MHRA Guidance: Borderline Products – Medical Devices and Other Products in Great Britain

Determining whether a product qualifies as a medical device is one of the most important regulatory decisions for manufacturers before placing a product on the Great Britain market. Many products fall into a "borderline" category because they may share characteristics with medicines, cosmetics, food supplements, biocides, personal protective equipment (PPE), or other regulated products.

To provide greater regulatory clarity, the Medicines and Healthcare products Regulatory Agency (MHRA) published the guidance Borderline Products – Medical Devices and Other Products in Great Britain. The guidance explains how the MHRA determines whether a borderline product is a medical device and whether the UK Medical Devices Regulations apply, helping manufacturers classify products correctly and comply with the appropriate regulatory framework.

What Are Borderline Products?

Borderline products are products whose regulatory status is not immediately clear because they may meet the definitions of more than one regulated product category. Examples include products that may resemble medicines, cosmetics, food supplements, biocides, laboratory equipment, or personal protective equipment while also having potential medical applications.

The guidance emphasizes that a product should not automatically be considered a medical device simply because it is marketed as one in another country. Each product is assessed individually under the UK regulatory framework based on its characteristics and intended purpose.

How the MHRA Determines Whether a Product Is a Medical Device

The MHRA evaluates borderline products on a case-by-case basis using the legal definition of a medical device under the UK Medical Devices Regulations. The primary considerations include the product's intended purpose, how it achieves its intended action, and the claims made by the manufacturer.

A key distinction is the product's principal mode of action. Medical devices achieve their primary intended purpose mainly through physical or mechanical means. These principles help distinguish medical devices from medicinal products and other regulated product categories.

Products Commonly Considered Borderline

The guidance highlights several product categories that frequently require regulatory assessment before their classification can be confirmed. These include products that may fall between medical devices and medicines, cosmetics, food supplements, herbal medicinal products, biocides, personal protective equipment, laboratory equipment, and other consumer products.

Because product design, intended use, scientific evidence, and promotional claims can differ significantly, manufacturers are encouraged to evaluate each product individually rather than relying on classifications applied to similar products.

Factors Considered During Classification

The guidance explains that the MHRA considers multiple factors when determining whether medical device regulations apply. These include the manufacturer's intended purpose, product labeling, instructions for use, advertising materials, mechanism of action, scientific evidence supporting the product, and the way the product is presented to users.

No single factor determines classification on its own. Instead, the overall evidence is assessed to establish the most appropriate regulatory pathway for the product.

Borderline Determinations

To improve regulatory consistency, the MHRA has published examples of products that have previously been assessed as either within or outside the scope of the medical device regulations. These determinations provide practical guidance for manufacturers when evaluating similar products, although each new product continues to be assessed based on its own characteristics and intended purpose.

The guidance also references additional European MEDDEV guidance documents that support classification decisions for medical devices, medicinal products, in vitro diagnostic medical devices, and active implantable medical devices where applicable.

Seeking Advice from the MHRA

Where uncertainty remains after reviewing the available guidance, manufacturers may seek advice from the MHRA regarding the regulatory status of their products. Providing detailed information about the product's intended purpose, composition, mechanism of action, labeling, and supporting evidence helps facilitate the assessment process and supports appropriate classification before placing the product on the market.

By focusing on the product's intended purpose, primary mode of action, scientific evidence, and overall presentation, the guidance helps manufacturers identify the appropriate regulatory pathway and avoid product misclassification.

References

• MHRA Guidance: Borderline Products – Medical Devices and Other Products in Great Britain