CHMP releases concept paper on the need for clearer/updated dossier requirements for medical devices that are supplied along with medicinal products

Medicinal products are often supplied along with a medical device, where the device is required for the administration or localisation of the medicine. Currently, Annex 1 of the Directive 2001/83/EC outlines the dossier requirements for the medical device, however given the vast technological developments in devices over the last decade, the changes in medicinal product and device legislation, and the diversity of devices now available on the market, this information is no longer sufficient.

The Committee for Human Medicinal Products (CHMP), specifically the Quality Working Party and the Biologics Working Party, recommended developing a guideline on quality aspects of the dossier requirements for Drug Device Combinations for Marketing Authorisation Applications, line extension applications and variations. Marketing Authorisation holders will be expected to demonstrate that the combination has been appropriately designed and controlled and can be used correctly in the intended clinical situations.

A concept paper was released on 16th February 2017 for a public consultation (to access the concept paper, click here. Once comments have been received (deadline 16th May 2017), the CHMP will draft the Guideline which will then be released for a 6 month external consultation.
The CHMP encourages professionals from academia, international scientific societies, the pharmaceutical industry, the medical devices industry and Notified Bodies and healthcare professionals to send their comments in for review. If you have any comments or feedback, you can send them to