Guidance

Borderlines with medical devices and other products in Great Britain

Updated 8 April 2024

In relation to the UK Medical Device Regulations 2002 (SI 2002 No 618, as amended)

Revision history	Date published	Changes
V1.0	February 2014	n/a
V1.1	May 2016	Contacts for MHRA
V1.2	January 2021	Amended for UK Regulations
V1.3	May 2021	Typo Corrected
V1.4	September 2021	View on POU water filters; typo
V1.5	June 2023	Minor updates – Amended for transitional arrangements
V1.6	March 2024	Minor updates – typo corrections, contacts list

Disclaimer

The guidance given presents the MHRA’s current views on the interpretation of the medical devices legislation as it relates to borderline products. It is intended as general guidance and should not be regarded as an authoritative statement of the law or as having any legal consequence. This guidance should not be relied on solely – manufacturers and others should consult the relevant legislation referred to and seek the views of their own professional advisors. The MHRA does not accept liability for any errors, omissions, misleading or other statements whether negligent or otherwise.

1. Introduction

Many manufacturers have difficulty in interpreting whether or not their product would be considered a medical device within the terms of the UK Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). This guidance document has been developed to aid with some of the more common areas of confusion.

It is often assumed that because a product is considered a medical device in some countries, for example in the USA, Canada or in Japan, that it will also be a medical device in the UK.  This is not the case and manufacturers should always refer to the UK definitions of a medical device when making any borderline determinations. Any such decision will be based on the stated intended purpose of the product and its mode of action. Manufacturers should also consult the available published guidance in order to determine whether or not their product is considered a medical device in the UK. The available published guidance is listed in section 23 of this document.

In general, medical devices must have a ‘medical purpose’ which is determined by the definition of a medical device. They must also act primarily in a way that is not metabolic, immunological or pharmacological.  Should they function in any way that is metabolic, immunological or pharmacological, in conjunction with having a medical purpose, they are likely to come within the remit of the regulations covering medicinal products instead. Further information on the borderline with medicinal products is available – see the list at the end of this document.

The word ‘manufacturer’ in the context of the UK MDR 2002 means the person or company who is placing the product on the market or into service in their own name. It does not necessarily mean the physical manufacturer of the devices concerned. If a company is a “virtual manufacturer”  then they take on full legal responsibility as the manufacturer of the product as defined in the UK MDR 2002.

This guidance document only covers borderline products with general medical devices as specified in Part II of the Medical Device Regulations 2002 (as amended), and therefore does not cover borderlines with in-vitro diagnostic medical devices or active implantable medical devices.

The advice given in this document is by nature general and if manufacturers are uncertain, they should seek further advice from the MHRA after consulting the other guidance documents.

Products falling outside the scope of the regulations for medical devices may still be covered by other parts of the Consumer Protection Act or other UK legislation and must be safe for their intended purpose.

This guidance is specific to products placed on the market in Great Britain. For information on how medical devices are regulated in Northern Ireland, please see our published guidance.

Medical devices bearing the CE mark will continue to be accepted on the Great Britain market for defined periods, dependant on the class of device they belong to and legislation complied with.  More information is available in the guidance on regulating medical devices in the UK here.

This guidance is specific to products conforming to the UKCA marking requirements unless otherwise stated.

2. Medical purpose

Although the UK MDR 2002 does not use the phrase ‘medical purpose’, medical devices are considered to be items intended to be used in a ‘medical’ context. Whether or not a product is considered to have a ‘medical purpose’ will be defined by the manufacturer’s intention for the product as defined in their labelling, instructions for use and promotional material and its mode of action in conjunction with the definition of a medical device as stated in the UK MDR 2002.

Note that not all equipment used in a healthcare environment or used by a healthcare professional will be considered to come within the definition of a medical device.

3. Medical / cosmetic / toiletry purpose

As medical devices are considered to be specifically intended for a ‘medical purpose’, products that do not have such a principal intended purpose are not considered to be medical devices, even if they may be considered to be used for the prevention of disease as a secondary purpose.

