13/14 March 2024
Since 16th February 2017 you can comment on a concept paper of the EMA on the development of a guideline with regard to the quality requirements of "combination products" - called "Drug-Device-Combination" (DCC) in the document.
The objective of the guideline is to describe the authorisation requirements on DCCs. According to the EMA, there are often gaps or inconsistencies in the authorisation dossier - particularly with regard to the description of the medical device. The complexity of medical devices is increasing continuously, so that also the criticality of these products concerning dysfunctions and misuses increases too.
The EMA fears that the CE marking of a medical device may be insufficient to ensure in combination with the medicinal product the quality, safety and efficacy of the combination product.
The guideline shall provide requirements on the data to be submitted with regard to quality aspects (and safety aspects) of the medical device. Moreover, changes to a DDC within the product lifecycle will be taken into account - also with regard to "variations" to the medical device.
The Concept paper on developing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of the medicinal product can be commented on until 16th May 2017.