Combination Products

Regenerative medicine is all about combining multiple disciplines to achieve multifactorial solutions to complex biological problems. In regulatory terms, a "combination product" arises when a product contains components or elements which, if used separately, would be regulated by different sets of regulations. So a product containing both cells and a biomaterial or delivery device may be regulated as a "combined advanced therapy medicinal product"... or it may not. Similarly a medical device such as a biomaterial for tissue regeneration may also contain a cytokine or other protein, or a drug substance. Correct classification of a product is absolutely critical: the cost and time impacts of incorrectly developing a product as a medical device when it is in fact a medicinal product, for example, are immense. There is no specific "combination product" legal category in the EU and products must be assessed according to one regulatory paradigm.

Innovative developments combining new materials and technologies present complex challenges to the regulatory frameworks for medicinal products and medical devices. An expert understanding of the legal definitions, the guidelines and precedent decisions is essential to enable correct classification of regenerative medicine products that may include elements of ATMPs, biomaterials and medical devices.

With  many years of experience with both medical devices and medicinal products, and over 15 years of full time involvement in regenerative medicine and tissue engineering products, we are ideally placed to provide reliable and consistent expert advice on classification and development of combination products in the EU.


Recent Projects

Clinical Development of A Drug-Device Combination

A US-based client wished to conduct a first-in-human clinical trial of a novel drug-device combination product in the UK. Both the medicinal substance and the medical device were well-known and approved separately in the EU but for different indications and intended purposes. CellData Services was p...

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Classification Challenge

A client asked us to assist with classification of a complex novel biomaterial consisting of elements of a medical device, medicinal products and human blood-derived proteins. The company had sought classification advice through both the UK Competent Authority and the European Medicines Agency...

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