CE Machinery Directive

Directives, standards, laws and guidelines shape the working day — depending on the industry, we encounter them at almost every step. At COMLOGOS we support numerous customers from the mechanical engineering sector every day. This article is therefore devoted to the CE Machinery Directive and its successor, the new Machinery Regulation — with particular attention to the translation of the associated documentation.

What is the CE Machinery Directive?

Machinery Directive 2006/42/EC remains the authoritative legal basis for mechanical engineering companies to this day. Following earlier versions dating back to 1989, it was published on 17 May 2006 and has been binding since the end of 2009 on companies that design, build and distribute machinery. The decisive factor was the inconsistent legislation across Europe; the Directive harmonises health and safety requirements and applies throughout the European Economic Area (EEA), including the EFTA states Iceland, Liechtenstein, Norway and Switzerland. The United Kingdom and Northern Ireland left the EEA with Brexit. Twenty-nine articles govern, among other things, placing on the market, scope, definitions, presumption of conformity, safeguard clauses, marking, exemptions and penalties.

The German Product Safety Act

Requirements arising from EU directives have to be transposed into national law. In Germany, the placing of products on the market and the safety requirements they must meet are governed by the Product Safety Act (Produktsicherheitsgesetz, ProdSG): under Section 3, a product may only be placed on the market if it does not endanger the safety and health of persons when used as intended or in a foreseeable manner. The requirements of Machinery Directive 2006/42/EC are implemented in the Ninth Ordinance on the Product Safety Act (9. ProdSV), colloquially known in Germany as the „Maschinenverordnung“ — not to be confused with the new EU Machinery Regulation (see the next section).

From directive to regulation: the new Machinery Regulation (EU) 2023/1230

Machinery Directive 2006/42/EC is being replaced: in June 2023, Machinery Regulation (EU) 2023/1230 was adopted. It entered into force on 19 July 2023 and becomes binding on 20 January 2027. Unlike a directive, an EU regulation does not have to be transposed into national law — it applies directly and uniformly in all member states.

There is no transition period: machinery placed on the market up to 19 January 2027 is governed by Machinery Directive 2006/42/EC; for all machinery placed on the market from 20 January 2027 onwards, the new Regulation applies exclusively.

In substance, the Regulation brings above all greater legal clarity and an alignment with the current state of the art. For the first time it addresses cybersecurity and risks arising from artificial intelligence, among other topics, and operating instructions may in principle also be supplied in digital form — although a paper version remains mandatory if the user requests one.

For translations, the basic principle remains unchanged — quite the opposite: the obligation to provide operating instructions in the official language(s) of the respective destination country remains in place and is being made more precise. Companies that manage their technical documentation multilingually are best served by adapting to the new regulation early. With well-maintained terminology and translation memory, the transition becomes routine rather than a project — for example, through professional technical translations with a documented quality process.

CE marking

Everyone knows the visible sign of EU-compliant product safety: the CE marking. It is intended to guarantee that users of the product — in our case, a machine — are not exposed to danger. Since it may only be affixed once all prescribed safety requirements have been met, only marked machinery may be distributed and operated within the EEA. In the case of machinery, the CE marking also attests to a successful conformity assessment, which is documented by the declaration of conformity in the technical documentation. These principles continue to apply unchanged under the new Machinery Regulation.

What does the Machinery Directive require of the operating instructions?

As we approach the subject of translation, we inevitably arrive at the operating instructions. They form part of the product and must accompany the machine on delivery and in use. It is the manufacturer’s duty to draw them up before the machine is placed on the market; distributors must ensure that the end user receives a copy. In terms of content, the operating instructions must, among other things:

• describe the intended use of the machine
• describe any reasonably foreseeable misuse
• take account of the expected level of knowledge and comprehension of the users

The wording must be adapted accordingly to the particular target group. Further requirements as to content are laid down in the product-specific type-C standards for each machinery category. The new Machinery Regulation (EU) 2023/1230 likewise upholds these obligations. Our article Translate operating instructions shows what this looks like in practice.

What does the Machinery Directive stipulate about translations?

The first general principle for drafting the operating instructions requires them to be written in one or more official languages of the EU. If no original instructions exist in the applicable official language of the user’s country, the manufacturer or an authorised representative must arrange for a translation.

Important: translated operating instructions must always bear the wording “Translation of the original instructions”. This is because the “original instructions” are solely the version for which the manufacturer assumes responsibility — irrespective of the language in which they were written.

The reason: if, for cost reasons, German original instructions were first translated into English and then from English into further languages (what is known as a relay translation), the English version would first have to be declared the “original instructions” by the manufacturer — because the rules make no provision for a “translation of the translation of the original instructions”. This logic continues to apply under the new Regulation as well.

Certified translations with COMLOGOS

The same linguistic requirements apply to the translation of the original instructions as to the original instructions themselves. More detailed quality requirements are set out in DIN EN IEC/IEEE 82079-1 (Preparation of information for use — structure, content and presentation): the content must be comprehensible, factually correct and adapted to the particular target group.

Both the person who writes the original operating instructions and the person who translates them must have expertise in technical communication, know the subject field in precise detail and be a native speaker of the target language. The same applies to the reviser of the translation. Only a precise, qualified translation conveys the statements of the original instructions correctly and meets every safety requirement.

Given these demanding professional requirements, a certified partner such as COMLOGOS is the first step towards conformity with the standards. Our process is certified to ISO 17100 (translation services), ISO 18587 (post-editing of machine translation) and ISO 9001 (quality management), and we work with native-speaker specialist translators. Our use of a translation memory system and our terminology management ensures consistent results that meet the quality and safety requirements of the Machinery Regulation.

But take care: not every translation service provider that works to ISO 17100 is automatically certified as well. Our article Certifications explains how to make the right choice.

If you have any questions about the Machinery Regulation and your operating instructions, our project managers will be happy to help.