Examples of the types of products that are not normally considered to be medical devices:

• baby nappies
• bed pans
• breast pumps
• deodorants / odour neutralisers, including those for use with medical devices
• feminine hygiene products (sanitary towels, tampons)
• gallipots, kidney bowls and similar holloware
• hand cleansing wipes (for general hand cleaning)
• hot water bottles, heat pads etc (with no medical claims)
• lubricants for body massages or sexual intercourse with no medical claims
• insect repellents
• instruments for tattooing
• mattress protectors / bed sheets
• muscle toning products
• ‘pill’ dispensers for tablets and capsules / storage boxes with reminders
• slimming products
• toothbrushes, dental sticks, dental floss
• tooth whitening / bleaching products
• un-medicated chewing gum
• wash bowls
• wigs / head scarves
• wrinkle treatments (with cosmetic purpose)
• “point-of-use” water filters which may be attached to water faucets, showers etc. (see MHRA’s guidance regarding classification of POU water filters)

Where there is a specific primary intended medical purpose, similar products may be considered to be medical devices. For example:

• bedwetting alarms for nocturnal enuresis
• breast pumps for treatment of inverted nipples
• external heat pads claiming pain relief, e.g. for the treatment of period pains
• incontinence products (e.g. adult nappies)
• muscle toning products with medical claims (such as treatment of incontinence)

• slimming products indicated for the treatment of clinical obesity which do not act in a metabolic, pharmacological or metabolic manner*.

• note that such products may be considered to be medical devices or medicinal products and the determining factor will be the mode of action of the product concerned. Thus, products for the treatment of obesity, which act by increasing metabolism or having a pharmacological or metabolic action, would be considered to be medicinal products and not medical devices.

4. General purpose products

Products that have a multiple purpose, which may occasionally be used within a medical environment, are not normally medical devices, unless a manufacturer ascribes a specific medical purpose to such products. Examples of such products are:

• disinfectants / cleaners intended for multi-purpose use, including hard surfaces (See also section 21 on Biocides)
• magnetoscopes, screens
• multipurpose PCs, scanners, printers etc.

5. Assistive technology products (aids for daily living)

Equipment intended for alleviation of, or compensation for a disability may or may not be considered medical devices. The determining factor will be whether or not there is a direct link between the corrective function of the equipment and the individual concerned and whether there is a stated medical purpose.

The following products are considered to be medical devices as there is such a direct link:

• baths with integral hoists
• external limb prostheses and accessories
• hearing aids
• mobility aids for the visually impaired
• orthopaedic footwear
• orthoses (lower/upper limb, spinal, abdominal, neck, head)
• patient hoists
• rehabilitation tricycles / mobility carts
• walking / standing frames
• walking sticks / crutches
• wheelchairs.

Other products, however, will be considered as ‘general equipment’ since it may be used ‘by all’ (rather than having a direct link with the individual concerned). Such products are usually considered as ‘aids for daily living’ and are not medical devices. For example:

• acoustic signals at traffic lights
• baths with doors
• grab rails (at doorways, stairs etc)
• personal alarm systems / home alarm systems
• portable ramps
• special water taps
• stair lifts
• toilet equipment for the disabled / elderly (e.g. toilet seats, shower seats, commodes).

MHRA have published separate guidance specifically on assistive technology products.

In cases of doubt, contact the MHRA for further advice; email: - [email protected]

6. Products for sports or leisure

In general, products for sport or leisure purposes are not considered to be medical devices. However, in some cases, products aimed at sports people may be considered to be medical devices. This is usually the case where specific claims are made for the treatment of pain or injury and the product acts in a physical manner; products such as sports helmets which only seek to prevent injury do not fit the definition of a medical device, and therefore are not considered to be medical devices (see also section 7 on personal protective equipment).

Examples of products considered to be medical devices are:

• heat / cold pads for pain relief
• bandages for sprains and similar
• support bandages
• gym equipment placed on the market specifically to measure, for example, heart rate or breathing rate*.

