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Statutory definitionEHDS

the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken.

Article 2, point (14), 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, 28, 30
EHDS, recitals:37

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