Manufacturers and EU Authorized Representatives in Switzerland

News: 21 April 2021

Switzerland and the EU have been in discussions about the future agreement between the two geographies related to medical devices and several other product types. The two parties have not agreed on the Institutional Framework Agreement nor the Mutual Recognition Agreement (MRA) covering medical devices. Please see the following for background reference. 

Mutual Recognition Agreements

Switzerland to become an EU third country
If the current MRA between Switzerland and EU is either not extended to include MDR or other temporary measures put in place, Switzerland will officially become a third country on 26 May 2021 in the context of medical devices covered by MDD and AIMDD. At that point, Manufacturers based in Switzerland will need to appoint an EU Authorized Representative (EUAR) in one of the EU 27 countries or Northern Ireland by 26 May 2021 for continued access to the European Market. Similarly, non-EU based Manufacturers with an EUAR based in Switzerland will have to appoint an EUAR based in one of the EU 27 countries or Northern Ireland. 

We understand that the situation may be a temporary disruption and that both Switzerland and the EU hope that agreements will be completed; however, they do not believe this will happen before the 26 May 2021 deadline. 
What does this mean for my products?
You will need an AR in an EU 27 countries or Northern Ireland and to update your product labelling urgently. You may struggle to place your products on the market if your labelling is not updated to reflect the EU 27 AR during the period where an MRA is not completed. Please prioritize your labelling plans to ensure continuous supply into the European Union.

My product is in the supply chain
We understand that you will have products in the supply chain, so we would like to confirm what we, as a notified body, will look for at each stage:

  1. Products already in the supply chain no longer owned by the manufacturer may retain the old labelling.
  2. For products still owned by the manufacturer in the distribution chain or on consignment in the hospital, Member States that are responsible for market surveillance may require updated labelling.
  3. For products in production over the next few months, we would accept over labelling as an interim solution, but we would expect to see plans for transitioning the labelling to the new AR.

Where can I find further information?
Detailed information is provided by the Swiss MedTech Group.

We are monitoring the situation and further information will be shared as we receive updates.

- ENDS -