Are you leveraging your CE mark in order to make your medical devices & IVD devices available in markets outside the European Union (EU)?
In many of these markets a Certificate of Free Sale is required to demonstrate EU compliance and forms part of the application process.
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):
- EU based manufactures must apply to the competent authority in the EU member state they are located.
- Manufacturers located outside the EU must contact their EU Authorised Representative who can apply to competent authority in the EU member state they are located. And since we are located in Malta our applications are submitted to the Malta Medicines Authority.
As is the case with many aspects of the EU it is never as straightforward as it may seem, and certain evidence of compliance will be required before the competent authority will issue a CFS. Fortunately, Medilink member Advena is experienced in making CFS applications. For those who are not yet a client of Advena and need to acquire a CFS email info@advena.mt to discuss your on boarding process.