Description: S4M Europe - Prestation de mandataire européen - Authorised representative - MDR (EU) 2017/745 - REGISTRATIONS
s4m europe - prestation de mandataire européen - authorised repr (1)
Welcome to S4M EUROPE
All medical device manufacturers are facing the requirements of the new European Medical Device Regulation : MDR (EU) 2017/745, if they want to continue selling their products on the European market.
The manufacturers based out the Europe and who wish to sell their products in the European Union are also impacted by this regulation. They first need an Authorised Representative (EC REP) as per article 11 of MDR.