New MDCG guideline for medical devices that incorporate a medicinal substance



Medical Device Regulation (EU) 2017/745, Official Journal of the European Union:

Medical Device Coordanation Group, MDCG 2020-12: “Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues”: