If the PPE is for the protection of the wearer it would fall under PPE regulations not the Medical Device Regs.
If you have yet to obtain a CE mark but you want to supply to the NHS – click here
Do you need to have the PPE conformity assessed?
Normally, yes and this includes Type Approval and quality assurance procedures as set out in EU Regulation 2016/425. However, for COVID-19 related PPE these have been eased, depending on how you are placing your PPE on the market.
The extent to which the conformity assessment rules have been eased depends on whether you are manufacturing COVID-19 related PPE for Government/NHS purchase/ donation or are more generally placing it on the market.
What do I need to do to have my PPE approved for sale or donation to the Government to be used by NHS healthcare workers?
Before COVID-19 related PPE is purchased by or donated to the Government/ NHS to be used by NHS healthcare workers, it must meet all the following criteria:
- The products are manufactured in accordance with either:
a) a relevant harmonised European standard, or
b) any of the standards referred to in the WHO guidelines or,
c) any other non-EU standard or technical solution, provided that the chosen standard or technical solution ensures an adequate level of safety in respect to the essential safety requirements
- The products have been assessed against the standard(s) or technical solution you have chosen by the cross-Government Decision Making Committee, which comprises the Health and Safety Executive (the Market Surveillance Authority), the Department for Health and Social Care, the Medicines and Healthcare products Regulatory Agency, the Office for Product Safety and Standards, and other experts as required.
- The products must be part of a purchase organised by or donation agreed by the UK Government or the National Health Service.
- The products will only be made available for healthcare workers.
- The products will only be made available for the duration of the current outbreak of COVID-19.
- The products will not enter regular distribution channels and will not be made available to other users.
- To enable the cross-Government Committee to assess your COVID-19 related PPE, you have registered your interest on the webform at
https://www.gov.uk/coronavirus-support-from-business and sent the Committee relevant documentation, including any test reports, that shows that the PPE has been designed and manufactured in line with a relevant European Standard, a standard referenced in the WHO guidelines, or an alternative technical solution that delivers adequate safety.
You will be told where to send that documentation by the Government/NHS purchaser who replies once you have registered your interest”