manufacturers  shall  have  the  possibility,  when  the 

intervention  of  a  notified  body  is  required,  to  choose  amongst 

those  bodies  published  by  the  Commission;  whereas  the  Member 

States  do'  not  have  an  obligation  to  designate  such  notified 

bodies,  they  must  ensure  however  that  bodies  designated  as 

notified  bodies  comply  with  the  assessment  criteria  laid  down  in 

this directive; 

Whereas  the  competent  authorities  in  charge  of market  surveillance 

must  be  able,  particularly  in  emergencies,  to  contact  the 

manufacturer  or  his  authorized  representative  established  in  the 

Community;  whereas  cooperation  and  exchange  of  information  between 

Member  States  are  necessary  in view  of  uniform  application  of  this 

Directive,  in particular  for the purpose of market  surveillance; 

OJno. L 197. 18.7.1987. o. 23 

-8-

Whereas  this  Directive  includes  •in  vitro  diagnostic  medical 
devices  incorporating  substances  derived  from  the  human  body,  it 
does not affect national regulations relating to the ethics of use 
of such substances; whereas for the purpose of overall  consistency 
between medical  devices  directives, the  Directive  93/42/EEC  needs 
to be amended accordingly;' 

HAVE ADOPTED THIS DIRECTIVE : 

Article 1 

Scope, Definitions 

This  Directive  shall  apply  to  in  vitro  diagnostic  medical 
devices  and  their  accessories.  For  the  purposes  of  this 
Directive,  accessories  shall  be  treated  as  in  vitro 
diagnostic medical devices  in their own right. Both  in vitro 
diagnostic  medical  devices  and  accessories  shall  hereinafter 
be termed devices. 

For  the purpose  of  this Directive, the  following  definitions 
shall apply : 

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

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

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

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

control of conception 

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

(b)  "in  vitro  diagnostic  medical  device"  means  any  medical 

-10-

device  which  is  a  reagent,  reagent  product,  calibrator, 

control  material,  kit,  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  state,  state  of  health  or 

disease  or  congenital  abnormality  or  to  determine  the 

safety  and  compatibility  with  potential  recipients. 

For  the  purpose  of  this  directive,  a  specimen  receptacle, 

whether  evacuated  or  not,  specifically  intended  by  its 

manufacturer  to  contain  a  specimen  for  the  purpose  of  in 

vitro  diagnostic  examination  is  considered  to  be  a 

device; 

Products  for  general  laboratory  use  are  not  devices 

unless  such  products,  in  view  of  their  characteristics, 

are  specifically  'intended  by  their  manufacturer  to  be 

used  for  in vitro  diagnostic  examination; 

(c)  "accessory"  means  an  article  which,  whilst  not  being  a 

device  in  the  meaning  of  paragraph  2 ( b ),  is  intended 

specifically  by  its  manufacturer  to  be  used  together 

with  a  device  to  enable  this  device  to  be  used  in 

accordance  with  its  intended  purpose; 

(d)  "Device  for  self-testing"  means  any  device  intended  by 

the  manufacturer  to be  used  in  the  home  environment; 

-li 

fe)  "Device  for  performance  evaluation"  means  any  device 

intended  by  the  manufacturer  to  be  subject  to  one  or 

more  performance  evaluation  studies  in  clinical 

laboratories  or  in  * other  appropriate  environments 

outside his own premises; 

(f)  "manufacturer"  means  the  natural. or  legal  person  with 
responsibility  for  the  design,  manufacture,  packaging 
and  labelling  of  a  device  before  it  is  placed  on  the 
market  under  his  own  name,  regardless  of  whether  these 
operations  are carried  out by thafr person himself  or on 
his behalf by a third party. 

The  obligations  of  this  Directive  to  be  met  by 
manufacturers  also  apply  to the natural  or  legal person 
who  assembles,  packages,  processes,  fully  refurbishes 
and/or  labels  one  or  more  ready-made  products . and/or 
assigns to them their intended purpose as devices with a 
view  to  their being  placed  on  the market, under  his  own 
namej 

(g)  "authorized  representative"  means  the  natural . or  legal 

person  established  within  the  Community  who,  being 
explicitely designated by the manufacturer, acts and may 
be  addressed by authorities  and bodies  in  the  Community 
in substitution  for the manufacturer, with  regard  to the 
latter's obligations in accordance with this Directive. 

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

-12-

(i) 

"placing  on  the market" means  the  first  making  available 

in  return  for payment  or  free  of  charge  of  a device  with 

a  view  to  distribution  and/or  use  on  the  Community 

market,  regardless  of  whether  it  is  new  or  fully 

refurbished; 

(j) 

"putting  into  service" means  the  stage  at  which  a device 

is  ready  for  use  on  the  Community  market  for  the  first 

time  for its intended purpose; 

(k) 

"calibrator",  "control  material"  mean  any  substance, 
material  or  article  intended , by  its  manufacturer  to 
establish  and/or  verify  performance  characteristics  of a 
device  in conjunction with the use of" that device; 

Where  à  device  incorporates  tissues  or  substances  of  human 
origin,  this  directive  shall  not  affect  national  regulations 
relating  to  the  ethics  of  the  collection  of  tissues  or 
as  well  as  any  regulations 
substances  of  human  origin 
relating  to  the  ethics  governing  distribution  of  given  types 
of devices  of such origin. 

-13-

4.  This  Directive  shall  not  apply  to  devices  manufactured  and 
used only within  the  same  institution  and on the premises of 
their manufacture.  This does not^affect  the  right  of Member 
States  to  subject  such  activities  to  appropriate  protection 
requirements. 

5.  This Directive  is a specific  directive  within  the meaning  of 

Article 2(2) of the Directive 89/336/EEC10.. 

. Article 2 

Placing on the market and putting into service 

Member  States  shall  take  all  necessary  steps  to  ensure  that 
devices may be placed  on the market and put  into service only 
if  they  comply  with  the  requirements  laid  down  in  this 
Directive  when  properly  installed,  maintained  and  used  in 
accordance with their intended purpose. 

Article 3 

Essential requirements 

Devices must meet the essential  requirements  set out  in Annex 
1 which apply to them, taking account of the intended purpose 
of the devices concerned. 

10 

Council  Directive  89/336/EEC  relates to electromagnetic  compatibility.  OJ No. L  J39,  23.5.1989,  p.  19; 
as last amended  by Directive  9 3/  68 /EEC 

(OJ  no  L  2 2 0,  3 0 . 8 . 1 9 9 3,  p.  1) 

i 

\ 

-14-

Article 4 

Free movement 

Member States shall not create any obstacle to the placing on 
the market or the putting into service within their territory 
of devices bearing  the CE-marking provided  for  in article  14 
or  labelled  as  devices  for  performance  evaluation  if  these 
devices  have  been  the  subject  of  an  assessment  of  their 
conformity in accordance with the provisions of article 9. 

2.  At  trade  fairs,  exhibitions,  demonstrations,  Member  States 
shall not create any obstacle to the showing of devices which 
do  not  conform  to  this  Directive,  provided  that  a  visible 
sign  clearly  indicates  that  such  devices  cannot  be  marketed 
or put into -service until they have been made to comply. 

3.  Member  States  may  require,  when  a  device  reaches  the  final 
user, information, as referred  to in Annex  1 point  13,  to be 
in  their  national  language(s)  or  in  other  Community 
language (s)  to  the  extent  that  it  is  needed  for  safe  and 
correct  use  of  the  device.  In  the  application  of  this 
provision Member States shall take into account  the principle 
of proportionality  and  in particular  whether  information  can 
be  provided  by  recognised  symbols  or  codes  and  whether  the 
device is intended for use by trained professionals. 

-15-

4.  Where  the devices  are  subject  to other  Directives  concerning 
other aspects and which also provide  for the  affixing  of the 
CE marking,  the  latter  shall  indicate  that  the  devices  also 
fulfil the provisions of the other Directives. 
However,  should  one  or  more  of  these  directives  allow  the 
manufacturer,  during  a» transitional  period,  to  choose  which 
arrangements to apply, the CE marking shall indicate that the 
devices  fulfil  the  provisions  only  of  those  directives 
applied by the manufacturer. In this case, the particulars of 
these directives, as published in the Official  Journal of the 
European Communities, must be given in the documents, notices 
or  instructions  required  by  the  directives  and  accompanying 
such devices. 

Article 5 

Reference to standards 

I9  Member  States .shall  presume  compliance  with  the  essential 
requirements  referred  to  in Article  3  in  respect  of  devices 
which  are  in conformity with  the relevant  national  standards 
which  transpose  the  harmonized  standards  the  reference  of 
which  have  been  published  in  the  Official  Journal  of  the 
European  Communities;  Member  States  shall  publish  the 
references of such national- standards 

/If  the  Member  State  or  the  Commission  considers  that  the 
harmonized  standards  do  not  entirely^  meet  the  essential 
requirements  referred  to  in  Article  3,  the  measures  to  be 
taken  with  regard  to  these  standards  and  the  publication 
referred  to  in paragraph  1 of  this Article  shall  be  adopted 
by the procedure defined in Article 6(2) 

• - 16-

Article 6 

Committee  on Standards  and Technical  Regulations 

1. 

The  Commission  shall  be  assisted  by  the  Committee  set  up  by 

Article  5 of Directive  83/189/EEC. 

The  representative  of  the  Commission  shall  submit  to  the 
Committee  a draft  of  the measures  to be  taken.  The  Committee 
shall  deliver  its  opinion  on  the  draft  within  a  time  limit 
which  the  chairman  may  lay  down  according  to  the  urgency  of 
the matter,  if necessary by taking  a vote. 

The  opinion  shall  be  recorded  in  the  minutes;  in  addition, 
each  Member  State  shall  have  the  right  to  ask  to  have  its 
position  recorded  in the minutes. 

The  Commission  shall  take  the  utmost  account  of  the  opinion 
delivered  by  the  Committee.  It  shall  inform  the  Committee  of 
the manner  in which  its opinion has been taken  into  account. 

Article 7 

Committee  on Medical  Devices 

The  Commission  shall  be  assisted  by  the  Committee  set  up  by 
Article  6(2) of Directive  90/385/EEC. 

Ziv 

-17-

The  representative  of  the  Commission  shall  submit  to  the 

Committee  a  draft  of  the  measures  to  be  taken.  The  Committee 

shall  deliver  its  opinion  on  the  draft  within  a  time  limit 

which  the  chairman  may  lay  down  according  to  the  urgency  of 

the  matter.  The  opinion  shall  be  delivered  by  the  majority 

laid  down  in  Article  148(2)  of  the  Treaty  in  the  case  of 

decisions  which  the  Council  is  required  to  adopt  on  a 

proposal 

from 

the 

Commission. 

The 

votes 

of 

the 

representatives  of  the  Member  States  within  the  Committee 

shall  be  weighted  in  the manner  set  out  in  that- Article.  The 

chairman  shall not vote. 

The  Commission  shall  adopt  the measures  envisaged  if  they  are 
in accordance with  the opinion of the Committee. 

If  the  measures  envisaged  are  not  in  accordance  with  the 
opinion  of  the  Committee,  or  if  no  opinion  is  delivered,  the 
Commission  shall,  without  delay,  submit  to  the  Council  a 
proposal  relating  to  the  measures  to  be  taken.  The  Council 
shall act by a qualified majority. 

If, on the expiry of a period  of three months  from the date of 

referai  to  the  Council,  the  Council  has  not  acted,  the 

proposed measures  shall be adopted by  the  Commission 

The  Committee  referred  to  in  paragraph  1  may  examine  any 
'question connected with  the implementation of  this Directive. 

-18-

Article  8 

Safeguard  clause 

Where  a  Member  State  ascertains  that  the  devices  referred  to 

in  Article  4 ( 1 ),  when  correctly  installed,  maintained  and 

used  for  their  intended  purpose  may  compromise  the  health 

and/or  safety  of  patients,  users  or,  where  applicable,  other 

persons,  and  the  safety  of  property,  it  shall  take  all 

appropriate  interim  measures  to  withdraw  such  devices  from 

the  market  or  prohibit  or  restrict  their  being  placed  on  the 

market 

or  put 

into 

service.  The  Member 

State 

shall 

immediately  inform  the  Commission  of  any  such  measures, 

indicating  the  reasons  for  its  decision  and,  in  particular, 

whether  non-compliance  with  this  Directive  is  due  to: 

(a)  failure  to  meet  the  essential  requirements  referred  to 

in Article  3; 

(b)  incorrect  application  of  the  standards  referred  to  in 

Article  5,  in  so  far  as  it  is  claimed  that  the  standards 

have  been  applied; 

(c)  shortcomings  in  the  standards  themselves. 

2. 

The  Commission  shall  enter  into  consultation  with  the  parties 

concerned 

as 

soon 

as  possible. 

Where, 

after 

such 

consultation,  the  Commission  finds  that: 

-19-

the measures are justified,  it shall immediately  so inform 
the Member  State  which  took  the  initiative  and  the  other 
Member  States;  where  the  decision  referred  to  in 
paragraph 1 is attributed to shortcomings in the standards, 
the  Commission  shall,  after  consulting  the  parties 
concerned,  bring  the matter  before  the  committee  referred 
to  in "Article '6 (1) within  two months  if  the Member  State 
which  has  taken  the  decision  intends  to  maintain  it  and 
shall initiate the procedures referred to in Article 6; 

the  measures  are  unjustified,  it  shall  immediately  so 
inform the Member  State which  took  the  initiative  and the 
manufacturer  or  his  authorized  representative  established 
within the Community. 

