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EMA Answers More Questions For Manufacturers of Drug-Device Combos

 
• By Neena Brizmohun

Will it be necessary to provide a new medical device notified body opinion when changes are being made to the medicine in an integral drug-device combination product? This is just one of the new topics addressed in an updated Q&A document from the European Medicines Agency.

Integral drug-device combination products include pre-filled syringes • Source: Shutterstock

Companies marketing integral drug-device combination products who want to make changes to the medicinal component might need to obtain a new/updated opinion from a notified body (NB) about the product’s device portion, the European Medicines Agency has clarified in a newly revised Q&A document.

Changes to the medicinal product, such as an extension of indication, new strength or new pharmaceutical form, may have an impact on the safety or performance of

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