1995/0013(COD) In vitro diagnostic medical devices: security requirements
Lead committee dossier:
Progress: Procedure completed
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | ECON |
POMPIDOU Alain ( EDA)
|
|
| Former Responsible Committee | ECON |
POMPIDOU Alain ( EDA)
|
|
| Former Committee Opinion | BUDG | ||
| Former Committee Opinion | RELA | ||
| Former Committee Opinion | CONT | ||
| Former Committee Opinion | ENER | ||
| Former Committee Opinion | ENVI |
TRAKATELLIS Antonios ( PPE)
|
Lead committee dossier:
Legal Basis:
EC before Amsterdam E 100A
Legal Basis:
EC before Amsterdam E 100ASubjects
Events
2002/05/07
EU - Implementing legislative act
Documents
1998/12/07
Final act published in Official Journal
Details
OBJECTIVES: to harmonise and improve the safety standards of in vitro diagnostic medical devices with a view to completing the internal market in this sector; to safeguard the health and safety of patients, users of the products in question and third parties. COMMUNITY MEASURE: European Parliament and Council Directive 98/79/EC on in vitro diagnostic medical devices. CONTENT: in vitro diagnostic medical devices are a sub-category of the medical devices defined in Directive 93/42/EEC. These devices are used in medicine for in vitro analysis of samples taken from the human body. The medical applications include analyses to evaluate the state of health (e.g. cholesterol, pregnancy), diagnose congenital diseases or anomalies, check the progress of a course of treatment (e.g. dosage and effect of drugs) or determine safety and compatibility in the case of organ or blood donations (e.g. to check for HIV or hepatitis). The directive lays down the conditions under which in vitro diagnostic medical devices may be placed on the market. It sets out the main requirements in terms of reliability of the devices, taking account of their purpose, and in terms of the protection of users and third parties. In addition, it harmonises the procedures for evaluating compliance to be applied by manufacturers before placing devices on the market. The directive requires Member States to implement a vigilance procedure so that any information which comes to their attention in relation to incidents involving devices carrying the CE mark is registered and evaluated centrally. In order to monitor the market, the directive makes provision for the implementation of a European database containing data relating to registration of manufacturers and devices, certificates and data obtained in accordance with the vigilance procedure. It states that Member States have an obligation to monitor the safety and quality of devices placed on the market. Finally, the directive makes it possible to take transitional national measures or Community measures to prohibit or restrict the placing on the market of certain products or groups of products on grounds of public health. ENTRY INTO FORCE: 7 December 1998. DEADLINE FOR TRANSPOSITION: 7 December 1999. Provision applicable from 7 June 2000.
1998/10/27
CSL - Final act signed
1998/10/27
EP - End of procedure in Parliament
1998/10/05
CSL - Act approved by Council, 2nd reading
1998/10/05
CSL - Council Meeting
1998/10/02
EC - Commission opinion on Parliament's position at 2nd reading
Documents
1998/06/18
EP - Text adopted by Parliament, 2nd reading
1998/06/18
EP - Decision by Parliament, 2nd reading
Documents
1998/06/17
EP - Debate in Parliament
Details
Commissioner Bangemann accepted all the rapporteur’s amendments, which contained welcome clarifications and additions. He was also in favour of setting up a European database in this area.
