Category drug-device combination products

The importance of Article 117 of the MDR, for Drug-Device Combination (DDC) products

Picture of a pen injector

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)…

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Combination products- Implementation of the transitional provisions for medical devices in Switzerland

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…

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Health Canada consults on its policy on the regulation and classification of Drug-device combination products

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…

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