The European Medicines Agency (EMA) has opened a consultation on a draft guideline on quality requirements for medical devices in human medicines that include a medical device, which are known as drug-device combination products. The draft guideline is open for consultation until 31st August 2019 and is part of a series of guidance documents related to the European Union’s (EU’s) medical device regulation (MDR).
The draft guideline is the second document in the EMA’s MDR series, and is the second which focuses on Article 117 obligations for combination products. The first draft guidance in EMA’s MDR series was a question-and-answer (Q&A) document which offers general Article 117 clarifications.
Drug-device combinations (DDCs) that fall within the scope of this guideline are medical devices that are integral to the medicinal product, co-packaged with the medicinal product or referenced in the medicinal product information and obtained separately. The draft guidance outlines the documentation that is required for DDCs in the quality section of the dossier for a marketing authorisation application (MAA).
Integral DDCs and non-integral DDCs are also defined in the guideline, with information regarding what the various modules should include and explanations on how an MAA for an integral DDC should include evidence of the conformity of the device part with the appropriate General Safety and Performance Requirements (GSPRs). In accordance with MDR, non-integral DDCs should be CE marked. The draft guidance also provides information on general considerations for submitting data, scientific advice and platform technology. Annex 1 of the draft guidance contains a proposed new template for the notified body opinion on the conformity of a device to the relevant GSPRs specified under MDR.
The EMA have stated that the guideline is intended to “increase transparency and consistency of information in regulatory submissions, reducing work for all stakeholders and ultimately improving patient safety”. The EMA is aiming to issue a finalised version of the guidance prior to MDR’s 26th May 2020 application.
To read the EMA’s draft guideline on the quality requirements for drug-device combinations, please click here.