Generic device group

Notified bodies use generic device groups when they sample technical documentation for class IIa and IIb devices. MDCG 2019-13 links the groups to EMDN levels, which makes the sampling plan predictable.

‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

EU MDR, Article 2(7)

‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

IVDR, Article 2(8)