In the light of the upcoming renewal of the Mutual Recognition Agreement (MRA) between Switzerland and the European Union, the Swiss Federal Office of Public Health has prepared an amendment to the not yet adopted Contingency MedDO (Medical Device Ordinance), which will enter into force next 26 May 2021 in case the MRA is not updated by the referred date.
The amendment includes the following transition periods regarding the appointment of a Swiss representative and labelling requirements:
- Until 31 of December 2021 for class III devices, class IIb implantable devices, and all active implantable devices.
- Until 31 March 2022 for non-implantable class IIb devices and class IIa devices.
- Until 31 July 2022 for class I devices, systems and procedure packs.
Furthermore, registration and notification obligations will be run via Swissmedic. Accordingly, economic operators who have already placed products on the market before 26 May 2021 in accordance with MDR and IVDR should complete their registration by 26 November 2021.
Access to technical documentation might be provided either by keeping a copy available at the authorized representative or by contractually guaranteeing that it will be handed over to Swissmedic upon request within 7 days.
Concerning the validated Summary of Safety and Clinical Performance (SSCP), it will be published by the manufacturer instead of uploaded by the Notified Body to EUDAMED.
Without prejudice to the established transition periods, Swiss Medtech ask those foreign companies which will no longer be willing to sell their products in the Swiss market to notify any stoppages, clarifying that the report will be included in the list of potentially missing medical products in the country – a list which will be periodically send to the Federal Council in anonymized form and which will be operational since October 2021.
As mentioned, the Contingency MedDO will only enter into force in case the MRA is not updated by 26 May 2021, trust MDlaw to keep you posted!