The Medical Device Coordination Group (MDCG) recently published the Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (MDCG 2022-5)
The guidance discusses the borderline between medical devices and medicinal products taking into account the relevant definitions and making practical examples, particularly focusing on herbal products, substance-based devices and combinations of medical device and medicinal product.
Below are listed the main novelties introduced by the guidance.
Substance-based medical devices
New definitions of pharmacological, immunological and metabolic means were introduced adding more precision to the respective definitions present in MEDDEV 2.1/3 rev 3. Focusing on pharmacological means the guidance lists the following examples:
- interaction between a ligand (e.g. agonist, antagonist) and a receptor;
- interaction between a substance and membrane lipids;
- interaction between a substance and components of the cytoskeleton.
Furthermore the guidance specifies that, when a substance-based device incorporates a substance, which, if used separately, would be considered a medicinal product and when the action of the medicinal product is ancillary to that of the device, a consultation with a competent authority or EMA is necessary.
Concerning the process of authorisation for (traditional) herbal medicinal products in the European Union, EU monographs (established by the EMA Committee on Herbal Medicinal Products – HMPC) must be considered. Also other official monographs, may be considered.
When a substance included in these monographs complies with the monograph regarding its composition/preparation, dosage and indication, it is a good indicator that the substance in question falls into the definition of herbal medicinal product.
However the fact that a monograph does not exist for a herbal substance in one of the abovementioned pharmacopoeias does not necessarily mean that it shall not be considered a herbal medicinal product.
Regulatory Pharma Net (RPN) is currently evaluating the impact of this new guidance on medical devices, directly involving the Notified Bodies. We are available to provide your company with any updates on the medical device regulatory framework and to assist on all regulatory needs.
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