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. Some questions which have the same answer have been grouped together.
Question: You made reference earlier to EN14683 IIR masks, Can you confirm what the verification process is for these masks?
This may relate to the Medical Devices Directive, which is not legislation that the BSIF include in our scope. Further information/help may be available from www.bhta.com – The British Healthcare Trades Association
Question: Presumably this presentation does not apply to hand gel/sanitiser, wipes, disinfectant etc as they are not PPE?
They are not PPE, so were not covered. This may relate to the Medical Devices Directive, which is not legislation that the BSIF include in our scope. Further information/help may be available from www.bhta.com – The British Healthcare Trades Association
Question: Do PPE items have to be registered with the MHRA; or only if they are both PPE and a Medical device?
Question: Is a Type I 3-ply mask considered RPE?
Question: How do we know which EU directive and then in PPE category which category is relevant for each type of mask – i.e FFP2, FFP3? Is there a definitive list held somewhere so it is really clear. I’m interested in IIR under MDD, FFP2 and FFP3.
This may relate to the Medical Devices Directive, which is not legislation that the BSIF include in our scope. Further information/help may be available from www.bhta.com – The British Healthcare Trades Association
Question: As disposable surgical masks are for protecting others rather than the wearer i.e. to stop the spread of COVID-10 virus, are they regarded as RPE?
They are not covered by the PPE Regulation, you would need to check if they are classed as RPE under the Medical Devices Directive, which is not legislation that the BSIF include in our scope. Further information/help may be available from www.bhta.com – The British Healthcare Trades Association
Question: If we have purchased disposable face masks that are used within the medical sector – what directive should we be checking the CE markings / certificates etc? The certificates we have received to date all refer to medical directives.
Question: Can you please clarify which EN regulation cover the popular masks e.g. 3 ply masks. Does a 3 ply masks need to comply with EN14683 for a civilian or is that only for medical use?
This may relate to the Medical Devices Directive, which is not legislation that the BSIF include in our scope. Further information/help may be available from www.bhta.com – The British Healthcare Trades Association
Question: Are Type IIR fluid resistant face masks considered Class I, II or III PPE? Therefore do they require Notified Body?
Question: Does the CE manufacturer declaration of conformity look the same for self declaration under the MDD 93/42/EEC?
Question: What category of PPE are surgical masks?
This may relate to the Medical Devices Directive, which is not legislation that the BSIF include in our scope. Further information/help may be available from www.bhta.com – The British Healthcare Trades Association
Question: We are not selling into the NHS. We see our market as companies returning to work and we are selling masks, hand sanitizing gel and wipes. We are making a point of saying that the goods we are advertising are not of a medical nature. Having said that we are doing our due diligence that the products have been tested to the required levels and are supplying supporting paperwork. Do they still count as PPE? If they don’t are they exclusive of VAT?
Masks that are RPE (Respiratory Protective Equipment) will be covered by the PPE Regulation. Sanitisers and wipesare not covered by the PPE Regulation, you would need to check if they are classed as RPE under the Medical Devices Directive, which is not legislation that the BSIF include in our scope. Further information/help may be available from www.bhta.com – The British Healthcare Trades Association
Question: COVID-19. In the likely event the government will enforce masks to be worn in public places, will Type IIR disposable surgical type masks be adequate for our workforce.
Question: If a mask FRSM has been approved for use for medical devices regulations does it follow that it would be suitable for use for PPE in category for social distancing in work circumstance even though it doesn’t necessarily have the PPE required registrations? Surely if its suitable for our nurses and doctors it would be?
At this moment in time we should wait for guidance from UK Government as to whether Masks will be required for non work related activities and to what specification will be required. Further information/help may be available from www.bhta.com – The British Healthcare Trades Association
Question: We have been advised that our staff do not require FFP2 or FFP3 masks and that a Type IIR face mask is sufficient. Should these be tested to EN149, EN14683 or both? We’ve received conflicting advice.
This may relate to the Medical Devices Directive, which is not legislation that the BSIF include in our scope. Further information/help may be available from www.bhta.com – The British Healthcare Trades Association
Question: Will EN14683 for medical masks come under the PPE 2016 EU Regulation?
No, This may relate to the Medical Devices Directive, which is not legislation that the BSIF include in our scope. Further information/help may be available from www.bhta.com – The British Healthcare Trades Association
Question: How do we know if a product falls under PPE regulations? I.e Nitrile gloves. Some manufacturers claiming it’s a medical device under 93/45 EEC
It is possible for products to be both Medical Devices and items of PPE and comply with both legislation. If they claim it is PPE then it needs to be compliant with the PPE Regulation, if Medical Device This will relate to the Medical Devices Directive, which is not legislation that the BSIF include in our scope. Further information/help may be available from www.bhta.com – The British Healthcare Trades Association