Jun 8, 2022

A mutual recognition agreement (MRA) aligning in vitro diagnostic (IVD) regulations between the European Union and Switzerland has officially expired following the In Vitro Diagnostic Medical Devices Regulation’s (IVDR) May 26, 2022 date of application, impacting certification and authorized representation requirements for manufacturers.

The European Commission has issued new guidelines covering how the expired MRA affects IVD manufacturers now that the IVDR has taken effect in Europe and the Ordinance on In vitro Diagnostic Medical Devices (IvDO) has come into force in Switzerland.

CE Marking and in-country representation effects

As became the case in May 2021, when the European Medical Devices Regulation (MDR) came online without an updated MRA between the EU and Switzerland, Swiss manufacturers of IVDs are now treated as any other “third country” manufacturers seeking CE Marking to sell their devices in the EU. Third-country designation affects CE Mark certification as well as Authorized Representation requirements.

This means that new IVDs developed by Swiss manufacturers must undergo EU conformity assessment body (CAB) review and certification. Furthermore, existing certificates issued under the erstwhile MRA for IVDs by CABs in Switzerland—even those issued before May 26, 2022—are in many cases no longer valid in the EU.

In cases where IVD devices are placed on the EU market after the IVDR May 26, 2022 date of application, any third-country manufacturers including those based in Switzerland must designate a European Authorized Representative established in an EU member state; Authorized Representatives based in Switzerland may no longer meet in-country representation requirements under the IVDR.

Swiss IvDO and EU IVDR timelines

The Swiss government has issued its own guidance on the IvDO, as well. The Swiss regulation aligns closely with the IVDR in terms of requirements for manufacturers, and also follows the IVDR’s transitional timelines regarding compliance deadlines according to IVD risk classifications as well as designations of Swiss Authorized Representatives.

Learn more about IVD regulations in Switzerland and Europe at Emergo by UL:

Author

  • Stewart Eisenhart

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