Drug-device combination products

What are Drug-device combination products?

Drug-device combination products (or Combination products) are defined as medicinal products containing one or more medical devices(s) as an integral part of the composition, as well as medicinal products for which one or more medical device(s) and/or device component(s) are necessary for use of the medicinal product.

Combination products are increasingly being developed, prescribed and used to treat health conditions within clinical and home settings, including healthcare professionals, patients and caregivers with various abilities, limitations, and prior experience with drug products.

New draft published

On 3 June 2019, the European Medicines Agency (EMA) launched a public consultation on a draft guideline concerning the necessary requirements for the submission of the dossier to obtain marketing authorization or to submit an application for post-marketing authorization of Combination products.

From 26 May 2020, applications for marketing authorisation of a medicinal product with a medical device as an integral part of the product shall prove that the part of the device meets the relevant requirements as per Annex I to Regulation (EU) No. 2017/745 (Medical Device Regulation, MDR).

The realization of a Combination product requires the performance of specific tests on all its components and an expertise able to guide companies in the evaluation of the best approach to ensure product efficacy and safety.

What are drug-device combination products?

There are two types of Drug-device combination products (DDCs):

​Integral DDCs

1. Devices that when placed on the market or put into service incorporate -as an integral part-, a substance that would be considered as a medicinal product if used separately, provided that the action of the substance is the main one (Article 1(8) MDR).
2. Devices intended to administer a medicinal product; they form a single integral product exclusively intended for being used in the given combination and which is not reusable (Article 1(9) MDR). Typically, these devices have measuring, metering or delivery functions.

For example single-dose pre-filled syringes, pens and injectors, drug-releasing intra-uterine devices, implants containing medicinal products whose primary purpose is to release the medicinal product.

Non-integral DDCs are DDCs for which two or more separate components (i.e. medicinal product(s) and device(s)) are not physically integrated during manufacturing, but where the medicinal product and the specific device(s) are combined for administration.

For example oral administration devices, refillable pens and injectors, injection needles and filter needles, nebulisers, vaporisers.

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