Swiss Authorized Rep
For Medical Device & IVD Manufacturers
MedEnvoy is an official Authorized Representative (CH-REP) in Switzerland
Switzerland was never a member of the European Union but in the interest of ensuring a smooth bilateral flow of goods across borders, it has traditionally signed Mutual Recognition Agreements (MRA) with the EU. When the EU Medical Device Regulation (MDR) took effect, an agreement to renew the medical device MRA had not been reached. Although the Swiss had updated their Medical Device Ordinance (MepV, MedDO) to diligently copy the MDR, without an MRA Switzerland became a “third country” to the EU, much like the UK. As such medical device and IVD manufacturers without a registered office in Switzerland must now appoint a local Swiss Authorized Representative and Swiss Importer to continue selling in Switzerland. MedEnvoy provides both services.
Medical device and IVD compliance is our singular focus. 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 regarding labeling, registration, technical documentation, importer appointment, incident reporting and more. We will guide you on how to most efficiently comply with the Swiss regulations, which are regularly updated.
We understand Swiss, EU and UK requirements
As your Swiss Authorized Representative we will:
✓ Advise you on labeling changes to comply with MedDO requirements
✓ Review your labeling to ensure ongoing compliance
✓ Fulfill vigilance and incident reporting requirements required of Swiss ARs
✓ If reportable events occur in Switzerland, cooperate with Swissmedic as required by law
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 early enough to ensure an uninterrupted flow of shipments into Switzerland. A reasonable lead time is 4-6 months. As your representative in Switzerland, MedEnvoy can help ensure you meet these deadlines.
Class IIb, Class III and active implantable devices: Swiss AR required by December 31, 2021
Class IIa, Class IIb non-implantable devices: Swiss AR required by March 31, 2022
Class I and System/Procedure Packs: Swiss AR required by July 31, 2022
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.