In the period March-May 2020, individuals and organisations all over the UK rose to the challenge of providing stopgap protective equipment to protect frontline workers during supply chain disruptions. As of May 2020, there are more PPE production groups than we can accurately list.
In May 2020, the UK Government clarified the regulatory position for PPE in the UK, in the form of guidance for manufacturers that includes references to the standards that need to be met:
- Guidance for small-scale manufacturers
- Guidance for high-volume manufacturers
- General guidance on PPE regulations
Can I put a ‘no liability’ claim on what I am selling/ donating to cover myself if it doesn’t work? If you are making PPE, it must meet [essential health and safety requirements] and if you supply it to others you are responsible for making sure it is safe for them to use. Including a “no liability” disclaimer does not exclude you from meeting your legal obligations nor protect you against claims should anyone be harmed by your product.
Can I make face masks for sale/ donation to the ordinary public and not sell/ donate it as PPE? You may be able to do so, but please speak to your Local Authority Trading Standards department about what you are selling/ giving away, what regulations apply to it and how you intend to describe what it is that you are selling. They can help you ensure your product is safe and does not mislead your buyers into thinking it provides protection against COVID-19 infection.
In response, some groups have ceased production. Others are continuing with independently tested or CE marked products (face shields in particular). Some charities are seeking product liability insurance and trustee liability insurance in addition to pursuing good design and manufacturing processes, and product testing.
If you need PPE and your local group has stopped production, or you have been volunteering and are looking for a new project, you are welcome to get in touch.
What are essential health and safety requirements?
Everyone making protective equipment wants to keep people safe - to do this, we need to make sure that each item protects the wearer in the way that it is meant to.
”Meet essential health and safety requirements’” generally means that the design has been evaluated, judged fit for purpose, doesn’t introduce extra hazards or potential harm, and that the production process has been documented. CE marking is the standard method for ensuring that this is the case.
This is based on the detailed definition in the EU regulation 2016/425 (Annex 2), which is usually interpreted by considering the requirements of British Standard EN166. EU recommendation 2020/403 encourages Notified Bodies (who award CE marks) to consider the minimum testing required based on WHO recommendations rather than conducting full EN166 testing.
For categories of PPE that cannot be self-certified, demonstrating that a product meets essential health and safety requirements usually involves your product being independently tested by a notified body and developing a technical file that includes:
- Requirements specification
- Risk file (covering all risks, both arising from use and manufacture)
- Design validation (showing the design meets the requirements and minimises risks)
- Material data sheets and supplier information
- Manufacturing SOP (including manufacturing SOP checklist, label content)
- Instructions for use
This is mandatory if you are seeking a CE mark. Where standards exist for a product, it is generally expected the design will have been tested against them to further show safety and suitability for purpose, though that can also be demonstrated through other methods, such as expert assessment or other performance testing.
Some notes on CE marking
If you agree to provide PPE solely to central NHS procurement, you are not required to obtain CE marking -- only to have your product independently tested. If you distribute directly to those needing your product, you are required to obtain CE marking and can ship your product once an initial assessment of your technical file has been conducted by the Notified body (source).
It is not possible to ‘CE mark a design’ - a CE mark applies to a combination of a design, process, materials, quality system and manufacturer. If any of these aspects change, the documentation needs reviewing and updating. Reapproval may be required if a Notified Body (external auditor for CE marking) is involved in granting the certificate.
It is possible to submit multiple materials for testing and CE approval provided they are available as finished products at time of testing. Continuity of supply is important as materials from different suppliers may not be identical. It is important to always obtain a material data sheet with any material to review its specification and ensure it does not contain any material hazardous to health.
Despite all this, it is still a good sign if a design has been part of a successful CE mark application as it implies that the design doesn’t have any inherent shortcomings. It is still important that the specific production process has sufficient controls in place to ensure quality and safety.
It is important to ensure that quality controls are in place for bought-in goods and materials, during the manufacturing process and especially at the finished goods stage prior to packing and shipping. This includes setting up a system for traceability such that if any defects for a particular batch are identified, that batch can be held and fully checked before despatch.
- UK Gov Policy Paper: PPE Plan
- UK Gov Guidance: Technical specifications for PPE
- UK Gov Guidance: Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak
- UK Gov Guidance: Personal protective equipment (PPE): export control process
- BSI PPE information page
- BSI PPE standards (free to download) -- also on google drive
- NHS supply chain covid-19 page
- NHS England guidance on supply and use of Personal Protective Equipment (PPE) and other supplies