BY COMPANIES
The purpose of this article is to provide an overview of the impacts of the implementation of the MDR (EU) 2017/745 on Combination products and Substance based devices based on the considerable experience gained by BSI since the entry into force of the legislation.
While there is no legal definition for a “combination product” within any EU Legislation, it is a commonly used term used to describe products that combine a medical device and medicinal product.
The area applies to many medical devices and medicinal products and as an indicator of the importance of this sector, in 2023 the market size for such products in the USA alone is valued at USD 47.6 Billion and is expected to grow at a compound annual growth rate (CGAR) of 7.7% for 2024 to 2030.
This article will discuss the following types of combination products, as well as provide an update on the implementation of the conformity assessment processes for substance-based devices, for which the MDR introduced a new Classification Rule and additional assessment considerations.
Integral Drug-Device Combinations (IDDCs)
When a medical device used to administer a medicinal product is placed on the market in such a way that the device and medicinal product form a single integral product, which is intended exclusively for use in the given combination and which is not reusable, this is a medicinal product regulated under the Medicinal Products Directive (2001/83/EC). The medicinal product has the principal action, and the device is intended to administer the medicinal product. Examples include pre-filled syringes, auto injector pens and pressurised metered dose inhalers.
Device-Drug Combinations
In this case, the device has the principal mode of action, and the medicinal substance or human blood derivative has an ancillary action. Examples include drug eluting stents or wound dressings with anti-microbial agents.
Substance-based MDR Rule 21 Devices
These types of products are comprised of a substance or combination of substances that achieve their intended purpose by physical means and thereby meet the definition as a medical device. Rule 21 devices are applied to the skin or body orifices and include orally ingested devices. Examples include comfort eye drops, creams for the treatment of eczema or tablets for the treatment of obesity. These are included within this article as they are borderline with medicinal products often provided in a dosage form more often associated with medicines.
Each type of the above products has its own regulatory route and assessment requirements under the MDR.