Five significant elements include:
1. From now on there will be a joint assessment conducted by experts from the European Commission and Member States prior to the designation of any notified body.
2. Member States will have strengthened surveillance and monitoring of the notified bodies. Anybody which fails to meet the requirements will have its designation withdrawn.
3. Further clarification of the skills and experience that staff of notified bodies have to have.
4. In terms of functioning of notified bodies, they will be able to carry out random and unannounced factory audits and to check samples of materials and final products (for substitutions or adulteration of materials).
The measures are laid down in a Commission Implementation Regulation on the designation of notified bodies (responsible for inspecting manufacturers of medical devices) and a Recommendation clarifying the tasks of these bodies in terms of control and checking of medical devices.
EU Commissioner for Consumer Policy, Neven Mimica, said: "With today's measures the European Commission further strengthens the safety of medical devices. We now have a clearer basis for unannounced audits, sample testing, or joint assessments by notified bodies. Full clarity can only be achieved through amending the basic legislation. I am committed to support the Parliament and the Council with a view to completing the on-going revision by early next year."
The medical devices sector covers some 10,000 types of products, anything from plasters to pacemakers.
See also: Medical Devices
Commission proposals for a regulation on medical devices and in vitro diagnostic medical devices were published in September 2012 and will be discussed by MEPs tomorrow (Wednesday, 25 September) at the Committee on the Environment, Public Health and Food Safety in Brussels.