According to the definition in the “Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices” prepared by the working group Borderline and Classification medical devices expert group of the European Commission, borderline products are those products which, due to their nature, do not clearly belong to a specific area and for which it is therefore difficult to define the reference regulations to be applied.
Alternatively, borderline products are those product falling into the definition of medical device, but excluded from the application of the relevant directives. When a product does not fall into the definition of medical device reported in the directive or is excluded from the application of the same directive, other directives or reference regulations are applied.
Products with such a difficult classification are defined as borderline since they are at the border between the definition of device and the definitions provided by regulations ruling other areas, such as IVDs, medicines, biocides, supplements, cosmetics and PPEs.
It is for the manufacturers to decide whether their products fall into the definition of medical device (Legislative decree 46/97 art. 1, section 2). In case of doubts, it is for the Competent Authorities to determine the classification of borderline products.
When deciding whether a product falls into the definition of medical devices it is essential to identify the destination of use and the mechanism of action.
Our consultancy company offers support to the manufacturer in the assessment/control of the applicability of the MD reference directive and in case in starting a certification procedure for these products.