Post market surveillance in Europe One of the changes in the new European Medical Devices Regulation (MDR 2017/745) is the strengthened post market surveillance requirements for medical device manufacturers in order to register their product in the European Union. This requires manufacturers for each medical device to plan, establish, document, implement, and maintain a post…
In January 2013 new Revision 8 of MEDDEV 2.12-1 about vigilance system in Europe was posted on the European commission webpage. The document itself can be found here. We’ll highlight below the changes that occured in the new guidance.
MEDDEV 2.7.1: clinical evaluation New Regulation on Clinical Evaluation One of the changes of the Medical Device Regulation by the European Commission is the compliance with clinical evaluation. This means that a report with an expert opinion of medical professionals about the quality and safety of the medical device will not be sufficient any longer.…