Recently, the Medical Device Coordination Group (MDCG) published the Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.
The guideline discusses the demarcation between medical devices and medicinal products, including crucial definitions and using practical examples, with a focus on herbal products, substance-based devices, and combinations of medical devices and medicinal products.
This document contains explanations beyond those provided in the relevant legislations and, for example, introduces more precise definitions of pharmacological, immunological and metabolic means. For more details, read the full guidance on borderline between medical devices and medicinal products.
As a basic rule, a product is regulated either by Regulation (EU) 2017/745 on medical devices (MDR) or by Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD). However, in case of medical devices incorporating a substance, which, if used separately, may be considered as a medicinal product, and which may have an ancillary action to that of the device, as well as in case of MD-MP combination products, both MDR and MPD apply, each regulating its respective part of the product.
The new guidance document is designed to identify the correct regulatory framework and provides among other things a flowchart for determining if a product fulfils the definition of a medical device. However, the categorization is still difficult when a substance-based device incorporates a substance that would be considered a medicinal product if used separately. Therefore, the guidance indicates that in such borderline cases, consultation with a competent authority might be necessary. a&r offers assistance with the new medical device regulation and support with all regulatory aspects in this context. Feel free to contact us anytime.