Medical Devices Regulation – finalisation European Parliament end 2015?
EU 2012/0266 to replace DD (93/42/EEC) and AIMDD (90/385/EEC)
EU 2012/0267to replace IVD Directive (98/79/EC)
According to recent estimates, people in Europe aged >65 will double until 2060, why medical devices an in vitro diagnostic medical devices will become increasingly important in the public health and medical care.
Under the Luxembourgian presidency, major progress shall be achieved by end of 2015 to finalize the rules on medical devices. The Council agreed on two draft regulations aimed at modernizing EU rules on medical devices and in vitro diagnostic medical devices. These include a wide range of products, from sticking plasters to hip replacements, pacemakers and laboratory tests for assessment of medical interventions.
The main objective of the two draft regulations is to ensure that medical devices are safe.
This should be achieved by increased control of devices before entering the market, and strengthening the rules on placing devices on the market, when they become available.
The rules for the designation of “Notified Bodies” have been tightened (e.g. unannounced inspections). Additional provisions are added on Manufacturers´ responsibility on quality and performance. The traceability of medical devices shall be granted by unique device identification number (UDI) as a registration process in a central EU Database, also to ease the recall of a product cross border. An EU Portal for the report of serious incidents will be set up. Aiming for reliable clinical data, there are continuous efforts for clinical investigation. In order to give more transparency for the patients, key information on the products, for high risk devices even a summary of safety, some clinical data and the performance shall be publicly accessible.