In the light of the approaching MDR date of application (26 May 2021) without the signed Mutual Recognition Agreement (MRA) between Switzerland and the European Union, the Swiss Federal Council adopted today preventive measures to avoid negative consequences that could occur in case of a ”worst-case scenario” – Switzerland obtaining the status of a ”third country”.
This could cause a disruption to the supply of safe and performing medical devices to the Swiss market and in terms of regulatory requirements, for ex. the need to appoint a Swiss Representative by any non-Swiss medical device manufacturer by 26 May 2021.
The Swiss Federal Council has confirmed today that the Modification of the Medical Device Ordinance will enter into force on 26 May 2021 to prepare for a scenario, where Switzerland no longer enjoys a special status with regard to the EU.
The Modification of the Swiss Medical Device Ordinance lays down requirements related to the appointment of an authorised representative, registration of economic operators and serious incidents to Swissmedic, UDI requirements, recognition of CE Certificates, technical documentation and also applies to IVDs for the time being.
The amendment includes important transition periods regarding the appointment of a Swiss authorised representative, which is mandatory for any non-Swiss manufacturer:
- By 31 of December 2021 for class III devices, class IIb implantable devices, and all active implantable devices.
- By 31 March 2022 for non-implantable class IIb devices and class IIa devices.
- By 31 July 2022 for class I devices, systems and procedure packs.
Furthermore, registration and notification obligations will be run via Swissmedic, as Switzerland does not have access to EUDAMED. Economic operators shall register in 3 months following the placing of a device on the Swiss market. Economic operators who have already placed products on the market before 26 May 2021 should complete their registration by 26 November 2021.
As per the concept of the Blue Guide, all devices placed on the Swiss market before 26 May 2021 are not impacted.