Glossary

Compatibility [MDR/IVDR]

MDR IVDR

‘Compatibility’ is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:

(a) perform without losing or compromising the ability to perform as intended, and/or

(b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or

(c) be used together without conflict/interference or adverse reaction.

 

[Definition under (EU) 2017/745 Article 2 No. 25 also corresponds to definition under (EU) 2017/746 Article 2 No. 18]