Glossary

Common specifications [MDR/IVDR]

MDR IVDR

‘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.

 

[Definition under (EU) 2017/745 Article 2 No. 71 also corresponds to definition under (EU) 2017/746 Article 2 No. 74]