Global manufacturing is built on complex, interdependent documentation. A single product might generate patents, component specifications, installation guides, maintenance manuals, safety data sheets, training materials and packaging copy, all of which need to be accurate in every market where the product is sold or assembled. That scale creates real exposure when translation is treated as an afterthought rather than a core part of the production process.

What technical document translation actually covers

The scope of technical document translation in manufacturing is broader than most people outside the industry realise. Documents span the full product lifecycle, and each type carries its own accuracy requirements and its own risk profile if mistranslated.

Commonly translated content includes:

• Installation, operation and maintenance manuals (IOMs)
• Work instructions and standard operating procedures (SOPs)
• Safety data sheets (SDS), warnings and signage
• Technical data sheets and product specifications
• Quality assurance and validation documentation
• Patents and regulatory submissions
• Employee handbooks and training materials
• Packaging labels and end-user licence agreements

That鈥檚 a significant content footprint, and it spans multiple audiences, including operators on the shop floor, engineers in the field, regulators in each relevant market and customers receiving your product.

Each audience has different comprehension needs and a different tolerance for ambiguity. An experienced maintenance engineer can interpret a vague instruction in context. An operator following a safety procedure in their second language cannot afford that ambiguity. Effective technical document translation accounts for these distinctions rather than applying a one-size-fits-all approach across content types.

Where poor technical document translation creates risk

The risks of inadequate technical document translation fall into three broad categories: safety, compliance and commercial performance.

Safety risk is the most direct. When operators or maintenance teams work from translated documentation that contains errors, ambiguities or cultural mistranslations, the potential for injury or equipment damage is real. A illustrates the scale of the problem: an incorrect translation of 鈥渘on-modular cemented鈥� as 鈥渨ithout cement鈥� resulted in several knee implants being applied incorrectly. Manufacturing carries equivalent exposure whenever safety-critical instructions cross a language boundary without proper quality assurance.

Compliance risk is particularly acute for manufacturers selling into regulated markets. EU regulations covering machinery, medical devices and product labelling all place the responsibility for correct language documentation firmly on the manufacturer. Errors in translated regulatory submissions can delay market entry, trigger clarification requests from authorities or, in serious cases, result in enforcement action. These are not hypothetical outcomes but common causes of timeline slippage on international product launches.

Commercial risk is less obvious but equally significant. Poorly translated customer-facing documentation 鈥� user manuals, quick-start guides, troubleshooting content 鈥� increases support costs, damages product perception and erodes the trust that manufacturers work hard to build in new markets. A product that works flawlessly but arrives with confusing instructions creates a poor first impression that鈥檚 difficult to reverse.

How consistency tools protect quality across markets

For manufacturers with multiple product lines, production sites or markets, consistency across translated documentation is as important as accuracy in any individual document. A component referred to by three different names across three translated manuals creates confusion for engineers, complicates spare parts procurement and introduces latent risk whenever someone uses the wrong term in a safety context.

Two tools sit at the heart of consistent technical translation: translation memories (TMs) and termbases.

A translation memory is a language-specific database that stores every approved translation your organisation has produced. When the same phrase appears in a new document, the TM surfaces the existing translation for the linguist to apply or adapt. The practical benefits are significant: you never pay to translate the same content twice, your terminology stays consistent across documents, and turnaround times improve as content volumes grow. For manufacturers producing large volumes of structured technical content 鈥� IOMs, SOPs, safety procedures 鈥� TMs typically generate material cost savings over time.

A termbase is a managed multilingual glossary of approved terminology covering your components, processes, branded terms and safety concepts. Where a TM operates at the sentence level, a termbase operates at the word level, ensuring that specific terms are always translated the same way regardless of which document they appear in or which linguist is working on it. In manufacturing, where precise terminology is tied to safety and quality outcomes, a well-maintained termbase is one of the most valuable translation assets a company can hold. It also reduces onboarding time when new translation teams pick up your content.

Both tools accumulate in value over time. The more content you produce, the more leverage you get from your existing assets, and the more your translation investment compounds rather than resets with each new project.

