Impact of the revision of a harmonised standards on the validity of an EC type-examination certificate

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The European Commission has published a guide on the impact of the revision of  harmonised standards on the validity of an EC type-examination certificate. This guide is based on the Blue Guide and PPE Regulations 2016/425. It sets out the main principles to be taken into account when assessing the impact of changes in a revised standard. 

The following elements are recalled:

  • the revision of a standard does not systematically affect the validity of the EC type-examination certificate issued by the notified body, even if the certificate referred to the old standard;
  • manufacturers must carry out an impact study on the changes induced by the revised standard with regard to the essential health and safety requirements;
  • this impact assessment must be discussed with the notified body that issued the EC type-examination certificate for approval;
  • when the design of the personal protective equipment is affected by the revised standard, an additional assessment must be carried out by the body in charge of the EC type-examination certificate;
  • when the revision of the standard concerns only documentary or administrative aspects, there is no need to review the EC type-examination certificate. 

To find out more 


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