Swiss Authorized Rep
For Medical Device & IVD Manufacturers
MedEnvoy is a Registered Authorized Representative (CH-REP) in Switzerland
Serving 100+ Manufacturers Worldwide
One of Switzerland’s Largest CH-REP Providers
Switzerland was never a member of the European Union but has traditionally ensured a smooth bilateral flow of goods across borders using a Mutual Recognition Agreement (MRA) with the EU. When the EU Medical Device Regulation (MDR) took effect, the MRA has not renewed. Although the Swiss had updated their Medical Device Ordinance (MepV, MedDO) to transpose the MDR into Swiss law, the lack of an MRA meant Switzerland became a “third country” like the UK. That’s why medical device and IVD manufacturers without a registered office in Switzerland must now appoint a local Swiss Authorized Representative and Swiss Importer. MedEnvoy provides both services.
As Your Swiss Authorized Representative We Will:
We fully understand the specific requirements imposed on manufacturers by Swissmedic and the Swiss Medical Devices Ordinance (MedDO) and how those overlap with specific EU MDR/IVDR and UK MMDA requirements. We will guide you on how to comply with the Swiss regulations most efficiently. We will:
✓ Advise you on labeling changes to comply with MedDO requirements
✓ Review your labeling to ensure ongoing compliance
✓ Assist in device registrations with Swissmedic
✓ Fulfill vigilance and incident reporting requirements required of CH-REPs
✓ Cooperate with Swissmedic if reportable incidents occur
Deadlines for Appointing Your Swiss CH-REP
You will be required to appoint a Swiss AR by the deadlines shown below. Because it can take several months to modify your labeling, review/sign contracts and register with Swissmedic, we recommend that you select your Swiss AR now to ensure an uninterrupted flow of shipments into Switzerland. As your representative in Switzerland, MedEnvoy can help ensure you meet these deadlines.
Class I + System/Procedure Packs: July 31, 2022
Class IIa/IIb Non-Implantable: March 31, 2022
Class IIb/III + Active Implantable: December 31, 2021
Medical devices that have obtained CE Marking under the EU MDR or the old Medical Devices Directive (MDD) will require a Swiss AR. If you hold valid CE certificates issued under the MDD, please ask us for details.