# Borderline products: classifying medical devices and risk

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/a2a40440-f541-40f1-b60c-3dd84ecbf3e7
Type: Detailed Guide
Published: January 6, 2021
Updated: July 11, 2023

> This guidance document issued by the Medicines and Healthcare products Regulatory Agency (MHRA) outlines the criteria for identifying and classifying 'borderline products' within the United Kingdom. These are items that may be difficult to distinguish from medical devices, such as medicines, cosmetics, or food supplements. The MHRA determines a product's status based on its intended purpose and mode of action, emphasizing that a medical device must primarily achieve its function through physical or mechanical means rather than pharmacological or immunological methods. Under the regulatory framework of the UK Medical Devices Regulations 2002 (UK MDR 2002), general medical devices are categorized into four risk levels: Class I (low risk), Class IIa, Class IIb, and Class III (high risk). In vitro diagnostic devices (IVDs) follow a separate four-group classification based on their specific utility and risk profile. A recent determination (Case 2023/07/1) specifically reclassified self-propellant sprays, such as ethyl chloride canisters used for numbing, as Class IIa active devices because they administer energy. The main issue addressed is the potential for manufacturers to misclassify products or incorrectly assume that international designations apply in the UK. Manufacturers are required to review existing MHRA guidance before marketing their products. If uncertainty remains regarding a product's classification or status, the MHRA mandates that companies contact their specialized borderline team via email with full product details, including mechanism of action and labeling, to ensure legal compliance.

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## Content

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, the 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 or 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, its 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 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 We 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. We 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. We 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 (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 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: 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 MDR 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 can email devices.borderlines@mhra.gov.uk , including full details of the product, its intended purpose and how it works. Further guidance Borderlines between medical devices and medicinal products Borderlines between medical devices and other products (such as personal protective equipment, cosmetics and biocides) 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 explains 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 covers risk classification of medical devices. Annex A – MHRA borderline determinations Where MHRA Borderlines has established a view regarding classifications of specific categories of medical devices, the MHRA is publishing this information to assist manufacturers to arrive at the appropriate classification for their products. Product Self-Propellant sprays The MHRA has reviewed the classification of a number of pre-filled, metallic canisters containing ethyl chloride with incorporated aerosol spray dispensing mechanism. The products are intended to be applied to unbroken skin, generally for heat transfer (cooling) and resultant numbing effects. MEDDEV 2.4/1 rev.9 explains that medical devices using prestored gases and/or vacuum as a power source are regarded as active devices. Metal Cannister and Glass Vial sprays that function via the self-propellant nature of the contents to dispense the liquid/gas as a spray or a jet, will be considered active devices. This includes where vapor is acting as the propellant. As these spray products are administering energy in the form of a spray, they will generally be considered class IIa devices. (Application of Rule 9, Annex IX 93/42/EEC (MDD)) Case: 2023/07/1