3.  Where  a  non-complying  device  bears  the  CE  marking,  the 
competent  Member  State  shall  take  appropriate  action  against 
whomsoever  has  affixed  the  marking  and  shall  inform  the 
Commission and the-other Member States thereof. 

4.  The  Commission  shall  ensure  that  the Member  States  are  kept 

informed of the progress and outcome of this procedure. 

Article 9 

Conformity assessment procedures 

1.  For  all  devices  other  than  those  covered  by  Annex  2  and 
devices  for  performance  evaluation,  the  manufacturer  shall, 
in  order  to  affix  the  CE  marking,  follow  the  procedure 
referred  to  in  Annex  3  and  draw  up  the  EC  declaration  of 
conformity required before placing the' devices on the market. 

-20-

For  all  devices  for  self-testing  the  manufacturer  shall, 

prior  to  the  drawing  up  of  the .aforementioned  declaration  of 

conformity,  fulfil  the  supplementary  requirements  set  out  in 

Annex  3  point  6.  Instead  of  applying  this  procedure,  the 

manufacturer  may  also  follow  the  procedure  referred  to  in 

paragraph  2. 

2. 

For  all  devices  covered  by  Annex  2  other  than  those  intended 

for  performance  evaluation,  the  manufacturer  shall,  in  order 

to affix  the CE-marking  either : 

;a)  follow  the  procedure  relating" to  the  EC  declaration  of 

conformity  set  out  in  Annex  4  (full  quality  assurance) 

or 

;b)  follow  the procedure  relating  to  EC  type  examination  set 

out  in Annex  5 coupled with : 

(i)  the  procedure  relating  to  EC  verification  set  out 

in Annex  6, or 

(ii)  the  procedure  relating  to  the  EC  declaration  of 

conformity  set  out  in  Annex  7  (production  quality 

assurance) 

In  the  case  of  devices  for  performance  evaluation,  the 
manufacturer  shall  follow  the  procedure  referred  to  in  Annex 
8  and  draw  up  the  statement  set  out  in  that  Annex  before 
placing  such devices on the market. 

-21-

During  the  conformity  assessment  procedure  for  a device, the 
manufacturer  and,  if  involved,  the  notified  body  shall  take 
account  of  the  results  of  any  assessment  and' verification 
operations which, where appropriate, have been carried out in 
accordance  with  this  Directive  at  an  intermediate  stage  of 
manufacture. 

5.  The  manufacturer  may  instruct  his  authorized  representative 
established  in  the  Community  to  initiate  the  procedures 
provided for in Annexes 3, 5, 6 and 8. 

6.  The manufacturer must keep the declaration of conformity, the 
technical  documentation  referred  to  in  Annexes  3  to  8,  as 
well  as  the  decisions,  reports  and  certificates  established 
by-notified  bodies,  and  make  it  available  to  the  national 
authorities  for  inspection purposes  for  a period  ending five 
years  after  the  last  product  has. been  manufactured.  Where 
the  manufacturer  is  not  established  in  the  Community,  the 
obligation to make  the aforementioned  documentation  available 
on  request  applies  to  his  authorized  representative 
established within the Community. 

7.  Where  the  conformity  assessment  procedure  involves  the 
intervention  of  a  notified  body,  the  manufacturer,  or  his 
authorized  representative  established  in  the  Community,  may 
apply  to  a  body  of  his  choice  within  the  framework  of  the 
tasks for which the body has been notified. 

-22-

8.  The  notified  body  may  require,  where  duly  justified,  any 
information  or  data, which  is necessary  for  establishing  and 
maintaining  the  attestation  of  conformity  in  view  of  the 
chosen procedure. 

9.  Decisions  taken  by  the  notified  bodies  in  accordance  with 
Annexes 3, 4 and 5 shall be valid for a maximum of five years 
and may be extended on application, made at a t.ime agreed in 
the  contract  signed  by  both  parties,  for  further  periods  of 

V 

five years. 

10.  The  records  and  correspondence  relating  to  the  procedures 
referred  to  in  paragraphs  1  to  3  shall  be  in  one  of  the 
official  languages  of the European Community  and  in the case 
of  involvement  of  a  notified  body  in  a  Community  language 
acceptable to the notified body. 

11.  By  derogation  from  paragraphs  1  to  3,  the  competent 
authorities  may  authorize, "on  duly  justified  request,  the 
placing  on  the  market  and  putting  into  service,  within  the 
territory  of  the  Member  State  concerned,  of  individual 
devices  for which  the procedures  referred  to  in paragraphs 1 
to 3 have not been carried out and the use of which is in the 
interest of protection of health. 

- 23 -

Article  10 

Registration  of  manufacturers 

Any  manufacturer,  who  places  devices  on  the  market  under  his 

own  name,  shall  notify  the  competent  authorities  of  the 

Member  State  in  which  he  has  his  registered  place  of  business 

of  the  address  of  the  registered  place  of  business,  the 

categories  of  devices  as  defined  in  terms  of 

common 

characteristics  of  technology  and/or  analytes • and  of  any 

significant  change  thereto.  The  before  mentioned  notification 

shall  also  include  any  new  device  as  referred  to  in  Article 

11(4). 

2. 

Where  a  manufacturer,  who  places  devices  'on  the  market  under 

his  own  name,  does  not  have  a  registered  place  of  business  in 

a 

Member 

State, 

he 

shall 

designate 

an 

authorized 

representative  established  in  the  Community.  The  authorized 

representative  shall  inform  the  competent  authorities  of  the 

Member  State,  in  which  he  has-  his  registered  place  of 

business,  of  all  particulars as  referred  to  in  paragraph  1. 

3. 

The  Member  States  shall  on  request  inform  the  other  Member 

States  and  the  Commission  of  the  details  referred  to  in 

paragraphs  1  and  2.  The  procedures  implementing  the  present 

Article 

shall  be  adopted  in  accordance  with  the  procedure 

referred  to  in Article 7 ( 2 ). 

-24-

Article  11 

Vigilance 

Member  States  shall  take  the  necessary  steps  to  ensure  that 

any  information  brought  to  their  knowledge,  in  accordance 

with  the  provisions  of  this  Directive,  regarding  the 

incidents  mentioned  below  involving  devices  bearing  CE 

marking  is recorded  and evaluated  centrally : 

(a)  any  malfunction, 

failure  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,  directly  or  indirectly,  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. 

2. 

Where  a  Member  State  requires  medical  practitioners,  the 

medical  institutions  or  the  organizers  of  external  quality 

assessment  schemes  to  inform  the  competent  authorities  of any 

incidents  referred  to  in  paragraph  1,  it  shall  take  the 

necessary  steps  to  ensure  that  the manufacturer  of  the  device 

concerned,  or  his  authorized  representative  established  in 

the  Community,  is also  informed  of the  incident. 

-25-

3. 

After  carrying  out  an  assessment,  if  possible  together  with 

the  manufacturer/  Member  States  shall,  without  prejudice  to 

Article  8,  immediately  inform  the  Commission  and  the  other 

Member  States  of  the  incidents  referred  to  in  paragraph  1  for 

which  relevant  measures  have  been  taken  or  are  contemplated. 

4. 

Where,  in  the  context  of  notification  referred  to  in  Article 

1.0,  a  device  notified,  bearing  a  CE  marking,  is  a  "new" 

product,  the  manufacturer 'shall  indicate  this  fact  on  his 

notification.  The  competent  authority  so  notified  may  at  any 

time  within  the  following  two  years  and  on  justified  grounds, 

require  the  manufacturer  to  submit  a  report  relating  to  the 

experience  with  the  device  subsequent  to  its  being  placed  on 

the  market.  For  this  purpose,  a  device  is  "new"  if  : 

(a)  such  a  device,  for  the  relevant  analyte  or  other 

parameter,  has  not  been  continuously  available  on  the 

Community  market  during  the  previous  three  years, 

(b)  the  procedure  involves  analytical  technology  not  used  in 

connection, with  a  given  analyte  or  other  parameter  on 

the  Community  market  continuously  during  the  previous 

three  years. 

5. 

The  Member  States  shall  on  request  inform  the  other  Member 

States  of  the  details  referred  to  in  paragraphs  1  and  4.  The 

procedures  implementing  the  present  Article  shall  be  adopted 

in  accordance  with  the  procedure  referred  to  in Article 7 ( 2 ). 

-26-

Article. 12 

Modification  of Annex  2,  derogation  clause 

1. 

Where  a Member  State  considers  that  : 

(a)  the  list  of  devices  covered  by  Annex  2  should  be 

modified  or  extended,  or 

(b)  the  conformity  of  a  device  or  a  category  of  devices 

should  be  established  by  way  of  derogation  from  the 

provisions  of  Article  9,  by  applying  one  or  several 

alternative  given  procedures  taken  from  amongst  those 

referred  to  in Article  9, 

it  shall  submit  a  duly  substantiated 

request 

to-  the 

Commission  and  ask  it  to  take  the  necessary  measures.  The 

measures  shall  be  adopted  in  accordance  with  Article 7 ( 2 ). 

2. 

When  a  measure  is  to  be  taken  in  accordance  with  paragraph  1, 

due  consideration  shall  be  given  : 

(a)  to  any  relevant  information  available  from  the  vigilance 

procedures  and  from  external  quality  assessment  schemes 

as  referred  to  in Article  11 

(b)  to  the  following  criteria 

(i)  whether  total  reliance  has  to  be  put  on  the  result 

obtained  with  a  given  device,  having  a  direct 

impact  on  the  subsequent  medical  action,  and 

- 27 -

ii)  whether  an  action  taken  on  the  basis  of  an 

incorrect  result  obtained  using  a  given  device 

could  prove  to  be  hazardous  to  the  patient  or  third 

party  as  a  consequence  of  false  positive  or  false 

negative  results,  and 

;iii) whether  the  involvement  of  a  notified  body  is 

appropriate  and  justified. 

3. 

The  Commission  shall  inform  the  Member  States  of. the  measures 

taken  and,  where  appropriate,  publish  these  measures  in  the 

Official  Journal  of  the  European  Communities. 

Article  13 

Notified  bodies 

Member  States  shall  notify  the  Commission  and  other  Member 

States  of  the  bodies  which  they  have  designated  for  carrying 

out  the  tasks  pertaining  to  the  procedures  referred  to  in 

Article  9  and  the  specific  tasks  for  which  the  bodies  have 

been  designated.  The  Commission  shall  assign  identification 

numbers  to  these  bodies,  hereinafter  referred  to  as  "notified 

bodies". 

-28-

The  Commission  shall  publish  a  list  of  the  notified  bodies, 

together  with  the  identification  numbers  it  has  allocated  to 

them  and  the  tasks  for  which  they  have  been  notified,  in  the 

Official  Journal  of  the European  Communities.  It  shall  ensure 

that  the  list  is kept up to date. 

2. 

Member  States  shall  apply  the  criteria  set  out  in Annex  9 for 
the  designation  of bodies. Bodies  that meet  the  criteria  laid 
down  in  the  national  standards  which  transpose  the  relevant 
harmonised  standards  shall  be  presumed  to  meet  the  relevant 
criteria. 

A  Member  State  that  has  notified  a  body  shall  withdraw  that 
notification  if  it  finds  that  the  body  no  longer  meets  the 
criteria  referred  to  in  paragraph  2.  It  shall  immediately 
inform  the  other  Member  States  and  the  Commission  of  any 
withdrawal  of  notification  for  the  aforementioned  or  any 
other  reason. 

The  notified  body  and  the  manufacturer,  or  its  authorized 
representative  established  in  the  Community,  shall  lay  down, 
by  common  accord,  the  time  limits  for  completion  of  the 
assessment  and  verification  operations  referred  to  in  Annexes 
3  to 7. 

5. 

The  notified  body  must  make  available  to  the  other  notified 

bodies  and  the  competent  authority,  on  request,  all  relevant 

information  concerning  approvals  and  certificates  issued, 

refused  or withdrawn. 

-29-

Article 14 

CE-marking 

1.  Devices,  other  than  devices  for  performance  evaluation, 
considered  to meet  the essential  requirements  referred  to in 
Article  3 must  bear  the  CE  marking  of  conformity  when  they 
are placed on the market. 

2: 

The  CE-marking  of ^conformity,  as  shown  in  Annex  10,  must 
appear  in  a  visible,  legible  and  indelible  form  on  the 
device,  where  practicable  and  appropriate,  and  on  the 
instructions,  for  use.  Where  applicable  the  CE "marking  of 
conformity  must  also  appear  on  the  sales  packaging.  The  CE 
marking  shall be  accompanied  by  the  identification number of 
the  notified  body  responsible  for  implementation  of  the 
procedures set out in Annexes 4, 6 and 7. 

