Accessory for an in vitro diagnostic medical device

Under the IVDR such an accessory falls within the scope of the regulation and is classified on its own. Specimen receptacles, for example, have their own definition in the IVDR, so it is worth checking which definition fits before deciding on the route.

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

IVDR, Article 2(4)