Volume: 4 Issue: 3
The Council of the EU adopted on 7 March 2017 the latest texts of the draft Regulation on medical devices and the draft Regulation on in vitro diagnostic medical devices, marking another milestone towards the coming into force of both regulations. Political agreement on the reforms was reached by the Council and the EU Parliament last summer, with the latest texts reflecting comments by MEPs; the Parliament is now set to vote on adopting the Regulations in April this year before publication in the official journal, with the Regulations thus set to come into force in May 2017.
The draft regulations aim to update medical device rules to ensure they stay relevant given the progress of technology; measures include the creation of a central database with information on medical device products within the EU, and measures to make more clinical data about devices available to allow their continual improvement by manufacturers. Under the new rules manufacturers will be required to implement a ‘post-market surveillance system’ to monitor the quality of their devices.