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Swissmedic Device/IVD Database Key Dates

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Swissmedic now handles registration of economic operators, medical devices and in vitro diagnostic medical devices directly, since the agreement on mutual recognition of conformity assessments (MRA) between Switzerland and the EU has not been updated.

  • Registration of companies and economic operators – ACT module (available early 2024)
  • Swissdamed – freely accessible platform (available early 2024)
  • Registration of devices – UDI module (available from summer 2024)

Since the Mutual Recognition Agreement (MRA) addressing conformity assessments between the country and the European Union has ended, medical device and in vitro diagnostic (IVD) manufacturers must now comply with important regulatory compliance obligations in Switzerland. The European Medical Devices Regulation’s (MDR) and the in vitro diagnostic Medical Devices Regulation’s (IVDR) effective dates of 2021 and 2022, respectively have already closed. In the absence of a new MRA, Switzerland currently has “third country” status with the EU; as a result, goods such as medical devices and IVDs can no longer be freely shipped between Switzerland and the EU.

In order to manage their device registrations in Switzerland, manufacturers must now comply with the requirements of the Medical Devices Ordinance (MedDO) and the Ordinance on in vitro Diagnostic Medical Devices (IvDO), register with Swissmedic, and designate Swiss Authorized Representatives (CH-REP). However, it is anticipated that devices approved by the US Food and Drug Administration (FDA) would be recognized under future Swiss legislation. Swiss regulations do closely accord with standards of the EU MDR and IVDR, on the other hand CE certifications are still recognized in the nation.

Key DeadlinesRisk Class
For Medical Device Manufacturers
December 31, 2021Class III, Class IIb implantable and active implantable devices
March 31, 2022Class IIb non-implantable and Class IIa devices
July 31, 2022Class I devices
For IVD Manufacturers
December 31, 2022Class D devices
March 31, 2022Class B and C devices
July 31, 2023 Class A devices