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.
S4M EUROPE (Solution For Manufacturers) is a company providing services as a European Authorised Representative (EC-REP) in accordance with the MDR (EU) 2017/745. As an Authorised Representative, we provide a registered address in the European Union for the manufacturers based outside the Europe, and represent them towards the European Commission, Competent Authorities and Notified Bodies.
The main tasks of an EC-REP are:
We collaborate with QA/RA Experts, lawyers and working in partnership with others experts in the medical devices field.