The European Medicines Agency (EMA) has released a draft guideline on the quality requirements for medical devices in drug-device combinations for public consultation.
Drug-device combinations are medical devices in human medicines that include a device for the administration, dosing or use of the medicine.
The guideline addresses the new obligations in the EU Medical Devices Regulation (MDR 2017/745), in particular the requirements under Article 117. Article 117 foresees that a marketing authorisation application will include a CE certificate or declaration of conformity for the device or, in certain cases, an opinion from a notified body. In the draft guideline it is specified which information about the device that needs to be submitted as part of an initial marketing authorisation application.
Comments on the public consultation must be submitted by 31 August 2019.
Draft guideline: Quality requirements for drug-device combinations
Lise Lyck
lly@dhigroup.com
Tel +45 4516 9307
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