Documents
1998/06/03
EP - Committee recommendation tabled for plenary, 2nd reading
Documents
1998/06/03
EP - Vote in committee, 2nd reading
1998/06/02
EP - Committee recommendation tabled for plenary, 2nd reading
Documents
1998/04/02
EP - Committee referral announced in Parliament, 2nd reading
1998/03/26
EC - Commission communication on Council's position
Documents
1998/03/23
CSL - Council position
Documents
1998/03/23
CSL - Council Meeting
1998/03/22
CSL - Council position published
Documents
1997/11/27
CSL - Council Meeting
1997/05/21
CSL - Debate in Council
Documents
1997/05/21
CSL - Council Meeting
1996/12/20
EC - Modified legislative proposal
Documents
1996/12/19
EC - Modified legislative proposal published
Documents
1996/03/12
EP - Text adopted by Parliament, 1st reading/single reading
1996/03/12
EP - Debate in Parliament
Details
The rapporteur, Mr Pompidou (UPE, F), referred to the problems associated with this proposal, which had to reconcile two essential requirements, namely to ensure the free movement of products while at the same time protecting the health and safety of EU citizens. He thought that the ‘new approach’ was not appropriate for dealing with the problems posed by the stability of biological reactants, which in 35% of cases could lead to serious errors in diagnosis. For this reason he called for a quality control system to be introduced before and after the product was placed on the market, as this was the only way in which public health and safety could be guaranteed. Finally, the rapporteur stressed that a centralised database was needed in order to ensure consistency in the information being supplied to this sector. Commissioner Bangemann said that everyone was in favour of providing better protection for patients and declared that the Commission could accept 47 of the 78 amendments tabled. These were Amendments Nos 1 to 6, 8, 10 to 16, 19 and 21 in part, 22 to 29, 32 to 34, 36 to 39, 41, 42, 44 and 45 to 47 in part, 48 to 52, 56 in part, 58 to 60, 68 in part and 74. However, the Commission could not accept the compulsory use of labels in the national language of the country in which the product was marketed. The Commissioner went on to explain that most of the products were used by professionals who had a knowledge of foreign languages and that the cost of such a measure would be excessive, especially for smaller countries. However, he did not rule out the possibility of Member States introducing this requirement on a national basis. Finally, Mr Bangemann expressed his support for a regulatory committee.
Documents
1996/03/12
EP - Decision by Parliament, 1st reading
Documents
1996/02/06
EP - Committee report tabled for plenary, 1st reading/single reading
Documents
1996/02/06
EP - Vote in committee, 1st reading
1996/02/05
EP - Committee report tabled for plenary, 1st reading
Documents
1995/10/25
ESC - Economic and Social Committee: opinion, report
Details
The ESC endorsed the proposal and was pleased that the implementation of the in vitro diagnostic medical devices directive would remain in the hands of the Member States. This was a further indication that the concept of subsidiarity had been correctly understood by the Commission. The ESC noted that control materials for external quality assurance were expressly excluded from the scope of the draft Directive. This should be reviewed, at least in respect of stable control materials, which were frequently in no way different from those used for internal monitoring. In the ESC’s view, the directive should embrace all control materials, irrespective of the way in which they were used in medical laboratories. Exceptions could be made in the case of preparations using fresh blood, which could only be conserved for limited periods. The European standards bodies CEN/Cenelec should establish a standard in order to take account more effectively of the traceability requirement. It was important for users to continue to participate in the work of the working parties concerned on any future further development of the directive on in vitro diagnostic medical devices. The ESC considered that, particularly for self-testing devices, the ‘instructions for use’ should be in the language of the target country so that they could be understood by the users.
Documents
1995/05/24
EP - POMPIDOU Alain (EDA) appointed as rapporteur in ECON
1995/05/24
EP - POMPIDOU Alain (EDA) appointed as rapporteur in ECON
1995/05/15
EP - Committee referral announced in Parliament, 1st reading
1995/04/19
EC - Legislative proposal
Documents
1995/04/19
EP - TRAKATELLIS Antonios (PPE) appointed as rapporteur in ENVI
1995/04/18
EC - Legislative proposal published
Documents
1994/10/24
all - Additional information
Documents
- Implementing legislative act: 32002D0364
- Implementing legislative act: OJ L 131 16.05.2002, p. 0017-0030
- Final act published in Official Journal: Directive 1998/79
