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Medical Devices Borderline

As defined in the “Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices” drafted by an exert 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 any reference regulations to be applied.

Alternatively, borderline products are those products falling into the definition of medical device (MD), but excluded from the application of the relevant legal provisions. When a product does not fall into the definition of medical device reported in the Regulation (EU) 2017/745 (MDR) or is excluded from the application of the said regulation, other sectors’ legal provisions are applied.

Products with such a difficult classification are defined as borderline since they are at the border between the definition of medical device and the definitions provided by provisions ruling other areas, such as in vitro diagnostics (IVDs), medicines, biocides, food supplements, cosmetics and personal protection equipment (PPE).

It is for the manufacturers to decide whether their products fall into the definition of medical device (MDR). In case of doubts, it is for the Competent Authorities to determine the suitable classification of borderline products.

When establishing whether a product falls into the definition of medical device, it is essential to identify its intended use and mechanism of action.

Di Renzo Regulatory Affairs has a special unit dedicated to regulatory activities for MDs and IVDs, and can therefore assist companies in the preliminary assessment phase, and the following classification or re-classification of borderline products.

Foto di stevepb da Pixabay