Term

CE marking of conformity

Statutory definitionEHDS

‘a marking by which the manufacturer indicates that the EHR system is in conformity with the applicable requirements set out in this Regulation and other applicable Union law providing for its affixing pursuant to Regulation (EC) No 765/2008 of the European Parliament and of the Council.’
— Article 2(2), point (p), EHDS Regulation

Definition given by the EHDS Regulation itself.

Where this term is used

EHDS, Articles:2, 30, 32, 33, 41, 45

EHDS, recitals:40

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