28. May 2021

CE Machinery Directive

Directives, standards, laws and guidelines not only determine our everyday working lives. Depending on the industry, we are regularly confronted with certain specifications in various work steps. At COMLOGOS, for example, we support numerous customers from the mechanical engineering industry on a daily basis. For this reason, we would like to dedicate this blog post to the CE Machinery Directive and pay particular attention to translations in this context.

What is the CE Machinery Directive?

The Machinery Directive 2006/42/EC is the most important legal basis for mechanical engineering companies. Following previous versions from 1989, 2006/42/EC was published on May 17, 2006. Since the end of 2009, it has been mandatory for companies that design, build and sell machinery. The directive was drawn up in response to inconsistent legislation at European level with regard to product and machinery law. From the first draft, it was intended to guarantee the standardization of health and safety requirements in connection with machinery and to be binding for all machinery manufacturers and distributors in the European Economic Area (EEA) (including the EFTA states of Iceland, Liechtenstein, Norway and Switzerland). Great Britain and Northern Ireland left the EEA with Brexit. 29 articles describe important legal requirements, for example with regard to placing on the market, areas of application, definitions of terms, presumption of conformity, but also safeguard clauses, labeling rules, exemptions and sanctions.

The German Product Safety Act

Legal regulations arising from EU directives must be enshrined in laws at national level. Legal matters that describe the market launch of products (in the broadest sense) and their safety requirements are laid down in Germany in the Product Safety Act (ProdSG). According to §3, a market launch is only permitted if the product “does not endanger the safety and health of persons when used as intended or in a foreseeable manner”. The law consists of 14 ordinances covering various specialist areas. Specifications from the European Machinery Directive 2006/42/EC can be found in the 9th Product Safety Ordinance, the so-called “Machinery Ordinance”. Here, explicit reference is made to Annex I of the Machinery Directive, which means that the requirements of the latter have a direct effect.

CE marking

Everyone is familiar with a visible sign of EU-compliant product safety: the CE mark. The CE mark is intended to guarantee that the user of the product (in our specific case a ‘machine’) is not exposed to any risks. As it may only be affixed if all the safety requirements prescribed by the EU are met, only machines with this marking may be sold and used in the EU. In the ‘machinery’ sector, a CE marking also means a successful conformity assessment, which is additionally documented by the corresponding declaration of conformity in the associated technical documentation.

Planned revision of the Machinery Directive

All European regulations and directives are regularly reviewed and adapted to the new state of the art. This review process has already been taking place for the Machinery Directive since 2016. The results of a public survey of users of the directive have been compiled and will be incorporated into a new draft. The general public will be given the opportunity to provide feedback and propose solutions. Essentially, the new version should bring more legal clarity and be adapted to technical progress. The new version is not expected to be applied before 2024.

Machine

What requirements does the Machinery Directive place on the operating instructions?

If we approach the subject of translation in connection with the Machinery Directive, we inevitably end up with the operating instructions. According to Annex I No. 1.7.4, operating instructions are an integral part of the product and must therefore accompany the machine when it is delivered and used. It is the manufacturer’s duty to draw them up before placing the machine on the market. Furthermore, distributors of the machinery must ensure that the end user of the machinery is provided with a copy of the instructions.

The contents of the operating instructions must include the following:

  • Description of the intended use of the machine
  • Description of any reasonably foreseeable misuse of the machine
  • Consideration of the expected general level of knowledge and understanding of consumers.

The wording must be adapted accordingly to the respective target group. Further requirements for the content of operating instructions are defined in the so-called type C standards depending on the machine category.

What does the Machinery Directive prescribe for translations?

The first general principle of the Machinery Directive on the drafting of the instructions stipulates that they must be written “in one or more official languages” of the EU. If there are no “original instructions” in the applicable official language in the country of use at the time of delivery, the manufacturer or an authorized representative must provide a translation.

Important:
Translated operating instructions must always bear the note “Translation of the original operating instructions“!
This is because the “original operating instructions” are only the version of the operating instructions for which the manufacturer assumes responsibility – regardless of the language in which they were written.

This note is important for the following reason:
If, for example, for cost reasons, an original German instruction manual is first translated into English and then translated from English into other languages (a so-called relay translation), the English version, which has actually already been translated, would first have to be declared an ‘original instruction manual’ by the manufacturer (for which the manufacturer bears full responsibility, as already mentioned), as the EU Directive does not provide for a “translation of the translation of the original instruction manual”.

Certified translations with COMLOGOS

The same linguistic requirements apply to the translation of the original operating instructions as to the actual original operating instructions. More precise requirements for the quality of the operating instructions, and therefore also the translation thereof, are set out in DIN EN 82079-1 (Preparation of instructions for use – Structure, content and presentation;

General principles and detailed requirements):
The content must be understandable, correct and adapted to the respective target group. The person who prepares the original operating instructions, as well as the person who prepares the translation, must be competent in technical communication, have in-depth knowledge of the specialist area and be a native speaker of the target language. The same applies to the reviser of the translation. A correct reproduction of the statements in the original operating instructions is only possible with a precise and qualified translation in order to continue to satisfy all safety aspects.

Due to the high technical demands and the imperative need for an accurate and terminologically correct translation that is understandable for all target groups, a certified partner such as COMLOGOS is the first step towards compliance with the standards. Thanks to our ISO 17100 (requirements for translation services) and ISO 9001 (quality management) certifications, we can provide you with high-quality, certified translations with the help of our highly trained native-speaker specialist translators. Our work with a translation memory system and our terminology management services guarantee consistent, high-quality translations that meet the quality and safety requirements of the Machinery Directive.

But watch out!
Not every translation service provider that works according to ISO 17100 is automatically certified! Read our article on “Certification”on how to make the right choice.https://comlogos.com/expertenblog/Weitere Questions?

For everything at a glance, please download the leaflet “CE Machinery Directive” down. If you have any further questions, please do not hesitate to contact our project managers.

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