MHRA updates guidelines on the classification of borderline products with medical devices in the UK
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has recently published an update to its guide "Borderlines with medical devices and other products in Great Britain", an essential document for manufacturers operating in the UK market and dealing with products that straddle the border between different regulatory frameworks - such as cosmetics, food supplements or personal care products.
What's at stake?
This guide aims to clarify how the MHRA assesses whether a product is considered (or not) a medical device, based on its mode of action, stated purpose and composition. Borderline cases are particularly relevant for:
Products with therapeutic or preventive claims, but without sufficient clinical evidence to meet the criteria for a medical device;
Substances applied to the body that interact with tissues without a physiological mechanism of action;
Products initially registered as cosmetics or supplements, but which are derived for medical purposes.
As a manufacturer, this is important to you!
Correct regulatory classification has direct implications for the process of placing products on the market, conformity assessment requirements, technical documentation requirements and post-market surveillance.
After Brexit, the UK market no longer follows the European MDR, so it is essential to understand the specific differences in the MHRA's approach. Manufacturers looking to maintain or expand their presence in the UK should review their portfolios and ensure that:
The purpose of the product is clearly defined and supported by data;
The classification follows local guidelines (not just the MDR/IVDR);
They are prepared to interact with the MHRA in the event of reclassification or doubts.
Analyze the full document below.
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