*Gym equipment that contains within it an element that measures heart rate is not a medical device because its primary purpose is as a piece of fitness equipment, not principally to measure a physiological function. Blood pressure monitors, even if intended to be used in a gym, however, would be considered to be medical devices.

7. Personal protective equipment

Some products may appear to have a medical purpose, but in fact are designed to protect the user. Such products are usually considered to be personal protective equipment (PPE) rather than medical devices. This will depend upon the intended purpose for the individual product concerned. For example:

• eye protecting equipment (e.g. goggles, visors) with no corrective function
• ionising radiation protective clothing: if intended for the protection of healthcare professionals will be PPE but if intended for patient protection would usually be medical devices: radiation shields placed in the environment are neither considered to be PPE nor medical devices
• latex / rubber gloves may be PPE or medical devices, or both – examination gloves and surgical gloves are medical devices. Gloves for other purposes would not be medical devices (e.g. for use in the home or in a laboratory). The key determining factor will be the principal stated purpose of the product by the manufacturer when they place it on the market
• masks may be PPE or medical devices, or both – masks intended for the protection of the user (e.g. from the environment) are PPE, whereas surgical masks(e.g. for use in an operating theatre or other medical procedures) are medical devices as they are intended to protect the patient rather than the user
• mouth guards are only medical devices when intended for a specific ‘medical’ purpose, for example as a retainer following orthodontic treatment or for use in the treatment of sleep apnoea or for bruxism. In most other cases these products will be PPE, including those intended for sports purposes
• self-rescue apparatus
• sports helmets for the prevention of injury.

It should be noted that amendments to the UK Medical Device Regulation 2002 contains  provisions for products that are intended to be used both as medical devices and personal protective equipment. In such cases the product should be UKCA marked as a medical device. However, the manufacturer must also fulfil the relevant basic health and safety requirements of the PPE (Enforcement) Regulations 2018 (SI 2018 No. 390), the UK legislation on  personal protective equipment.

Further information on the PPE Regulations can be obtained from the Office for Product Safety and Standards (OPSS).

8. Other products

Below are some general products that are not considered to be medical devices:

• filters / purifiers / decontamination units for air and/or water
• non-prescription sunglasses / spectacles / contact lenses (unless there is another medical purpose assigned to them by the manufacturer)
• non-sterile clothing / apparel for home, occupational or recreational use
• products or instruments for use on cadavers e.g. autopsy saws
• UV lamps not intended for use on medical devices

9. Software

Software may be considered to be a medical device provided that the purpose fits the definition of a medical device. The definition of a medical device includes standalone software and specifies that when software is used in combination with a device which is ‘intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes’ that it will be considered to be a medical device.

For example:

• software intended to enhance images from x-ray or ultrasound would be considered a medical device
• software that is simply a patient management system or a records storage system would not be considered a medical device
• telecare alarm systems are unlikely to be considered medical devices, however some specific telehealth systems or products used with such systems may come within the remit of the UK MDR 2002. Further advice should be sought from MHRA.

MHRA have published separate specific guidance on regulation of medical device software and apps, including their classification.

Guidance document MEDDEV 2.1/6, accessible in section 23, also provides specific guidance on this issue.

10. Machinery

The Supply of Machinery (Safety) Regulations 2008, which covers machinery, no longer contains a clause excluding medical devices from its provisions. The UK MDR 2002 also contains provisions relevant to machinery that is also a medical device. In such cases the machinery should be UKCA marked as a medical device. However, the manufacturer must also fulfil the essential health and safety requirements of the Machinery Directive 2006/42/EC, implemented into UK law by the Supply of Machinery (Safety) Regulations 2008, where these are more specific than the essential requirements in the UK MDR 2002.

Further guidance is available from the Health and Safety Executive (HSE) on machinery.

11. Medical devices / medicinal products

For specific guidance on the borderline between medicinal products and medical devices, please refer to the specific guidance documents that are available via the MHRA website (see section 23 and appendix).

