Most manufacturers treat the product manual as a low-stakes user document. In reality, the manual, the instructions for use (IFU), and the labeling are among the first things a regulator examines — and a single omission or a mismatch between language versions can stall certification, hold up market entry, or trigger a recall. This article maps the standards that govern the manual itself, then the core regulations across the key industries pursuing entry into the North American market.
Why the manual gets treated as an afterthought
Talk to the people who own manual production inside a manufacturing company and a familiar set of assumptions surfaces:
“Users don’t really read it, so it doesn’t need to be perfect.”
“If we include every safety warning, the document balloons — so we keep only the essentials.”
“Minor differences between language versions don’t matter. No one is comparing them side by side.”
The belief that a manual is simply a courtesy for the end user — and therefore not worth much effort if users ignore it — is common not only among documentation staff but among the managers above them. It is not unusual to see a manual shipped with significant information missing, justified by the same line: “users won’t read it anyway.”
That assumption is a liability.
The manual is a direct target of regulatory scrutiny
A product manual is not only a convenience for end users. In most regulated markets, the manual, the IFU, and the labeling are themselves evaluated during certification — the regulator reads them before the product ever reaches a customer.
In the United States, the FDA assesses the IFU’s safety information, usability, and labeling consistency directly as part of a medical device 510(k) review. In the EU, a Notified Body reviews the consistency of the IFU across two dozen or more languages during MDR certification. The EU’s General Product Safety Regulation (GPSR) requires safety information in the official languages of every member state for all consumer products, and non-compliance blocks market placement outright.
A single missing line, a mismatch between the label and the manual, or a discrepancy between language versions can become a certification delay, a market-entry hold, a recall, or a legal dispute. The view that “users don’t read it” misreads what a manual is. It is not a document only the user sees. It is the document the regulator sees first.
This series maps the regulatory landscape that manufacturers expanding into global markets need to understand. Part 1 covers the standards that apply across industries, followed by the core regulations that distinguish the key sectors.
The standards that apply to the manual itself
Two layers govern every regulated manual: a common layer that applies regardless of industry, and an industry-specific layer on top of it.
The international standard for preparing user information is IEC/IEEE 82079-1 (Preparation of information for use), which sets the baseline principles for how a manual is structured, what it must contain, and how it should be expressed.
For safety messaging, North America runs effectively on the ANSI Z535 series — Z535.6 governs safety messages in product manuals, Z535.4 governs product labels, and Z535.1–3 cover colors and symbols. The ISO 3864 series plays the equivalent role in the EU. Across consumer products, the EU GPSR (Reg. 2023/988) has, since December 2024, mandated safety information in the official languages of every member state.
How requirements change by industry
On top of that common layer, each industry adds its own rules for manuals, labeling, and safety messaging. The contrast across key sectors is sharp:
Automotive and automotive electronics. Vehicle and component manuals answer to the EU General Safety Regulation (GSR, Reg. 2019/2144) and the UNECE WP.29 series, while the US side is governed by FMVSS (49 CFR Part 571) and component labeling under 49 CFR Part 567. More recently, functional safety (ISO 26262), cybersecurity (ISO/SAE 21434, UN R155), and software update management (UN R156) have extended into manual and technical-documentation requirements.
Healthcare and medical devices. Here the EU MDR (Reg. 2017/745) and the US FDA’s 21 CFR Part 801 are the two anchors for IFU and labeling, with usability engineering (IEC 62366-1), risk management (ISO 14971), device symbols (ISO 15223-1), and electrical safety (the IEC 60601-1 series) applied alongside them. This is the most documentation-intensive sector, and the one where a US market-entry decision hinges most directly on the IFU.
Robotics and smart logistics. Industrial robots fall under ISO 10218-1/-2, collaborative robots under ISO/TS 15066, and autonomous mobile robots (AMR/AGV) under ISO 3691-4. A defining feature here is the dual structure: a manufacturer’s manual (ISO 10218-1) and a system integrator’s manual (ISO 10218-2) are written separately.
Industrial infrastructure and heavy equipment. For general industrial machinery, the EU Machinery Regulation (Reg. 2023/1230) replaces the prior Directive 2006/42/EC from January 2027 and specifies mandatory manual content in Annex III, with ISO 12100 for safety principles and ISO 20607 as the direct guide to manual authoring. Industrial trucks (forklifts) sit on two North American pillars — ANSI/ITSDF B56.1 and OSHA 29 CFR 1910.178 — with ISO 3691-1 as the international standard; electric forklifts add NFPA 70E (electrical safety) and NFPA 855 (battery energy storage). Earth-moving equipment such as excavators follows the ISO 20474 series and the operator-manual standard ISO 6750-1.
Smartphones and wearables. Under the EU CE framework, the Low Voltage Directive (2014/35/EU), EMC Directive (2014/30/EU), and RoHS (2011/65/EU) apply as a baseline, with IEC/EN 62368-1 for ICT and AV equipment. In the US, FCC Part 15 (radiated emissions), Canada’s ICES, and Korea’s KC certification each carry their own in-manual disclosure obligations.
The bottom line for manufacturers entering the US market
- The manual, IFU, and labeling are evaluated during certification — not after, and not optionally.
- US market access in particular runs through ANSI Z535, FDA 21 CFR Part 801, OSHA 1910.178, FMVSS, and FCC Part 15, depending on the product.
- Inconsistency across language versions is itself a compliance defect, not a cosmetic one.
- Getting the document wrong is not a writing problem after the fact — it is a market-access problem before the fact.
Common questions
Q1. Are product manuals part of regulatory review?
Yes. In a medical device 510(k) review, an MDR conformity assessment, or a GPSR market check, the regulator evaluates the manual, the IFU, and the labeling — not only the product itself.
Q2. Which standards apply to the manual itself, regardless of industry?
Information for use follows IEC/IEEE 82079-1. Safety messaging follows the ANSI Z535 series in North America and the ISO 3864 series in the EU. For consumer products, the EU GPSR (Reg. 2023/988) has required safety information in every member-state language since December 2024.
Q3. Do the language versions of a manual have to match?
Yes. A discrepancy between language versions is treated as a compliance defect in its own right, and it can lead to certification delays, market-entry holds, recalls, or legal disputes.
What comes next in this series
The installments ahead go deep on the sectors where the stakes for North American market entry are highest and the multilingual-documentation challenges are most demanding — medical devices, industrial machinery and heavy equipment, and robotics. The next article covers the regulatory landscape that most affects medical device manufacturers entering the North American market: healthcare and medical device documentation.
A manual is not a courtesy to the user. It is the first document a regulator reads. Treat it accordingly.
Since its founding in 1990, Hansem Global has spent 35 years producing multilingual manuals for global manufacturers. The company holds an operating record of 35 years without a manual-related incident and 20 years without a multilingual-manual incident, and is certified to four international standards — ISO 9001, 17100, 27001, and 18587. Ranked the 49th-largest LSP worldwide in CSA Research’s 2025 listing, Hansem Global has held the undisputed top position in Korea since it first appeared in CSA Research’s rankings more than a decade ago.