Validity of an EC type-examination certificate and revision of harmonised standards

Regulation (EU) 2016/425 on personal protective equipment

Commissione Europea, 25.03.2019

The "Blue Guide" and Regulation (EU) 2016/425

The issue of the revision of harmonised standards is a horizontal one in EU product legislation.

The "Blue Guide on the implementation of EU product rules"1, in point 4.1.2.6. 'Revision of harmonised standards', provides useful guidance on the implications on already issued certificates of the removal of old references of harmonised standards from the OJEU and the subsequent citing of their new versions in the OJEU.

According to the "Blue Guide", 'the removal of the reference of a harmonised standard from the Official Journal after its revision does not automatically invalidate existing certificates issued by notified bodies’. In fact, the revision of the harmonised standards per se does not have by default impact on the validity of the EC type-examination certificate, and ‘products produced according to the old certificate may still benefit from the continuing conformity with the essential requirements and may continue to be placed on the market until the end of validity of the relevant certificates issued by notified bodies’.

Then, the "Blue Guide" clarifies that 'however, manufacturers must assess the extent of the changes to the superseded version of the standard. The kind of action to be taken by the manufacturer depends on the nature of the changes in the harmonised standards, in particular whether these changes are material with regard to the coverage of the essential requirements and whether they concern the product in question'.

This is reflected in Article 8 and of the PPE Regulation which requires manufacturers to ensure that PPE ‘has been designed and manufactured in accordance with the applicable
essential health and safety requirements’, and ‘series production’ must ‘remain in conformity with the Regulation’. The manufacturers shall therefore assess changes in the harmonised
standards by reference to which the conformity of the PPE is declared and shall adequately take
them into account.

Furthermore, concerning EU type-examination, Annex V, point 7.3 of the Regulation sets down that ‘the manufacturer shall ensure that the PPE continues to fulfil the applicable essential health and safety requirements in light of the state of the art’. Additionally, point 7.2 requires that the ‘The manufacturer shall inform the notified body that holds the technical documentation relating to the EU type-examination certificate of all modifications to the approved type and of all modifications of the technical documentation that may affect the conformity of the PPE with the applicable essential health and safety requirements or the
conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU type-examination certificate’. The “Blue Guide” also clarifies that ‘the notified body shall keep itself appraised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly’.

This obligation of the notified bodies is also reflected in PPE Regulation, in particular in Annex V, point 7.1.

[...] segue in allegato

Fonte; EC

Collegati:
[box/note]Regolamento DPI | Regolamento (UE) 2016/425
Norme armonizzate direttiva DPI Agosto 2018[/box/note]

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