Swiss Authorized Rep
For Medical Device & IVD Manufacturers
MedEnvoy is an official Authorized Representative registered with Swissmedic
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 could not be reached. Although the Swiss had updated their Medical Device Ordinance (MedDO) to generally 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 Swiss regulations.
We understand overlapping 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
✓ Make a copy of your technical file available for Swissmedic, if needed
Deadline for appointing your Swiss Authorized Representative
You will be required to appoint a Swiss AR by the deadlines shown below. As your representative in Switzerland, MedEnvoy can help ensure you meet 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 get an early start to ensure an uninterrupted flow of shipments into Switzerland.
Class IIb, Class III and active implantable devices: Swiss AR required by 31 December 2021
Class IIa, Class IIb non-implantable devices: Swiss AR required by 31 March 2022
Class I and System/Procedure Packs: Swiss AR required by 31 July 2022
Medical devices that have obtained CE Marking under the EU MDR will be regulated under MedDO and require a Swiss AR. Manufacturers holding valid CE certificates issued under the old EU Medical Devices Directive (MDD) and which currently have an EU Authorized Representative can continue to sell those devices in Switzerland until the deadlines noted above.