EMA has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation.

The guideline addresses the new obligations in Regulation (EU) 2017/745 on medical devices, in particular the requirements under Article 117. This article foresees that the marketing authorisation application should include a CE (Conformité Européenne) certificate or declaration of conformity for the device or, in certain cases, an opinion from a notified body (NB) on the conformity of the device.

EMA will take into account comments received during the consultation, with a view to finalising the guidelinebefore the regulation fully applies on 26 May 2020.