GovWire

CEmarking will continue to be recognised on the Great Britain (England, Scotland, Wales) market until 30 June 2023. Currently, from 1 July 2023, new goods placed on the Great Britain market will need to conform with UKCA marking requirements. 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 does intend to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023. 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 MHRAs 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 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 