An amendment to the Medical Devices Ordinance (MedDO) has been prepared, which will come into force on 26 May 2021 if the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) has not been updated by that date. This amendment is referred to as the Eventual-MepV (Contingency MedDo), but the explicit content is not publicly available yet. As the clock is relentlessly ticking towards 26 May 2021, Swiss Medtech has been able to share some relevant information for the industry to prepare for the regulatory requirements the amendment introduces:
Swiss Authorised Representative: The Eventual-MepV provides for transitional periods for the appointment of a Swiss authorized representative, including corresponding labelling:
- Until 31 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.
Access to the technical documentation: Access to the technical documentation may be provided by keeping a copy available on the authorized representative’s premises or by a contractually guaranteed assurance that delivery will occur within seven days at Swissmedic’s request.
Registration obligations: In the absence of Eudamed, registration obligations will be fulfilled by submitting information to Swissmedic. Economic operators who have already placed devices on the market before 26 May 2021 following the MDR and IVDR must complete the registrations by 26 November 2021.
Summary of Safety and Clinical Performance (SSCP): The validated SSCP is not uploaded by the Notified Body in Eudamed but has to be made publicly available by the manufacturer - for example, on its website.