We have published these documents for new suppliers and manufacturers to understand our requirements. Products must comply with the stated standards, legislation and/or directives (as amended, extended or re-enacted from time to time).
This guidance is for you if you want to make and supply high volumes of Personal Protective Equipment (PPE) for any of the specifications set out on the central page. These specifications now include a revised specification for gowns, surgical face masks, respirator masks, eye protection and gloves. Others specifications remain unchanged but will be updated in due course. You will need to meet these specifications, as relevant, if you wish to propose supply of any of these products to the UK to protect NHS health workers from Covid-19 and you do not have a CE mark, or wish to propose the alternative use of an existing CE marked product against the relevant legislation:
- If intended to protect the wearer: EU regulation 2016/425 on Personal Protective Equipment (PPE)
- If intended to protect the patient: Medical Devices Regulations (MDR 2002) which implements Directive 93/42/EEC on medical devices
- If you claim it is dual purpose (MD and PPE), the product must comply with MDR. In addition, they must meet the relevant essential health and safety requirements (EHSR) of the PPE Directive
This guidance sets out the technical requirements for these products, including what is ‘essentially acceptable’ in the context of the Covid-19 threat and how to then apply for a derogation to the MDR or regulatory flexibilities for PPE.
You should refer to the user guidance document, titled ‘User Guidance’ which sets out the process of application and consideration for all manufacturers and applies to all of the specifications in place.
Where new suppliers have product that meets these requirements, we welcome offers of support through our online form for suppliers who have not already completed this form. If you have already submitted your form there is no need to resubmit. Please note once information is submitted we will work with you to understand the evidence held to support the minimum specifications.
Once a decision has been taken to authorise production with the relevant regulator, the central purchasing team will make contact with you about the relevant order including in relation to the size of the PPE where more than one size can be produced.