Leveraging Your CE Mark With a Certificate of Free Sale.
The medical device regulation (EU) 2017/745 (MDR) and the in vitro diagnostic medical device regulation (EU) 2017/746 gives a clear pathway for manufactures on how to obtain a Certificate of Free Sale (CFS): 1) EU based manufactures must apply to the competent authority in the EU member state they are located. 2) Manufacturers located outside … Read more