It  is  prohibited  to  affix  marks  or  inscriptions  which  are 
likely to mislead "third parties with regard to the meaning or 
the graphics of the CE marking. Any other mark may be affixed 
to the device, to the packaging or to the instruction leaflet 
accompanying  the  device  provided  that  the  visibility  and 
legibility of the CE marking is not thereby reduce. 

u^r  '-i 

-30-

Article  15 

Unduly  affixed  CE  marking 

Without  prejudice  to Article  8 : 

a)  where  a Member  State  establishes  that  the  CE  marking  has  been 

affixed 

unduly, 

the 

manufacturer 

or 

his 

authorized 

representative  established  within  the  Community  shall  be 

obliged  to  end  the  infringement  under  conditions  imposed  by 

the Member  State 

(b)  where  non-compliance  continues,  the  Member  State  must  take 

all  appropriate  measures  to  restrict  or  prohibit  the  placing 

on  the  market  of  the  product  in  question  or  to  ensure  that  it 

is  withdrawn  from  the  market,  in  accordance  with  the 

procedure  in Article  8. 

Article  16 

Decisions  in  respect  of  refusal  or  restriction 

1. 

Any  decision  taken  pursuant  to  this  Directive  : 

(a)  to  refuse  or  restrict  the  placing  on  the  market  or  the 

putting  into  service  of  a  device  or 

(b)  to  withdraw  devices  from  the  market 

-31-

shall  state  the  exact  grounds  on  which  it  is  based.  Such 
decisions  shall  be  notified  without  delay  to  the  party 
concerned,  who  shall  at  the  same  time  be  informed  of  the 
remedies  available  to him under the national  law in  force in 
the Member  State  in question and of the time  limits  to which 
such remedies are subject. 

2.  In the event of a decision as referred to in paragraph  1, the 
manufacturer, or his authorized  representative  established in 
the  Community,  shall  have  an  opportunity  to put  forward  his 
viewpoint  in  advance,  unless  such  consultation  is  not 
possible because of the urgency of the measure to be taken. 

Article 17 

Confidentiality 

Without  prejudice  . to  the  existing  national  provisions  and 
practices  on medical  secrets, Member  States  shall  ensure  that all 
the  parties  involved  in  the  application  of  this  Directive  are 
bound  to  observe  confidentiality  with  regard  to  information 
obtained  in  carrying  out  their  tasks.  This  does  not  affect  the 
obligations  of  Member  States  and  notified  bodies  with  regard  to 
mutual  information  and  the  dissemination  of  warnings,  nor  the 
obligations  of  the persons concerned  to provide  information  under 
criminal law. 

J.°V 

-32-

Article 18 

Cooperation between Member States 

Member States shall take appropriate measures to ensure that 
competent authorities charged with the implementation of the 
present Directive cooperate with each other and convey to each 
other the information necessary to ensure compliance with the 
provisions of this Directive. 

Article 19 

Amendment of--Directives 

Directive 93/42/EEC is hereby amended as follows : 

a)  Article 1(2) c) shall read as follows : 

" (c) in  vitro  diagnostic  medical  device  means  any  medical 
device  which  is  a  reagent,  reagent  product,  calibrator, 
control  material,  kit,  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  state, state 
of health or disease or congenital abnormality or to determine 
the safety and compatibility with potential recipients". 

Cf) 

b) 

Article  l(5)f shall  read as follows : 

-33-

"(f)  transplants  or  tissues  or  cells  of  human  origin, 

unless  a  device  is  manufactured  utilizing  tissues  or 

substances  derived  from such tissues which  are non  viable 

or rendered non viable. In this case, the  directive  shall 

not affect national  regulations  relating  to  the  ethics of 

the  collection  of  tissues  or  substances  of  human  origin, 

as  well  as  any  regulations  relating  to  the  ethics 

governing  distribution  of  given  types  of  devices  of  such 

origin." 

c) 

Annex  I, paragraph  8.2,  shall  read as follows : 

"8.2.Where  a  device  is  manufactured  utilizing  human 

tissues  or  substances  derived  from human  tissues, the use 

of  such  tissues  or  substances  must  be  subject  to  the 

relevant  validated  selection  and  screening  procedures, 

including  traceability  as  appropriate  in  relation  to  the 

inherent risk. 

Tissues  of animal  origin must originate  from  animals  that 
have 
and 
surveillance  adapted  to the intended  use of  the tissues. 

to  veterinary 

subjected 

controls 

been 

Processing,  preservation,  testing  .and  handling  of 

tissues,  cells  and  substances  of  human  or  animal  origin 

must be  carried  out  so as to provide  optimal  security.  In 

particular  safety  with  regard  to  viruses  and  other 

transmissible  agents must  be  addressed  as  appropriate  by 

implementation  of  validated' methods  of  elimination  or 
inactivation  of  such  viruses  or  other  transmissible 

agents  in the course of the manufacturing process,  taking 

into  account  the  sourcing  and control methods  applied." 

- 34 -

d) 

Annex  I  paragraph  13.3  shall  be  completed  by  the 

following  subparagraph  : 

"n)  in  the  case  of  devices  incorporating  tissues  of 

human  origin  or  substances  derived  from  such  tissues,  a 

statement  indicating  that  the  device  incorporates  tissue 

or  substances  derived  from  tissue  of  human  origin  as 

appropriate" 

e)  In  annex  II paragraph  3.2c)  and  annex  III  paragraph  3  the 

following  indent  shall  be  included  as  third  last  indent  : 

"in  the  case  of  devices  incorporating  tissues  of  human  or 

animal  origin,  information  on  the  selection  and  origin" 

f)  Annex  IX,  section  III, paragraph  4.5  : the  following  sub 

paragraph  shall  be  added  : 

"All  devices  manufactured  utilizing  human  tissues  or 

substances  derived  from  such  tissues  are  in  class  III." 

2. 

In  Directive  89/392/EEC,  the  text  of  Article  1 ( 3 ),  second 

indent  " machinery  for  medical  use,  used  in  direct  contact 

with  patients"  is  replaced  by  the  following  text  : 

"- medical  devices" 

4C°> 

- 35 -

Article  20 

Implementation,  transitional  provisions 

Member  States  shall  adopt  and  publish  the  laws,  regulations 

and  administrative  provisions  necessary  to  comply  with  this 

Directive- not  later  than  1  April  1998.  They  shall  immediately 

inform  the  Commission  thereof. 

The  Standing  Committee  referred  to  in Article  7 may  assume  its 

tasks  from  the  date  of  notification  of  this  Directive.  The 

Member  States  may  take  the  measures  referred  to  in  Article  13 

on  notification  of  this  Directive. 

When  Member  States  adopt  these  provisions,  these  shall  contain 
a  reference  to  this1Directive  or  shall  be  accompanied  by  such 

a  reference  at  the  time  of  their  official  publication.  The 

procedures  for  such  reference  shall  be  adopted  by  Member 

States. 

Member  States  shall  apply  these  provisions  with  effect  from 

1  July  1998. 

Member  States-  shall  communicate  to  the  Commission  the  texts 

of  the  provisions  of  national  law  which  they  adopt  in  the 

field  covered  by  this  Directive. 

52> 

36 

Member  States  shall  take the necessary  action  to  ensure  that 
the notified bodies which are responsible pursuant  to Article 
9  for  conformity  assessment  take  account  of  any  relevant 
information  regarding  the  characteristics  and  performance  of 
such  devices,  including  in  particular  the  results  of  any 
relevant  tests  and  verification  already  carried  out  under 
pre-existing  national  law,  regulations  or  administrative 
provisions in respect of such devices. 

Member  States  shall  accept  during  a  period  of  four  years 
following  adoption  of  the  present  Directive  the  placing  on 
the market  and putting  into  service  of  devices  which  conform 
to  the  rules  in  force  in  their  territory  on  the  date  of 
adoption of this Directive. 

Article 21 

This Directive, shall  enter  into  force the twentieth  day  after its 
publication. 

This Directive is addressed to the Member States. 

Article 22 

-37-

Annex 1 

ESSENTIAL REQUIREMENTS 

I.  GENERAL REQUIREMENTS 

The  devices must  be  designed  and manufactured  in  such  a way 
that,  when  used  under  the  conditions  and  for . the  purposes 
intended,  they  will  not  compromise,  directly  or  indirectly, 
the clinical  condition  or the  safety of the patients, e-r- the 
safety  and  health  of  users  and,  where  applicable,  other 
persons,  and the  safety of property. Any  risks, which may be 
associated  with  their  use,  must  be  acceptable  when  weighed 
against the benefits to the patient and are compatible with a 
high level of protection of health and safety. 

The  solutions  adopted by the manufacturer  for  the design and 
construction  of  the  • devices  must  conform  to  safety 
principles,  taking  account  of  the  generally  acknowledged 
state of the art. 

In selecting  the most appropriate  solutions, the manufacturer 
must apply the following principles in the following order : 

eliminate or reduce risks as far as possible  (inherently 
safe design and construction)* 

where  appropriate  take  adequate  protection  measures  in 
relation to risks that cannot be eliminated» 

J 

inform  users  of  the  residual  risks  due  to  any 
shortcomings of the protection measures. 

-38-

The  devices must  be  designed  and manufactured  in  such ~a~ way 
that  they  are  suitable  for  the  purposes  referred  to  in 
Article  l(2)(b),  as  specified  by  the  manufacturer,  taking 
account  of  the generally  acknowledged  state of  the  art. They 
must  achieve  the  performances  in  particular  in  terms  of 
analytical  sensitivity,  specificity,  accuracy,  repeatability, 
reproducibility  and  limits  of  detection  stated  by  the 
manufacturer. 

The  traceability  of  values  assigned  to  calibrators  and/or 
controls materials must be assured through available reference 
measurement  procedures  and/or  available  reference  materials 
of higher order. 

The  characteristics  and performances  referred  to  in  Sections 
1 and 3 must not be adversely  affected  to such a degree that 
the  health-',or" the  safety  of  the  patient  or  the  user  and, 
where  applicable,  of  other  persons,  are  compromised  during 
the lifetime of the device, as indicated by the manufacturer, 
when  the  device  is  subject  to  the  stresses  which  can  occur 
during normal conditions  of use. When no  lifetime  is stated, 
the  same  applies  for  the 'lifetime  reasonably  to  be  expected 
of  a  device  of  that  kind,  having  regard  to  the  intended 
purpose and the anticipated use of the device. 

The devices must be designed, manufactured  and packed in such 
a  way  that  their  characteristics  and  performances  during 
their  intended  use  will  not  be  adversely  affected  in  the 
storage and transport  conditions  (temperature, humidity,  ...) 
taking account of the instruction and information provided by 
the manufacturer. 

II.  REQUIREMENTS REGARDING DESIGN AND MANUFACTURING 

-39-

6.  Chemical and physical properties 

6.1. The devices must be designed  and manufactured  in such a 

way  as  to  achieve  the  characteristics  and  performances 
referred  to  in Section  I on  the  "General Requirements". 
Attention must be paid  to the possibility  of impairment 
of analytical performance  due to incompatibilityvbetween 
the  materials  used  and  the  samples  (such . as  biological 
tissues,  cells,  body  fluids  and  micro-organisms) 
intended  to be  used  with  the  device,  taking  account  of 
its intended purpose. 

6.2. The devices must be designed, manufactured  and packed in 
such  a  way  as  to  reduce  as  far  as  possible  the  risk 
posed  by  leakage products, contaminants  and  residues  to 
the  persons  involved  in  the  transport,  storage  and  use 
of  the  devices,  taking  account  of  the  intended  purpose 
of the products. 

7.  Infection and microbial contamination 

7.1. The  devices  must  be  designed  in  such  a  way  as  to 
eliminate  or  reduce  as  far  as  possible  the  risk  of 
infection  to the user or other persons. The design must 
allow  easy handling  and, where necessary,  reduce  as far 
as possible contamination of and leakage  from the device 
during use and, in the case of specimen receptacles, the 
risk of contamination of the specimen. The manufacturing 
processes must be appropriate for these purposes. 

-40-

7.2.  Where  a  device  incorporates  biological  substances," "the 
risks of infection must be reduced as far as possible by 
selecting  appropriate donors, appropriate  substances and 
using  appropriate  ihactivation,  conservation,  test  and 
control procedures. 

7.3. Devices  labelled  either  as "STERILE",  or, as  h&Ying  & 
special  microbiological  state  must  be  designed, 
manufactured  and  packed  in  an  appropriate  pack, 
according  to  procedures  suitable  to  ensure  that  they 
remain  in  the  microbiological  state  indicated  on  the 
label  when  placed  on  the  market,  under  the  storage  and 
transport  conditions  as  laid  down  by  the  manufacturer, 
until the protective packaging is damaged or opened. 

7.4.  Devices  labelled  either  as  "STERILE",  or,  as  having  a 
special  microbiological  state  must  have  been' processed 
by an appropriate, validated method. 

7.5. Packaging  systems  for devices  other  than  those  referred 
to  in  section  7.3  must  keep  the  product  without 
deterioration  at  the  level  of  cleanliness,  if  any,  as 
indicated by the manufacturer  and, if the devices are to 
be  sterilized  prior  to  use,  reduce  as  far  as  possible 
the risk of microbial contamination. 

• Steps  shall  be  taken  to  reduce  microbial  contamination 
during  selection  and  handling  of  raw  materials, 
manufacture,  storage  and  distribution  where  the 
performance  of  the  device  can  be  adversely  affected  by 
such contamination. 

<y 

8.  Construction and environmental properties 

-41-

8.1. If  the  device  is  intended  for  use  in  combination  with 
other  devices  or  equipment,  the  whole  combination, 
including  the  connection  system  must  be  safe  and  must 
not  impair  the  specified  performances  of  the  devices. 
Any  restrictions  on use must  be  indicated  on  the  label 
and/or in the instructions for use. 

