BMTA Newsletter BMTA Newsletter - Summer 2020 | Page 21

bmta.co.uk CE Certificate Checklist Does the certificate contain a certificate number or reference and a statement that it remains the property of the notified body? Does the certificate clearly contain the notified body’s name and number (4 dig-its – i.e. 0123)? Does the certificate include a signature/name of individual certifying the prod-uct on behalf of the notified body? Is the notified body from within the EU? There are few Non-EU notified bodies, so please exercise caution Does the certificate show a date of issue (will usually be dated after April 29th 2018)? Does the certificate show a date of expiry (will be maximum of 5 years from the date of issue)? Does the certificate state that the PPE certified is in accordance with Regulation (EU) 2016/425? Does the certificate include the full name and address of the Manufacturer? Does the certificate contain a clear description of the product(s) certified, in-cluding model references, specifications and test report references? Does the certificate include a full list of the terms and conditions (often provided as an additional page or a link to a webpage)? Are there any indications that the certificate has been tampered with (different fonts, font sizes, colour changes etc.)? If you have answered ‘No’ to one or more of the first 10 questions and/or yes to the last question then you should immediately contact the PPE supplier for advice. You can also contact the notified body relating to any certificate and confirm its authenticity. A list of notified bodies within the EU and the product risk category they are scoped for, can be viewed via the following link; https://ec.europa.eu/growth/tools-databases/nando/index.cfm? Declaration of Conformity The Declaration of Conformity is another piece of supporting documentation that has seen a substantial increase in dubious/counterfeit content finding its way onto the market. The Declaration of Conformity is not a quality certificate or guarantee of safety; it is instead a declaration by the manufacturer that the PPE specified on the Declaration of Conformity complies with the requirements of the relevant legislation – which for PPE is the (EU) PPE Regulation 2016/425. The Declaration must include certain information and be issued by the manufacturer of the PPE; on the next page, we provide a checklist for assessment of any Declaration of Conformity. Declaration of Conformity – Checklist Does the declaration state a description of the PPE concerned, including the product reference, type of PPE & batch or serial number? Does the declaration state a description of the PPE concerned, including the product reference, type of PPE & batch or serial number? Does the declaration state that it is issued under the sole responsibility of the manufacturer? Does the declaration state the object of the declaration – identifying the PPE for traceability purposes, (a colour image may be included)? Does the declaration state that this PPE is in conformity with the relevant legis-lation (for PPE – (EU) PPE Regulation 2016/425)? Does the declaration detail the relevant harmonised standards that the PPE is compliant with, including the date of the standard? If not, does it refer to other technical specifications, including the date of the specification to which conformity is declared? Does the declaration detail the notified body who performed the EU type exami-nation (module B)? This must be referenced both Name & Number Does the declaration detail all the relevant EU type certificate reference num-bers? If applicable, does the declaration state that the PPE is subject to a conformity assessment procedure (Module C2 or Module D)? If applicable, does the declaration state the details of the notified body who provides the surveillance of the conformity assessment procedure? Does the declaration carry a signature and/or description of the individual at the manufacturer responsible for issuing the declaration? If you have answered ‘No’ to any of the above questions, or have not been provided with a Declaration of Conformity then you should raise this with the supplier of the PPE or the listed Manufacturer/Authorised representative.