Back to Contents

Volume: 4 Issue: 3
(March 2017)

Keywords:
eu council adopts latest versions medical device regulations council eu adopted 7 march 2017 latest texts draft regulation medical

Jurisdictions:
EU

Options:
Share This Page



EU Council adopts latest versions of medical device regulations

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.

Search Publication Archives



Our publication archives contain all of our articles.
Can’t find what you are looking for?
Try an Advanced Search

Log in to digital health legal
Subscribe to digital health legal
Register for a Free Trial to digital health legal
Sign up for e-mail alerts
digital health legal Pricing

Social Media

Follow digital health legal on TwitterView digital health legal LinkedIn Profiledigital health legal RSS Feed