Regulatory status of equipment being used to help prevent coronavirus (COVID-19)
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
CE-marked medical devices continue to be accepted on the Great Britain market with the deadline for acceptance depending on the type of device and the legislation it complies with. The latest of these deadlines is 30 June 2030. Separate rules exist for Great Britain and Northern Ireland. For further information on the regulatory requirements for medical devices, please refer to our guidance.
The government has extended acceptance of CE marked medical devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.
Antimicrobial hand sanitisers and gels
Hand sanitising products fall into 1 of 3 regulatory groups depending on the products’ intended use, function, composition or how they are described:
- Products primarily used to clean and/or moisturise skin whilst providing a secondary antimicrobial effect such as a liquid soap or solid soap bars, are classed as a cosmetic
- Products primarily claiming to kill germs, disinfect or sanitise or using an active antimicrobial ingredient such as the hand sanitisers used in hospitals, are classed as a biocide
- Products specifically used as surgical scrubs for use in operating theatres and products which make claims to treat/prevent infection associated with specifically named pathogens are classed as medicines
We recommend that you contact your local Trading Standards Office for initial advice on the regulations that might apply to your specific product. You may also find that the relevant trade associations may be able to provide information and advice.
If a product is a cosmetic
The regulations that apply are the Cosmetic Product Regulations. These are regulated through your local trading standards. There is guidance and you can use the ‘find my local TS Service’ tool.
If a product is a biocide
There is more than one regulation that may apply. These are regulated through the Health and Safety Executive. For guidance contact HSE at biocidesenquiries@hse.gov.uk and there is guidance.
There is additional information on the supply of biocidal hand sanitisers.
If a product is a medicine
A Marketing Authorisation is required. General hand sanitiser products are not permitted to name specific pathogens.
Claims to treat or prevent infection associated with specifically named pathogens (such as SARS-CoV-2) could bring the product within the remit of the medicines regulations. Please refer to Appendix 5 in MHRA’s Guidance note 8 – a guide to what is a medicinal product for further information.
If you require further information and advice with respect to the naming of specific pathogens please contact the MHRA Medicines Borderline Section at borderline_medicine@mhra.gov.uk.
HMRC changes to help businesses producing hand sanitiser and gel
To stop the spread of coronavirus HMRC has made temporary changes to the use and supply of denatured alcohol and duty-free spirits, to help businesses who produce hand sanitiser and gel.
Face masks and face coverings
The regulations are different depending on the type of product.
Surgical (medical) face masks
These are mainly intended for health care staff to wear to protect patients during surgical procedures and other medical settings.
If you make a surgical mask, intended to protect the patient, they are Class I medical devices. They must meet the design and safety requirements of the UK Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) and be CE, CE UKNI or UKCA marked before you can sell them in the UK.
If they are not CE/CE UKNI/UKCA marked you must apply for exemption from the regulations. We may authorise you to supply a non-CE/CE UKNI/UKCA marked device in the interest of protecting health.
If the surgical masks you want to supply are sterile, then you also need a CE, CE UKNI or UKCA certificate from an EU Notified Body or UK Approved Body (please read as UK Notified Body in this document for the purposes of Northern Ireland) for the sterility aspects. We regulate these types of masks and the Guidance on Class 1 Medical Devices gives further information.
Transparent face masks
If you make a clear surgical/medical face mask intended to protect patients, they are Class I medical devices and must meet the design and safety requirements as above.
Transparent masks may only state that they are Type IIR when they have met the requirements of the EN 14683:2019 standard in full. If only partial compliance is achieved then they must not be labelled or advertised as Type IIR.
The Department of Health and Social Care (DHSC) have recently published a new technical specification specifically relating to transparent face masks. Manufacturers of transparent face masks should be aware of this specification when bringing their product to market as a medical device.
More information on the transparent face mask technical specification.
Products incorrectly labelled or advertised will be subject to regulatory compliance action.
Face masks intended to protect the wearer (PPE)
If your masks are intended to protect the wearer, they are regulated as personal protective equipment and need to meet the regulations covering PPE products. They will need an EU Notified Body/UK Approved Body to verify the relevant requirements are met. They are not medical devices.
If you need advice on these regulations, see the OPSS coronavirus guidance for business and local authorities.
Face coverings
Face coverings intended for use by the general public are not PPE or medical devices. As such they do not carry a CE/CE UKNI/UKCA mark and should not be sold or donated as PPE or medical devices.
If you wish to sell face coverings or supply them to others outside your household or family, the face coverings must meet the existing requirements of the General Product Safety Regulations 2005 (GPSR).
The GPSR sets out the responsibilities of the producers and distributors of these products.