8.2  Devices must be designed  and manufactured  in  such  a way 

as to remove or reduce as far as possible : 

the  risk  of  injury,  in  connection  with  their 
physical 
of 
volume x pressure, dimensional" and where appropriate 
ergonomie features; 

features, 

including 

aspects 

with 

connected 

reasonably 

risks 
foreseeable 
external  influences,  such  as  magnetic  fields, 
external 
electrostatic 
discharge,  pressure,  temperature  or  variations  in 
pressure or acceleration. 

electrical 

effects, 

Devices must be designed  and manufactured  in  such  a way 
as  to  provide  an  adequate  level  of  intrinsic  immunity 
from  electromagnetic  disturbance  to  enable  them  to 
operate in accordance with their intended purpose. 

^ 

-42-

Devices must be designed, and manufactured  in such  a way 
as  to  reduce  as  far  as  possible  the  risks  of  fire  or 
explosion  during  normal  use.  Particular  attention  must 

•L 

be paid  to devices whose  intended use  includes  exposure 
to  or  use  in  association  with  flammable  substances  or 
substances which could cause combustion. 

4. Devices must be designed  and manufactured  in such  a way 
as to facilitate the management of safe waste disposal. 

5  The  measuring,  monitoring  or  display  scale  (including 
colour  change  and  other  visual  indicators)  must  be 
designed  and  manufactured  in  line  with  ergonomie 
principles,  taking  account  of  the  intended  purpose  of 
the device. 

Devices  which  are  instruments  or  apparatus  with  a measuring 
function 

9.1. Devices  which  are  instruments  or  apparatus  having  a 
primary  analytical  measuring  function  must  be  designed 
and  manufactured  in  such  a  way  as  to  provide  adequate 
stability and accuracy of measurement within  appropriate 
accuracy  limits,  taking,  into  account  the  intended 
purpose  of  the  device  and  of  available  and  appropriate 
reference  measurement  procedures  and  materials.  The 
accuracy  limits  have  to  be  specified  by  the 
manufacturer. 

CC 

-43-

9.2. When  values  are  expressed  numerically,  they  must  be 
given  in  legal  units  conforming  to  the  provisions  of 
Council Directive 80/181/EEC  n 

10.  Protection against radiation 

10.1 Devices shall be designed and manufactured  in such a way 
that  exposure of users and other persons  to the emitted 
radiation is reduced as far as possible-. 

10.2 When devices  are intended  to emit potentially hazardous, 

visible and/or invisible radiation, they must be : 

- designed  and  manufactured  in  such  a way  as  to  ensure 
that the quality and quantity of radiation  emitted can 
be adjusted and controlled; 

- fitted, where practicable, with visual  displays  and/or 

audible warnings of such emissions. 

10.3 The  operating  instructions 

for  devices  emitting 
radiation  must  give  detailed  information  as  to  the 
nature of the emitted radiation, means of protecting the 
user, and  on ways  of avoiding  misuse  and  of  eliminating 
the risks inherent in installation. 

OJ  Nr.  L  39.  15.02.1980,  p. 40, directive  as  last  amended  by  Directive  89/617/EEC,  OJ  Nr.  L 357, 
07.12.1989. P. 28. 

(a\ 

-44-

11.  Requirements  for  medical  devices  connected  to  or  equipped 

with an energy source 

11.1 Devices  incorporating  electronic  programmable  systems 
must be designed to ensure the repeatability, reliability 
and  performance  of  these  systems  according  to  the 
intended use. 

11.2 Devices must be  designed  and manufactured  in  such  a way 
as  to  minimize  the  risks  of  creating  electromagnetic 
fields which could impair the operation of other devices 
or equipment in the usual environment. 

11.3 Devices must be designed  and manufactured  in  such  a way 
as to. avoid,  as  far as possible,  the  risk  of  accidental 
electric  shocks  during  normal  use  and  in  single  fault 
condition,  provided  the  devices  are  installed  and 
maintained correctly. 

11.4 Protection against mechanical and thermal risks 

11.4.1 Devices must be designed and manufactured  in such a way 
as  to  protect  the  user  against  mechanical  risks 
connected with,  for example, resistance,  stability  and 
moving  parts. 
Annex  1,  sections  1.3  and  1.4  of 
Directive 89/392/EEC 12 shall apply, were appropriate. 

12  Council  Directive  89/392/EEC,  OJ  Nr.  L  183,  29.6.1989,  as  last  amended  by  Council  Directive 

93/68/EEC, OJ Nr.  L 220, 30.8.1993, p. I 

- 45 -

11.4.2 Devices  must  be  designed  and manufactured  in  such  a  way 

as  to  reduce  to  the  lowest  possible  level  the  risks 

arising  from  vibration  generated  by  the  devices,  taking 

account  of  technical  progress  and  of  the  means 

available  for  limiting  vibrations,  particularly  at 

source,  unless, the  vibrations  are  part  of  the  specified 

performance. 

11.4.3 Devices  must  be  designed  and manufactured  in  such  a  way 

as  to  reduce  to  the  lowest  possible  level  the  risks 

arising  from  the  noise  emitted,  taking  account  of 

technical  progress  and  of  the  means  available  to  reduce 

noise,  particularly  at  source,  unless  the  noise  emitted 

is  part  of  the  specified  performance. 

11.4.4  Terminals  and  connectors  to  electricity, 

gas  or 

hydraulic  and  pneumatic  energy  supplies  which  the  user 

has  to  handle  must  be  designed  and  manufactured  in  such 

a  way .as .to minimize  all  possible  risks. 

11.4.5 Accessible  parts  of  the  devices  (excluding  the  parts  or 

areas 

intended 

to 

supply 

heat 

or 

reach 

given 

temperatures)  and  their  surroundings  must  not  attain 

potentially  dangerous  temperatures  under  normal  use. 

12.  Requirements  for  devices  for  self-testing 

- 46 -

Devices  for  self-testing  must  be  designed  and  manufactured  in 

such  a  way  that  they  perform  appropriately  for  their  intended 

purpose  taking  into  account  the  skills  and  the  means 

available  to  users  and  the  influence  resulting  from  variation 

that  can  reasonably  be  anticipated  in  users'  technique  and 

environment.  The  information  and  instructions  provided  by  the 

manufacturer  should  be  easily  understood  and  applied  by  the 

user. 

12.1  Devices 

for 

self-testing 

must 

be 

designed 

and 

manufactured  in  such  a  way  as  to  reduce  as  far  as 

practicable  the  risk  of  user's  error  in  handling  and  in 

interpretation  of  the  result. 

12.2  Devices 

for 

self-testing 

must, 

where 

reasonably 

possible,  include  a  method  of  user  control,  i.e.  a 

procedure  by  which  the  user  can  reasonably  verify  that, 

at  the  time  of  use,  the  product  will  perform  as 

intended. 

13.  Information  supplied  by  the  manufacturer 

13.1  Each  device  must  be  accompanied  by  the  information 

needed  to  use . it  properly,  taking  account  of  the 

training  and  knowledge  of  the  potential  users  and  to 

identify  the  manufacturer. 

-47-

This  information  comprises  the data  on  the  label  and in 
the instructions for use. 

As  far  as  practicable  and  appropriate,  the  information 
needed to use the,device properly must be set out on the 
device  itself  and/or  on  the  packaging  or,  where 
appropriate, on  the  sales packaging.  If  individual  full 
labelling  of  each  unit  is  not  practicable,  the 
information  must  be  set  out  on  the  packaging  and/or  in 
the  instructions  for  use  supplied  with  one  or  more 
devices. 

Instructions for use must accompany or be included in the 
packaging of one or more devices. 

By  way  of  exception,  no  such  instructions  for  use  are 
needed for a device if it can be used properly and safely 
without them. 

13.2 Where  appropriate,  this  information  to  be  supplied 
should  take  the  form  of  symbols.  Any  symbol  and 
identification  colour  used  must  conform  to  the 
harmonized  standards.  In  areas  for  which  no  standards 
exist, the symbols and colours as used must be described 
in the documentation supplied with the device. 

L< 

-48-

13.3 In the case of devices containing  a substance or being a 
preparation  which may be  considered  as being dangerous, 
taking  account  of  the  nature  and  quantity  of  its 
constituents  and  the  form under which  they  are present, 
relevant  danger  symbols  and  labelling  requirements  of 
Directive  67/548/EEC  and  Directive  88/379/EEC  shall 
apply.  Where  there  is  insufficient  space  to  put  all 
information  on  the  device  itself  or  on  its  label,  the 
relevant  danger  symbols  shall  be  put  on  the  label  and 
the other  information required by those Directives  shall 
be given in the instructions for use. 

The  provisions  of  the  aforementioned  directives  on  the 
safety  data  sheet  shall  apply,  unless  all  relevant 
information  as  appropriante  is  already  made  available by 
the instructions for use. 

13.4 The  label must  bear  the  following  particulars  which may 

take the form of symbols as appropriate: 

a) the  name  or  trade  name  and  address  of  the 
manufacturer. For devices imported into the Community, 
in  view  of  their  distribution  in  the  Community,  the 
label,  or  the  outer  packaging,  or  instructions  for 
use, shall contain in addition the name and address of 
the  authorized  representative  of  the  manufacturer 
established within the Community; 

G?C? 

-49-

b) the  details  strictly  necessary  for  the  user  to 

identify  the device and the contents of the packaging. 

c) where  appropriate,  the  word  "STERILE"  or  a  statement 
indicating  any  special  microbiological  state  or  state 
of cleanliness; 

d) where  appropriate,  the  batch  code,  preceded  by  the 

word  "LOT", or the serial number; . 

e) where  appropriate,  an  indication  of  the  date  by  which 
the  device  or part  of  it  should  be  used,, expressed  as 
the year, the month and, where  relevant, the day; 

f) in  cases  of  devices  for  performance  evaluation,  the 

words  "for performance  evaluation only"; 

g) where  appropriate, a statement  indicating  the  in vitro 

nature of the device; 

h) any  special  storage  and/or handling conditions; 

i) where  applicable  any special operating  instructions; 

j)  appropriate warnings  and/or precautions  to take; 

k)  if  the  device  is  intended  for  self-testing,  this  fact 

should be clearly  stated. 

1)  In  the  case  of "devices incorporating  tissues  of  human 
origin  or  substances  derived  from  such  tissues,  a 
statement  indicating  that  the  device  incorporates 
tissues  or  substances  derived  from  tissue  of  human 
origin. 

13.5  If  the  intended  purpose  of  the  device  is  not  obvious  to 
the  user,  the  manufacturer  must  clearly  state  the 
intended  purpose  in  the  instructions  for  use  and,  if 
appropriate,- on the label. 

-SO 

IS. 6 Wherever  reasonable  and  practicable,  the  devices  and 

detachable 

components 

must 

be 

identified, 

where 

appropriate  in  terms  of  batches,  to  allow  all 

appropriate  action  to detect  any potential  risk  posed  by 

the devices  and detachable components. 

13.7  Where  appropriate,  the  instructions  for  use must  contain 

the  following particulars : 

a) the  details  referred  to  in  Section.  13.4,  with 

exception of points d) and e) ; 

b) composition  of  the  reagent  product  by  nature  and 

amount or concentration of the active  ingredient(s) of 

the  reagent(s)  or  kit tas well  as  a  statement  that  the 

device  contains  other  ingredients  influencing  the 

measurement; 

c) the  storage  conditions  and  shelf  life  following  the 

first  opening  of  the  immediate  container,  together 

with  the  storage  conditions  and  stability  of  working 

reagents; 

d)  the performances  referred  to in Section  3; 

e) a  statement  of  any  special  materials  required 
including  information  necessary  to  enable  those 
special materials  to be  identified  for proper use; 

f) the  type  of  specimen  to  be  used,  any  special 
conditions  of  collection,  pre-treatment  and,  if 
necessary,  storage conditions; 

g) a detailed description  of the procedure  to be  followed 

in using  the device; 

/ 

s/ 

D 

-51-

h) the  measurement  procedure  to  be  followed  with  the 

device including as appropriate : 

-  the principle of the method; 

analytical 

-  the  specific  analytical performance  characteristics 
'(e.g. 
specificity, 
accuracy,  repeatability,  reproducibility  and  limits 
of  detection),  limitations  of  the  method  and 
information  about  the  use  of  available  reference 
measurement procedures and materials by the user; 

sensitivity, 

-  the  details  of  any  further  procedure  or  handling 
needed  before  the  device  can  be  used  (for  example 
reconstitution,  incubation,  dilution,  instrument 
checks, etc); 

-  the  indication  whether  any  particular  training  is 

required; 

i) the  mathematical  approach  upon  which  the  calculation 

of the analytical result is made; 

j) measures  to be  taken  in the  event  of  changes  in the 

analytical performance of the device; 

k) information appropriate to users on : 

internal  quality  control  including  specific 
validation procedures, 

- the traceability of the calibration of the device; 

1) the  reference  intervals  for  the  quantities  being 

determined; 

