Question: I receive several offers a day from manufacturers outwith the EU of category 2 PPE, who provide a Declaration of Conformity which is only signed off by the manufacturer. My question is do manufacturers outwith the EU need there DoC to be signed off by a EU representative or a Notified Body?
All Declarations Of Conformity should be created and ‘signed off’ by the Manufacturer. The Notified Bodies will sign off the Module B EU Type Certificate only.
Question: As a buyer I am assessing the declaration of conformity and the CE certificate. Do I also need to request product instructions or is that purely for the end user?
These are specifically for the End User, however they may prove useful in assessing whether PPE provided by a manufacturer is compliant as the detail of Notified Body name/address/number and product description/coding should match that on the Declaration Of Conformity
Question: should the supplier of PPE be checking compliance before being sent to end user, take it that online suppliers are harder to monitor?
Yes, it is an obligation for all economic operators, which includes those selling online and ‘drop-shipping’
Question: Thank you for your nice presentation. I want to ask about the compliance verification or surveillance appart of HSE company adviser/auditor who could ask for the PPE compliance taking in account that there is no details in our regulation about PPE requirements?
There are market policing authorities in each Country responsible for investigating and assessing compliance, such as Trading Standards, Health & Safety Executive and Local Authorities in the UK
Question: If a manufacturer is not legally obliged to provide a copy of the EUType examinaton cert, how can we check the product/certificates authenticity?
The Declaration Of Conformity should provide details of the Module B EU Type Examination Certificate. Using this detail it is possible for Notified Bodies to verify the certificate and what is covered by the certificate
Question: Should all certificates and declarations be in English?
Declarations Of Conformity need to be isued in all of the languages of the countries in which it may apply. Most EU Module B Certificates are issued in English and may also be issued in the language of the Country the Notified Body is based in
Question: Apparently Chinese regulations dictate that manufacturers cannot place CE marking on non medical PPE. Does this mean the product cannot be imported?
It is a requirement of the PPE Regulation that the product be CE Marked if it is not marked, then it may be deemed non-compliant
Question: In addition to placing the UIS in the packaging, can it also be made aware on a website for reference purposes?
It can be made available on a website, however it is a requirement that it MUST accompany each piece of PPE in the smallest commercial unit it is sold in
Question: Do we need user instruction sheets for disposable masks and antibac gel and wipes?
If the products require CE Marking to be compliant then they will require User Instruction sheets
Question: Can a user instruction sheet be the markings on the side of a box or will it be a separate sheet?
It needs to be a separate sheet that can still be referred to if the packaging is discarded
Question: Is there a way to check the validity of the certificate number online on the the Notified Body’s website?
Yes -either via email or some Notified Bodies have online database tools. You may need to provide a full un-redacted Declaration Of Conformity or Module B EU Type Certificate as redacted documents will be considered fake
Question: Do all DOC have numbers?
No, but it is an option that most manufacturers of PPE take up as it allows further traceability
Question: On the BSIF sample Moduel B EU Cert, only the signature was there, no traceability to a name and title within the manufacturer. Are these two things needed. Also, where it was drawn up?
The Module B mock up does show the name/address of the (imaginary) manufacturer. It is not required on a Module B to detail the title/name of an individual within the manufacturer or the place of issue – these details are provided on the Declaration Of Conformity from the Manufacturer
Question: Based on the discussion about “Documentation”, is it the requirements under the PPE Regulations for users of PPE to check all documentation? and if yes, how can we identify counterfit documents?
It is important that the person responsible for issuing the PPE (by determining it’s suitability for use) check the compliance of the product. Our guide may help with this; https://www.bsif.co.uk/wp-content/uploads/2020/04/CE-Certificate-Checklist-2020-2.pdf
Question: If any of the information on any certificate provided is redacted, should I be concerned?
This is common occurrence as suppliers attempt to hide manufacturer details. A Notified Body will not accept a Module B Certificate or a Declaration Of Conformity as genuine if it has been in any way amended from its original state
Question: If a manufacturer is outside the EU, do they have to have there declaration of conformity signed off by a notified body or EU representative for any category of PPE?
