Are you a Manufacturer domiciled outside of Switzerland and wanting to market your Medical Devices in Switzerland?
Since 26 May 2021, with the full application of the MDR (EU) 2017/745 and having not reached an institutional agreement, Switzerland is officially considered a “Third Country” for Europe.
What is the timetable for appointing a Swiss AR?
Art. 104 of MedDo outlines the following transition periods for the appointment of a Swiss Authorised Representative:
- by 31 December 2021 for class III devices, class IIb implantable devices and active implantable devices;
- by 31 March 2022 for non-implantable class IIb devices and class lla devices;
- by 31 July 2022 for class I devices.
For systems and procedure packs, a Swiss AR must be appointed by 31 July 2022 (Art. 51 paragraph 5).
Thema is able to carry out the service of Swiss Authorised Representative in full compliance with the Swiss regulation.
As Swiss Authorised Representative (CH REP), Thema is in charge of:
- Fulfilling reporting obligations to the Regulatory Authority Swissmedic.
- Taking action in case of field corrective actions and adverse events.
- Ensuring compliance with post-market surveillance obligations.
- Registering the devices on the Swissmedic database within the prescribed time.
Thema assures compliance with the assigned obligations through a process-managed corporate structure according to ISO 13485:2016 Standard.
Download CH REP service document
