Solution 1.

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

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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

For Manufacturers who have or want to set up a subsidiary in the European Union

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Supported by MDSS Consulting - Your partner for the best solution!

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.

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Need support with the transition to MDR?

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