The EMA has launched a consultation on its guideline for quality requirements for drug-device combination products.
This guideline from the European Medicines Agency (EMA) refers to requirements listed in Regulation 2017/745, particularly with regard to CE mark requirement. EMA say:
“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.”