Machine translation in manufacturing: where it helps and where it doesn’t

Machine translation (MT) has advanced considerably in recent years, and for certain types of manufacturing content, it can meaningfully reduce costs and improve turnaround times. The key is understanding where it can be deployed safely and where it cannot.

Technical content that is highly structured, repetitive and written in controlled language is well-suited to MT with human post-editing. Work instructions, product specifications, parts lists and standard operating procedures often fall into this category, particularly when a well-populated TM already exists to ensure consistency. In these cases, MT accelerates the process while human post-editors check accuracy and flag anything the model has mishandled.

Safety-critical content is a different matter. Any document where a mistranslation could cause harm 鈥� safety data sheets, operating instructions for high-risk equipment, hazard warnings 鈥� requires full human translation and review, regardless of how confident an MT output looks. MT models can produce fluent, plausible-sounding text that is factually incorrect, and in a safety context, plausible-but-wrong can be very dangerous.

A structured approach to MT and AI deployment involves analysing your content types and quality requirements before applying the technology. Reputable providers of technical document translation will carry out this analysis and configure MT outputs accordingly, rather than applying the same approach across your entire content portfolio. Where MT is used, workflows certified to ISO 18587 for post-editing of machine translation provide a documented quality standard that supports both internal governance and external audit requirements. Plus, leveraging all legacy content through the translation memories you鈥檝e built as a database can condition AI applications for more reliable and consistent output, thus reducing localisation budget and the time it takes to publish.

Treating translation as part of the production process

The manufacturers that manage multilingual documentation most effectively tend to share one common characteristic: they plan for translation early rather than commissioning it at the end of the production cycle. When language requirements are identified during product development rather than at the point of market submission, there鈥檚 more time to establish terminology, build streamlined language operations and review source content before it gets multiplied across languages.

Source content review is worth mentioning as a crucial part of the translation process. Ambiguities, inconsistencies and unnecessarily complex phrasing in a source document get carried into every target language translation. Addressing them once at source is far more efficient than correcting them market by market. Many manufacturers find that a structured review of their source documentation before translation begins improves both translation quality and the readability of the original English content.

Sandberg provides technical document translation for manufacturers across industrial equipment, automotive, energy, civil engineering and related sectors. Find out more about our manufacturing translation services or get in touch to discuss your documentation needs.

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Considering that the translation product can be an operating manual or even a safety manual, badly translated terms and unclear instructions can drastically alter the way the product or service is perceived. An otherwise satisfied customer will become frustrated, grappling with a piece of machinery or software product as they attempt to puzzle out the meaning of the text.

One and the same word form can have different meanings in different areas of science and engineering. A specific term will therefore be different depending on its context of use and may result in a nonsensical translation. At the very least, this can result in a lower NPS () and mean that instead of waxing lyrical about a product to friends and colleagues, the dissatisfied end user is likely to damage your brand鈥檚 reputation by negative word of mouth.

A clear example of the importance of technical translation accuracy is the , which was developed by the Society of Automotive Engineers to tackle the inaccurate translation of automotive documents. Incorrectly translated documentation can have large repercussions, such as higher warranty costs, damage to vehicles and even injury to those operating a machine. Just like we wouldn鈥檛 put a one-year-old behind the wheel, we wouldn鈥檛 ask a linguist with no understanding of automotive vehicles to translate a manual for a tractor.

Why subject-matter expertise matters for technical translation accuracy

Our Lead Finnish Translator, Antti, is convinced of the benefits of translators who are knowledgeable in their subject area. 鈥淭he most important benefit you can draw from being familiar with the subject content is being able to spot if a phrase or term is incorrect, either in a reference text or a previous translation done by someone else. Any good translator should be able to handle several types of texts, so although in-depth knowledge doesn鈥檛 automatically guarantee better results in any given text, experience can sometimes help you put right something that may have been wrong in previous texts for years. It feels good when you can improve the quality of the client鈥檚 translations in this way.鈥�

Senior Norwegian Translator 闯酶谤苍 is particularly interested in diligently researching terminology. 鈥淚mages are often very helpful for clarifying a term, as you can see exactly which part of the product a specific word or phrase refers to. Terminology is often the first thing you research when you translate a new technical text, because a good understanding of the terms will help you translate with a better flow.鈥�

Considering how a term is used in the real world is therefore imperative. The translation of 鈥減ocket鈥�, for example, is entirely dependent on context, as it can have several different meanings. 鈥淧ocket鈥� can indicate an 鈥渁ir pocket鈥� in aviation, 鈥渟urroundings鈥� in military use, a 鈥渄ead zone鈥� in radio, a 鈥渄eposit鈥� in geology and a 鈥渃able channel鈥� in electrical engineering.

