The mandate and liability
What the AR agreement covers.
Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
Since 26 May 2021, when the MDR became applicable without an updated EU-Switzerland Mutual Recognition Agreement for medical devices, Swiss manufacturers have been treated as third-country manufacturers in the EU.
The MRA chapter on medical devices was not updated for the MDR. Swiss manufacturers therefore need an EU Authorised Representative to place devices on the EU market, and their devices need an EU importer. In the other direction, EU manufacturers need a Swiss Authorised Representative (CH-REP) for the Swiss market under Swiss law.
Yes. Without an updated MRA for medical devices, Swiss manufacturers are treated as third-country manufacturers under the MDR and IVDR.
Since the MDR became applicable on 26 May 2021; the same applies under the IVDR.
No. The Authorised Representative must be established in the EU.
What the AR agreement covers.
Label requirements for non-EU manufacturers.
Economic operator registration.
Note: This guide provides general information about Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), not legal advice. Specific obligations depend on your device and company structure. Last reviewed 30 September 2026.
Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.