License Holding

CE Rep & CE Marking

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Before the medical device can be marketed and supplied in the European market, the manufacturer must appoint an EC Representative for manufacturers not based in Europe. The product must be affixed with the EC Rep and the CE marking by undergoing conformity assessment to demonstrate the device has met the essential requirements defined in the applicable requirements in:

 

  • European Medical Device Regulation (MDR 2017/745), with 3 years transition and extended until effective on 26 May 2021

 

  • In-vitro Diagnostic Medical Device Regulation (IVDR 2017/746), with 5 years transition until effective on 26 May 2022

 

  • EU MDD/AIMDD/IVDD directives