It鈥檚 easy to imagine that can arise if 鈥渁 pocket of gold ore鈥�, for example, is translated in a military context, where a pocket refers to isolated, surrounded pockets of combatants who are being attacked by an opposing force . Similarly, an air pocket in aviation simply refers to turbulence. Getting the term wrong here will baffle the end user who is attempting to access a particular product or service.

How context shapes technical translation accuracy

Translation errors of this nature, where the translator has disregarded the context, can lead to confusing or misleading representations of the client’s product, undermining technical translation accuracy. This can happen when low-quality machine translation is used or when somebody translates without the proper training. An example from the German language is 鈥淜raft鈥�, which can be translated as 鈥渇orce鈥�, 鈥減ower鈥�, 鈥渟trength鈥� or 鈥渢hrust鈥� .

The term 鈥減ower鈥� can have very different meanings depending on context in the Nordic languages as well, as Antti explains. 鈥淭here are several Finnish translations for 鈥榩ower鈥�, ranging from teho and voimakkuus to 蝉盲丑办枚惫颈谤迟补. The first one is what you would use when describing the power output of an engine, for example. Voimakkuus could refer to the power or strength of a signal, and 蝉盲丑办枚惫颈谤迟补 (or just virta) is what鈥檚 involved when you鈥檙e talking about electrical power.鈥�

The same issue arises in Norwegian. 鈥淧ower can be translated in several ways for technical applications depending on what kind of power the text refers to,鈥� explains 闯酶谤苍. 鈥淓lectrical power (蝉迟谤酶尘, and there are different types of electrical power, such as sterk蝉迟谤酶尘听鈥榩ower current鈥� or 鈥榟eavy current鈥� and nett蝉迟谤酶尘 鈥榤ains current鈥� or 鈥榩ublic current鈥� or simply 鈥榩ower鈥�), or mechanical power (arbeid听鈥榳辞谤办鈥�, energi听鈥榚nergy鈥� and kraft听鈥榝辞谤肠别鈥�).鈥�

But there are ways we can help our translators understand the context behind a term. For example, the original PDF of a user manual, containing images and diagrams relating to the product and its constituent parts, is often indispensable. Screenshots of single-word strings in help pages can also help the translator understand if the string refers either to a call to action framed as a button or to a menu item.

Terminology and style consistency across content

Although understanding the context of a term and the concept behind it in the target language and culture is vital, there might sometimes be other necessary requirements. Some manufacturers may simply prefer one term over another. This can be down to stylistic preferences, or there may be a technical reason for a particular usage.

Term bases, which are databases containing preferred terminology and other information such as meanings and examples of usage, can be incredibly useful for linguists to maintain technical translation accuracy across different languages. They can be maintained and built upon over time, for specific domains, products and customers, meaning that linguists can find out preferred terms with a few clicks of the mouse.

鈥淭erm bases are particularly helpful if entries have definitions explaining the terms so that we know it is right in the context. Sometimes terms can have several synonyms, and the term base is then good for showing which term our clients prefer,鈥� says 闯酶谤苍.

Our translators and project managers have extensive experience in using term bases created using specialist software. Instead of a translator having to search through a large, convoluted Excel spreadsheet full of preferred terms and definitions, the software efficiently identifies the entries that are most useful for the translation of a particular word or phrase. The value of term bases can therefore not be underestimated.

Get technical translation right from the start

In summary, the importance of technical translation accuracy and employing a translator with subject-matter knowledge and experience cannot be underestimated. Not only will the translator provide high-quality translations,听 but they may also spot past errors or be able to contribute towards improving the term bases and translation memories.

