The European Medicines Agency (EMA) released a draft guideline for public consultation on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations. The guideline covers devices that are necessary for the administration, dosing or use of the medicine. They can be integral, co-packaged or referred to in the product information of the medicine but obtained separately.
It is intended that this guideline will increase transparency and consistency of information in regulatory submissions, reducing work for all stakeholders and ultimately improving patient safety.
The draft guideline is available here.
How to give feedback:
EMA will take into account comments received during the consultation, with a view to finalising the guideline before the regulation fully applies on 26 May 2020. Stakeholders are invited to send their comments by 31 August 2019 to QWP@ema.europa.eu using this template.