European Council and European Parliament have reached political agreement on the medical devices and in vitro diagnostic medical devices regulations on 25 May 2016.2 The agreement is still subject to the approval by the Council's Permanent Representatives Committee and of the Parliament's ENVI committee.1
The aims of the agreed draft regulations are to make sure that medical devices and in vitro diagnostic medical devices are safe and to allow patients to benefit of innovative healthcare solutions in a timely manner. The purpose of the agreement is to ensure the safety of medical devices by strengthening the rules on placing devices on the market and tightening surveillance once they are available. 1
European Council states that next the Council's Permanent Representatives Committee will be invited to endorse the agreement probably mid-June 2016. Once the Parliament's ENVI committee has also confirmed that it can accept the compromise the Council will be invited to confirm the agreement. 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. 1
There are over 500 000 medical and in vitro diagnostic devices on the market in Europe and the sector employs over 500 000 people in about 25 000 companies.1
1. European Council / Council of the European Union: Medical devices: deal reached on new EU rules. Press release, 25.5.12016.
2. MedTech: Council and European Parliament reached political agreement on the medical devices and in vitro diagnostic medical devices regulations. 25.5.2016.