Autorised representative

All manufacturers of Medical Devices and IVDs based outside the territory of the European Union must have their representative in the territory of the European Union who maintains relations with the Competent Authorities in accordance with the provisions of European Regulations 745/2017 and 746/2017. With regard to marketing in Switzerland, Switzerland has officially become a Third Country since May 26, 2021, following the full application of MDR (EU) 2017/745 in Europe, and the new Swiss Law on Medical Devices came into force. and the revision of the Ordinance relating to Medical Devices ODmed RS 812.213.

This ordinance provides that Swiss Manufacturers must designate a European Authorized Representative (or Authorized Representative) to export their devices to Europe and, at the same time, that European Manufacturers must appoint a Swiss Authorized Representative (or Authorized Representative) CH REP to export their made in Switzerland.

Depending on the risk class of the device, Article 104a ODmed provides for different transition periods and the CH REP must be appointed in compliance with the following deadlines:

by 31 December 2021 for class III devices, class IIb implantable devices and active implantable medical devices;

by 31 March 2022 for non-implantable class IIb devices and class IIa devices;

by 31 July 2022 for class I devices.

Article 51 paragraph 5 MedD provides for the following transition period for the appointment of a Swiss Authorized Representative:

by 31 July 2022 for procedural systems and kits.

The Agent must:

Assist the manufacturer in reporting and managing incidents, in collaboration with the manufacturer and distributors

Be identified on product labeling

Have an updated copy of the technical file available for inspection by a competent authority upon request

Of course it is possible to identify a distributor as an authorized representative in Europe, as in other parts of the world, but it is certainly recommended, for an adequate protection of the manufacturer, as well as the confidentiality of regulatory information, to choose an independent agent focused on regulatory issues, rather than on the development of the market, which in the future could become the agent and distributor of a competitor.

Since its inception, Device & Care has played the role of "agent" for various foreign manufacturers, guaranteeing maximum confidentiality, professionalism and speed in protecting the interests of the manufacturer.