GovWire

Overview

Some products are hard to distinguish from a medical device, for example products that might be medicines, cosmetics, food supplements, biocidal products or personal protective equipment. These products are called borderline products until their status has been decided.

The MHRA determines whether a product falls within the definition of a medical device and provides information on whether a product is a medical device or not. The MHRA also determines whether a product is a medicine or not.

For products which are medical devices, MHRA also considers the risk classification applied to the device and whether this is appropriate.

Types of borderline products

The types of products which may fall into the borderline category include:

• medicines
• herbal medicinal products
• cosmetics
• biocides
• personal protective equipment
• machinery/laboratory equipment
• food supplements

Medical devices fall into one of three categories:

• general medical devices
• in vitro diagnostic medical devices (IVDs)
• active implantable medical devices

The MHRA can give advice if you are not sure which category your device fits into.

You should not assume that if your product is considered a medical device in countries outside the UK that it will be a medical device in the UK as well.

Decisions about whether a product is a medical device are based on the intended purpose of the product and its mode of action (what it is, what it does and how it does it).

If the product is a medical device, the principal intended action must primarily be fulfilled by physical or mechanical means. It may not act principally by pharmacological, metabolic or immunological means, although ancillary action is permitted.

This mode of action is the main difference between medicinal products and medical devices, both of which have medical purposes.

Not all items used in a health or care or hospital setting are considered to be medical devices.

How we decide if a product is a medical device and which risk class applies

• The MHRA usually decides whether a product is a medical device when the manufacturer is not sure if their product is a medical device and approaches the MHRA for advice.
• The MHRA may also review products when a complaint is received that a product is being marketed as a medical device and does not meet the regulations or when it is claimed to be a medical device but does not meet the criteria for it to be a medical device
• The MHRA will also review risk classification in response to advice requests, or if we become aware that a device which is on the market may have been misclassified.

We look at:

• the intended purpose for the product, including the claims about what the product is and what it does (explicit and implicit)
• the mode of action of the product (i.e. how it works)
• how the product is presented to the public through labelling, packaging, promotional literature and advertisements, including websites
• whether there are any similar products on the market and how they are regulated

Risk classification of medical devices

The legislation lays out a system for classifying medical devices into different risk classes. The higher the risk, the greater the level of assessment required by UK Approved Bodies.

General medical devices

Under Part II of the UK Medical Devices Regulations 2002 as amended (UK MDR 2002), general medical devices are grouped into four classes as follows:

Class I - generally regarded as low risk;

Class IIa - generally regarded as lower medium risk;

Class IIb - generally regarded as higher medium risk;

Class III - generally regarded as high risk.

Classification of a medical device will depend upon a series of factors, including:

• how long the device is intended to be in continuous use;
• whether or not the device is invasive or surgically invasive;
• whether the device is implantable or active;
• whether or not the device contains a substance which, if used separately, is considered to be a medicinal product and is liable to act on the body with an action ancillary to that of the device.

The classification rules by which the risk classification of a general medical device is determined are referred to in regulation 7, Part II of the UK MDR 2002. The risk classification system for general medical devices under Part II of the current UK MDR 2002 (as amended) is laid out in Annex IX of Directive 93/42/EEC as modified by Part 2 of Schedule 2A to the UK MDR 2002.

IVDs

Under Part IV of the UK Medical Devices Regulations 2002 (as amended), in vitro diagnostic medical devices (IVDs) are classified into four main groups reflecting key risk factors:

• general IVDs
• IVDs for self-testing, intended to be used by a layperson in the home environment
• IVDs coming within the classifications stated in List B, Annex II of Directive 98/79/EC as modified by Part 3 of Schedule 2A to the UK MDR 2002, referred to as Annex II List B
• IVDs coming within the classifications stated in List A, Annex II of Directive 98/79/EC as modified by Part 3 of Schedule 2A to the UK MDR 2002, referred to as Annex II List A

Determination of the classification of an IVD will depend upon the purpose and whether or not it is listed in Annex II.

The highest risk products are those in Annex II List A, followed by those in Annex II List B, then self-test and finally the general category.

The MHRA can give advice if you are not sure which risk class your device falls into.

Getting advice about your product

You can find advice on borderline products with medical devices, and medical device risk classification, in published guidance documents listed below. You should read these before contacting the MHRA.

If you then require advice about whether your product is a medical device, or which risk class your medical device falls into, you may email Devices.Borderlines@mhra.gov.uk including full details of the product, its intended purpose and how it works.

If you wish to know whether your product could be a medicine, rather than a medical device please refer to the medicines borderline page.

Guidance documents

MHRA guidance: Borderlines between medical devices and medicinal products

MHRA guidance: Borderlines between medical devices and other products (such as personal protective equipment, cosmetics and biocides)

MHRA Guidance Note 8 A guide to what is a medicinal product

Borderline products: how to tell if your product is a medicine

MEDDEV guidance documents

MEDDEV 2.1/3 rev.3 - borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative

MEDDEV 2.4/1 rev.9 - risk classification of medical devices