The Commission proposes important changes regarding various aspects relevant for the life-cycle of medical devices, such as the scope of the legislation, the pre-market assessment of devices, their control once on the market, the transparency of data concerning marketed devices and the management of the regulatory system by the authorities.
The revised regulatory framework for medical devices is comprised of the following:
- A proposal for a Regulation on medical devices (to replace: Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices);
- A proposal for a Regulation on in vitro diagnostic medical devices (to replace Directive 98/79/EC regarding in vitro diagnostic medical devices).
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