Borderline products: classifying medical devices and risk

AI Summary

This guidance document issued by the Medicines and Healthcare products Regulatory Agency (MHRA) outlines the criteria for identifying and classifying 'borderline products' within the United Kingdom. These are items that may be difficult to distinguish from medical devices, such as medicines, cosmetics, or food supplements. The MHRA determines a product's status based on its intended purpose and mode of action, emphasizing that a medical device must primarily achieve its function through physical or mechanical means rather than pharmacological or immunological methods. Under the regulatory framework of the UK Medical Devices Regulations 2002 (UK MDR 2002), general medical devices are categorized into four risk levels: Class I (low risk), Class IIa, Class IIb, and Class III (high risk). In vitro diagnostic devices (IVDs) follow a separate four-group classification based on their specific utility and risk profile. A recent determination (Case 2023/07/1) specifically reclassified self-propellant sprays, such as ethyl chloride canisters used for numbing, as Class IIa active devices because they administer energy. The main issue addressed is the potential for manufacturers to misclassify products or incorrectly assume that international designations apply in the UK. Manufacturers are required to review existing MHRA guidance before marketing their products. If uncertainty remains regarding a product's classification or status, the MHRA mandates that companies contact their specialized borderline team via email with full product details, including mechanism of action and labeling, to ensure legal compliance.