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Medical devices: new guidance for industry and notified bodies

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Question-and-answer document clarifies regulatory requirements for devices used in combination with medicines.

A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. This question-and-answer document provides practical considerations on the implementation of the medical devices and in vitro diagnostic regulations for combinations of medicinal products and medical devices.

Products that combine a medicinal product (or substance) and a medical device are regulated either under the pharmaceutical framework or the medical device framework, depending on their main mode of action. The revision is based on the experience gained since the implementation of the new regulations and actual cases encountered. The document covers regulatory and procedural guidance for:

  • integral drug-device combinations (medical devices that form an integral product with a medicine, such as pre-filled syringes) and their lifecycle management;
  • medicinal products that include a medical device in their packaging (referred to as co-packaged) and how these should be labelled;
  • the consultation procedure for medical devices with an ancillary medicinal substance (a substance that supports the proper functioning of the device) and;
  • the consultation procedure for companion diagnostics, diagnostic tests that are essential for the correct use of a specific medicine.

The guidance is provided to support the application of the regulations on medical devices (Regulation (EU) 2017/745) and on in vitro diagnostic devices (Regulation (EU) 2017/746). These two regulations changed the European legal structure for medical devices, introducing new responsibilities and requirements for EMA and national competent authorities in the assessment of certain categories of medical devices used in combination with medicines.

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