MDR - Annex I - article 12
Original text
Expert opinion
Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body.
Devices incorporating a substance considered to be a medicinal product are understood to be combined products.
Please note that the EU regulation does not explicitly name these products as combined products but this term has been coined by the industry to separate from medical devices.
In contrast to the US regulation 21 CFR 4, which names these products as combination products, the EU has no distinct regulation on these products.
In the case of devices referred to in the first subparagraph of Article 1(8), the quality, safety and usefulness of the substance which, if used separately, would be considered to be a medicinal product within the meaning of point (2) of Article 1 of Directive 2001/83/EC, shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC, as required by the applicable conformity assessment procedure under this Regulation.
The medicinal or pharmaceutical constituent part of a combined product needs to be assessed by the Medicinal Product Directive MPD 2001/83/EC.
Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body shall comply, where applicable and in a manner limited to the aspects not covered by this Regulation, with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions, as required by the applicable conformity assessment procedure under this Regulation.
The medicinal or constituent constituent part must be tested according Medicinal Product Direct MPD 2001/83/EC in order to assess the effects on the human body.
Please note that those substances not necessarily need to be pharmaceutical substances, but can be also other substances that are intended to be introduced into the human body, apart from medical devices and nanomaterials.
