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Regulatory Affairs, Medical Devices

Article 117: Preparing Drug Device Combination Product Manufacturers for the EU MDR - WHITEPAPER


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The EMA has seen an increase in the number of scientific advice requests and Marketing Authorisation Applications for devices  where a medicinal product incorporates, either in an integral or non-integral manner, a medical device component.

Previously, there were no clear regulatory requirements for such types of medical devices,  but Article 117 of the EU MDR has provided an amendment outlining specific requirements for drug device combination medical products.

This whitepaper offers advice to prepare drug device combination product manufacturers for the new regulations, including:

  • Seeking  Notified Body opinion

  • Products covered

  • Marketing Authorization applications

  • General Safety and Performance Requirements (GSPRs)

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