What you will learn
By the end of this topic, you should be able to define the information supplied with a device, derive content from intended purpose and risk, organise information across physical and digital locations, apply symbols and UDI appropriately, and control labelling through production and change.
Labelling is part of the product—not decoration
Information supplied by the manufacturer includes identification and markings on the device, labels on packaging, instructions for use, quick-reference material, electronic displays, software information and other accompanying documentation. Together these elements help identify, install, use, maintain, transport and dispose of the device safely.
Every instruction, warning, symbol and identifier should have a defined purpose, an authoritative source and a controlled relationship to the released device configuration.
Derive information from controlled product evidence
Purpose
Intended purpose, indications, patient population, users, environments and contraindications.
Risk
Residual risks, precautions, warnings, limitations and necessary training.
Performance
Claims, specifications, accuracy, operating limits and essential performance.
Operation
Preparation, use, cleaning, maintenance, troubleshooting and disposal.
Identity
Manufacturer, device, model, lot, serial number, software and UDI information.
Markets
Jurisdiction-specific language, symbols, representatives and regulatory statements.
Begin with MTL-102 — Intended Purpose, Users and Use Environments and the residual-risk decisions in MTL-114 — Medical-device Risk Management.
Place information where it supports the decision
Users may need information before purchase, before use, during a time-critical task or during maintenance. Decide what must appear directly on the device, primary package, secondary package, instructions, user interface or accessible electronic source.
Do not use the instructions for use to compensate for an avoidably confusing or unsafe design. Information for safety is a risk control whose effectiveness depends on users noticing, understanding and acting on it in the real use environment.
Build a complete and internally consistent content set
- Device and manufacturer identification, model and relevant production identifiers.
- Intended purpose, intended users, patient population and use environment.
- Indications, contraindications, warnings, precautions and residual risks.
- Handling, storage, transport, installation and preparation requirements.
- Operating steps, expected performance, limitations and interpretation of results.
- Cleaning, disinfection, sterilisation, maintenance and service information.
- Accessories, consumables, compatible systems and connection requirements.
- Disposal, serious-incident reporting and market-specific contact information.
Requirements vary by device and jurisdiction. Use an applicability matrix rather than copying a generic label template.
Connect UDI to product identity and traceability
UDI does not replace other traceability controls. The identifiers on product, packaging, records, software and regulatory databases must remain consistent.
Validate comprehension in the intended context
Use plain, specific language, legible typography and a clear information hierarchy. Select standardised symbols only when applicable and explain unfamiliar symbols where required. Translation must preserve technical meaning, warnings and terminology.
Evaluate critical information with representative users under realistic conditions. This may include finding a warning, identifying the correct variant, interpreting a result, following preparation steps or recovering from an error. Apply MTL-110 — Usability and Human Factors to information-dependent risk controls.
Control labelling in production and distribution
Approve masters before use and control artwork, translations, data fields, printers, software templates and electronic content. Prevent mix-ups between products, markets, languages and revisions. Verify variable data and reconcile quantities where necessary.
- Link each approved label to the product and market configuration.
- Restrict access to masters and printing parameters.
- Inspect identity, legibility, adhesion and machine-readable codes.
- Control obsolete stock and define implementation cut-in.
- Record the labelling version supplied with each released lot or device.
- Verify external websites or electronic instructions remain available and correct.
Assess every labelling change as a product change
A wording correction, new symbol, translated instruction, software screenshot or UDI update can affect risk controls, usability, submissions, registrations, stock and users. Review the technical source, markets, regulatory impact, validation need and implementation date.
Follow MTL-129 — Configuration and Change Management so the change reaches every affected product, record and channel without creating mixed configurations.
Common misconceptions
“The instructions can solve a poor design.”
Information can control residual risk, but should not replace practicable inherent-safety or protective design measures.
“A standard symbol needs no evaluation.”
Its applicability, placement, legibility and user understanding still need consideration.
“Labelling changes are only document changes.”
They can alter risk controls, claims, regulatory status, UDI, production and field communication.
Authoritative external references
- ISO 20417:2021 — Information to be supplied by the manufacturer
- ISO 15223-1:2021 — Symbols used with information supplied by the manufacturer
- ISO 15223-1:2021/Amd 1:2025
- FDA — UDI Basics
- Regulation (EU) 2017/745 — Annex I, Chapter III
Use the device-specific standards, current recognised editions and jurisdictional language and labelling rules that apply.
Treat supplied information as one controlled product system
Connect every label, instruction, symbol and identifier to the intended use, risks, evidence and exact released configuration.