NIST SP 951
A Guide to EU Standards and Conformity Assessment

Technical File

New Approach Directives contain more opportunities for self-declaration than mandated third party involvement; but the right to self-declare compliance with the law means that a manufacturer must be responsible for completing all the procedures required by the law.

Most New Approach Directives allow the manufacturer to "self-declare" compliance with Essential Health and Safety Requirements, but some directives require Notified Body intervention (See Modules). For example, Annex IV of the Machinery Directive lists types of machines that must be submitted to a Notified Body for evaluation. Whether or not the judgment of a Notified Body is required, the manufacturer is required to prepare a Technical File.

The Technical File is the written justification that all aspects of a product are safe. For goods that must bear CE marking, this written justification must be prepared before the product is placed on the market. The Technical File includes information that demonstrates the technical basis for conformity of the product to the applicable requirements of the directive.

The manufacturer must keep the Technical File for ten years after the last unit is placed on the market, unless the directive provides for a different duration.

Any person placing a product on the market but not in possession of the Technical File must, on request from national Surveillance Authorities, 1) state where the Technical File is situated, and 2) produce the Technical File promptly. Most manufacturers already possess 90% of the material necessary to compile a Technical File.

Content of the Technical File

The following main elements should be present in a Technical File:
	a general description of the product; design and production drawing and diagrams; detailed technical data for essential aspects of the product; a risk assessment; a list of standards and or solutions applied; reports of calculations and tests that have been carried out (calculations might include a bearing, belt, or pulley based on a chart in a catalog); certificates and inspection reports; in the case of series production, internal conditions that have been observed to safeguard compliance with the directive; a user's manual; and a Declaration of Conformity.

A Technical File may cover a range of product models or options. Similar but simpler models may be considered within the scope of the most complex or most hazardous combination evaluated.

A Technical File is proprietary in nature. It need not be given to one's customers or competitors. The Technical File must be kept available for inspection or control by national Surveillance Authorities who may ask to see all or parts of the Technical File.

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Technology Services, Standards Services Division, Global Standards and Information Group Contact: maureen.breitenberg@nist.gov A Guide to EU Standards and Conformity Assessment, NIST SP 951

Date Created: 05/31/00 Last Modified: 05/31/00