Glossary · EU medical devices: MDR

Drug-device combination (MDR Article 117)

Also known as: Drug-device combination product, Integral drug-device combination, Notified body opinion (Article 117)

Under the EU Medical Device Regulation (EU) 2017/745, a drug-device combination is a product that combines a medical device and a medicinal product. Where device and medicinal product form a single integral product intended exclusively for use in that combination and not reusable, such as a prefilled syringe or pen, it is regulated as a medicinal product under Directive 2001/83/EC, and Article 117 MDR requires the marketing authorization application to include evidence that the device part meets the relevant general safety and performance requirements.

EU
MDR
Pharma

In one sentence

Drug-device combinations under MDR Article 117: integral products are medicines, but the device part must meet the relevant MDR GSPR.

Example

A pharmaceutical company files a marketing authorization application for a biologic in a single-use prefilled pen. Because the pen has no CE marking, it includes a notified body opinion confirming that the pen meets the relevant GSPR.

How it applies

Which law: The principal intended action decides. If the device part is the carrier or administration aid and the product is integral, it is a medicinal product. If the medicinal substance only has an action ancillary to the device, it is a medical device under the MDR, class III under Rule 14, and the notified body consults a medicines authority on the substance.
Article 117: For integral products, the marketing authorization dossier includes the EU declaration of conformity or the CE certificate for the device part or, if there is none, a notified body opinion on the device part’s conformity with the relevant GSPR.
Non-integral products: A device supplied separately or co-packaged with a medicine, such as a reusable injector pen, is a medical device in its own right and needs its own conformity assessment and CE marking.
Manufacturing: The finished combination product is made under medicinal product GMP; the device supplier’s quality system is usually ISO 13485-based and has to be integrated through supplier qualification and quality agreements.
Technical documentation: The device evidence sits in the quality module of the Common Technical Document. It draws on the same design, risk management and usability records a device manufacturer would keep.

Integral vs. non-integral combination

An integral combination is one product: drug and device cannot be separated and are used only together, so medicinal product law governs and the device part is covered through Article 117. A non-integral combination consists of two products, each under its own law. Changing the design, for example from a separate injector to a prefilled pen, changes the regulatory route.

Compared with the USA

The FDA treats such products as combination products under 21 CFR Part 4. The primary mode of action determines the lead center, and the Office of Combination Products coordinates assignment; current good manufacturing practice requirements for both constituent parts apply.