This series set out to remind those responsible for manufacturers’ manuals of one thing: the manual is the certification record a regulator reviews first, not material the user never reads.
In medical devices the manual is reviewed directly under FDA 510(k). Industrial machinery treats it as a certification audit item, and in robotics it is where the certification process starts.
The industry changes, but the same fact recurs in a different form. Because the precision of a single line in the manual decides certification, safety, and legal liability, the three industries converge on one conclusion.
This concluding installment of our Manuals Under Regulatory Scrutiny series sets out what is changing in manual compliance over the next decade: stronger multilingual mandates, digital accessibility, and the spread of eIFU across industry boundaries. It also explains the operating principles manufacturers need to meet these changes.
Three Trends of the Next Decade
Over the next decade, the manual environment will see these three trends advance at the same time, raising operational complexity in a structural way.
| Trend | Core regulations & standards | Impact on manual operations |
|---|---|---|
| Stronger multilingual mandates | 27 EU official languages · Canada EN/FR · EU MDR Class IIb (24+ languages) · EU Machinery Regulation | Multilingual capability is no longer a luxury but a condition of market entry |
| Mandatory digital accessibility | EU Accessibility Act, Directive 2019/882 (in force June 2025) · EN 301 549 | Manuals must be delivered in formats accessible to people with visual, hearing, and cognitive disabilities |
| Expanding eIFU | Medical: EU Reg. 2021/2226 · Machinery: EU Reg. 2023/1230 · US FDA | Print and multilingual duties remain, plus new burden of digital version control and simultaneous updates |
Stronger Multilingual Mandates
The 27 EU member states each require their own official language, and Canada makes English–French bilingualism a legal requirement. EU MDR Class IIb medical devices demand IFU consistency across 24-plus languages, and the new EU Machinery Regulation strengthens the multilingual obligation for industrial machinery manuals. Multilingual capability has become a condition of market entry rather than a margin of comfort.
Mandatory Digital Accessibility
The EU Accessibility Act (Directive 2019/882) took effect in June 2025, requiring digital manuals and eIFUs to comply with EN 301 549. Manuals must be delivered in a format accessible to people with visual, hearing, and cognitive disabilities.
Expanding eIFU (Electronic Instructions for Use)
Medical devices, under EU Reg. 2021/2226, and industrial machinery, under EU Machinery Regulation 2023/1230, have begun to allow digital IFUs on a conditional basis. The US FDA continues to widen the scope of permitted eIFUs for prescription medical devices. Print obligations and multilingual requirements remain in place, and a new operational burden is added: version control of the digital manual and simultaneous multilingual updates.
These three trends advance at once and feed on one another. The result is an environment that demands more languages, on a shorter cycle, across more media, at a higher level of consistency.
The Operating Principles a Manufacturer Needs: A Four-Stage System
Responding to regulatory and environmental change is not a matter of improving the unit of manual writing; it is a matter of designing the operating system itself. The whole series arrives at one conclusion: treat the manual as a continuously operated system, not a one-time production task. The four-stage operating system that Hansem Global has built with global manufacturers over 35 years in the multilingual manual business is as follows.
Stage 1. Regulatory Guidelines by Industry and Country
Automotive ISO 26262, medical-device FDA 510(k) and EU MDR, industrial-machinery EU Machinery Regulation, industrial-truck ANSI/ITSDF B56.1, robotics ISO 10218 series — the core regulations for each industry are organized, then reworked into tables and checklists that show exactly how each must be reflected in the manual, country by country and language by language. The key is that these are not raw legal texts but “how to apply it in production” guidance, in a form a practitioner can use immediately. Leading global manufacturers manage these regulatory registers as a dedicated document format running to hundreds of pages.
Stage 2. A Dedicated Regulatory Owner
Within the manual production team, a person is assigned to own the update, distribution, and training of the regulatory guidance. The role collects and reviews the latest regulatory information arriving from legal teams or clients, reworks it into a form fit for practical application, and shares it systematically with the writers. In an environment where regulations change often, this is the single most decisive operational asset.
Stage 3. An Automated Database System
When regulatory guidelines run to hundreds of pages, omissions creep in as writers search and apply them by hand. So the regulatory information is turned into a database: select the product and the language, and the relevant regulatory items output automatically. On top of this automation, Hansem Global runs roughly 60 in-house QA tools that minimize human error in multilingual manual production, designing new tools and retiring old ones to fit each client and document, keeping the review system evolving.
Stage 4. Common-File Operations
Regulatory items that apply across many product lines, such as disposal markings, certification marks, and international symbols, are separated into a dedicated Common file and templatized. This maintains consistency while increasing production speed, and allows flexible response to regulatory change.
Where Does Your Organization Stand? A Four-Point Self-Check
These four stages are not sequential grades. They are four components needed simultaneously for global manual operations. You can audit your current operation against the risk of each one being absent.
| Operating element | Risk if missing | What it gives you |
|---|---|---|
| 1. Regulatory guidelines | Writers interpret raw legal text themselves, leading to omissions and mistranslations. | Reworked as “how to apply it in production,” ready for immediate use |
| 2. Dedicated regulatory owner | Regulatory changes reach the floor late, or only in part | Systematic collection, processing, and distribution of the latest rules |
| 3. Automated DB + QA tools | Hundreds of pages of guidance applied by hand, leading to human error | Pick product and language, the relevant rules output automatically, verified by ~60 tools |
| 4. Common files | Inconsistent certification marks and symbols; slow to reflect changes | Shared items templatized: consistency, speed, and flexibility |
Only when all four are in place does the manual become a continuously operated system rather than a one-time production task. That is the operating principle a manufacturer needs to face the manual environment of the next decade.
Closing the Series: The One-Line Message
The manual is not a friendly guide that only the user reads. It is the certification record a regulator reviews first, and the information asset that underpins the credibility of global operations.
The manual should be designed first as infrastructure, not tidied up last. A single omitted line carries into certification delay, a market-entry hold, and legal liability. And the operating system that treats the manual as infrastructure for certification, service, and law will decide the next decade of global expansion.
We hope this series gives those responsible for manufacturers’ manuals, and the decision-makers above them, a reason to look at the manual again.
Hansem Global is a language-service company that has produced multilingual manuals for global manufacturers for 35 years, since its founding in 1990. It holds 35 years of zero-incident manual production and 20 years of zero-incident multilingual manual delivery, with four international certifications (ISO 9001 · 17100 · 27001 · 18587). Ranked the world’s No. 49 LSP in CSA Research’s 2025 report, Hansem Global serves manufacturers across global markets.
To discuss how to apply the four-stage operating system from this series to your own manuals, contact Hansem Global.