Europe – MDCG 2020-12 : MDCG 2020-12 : Guide relatif aux DM combinés à un substance active médicamenteuse ou conteant des tissus d’origine animale

Consultation procedure under the MDD and AIMDD

According to Annex I section 7.4 of Directive 93/42/EEC on medical devices (the MDD), and Annex I section 10 of Directive 90/385/EEC on active implantable medical devices (the AIMDD), for devices containing a substance which, if used separately, would be considered to be a medicinal product and which is liable to act upon the body with an action ancillary to that of the device, the notified body is required, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, to seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMA) on the quality and safety of the substance in the medical device, including the clinical benefit/risk profile of the incorporation of the substance into the device. Similarly, where changes are made to that
substance, particularly relating to its manufacturing process, the notified body is required to consult with the same authority in order to confirm that the quality and safety of that substance are maintained and to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device. This consultation on changes is referred to as supplementary consultation in this guidance document…