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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.