In the pharmaceutical industry, the correct classification of medical devices and medicines is of pivotal importance, not only for the end-user, but also for regulatory purposes. The problem is that, sometimes, this classification is not so straightforward. Welcome to the case of Borderline products!
Borderline products are those products which by their nature are not immediately attributable to a specific sector, for which it is therefore difficult to define which reference legislation to apply.
For a borderline product, the identification of the correct legal context may require in-depth analysis both in the context of the regulations in the medical device sector (medical devices and in vitro diagnostic) but also in the context of other regulations such as those on drugs, on biocides, on cosmetics, and on food supplements as well.
The correct qualification of a product is important as different interpretations of the community law, in addition to creating a distortion of the internal market, could pose a risk to public health.
In April 2022 the Medical Device Coordination Group has published guideline 2022-5 “Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.” This guideline clarifies how to deal with cases in which it appears we are dealing with both a medical device and a medicine and helps direct the manufacturer towards the correct regulatory path.
However, it is the manufacturer’s responsibility to establish whether their product falls within the definition of a medical device. In the event that doubts should be posed about the correct legal qualification of the product, the Regulation has provided clear procedural indications, in particular for those situations for which a shared and documented interpretation is not already available.
What is the regulatory definition of a medical device and medicinal product (MDR – MPD)?
Medical Device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
- devices for the control or support of conception;
- products specifically intended for the cleaning, disinfection or sterilization of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
- Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
- Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
When determining whether a product falls within the definition of a medical device, it becomes essential to identify its intended use and mechanism of action.
When deciding whether a product falls under the MDR or MPD, a particular account must be taken of the product’s primary mode of action. The action of the substance must be scientifically objective and therefore the intention of the manufacturer is not relevant. In line with this, intentionality is not mentioned in the MDR legal provisions under discussion.
A medical device does not achieve its intended primary action by pharmacological, immunological or metabolic means, in or on the human body, but may be aided in its function by such means. The concept that a medical device can be assisted in achieving its primary intended action by pharmacological, immunological or metabolic means should be understood to include cases where the medical device incorporates, as an integral part, a substance which, when used separately, would be considered a medicinal product and which performs an action ancillary to that of the device. 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.
Typically, the primary action intended by the medical device is achieved by physical means (including mechanical action, physical barrier such as a film, lubrication, heat transfer, radiation, ultrasound, replacement or support of organs or body functions). Furthermore, hydration or dehydration and pH modification can also be means by which a medical device achieves its main intended action.
The guideline MDCG 2022-5 recalls a very important general rule: a product is regulated either by the MDR (Medical Device Regulation) or by the MPD (Medicinal Product Directive) and, therefore, cannot refer to both regulatory landscapes. MDR and MPD cannot be applied cumulatively.
The decision tree (MDCG 2022 – 5) below requires a case-by-case evaluation and is intended to help determine whether a product meets the definition of a medical device for MDR.
From this analysis it appears quite clear that the aspects concerning medical devices are multiple and lead to very different regulatory paths.
A manufacturer that is designing a medical device must be completely aware of the “regulatory nuances” that govern the industry, in order to act in complete compliance.
A certainly intelligent approach is to turn to a team of expert consultants, equipped with transversal skills who sit on the same side as the manufacturer to advise him on the best path to follow, both from a practical and economic point of view.
At ToxHub, our expert European Registered Pharmacologist Giorgina Mangano, can offer comprehensive and accurate justifications for the classification of substance-based Medical Devices under Rule 21 of the MDR, supporting device intended primary action without relying on pharmacological, immunological, or metabolic means in or on the human body and validating its accurate classification.
Article issued by Maria Labianca