Medical devices: EU reached a deal on new rules
The Netherlands presidency of the European Council and representative of the European Parliament agreed new rules on medical devices and in vitro diagnostic medical devices.
The agreement, which is still subject to approval by the Council’s Permanent Representatives Committee and of the Parliament’s ENVI committee, will endorse mid-June 2016. The new rules will apply three years after publication as regards medical devices and five years after publication as regards IVDs.
The deal reached, which includes two draft regulations, aims to ensure the safety of medical devices and in vitro diagnostic medical devices by stronger rules on placing devices on the market and by a strict post-market surveillance.
New rules establish that manufacturers will be responsible for the follow-up of the quality, performance and safety of devices placed on the market.
The aim of new rules is to improve patients’ health and to allow people benefit from innovative health care solutions in a timely manner.