BSIF have provided the answers to the questions asked in good faith and to the best of our ability. BSIF cannot be held legally liable for the answers provided.
Question: with reference to the exception for healthcare workers procured via Government. Please advise does this apply to Local Government procuring for staff not all of whom are healthcare e.g. childrens services, schools, housing etc?
The easement now covers all workers not just healthcare. Important please note that it is only in the context of protection against Covid 19
Question: What category of PPE does face shields for protection against covid 19 fall into?
Category II PPE.
Question: A lot of companies are producing 3D faceshields .. do they not need to conform?
Yes they need to be safe
Question: Does the Covid 19 specific PPE need to have a CE mark
There are a variety of UK Government guidance which I am happy to share
Question: In the slide about 2020/425 it indicated goods could be sold to ‘other’ workers for covid protection. Does this include industrial businesses if the intention is to protect against covid.
Yes please see above. The easement is 2020/403
Question: EU Recommendation just for healthcare or industry?
As above
Question: with the government issuing ‘relaxed’ rules for procuring emergency PPE what impact does this have on certification process
It has to follow the OPSS guidance which is available on the BSIF website
Question: who is responsible for checking the government supply that is coming into the country and being distributed to health workers
Responsibility for checking and assessing is the cross Government committee made up of industry regulators.
Question: 2020/403 provides the flexibility to provide non ce marked products to be sold in the uk for NHS and healthcare only. Is it a requirement to have these tested, and if so, who does this, and how do we know it is genuine.
It has to follow the OPSS guidance which is available on the BSIF website
Question: We have received a declaration of due diligence form distributor for non-CE masks, they have named the manufacturer and confirmed documentation check on conformity assessment. I’m unsure whether I can accept this as a proof of validation under the relaxed rules. Can you recap what I should be asking for in this situation?
Ask for the manufacturers Declaration of Conformity
Question: If a university were offered PPE products (Masks) from ex-alumni or other institutions in China does EU 2020/403 require them to check certification is valid prior to donating these to the NHS or local Social Care Bodies?
Yes it does