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The new Machinery Regulation allows the provision of operating instructions and declarations of conformity in digital form. Manufacturers of customized machinery, in particular, welcome this change as the development of printed operating instructions consumes significant resources. In addition, many documents are already available digitally for internal use.
What are the formal requirements under the Machinery Regulation for publishing operating instructions and declarations of conformity in digital form? And are operating instructions and declarations of conformity already allowed to be provided in digital form under the current Machinery Directive? This technical article aims to answer these questions.
Currently, machine manufacturers must be familiar with both the Machinery Directive and the Machinery Regulation. The provisions of the Machinery Regulation apply to all machinery and associated products, which are initially placed on the market starting January 20, 2027. The Machinery Directive continues to apply to all machinery and associated products placed on the market before the deadline.
The Machinery Regulation allows operating instructions to be made available in digital form. However, the question arises: can the operating instructions be provided exclusively in digital form for machinery first placed on the market before January 20, 2027, and is therefore subject to the Machinery Directive? The “Guide to application of the Machinery Directive 2006/42/EC” Edition 2.3, published in April 2024, comments on this for the first time.
Section 255 explains that, due to the widespread availability of the Internet across EU households, digital provision of the operating instructions is already permissible today if the formal provisions of the Machinery Regulations are complied with. If the instructions are provided digitally, the manufacturer must comply with the following formal requirements in accordance with article 10 paragraph 7 of the Machinery Regulation:
The “Guide to application of the Machinery Directive 2006/42/EC” also recommends including the statement ‘The purchaser has the right to request to obtain, free of charge, the instructions for use in paper format.’
on the machine itself, on the packaging or in the accompanying documentation. The statement should also include the contact details of the manufacturing company and information on how the operation instructions can be obtained.
In the case of machinery or associated products intended for non-professional users, the manufacturer must provide the essential safety information in paper form (article 10 paragraph 7 subparagraph 4). According to the guide, this must contain at minimum information on the assembly, commissioning, use, maintenance and transportation of the machine. The “essential safety information” is determined by the risk assessment.
Neither the Machinery Regulation nor the “Guide to application of the Machinery Directive 2006/42/EC” require a specific file format. However, it is generally advisable to choose a format that is already widely used and future-proof. In addition, as mentioned above, care must be taken to ensure that the digital operating instructions can be printed out, downloaded and saved on an electronic device at any time in accordance with article 10 paragraph 7 of the Machinery Regulation.
The Machinery Regulation defines the formal requirements for the provision of digital declarations of conformity in article 10 paragraph 8, whereas the “Guide to application of the Machinery Directive 2006/42/EC” addresses this topic in § 261. Digital declarations of conformity under the Machinery Directive are also permitted if the formal requirements of the Machinery Regulation are met.
The Machinery Regulation stipulates that digital declarations of conformity must be made accessible by means of an Internet address (URL) or a machine-readable code (e.g. QR code) in the operating instructions. Like digital operating instructions, declarations of conformity must be accessible online for the expected service life of the machine, but for at least 10 years.
Machinery is often also covered by other EU legislation in conjunction with the Machinery Regulations. Some EU legislation, such as Directive 2014/34/EC on equipment and protective systems intended for use in potentially explosive atmospheres, also known as the ATEX Directive, does not contain any provisions on the digital declaration of conformity.
For machinery, however, the declaration of conformity in accordance with the Machinery Regulation contains a list of all applicable EU legislation. A digital declaration of conformity is therefore always possible for machinery that is covered by several pieces of EU legislation.
Starting January 20, 2027, the Machinery Regulation will enable digital provision of operating instructions and declarations of conformity. For machines placed on the market before this date, digital operating instructions and digital declarations of conformity are permitted if they meet the requirements of the Machinery Regulation. Technologies for the provision of digital product information are already available today, however, without accompanying software solutions, will require significant resources. Nevertheless, the Machinery Regulation creates a modern basis for efficient access to technical documentation.
Posted on: 2024-11-04
Stefan Winkler
Managing Director of Winkler GmbH. Certified Product Compliance Officer ISO/IEC 17024; many years of experience in development/design, technical writing, CE marking consulting and CE marking project management.
E-Mail: stefan.winkler@winklergmbh.de
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