The political agreement reached is still subject to the approvals (Council’s Permanent Representatives Committee and Parliament’s ENVI committee).
The agreed two draft regulations are expected to achieve a twofold aim : making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit of innovative health care solutions in a timely manner. Following the revision of the texts by the lawyer-linguists the 2 regulations will have to be formally adopted by the Council and the Parliament. The new rules will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.
http://www.consilium.europa.eu/fr/press/press-releases/2016/05/25-medical-devices/
Medical devices and in vitro diagnostic medical devices cover a wide range of products, from sticking plasters to hip replacements, and from pregnancy tests to HIV tests.
25 000 medical devices manufacturers in the EU, many of which are SMEs and which employ more than half a million persons”,.