Handling and storage of the dossier for non-electrical equipment category M2 and 2 according to Annex VIII, point 2
M-O-04, Rev 01
According to Article 13 (1) (b) (ii) of the Directive 2014/34/EU the manufacturer must communicate the dossier to NOBEL CERT, which shall acknowledge receipt and shall retain that.
according to clarrification sheet No. ExNBG/CS/036, approval of the completeness or even correctness by the notified body is neither necessary nor permissible.
The acknowledgement receipt (A.R), shall include a statement that it cannot be seen as a certificate of conformity.
To get legal safety that the dossier stored is indeed the dossier communicated by the manufacturer without having checked the completeness, the Co-ordination of Notified Bodies Directive 2014/34/EU of the European Parliament and of the Council (ATEX), has recommended to the Notified Bodies only to accept the dossier sealed by the manufacturer.
If the dossier is submitted to NOBEL CERT in digital format, it must be also sealed by the client with using appropriate method such as encryption, digital signature, password protection or PDF/A.
NOBEL CERT perform below checks on the received technical file:
name and contact information of the client and conformity with the information in the completed application form;
clear identification of the type and model(s) of the applied product and conformity with the information in the completed application form;
conformity of the ATEX marking of the applied product with the information in the completed application form;
legible wording;
Regarding digital documents, in order to guarantee their durability during the storage period, controlling the absence of any viruses, being locked the original content, being protected with methods such as password protection, encryption, being digitally signed or has been made in secured PDF template, and also, if the digital dossier is presented on a CD or an external memory, controlling the suitability of the hardware used.
in case of any noncnoformity for the above check points is seen, the media in which the technical file has been stored, is not accepted and will be returned to the client.
With respect to the media used, it is accepted that this technical documentation may be either in paper or in electronic format so long as it is "legible" and "readable" over the period concerned.
in cases of receiving the technical documentation in a media such as CD, flash memory or external drive or via email or any information sharing platform, after scanning the information on the media for detection and destroying any probable virus, a copy of the information is transferred to the main could drive of NOBEL CERTIFICATION Italia.
to ensure the durability of those received technical files from the client only in digital format, over duration of intended validity of "acknowledge receipt", NOBEL CERT takes the following measures:
getting the service from credible and reputable cloud service providers to maintain the dossiers in the cloud drive of NOBEL CERT.
restricting access of the main part of staffs and collaborators to the could folder of NOBEL CERT management system documents in which the desired dossier has been placed.
getting periodic backups from the could folder of NOBEL CERT management system documents in which the desired dossier has been placed according to documents and records control procedure (P-S-01) for the purpose of maintenance the dossier in the other physical external drivers.
considering a secure location to store the external drive / original media received from client in which the backed up / original client files have been stored.
periodic scanning the external driver that is the maintain place of the periodic backups of the dossier for the purpose of prevention of its infection by virus.
the format of the documentation and the used media is selected by agreement between the manufacturer together with NOBEL CERT.
The Technical Documentation could be made on paper, stored in A4 size binders, sent in a sealed envelope and labelled so that from the outside it is possible to identify:
Name and address of the manufacturer;
Type and model (in Italian and / or English);
Equipment category and marking;
Identification number of the technical file;
Include a copy of the CE label on the cover.
The technical file must be properly packaged and sent to:floor T-1 , No. 285 , Comacchio St., Ferrara (FE) - Italia (CAP 44124)
Although not defined in ATEX directive, for reasons of agreement with the duty of the manufacturer to keep the dossier, NOBEL CERT should keep the dossier for a period ending at least 10 years after the last piece of equipment was placed on the market too.
Note: the validity of issued acknowledge receipt, shall be extended until the last piece of equipment was placed on the market too.
According to recommendation of ExNBG on clarification sheet No. ExNBG/CS/036, the client may be charged an annual fee to guarantee to get the information from the client when they stop placing of the product on the market, but NOBEL CERT acts as below arrangement:
NOBEL CERT Issues acknowledge receipt with 10 years validity and receives the whole fee once.
At the end of A.R validity duration, NOBEL CERT asks of the client if the product is still placed in the EU market or not.
If the answer is Yes, a quotation for re-issuing the A.R will be sent to the client
If the answer is No, NOBEL CERT requires the client to submit a declaration that placing the relevant product in the EU market, has been stopped.
The intention for technical file storage is that market surveillance authorities of EU in the different Member States should be given access to this dossier, in cases where there is a need to investigate the design or manufacturing details of a particular product.
