Switzerland participates in the internal market of the European Union through the Agreement on Mutual Recognition in relation to conformity assessment (MRA). In the absence of an update of the MRA to include Regulation (EU) 2017/746, the part of the MRA chapter covering in vitro diagnostic medical devices ceased to apply as of 26 May 2022. Switzerland is thus considered a third country in the field of in vitro diagnostic medical devices. This is also clearly expressed in the European Commission’s notice setting out the following consequences for in vitro diagnostics after 26. May 2022 (quote):
- For all new in vitro diagnostic medical devices, Swiss manufacturers will be treated as any other third country manufacturer intending to place its devices on the EU market. In particular, in vitro diagnostic medical devices of Swiss manufacturers requiring certification on the basis of a conformity assessment procedure must be certified by conformity assessment bodies established within the EU.
- Certificates issued under the MRA by conformity assessment bodies established in Switzerland will no longer be recognised as valid in the EU even if they were issued before 26 May 2022.
- For in vitro diagnostic medical devices placed on the market after 26 May 2022, Swiss manufacturers and third country manufacturers whose authorised representative was previously established in Switzerland must designate an authorised representative established in the EU.
The consequences are identical to the consequences that apply to medical devices from the entry into force of Regulation (EU) 2017/745 on 26 May 2021 and published in the European Commission Notice of 26 May 2021.
On 19 May 2021, the Swiss Federal Council adopted an amendment to the Swiss Medical Devices Ordinance (MedDO) establishing conditions for trade of medical devices covered by EU issued certificates on the Swiss market. This includes the recognition of existing certificates issued under the MRA by conformity assessment bodies established in the EU and transitional timelines for the designation of a representative in Switzerland for EU/EEA manufacturers of medical devices.
See here for more information on MedDO.
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