Combination Products and MDR: EMA Offers New Draft Guideline

Regulatory NewsRegulatory News | 03 June 2019 |  By 

With a focus on drug-device combination products, the European Medicines Agency (EMA) on Monday issued its second draft guideline as part of a series related to the EU’s medical device regulation (MDR).

The draft guideline covers the documentation expected for drug-device combinations (DDCs) in the quality part of the dossier for a marketing authorisation application (MAA). DDCs falling 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 guideline also defines integral DDCs and non-integral DDCs, with details on what the various modules should include, and explains how an MAA for an integral DDC should include evidence of the conformity of the device part with the relevant General Safety and Performance Requirements (GSPRs). A non-integral DDC should be CE marked in accordance with MDR.

The draft guideline also offers general considerations for submitting data, platform technology and scientific advice.

A new template for the notified body opinion on the conformity of a device to the relevant GSPRs specified under MDR is proposed in the draft guideline as well.

“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,” EMA said. The regulator added that it will consider comments received during a 3-month public consultation, with the goal of issuing a finalized version of the new draft guideline prior to MDR’s 26 May 2020 application.

The draft guideline is not only the second in EMA’s MDR series, but also the second to focus on Article 117 obligations for combination products. This underscores “the blurring of traditional boundaries between medicines and devices,” EMA executive director Guido Rasi previously noted. The first draft guideline in EMA’s MDR series used a Q&A format to offer general Article 117 clarifications.

Draft guideline


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