Glossary

CE marking of conformity [MDR/IVDR]

MDR IVDR

‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing.

 

[Definition under (EU) 2017/745 Article 2 No. 43 also corresponds to definition under (EU) 2017/746 Article 2 No. 35]