A good linguist does not translate in a vacuum. They require the original source text or helpful screenshots to allow them to comprehend the full context of a term in its original context of use. Term bases are also incredibly useful in maintaining consistency in style and terminology. Find out more about how we support manufacturing translation services and other technical industries here, or read more about our approach to technical document translation.

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The current state of the heavy machinery sector

The global machinery market saw a healthy growth from , an annual growth rate of 7.6%, as the sector recovered from the pandemic lockdowns. Some analysts expect a further growth rate of 6.6% by 2027, driven in part by an increased demand for construction and infrastructure equipment.

The highest growth rates are expected in the Asia Pacific region, as ongoing large-scale infrastructure projects in China and India continue to be rolled out rapidly, including new highways and airports.听

European machinery and equipment manufacturers have also witnessed a significant recovery, with revenue growth spiking to 18% in 2022 compared to 7% in the North American sector. However, Europe lags in profitability, with EBIT margins falling to 8.6%, whereas North America achieved 10.4% over the same period, as reported in a . A large part of the reason is the inflationary pressures in Europe, particularly on energy costs, which have been mitigated in America through shale gas exploration.

The heavyweights of heavy machinery

In the construction industry, the US-based Caterpillar Inc. dominates the market. In 2023, Caterpillar Inc. reported establishing itself as the world鈥檚 leading manufacturer of construction and mining equipment, off-highway diesel and natural gas engines, industrial gas turbines and diesel-electric locomotives. Key competitors in the global market include Japanese Komatsu and Hitachi, US company John Deere and Swiss manufacturer Liebherr.听

Other notable players within the heavy machinery market are Daimler Trucks, one of the leading heavy machinery manufacturers in the world. With origins dating back to the 1890s, the company has a global presence, employing more than 100,000 people in 42 production sites worldwide. They produce lorries of various sizes and models, including commercial vehicles, buses and specialised vehicles like fire engines.听听

Founded in 1927, the Volvo听Group is another prominent player in the heavy machinery market, producing commercial vehicles, construction equipment and diesel engines. Volvo operates in several markets, including Europe, North America and Asia. In April 2021, Volvo Group sold its UD Trucks division, generating a USD 2.3 billion payout.听

To preserve its competitive stance globally, the Volvo Group has been steadily investing nearly (December 2022) in research and development (R&D), primarily focused on battery-powered commercial vehicles.

Paccar is a well-known American manufacturer of light, medium and heavy-duty commercial vehicles, marketed worldwide under the Kenworth, Peterbilt and DAF brands. Paccar also produces industrial winches under the Braden, Carco and Gearmatic nameplates.听

Scania, a Swedish manufacturer of heavy commercial vehicles and engines established in 1891, reported an impressive growth in in 2023. The company鈥檚 workforce grew to 58,163 people, an increase of 2,500 from the previous year. Scania has been focusing strongly on alternative fuel and electric vehicles, selling 6,454 units in 2023, a slight decrease from the previous year but still a substantial part of their total delivery of 91,652 vehicles.听

The main challenges facing the heavy machinery sector听

Skilled labour shortage

A critical issue in the heavy machinery sector is the lack of skilled manpower. By 2050, 30% of the global workforce will be 50 years of age or older; however, in the EU, only remain active in the labour market. This scenario underscores the urgent need for young recruits who are either highly skilled or given training opportunities within companies, in addition to finding ways to retain older workers.

In Europe, the number of unfilled jobs in the sector rose by around 70% from 2020 to 2022 and has remained just above 500,000 vacancies since the beginning of 2022. Germany alone reported approximately 250,000 vacancies in the machine sector in 2022, a doubling from the previous year as highlighted by a In a figures show that the increased integration of smart connected devices, equipment and systems require highly skilled roles, which are expected to grow the fastest between 2022 and 2032. 听

Understanding the evolving expectations of new generations and the changing needs of older workers is crucial. Companies are also implementing internal systems to enable workers to upskill and work flexibly when the need arises, such as the 听positions, which have proven highly successful.听

Big Data and heavy machinery

The industrial equipment industry is not immune to technological innovation, Big Data and artificial intelligence. The integration of advanced technologies like the Internet of Things (IoT) is and making it smarter.听

systems, where vast amounts of data can be generated and analysed at once, enable fast decision-making, predictive maintenance and operations optimisation. Maintaining such systems requires an ongoing and dedicated investment in equipment, resources and skills training for engineers and technicians.

