5. Borderline products


Borderline products

Borderline products are considered to be those products where it is not clear from the outset whether a given product is a Medical Device, an IVD or an active implantable Medical Device. Borderline cases can also be defined as those cases where the product falls within the definition of a Medical Device but is excluded from the Directives by their scope. Other Community and/or national legislation may then be applicable [1].

The European Commission (EC) published a ‘borderline and classification’ manual as a tool containing views of the Working Group on Borderline and Classification and are not legally binding. These views are about healthcare products whose regulatory status had to be clarified. The decisions in this manual typically conclude with a harmonised view about whether such borderline products are Medical Devices, IVDs, medicinal products or some other category of products (e.g., cosmetic product, biocide etc.).

There has been an ongoing need over the years for such harmonised decisions due to the presence on the EU market of a variety of products whose main mode of action was unclear or contested.  Historically, the EU Member States, primarily via their national competent authorities, have been the bodies empowered to take these decisions. Experts from Member States and other stakeholders (which can include patients) therefore meet on a regular basis to discuss borderline and classification cases in order to ensure a uniform approach. One such forum for these discussions is the Borderline and Classification sub-group of the Medical Devices Coordination Group, which is chaired by the EU Commission and attended by national competent authorities for both Medical Devices and medicinal products. This subgroup’s primary aim is to provide a forum to exchange views and, ideally, reach consensus about the regulatory status of the contested borderline product [2].

EMA has a role in some of these borderline decisions because it can provide an expert opinion about whether the product’s primary mode of action seems to be pharmacological, immunological or metabolic in nature – if this is the case, the product is typically seen as being a medicinal product and not a Medical Device.



[1] MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES (europa.eu).Source: https://ec.europa.eu/health/sites/default/files/md_topics-interest/docs/md_borderline_manual_05_2019_en.pdf

[2] Medical devices | European Medicines Agency (europa.eu) Source: https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices