The technical file consists of all the technical documentation of a product made available or placed into service on the EEA market. The operator responsible for the conformity of the product must setup a technical file with all relevant information, regardless of assessment module used. The technical documentation must be kept for at least a period of 10 years.
The technical documentation can, in theory, be written in any language as chosen by the manufacturer however if assessment by a notified body is required the language must be appropriate for the chosen body. If a product is subject to re-designs and/or re-assessments the technical file must reflect all versions of the product and describe the various changes in detail, including how they can be identified. A technical file does not have a set format (i.e. online, in paper or forms). It is up to the manufacturer to determine what information is relevant. The appropriate directive will give further requirements as to what a technical file must contain.
In the case of RCD 2013/53/EU, the technical file must contain at a minimum:
- A general description of the type;
- Conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, and other relevant data;
- Descriptions and explanations necessary for the understanding of said drawings and schemes and the operation of the product;
- A list of the standards referred to in Article 14, applied in full or in part, and descriptions of the solutions adopted to fulfil the essential requirements when the standards referred to in Article 14 have not been applied;
- Results of design calculations made, examinations carried out and other relevant data;
- Test reports, or calculations namely on stability in accordance with point 3.2 of Part A of Annex I and on buoyancy in accordance with point 3.3 of Part A of Annex I;
- Exhaust emissions test reports demonstrating compliance with Section 2 of Part B of Annex I;
- Sound emissions test reports demonstrating compliance with Section 1 of Part C of Annex I.
If you are performing an assessment with EMCI Register or want to perform self-assessment using Module’s A or A1 you can use the EMCI Register audit application to ensure that the technical file is created in a uniform manner covering all relevant norms and meeting legal requirements on compliance and storage. See our page here…