12. Accessories

The UK MDR 2002 defines an accessory as:

‘an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical devices to specifically enable the medical devices to be used in accordance with its intended purpose or to specifically and directly assist the medical functionality of the medical device in terms of its intended purpose’.

Accessories should be classified in their own right as a medical device and do not necessarily take the classification of the device with which they are intended to be used. As this is the case, the determination as to whether or not a product is an accessory will be based on whether or not the product is specifically intended, by its manufacturer, to be used together with a medical device in order for the accessory to enable the device to be used in accordance with its intended purpose/use by its manufacturer. A product can only become an accessory to a medical device if there is an established intended use in conjunction with a medical device. If a medical device can fulfil its original intended purpose without the supplementary use of a product, that product would not qualify as an accessory to a medical device.

Examples of such potential accessories are:

• contact lens care products
• disinfectants specifically intended for medical devices
• gas cylinders / pressure release devices for use in conjunction with anaesthesia machines
• pouches for packaging re-sterilised medical devices
• specialised water treatment devices for use with dialysis machines
• specific battery chargers for battery-driven electromedical devices
• sterilisers for use with medical equipment.

13. Raw materials and component parts

A medical purpose will relate to the finished product (rather than component parts), irrespective of whether they are intended to be used in combination. Therefore, raw materials, component parts or products at stages of intermediate manufacture are not normally considered to be medical devices. Manufacturers should be aware, however, that raw materials / components may have properties or characteristics which will affect the quality and safety of finished medical devices and therefore must take responsibility for the selection and control of such raw materials / components and ensure their compatibility for the finished device.

14. Spare parts

Spare parts supplied for the replacement of existing components of a medical device that has already been UKCA marked are not usually considered to be medical devices unless they are likely to significantly change the characteristics or performance of the finished device. If this is the case, then such spare parts are likely to be considered medical devices in their own right.

15. Repairs

Where a device is ‘repaired’ and returned to its original owner after the repair the components used in the repair would not require UKCA marking as medical devices and the repaired device will not require UKCA marking a second time. The device is not being ‘placed on the market’ but returned to its owner.

16. Second-hand and fully refurbished devices

Second-hand medical devices are those which are already on the market and have been ‘pre-owned’ and used and that are subsequently ‘sold on’ for the same continued use. These products are considered to be already UKCA marked and first placed on the market and do not require further marking by their new owner.

A medical device that has been fully refurbished is not the same as one that has been repaired or undergone maintenance.

Fully refurbished medical devices are considered to come within the requirements of the medical device regulations and will require UKCA marking by the person undertaking the full refurbishment. They will be considered to be the ‘manufacturer’ under the regulations and are required to place the product on the market under their own name. ‘Fully refurbished’ is considered to mean that a device has been completely rebuilt / made as new from used devices and is assigned a new ‘useful life’. It would also be considered as a new device if a new intended purpose was assigned.

Further information may be obtained from the guidance document ‘Placing on the market of fully refurbished medical devices’.

17. Final processing

Some devices may not be supplied in their final state (i.e. may not be immediately available for use) once placed on the market. They may require some further processing prior to being ‘usable’, for example processing, preparation, installation, assembly or fitting. These activities are not usually undertaken by the manufacturer but are carried out by the healthcare professional or the final user.

Examples of such activities are:

• adaptation of a prosthesis to the needs of the individual patient
• assembly of systems
• configuration of electronic equipment
• fitting of contact lenses
• preparation of dental fillings
• sterilisation of medical devices supplied non-sterile.

Whilst the majority of these activities will not fall within the remit of the MDR 2002, a distinction must be made between activities carried out by a healthcare professional in the course of their expert activity and activities carried out by a specialist expert in such processing (for example assembly of spectacles from lenses and frames to a prescription). The latter may be considered to be processing or assembling activities and as such come within the remit of Regulation 14 of the UK MDR 2002 and thus require to be covered by the requirements of the medical device legislation.

