Falsified device

The definition targets deliberate falsification and is separate from intellectual property disputes. Importers and distributors who believe a device is falsified are expected to inform the authorities.

‘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;

EU MDR, Article 2(9)

‘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;

IVDR, Article 2(10)