Substance

MDR Annex VIII rule 21 covers devices made of substances that are introduced into the body and absorbed or locally dispersed, so this definition decides whether the rule applies. It also matters at the borderline with medicinal products.

In this context, ‘substance’ means any matter that is part of the medical device, including those according to the definition of ‘substance’ in Article 1(3) of Directive 2001/83/EC. This is provided that they are not excluded by the MDR (e.g. exclusion criteria in article 1 (6) (h)).

MDCG 2021-24 Rev.1, Section 4.2, Rule 21, General explanation of the rule

"Substance: Any matter irrespective of origin which may be: — human, e.g. human blood and human blood products; — animal, e.g. micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts, blood products; — vegetable, e.g. micro-organisms, plants, parts of plants, vegetable secretions, extracts; — chemical, e.g. elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis."

MDCG 2022-5 Rev.1, Section 1.2.2, Definitions of pharmacological, immunological, metabolic means, Note 1 (quoting Directive 2001/83/EC)

MDCG 2021-24 defines substance for rule 21 as any matter that is part of the device, including substances under Directive 2001/83/EC, unless excluded by the MDR. MDCG 2022-5 quotes the Directive 2001/83/EC definition, which lists the possible origins: human, animal, vegetable and chemical.