18. Custom-made devices

Custom-made devices are usually one-off devices made specifically for one individual patient on the basis of a written prescription from a healthcare professional. These products must comply with the UK MDR 2002 requirements and there are specific conformity assessment routes for them. Examples of such devices are dental appliances, prostheses and hearing aid inserts. Intermediate products as described in the previous section may be considered as medical devices where they are specifically intended for these types of custom-made devices. This would include items such as dental alloys, dental ceramics, modular components for prostheses etc.

MHRA have published specific guidance on custom-made devices.

19. Procedure packs / assembling and processing

Regulation 14 of the UK MDR 2002 provides for manufacturers who put together medical devices already carrying the UKCA / CE mark into kits or procedure packs for specific uses. Kits or procedure packs will come within the remit of the regulations and manufacturers need to comply with specific elements of the regulations, although the kit or procedure pack itself does not need to carry an additional UKCA/ CE mark. Such kits may also include non UKCA / CE marked products. For example, such a kit may contain a medicinal product, which must meet the requirements of the regulations covering medicinal products, including those covering labelling, packaging etc. Where such kits / procedure packs are sterilised after completion, the assembler will require certification via a UK Approved Body for the sterilisation process.

If any of the medical devices contained in such a kit are not UKCA / CE marked by the original manufacturer, then the person putting the kit on the market is considered to be the manufacturer and the whole kit would need to be UKCA marked as a medical device in its own right.  That is, the ‘assembler’ in such cases would be regarded as the manufacturer of the whole kit.

In addition, if the UKCA / CE marked devices are placed in the kit for a purpose not compatible with the original manufacturer’s stated intended purpose then the person assembling the kit will be deemed to be placing a medical device on the market in its own right and therefore must meet the full requirements of the UK MDR 2002.

The assembling of medical devices is likely to come within the remit of the UK MDR 2002, for example the assembling of UKCA / CE marked spectacle frames and lenses for specific patients, along with associated processes such as glazing, and surfacing.

20. In-house manufacturing

Under the UK MDR 2002 the manufacturer is defined as the natural or legal person responsible for the manufacturing activities related to a device with a view to it being placed on the market or put into service under the manufacturer’s own name. In order to be a medical device, the product must be placed on the market or put into service. Where the device is manufactured by the user of a product (for example in a hospital) without being transferred to another person / legal entity or where it is supplied for use by the hospital’s own patients, it would not be considered to come within the remit of the UK MDR 2002. The key is there is no transfer of ownership of the product.  Where the manufacture of an ‘in-house’ design has been subcontracted to an external party by the user, this will still be considered to be ‘in-house’ provided that the product is not supplied to any third party.

MHRA has published further details on in-house manufacturing. 

21. Biocides

Products intended to disinfect may come within the remit of the biocides regulations, the UK MDR 2002, or the regulations covering medicinal products for human use, depending upon their intended purpose, composition and the claims made for the products concerned.

In general, for a product to be acceptable as a medical device it must be a disinfectant that is specifically indicated for the disinfection of medical devices. For example, wipes for disinfecting stethoscopes.

Biocides intended as general-purpose disinfectants for rooms, hard surfaces etc are not considered to be medical devices.

The Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013, covering Biocides, contains provision for products intended for both general disinfectant use and use with medical devices. In such a case both the regulations covering medical devices and those covering biocides would apply to a single product and the product should be labelled in accordance with both sets of regulations.

Disinfectant products for use on humans may also be regulated in various ways.

• Hand gels / washes intended for general purpose use (including by healthcare professionals) are generally regarded as biocides, unless there are claims for the control of specific pathogens, in which case they may be considered to be medicinal products.
• Surgical scrubs are regarded as medicinal products.
• Pre-injection swabs / wipes:

a)  alcohol only wipes are considered to be medical devices

b)  those containing anti-microbial substances such as chlorhexidine, cetrimide or iodine are considered to be medicinal products (see additional advice in section 23 below and on the MHRA website).

Further guidance on the requirements and enforcement of the biocidal product regulations can be obtained from the Health and Safety Executive (HSE).

