For the Machinery Directive 2006/42/EC, the term “technical file” corresponds to “technical documentation” under the Machinery Regulation (EU) 2023/1230; an initial rather noticeable difference in terminology. The differences are mainly in form, while the concept expressed by both definitions is similar. To make reading easier, in this book we will mainly use the term technical file to also refer to the Machinery Regulation (EU) 2023/1230, as it is the most established in common usage.

The technical file consists of the set of documents generated – or rather those that the manufacturer must generate – during the design and manufacturing of the machinery, clarifying its specific characteristics and being able to demonstrate conformity with essential health and safety health requirements. For the Machinery Directive 2006/42/EC, the technical file does not necessarily have to be located within the European Union or be physically available. However, the technical file must be able to be compiled and made available within a timeframe compatible with its importance, upon a legitimate request from the competent authorities. The Machinery Regulation (EU) 2023/1230, on the other hand, explicitly requires the manufacturer to draw up the documentation related to the technical file before placing the machinery on the market. This requirement aims to ensure that the manufacturer can efficiently and quickly provide the documentation at any future time, upon a legitimate request from the competent authorities.

Under the Machinery Regulation (EU) 2023/1230, the technical file must also include specific information regarding the software and sensor-fed, remotely-driven or autonomous machinery which have not been covered by the Machinery Directive 2006/42/EC. This update is quite reasonable, considering that in the intervening time technological advancements in machinery have already taken place. For this reason, the manufacturer may voluntarily follow these requirements even while the Machinery Directive 2006/42/EC is still in force, as they could prove particularly useful in systematically assigning responsibility in the event of an accident.

The documentation that makes up the technical file is mostly generated by the manufacturer during the production process; it is assumed that this would happen even in the absence of specific legal obligations. However, some documents may fall outside normal company procedures: since they stem from binding legal requirements, the manufacturer cannot exempt themselves from preparing them.

The manufacturer must archive the technical file and make it available to the competent authorities upon a justified request for at least ten years from the date of manufacture of the machinery or of the last unit produced in the case of series production. This implies the need for a highly organised company, to ensure proper archiving of documentation, so that it can be easily retrieved over time. Since the company structure and personnel may change over the years, this must not hinder the effective retrieval of the documentation. Therefore, strict and efficient company procedures are essential for this purpose.