Gain market access in Europe with CE Mark approval for your Medical Devices
Medical Device (IV/MDD/AIMD) CE marking is the manufacturer’s declaration that the medical device manufactured and sold in Europe meets the appropriate regulatory requirements.
The Medical Device in USA are regulated by FDA whereas the European Union consists of all member countries follow CE Marking (MDD /IVD/AIMD) regulation. The new regulation which is released will be effective from March 2020 is called Medical Device Regulation (MDR)
The FDA classification of Medical Device is Class 1, 11 and 111 whereas the EU classification is Class 1, Class 1s, Class 1m, Class 11a, Class 11b and Class 111.
Medical Device CE Marking Certificate is provided by Notified Body after review of Technical File whereas in USA FDA will review the Files and gives the approval only.
It is very important to hire the service of experienced consulting firm for properly plan the certification, which will help to reduce the timeline and disqualification chance.