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EMA Publishes Second Draft Guideline on New MDR Rules Specifying Quality Requirements for Drug-Device Combinations

Over the past several years, the number of scientific advice requests and marketing authorisation applications for products that contain drug and device components, or drug-device combinations (DDCs), has continued to rise.

This increase also reflects the potential for devices to decrease burdens on patients and providers, such as products with automated functions that could help patients manage self-administration of medicines.

The European Medicines Agency (EMA) recognised that DDCs will become more commonplace as technology continues to advance. As a result, the EMA recently published a second draft guidance in a series of guidances to help manufacturers prepare for compliance under the new EU Medical Device Regulation (MDR), in particular the requirements under Article 117. This guidance outlines quality requirements for DDCs, expanding on the first draft guidance for DDCs released earlier this year.

This guideline aims to increase transparency and consistency of information in regulatory submissions, reducing work for stakeholders and ultimately improving patient safety. It defines DDCs, including integral devices such as implants that release medicinal product and drugs with an embedded sensor, and non-integral devices such as injection needles and inhalers.

In detail, the guidance explains how evidence should be included in marketing authorisation applications for integral DDCs. To meet EMA requirements, manufacturers of these devices can use an EU Declaration of Conformity or a Certificate of Conformity from a notified body (NB). In certain cases when evidence of conformity is unavailable, products could confirm meeting the relevant General Safety & Performance Requirements, or alternatively, they can submit a NB opinion.

For non-integral DDCs, manufacturers will need to ensure the devices are CE marked and, in some cases, may need to include additional information about the impact of a product’s quality, safety and efficacy.

Further, the draft guidance offers considerations for manufacturers for submitting data, platform technology and scientific advice, as well as a template for NB opinion on device conformity.

Over the next three months, the EMA is accepting feedback, with the goal of issuing a finalised version of the new draft guideline prior to MDR’s 26 May 2020 application.

Lastly, the European Commission also issued a Q&A document recently to clarify new obligations under MDR and In Vitro Diagnostic Medical Device Regulation (IVDR) regarding NBs. The document, endorsed by the Medical Device Coordination Group, answers four sets of questions on a variety of MDR/IVDR topics from organisational and general requirements to resources and process requirements.

A Way Forward

To get ahead of the market, especially for manufacturers of emerging technologies, device developers should seek regulatory counsel and advice early, and provide them with any necessary information or samples that could help authorities better understand the product. Additionally, conducting a gap analysis and prioritising product portfolios can help in reducing timeline delays.

Adopting a strategic partner with regulatory expertise can help manufacturers with the needed advice and strategic planning to ensure essential documentation and clinical evidence for compliance under the new MDR.

Read our whitepaper, “Higher Costs and Bottlenecks: Strong business strategy can help ease EU medtech regulatory reform effects,” to learn steps that device developers must address immediately to prepare for the coming regulations.

Download the whitepaper

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