Handling and storage of the dossier for non-electrical equipment category M2 and 2 according to Annex VIII, point 2
M-O-04, Rev 03
According to Article 13 (1) (b) (ii) of the Directive 2014/34/EU the manufacturer must communicate the dossier to ConformEx, 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 on received ATEX technical documentation, 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.
in case that the dossier is submitted to ConformEx 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.
for both cases of submission the technical documentation in paper or in digital forms, below information should be submitted:
a cover page demonstrating the main informaiton regarding the product in question; and
main content of technical documentation.
In case of digital submission, below requirements should be fulfilled:
the files for "cover page" and "technical file content", should be submitted together in one folder (e.g. in the form of a combined file such as RAR)
the name which is assigned to the file for "technical file content" should be clearly stated in the cover page.
ConformEx requires the following information to be included on the cover page of technical file
the product subjected to the technical file must be relevant to the subject of Article 13 (1) (b) (ii) of the Directive 2014/34/EU.
the title (subject) of the document must be clearly stated. e.g. “technical documentation dossier of ATEX – Cover page”;
in the case of digital submission, the name which is assigned to the file for "technical file content" should be clearly stated in the cover page;
making a clear reference to the "technical file number";
name and contact information of the client (the information should be in compliance with the information in the completed application form);
clear identification of the type and model(s) of the applied product (the information should be in compliance with the information in the completed application form);
the ATEX marking of the applied product (the information should be in compliance with the information in the completed application form);
technical file preparation date;
technical file revision number;
a declaration stating the absence of any viruses and that the technical file is provided in a locked or sealed form and in the desired format (e.g., PDF file, paper form, or other form);
approver person name and signature;
stamp of the company;
contact details of the approver including telephone number and email address.
Note: Regarding digital documents, in order to guarantee their durability during the storage period, follwoing checks are done:
absence of any viruses;
being locked the original content;
being protected with methods such as password protection; and
if the digital dossier is presented on a CD or an external memory, 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.
the format of the documentation and the used media is selected by agreement between the manufacturer together with ConformEx.
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 remains "legible" and "readable" over the period concerned.
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 the cover sheet information.
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 (ConformEx).
in case of submission in paper, the technical file must be properly packaged and sent to:floor T-1 , No. 285 , Comacchio St., Ferrara (FE) - Italia (CAP 44124)
in case of sending technical file in digital form by email, the main content and cover page files, shall be sent to atex@conformex.it and the password of the main content file shall be sent to the legal email address of ConformEx nobelcertificationitalia@legalmail.it
Note: ConformEx commits and declares that it shall not and will not open the received email on the above-mentioned legal email which include the password of the main content of technical file, unless in particular circumstances, any of legal authorities in Italy or EU require ConformEx to share technical file with them following an investigation.
Although not defined in ATEX directive, for reasons of agreement with the duty of the manufacturer to keep the dossier, ConformEx 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.
to ensure the durability of those received technical files from the client only in digital format, over duration of intended validity of "acknowledge receipt", ConformEx takes the following measures:
getting the service from credible and reputable cloud service providers to maintain the dossiers in the cloud drive of ConformEx;
restricting access of the main part of staffs and collaborators to the could folder of ConformEx management system documents in which the desired dossier has been placed;
getting periodic backups from the could folder of ConformEx 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.
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 ConformEx acts as below arrangement:
ConformEx Issues acknowledge receipt with 10 years validity and receives the whole fee once.
At the end of A.R validity duration, ConformEx 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, ConformEx requires the client to submit a declaration that placing the relevant product in the EU market, has been stopped.
Access to ATEX technical file by authorities in special circumstances
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.
Details for Access to ATEX technical file by authorities in special circumstances under which the need arises to review the technical file of products having an ATEX acknowledge receipt. click here
