In May 2024, the European Medicines Agency (EMA), together with the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh), published the fourth revision of the Questions and Answers format guidance on products that combine a medicinal product and a medical device (both MD and IVD) for manufacturers applying for market access authorisation and accredited Notified Bodies.
The document is based on experience and real cases and conveys extremely useful practical information, considering that many of the most innovative devices in production include a medicinal product (or substance) part in addition to the device itself. Such devices are regulated in the pharmaceutical and/or medical device framework, depending on the product’s main mode of action, in a legal context that is not always easy to interpret.
The guide is intended as a support to the Medical Devices Regulation MDR (EU) 2017/745 and the In Vitro Diagnostic Devices Regulation IVDR (EU) 2017/746.
The main objects of the questions and answers
Specifically, the set of questions that make up the guide concern the management procedures throughout the product life cycle and the application for authorisation for:
- Medical Devices and medicinal products that constitute an integral product with a medicine (integral combination products), such as pre-filled syringes;
- medicines that include a (co-packaged) medical device and labelling in their packaging;
- products composed of medicinal substances that, as an integral part of the medical device, perform an auxiliary, ancillary function, i.e. support the proper functioning of the device;
- consultation procedures for companion diagnostics, and diagnostic tests essential for the correct use of a specific medicine.
The document presents significant changes compared to the previous version published in November 2023, in particular, because it contains more sections.
To name a few, the new question 1.3. specifies how to obtain advice on the classification of drug-device combination products, in particular for borderline products, which are those products for which it is unclear whether the legal reference context to be applied is that of Medical Devices or that of drugs. In a nutshell, the decision on product classification lies with the national authorities responsible for medicinal products and/or Medical Devices.
Can applicants for authorisation submit the Notified Body’s declaration of partial compliance with the General Safety and Performance Requirements (GSPR)? What is the weight of the Notified Body’s opinion? This, in short, is question 2.4. which is answered negatively. The guide states that the opinion of a Notified Body cannot be accepted, elaborating on the reasons for this.
Question 2.7 deals with minor changes made to integral drug-device combination products, and drug-device combinations (DDC). As with any other change, the authorisation holder is required to determine whether the change significantly affects the quality and efficacy of the device and, if so, to apply for a variation; numerous insights and facets are included in the answer, which should be read carefully.
Inside the guide, you can delve into all the questions and answers.
>>> THEMA, in partnership with other companies of the Complife Group, can be your strategic ally in demonstrating the compliance of drug-device combination products, especially borderline Medical Devices supported by a medicinal product with ancillary function. Contact us for more information: sales@thema-med.com
Source:
https://www.ema.europa.eu/en/news/medical-devices-new-guidance-industry-notified-bodies
QWP-BWP Guideline on medicinal products used with a medical device (europa.eu)
