Long awaited, widely feared and stunned:
The newly published MDCG document 2022-05 presents medical device manufacturers of material medical devices with already suspected but at least considerable challenges.
While the Medical Device Regulation (MDR) 2017 still supported this type of medical device as such with the official naming of "substances and combinations of substances" and thus legitimized it, these are now five years after their entry into force by means of the EU guideline of the Medical Device Coordination Group faced significant hurdles. The guideline on the distinction between medical devices and medicinal products ( Guidance on borderline between medical device and medicinal products under Regulation (EU) 2017/745 on medical devices ) aims to identify so-called borderline products in accordance with the legal requirements of the regulation for medical devices and the directive for to correctly categorize medicinal products (Medicinal Product Directive, MPD). This rather questionable help for interpreting and enforcing the legal areas mentioned means a rethinking in the medical device industry and presents many manufacturers with strategic decisions that are definitely business-threatening.
It is repeatedly pointed out that the main mode of action of the product, taking into account the scientific data on the state of the art, is decisive for the classification. The intention of the manufacturer with regard to the effects of substances as well as the manner of administration or the availability and effect on the body have been determined to be irrelevant for the decision to classify a substance as a medicinal product or medical device. Nevertheless, the principle of the MDR remains: the intended main effect lays the foundation for the decision as to whether it is a medical device or a drug.
According to the figure below, three aspects must be defined:
The specific medical purpose is determined by the manufacturer from the points listed in Article 2(1) of the MDR.
The intended main effect of a medical device is described in the labeling and in the manufacturer's statements and must be based on the latest scientific findings on the main mode of action in each case.
The main mode of action is the principle by which the product achieves its intended main effect, ie pharmacological, immunological, metabolic, physical or otherwise. It is objective and must reflect the latest scientific developments.
Flow chart for determining whether a product meets the definition of a medical device (Source: MDCG 2022-05)
If the scientifically based, fundamental main mode of action to achieve the primarily intended effect is not pharmacological, immunological or metabolic, it is a medical device. After all, note 3 makes it clear that only the main mode of action in connection with the intended main effect has to be taken into account.
In addition, it was not neglected to redefine or define precisely these modes of action in the present document.
A “pharmacological principle” is understood to mean an interaction, typically at the molecular level, between a substance or its metabolites and a component of the human body, which leads to an initiation, amplification, reduction
