European Authorized Representative

(EC REP)

Medical Devices
MDR (EU) 2017/745
MDD (EU) 93/42/EEC

In-Vitro Devices
IVDR (EU) 2017/746
IVDD (EU) 98/79/EC


The appointment of an European Authorized Representative (EC REP) for the Member States outside of the EU is a requirement of the European Medical Device Regulations to place medical and in-vitro devices in the EU Market.


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