Technical Files

A Technical File comprises all the documentation necessary to back up a manufacturers declaration of conformity  with specified criteria.

For the purposes of this Guide, it is assumed that the Technical File is in support of the manufacturers Declaration of Conformity with the ATEX Directive.

In particular, it is assumed that such a Technical File is available as an input to the Type Examination process although, in practice, the Technical File is not usually complete until the Notified Body has assembled all the information as part of the process.

The specific requirements are given in Annex III, to the directive, Paragraph 3.   Almost identical text is reproduced in Annex VIII to the directive which covers the manufacturers sole responsibility under the module for "Internal Control of Production".

The text reproduced here is from Annex III:

"The technical documentation shall enable the conformity of the product with the requirements of the directive to be assessed.  It shall, to the extent necessary for such assessment, cover the design, manufacture and operation of the product and shall to that extent contain:

a.        a general type-description;

b.       design and manufacturing drawings and layouts of components, sub-assemblies, circuits, etc.;

c.        descriptions and explanations necessary for the understanding of said drawings and layouts and the operation of the product;

d.       a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where the standards referred to in Article 5 have not been applied;

e.        results of design calculations made, examinations carried out, etc.;

f.         test reports."

(Note that the reference to standards and Article 5 is to give special status to the "Harmonised Standards".)

We take particular care to ensure that the combination of a Type Examination Certificate and its associated Certification Report, together with the defined schedule drawings and other collated documents, meet all the requirements to satisfy the directive in respect of the technical documentation.

For Annex VIII, Internal Control of Production, the manufacturer has sole responsibility for the creation of an equivalent Technical File.  However, for certain types of equipment (Non-electrical Category 2), the manufacturer must deposit the Technical File with a Notified Body

Retention of Technical Files

For both Annex III, Type Examination, and Annex VIII, Internal Control of Production, the directive specifies that the manufacturer (or his authorised representative established in the community) shall keep the Technical File for a period not less than 10 years after the last item was manufactured.

Although not specific, it can be inferred that a similar obligation lies with the Notified Body that holds a copy of the Technical File.

It has been agreed by the European group of Notified Bodies appointed for the ATEX Directive (ExNB) that there should be a charge for storage of technical files and that the charging regime should be based on encouraging the manufacturer to advise the Notified Body when production has ceased, thus enabling the Notified Body to dispose of the Technical File ten years later.

Baseefa will charge as follows :

1.        For Technical Files created by Baseefa as part of Type Examination - free for ten years

2.        For Technical Files transferred from EECS or other Notified Bodies by specific agreement - free for ten years. 

3.        For Technical Files where Baseefa is responsible for the production phase (QA Notification or Verification) - free for ten years after last Notification or Verification Certificate.

4.        For Technical Files where Baseefa has had no part in preparation or in the production phase (normally in accordance with Annex VIII) - an initial fee in accordance with our standard scale, to cover ten years retention.

5.        Other than for Technical Files where there is continuing involvement with the production phase, there will be a renewal charge every three years, in accordance with our standard scale, to retain the Technical File for the following ten years.  If we are advised that production has ceased and will not be resumed, the retention period will not be extended and no fee will be payable.

Technical File Review

On an optional and voluntary basis, we will review the content of any technical file deposited with us for retention.  A certificate will be issued confirming that the Technical File contains appropriate information to demonstrate compliance, but that Baseefa has not verified any of the information in the file.  Please ask for a quotation when you deposit the file.

We can also assist with preparation of files.