From May 26, 2022, the agreement between Switzerland and the European Union on mutual recognition for the market of in vitro diagnostic medical devices will no longer apply. Until that date, Swiss manufacturers could place IVD medical devices on the European Union thanks to the Mutual Recognition Agreement (MRA) without any additional regulatory requirements. However, this will change in two days with the IVDR becoming applicable on the EU market. Contrary to the Directive, which the Regulation will replace on May 26, 2022, the MRA will no longer cover IVDs.
What does this mean for manufacturer?
Before the application of the new Regulation, Switzerland and the European Union benefited from the mutual recognition of conformity assessments, the absence of the need for an authorised representative, and the alignment of technical regulations. On the contrary, from May 26, 2022, Switzerland is considered as a third country. Therefore, the following conditions start to apply:
- Swiss manufacturers of IVDs have to undergo the assessment process through conformity assessment bodies established within the EU
- Conformity assessment certificates from Swiss bodies are no longer valid in the EU (also when issued before May 26, 2022)
- Swiss manufacturers, as any other non-EU manufacturer of IVDs, have to appoint an Authorised Representative based in the EU, if they want to sell on the European territory
From May 26, 2022, affected stakeholders (e.g. manufacturers, EU importers and distributors, authorised representatives) have to comply with the Regulation (EU) on in vitro diagnostic medical devices.
It is important to point out that the lack of a mutual agreement means that special conditions apply also for EU manufacturers who want to place their IVDs on the Swiss market.
European Commission. (2022). Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices. Retrieved on 24/05/2022 from https://ec.europa.eu/health/latest-updates/notice-stakeholders-status-eu-switzerland-mutual-recognition-agreement-mra-vitro-diagnostic-medical-2022-05-24_en