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