… and why a Swiss REP is required.
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Swiss Authorised Representative
Medical devices (MD)
From 26 May 2021, it is mandatory that non-Swiss based manufacturers designate a Swiss-based Authorised Representative. This is a result of the Mutual Recognition Agreement on medical devices, between Switzerland & the European Union, not being updated with the MDR. This caused Switzerland to become a third country and ended the mutual recognition. The same is expected to happen from 26 May 2022.
At Obelis, we …
- assume the role of Swiss Authorized Representative
- ensure technical documentations have been drawn up
- keep a copy of technical documentations readily available for inspection
- cooperate and Provide SwissMedic all information upon request
- inform the manufacturer of complaints and incidents
- perform actor registration via SwissMedic
- register devices to SwissMedic
- provide ongoing regulatory news and updates
Swiss law has clearly defined the role and tasks of a Swiss Authorised Representative, where professionalism and qualifications need to be at the same level of those under the EU MDR. This means that it is highly recommended to designate a professional agency as CH Authorised Representative.
Non-Swiss manufacturers should designate a CH Authorised Representative at the latest:
- By 31 of December 2021 for class III devices, class IIb implantable devices, and all active implantable devices.
- By 31 March 2022 for non-implantable class IIb devices and class IIa devices.
- By 31 July 2022 for class I devices, systems and procedure packs.
Economic operators based in Switzerland – i.e., manufacturers, importers, authorised representatives, persons who assemble systems and treatment units – need to register to Swissmedic to obtain Swiss Single Registration Number (CHRN), which will serve as the identification number in diverse contexts and processes.
- Within 3 months following the placing of a device on the Swiss market.
- By 26 November 2021 for companies who have already placed products on the market before 26 May 2021.
In-vitro medical devices (IVD)
From May 26, 2022, the agreement between Switzerland and the European Union on mutual recognition of in vitro diagnostic medical devices no longer applies. From this date, Switzerland is considered as a third country.
On May 4, 2022, Swiss legislator has officially adopted the new Swiss IVD Ordinance (IvDO). This means that IVD manufacturers need to be compliant with the new Swiss IVD Ordinance if they want to place IVDs on the Swiss market.
The deadlines to appoint a Swiss Authorized Representative (CH-REP) under the IvDO for manufacturers already on the market are:
- Class D → December 31, 2022
- Class C & B →March 31, 2023
- Class A → July 31, 2023
Manufacturers entering the Swiss market after May 26, 2022, must appoint a Swiss Authorized Representative immediately.
Cosmetics (COS)
For the moment, EU Cosmetics Regulation should be followed to enter the Swiss market. Contact us for further details, or find more information here.