Drug-device combination products are increasingly prevalent in modern medicine, and include a range of products such as medical devices that have been impregnated or coated with a drug or biologic product; these can include items such as catheters with an antimicrobial coating, pre-filled syringes, and transdermal patches.
However, despite their many clinical applications and benefits for the patient, the approval process for combination devices by the relevant regulatory body is always far more complex than if the product is simply a medical device, drug, or biologic.
Combination products in the EU
For manufacturers looking to place the product on the EU market, an opinion of a competent authority designated by an EU Member State must be included in the evaluation by the Notified Body — a process that can take up to 210 days plus clock stops to complete.
The Regulation for Medical Devices (Regulation EU 2017/745) — otherwise known as the MDR — addresses devices that contain a medicinal product and separates them into two categories:
- Article 1(8): Devices incorporating as an integral part a substance that, if used separately, would be considered a medicinal product and the action of the substance is principal.
- Article 1(9): Devices intended to administer a medicinal product where they form a single integral product intended exclusively for us in the given combination which is not reusable.
Combination products the US
Similarly, in the US, the Office of Combination Products (OCP) — part of the FDA — facilitates the pre-market review of combination products and decides on the relevant process based on the product’s primary mode of action (PMA). This can take up to two months to complete, before the pre-market review can commence.
In terms of legislation in the US, combination products must adhere to two separate rulesets, which adds a layer of complexity. Guidance issued by the FDA in 2015 states the “The cGMP requirements for constituent parts of cross-labelled combination products that are entirely manufactured at separate facilities are the same as those that would apply if these constituent parts were not part of a combination product”
Combination products in the UK
Post-Brexit, the UK has continued to regulate drug and device combination products and devices containing medicines, according to the EU Medical Device Directive (MDD) — the legislation that preceded the MDR — as transposed by the UK MDR 2002.
All devices must be registered with the MHRA, and non-UK manufacturers must assign a UK Responsible Person (UKRP).
Due to the complexity in regulation for combination devices across regions, it’s recommended that you put a robust regulatory strategy in place for combination products right from the very beginning — to ensure greater chance of success at the approval stage.
At Woodley BioReg, our team of expert MedTech consultants can help to create a comprehensive and effective regulatory strategy.
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