September 1, 2023
Following the recent update on the Swiss Database on Medical Devices (Swissdamed), it’s important to remind medical device and in vitro diagnostic (IVD) manufacturers of key regulatory compliance requirements in Switzerland now that the Mutual Recognition Agreement (MRA) regarding conformity assessments between the country and the European Union has expired.
Third-country status and what that means for compliance
The MRA between Switzerland and the EU expired following dates of application of the European Medical Devices Regulation (MDR) in 2021 and In Vitro Diagnostic Medical Devices Regulation (IVDR) in 2022. In lieu of a new MRA, Switzerland now holds “third country” status in relation to the EU; as such, products including medical devices and IVDs may no longer be shipped freely between Switzerland and the EU.
Now, manufacturers must meet requirements of Switzerland’s Medical Devices Ordinance (MedDO) and Ordinance on In Vitro Diagnostic Medical Devices (IvDO); register with Swiss medical device market regulator SwissMedic; and appoint Swiss Authorized Representatives (CH-REP) to manage their device registrations in the country. Swiss regulations do align closely with requirements of the EU MDR and IVDR, and CE certifications are still recognized in the country; however, it is expected that devices authorized by the US Food and Drug Administration (FDA) will be recognized in future Swiss legislation.
CH-REP compliance deadlines have passed
Medical device and IVD manufacturers should be aware that all deadlines for designating the CH-REP have passed, and remain in force unless and until Swiss and EU governments establish a new MRA.
For medical device manufacturers, key deadlines were:
- December 31, 2021 for Class III, Class IIb implantable and active implantable devices
- March 31, 2022 for Class IIb non-implantable and Class IIa devices
- July 31, 2022 for Class I devices
For IVD manufacturers, deadlines were:
- December 31, 2022 for Class D devices
- March 31, 2022 for Class B and C devices
- July 31, 2023 for Class A devices
Manufacturers must also verify that their labeling includes information identifying their CH-REPs.
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