Glossary

Falsified device [MDR/IVDR]

MDR IVDR

‘Falsified device’ means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights.

 

[Definition under (EU) 2017/745 Article 2 No. 9 also corresponds to definition under (EU) 2017/746 Article 2 No. 10]