AI, automation and Big Data integration can also help mitigate the shortage of skilled staff in the sector by simplifying and optimising processes. For example, machine parts can be exchanged before they break, and changes and upgrades can be planned proactively.听

Carbon footprint and the price of transition

Another challenge the sector faces is the transition to a sustainable low-carbon future. The term 鈥渮ero carbon鈥� is still widely used to describe Electrical Vehicles (EVs), despite a from the Advertising Standards Authority stating that it is misleading to call an EV 鈥渮ero carbon鈥� unless referring exclusively to driving it. This is because CO2 is released during the vehicles鈥� manufacturing process听and potentially in the production of the electricity that powers them.听听

The increased demand for batteries is also not without its environmental impact. , it takes 2.2 million litres of water to produce 1 tonne of lithium. When Chile, for example, produces 8 million tonnes of lithium, this will have used around 17.6 trillion litres of water, in addition to the impact the mining has on the surrounding communities and the environment. 听

Furthermore, that the cobalt used in batteries, including vehicle batteries, is in some cases sourced from mines where child labour and other dangerous work practices are rife. 听

The EU , which means that European companies must document that the products they import adhere to environmental and human rights standards. For the machine industry, it will be necessary to carefully build supply chains, as any environmental or human rights impact will undoubtedly come under scrutiny as the transition to the desired low-carbon reality gathers pace.

Inflation and profitability

As mentioned before, revenue and productivity have both increased in Europe, but profitability is weaker than in North America. , including the increased price of energy, fuelled largely by sanctions on Russia, and interruptions of supply chains.听

The development of shale gas has helped the US keep gas prices down. This has had knock-on effects across the market, not least on energy-intensive steel production, which is extensively used in the production of heavy machinery.

The conflict in the Middle East is also driving up volatility, as well as insurance costs and transportation times for goods that are re-routed away from the Suez Canal.听

Businesses that are robust enough to withstand these difficulties and perhaps even increase their efficiency to thrive in troubled times will stand even stronger in a global industry where there will always be an element of volatility.听

Innovation and R&D

Patents remain vital for protecting and maintaining a company鈥檚 competitive edge. Innovation is crucial in a mature market like heavy machinery, where distinguishing a product by solving problems more efficiently can drive sustainable growth.听

Patent applications to the听 from 181,532 in 2019 to 199,275 in 2023. However, the number of patents for specialised machines in 2022. The top five countries for patent applications were the USA, Germany, Japan, China and the Republic of Korea, with a total of 57% of applications coming from outside Europe and the UK. 听

Notably, the Nordic countries of Sweden, Denmark and Finland rank in the top five for the number of patent applications as a share of the population. Denmark and China are the only two countries that have had stable growth in the number of issued patents across all major sectors. 听

As skilled labour becomes scarcer, innovative industrial equipment that enhances efficiency and productivity per working hour will be essential for future success. 听

Heavy machinery translation and localisation

In the global market, making use of heavy machinery translation services provides significant added value and is often a crucial necessity.

The most successful companies in the global marketplace are those that maintain the integrity of their product while adapting it to meet local preferences. Swedish furniture giant IKEA, for example, not only tailors its product range to fit local needs but also makes linguistic and cultural changes so that its product and marketing materials resonate with the target audience.听

Although industrial machines are not typically marketed directly to consumers like an IKEA coffee table, the underlying principle remains the same: reaching international audiences is crucial for growth and overall business sustainability. To succeed, business must tailor their offerings to appeal directly to decision-makers in the industry or industries they aim to penetrate.听

Localisation covers a range of activities and areas crucial for commercial success. This can include product adjustments to meet specific local conditions, such as modifying machinery to handle dry, sandy environments or cold, snowy conditions.听

In addition, localising product descriptions enhances听the connection with local buyers, while localised customer service and helplines foster long-term relationships.听听

With the global shortage of skilled labour, attracting qualified and highly motivated people from all over the world is another obvious benefit of a global approach, guided by the principle that has made Spotify a success: Think Global, Act Local.