-52-

m) if  the  device  must  be  used  in  combination  with  or 
installed  with  or  connected  to other medical  devices 
or  equipment  in order  to operate  as required  for  its 
intended 
its 
sufficient 
characteristics  to  identify  the  correct  devices  or 
equipment to use in order to obtain a safe and proper 
combination; 

purpose, 

details 

of 

n) all  the  information  needed  to  verify  whether  the 
device is properly installed and can operate correctly 
and  safely, plus  details  of  the nature  and  frequency 
of  the  maintenance  and  calibration  needed  to  ensure 
that  the  device  operates  properly  and  safely; 
information about safe waste disposal; 

o) the  necessary  instructions  in  the  event  of  damage to 
the  sterile  protective  packaging  and  details  of 
appropriate 
or 
of 
decontamination; 

resterilization 

methods 

p) if  the  device  is  reusable,  information  on  the 
appropriate  processes  to  allow  reuse,  including 
cleaning,  disinfection, packaging  and  resterilization 
or decontamination,  and any restriction  on the number 
of reuses; 

q) precautions  to  be  taken  as  regards  exposure,  in 
reasonably  foreseeable  environmental  conditions,  to 
magnetic  fields,  external  influences,  electrostatic 
discharge,  pressure  or  variations  in  pressure, 
acceleration, thermal ignition sources, etc.; 

-53-

r) precautions  to be  taker! against  any  special, unusual 
risks  related  to  the  use  or  disposal  of  the  device 
including  special  protective  measures;-  where  the 
device includes substances of human or animal origin, 
attention shall be drawn to their potential infectious 
nature; 

s)  specifications for devices for self-testing : 

-  the results need to be expressed and presented  in a 
way  that  is  readily  understood  by  a  non 
professional • person;  information  needs  to  be 
provided  with  advice  to  the  user  on  action  to  be 
taken 
or 
indeterminate  result)  and  on  the  possibility  of 
false positive or false negative result; 

(in  case  of  positive,  negative 

-  specific  particulars  may  be  omitted  provided  that 
the  other  information  supplied  by  the  manufacturer 
is sufficient to enable the user to know how to use 
the device and to understand  the result(s) produced 
by the device; 

-  the  information  provided  must  include  a  statement 
clearly directing that the user should not take any 
decision  of  medical  relevance  without  first 
consulting his or her medical practitioner; 

t) date of issue or last revision of the instructions for 

use. 

^v 

54-

Annex  2 

LIST OF DEVICES REFERRED TO IN ARTICLE 9(2) 

1.  Reagents  and  reagent  products  for  blood  grouping  ( A BO 

system and Rho/D) 

2.  Reagents  and  reagent  products  for  the  detection  in  human 
specimens of markers of HIV infection, Hepatitis B and C . 

^2. 

55-

Annex 3 

EC DECLARATION OF CONFORMITY 

The EC declaration of conformity is the procedure whereby the 
manufacturer  or  his  authorized  representative  established  in 
the Community who fulfils the obligations  imposed by Sections 
2  to  5  and  additionally, 4in  the  case  of  devices  for  self-
testing,  the  obligations  imposed  by  Section  6,  ensures  and 
declares  that  the  products  concerned  meet  the  provisions  of 
this  Directive  which  apply  to  them.  The  manufacturer  must 
affix the CE marking in accordance with Article 14. 

2.  The  manufacturer  must  prepare  the  technical  documentation 
described  in  Section  3  and  ensure  that  the  manufacturing 
process  follows  the  principles  of  quality  assurance  as  set 
out in section 4. 

3.  The  technical  documentation  must  allow  assessment  of  the 
conformity  of  the  product  with  the  requirements, of  the 
Directive. It must include in particular : 

-^ 

-56-

-  a general description of the product, including  any  variants 

planned; 

-  the documentation  of the, quality  system; 

- design  information,  including  performance  characteristics 

and  limitation,  methods  of  manufacture  and,  in  the  case  of 

instruments,  design  drawings,  diagrams  of  components,  sub 

assemblies, circuits, etc.; 

-  the  descriptions  and  explanations  necessary  to  understand 

the  abovementioned  characteristics,  drawings .and  diagrams 

and the operation of the product; 

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

-  in  the  case  of  sterile  products  or  products  with  a  special 
microbiological  state or state of cleanliness, a  description 
of the procedures  used; 

-  the  result's  of  the  design  calculations  and  of  the 

inspections  carried out, etc... 

-  if  the  device  is  to  be  combined  with  other  device (s)  in 

order  to operate  as intended, proof must be provided  that  it 

conforms  to  the  essential  requirements  when  combined  with 

any  such  device(s)  having  the  characteristics  specified  by 

the manufacturer; 

- the test reports,* 

-57-

- adequate  performance  evaluation  data,  supported  by  a 
reference  measurement  system  (when  available),  originated 
from studies in a clinical or other appropriate  environment 
or  resulting  from  available  literature;  this  applies  in 
particular  to  biological  materials,  culture  media  and 
devices using a new technology; 

- the labels and instructions for use. 

The manufacturer  shall take necessary measures  to ensure^ that 
the manufacturing  process  follows  the principles  of  quality 
assurance as appropriate for the products manufactured. 

The system shall address : 

the organizational structure and responsibilities, 

the manufacturing  processes  and systematic  quality  control 
of production; 

the means to monitor the performance of the quality system; 

"6 

-58-

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

(i)  any  malfunction,  failure  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, directly or indirectly,  might lead to or 
might have led to the death of a patient or user or to a 
serious deterioration in his state of health; 

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

6.  For devices  for  self-testing  the manufacturer  shall  lodge an 
application  for  examination  of  the  design  with  a  notified 
body. 

6.1  The application shall enable the design of the device to 
be  understood  and  shall  enable  conformity  with  the 
design-related  requirements  of  the  directive  to  be 
assessed. 

\, 

-59 

It shall include : 

test reports including, where  appropriate, results of 
studies carried out with lay persons; 

data showing the handling suitability of the device in 
view of its intended purpose for self-testing; 

the information to be provided with the devi-ce on its 
'label and its instructions for use. 

6.2 The  notified  body shall  examine  the  application  and,  if 
the  design  conforms  to  the  relevant  provisions  of  this 
Directive  shall  issue  the  applicant  with  an  EC  design-
examination certificate. The notified body may.require the 
application  to be  completed by  further  tests  or proof to 
allow  assessment  of  conformity  with  the  design-related 
requirements  of  the  Directive.  The  certificate  shall 
contain the conclusions of the examination, the conditions 
of  validity,  the  data  needed7 for  identification  of  the 
approved  design  and, where  appropriate,  a description  of 
the intended purpose of the product. 

6.3 The applicant  shall inform the notified body which issued 
the EC designed-examination certificate of any significant 
change  made  to  the  approved  design.  Changes  to  the 
approved  design  must  receive  further  approval  from  the 
notified  body  which  issued  the  EC  design-examination 
certificate  wherever  the  changes  could  affect  conformity 
with  the  essential  requirements  of  the  Directive  or with 
the  conditions  prescribed  for  use  of  the  product.  This 
additional approval shall take the form of a supplement to 
the EC design-examination certificate. 

60-

Annex 4 

EC DECLARATION OF CONFORMITY 

(FULL QUALITY ASSURANCE SYSTEM) 

1.  The  manufacturer  must  ensure  application  of  the  quality 
system  approved  for  the  design,  manufacture  and  final 
inspection of the products concerned, as specified  in Section 
3, and is subject to audit as laid down in section 3.3  and to 
the EC surveillance as specified in Section 4. 

2.  The  declaration  of  conformity  is  the  procedure  whereby  the 
manufacturer who  fulfils the obligations  imposed by Section 1 
ensures  and  declares  that  the  products  concerned  meet  the 
provisions of,this Directive which apply to them. 

The  manufacturer  shall  affix  the  CE  marking  in  accordance 
with Article 14 and shall draw up a declaration of conformity 
covering the products concerned. 

3.  Quality system 

3.1 The manufacturer must lodge an application  for assessment 

of his quality system with a notified body. 

% 

61 -

The application must include: 

- the  name  and  address  of  the  manufacturer  and  any 
additional  manufacturing  site  covered  by  the  quality 
system; 

- adequate  information on the product or product  category 

covered by the procedure; 

- a written declaration that no such application has been 
* lodged  with  any  other  notified  body  for  the  same 

product-related quality system; 

- the documentation on the quality system; 

- an  undertaking  by  the  manufacturer  to  fulfil  the 

obligations imposed by the quality system approved; 

- an undertaking by the manufacturer to keep the approved 

quality system adequate and efficacious; 

- an undertaking by the manufacturer to institute and keep 
up  to date  a systematic  procedure  to  review  experience 
gained * from ,devices in the post production phase and to 
implement  appropriate  means  to  apply  any  necessary 
corrective  action  and  notification  as  referred  to  in 
Annex 3, section 5 . 

3.2 Application  of  the  quality  system  must  ensure  that  the 
products conform to the provisions of this Directive which 
apply  to  them  at  every  stage,  from  design  to  final 
inspection.  All the elements, requirements and provisions 
adopted by the manufacturer for his quality system must be 
documented  in a systematic and orderly manner  in the form 
of  written  policies  and  procedures,  such  as  quality 
programmes,  quality  plans,  quality  manuals  and  quality 
records. 

- 62 -

It  shall  include  in particular  an  adequate  description  of: 

(a)  the  manufacturer's  quality  objectives; 

(b)  the  organization  of  the  business  and  in  particular: 

-  the  organizational  structures,  the  responsibilities 

of  the  managerial  staff  and  their  organizational 

authority  where  quality  of  design  and  manufacture 

of the products  is concerned; 

-  the  methods  of  monitoring  the  efficient  operation 

of  the  quality  system  and  in particular  its  ability 

to  achieve  the  desired  quality  of  design  and  of 

product,  including  control  of  products  which  fail 

to conform; 

(c)  the  procedures  for monitoring  and  verifying  the  design 

of  the  products  and  in  particular: 

-  a  general  description  of  the product,  including  any 

variants  planned; 

-  all  documentation  referred  to  in  Annex  3,  section 

3, indents  3 to 11; 

-  in  the  case  of  devices  for  self-testing,  the 

information  referred  to in Annex  3,  section  6.1; 

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

(d)  the  inspection  and  quality  assurance  techniques  at  the 

manufacturing  stage  and  in  particular: 

-  the  processes  and  procedures  which  will  be  used, 
and 
regards 

sterilization 

as 

particularly 
purchasing; 

*> 

-63-

-  the product  identification procedures  drawn  up  and 
kept  up  to  date  from  drawings,  specifications  or 
other  relevant  documents  at  every  stage  of 
manufacture; 

the appropriate^tests and trials which will be carried 
out  before,  during  and  after  manufacture,  the 
frequency  with  which  they  will  take  place,  and  the 
test  equipment  used;  it  must  be  possible  to  trace 
back the calibration of the test equipment adequately. 

3.3  The  notified  body  must  audit  the  quality  system  to 
determine  whether  it meets  the  requirements  referred  to 
in  Section 3.2.  It  must  presume  that  quality  systems 
which  implement  the  relevant  harmonized  standards 
conform to these requirements. 

The assessment team must include at least one member with 
past  experience  of  assessments  of  the  technology 
The  assessment  procedure  must  include  an 
concerned. 
inspection  on  the  manufacturer's  premises  and,  in  duly 
substantiated 
the 
manufacturer's suppliers and/or subcontractors to inspect 
the manufacturing processes. 

premises 

cases, 

the 

on 

of 

The  decision  shall be notified  to the manufacturer.  It 
must  contain  the  conclusions  of  the  inspection  and  a 
reasoned assessment. 

'3.4  The  manufacturer  must  inform  the  notified  body  which 
approved  the  quality  system  of  any plan  for  substantial 
changes  to  the  quality  system  or  the  product-range 
covered. 

-64-

The  notified  body  must  assess  the  changes  proposed  and 
verify  whether  after  these  changes  the  quality  system 
still meets the requirements  referred  to in Section 3.2. 
It must  notify  the manufacturer  of  its  decision.  This 
decision must  contain  the  conclusions  of  the  inspection 
and a reasoned assessment. 

4.  Surveillance 

4.1  The  aim  of  surveillance  is  to  ensure  that  the 
manufacturer  duly fulfils the obligations  imposed by the 
approved quality system. 
t-

4.2  The 'manufacturer  must  authorize  the  notified  body  to 
carry  out  all  the  necessary  inspections  and  supply  it 
with all relevant information, in particular: 

- the documentation on the quality system; 

- the  data  stipulated  in the part  of  the  quality  system 
relating  to  design,  such  as  the  results  of  analyses, 
calculation, tests, etc.; 

- the  data  stipulated  in the part  of  the  quality  system 
relating to manufacture, such as inspection reports and 
test  data,  calibration  data,  qualification  reports  of 
the personnel concerned, etc. 

4.3 The notified body must periodically  carry out  appropriate 
inspections  and  assessments  to  make  sure  that  the 
manufacturer  applies the approved  quality  system and must 
supply the manufacturer with an assessment report. 

<X7 

-65-

4.4 In addition, the notified body may pay unannounced visits 
to  the  manufacturer.  At  the  time  of  such  visits,  the 
notified body may, where necessary,  carry  out or  ask  for 
tests in order to check that the quality system is working 
It  must  provide  the  manufacturer  with  an 
properly. 
inspection  report 'and,  if  a  test  has  been  carried  out, 
with a test report. 

-66-

Annex 5 

EC TYPE-EXAMINATION 

1.  EC  type-examination  is  the  part  of  the  procedure  whereby  a 
notified body  ascertains  and  certifies  that  a  representative 
sample  of  the  production  envisaged  fulfils  the  relevant 
provisions of this Directive. 