The Declaration Of Conformity is assessed by the notified body for all Category II & III PPE. Category I does not require Notified Body assessement, but there s a requirement for the D of C to meet the requirements of the PPE Regulation
Question: can an importer get a notified body to certify a product or must it be the manufacturer?
It must be the manufacturer, however if an importer or distributor decide to offer the product under their trademark or brand, then they take on the obligations of a Manufacturer and obtain certification from a Notified Body with the assistance of the manufacturer
Question: Must DoC form be from an EU entity or can I accept one from a Chinese body.
Declaration Of Conformity needs to come from the manufacturer, wherever they are based in the World but must comply with the requirements of the PPE Regulation
Question: Can CE marked RPE be labelled with markings not normally recognised outside the EU for example FFP2 & KN95
Yes, but the product must be compliant with all markings
Question: Are there any giveaway signs on the counterfeit Inspec certificates to confirm them as such? We have sent details to Inspec for their confirmation but responses are very slow.
Many of the counterfeit certificates are now difficult to tell apart from genuine certificates. It is best to get the issuing Notified Body to verify them
Question: Can I rely on an EU Declaration of Conformity?
Providing it is suitably completed, yes. You can always check the details by with the notifying body who raised the Module B certificate detailed on the D Of C
Question: If a piece of PPE is going through its CE certification process thus no CE cert is available, what acceptable documentation can be shown to to verify this ? I had a vendor send me a quote from the BSI… but that tells me nothing ?
If it is certification to the PPE Regulation then only completed documents are acceptable to show compliance. If it is to the (EU) 2020/403 process for PPE to provide protection for Covid19 exposure, then the notified body must issue notification that the process has begun and the PPE meets the essential health and safety requirements for that product type.
Question: As an importer, can we import PPE (specifically face masks) which already has certification to a notified body without any further action from us? i.e. would we need to have a further assessment done by a notified body?
The Manufacturer needs to have the PPE assessed and certified by the Notified Body if relevant, not the importer.
Question: Is there a way to check if a notified body in China or USA is genuine and access their contact details, in a similar way we can check on NANDO for EU Notified Bodies?
Nando shows the only Notified Bodies that are approved to assess/certificate PPE to the PPE Regulation.
Question: What is your view on cat 1 PPE from outside the EU where the company provide a CE certificate which isn’t from a notified body, but have a EU representative from the EU to sell their products. The CE certificate isn’t required, but it raises doubts over the authenticity of the product?
Due Diligence would suggest that you compare the detail on the Declaration Of Conformity with the User Instruction Sheet and the markings on the PPE. If there is variation it warrants closer attention
Question: The information mentioned about CE marking being printed and visible on the product or the packaging. I want to understand if it MUST be printed and visible on the product unless it doesn’t fit or is it up to the manufacturer to choose whether they want it on the product or the just on the packaging.
It is a requirement that it should be on the product unless there are specific reasons it cannot be. I.E. too small to apply the marking, product cannot be marked without affecting it etc.
Question: If a ppe product description says it meets the requirements of EN425 for example does this means it complies with EN425 and can be used safely?
If PPE is CE marked and has details of a standard (I.E. EN 166:2001) then it means it has be assessed and meets some or all of the requirements of the standards. The User Instructions and/or Declaration Of Conformity will detail any particular part of the standard it does not comply with
Question: What’s the permitted timescale between a Module B and a C2 or D. Can the product be placed on the market with a Module B if there are plans in place for a C2/D?
The Module C2 or D process needs to be in place in line with the Module B in order to prove that the production control QA processes are in place and Product assessment takes place as part of Module B for Category II & III PPE so this should also apply in line with Module B
Question: Is there a CE mark termed Chines Export i.e. CE Alan Rose
Chinese Export (CE) was popular in the 90’s, it is not often seen now
Question: I work in the promotional merchandise industry, if I was to sell branded PPE does a factory need to abide by the PPE regulation or does it depend who I am selling the goods to?
The customer has no bearing on the compliance of the product unless they are specificallty exempt from the PPE Regulation (Military, Law and order for example). All PPE to be placed on the market in the EU/UK needs to conform to relevant legislation