The modified Commission proposal on in vitro diagnostic medical devices incorporates a number
of amendments adopted by Parliament, and in particular those concerning:
- clearer demarkation of the scope in comparison with Directive 89/392/EEC relating to machinery;
- the clarification that the aspects concerning medical prescriptions for devices are not affected by
the harmonizations;
- the tightening-up of the protection requirements with a view, in particular, to minimizing the risks,
including the risks relating to the packaging;
- the clarification of the powers of the Member States' authorities and the strengthening of their
market surveillance powers;
- the establishment of a European Union database on the products placed on the market;
- extension of the group of in vitro diagnostic devices which must be submitted to third-party
certification before they are placed on the market;
- the inclusion in the scope of Directive 93/42/EEC of certain medical devices manufactured using
products derived from human tissues or cells;
- the amendments to Directive 93/42/EEC to bring it closer into line with this Directive.
The Commission has not approved the amendments concerning: the obligation that the information
accompanying the products placed on the market must be available in the national language(s); the
type of committee; application of the transitional system for notification of devices placed on the
market to all Member States.
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