2.  The application for EC type-examination shall be lodged by the 
manufacturer  or by  his  authorized  representative  established 
in the Community with a notified body. 

The application shall include: 

the name  and address of the manufacturer  and  the name and 
address of the authorized representative if the application 
is lodged by the representative; 

the  documentation  described  in  Section 3 needed  to  assess 
the  conformity  of  the  representative  sample  of  the 
production  in  question,  hereinafter  referred  to  as  the 
The 
"type",  with  the  requirements  of  this  Directive. 
applicant  shall  make  a  "type"  available  to  the  notified 
body. 
The  notified  body  may  request  other  samples  as 
necessary; 

a written  declaration  that no  application  has been  lodged 
with any other notified body for the same type. 

-67-

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

- a general  description  of  the  type,  including  any  variants 

planned; 

- all documentation referred to in Annex 3, section 3, indents 

3 to 5, 7, 10 and 11, 

The notified body shall: 

4.1 examine  and  assess  the  documentation  and  verify  that the 
type  has  been  manufactured  in  conformity  with  that 
documentation;  it shall also record the items designed in 
conformity with the applicable provisions of the standards 
referred  to  in  Article 5,  as  well  as  the  items  not 
designed, on , the  basis  of  the  relevant  provisions  of  the 
abovemehtioned standards; 

4.2 perform or have performed appropriate examinations and the 
tests necessary to verify whether the solutions adopted by 
the manufacturer meet  the  essential  requirements  of  this 
Directive  if the  standards  referred  to  in Article 5 have 
not been  applied;  if the  device  is  to be  combined  with 
other  device (s)  in  order  to  operate  as  intended,  proof 
must  be  provided  that  it  conforms  to  the  essential 
requirements when combined with any such device(s) having 
the characteristics specified by the manufacturer; 

-68-

4.3  carry  out  or  ask  for  the  appropriate  examinations  and  the 
tests necessary  to verify whether,  if the manufacturer  has 
chosen  to  apply  the  relevant  standards,  these  have 
actually been  applied; 

4.4  agree  with  the  applicant  on  the place  where  the  necessary 

examinations  and tests will be carried out. 

5. 

If  the  type  conforms  to  the provisions  of  this  Directive,  the 
notified  body  shall  issue  the  applicant  with  an  EC  type-
examination  certificate.  The  certificate  shall  contain  the 
name  and  address  of  the  manufacturer,  the  conclusions  of  the 
examination,  the  conditions  of  validity  and  the  data  needed 
for  identification  of  the  type  approved.  The  relevant  parts 
of  the  documentation  shall  be  annexed  to  the  certificate  and 
a  copy  shall be  kept by the notified body. 

6. 

The  applicant  shall  inform  the notified  body  which  issued  the 
EC type-examination  certificate  of any significant  change made 
to the approved product. 

Changes  to  the  approved  product  must  receive  further  approval 
from  the  notified  body  which  issued  the  EC  type-examination 
certificate  wherever  the  changes  may  affect  conformity  with 
the  essential  requirements  or  with  the  conditions  prescribed 
for  use  of  the  product. 
This  new  approval  shall,  where 
appropriate,  take  the  form  of  a  supplement  to  the  initial  EC 
type-examination  certificate. 

7.  Administrative provisions . 

-69-

Other  notified  bodies  may  obtain  a  copy  of  the  EC  type-
examination certificates and/or the supplements thereto.  The 
annexes  to  the  certificates  must  be  made  available  to  the 
other  notified  bodies  on  reasoned  application,  after  the 
manufacturer has been informed. 

-70-

Annex 6 

EC VERIFICATION 

EC verification  is the procedure whereby  the manufacturer  or 
his  authorized  représentative  established  in  the  Community 
ensures  and  declares  that  the  products  which  have ' been 
subject  to the procedure  set out  in Section 4 conform  to the 
type described in the EC type-examination certificate and meet 
the requirements of this Directive which apply to them. 

prepare 

2.1  The  manufacturer  must  take  all  the  measures  necessary  to 
ensure that the manufacturing process produces products which 
conform  to  the  type  described  in  the  EC  type-examination 
certificate  and  to  the  requirements  of  the  Directive  which 
Before;, the  start  of  manufacture,  the 
apply, to  them.' 
manufacturer ' . must 
the 
manufacturing process, in particular  as regards  sterilization 
and  the  suitability  of  starting  materials,  where  necessary, 
and define  the necessary  testing procedures  according  to the 
state of the art. All the routine, pre-established  provisions 
must  be  implemented  to  ensure  homogeneous  production  and 
conformity  of the products with  the  type described  in the EC 
type-examination certificate and with the requirements of this 
Directive  which  apply  to  them.  The manufacturer  must  affix 
the  CE  marking  in  accordance  with  Article 14  and  draw  up  a 
declaration of conformity covering the products concerned. 

documents 

defining 

-71-

2.2  To  the  extent  that  for  certain  aspects  the  final  testing 
according  to  section  6.3  is  not  appropriate,  adequate  in 
process  testing,  monitoring  and  control  methods  shall  be 
established  by  the  manufacturer  with  the  approval  of  the 
notified  body.  The  provisions  of  Annex  4  section  4  shall 
apply accordingly in relation to the above mentioned  approved 
procedures. 

3.  The manufacturer must  undertake  to  institute  and  keep  up  to 
date a systematic procedure  to review experience  gained  from 
devices  in  the  post-production  phase  and  to  implement 
appropriate  means  to  apply  any  necessary  corrective  and 
notification action as referred to in Annex 3 section 5. 

The notified body must carry out the appropriate  examinations 
and  tests  in  order  to  verify  the  conformity  of  the  product 
with  the  requirements  of  the  Directive  either  by  examining 
and  testing  every  product  as  specified  in  section  5  or  by 
examining  and  testing  products  on . a  statistical  basis  as 
specified in section 6, as the manufacturer decides. 

In  as  far  as  the  conduct  of  examinations  and  tests  on  a 
statistical  basis  is not  appropriate,- examinations  and  tests 
may  be  carried  out  on  a  random  basis  provided  that  such 
procedure  in  conjunction  with  the  measures  taken  in 
accordance  with  section  2.2  ensures  an  equivalent  level  of 
conformity. 

5.  Verification by examination and testing of every product 

-72-

5.1 Every product is examined individually and the appropriate 
tests defined  in the  relevant  standard(s)  referred  to in 
Article 5 or equivalent tests must be carried out in order 
to verify the conformity of the products with the EC type 
described in the type-examination certificate and with the 
requirements of the Directive which apply to them. 

5.2 The  notified  body  must  affix,  or  have  affixed,  its 
identification  number  to  each  approved  product  and  must 
draw  up  a written  certificate  of  conformity  relating  to 
the tests carried out. 

6.  Statistical verification 

6.1 The manufacturer must present the manufactured products in 

the form of homogeneous batches. 

6.2 A  random  sample  is  taken  from  each  batch.  The  products 
which make up the sample are examined individually and the 
appropriate  tests  defined  in  the  relevant  standard(s) 
referred  to  in  Article 5 " or  equivalent  tests  must  be 
carried  out  to verify, where  appropriate,  the  conformity 
of  the  products  with  the  type  described  in  the  EC type-
examination  certificate  and with  the  requirements  of the 
Directive  which  apply  to  them  in  order  to  determine 
whether to accept or reject the batch. 

- 73 -

3  Statistical 

control  of  products  will  be  based 

on 

attributes,  entailing  a  sampling  system  ensuring  a  limit 

quality  corresponding  to  a  probability  of  acceptance  of 

5%,  with  a  non-conformity  percentage  of  between  3  and  7%. 

The  sampling  method  will  be  established  by  the  harmonized 

standards  referred  to  in Article  5,  taking  account  of  the 

specific  nature  of  the  product  categories  in  question. 

6.4  If  the  batch  is  accepted,  the  notified  body  affixes,  or 

has  affixed  its  identification  number  to  each  product  and 

draws  up  a  written  certificate  of  conformity  relating  to 

the  tests  carried  out.  All  products  in  the  batch  may  be 

put  on  the market  except  any  in  the  sample  which  failed  to 

conform. 

If  a  batch  is  rejected  the  competent  notified  body  must 

take  appropriate  measures  to  prevent  the  batch  from  being 

placed  on  the  market.  In  the  event  of  frequent  rejection 

of  batches,  the  notified  body  may  suspend  the  statistical 

verification. 

The  manufacturer  may,  on  the  responsibility  of  the 

notified  body,  affix  the  notified  body's  identification 

number  during  the  manufacturing  process. 

a i 

74-

Annex 7 

EC DECLARATION OF CONFORMITY 

(PRODUCTION QUALITY ASSURANCE) 

1.  The  manufacturer  must  ensure  application  of  the  quality 
system approved  for the manufacture of the products  concerned 
and  carry  out  the  final  inspection,  as  specified  in  Section 
3,  and  is  subject  to  the  EC  surveillance  referred  to  in 
Section 4. 

The  declaration  of  conformity  is  the  part  of  the' procedure 
whereby  the manufacturer  who  fulfils  the  obligations  imposed 
by Section 1 ensures and declares that the products  concerned 
conform  to  the  type  described  in  the  EC  type-examination 
certificate  and  meet  the  provisions  of  this  Directive  which 
apply to them. 

The manufacturer must affix the.CE marking  in accordance with 
Article 14 and draw up a declaration of conformity. 

3.  Quality system 

-75-

3.1 The manufacturer must lodge an application for'assessment 

of his quality system with a notified body. 

The application must include: 

-, all documentation and undertakings  referred  to' in Annex 
.. 4 section 3.1 and 

- the technical documentation on the types approved and a 

copy of the EC type-examination certificates. 

3.2  Application  of  the  quality  system  must  ensure  that  the 

products  conform  to  the  type  described  in  the  EC type-
examination certificate. 

All  the  elements, requirements  and provisions- adopted  by the 
manufacturer  for  his  quality  system  must  be  documented  in a 
systematic  and  orderly  manner  in  the  form  of  written  policy 
statements  and procedures.  This  quality  system  documentation 
must permit  uniform  interpretation  of  the  quality policy  and 
procedures  such  as  quality  programmes,  plans,  manuals  and 
records. 

It must include in particular an adequate description of: 

the manufacturer's quality objectives; 

(b)  the organization of the business and in particular 

-76-

the organizational structures, the responsibilities of 
the  managerial  staff  and  their  organizational 
authority  where  manufacture  of  the  products  is 
concerned; 

the methods  of monitoring  the  efficient  operation' of 
vthe  quality, system  and  in  particular  its  ability  to 
achieve  the  desired  quality  of  product,  including 
control of products which fail to conform; 

c) the  inspection  and  quality  assurance  techniques  at  the 

manufacturing stage and in particular: 

- the  processes  and  procedures  which  will  be  used, 
particularly as regards sterilization and purchasing; 

- the product  identification procedures  drawn up and kept 
up  to  date  from  drawings,  specifications  or  other 
relevant documents at every stage of manufacture; 

d) the appropriate tests and trials to be carried out before, 
during  and  after  manufacture,  the  frequency  with  which 
they  will  take  place,  and  the  test  equipment  used;  it 
must be possible  adequately  to trace back  the calibration 
of the test equipment. 

-77-

3.3 The  notified  body  must  audit  the  quality  system  to 
determine whether it meets the requirements referred to in 
Section 3.2.  It must  presume  that  quality  systems which 
implement  the  relevant  harmonized  standards  conform  to 
these requirements. 

The assessment  team must include at least one member with 
past  experience  of  assessments  of  the  technology 
concerned. 
The  assessment  procedure  must  include  an 
inspection  on  the  manufacturer's  premises  and,  in  duly 
substantiated cases, on the premises of the manufacturer's 
suppliers 
the 
subcontractors 
manufacturing processes. 

inspect 

and/or 

to 

The  decision  must  be  notified  to  the  manufacturer  after 
the  final  inspection  and  contain  the  conclusions  of  the 
inspection and a reasoned assessment. 

3.4 The  manufacturer  shall  inform  the  notified  body  which 
approved  the  quality  system  of  any  plan  for  substantial 
changes to the quality system. 

The  notified  body  must  assess  the  changes  proposed  and 
verify  whether  after  these  changes  the  quality  system 
still meets the requirements referred to in Section 3.2. 

It  must  notify  the  manufacturer  of  its  decision.  This 
decision  must  contain  the  conclusions  of  the  inspection 
and a reasoned assessment. 

Surveillance 

The provision of Annex 4, section 4, shall apply 

"15 

-78-

Annex  8 

STATEMENT AND  PROCEDURES CONCERNING  DEVICES 

FOR PERFORMANCE  EVALUATION 

1. 

For  devices  for  performance  evaluation  the  manufacturer  or 

his  authorized  representative  established  in  the  Community 

shall  draw  up  the  statement  containing  the  information 

stipulated  in  Section 2  of  this  Annex  and  ensure  that  the 

relevant provisions  of this Directive  are met. 

2. 

