Directive 2007/47/EC amends Directive 90/385/EEC on active implantable medical devices and Directive 93/42/EEC on medical devices.

The changes concern, among others, the essential requirements which medical devices must satisfy in order to be lawfully placed on the market, the corresponding conformity assessment procedures and the classification of devices.

Since Directive 2007/47/EC is addressed to the Member States, preliminary transposition into national law is indispensable for the application of the corresponding provision by the various economic operators.

Article 4 of the Directive states that the Member States "shall apply the transposition measures as from March 21 , 2010".

As no provision is made for a period of transition, a number of questions have been raised, and the following interpretation by the Commission's services are meant to be a guide to uniform practice throughout the EU.