Following the entry into force of the EU Regulation 2017/745 on medical devices in May 2021 and following the failure in finding an agreement between the European Union and Switzerland on the update of the Mutual Recognition Agreement (MRA), in order to distribute medical devices in Switzerland, it is necessary to identify an authorized representative within the Swiss territory (Swiss AR).
Recently Swiss Medtech, the association of Swiss medical technology companies, updated the guidance for importers and distributors to better detail the implications of identifying a Swiss AR.
Swiss Medtech confirmed that the Swiss AR is mandatory for any manufacturer not based in Switzerland that wants to place its products on the Swiss market; the manufacturer will have to designate a single Swiss AR for all products of a generic device group.
The identified Swiss AR should at least:
- be reported on the packaging of the product;
- have permanently and continuously at its disposal at least one person responsible for regulatory compliance (to be noted that the responsibilities of this person are basically the same identified by the EU in article 15 of the EU Regulation 2017/745);
- be registered with Swissmedic (i.e. the Swiss Competent Authority);
- fulfill the obligations of manufacturers to report serious incidences and field safety corrective actions within Switzerland to Swissmedic.
The following transitional periods have been defined for the designation of Swiss ARs
- for class III devices, class IIb implantable devices and active implantable medical devices: until 31 December 2021
- for non-implantable class IIb devices and class IIa devices: until 31 March 2022
- for class I devices as well as systems and procedure packs: until 31 July 2022
Regulatory Pharma Net is always available to provide you with up-to-date information on the regulatory requirements of medical devices and to support your company with any need in relation to medical devices.