MEP proposes tighter tests on potentially risky medical devicesBMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f2940 (Published 08 May 2013) Cite this as: BMJ 2013;346:f2940
- Rory Watson
A German Socialist member of the European parliament is leading moves to introduce more stringent market authorisation procedures in the European Union on medical devices that present the highest potential risks to patients. Dagmar Roth-Behrendt is proposing that class III (the highest risk category) innovative devices be subject to a centralised approval procedure administered by the European Medicines Agency.
The initiative comes as the EU updates its existing 20 year old regulatory framework for medical devices. This task has become more urgent after the discovery last year of defective silicone gel breast implants manufactured by the French company Poly Implant Prothèse (PIP). …