# Borderline products: medical devices and other products

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/ade30de4-50d1-47df-b9c3-2667af5a2f39
Type: Guidance
Published: January 19, 2015
Updated: June 29, 2026

> This guidance document, issued by the Medicines and Healthcare products Regulatory Agency (MHRA), outlines the criteria for determining whether a product is legally classified as a medical device under Part II of the Medical Device Regulations 2002. This regulatory framework is specifically applicable to products marketed in Great Britain, including England, Wales, and Scotland, while separate protocols exist for Northern Ireland. Because this is a general guidance document and not a compliance report, there are no specific company names, inspection dates, or documented violations included. Instead, the document provides the necessary framework for manufacturers to assess their products against established legal definitions. The required action for stakeholders is to perform a thorough classification review of their products to ensure they meet the regulatory standards mandated by British law. Accurate classification is essential for ensuring that healthcare products are appropriately registered, monitored, and compliant with safety requirements. By following this guidance, manufacturers can successfully navigate the transition of medical device oversight in the post-Brexit market, ensuring all therapeutic or diagnostic tools are correctly categorized and meet the rigorous standards necessary for public use and safety.

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## Content

This guidance explains when a product would be considered a medical device within the terms of Part II of the Medical Device Regulations 2002. This guidance is specific to products placed on the market in Great Britain (England, Wales and Scotland). Find out how medical devices are regulated in Northern Ireland .

## Attachments

- [Borderlines with medical devices and other products in Great Britain](/government/publications/borderlines-with-medical-devices/borderlines-with-medical-devices-and-other-products-in-great-britain)