22. Other borderlines

In the majority of cases, food supplements and herbal treatments would be unlikely to be considered medical devices, even when medical claims are made. Such products are likely to come within the legislation covering medicinal products, food supplements or traditional herbal medicinal products depending upon the intended purpose for the specific product. The MHRA’s  Guidance Note 8 “A guide to what is a medicinal product” should be consulted in the first instance.

If, after reading this document and consulting the published guidance available (listed at the end of this document) a manufacturer is still unsure of the correct regulatory route or classification of their product, further advice should be requested from MHRA prior to placing the product on the market.

23. List of guidance and contacts

MHRA guidance

Topics listed below are available from the MHRA’s web pages on www.gov.uk

• ‘A guide to what is a medicinal product’
• In-house manufacturing
• Guidance for manufacturers of custom-made devices (including dental)
• Borderlines between medical devices and medicinal products

Additional guidance documents

The following MEDDEV guidance documents are relevant to medical devices. These can be accessed via the links below.

Definitions and classification of medical devices

• MEDDEV 2.4/1 Guidelines for the classification of medical devices
• MEDDEV 2.1/1 Guidelines covering definitions of ‘medical devices’, ‘accessory’ and ‘manufacturer’
• MEDDEV 2.1/5 Medical devices with a measuring function
• MEDDEV 2.1/6 Qualification and classification of standalone software.

Borderlines with medicinal products

• MEDDEV 2.1/3 ‘Demarcation between Medical Devices and Medicinal Products’

Borderlines with in vitro diagnostic medical devices

• MEDDEV 2.14/1 IVD borderline issues
• MEDDEV 2.14/2 IVD research use only products
• MEDDEV 2.14/3 Supply of instructions for use for IVD medical devices

Borderlines with the Active Implantable Medical Devices Directive

• MEDDEV 2.1/2 Field of application for Directive 90/385/EEC

Other information

Contact the MHRA about borderlines with medical devices via email: [email protected].  

Certain borderline products have been specifically determined as within or outside the remit of the medical device regulations. These decisions are recorded in the document here, which manufacturers may wish to consider when classifying their product.

Cosmetics Directive, Electromagnetic Compatibility Directive, the Low Voltage Directive, Personal Protective Equipment Directive and the General Product Safety Directive

Office for Product Safety and Standards (OPSS)

Website: https://www.gov.uk/government/organisations/office-for-product-safety-and-standards  

Telephone:  0121 345 1201          

Email: [email protected]

Biocides

The Health and Safety Executive (HSE)

Website: https://www.hse.gov.uk/biocides/

Email: [email protected]

Machinery

The Health and Safety Executive (HSE)

Website: https://www.hse.gov.uk/work-equipment-machinery/index.htm

Tel: 0300 003 1647

HSE contact page: Contact the Health and Safety Executive

Appendix:  Words and phrases

The words and phrases listed below are all likely to have contributed to a determination by the MHRA that the product they were associated with was a medical device. In some cases specific wording may imply that a product would be considered as a medicinal one (consult appendix 1 of the MHRA’s ‘A guide to what is a medicinal product’ for details).

• Aids treatment
• Alleviates
• Avoids
• Can benefit those who suffer from
• Clinically proven
• Combats
• Compensates for
• Counteracts
• Cure / cures
• Diagnoses / assists diagnosis
• Eases symptoms
• Eliminates
• Heals
• Help/help with
• Investigation
• Monitors
• Pain relief / relief from pain
• Prevents
• Protects against
• Repairs
• Stops
• Traditionally used for
• Treats / clears infestations
• Treats / Treatment / Treating

Although such words or phrases may contribute to such a determination, the intended and implied meaning of the words used will be considered in context with relation to the product concerned and its intended purpose. This is not an exhaustive list and should not be considered as such.

It should be noted that general disclaimers (for example ‘this product is not a medical device’) are not acceptable if medical claims are made or implied elsewhere in the product labelling or associated promotional material, including those made on websites or online advertisements.

Anecdotal quotes and testimonials are considered to be implied claims by the manufacturer if they are repeated in product literature, promotional material or websites.