Update to the Borderline Manual provides both guidance on product classification and insight into the Working Group thought process.
The European Commission has published an updated version of the Manual on Borderline and Classification for Medical Devices, commonly referred to as the Borderline Manual.
There are six new additions to the Manual, four of which relate to products which the Working Group concludes are not appropriate for classification as a medical device. The route by which the Working Group came to its conclusion concerning the appropriate classification of the products under review demonstrates the Group’s related thought process. Its associated conclusions could, in some instances, be applied in determining the appropriate classification of other products.
The update includes new opinions concerning the following products:
Red blood cell additive solutions containing adenine are to be considered Class III medical devices. The product could have a metabolic mode of action or a pharmacological mode of action (or both) as defined in MDCG 2022-5. As an ancillary medicinal product, red blood cell additive solutions containing adenine fall within Rule 14 Annex VIII of the MDR;
Medical examination table covers are considered medical devices. This is because their intended purpose is to ensure a good level of hygiene and to prevent the transmission of infectious agents, which can be easily transferred from patient to patient through contact with a common surface;
Dual-action cream with menthol and capsaicin is not considered a medical device. The Working Group concluded that both substances have a pharmacological mode of action. In its conclusion, the Working Group recalled that it is the manufacturer that bears the burden of proof for the non-pharmacological, non-immunological, or non-metabolic effect of their product;
A mobile sterile air systems is not considered a medical device. This is because, although the system enables an appropriate environment to perform medical interventions, it does not itself have a medical purpose;
Lactose vaginal tablets are not considered a medical device as they achieve their principal intended action by metabolic means in or on the human body;
Microabrasion dental stain removers (tooth whitening), classification of which has been the subject of some debate in recent years, are not considered a medical device. The Working Group concluded that products used for improving the appearance of teeth do not comply with the legal definition of medical device established in the MDR.
As with previous versions, Version 4 of the Manual underlines that the document represents the view of the EU Member State members of the Borderline and Classification Working Group, a subgroup of the Medical Device Coordination Group (MDCG) and that the views are not legally binding. Experience indicates, however, that the opinions presented in the Manual can influence the approach of both competent authorities and notified bodies to appropriate classification, not only of the products that are the subject of Committee review, but also products that could be perceived to be equivalent.