The  statement  shall contain the  following  information: 

the  list  of  laboratories  or  other  institutions  taking  part 
in the performance  evaluation  study; 

in  the  case  of  devices  for  self-testing,  the  place, 
starting  date and scheduled  duration  for the  investigations 
and the number of  lay-persons  involved. 

a  statement  that  the  device  in  question  conforms  to  the 

requirements  of  the  Directive,  apart  from  the  aspects^ 

covered  by  the  investigation  and  apart  from  those 

specifically  itemised  in  the  statement,  and  that  every 

precaution  has  been  taken  to protect  the  health  and  safety 

of the patient, user  and third parties. 

-79-

The  manufacturer  shall  also  undertake  to  keep  available" for 
the competent national authorities  the documentation  allowing 
an understanding  of  the design, manufacture  and  performances 
of the product, including the expected performances, so as to 
allow  assessment  of  conformity with  the requirements of  this 
Directive.  This  documentation  must  be  kept  for  a  period 
ending  at  least  five  years  after  the  end  of  the performance 
evaluation. 

The  manufacturer  shall  take  all  the  measures  necessary  for 
the  manufacturing  process  to  ensure  that  the  products 
manufactured  conform  to  the  documentation  mentioned  in  the 
first paragraph. 

HI 

-80-

Annex 9 

CRITERIA FOR THE DESIGNATION OF NOTIFIED BODIES 

The  notified  body,  its  Director  and  the  assessment  and 
verification  staff  shall  not  be  the  designer, .manufacturer, 
supplier,  installer  or  user  of  the  devices  which  they 
inspect,  nor  the  authorized  representative  of  any  of  these 
persons.  They  may  not  be  directly  involved  in  the  design, 
construction,  marketing  or  maintenance  of  the  devices,  nor 
represent  the parties engaged in these activities. This in no 
way  precludes  the  possibility  of  exchanges  of  technical 
information between the manufacturer and the body. 

The notified body and its staff must carry out the assessment 
and  verification  operations  with  the  highest  degree  of 
professional  integrity  and  the  requisite  competence  in  the 
field of medical  devices  and must be  free  from  all pressures 
and  inducements,  particularly 
financial,  which  might 
influence  their  judgment  or  the  results  of  the  inspection, 
especially  from persons or groups of persons with an interest 
in the results of the verifications. 

Should the notified body subcontract  specific tasks connected 
with the establishment  and verification of the facts, it must 
first  ensure  that  the  subcontractor  meets  the  provisions  of 
the Directive.  The notified body  shall  keep  at the disposal 
of the  national  authorities  the  relevant  documents  assessing 
the  subcontractor's  qualifications  and  the  work  carried  out 
by the subcontractor under this Directive. 

<\<k 

-81-

3.  The  notified  body  must  be  able  to  carry  out  all  the  tasks 
assigned  to  such  bodies  by  one  of  Annexes  3  to  7  and  for 
which  it has  been  notified,  whether  these  tasks  are  carried 
out  by  the  body  itself  or  on  its  responsibility.  In 
particular,  it must have  the necessary  staff  and possess  the 
facilities  needed  to "perform  properly  the  technical  and 
administrative  tasks entailed  in assessment  and verification. 
It must  also  have  access  to  the  equipment  necessary  for  the 
verifications required. 

4.  The notified body must have: 

sound  vocational  training  covering  all  the  assessment  and 
verification  operations  for  which  the  body  has  been 
designated; 

satisfactory  knowledge  of  the  rules  on  the  inspections 
which  they  carry  out  and  adequate  experience  of  such 
inspections; 

the  ability  required  to draw up  the  certificates,  records 
and  reports  to demonstrate  that -the inspections  have been 
carried out. 

5.  The  impartiality  of  the  inspection  staff must  be  guaranteed. 
Their  remuneration  must  not  depend  on  the  number  of 
inspections  carried  out,  nor  on  the  results  of  the 
inspections. 

-82-

6.  The  body  must  take  out  civil  liability  insurance,  unless 
liability  is assumed by the State under  domestic  legislation 
or  the  Member  State  itself  carries  out  the  inspections 
directly. 

7.  The  staff  of  the  inspection  body  are  bound  to  observe 
professional  secrecy with regard to all information gained in 
the  course  of  their  duties  (except  vis-à-vis  the  competent 
administrative  authorities  of  the  State  in  which  their 
activities  are  carried  out)  under  this  Directive  or  any 
provision of national law putting it into effect. 

83-

Annex 10 

CE MARKING OF CONFORMITY 

The  CE  conformity  marking  shall  consist  of  the  initials  "CE" 
taking the following form : 

If  the marking  is  reduced  or  enlarged  the  proportions  given 
in the above graduated drawing must be respected. 

The  various  components  of  the  CE  marking  must  have 
substantially  the  same  vertical  dimension,  which  may  not  be 
less  than  5  mm.  This  minimum  dimension  may  be  waived  for 
small-scale devices. 

ANNEX 

D R A FT 

DECISION OF THE EEA JOINT COMMITTEE 

No.  [ 

,..] 

amending Annex II, Technical regulations, standards, 
testing and certification, to the Agreement on the 
European Economic Area 

THE EEA JOINT COMMITTEE, 

Having regard to the Agreement on the European Economic Area, as adjusted by the Protocol 
Adjusting the Agreement on the European Economic Area, hereinafter referred to as the 
Agreement, and in particular Article 98 thereof; 

Whereas Directive ....../ 
medical devices is to be integrated into the Agreement, 

/EEC of..../ 

(OJNo. L 

/ 

...) on in vitro diagnostic 

HAS DECIDED AS FOLLOWS : 

Article 1 

The following shall be inserted in Annex II to the Agreement : 

Directive 

/EC on in vitro diagnostic 

/ 
medical devices 

Article 2 

The texts of Directive ..../...../.EC  in the Finnish, Icelandic, Norwegian and Swedish languages, 
which are annexed to the respective language versions of this decision, are authentic 

Article 3 

This Decision shall enter into force on [ 
Article  103(1) of the Agreement have been made to the EEA Joint Committee 

], provided that all the notifications under 

] [ 

- 2-

Article 4 

This decision shall be published in the EEA Section of,  and in the EEA Supplement to, the 
Official Journal of the European Communities 

For the EEA Joint Committee 
The President 

The Secretaries 
to the EEA Joint Committee 

ANNEX 

FINANCIAL  STATEMENT 

Financial implications (details for publication in the working  papers) 

1. 

TITLE OF  OPERATION 

Proposal for a Directive on in vitro diagnostic medical devices 

2. 

BUDGET  HEADING 

B5-300 

Measures concerning the internal market; Operating  appropriations 

B5-7210 

Development  of a data interchange system 

3. 

LEGAL BASIS 

4. 

4.1 

Article  100a,of the EC Treaty. 

DESCRIPTION  OF OPERATION 

Specific  objectives  of  operation:  Jhe^specific  objective  of  this  operation  is  to 
establish the internal market in in-vitro diagnostic medical devices. 

This  proposal  is  intended  to  complement  the  existing  Directives 90/385/EEC  (on 
active  implantable  medical  devices)  and  93/42/EEC  (on  medical  devices)  by 
introducing  Community legislation governing the placing on the market  of in vitro 
diagnostic  medical  devices.  The  Directive  aims  at  ensuring  the  safety  and 
protecting  the  health  of patients,  users  of the  devices  concerned  and  third  parties. 
Harmonized  rules  will  ensure  free  movement  of  the  devices  and  prevent  the 
emergence of new barriers to trade. 

2-

Following the principles laid down in the new approach, the Directive provides for 

harmonization  of  the  essential  safety  requirements  and  for  the  conformity 

assessment procedures which in vitro diagnostic medical devices must satisfy when 

they  are  placed  on  the  market.  Effective  implementation  of  this  Directive  will 

entail: 

drafting  of  harmonized  standards  by  the  CEN/CENELEC; 

if  these  are 

applied, conformity with the- essential requirements in the Directive will be 

presumed; 

establishment by the parties concerned and submission by the Commission 

of the guidelines necessary to  ensure uniform  application  of the Directive, 

on  its  scope,  the  principles  to  be  applied,  the  means  to  be  employed  to 

meet the essential requirements, etc.; 

concertation between the notified bodies on the certification procedures; 

exchanges  of 
application and monitoring of the Directive; 

information  between  the  Member  States  concerning 

management  by  the  Commission  of  the  procedures  for  implementing  the 
safeguard  clauses,  which  will  imply  seeking  the  opinion  of  high-level 
experts. 

4.2 

Duration:  Ad hoc measure. 

4.3 

Target  population:  Every  citizen  in  the  Community  is  a  potential  user  of  the 
devices  covered  by the Directive,  since  the  products  are  employed  in the  health 
care sector. 

- 3-

5. 

CLASSIFICATION  OF EXPENDITURE 

5.1 

Non-compulsory  expenditure. 

5.2 

Differentiated  appropriations. 

5.3 

No revenue is expected. 

6. 

TYPE OF  EXPENDITURE 

The expenditure will be on: 

(a) 

standardization:  The  proposal  for  a  Directive  lays  down  the  essential 

requirements.  Article 5 refers to  harmonized  standards.  As with the  other 

new  approach  Directives, 

the  Commission  plans 

to  give 

the 

CEN/CENELEC  a  mandate  to  draft  the  relevant  harmonized  standards. 

This mandate will cover technical formulation  of the essential  requirements 

defined  in the proposal.  It  will be governed  by the  framework  contract  of 

15 September  1992,  which  provides  for  financial  support  from 

the 

Commission. 

(b) 

development  of a data interchange system:  The registration  procedures  for 

manufacturers  (Article  10)  and  the  vigilance  system  (Article  11)  involve 

exchanges  of  official  data  between  the  Member  States,  the  parties 

concerned  and  the  Commission.  The  development  of  a  system  facilitating 

data  interchange  will  therefore  be  essential  if  the  directive  is  to  be  fully 

effective.  To  this  end,  the  profiles  of  the  data  to  be  exchanged  must  be 
established,  procedures  must  be  devised  and  common  software  must  be 
provided. 

4-

6.1 

100% subsidy:  none. 

6.2 

Subsidy for joint financing with other sources in the public and/or private  sector: 

none. 

6.3 

Interest subsidy:  none. 

6.4 

Other:  none. 

6.5 

Should the operation prove an economic success, is there provision for all  or part 

of the Community contribution to be reimbursed?  No. 

6.6  Will the proposed operation cause any change in the level of revenue?  No. 

- 5-

7. 

FINANCIAL IMPACT 

7.1  Method of calculating total cosî of operation 

7.1.1  Standardization 

(a) 

Estimated cost of: 
- drafting the standards: In the order of 25 harmonized  standards will have 
to be drafted. 
The funding will depend on the work given to the contractors. 
On average, the estimated  financial  contribution from the Commission  for 
drafting  a  standard  is  a flat rate  of ECU  50  000.  Total  expenditure  of 
ECU 1.25 million is expected. 

- developing a data interchange system between the Member States. 
The cost of a project  such as referred  to in point 6b, to be carried  out in 
1996/1997, is estimated at ECU 300 000. 

- 6-

(b) 

The indicative schedule of appropriations could be as follows 

Commitment appropriations 
(1.000 ECU 

1995 
1996 
1997 
1998 
1999 

750 
650 
150 

1550 

7.2 

Itemized  breakdown of cost 

Payment appropriations 
(1.000 ECU) 
350 
500 
300 
300 
100 
1550 

ECU 

BREAKDOWN 

1994 

1995 

PERCENTAGE 

BUDGET 

PRELIMINARY 

CHANGE 

DRAFT BUDGET 

Standardization  (B5-300) 

-

-

*  Mandate 

750 000 

7.3 

Indicative  schedule of commitment  appropriations 

ECU 

1994 
BUDGET 

1995 
PRELIMINARY 
DRAFT BUDGET 
750 000 

1996 

500 000 

INDICATIVE  SCHEDULE 
1999 

1997 

1998 

150 000 

150 000 

Standardization 
(B5-300) 
Mandate 

Development  of a 
data  interchange 
system between  the 
Member  States 
(B5-7210) 

2000 

l< 

8. 

FRAUD PREVENTION  MEASURES 

The  Commission  verifies  the  subsidies  or  receipt  of the  services  and  preparatory, 

feasibility  or  evaluation  studies  ordered  before  payment,  taking  account  of  the 

contractual  obligations  and  of  the  principles  of  economy  and  sound  financial  or 

general  management.  All  agreements  or  contracts  concluded  between  the 

Commission  and  recipients  of  payments  include  fraud  prevention  clauses  (on 

monitoring,  submission of reports, etc.). 

9. 

ELEMENTS OF COST-EFFECTIVENESS  ANALYSIS 

9.1 

Objectives 

This  new  approach  Directive  is a  measure  to  complete  the  internal  market.  The 
reference  to  harmonized  standards  is  part  of  the  Commission's  multiannual 
programme to support reinforcement  and extension of European  standardization. 

9.2 

Grounds for the operation 

The.  national  legislation  on  in  vitro  .diagnostic  medical  devices  is  extremely 

heterogeneous  and takes different  approaches to  safety  which  make application  of 

the principle of mutual recognition delicate. 

t \o 

The diverging requirements imposed by the national  systems, both  on the  products 

and  on  the  procedures  for  placing  them  on  the  market,  give  rise  to  enormous 

wastage of human and financial resources  at the expense of the manufacturers  and 

of the Member  States. 

The Community  procedures will avoid multiple repetition  with the  same  objective. 

In  addition,  the  harmonized  requirements  will  allow  industry  to  make  savings  on 

unit production  costs. 

