MDCG 2022-5 "Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745" has been published. Link to document (PDF)
This long awaited document provides a consistent approach with regards to borderline products between medical devices and medicinal products. Definitions for pharmacological, immunological and metabolic means are provided by establishing the principal mode of action of the product, necessary to determine whether a product should fall under the MDR or the MDP scope.
Main points to be checked:
The determination of the nature of the substance, i.e. whether it is "considered to be a medicinal product" is independent of the intention of the manufacturer, of the quantity of the substance in the device and of the method or route of administration. Also, the determination of whether the substance “has an action ancillary to that of the device” is scientifically objective and does not depend on the manufacturer’s intention for the action of that substance in the device. Determining whether the substance “has an action ancillary to that of the device” should take into account the availability of the substance to the human body or its constituents and/or the quantity that is available to the human body or its constituents. It falls under the obligations of the manufacturer to demonstrate whether or not the substance has any action ancillary to that of the device, based on state of the art scientific data. A simple claim would not be sufficient.
With regards to herbal medicinal products, since they are usually multicomponent mixtures, if the pharmacodynamics are unknown, the principal mode of action could be difficult to define. So in case of doubt, if it is not clear which substance is responsible for the principal intended action of the product or if it is achieved by pharmacological, immunological or metabolic means, Article 2(2) of Directive 2004/27/EC amending Directive 2001/83/EC will apply and the product will be considered as a medicinal product.
This webinar aims to discuss the most relevant and tricky aspects of this guideline. Thanks to our long-standing expertise on substance-based medical devices, combination products and medicinal products we can provide decision-useful tips to support manufacturers to achieve successful market access for all their products.