Combination Devices: new guidance for industry and notified bodies
Revision of Guidance:
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.
Related Articles
-
The position paper from the European Commission’s Medical Device Coordination Group (MDCG) recommends an extended timeline to allow certain MDD or AIMDD certified legacy devices to come into compliance with MDR.
-
Device manufacturers and importers will have two years to modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026.
-
Karandeep Badwal, consultant and president of QRA Medical, discusses the change in focus from EU MDD to EU MDR, and how companies will need to adapt to meet new reporting requirements and maintain compliance in the European market.
-
Post-market surveillance plays a critical role in the UK’s medical device regulatory framework. Manufacturers must prioritize establishing a comprehensive PMS system, developing clear and organized PMS plans, and promptly reporting incidents and corrective actions.