- Final act published in Official Journal: OJ L 331 07.12.1998, p. 0001
- Commission opinion on Parliament's position at 2nd reading: EUR-Lex
- Commission opinion on Parliament's position at 2nd reading: COM(1998)0548
- Text adopted by Parliament, 2nd reading: OJ C 210 06.07.1998, p. 0170-0194
- Text adopted by Parliament, 2nd reading: T4-0362/1998
- Decision by Parliament, 2nd reading: T4-0362/1998
- Debate in Parliament: Debate in Parliament
- Committee recommendation tabled for plenary, 2nd reading: A4-0225/1998
- Committee recommendation tabled for plenary, 2nd reading: OJ C 210 06.07.1998, p. 0009
- Committee recommendation tabled for plenary, 2nd reading: A4-0225/1998
- Commission communication on Council's position: EUR-Lex
- Commission communication on Council's position: SEC(1998)0555
- Council position: 05255/1/1998
- Council position: OJ C 178 10.06.1998, p. 0007
- Council position published: 05255/1/1998
- Debate in Council: 2007
- Modified legislative proposal: EUR-Lex
- Modified legislative proposal: OJ C 087 18.03.1997, p. 0009
- Modified legislative proposal: COM(1996)0643
- Modified legislative proposal published: EUR-Lex
- Modified legislative proposal published: COM(1996)0643
- Text adopted by Parliament, 1st reading/single reading: OJ C 096 01.04.1996, p. 0017-0031
- Text adopted by Parliament, 1st reading/single reading: T4-0115/1996
- Debate in Parliament: Debate in Parliament
- Decision by Parliament, 1st reading: T4-0115/1996
- Committee report tabled for plenary, 1st reading/single reading: A4-0031/1996
- Committee report tabled for plenary, 1st reading/single reading: OJ C 078 18.03.1996, p. 0002
- Committee report tabled for plenary, 1st reading: A4-0031/1996
- Economic and Social Committee: opinion, report: CES1153/1995
- Economic and Social Committee: opinion, report: OJ C 018 22.01.1996, p. 0012
- Legislative proposal: EUR-Lex
- Legislative proposal: OJ C 172 07.07.1995, p. 0021
- Legislative proposal: COM(1995)0130
- Legislative proposal published: EUR-Lex
- Legislative proposal published: COM(1995)0130
- Legislative proposal: EUR-Lex OJ C 172 07.07.1995, p. 0021 COM(1995)0130
- Economic and Social Committee: opinion, report: CES1153/1995 OJ C 018 22.01.1996, p. 0012
- Committee report tabled for plenary, 1st reading/single reading: A4-0031/1996 OJ C 078 18.03.1996, p. 0002
- Text adopted by Parliament, 1st reading/single reading: OJ C 096 01.04.1996, p. 0017-0031 T4-0115/1996
- Modified legislative proposal: EUR-Lex OJ C 087 18.03.1997, p. 0009 COM(1996)0643
- Council position: 05255/1/1998 OJ C 178 10.06.1998, p. 0007
- Commission communication on Council's position: EUR-Lex SEC(1998)0555
- Committee recommendation tabled for plenary, 2nd reading: A4-0225/1998 OJ C 210 06.07.1998, p. 0009
- Text adopted by Parliament, 2nd reading: OJ C 210 06.07.1998, p. 0170-0194 T4-0362/1998
- Commission opinion on Parliament's position at 2nd reading: EUR-Lex COM(1998)0548
- Implementing legislative act: 32002D0364 OJ L 131 16.05.2002, p. 0017-0030
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1) OBJECTIVE
To ensure the free movement of in vitro diagnostic devices by
harmonizing the national laws on the reliability of these
products and on the protection of the health and safety of
patients, users and third parties.
2) CONTENTS
1. This proposal applies to in vitro diagnostic medical devices.
2. These devices are products used for the in vitro analysis of
tissues or substances from the human body. The types of analysis
covered are as follows:
* state of health;
* congenital diseases or anomalies;
* checking the progress of courses of treatment;
* determining compatibility in the case of organ or blood
donations.
3. The proposal lays down the objectives or "essential
requirements" of safety, health, design and manufacture which
must be met by in vitro diagnostic medical devices when they are
manufactured and placed on the market.
4. Harmonized European standards on the prevention of risks
relating to the design, manufacture and packaging of products
are drawn up by the European standards bodies on the basis of
the essential requirements. These standards, which are not
mandatory, are published in the Official Journal of the European
Communities in the form of national standards with identical
contents.
5. Any product manufactured in accordance with harmonized
standards is presumed to conform to the essential requirements.
7. The product conformity assessment procedures and the
essential requirements are based on the modular approach set out
in Council Decision 93/465/EEC. Conformity assessment is the
responsibility of:
* manufacturers or their authorized representatives themselves;
or
* more rarely, bodies which may be designated by the Member
States in accordance with joint evaluation criteria and
notified to the Commission and the other Member States.
