Accessory for a medical device

Under the EU MDR an accessory is regulated as if it were a device, with its own classification and conformity assessment. The test is whether the manufacturer intends it specifically for particular devices; a general-purpose item that happens to be used with a device is not an accessory.

‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

EU MDR, Article 2(2)