Spotlight on MDR impact on drug-device combination products

The European Medicines Agency (EMA), which oversees the European Union’s pharmaceutical market, has begun rolling out guidance and clarifications regarding Medical Devices Regulation (MDR) compliance issues for manufacturers of combination products with drug and medical device components.

According to the EMA website as well as Emergo by UL consultants in Europe, the agency plans to publish draft guidelines in June 2019 covering quality requirements for combination medicinal products that include device components, or drug-device combination products. The guidelines will specifically address Article 117 of the MDR, which will establish new compliance obligations for drug-device combination products.

EMA plans to finalize these guidelines ahead of the May 2020 deadline whereby the MDR becomes fully applicable.

EMA and Notified Body roles under MDR Article 117

Earlier in 2019, EMA published a Q&A guide for manufacturers of drug-device combination products that will have to meet MDR Article 117 regulatory requirements next year. EMA notes that Article 117 of the Regulation requires Notified Body involvement for European market authorization of a medicinal product that incorporates an integral medical device, or drug-device combination product.

“This applies to medicinal products that form an integral product with a medical device, where the action of the medicinal product is principal i.e. those that fall under second subparagraph of Article 1(8) and where a medical device is used to administer a medicinal product, i.e. second subparagraph of Article 1(9) of the medical devices Regulation,” EMA states in the Q&A document.

Some key issues addressed by the EMA Q&A include:

• For qualifying drug-device combination products, marketing authorization dossiers should include conformity assessment results or CE Mark issued by Notified Bodies for device components); for device components lacking CE Marking, manufacturers will have to submit opinions from Notified Bodies regarding conformity of those components to MDR requirements.
• In order to fall under MDR Article 117 requirements, a product’s device and medicinal components must form a “single integral product;” the product must be intended for use only in the drug-device combination; and the product must not be reusable.
• For new marketing authorization applicants, a Declaration of Conformity or CE Mark will be required for the device component of a drug-device combination product, which will help to determine whether the device component meets MDR requirements established in Annex I of the Regulation. Otherwise, applicants must provide opinions from Notified Bodies supporting conformity to MR Annex I rules.
• Drug-device combination products currently authorized for sale in the European Union or those whose applications will be submitted prior to the May 26, 2020 MDR enforcement date will not be impacted by MDR Article 117 requirements, according to the EMA. However, such products may become subject to MDR Article 117 requirements if manufacturers make substantial changes to, replace or add device components to their products.

Emergo by UL will provide additional coverage of EMA’s draft guidelines on drug-device combination products and MDR requirements following their publication.

Learn more about European medical device and combination product regulations:

• EU Medical Devices Regulation (MDR) 2017/745 gap assessment and transition consulting
• Medical device classification consulting for Europe
• European CE Marking strategy for medical devices
• Whitepaper: Understanding the European MDR
• Whitepaper: EU classification of borderline and combination products