Specialist knowledge

Heavy machinery translation often requires linguists with specialised knowledge of commercial and regulatory needs as well as technical terminology. 听

Professional localisation services use several tools to ensure that translations are linguistically accurate and industry-specific (e.g. a 鈥減ipe鈥� may mean something very different in the oil-drilling industry than in the construction industry). This includes maintaining term bases with preferred translations and technical terminology.听

Automated solutions can also be beneficial for ensuring accuracy and consistency across technical translations. However, it is essential that a competent human translator reviews all content for accuracy and adherence to agreed terminology.

Common content types for heavy machinery translation听

There are several key areas where the heavy machinery sector needs translation services:听

Product information

Key product information translation may be mandated by regulations such as the on machinery. This regulation stipulates that all key information regarding machines, including statements of conformity, instructions and a broad range of other documentation, shall be presented 鈥�…in a language which can be easily understood by users.鈥�听If necessary, it shall 鈥�… be translated into the language or languages required by the Member State in which the machinery or related product is placed on the market, is made available on the market or put into service.鈥�

Product descriptions

In a market dominated by established players, standout product descriptions can significantly impact how a company鈥檚 unique selling points are communicated to a technically savvy audience.听 A specialised translator can help ensure that the terminology and meaning are spot-on for every听audience.听

Safety information

Heavy industrial machines and construction machinery are high-risk entities to use, with the construction sector topping the stats for .听Given these risks, it鈥檚 crucial that product manuals and operating instructions are clearly presented in a language that each user fully understands, both for safety and regulatory compliance.听听

Patents听听

When it comes to patents, translators should have experience with both technical and legal translation to ensure precise and effective communication.

Reach global audiences in a global industry

Producers of heavy machinery 鈥� whether it is industrial equipment or machinery, construction machinery or heavy goods vehicles 鈥� face numerous challenges including the need for skilled labour, increased globalisation, the integration of technologies like Big Data, IoT and AI, and evolving sustainability and low-carbon requirements.听

Despite these challenges, the sector is strong and continues to grow and improve. For instance, the UK government’s Advanced Manufacturing Plan, launched in November 2023, highlights 听across Europe, the UK and Asia.听

But to ensure compliance with regulations and maintain a competitive edge in such a globalised and competitive industry, high-quality heavy machinery translation services are a necessary component of a successful global sales and marketing strategy.

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The machinery sector 鈥� producing success听

A听 published in April 2021 laid bare the importance of the machine manufacturing sector in Europe:听听

鈥淭he machinery sector is a major contributor to the European economy, with a current annual turnover of 鈧�700 bn. Machinery and equipment manufacturing was the principal business activity of 80,000 enterprises across the EU27 in 2018. These enterprises had a total of 3 million employees in the EU27 in 2018, according to Eurostat figures.鈥�听

Perhaps unsurprisingly, Germany鈥檚 sector is the largest in Europe, with a nominal turnover of 鈧�226 bn in 2018. However, the Nordic machinery market is making great strides; we saw 5.7% year-on-year growth from 2016 through to 2019, slightly higher than the 5.2% recorded by Germany in the same period, according to a McKinsey report detailing the rise of Nordic companies in the global machinery market.听

Relevant content in the local language helps forge stronger bonds with your in-country staff and the networks they are trying to build in a new market. Furthermore, making the effort to localise content for your overseas supply chain shows commitment and goes a long way towards facilitating smoother relationships with those suppliers.听

See below how you could categorise the content you are considering for translation. Start by mapping out your stakeholders and content types, then proceed to prioritise them in terms of how much value localising them could add to your new business development goals.听

Imports increasingly important听

As the European machinery sector has shown resilience and is bouncing back strongly from the upheaval of the two pandemic years, the longer-term trend shows that Europe鈥檚 share of the total global market has shrunk from 41% in 1998 to 24% in 2019, while the Asia-Pacific region has increased its share from 28% to 53% over the same period.

