Conformity Assessment Bodies (CABs) verify with manufacturers the compliance of medical devices with the legal requirements. They carry out so-called conformity assessment procedures for all devices classified outside the lowest risk classification. Once the procedure has been successfully concluded, the relevant manufacturer is issued with the appropriate EC certificate empowering it to conformingly place its devices on the market.
Swissmedic is the designating authority (“DA”) for Swiss CABs for medical devices. Swissmedic conducts inspections for designation, renewal of designation and surveillance of Swiss CABs according to defined procedures. Furthermore, assessment and surveillance activities encompass the review of the CAB’s documentation, sampling of conformity assessment procedures conducted by the CAB and observed audits. Information concerning the designation and surveillance of Swiss CABs is published in Swissmedic’s annual report.
- Sections 4 and 4a of the Medical Devices Ordinance (MedDO; 812.213)
- Akkreditierungs- und Bezeichnungsverordnung (AkkBV; SR 946.512)
- Art. 1, art. 4 para. 1 and annex 2 of the Verordnung des Schweizerischen Heilmittelinstituts über seine Gebühren (GebV-Swissmedic; SR 812.214.5)
Specific competencies of the individual bodies are listed according to medical device groups. These can be found:
- for Swiss bodies: