Common specifications (CS)

Unlike harmonised standards, common specifications are binding where they exist: a manufacturer who does not follow them must justify a solution that is at least as safe. They are adopted by the European Commission through implementing acts.

‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

EU MDR, Article 2(71)

‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

IVDR, Article 2(74)