As a result, there are significantly more machines and machine equipment coming into European countries from outside the continent; from traditional import markets, such as the USA, and increasingly from Asian countries such as China.听

With relatively , many consider the EU an attractive export target. There is, however, a key hurdle that businesses must be able to clear, preferably with as little friction as possible, and that is compliance with all relevant EU directives and regulations.听

For machine importers in the EU, the big one is Directive 42, a.k.a听Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on Machinery, and Amending Directive 95/16/EC.听听听

Purpose of Directive 42听

The purpose of this directive is to create a common standard for safety across all member states of the EU and EEA, both for users and the general public. Although member states are responsible for such standards within their own respective territories, the directive is aimed at reducing barriers to cross-border trade within the Union by diverging standards. Any equipment that fulfils the requirements of the directive may be sold legally within all member states of the European Union and EEA.听

The machine regulation regulates…听

…machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices, and partly completed machinery, among other machinery.听

The directive gives a of the term 鈥渕achine鈥�, and all machines that fit this definition and are not specifically excluded, are covered by the regulation. A conveyor belt, for example, is considered a machine in its own right because it fulfils the criteria of being a mechanical moving part that is an interchangeable piece of equipment. But the entire machinery that the conveyor belt is part of, for example newspaper prints or a bottle filler, is also considered a machine in its assembled state.

Translation requirements听听

For all machines that fall under the directive鈥檚 definition, it is necessary to provide appropriate instructions and safety notices, according to the expected level of proficiency of the user 鈥� it may be necessary to write very different instructions to a general consumer compared to a professional and trained operator. The instructions must also be localised to the individual country in which the machines are sold, as per section 1.7 of the directive: 鈥�All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service. The instructions accompanying the machinery must be either 鈥極riginal instructions鈥� or a 鈥楾ranslation of the original instructions鈥�, in which case the translation must be accompanied by the original instructions.鈥�听

The EU has 24 official languages, so all information and warnings must be available in those 24 languages if the machinery is to be sold throughout the Union. If you are only selling to one or three countries, for example, only that one or those three languages need to be included.听

In most cases, instructions and warnings for any product, including machines, are written in the language of the manufacturer, so if a machine is produced in Germany, the original instructions and warnings are likely to be in German. Rather than composing new instructions for the Finnish, Swedish and French markets, for instance, the original German content is translated into these official languages. Even if a company hedges its bets by having its instructions and warnings written in English, so often the Lingua Franca of our day, this will not be enough to fulfil the requirement of the directive.听听

Who is responsible for implementation?听

The responsibility for ensuring that the instructions and safety warnings are compliant with Directive 42 depends on two circumstances: The default position is that the manufacturer, which means any individual or company who designs and/or manufactures completed or partly completed machinery, as defined above, is responsible for the conformity of this machinery. However, in the absence of a manufacturer as defined above, any individual or company who 鈥溾�� places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer.鈥�听

This may include those cases where importers who aren鈥檛 themselves the manufacturer, but may sell equipment, including equipment that has been assembled from various imported parts, will for the purpose of this regulation be regarded as the manufacturer.听

How to ensure translations are compliant听

An obvious challenge for any company or person who is the responsible party, is not only to have the relevant texts translated into all required EU languages 鈥� potentially all 24 鈥撎齜ut also to ensure that these translations fulfil the formal quality requirements.听听

Instructions and maintenance documentation often consist of complicated technical jargon that an average multi-language speaker might not be familiar with. It鈥檚 crucial here to use the correct terminology, because a mistake could have profoundly negative consequences, and even lead to accidents or personal/property damage.听

Partner with machine experts听

To make the process of ticking the boxes and fulfilling the language requirements of Directive 42 easy for you, we at Sandberg offer you a partnership with the experts. Over the past two decades, we have built up a strong base of internal competency and skills in the field of technical translation, with our linguists tackling everything from rock crushing and timber felling machines to hoisting, garage gates and garden maintenance equipment. You can read more about technical translation generally, and how 22% of manufacturing companies reported lost business due to language barriers, in this blog article.听

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How to appoint an authorised representative

The European Union is in the process of transitioning from the Medical Devices Directive (MDD) to the more onerous Medical Devices Regulation (MDR). The requirements for the documentation that accompanies your product will vary depending on your product鈥檚 classification.

The appointment of an authorised representative within the EU will be necessary in order to sell medical devices to the member states. They have to 鈥�verify that the EU declaration of conformity and technical documentation have been drawn up [鈥” and they need to hold your documentation in readiness for requests from bodies within the member states. They will also act as your point of contact for regulatory, legal or product quality queries.

