Glossary · Regulation
Intended Purpose
intended use
Intended Purpose
RegulatoryThe use for which a product is intended according to the data supplied by the manufacturer in labelling, instructions or promotional material.
Classification follows what the manufacturer claims, including on a website — a disclaimer does not undo a stated medical purpose.
Context
SourceRegulation (EU) 2017/745 (MDR), Art. 2(12); CJEU C-329/16