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Detailed guide: Regulatory status of equipment being used to help prevent coronavirus (COVID-19)

Medicines Healthcare Products Regulatory Agency

February 25
15:58 2021

CE marking will continue to be recognised on the Great Britain (England, Scotland, Wales) market until 30 June 2023. 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.

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.

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.

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

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