The guideline “MDCG 2022 - 5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices” of the Medical Device Coordination Group (MDCG) has recently been published, in order to provide support in the correct classification of borderline products, i.e. products that are not immediately ascribable to a specific sector due to their nature, for which it is not easy to identify its applicable legislation.

The first part of the document provides the definitions used (a diagram is also provided to facilitate product evaluation, and to establish whether or not it falls within the definition of a medical device), as well as general rules to be applied to identify the nature of a product. Concrete examples are then provided of medical devices (specifying that if a solution contains a medicinal product as a main ingredient, the product will be considered a medicinal product; conversely, solutions incorporating medicinal substances with an auxiliary action, such as preservatives, these substances are classified as medical devices), of medical device accessories (e.g., products to treat contact lenses), as well as medicinal products (e.g., disinfectants to be used on the non-intact skin of the patient before surgery, gases to be used in anaesthesia and inhalation therapy, etc.).

The second part of the Guideline contains separate chapters on specific product categories, such as:

- herbal products (which are usually medicinal products, but it is not excluded that they may qualify as medical devices if the action of its herbal component is only ancillary, and the main action is obtained by physical or mechanical means);

- substance-based medical devices (i.e. medical devices that are composed of substances permitted for this type of product, whose main action is not by pharmacological, metabolic or immunological means);

- medical device and medicinal product combination (in order to identify the correct regulatory reference framework, the first step is to establish whether the product is an "integral" product within the meaning of Regulation 745/2017, and then to understand whether the action of the medicinal product incorporated into the device is principal or ancillary to the function performed by the medical device itself. If the main action of the integral product is carried out by the medical device, the entire product will be considered as a device, and thus be governed by Regulation 745/2017).  

In addition to providing the relevant definitions and referencing the relevant regulatory provisions, numerous examples are given as further support for the purposes of correct classification for each product category.

The document may be subject to modifications by the MDCG in order to reflect scientific and technical developments, as well as the results of regulatory discussions held by the working group.