The first step, therefore, is to find and appoint an authorised representative within a member state. Depending on where your representative is based, this can be dealt with in English, so at this point, you don鈥檛 necessarily have a language barrier to overcome.

How to keep control of your content

Translations must be accurate, up to date and in an official Union language

Although you can deal with your authorised representative in English, once you are ready to take the product to the wholesalers, distributors and consumers, the new MDR regulation states that:

鈥�Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up to date [鈥鈥�, and then goes on to say, 鈥�The EU declaration of conformity shall [鈥 be translated into an official Union language or languages required by the Member State(s) in which the device is made available.鈥�

At this point, you need to decide whether you want to be in control of the translation process, translation partner selection and quality of your content. If you want to relinquish that control, your rep or business partners in the markets will take the task on. One alternative is that you control the localisation of the assets that are key to your brand, whilst they take care of content that has less visibility or more local flavour.

Some translated content may have to be attached to your product before it leaves the UK, whereas other content may be added to the packaging in the target country. But this need not dictate who is in control of producing the translations and making sure they are fit for purpose. How you choose to sell your medical device in the target country also has a bearing on these decisions.

There is much to be said for working with a trusted language services partner who ensures that your content is translated with a process that you have full control over and can audit, review, change and influence according to your evolving business needs.

How to impress distributors of medical devices

You can choose from a number of channels for selling your medical device to European markets: directly from your own website, through online marketplaces like Amazon, or through distributors and wholesalers in the European countries.

Networking with distributors is best done at exhibitions and shows where manufacturers and importers meet to seek out the new and interesting or the tried and tested. Marketing material in the local market鈥檚 language is not only a powerful way to communicate the key points of your product, it鈥檚 also a matter of courtesy and shows commitment from your side. From pop-up banners to brochures and hand-outs, impress your potential partners by bridging the language gap so that they don鈥檛 have to. 

How to engage consumers

Sales exhibitions and shows were of course put on hold during the recent pandemic, and the increased uptake of online shopping has most probably led to a permanent shift in consumer habits, according to a report by consultancy firm McKinsey, . Whether your distributors use online sales channels, or you sell your product directly to consumers, the value of a clear and culturally appropriate description of the product and sales pitch is of utmost importance.

Online marketplaces, such as Amazon, sometimes offer you automated translations on their platforms. The algorithms behind them may produce results out of context; laughter may be the best medicine, but not if you want your product to be taken seriously. A company selling suitcase and storage boxes that they called 鈥榯runks鈥� recently appeared on the Swedish Amazon page with a translation in Swedish for 鈥榰nderpants鈥� 鈥� admittedly a correct translation, but not in that context.

A quality check performed by a human linguist is therefore not a luxury, but essential to ensuring that your product inspires confidence in buyers, retailers or consumers. A transparent quality control process is key in protecting the value of your brand.

How to support users of medical devices

Information needs to be written differently if the user is an ordinary consumer or a health professional

At some point, your product reaches the consumers 鈥� the end users of the medical device you manufacture. The EU regulations are likely to require product information to be displayed in the native language of the user. In addition, the information needs to be written differently if the user is an ordinary consumer or a health professional.

Whether you have a product of a less medical nature in the Class I category, or an implant to go into a patient鈥檚 body in Class III, the instructions must be written well. You may consider presenting everything in one multilingual booklet or package the materials individually for each market, adjusting to the local complexity.

How to select a language services partner

With more than 20 years in business, Sandberg has considerable expertise in medical translation, technical translation and marketing translation. As your language solutions partner, we help you take your product to new markets, or improve your penetration in existing markets with culturally appropriate translations that meet regulatory requirements.

When you work with Sandberg, you maintain control over your content and have a partner on your home soil. We help you create and maintain glossaries (term bases) and translation memories (TMs) that are reused whenever a new translation is needed or an update to an existing translation is necessary. With them, you ensure consistency, quality and speed, as well as compliance with regulatory requirements.

We offer a completely free assessment of your current needs and provisions. Contact us today to have a chat about where to start.

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