There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)Published 26 March 2020
Last updated 27 March 2020 — see all updates From: Medicines and Healthcare products Regulatory Agency
Contents
- Antimicrobial hand sanitisers and gels
- Face masks
- Gloves
- Offers to supply or donate healthcare equipment to the NHS/healthcare providers
- Failure to comply with the relevant regulations
- Further information
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.
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.
Face masks
The regulations are different depending on the type of face mask.
Surgical (medical) face masks
If you make this type of mask, intended to protect the patient, they are Class I medical devices and must meet the design and safety requirements of the Medical Device Regulations (MDD/MDR) and be CE marked before you can sell them in the UK, or you may be able to apply for exemption from the regulations.
If the surgical masks you want to supply are sterile, then you also need a CE certificate from a notified body for the sterility aspects. We regulate these types of masks and the Guidance on Class 1 Medical Devices gives further information.
General face masks
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 a notified body to verify the relevant requirements are met. They are not medical devices.
If you need advice on these regulations, contact OPSS.enquiries@beis.gov.uk.
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 Medical Device Regulations (MDD/MDR) and need to be CE 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 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 certificate from a notified body. See our Medical devices: conformity assessment and the CE -mark guidance.
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 Rule 13 of Directive 93/42/EEC and will need a CE certificate from a notified body. See our Medical devices: conformity assessment and the CE mark guidance.
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 notified body to verify the relevant requirements are met. They are not medical devices.
If you need advice on these regulations, contact OPSS.enquiries@beis.gov.uk.
Medical Devices Directive 93/42/EEC 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 Medical Devices Directive and the PPE regulation.
Further MHRA advice
After reading the relevant guidance for CE marking of medical devices, if you have any further questions, contact us at devices.regulatory@mhra.gov.uk.
There is further information in our Medical devices regulation and safety guidance.
Offers to supply or donate healthcare equipment to the NHS/healthcare providers
Use this service to submit information about how your business might be able to help with the response to coronavirus. You’ll be asked some questions about the type of support you can give. You’ll then be contacted as soon as possible if your support is needed.
Make sure you follow the guidance on this page about the regulations that apply before registering your details.
Failure to comply with the relevant regulations
Medical devices
If you claim to hold a valid CE 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 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.
