medicines-medical devices-regulatory affairs
An application for authorisation of an integral combination product (a medicinal product with an integral medical device component) in the EU must prove that the medical device component meets the general safety and performance requirements (GSPRs) according to Annex I…
Last updated: 23 May 2024 To view updates, click on the ‘+’ sign below. The importance of Article 117 of the MDR, for Drug-Device Combination (DDC) products should not be underestimated. Anyone in regulatory affairs working on Drug-Device combination (DDC)…
Combination products are medicinal products with a medical device component. Combination products can either be non-separable combinations or separable combinations. EU MDR amendment of 20 March 2023 Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional…
Health Canada is consulting on its current policy on the regulation and classification of Drug-device combination products (DDCPs). Why is Health Canada consulting on this policy? Health Canada is updating its policy on DDCPs to provide more detail and clarity…