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.
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 specifies which information about the device needs to be submitted as part of the initial marketing authorisation application and subsequently during the product lifecycle. It also contains a proposed template for the NB opinion on the conformity of the device to the relevant general safety and performance requirements laid down in Regulation (EU) 2017/745.
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.
Stakeholders are invited to send their comments by 31 August 2019 to qwp@ema.europa.eu using the template provided.
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.