Term
Intended purpose
Statutory definitionEHDS
‘the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.’
The EHDS Regulation does not define this term itself; it refers to it through Article 2(1). See Article 2.
Questions about what this term means for your organisation? Contact Mr. Dr. Vlieger.