Slide background
Slide background

Validity EC type-examination certificate/revision of harmonised standards

ID 8054 | | Visite: 273 | 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based on a previous version of a harmonised standard, after the end of the transition period given in the OJEU for the superseded standard.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Then, the "Blue Guide" clarifies that 'however, manufacturers must assess the extent of the changes to the superseded version of the standard.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]



Tags: Marcatura CE Regolamento DPI Abbonati Marcatura CE

Articoli correlati

Ultimi archiviati Marcatura CE

Giu 14, 2019 55

Direttiva (UE) 2019/944

Direttiva (UE) 2019/944 del Parlamento Europeo e del Consiglio del 5 giugno 2019 relativa a norme comuni per il mercato interno dell'energia elettrica e che modifica la direttiva 2012/27/UE GU L 158/125 del 14.06.2019 Entrata in vigore: 04.07.2019 ... Articolo 1 Oggetto La presente direttiva… Leggi tutto
Decisione di esecuzione UE 2019939
Giu 07, 2019 81

Decisione di esecuzione (UE) 2019/939

Decisione di esecuzione (UE) 2019/939 della Commissione del 6 giugno 2019 che designa gli organismi di rilascio incaricati di gestire un sistema di attribuzione degli identificativi unici del dispositivo (UDI) nel settore dei dispositivi medici GU L 149/73 del 07.06.2019 Entrata in vigore:… Leggi tutto
FEM OND
Mag 06, 2019 203

FEM | Position paper sulla revisione direttiva OND

FEM | Position paper sulla revisione direttiva OND FEM, 06.05.2019 La FEM ha presentato il proprio contributo sulla revisione della direttiva sul rumore da esterno (OND) in previsione del documento di lavoro dei servizi della Commissione sulle sue conclusioni e valutazioni relative alla valutazione… Leggi tutto
Mag 03, 2019 192

Rettifica del regolamento (UE) 2017/746 | 03.05.2019

Rettifica del regolamento (UE) 2017/746 | 03.05.2019 Rettifica del regolamento (UE) 2017/746 del Parlamento europeo e del Consiglio, del 5 aprile 2017, relativo ai dispositivi medico-diagnostici in vitro e che abroga la direttiva 98/79/CE e la decisione 2010/227/UE della Commissione (GU L 117 del… Leggi tutto
Mag 03, 2019 266

Rettifica del regolamento (UE) 2017/745 | 03.05.2019

Rettifica del regolamento (UE) 2017/745 | 03.05.2019 Rettifica del regolamento (UE) 2017/745 del Parlamento europeo e del Consiglio, del 5 aprile 2017, relativo ai dispositivi medici, che modifica la direttiva 2001/83/CE, il regolamento (CE) n. 178/2002 e il regolamento (CE) n. 1223/2009 e che… Leggi tutto
Guide NRMM FEM 2019
Apr 24, 2019 189

Guide to identify non-road mobile machinery and engines

Guide to identify non-road mobile machinery and engines compliant with Reg. (EU) 2016/1628 FEM, April 2019 FEM, together with its partner industry associations CECE, CEMA, EUROMOT, EGMF and EUnited Municipal Equipment developed a joint Guidance document intended to support market surveillance… Leggi tutto

Più letti Marcatura CE

Ott 01, 2017 42668

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) G.U.U.E L… Leggi tutto