Module 19 2021

02/06/2021

• Qualification – is it an IVD?

‘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);

7

• MDR or IVDR?

Medical Device

MD accessory

IVD

IVD accessory

IVD accessory

8

4