Solution 1.

MDR (EU) 2017/745 / IVDR (EU) 2017/746
Article 11. MDR and additional services on request
(e.g. Vigilance)


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Solution 2.


MDR (EU) 2017/745 / IVDR (EU) 2017/746

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For Manufacturers who have or want to set up a subsidiary 
in the European Union
  • You are the Manufacturer
  • You are the Importer
  • You are the EC REP (maintained by MDSS)

Let Europe Know You!



Specifically for Swiss companies - open up your office in the EU!  

In particular, it was communicated that Swiss companies utilize their own subsidiary in the remaining EU market to cope with the EC REP requirements. MDSS has the solution for you!

See also the Information of the Swiss Manufacturer Association for Medical Devices Swiss Medtech.


Contact us for more info about this MDR/IVDR solution!



Need support with the transition to MDR?

Checklist for GSPR compliance to support manufacturers with the transition from MDD to MDR.