Designated bodies

A designated body (Swiss term) is the same as a notified body (EU term).  

Designated bodies verify medical devices’ compliance with legal requirements. These bodies carry out conformity assessment procedures for all devices classified outside the lowest risk classification. Once the procedure has been successfully concluded, the manufacturer is issued with the corresponding certificate(s) empowering it to place its devices on the market.

Swissmedic is the designating authority (DA) for Swiss designated bodies for medical devices. The Agency inspects Swiss designated bodies in line with defined procedures as part of its designation, and surveillance activities. Swissmedic's assessment and surveillance activities also include reviewing documents issued by designated bodies, inspecting randomly selected conformity assessment procedures, and audits under observation. Information regarding the designation and surveillance of Swiss designated bodies by Swissmedic is published each year in the annual report.

Legal framework:

  • Section 5 of the Medical Devices Ordinance (MedDO; SR 812.213)
  • Section 4 of the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219)
  • Art. 1, Art. 4 para. 1 and Annex 2 of the Ordinance on the Fees charged by the Swiss Agency for Therapeutic Products (FeeO-Swissmedic; SR 812.214.5)

List of designated bodies:

  • Swiss bodies:

Scope SQS under the previous legislation

The designation of SQS according to the 4th section of the old Medical Devices Ordinance dated 17 October 2001 (oMedDO) became void as of 26 May 2021 (Art. 107 para. 1 MedDO). This means that from this date, no new certificates can be issued in accordance with oMedDO. Certificates issued under the old legislation will retain their validity until the expiry date stated therein, but no longer than 26 May 2024 (Art. 100 para. 2 MedDO). SQS remain responsible for adequately monitoring the devices for which it issued certificates under the old legislation. In this regard, it remains to be subject to supervision by Swissmedic (Art. 107 para. 2 MedDO).

  • Foreign bodies: