Slide background
Slide background

Validity EC type-examination certificate/revision of harmonised standards

ID 8054 | | Visite: 488 | Documenti Marcatura CE UEPermalink: https://www.certifico.com/id/8054

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

In the case of the revision of harmonised standards and the subsequent citing of their references in the OJEU, market surveillance authorities and customs authorities in the Member States had different interpretations regarding the placing on the market of PPE with a valid EC type-examination certificate, based on a previous version of a harmonised standard, after the end of the transition period given in the OJEU for the superseded standard.

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Then, the "Blue Guide" clarifies that 'however, manufacturers must assess the extent of the changes to the superseded version of the standard.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]

Pin It


Tags: Marcatura CE Regolamento DPI Abbonati Marcatura CE

Articoli correlati

Ultimi archiviati Marcatura CE

Set 06, 2019 62

Rettifica del regolamento (UE) 2016/1628 | 06.09.2019

Rettifica del regolamento (UE) 2016/1628 GU L 231/29 DEL 06.09.2019 Rettifica del regolamento (UE) 2016/1628 del Parlamento europeo e del Consiglio, del 14 settembre 2016, relativo alle prescrizioni in materia di limiti di emissione di inquinanti gassosi e particolato inquinante e di omologazione… Leggi tutto
CETOP PP04
Set 05, 2019 92

Pressure equipment paper PED directive 2014/68/EU

Pressure equipment papers PED Directive 2014/68/EU CETOP Position Paper concerning EC directive “Pressure equipment” (2014/68/EU) The document describes the agreed CETOP position on the directive and its application to fluid power systems and components. The Technical Commission of CETOP, the… Leggi tutto

Più letti Marcatura CE

Giu 26, 2019 45514

Regolamento Prodotti da Costruzione (UE) 305/2011 - CPR

Regolamento CPR (UE) 305/2011 Regolamento (UE) N. 305/2011 del Parlamento Europeo e del Consiglio del 9 marzo 2011 che fissa condizioni armonizzate per la commercializzazione dei prodotti da costruzione e che abroga la direttiva 89/106/CEE del Consiglio (Testo rilevante ai fini del SEE) GU L 88/10… Leggi tutto