News
EU Regulation on medical devices |
14-10-2015 |
Christine Dawson
ESIP letter concening the trilogue discussions on the proposed EU Regulation on medical devices
On 12 October, ahead of the start of Trilogue discussions on the proposed EU Regulation on medical devices [COM (2012) 542], ESIP sent a letter to the rapporteur and shadows at the European Parliament, the Commission and the Luxembourg Presidency once again underlining their demands in four key areas.
- ensuring that notified bodies are sufficiently qualified and have the relevant expertise within their organisation;
- the requirement for high-quality clinical investigations for all class III devices and class IIb implantable medical devices;
- stronger provisions regarding transparency, particularly as regards clinical data;
- the obligation for medical device manufacturers to take out liability insurance