As face coverings are not medical devices, we do not regulate these products. There is guidance for makers and suppliers of face coverings from the Office for Product Safety and Standards.
Gloves
If the gloves you make are intended to be used by healthcare professionals to protect the patient during a medical examination or during a surgical procedure, these examination gloves or surgical gloves are regulated as medical devices.
They must meet the design and safety requirements of the MDR 2002 and need to be CE, CE UKNI or UKCA marked as medical devices before you can sell them in the UK, or you may be able to apply for exemption from the regulations.
Examination gloves
Examination gloves are usually considered to be Class I medical devices, and you can self-certify them as such, but if they are supplied sterile, they will also need a CE, CE UKNI or UKCA certificate from a notified body for the sterility aspects. See the guidance on Class 1 Medical Devices.
Surgical gloves
Surgical gloves are usually considered to be Class IIa medical devices and need a CE, CE UKNI or UKCA certificate from a UK Approved Body or EU Notified Body. See our guidance on conformity assessment of medical devices.
If either type of glove is coated with an antimicrobial agent, they are likely to be considered as devices incorporating medicinal substances and therefore Class III devices under Part II of the UK MDR 2002, Annex IX (as modified by Schedule 2A to the UK MDR 2002) and will need a CE, CE UKNI or UKCA certificate from a UK Approved Body or EU Notified Body. See our guidance on conformity assessment of medical devices.
PPE gloves
If the gloves you make are intended to protect the wearer (for example for use in laboratories or for other protective purposes) then they are considered personal protective equipment (PPE) and need to meet the regulations covering PPE products. They will need a UK Approved Body or EU Notified Body to verify the relevant requirements are met. They are not medical devices.
If you need advice on these regulations, see the OPSS coronavirus guidance for business and local authorities.
The UK MDR 2002 contains rules for gloves that are intended to be used both as medical devices and PPE and as such have a ‘dual use’. In such cases they will need to meet the relevant requirements of the UK MDR 2002 and the PPE regulation.
Further MHRA advice
After reading the relevant guidance for medical devices, if you have any further questions, contact us at info@mhra.gov.uk.
There is further information in our Medical devices regulation and safety guidance and our guidance on the regulating medical devices in the UK.
Failure to comply with the relevant regulations
Medical devices
If you claim to hold a valid CE, CE UKNI or UKCA mark for a medical device but are breaching the regulations, typically, you will be contacted by the MHRA compliance unit outlining our concerns and requesting further information.
We administer and enforce the law on medical devices in the UK. We have a range of investigatory and enforcement powers to ensure their safety and quality.
Medicines (for human use)
Similarly, there are robust regulatory controls for medicinal products including their manufacture, distribution, retail sale / supply and advertising. Under the Human Medicines Regulations 2012, breaches of legal requirements constitute criminal offences and the legislation empowers MHRA officers to undertake investigations using powers of entry, seizure and detention. Criminal prosecutions can be brought through the Crown Prosecution Service (CPS).
Personal protective equipment
If you claim to hold a valid CE, CE UKNI or UKCA mark for PPE, enforcement authorities in the UK such as trading standards authorities and the Health and Safety Executive), will be able to take action against ‘economic operators’ (i.e. manufacturers, importers and distributors) if they do not comply with the obligations in EU PPE Regulation.
Further information
- MHRA guidance on COVID-19
- Coronavirus: global crackdown sees a rise in unlicensed medical products related to COVID-19
- Dedicated website for reporting any incidents involving medical equipment relating to COVID-19 treatment
- Reporting a counterfeit product
Information from other organisations
- Office for Product Safety and Standards (OPSS): COVID-19 guidance for businesses
- Department of Health and Social Care: Technical Specifications for Personal Protective Equipment (PPE)
Further MHRA advice
After reading the relevant guidance for conformity assessment of medical devices, if you have any further questions, contact us at info@mhra.gov.uk.
There is further information in our medical devices regulation and safety guidance.
Also see the Department of Health and Social Care: Technical Specifications for Personal Protective Equipment (PPE). This contains some relevant standards or equivalent technical solutions to manufacture medical devices listed above to if they do not hold a CE, CE UKNI or UKCA mark.
Updates to this page
Last updated 1 July 2023 + show all updates
-
This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
-
Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.
-
Added a new section on transparent face masks.
-
Updated references to CE, CE UKNI and UKCA markings in line with the end of the Brexit transition period.
-
Removed guidance on 'Offers to supply or donate healthcare'
-
Added explanations about the regulations around face coverings.
-
Added a section linking to further MHRA advice.
-
Added a new section on Information from other organisations
-
Added information on how to make an offer to supply or donate healthcare equipment.
-
First published.