The  harmonization  of  standards  is  designed  to  pool  resources  and  thereby  avoid 
duplication of expenditure by the Member  States. 

All  in  all,  the  resources  required  from  the  Community  budget  are  only  a  small 
proportion  of the total  resources  which the Member  States  and  parties  concerned 
will release for the common good  as a result of the operation. 

9.3  Monitoring  and evaluation  of the operation 

9.3.1  Performance  indicators selected 

degree of harmonization  of standards (number of standards); 

number of certifications  carried  out; 

number of reports of undesirable incidents; 

number of infringement  procedures. 

\\\ 

9-

9.3.2  Details and frequency  of planned  evaluation: 

regular progress reports on standardization under Council 

Directive 83/189/EEC, at least once a year. 

9.4 

Coherence -with financial  programming 

9.4.1  The operation is included in DG Ill's financial  programming. 

9.4.2  Broader  objectives  defined  in DG Ill's financial  programming:  not applicable. 

9.4.3  Main factors  of uncertainty which could affect  the specific  results of the  operation: 

not applicable. 

10. 

ADMINISTRATIVE  EXPENDITURE (PART A OF THE BUDGET) 

10.1  The  proposed  operation  will  involve  an  increase  in  the  number  of  Commission 

staff for  administration  of the Directive. 

The  procedures  concerning  the  safeguard  clauses,  monitoring  of  European 
standardization  and  administrative  cooperation  presuppose  the  availability  of  staff 
capable  of  administration  and  evaluation  of  analyses  and  technical  or  legal 
opinions. 

The  staff  requirements  will  be  covered  either  by  internal  redeployment  or  by  a 
Commission  decision  allocating  resources  in  the  budgetary  procedure. 
It  is 
estimated  that Unit III.D.2 will require one grade A official  from  1995 on. 

10-

FINANCIAL  STATEMENT 

Financial implications (details for internal  information) 

10.2  Amount  of  staff  and  operating  expenditure generated  by  the proposed  operation 

subject  to  the  outcome  of  the  budgetary procedure  and  the  decision  allocating 

resources 

10.2.1 

Expenditure on staff covered by the Staff Regulations 
Titles Al  and A2 :  ECU 90 000 per year 

This item  should  be  covered  either  through  redeployment  or  under  the 

allocation of resources decided each year by the Commission. 

10.2.2  Other expenditure from Part A of the budget: 

Budget items concerned  and type of expenditure 

(a) A2500:  Meetings  of  experts:  To  promote  uniform  application  of 
the  Directive,  the  Commission  plans  regular  meetings  with 
the  experts  from  the  Member  States,  representatives  of  the 
notified  bodies  and  the  European  federations  to  coordinate 
their activities and harmonize their practices. 

Estimated  annual cost (from  1996 on): 
24 experts x 3 meetings  per year x ECU  658 per  expert  per 
meeting = ECU 47.376 per year. 

11 

(b) A1178  Technical  assistance 

In  the  pre-impiementation  phase 
Consultants: 
(1996-1997)  consultants'  fees  are  estimated  to  total 
ECU 25 000 per year. 

(c) A 2600" Studies 

The 
the 

to  administer 

technical  opinions 
Technical  opinions: 
required 
clause 
procedures  will  be  funded  by  study  contracts. 
ECU 40 000  per  year  must  be  earmarked  for  this 
purpose from  1998 on. 

safeguard 

10.3 

Itemized  breakdown of cost (Part A of the budget) 

ECU 

BREAKDOWN 

1994 BUDGET 

1995 
PRELIMINARY 

PERCENTAGE 
CHANGE 

(a) Al,  A2 

(b) A2550:  meetings 

Member  States 

(c) A ll 78 /technical 

assistance  (safeguard 
clauses) 

DRAFT BUDGET 

90.000 

-. 

-

25.000 

or Al 178 according to nomenclature for  1995. 
or Al 178 according to nomenclature for  1995. 

-  12 

10.4 

Indicative schedule of appropriations 

ECU 

INDICATIVE  SCHEDULE 

1994 

1995 

1996 

1997 

1998 

1999 

2000 

BUDGET 

(a)Al,A2 

90.000 

90.000 

90.000 

90.000 

90.000 

90.000 

(b) Meetings with  the 

-

47 376 

47  376 

47  376 

47  376 

47  376 

Member  States  (A2500) 

(c) Studies and 

consultations 

*  Consultants  (Al 178) 

* Technical  opinions 

(A2600) 

TOTAL 

25 000 

25 000 

25 000 

40 000 

40  000 

40 000 

-

115.000 

162.376 

162.376 

177.376 

177.376 

177.376 

IMPACT  ASSESSMENT  FORM 

TITLE OF  PROPOSAL: 

Proposal  for  a Directive of  the European  Parliament  and the Council  on in  vitro 

diagnostic  medical  devices. 

REFERENCE NUMBER:  2111.2.1.1 

THE  PROPOSAL 

This proposal  is for  a new approach  Directive based  on Article  100a of  the 
Treaty.  It  is intended  to achieve the following  objectives: 

to complete  the harmonization  started  by Directive 90/385/EEC  on  active 

implantable  medical devices and Directive 93/42/EEC  on  medical  devices 

for  the products  concerned; 

to ensure  free  movement  of in vitro diagnostic  medical  devices  by 

harmonizing  the national  legislation  to protect  the health  and  safety  of 

patients  and  users; 

to remove  the existing barriers  created  by  the diverging  regulations  and 

prevent  the emergence of  new barriers.  This proposal  is essential  to 

prevent  the national  legislation  implementing  the  abovementioned 

Directives  from  deepening  the  differences; 

to create a favourable  environment  with  uniform  conditions  of  competition 

to enable the industry  to benefit  from  the scale of  the European  Economic 

Area  and  to help  make European  industry  more  competitive. 

- 2-

2. 

THE IMPACT ON BUSINESS 

(a)  Nature of the businesses concerned 

The in vitro diagnostic device industry is highly developed in the 
Community and the EFTA countries.  Estimates put world production in 
1992 at ECU  12.2 billion, of which 39% was from  the USA, 38% from, 
Western Europe and  12% from Japan. 

Most of the 350 to 400 European undertakings in this sector are small or 
medium-sized businesses.  Research activities are intense and account for an 
estimated  15 to 20% of the jobs in this industry. 

(b)  Geographical distribution of the industry and market 

In Europe the leading manufacturers  of in vitro diagnostic medical devices 
are Germany,  Switzerland,  France, Sweden,  the Netherlands, the United 
Kingdom,  Italy and Belgium.  In  1992 the total market of ECU 4.6 billion 
broke down as follows:  Germany 25 % ;  Italy 23 % ;  France  18 % ;  Spain 
12%;  United Kingdom 4%;  Belgium 3.5%;  Switzerland  3%;  Austria 
3 % ;  Netherlands 2 % ;  Sweden 2 % ;  Finland  1 % ;  Denmark  1 % ;  Norway 
1%;  Ireland 0.5%  (source:  European Diagnostic  Manufacturers 
Association, EDMA). 

(c)  Are these businesses in regions eligible for regional aid in the Member 

States and under the ERDF? 

No particular concentration  in these regions is known. 

u> 

WHAT WILL  BUSINESS  HAVE TO DO TO COMPLY  WITH  THE 

PROPOSAL? 

The proposal  lays down  the essential requirements  which  devices placed  on  the 
market  must  meet in order  to protect  the health and  safety  of patients,  users and 
third  parties.  These requirements  will be given  firmer  shape by  harmonized 
standards  which  will be drafted  by the European  standardization  organizations 
CEN/CENELEC  and  will remain  voluntary. 

Before, placing  their devices on the market,  manufacturers  must ensure that they 

comply  with  the regulations.  The conformity  assessments  for  an extremely  large 

proportion  of  the devices  will be conducted  solely on  the  manufacturers' 

responsibility,  without  the intervention  of any  third  party. 

The Directive will require manufacturers  to apply  the appropriate  quality 

assurance principles  for  the devices  manufactured. 

However,  in  thé case of  devices particularly  sensitive for  health  protection 
purposes,  particularly  AIDS and  hepatitis tests,  third  party  certification  of  the 
design  and  manufacture  of  the devices is  required. 

For  monitoring  purposes,  manufacturers  must notify  one of  the  competent 

authorities  in  the Community  of their  marketing  activities  and  of  any 

undesirable  incidents. 

4. 

WHAT  ECONOMIC  EFFECTS  IS THE PROPOSAL  LIKELY  TO  HAVE? 

(a)  On  employment 

The proposal  will  have no particular  impact on  employment.  However,  the 
requisite adaptation  to the new rules will  help to safeguard  existing jobs 
and,  in  certain  cases,  to create new ones. 

4-

(b)  On  investment  and  the creation  of  new  businesses 

The proposal  will  have no direct  impact on business  start-ups  or  investment. 

Conditions  on  the single market  to be created  could  have consequences  for 

distribution  of  the devices.  It will be possible  to organize  distribution 

according  to the needs of  the European  market  without  having  to  maintain 

separate distribution  systems  in each  Member  State. 

(c)  On  the competitive position  of  businesses 

Initially,  adaptation  to the new  requirements  and  implementation  of  the 

quality  principles,  where still  necessary,  will  give rise  to extra  costs.  The 

three-year  transition  period  following  adoption  of  the Directive  will  make it 

possible to spread  these costs over  this entire period. 

Once the adjustments  have been  completed,  businesses  will  be able to 

benefit  from  the greater  rationalization.  Harmonization  of  the  diverging 

regulatory  systems  will  cut the costs caused  by  the current  divergency.  The 

European  dimension  of  the market  in  turn  will  allow  economies  of  scale. 

Businesses  will  face  tougher  competition  from  both  inside and  outside  the 
Community.  The abovementioned  effects  of  the proposal  will  make 
European  businesses  more competitive at  international  level. 

Once  the Community  legislation  is adopted  the Community  will  be  able  to 

use it in  its international  negotiations  to improve access  for  the  European 

industry  to  markets  in  third  countries. 

U1 

- 5-

(d)  On public  health 

By ensuring  that the devices placed on the market are reliable,  the Directive 

will  provide greater protection  for public health.  In particular,  the 

performance  and reliability  of in vitro diagnostic devices  will  make it easier 

to take medical decisions at an early  stage of treatment and yield  savings in 

health care costs. 

5. 

DOES  THE  PROPOSAL  CONTAIN  MEASURES  TO TAKE ACCOUNT OF 
THE  SPECIFIC  SITUATION  OF SMALL AND  MEDIUM-SIZED  FIRMS? 

The proposal  contains  no  specific  measures  applicable  solely  to  small  firms. 

The Directive  is limited  to the essential protection  requirements,  which  will  be 
laid  down  in  voluntary  harmonized  standards,  and  will  therefore  provide  a legal 
framework  which  can be  applied  flexibly.  The introduction  of  harmonized 
standards  will  make it easier  to comply  with  the Directive,  particularly  for  small 
firms.  The  manufacturer's  declaration  proposed  for  a very  large proportion  of 
the devices  will  limit  the costs  generated  by  the regulations  and  thus  take 
particular  account  of  the interests  of  small businesses. 

The  Commission  will  continue  to ensure close involvement  by  the  European 

federations  representing  the vast  majority  of  small  firms  in  this industry  when 

implementing  the proposed  Directive. 

6. 

CONSULTATION  AND  OPINION  OF THE TWO SIDES  OF INDUSTRY 

Since  1991  the Commission  has consulted  the industrial  and  trade  federations 

concerned  with  the aid  of  various  working  papers.  Four  meetings  were held  to 

examine  a  working  paper  at various  stages.  In  addition,  in  1992 and  1993 the 

EDMA,  assisted  by  the Commission,  organized  two workshops  specially  on  the 

proposal.  Many  bilateral  meetings  have been  held  with  the parties  concerned 

and  talks  on  the subject  have been  given  at numerous  conferences. 

- 6-

The following  federations and organizations have been consulted: 

(a)  Manufacturers 

EDMA  (European Diagnostic Manufacturers Association) 

EUROM (European Federation of Precision, Mechanical and Optical 
Industries) 

ELPA  (European Laboratory Plastics Association) 

(b)  Users 

1FCC (International Federation of Clinical Chemistry) 

ECCLS (European Council for Clinical and Laboratory  Standards) 

ICSH (International Council for Standardization in Haematology) 

ESCMID (European Society for Clinical Microbiology and  Infectious 
Diseases) 

WASP (World Association of Societies of Pathology - European section). 

The parties concerned have recognized the need for harmonization  with the aid 
of a Directive and support the principles established in this proposal. 

The EDMA,  which represents more than 300 small firms,  and the other 
industrial  federations  mentioned above have stressed the need to uphold the 
principle that the conformity  assessment for a large proportion  of the devices 
can be conducted on the manufacturers'  responsibility.  Under these 
circumstances,  the introduction of the vigilance procedures combined with 
notification  of new devices are recognized as adequate monitoring 
arrangements.  Consequently,  in the industry's view, any moves to extend third 
party certification  could upset the balance of the monitoring  measures proposed. 

ISSN 0254-1475 

COM(95) 130  final 

DOCUMENTS 

EN 

06  15 

Catalogue number  :  CB-CO-95-140-EN-C 

ISBN 92-77-87648-4 

Office for Official Publications of the European Communities 

L-29S5 Luxembourg