The European Medicines Agency (EMA) has recently released updated Q&A guidelines "New Guidance for Industry and Notified Bodies" that supports the industry and notified bodies in navigating the regulatory landscape for medical devices used in combination with medicines.
This Question-and-Answer document clarifies regulatory requirements for devices used in combination with medicine, offering practical considerations for the implementation of medical devices and in vitro diagnostic regulations.
Products that combine a medicinal product (or substance) and a medical device are regulated under either the pharmaceutical framework or the medical device framework, based on their primary mode of action. This revision draws from the experience gained since the new regulations were implemented and actual cases encountered.
The document provides regulatory and procedural guidance for:
integral drug-device combinations (medical devices that form an integral product with 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 labeled;
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, and diagnostic tests that are essential for correctly using a specific medicine.
This guidance is provided to assist in applying the regulations on medical devices and in vitro diagnostic devices (Regulation (EU) 2017/745) and on in vitro diagnostic devices (Regulation (EU) 2017/746). As a result of these two regulations, the European legal framework for medical devices was changed, and EMA as well as national competent authorities now have new responsibilities and requirements for evaluating certain categories of medical devices combined with medicines.
This Q&A document supports in ensuring that medical devices meet safety and performance standards, supporting the protection of public health.
For more details, you can visit the full guidance document here.
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