Glossary

Accessory for a medical device [MDR]

MDR

‘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).

 

[Definition according to (EU) 2017/745 Article 2 No. 2]