EMA has recently released an updated version of its Q&A document regarding combination products, which include both medicinal products and medical devices. The regulation of these products poses unique challenges, as they must adhere to the requirements of both medicinal product regulations (such as Good Manufacturing Practices, GMP) and medical device regulations (like ISO 13485).

The latest update, identified as Revision 4, includes substantial changes affecting 18 of the 23 questions in the document. Key topics addressed in this revision include:

– The applicable regulatory frameworks for products combining medicinal products with medical devices.

– The implications of Article 117 of the Medical Device Regulation (MDR) on medicinal products.

– Requirements for Notified Body Opinions concerning marketing authorisation for combination products.

– Updates on the declaration of conformity and submission of variations related to integral combination devices.

– Applicability of Unique Device Identifier (UDI) requirements to medicinal products containing medical devices.

– The impact of the MDR on co-packaged medical devices and labelling requirements for products that include medicinal components.

With these extensive revisions, the EMA continues to support manufacturers in navigating the complexities of compliance for drug-device combination products.