Private Health Journal

Glossary · Regulation

Intended Purpose

intended use

Intended Purpose

Regulatory

The 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