CE marking related to the registration medical devices in Europe.

MEDDEV 2.7.1

MEDDEV 2.7.1

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.…

EU medical Device Regulation

EU Medical Device Regulation changes

What happened before the EU Medical Device Regulation and In vitro Diagnostic Regulation ? See what changes in EU medical Device Regulation. The existing European regulatory framework originated in the 1990s consists of three directives designed to regulate about 500,000 types of medical devices (e.g. contact lenses, breast implants, x-ray machines, pacemakers) and in-vitro diagnostic…