Term

Common specifications

Statutory definitionEHDS

‘a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.’
— Article 2, point (71), Regulation (EU) 2017/745

The EHDS Regulation does not define this term itself; it refers to it through Article 2(1). See Article 2.

Where this term is used

EHDS, Articles:2, 12, 19, 30, 31, 32, 36, 37, 40, 45, 47, 48, 75, 78

EHDS, recitals:36, 42, 46, 99

Questions about what this term means for your organisation? Contact Mr. Dr. Vlieger.