Navigating Borderline Medical Device Classification and Risk in the UK

1. Overview of Borderline Products

Some products are difficult to categorise because they appear to fall partly within the definition of a medical device and partly within another category (such as cosmetics, medicines, food supplements, biocides, or personal protective equipment). These products are termed borderline products until their regulatory status is determined by the Medicines and Healthcare products Regulatory Agency (MHRA).
Source: Borderline products: classifying medical devices and risk

When assessing a product’s status, the MHRA considers its intended purpose, mode of action, and presentation to the public (including labelling and promotional materials). Not all items used in medical settings are automatically classified as medical devices.
Source: Borderline products: classifying medical devices and risk

2. Types of Borderline Products

Borderline products may include, but are not limited to:

• Medicines and herbal medicinal products
• Cosmetics and biocidal products
• Personal protective equipment
• Machinery or laboratory equipment
• Food supplements

These categories illustrate the breadth of products whose classification may be unclear without MHRA determination.
Source: Borderline products: classifying medical devices and risk

3. How the MHRA Decides if a Product is a Medical Device

The MHRA typically evaluates products when the manufacturer seeks advice, a complaint is received, or there is uncertainty about a product’s compliance with regulations. Key factors considered include:

• The intended purpose of the product (what it is meant to do)
• The mode of action (how it works)
• How the product is presented to users and customers

These factors help determine whether the product primarily acts through physical or mechanical means, which is a core element of medical device classification.
Source: Borderline products: classifying medical devices and risk

4. Risk Classification of Medical Devices

Once a product is determined to be a medical device, it falls under the UK Medical Devices Regulations 2002 (as amended) (UK MDR 2002). Medical devices are classified by risk:

• Class I – Low risk
• Class IIa – Lower medium risk
• Class IIb – Higher medium risk
• Class III – High risk

The classification is based on factors such as how the device is used, whether it is invasive or implantable, and whether it contains substances with medicinal action.
Source: Borderline products: classifying medical devices and risk

In vitro diagnostic devices (IVDs) have a separate risk classification system reflecting their distinct functions and use environments.
Source: Borderline products: classifying medical devices and risk

5. Borderlines with Other Products

The MHRA also publishes guidance on borderlines between medical devices and other categories, such as general consumer products or devices with aesthetic purposes. These documents clarify specific cases and help manufacturers understand when a product may fall inside or outside the medical device regulatory framework.
Source: Borderlines with medical devices and other products in Great Britain

Manufacturers should not assume that products classified as medical devices in other jurisdictions will automatically be regarded as such in the UK; the UK MDR 2002 definitions and criteria apply.
Source: Borderlines with medical devices and other products in Great Britain

6. Getting Advice from the MHRA

If uncertainty persists after consulting published guidance, manufacturers and stakeholders can request advice from the MHRA’s Borderline Products Section. Providing detailed information on the product’s intended purpose and mode of action helps inform the determination and appropriate risk classification.
Source: Borderline products: classifying medical devices and risk

7. Importance of Correct Classification

Correct classification affects:

• Regulatory compliance (whether UKCA marking and conformity assessment are required)
• Market access and legal placement in Great Britain
• Post-market obligations, including vigilance and reporting

Understanding and applying MHRA guidance helps ensure products are placed on the UK market in compliance with relevant laws and safety requirements.
Source: Borderline products: classifying medical devices and risk