Review of the Medical Device Directive: an effective evaluation of the functioning of the...

Commitment to review the Directive

The Medical Device (MD) Directive (93/42/EEC) requires the European Commission to submit, no later than five years after the date of implementation of the MD Directive, a report to the European Council on the operation of certain provisions of the Directive. These provisions include the management of incidents, clinical investigations conducted in accordance with Annex VIII of the Directive, and design examination and EC type examination of medical devices that incorporate as an integral part a medicinal substance liable to act on the