Specific medical purpose

Without a specific medical purpose a product is not a medical device under the MDR, however it is built. The purpose stated also drives classification, so it has to match across the labeling, the instructions and the technical documentation.

The specific medical purpose is specified by the manufacturer from those listed in the indents of Article 2(1) MDR.

MDCG 2021-24 Rev.1, Section 3.1, Basic terms and definitions (Specific medical purpose)

The specific medical purpose is specified by the manufacturer from those listed in the indents of Article 2(1) MDR.

MDCG 2022-5 Rev.1, Section 1.2.2, Definitions of pharmacological, immunological, metabolic means