8. Before they can be placed on the market, devices must bear
the CE marking of conformity which:
* confirms that they conform to the provisions of this proposal;
* consists of a single graduated drawing the "CE" mark,
accompanied by the identification number of the notified body
responsible for following the procedures;
* is affixed by the manufacturer or his authorized
representative
established in the Community.
9. If a device is subject to other Directives which require "CE"
marking, the affixing of the mark also indicates that the device
conforms to the requirements of those Directives.
10. Any other mark may also be affixed to the devices provided
there is no risk of it being confused with the conformity mark.
11. Penalties must be imposed by the Member States if they find
that the mark has been unduly affixed.
12. There is a safety clause which allows any Member State, in
an emergency, to withdraw the devices, when correctly installed,
maintained and used for their intended purpose, from the market
if they may compromise the safety of property and the health
and/or safety of users or third parties.
13. Administrative cooperation and the exchange of information
between the Member States are necessary to guarantee conformity
with this proposal.
14. There is a transitional period of four years during which
the Member States will authorize the placing on the market
and/or putting into service of devices confirming to the rules
in force in their territory from the date of adoption of this
proposal.
Source : European Commission - Info92 - 02/96�
New
Following the splitting of the initial Commission proposal and the adoption of Directive 98/79/EC concerning in vitro diagnostic medical devices, the proposed amendment seeks to extend the scope of application of Directive 93/42/EEC to medical devices incorporating derivatives of human blood and human plasma only.�
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Following the splitting of the initial Commission proposal and the adoption of Directive 98/79/EC concerning in vitro diagnostic medical devices, the proposed amendment seeks to extend the scope of application of Directive 93/42/EEC to medical devices incorporating derivatives of human blood and human plasma only.�
New
1) OBJECTIVE
To ensure the free movement of in vitro diagnostic devices by
harmonizing the national laws on the reliability of these
products and on the protection of the health and safety of
patients, users and third parties.
2) CONTENTS
1. This proposal applies to in vitro diagnostic medical devices.
2. These devices are products used for the in vitro analysis of
tissues or substances from the human body. The types of analysis
covered are as follows:
* state of health;
* congenital diseases or anomalies;
* checking the progress of courses of treatment;
* determining compatibility in the case of organ or blood
donations.
3. The proposal lays down the objectives or "essential
requirements" of safety, health, design and manufacture which
must be met by in vitro diagnostic medical devices when they are
manufactured and placed on the market.
4. Harmonized European standards on the prevention of risks
relating to the design, manufacture and packaging of products
are drawn up by the European standards bodies on the basis of
the essential requirements. These standards, which are not
mandatory, are published in the Official Journal of the European
Communities in the form of national standards with identical
contents.
5. Any product manufactured in accordance with harmonized
standards is presumed to conform to the essential requirements.
7. The product conformity assessment procedures and the
essential requirements are based on the modular approach set out
in Council Decision 93/465/EEC. Conformity assessment is the
responsibility of:
* manufacturers or their authorized representatives themselves;
or
* more rarely, bodies which may be designated by the Member
States in accordance with joint evaluation criteria and
notified to the Commission and the other Member States.
8. Before they can be placed on the market, devices must bear
the CE marking of conformity which:
* confirms that they conform to the provisions of this proposal;
* consists of a single graduated drawing the "CE" mark,
accompanied by the identification number of the notified body
responsible for following the procedures;
* is affixed by the manufacturer or his authorized
representative
established in the Community.
9. If a device is subject to other Directives which require "CE"
marking, the affixing of the mark also indicates that the device
conforms to the requirements of those Directives.
10. Any other mark may also be affixed to the devices provided
there is no risk of it being confused with the conformity mark.
11. Penalties must be imposed by the Member States if they find
that the mark has been unduly affixed.
12. There is a safety clause which allows any Member State, in
an emergency, to withdraw the devices, when correctly installed,
maintained and used for their intended purpose, from the market
if they may compromise the safety of property and the health
and/or safety of users or third parties.
13. Administrative cooperation and the exchange of information
between the Member States are necessary to guarantee conformity
with this proposal.
14. There is a transitional period of four years during which
the Member States will authorize the placing on the market
and/or putting into service of devices confirming to the rules
in force in their territory from the date of adoption of this
proposal.
Source : European Commission - Info92 - 02/96�
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