Conformity Assessment Bodies

Conformity Assessment Bodies (CABs) verify the compliance of medical devices with the legal requirements at the manufacturer. They carry out what are termed 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 place its conforming devices on the market.

Under articles 11 and 13 of the Medical Devices Ordinance (MedDo, SR 812.213), Swiss CABs are accredited organisations designated and monitored by Swissmedic. Specific competencies of the individual bodies are listed according to medical device groups. These can be found:

  • for Swiss bodies:
  • for Swiss and foreign bodies:

An international agreement between the Swiss Confederation and the European Union (MRA, SR 0.946.526.81) regulates the mutual recognition of conformity assessments. As a result, the working methods of the CABs and the competent authorities in Switzerland can be equated with those in the EU member states. Corresponding requirements and procedures are specified in various guidelines and directives issued by the EU Notified Bodies Operation Group (NBOG). They are published here:

The EU has assembled fundamental ideas on conformity assessments in a guide to the implementation of product rules in the EU, which can be found here: