IFU and information provided by the manufacturer: how to align MDR, ISO 20417 and ISO 15223-1?
Medical devices regulation
Medical device manufacturers know that the Instructions for Use (IFU) is just one element in the information package required by the MDR. Between regulatory obligations, normative requirements and risk management, correctly structuring labels, packaging and the IFU becomes a balancing act. ISO 20417 provides a useful framework, but does not replace MDR obligations, which remain a priority.
This article offers a practical cross-reading.
1. Why "information supplied by the manufacturer" is at the heart of MDR compliance
The MDR places this information at the heart of risk management and fitness for use. The GSPR, and in particular sections 23.1 and 23.4, require the manufacturer to provide all the data necessary for safe, intended use.
This information may appear on the device, its packaging or in the IFU, and must be available and updated on the manufacturer's website where available.
In practice, the IFU is also the main medium for communicating residual risks identified via ISO 14971. It is therefore a safety document in its own right, not a simple instruction manual.
2. What exactly does ISO 20417 cover?
The standard defines and structures the "information provided by the manufacturer" (definition 3.10) and distinguishes several categories:
label,
marking,
packaging,
accompanying information (audio, electronic, multimedia, printed, tactile),
other information such as instructions for use and technical description.
The diagram in the standard illustrates this breakdown. It also clarifies what is outside the scope of the standard: commercial documents, delivery notes, customs documents... all content that does not fall within the scope of the device's regulatory compliance.
3. Device identification: required and conditional elements
ISO 20417 requires that at least one distinct product identifier be provided (1:1 device identification).
A series of conditional elements revolve around this identifier:
brand name,
model number
catalog number,
description.
The standard's "required / conditional / optional" scheme provides a clear structure for the identification strategy. This helps to avoid duplication and unnecessary variants within a product range.
4. Date format: ISO 20417 requirements section 5.4
All machine-readable dates must follow ISO 8601-1:
YYYY-MM-DD,
YYYY-MM,
YYYY-MM, YYYY-MM, YYYY.
This requirement applies to labels, packaging, IFUs and, more generally, to any medium where a date appears: date of manufacture, best-before date, shelf life after opening, etc.
This normative choice limits interpretations and avoids errors linked to the diversity of national standards.
5. Essential information on the label, packaging and IFU
ISO 20417 and MDR complement each other:
Label
device identification,
manufacturer identification (name + address),
symbols required by ISO 15223-1,
storage conditions,
sterility, if applicable,
UDI-DI + UDI-PI,
essential warnings compatible with label size and medium.
Packaging
contents of packaging,
opening instructions,
storage and transport conditions,
UDI,
language version if multiple.
IFU
Instructions for use must cover :
destination and intended users,
expected performance,
instructions for installation, use, cleaning and maintenance,
residual risks (GSPR 23.4),
limitations of use, contraindications, precautions, warnings,
reasonably foreseeable interference,
environmental conditions (magnetic field, EMI, humidity, temperature...),
material restrictions (CMR, endocrine disruptors, allergens),
end-of-life and disposal,
updates available on the website (GSPR 23.1).
6. Obligation to cover residual risks: MDR / ISO 20417 articulation
This is a fundamental point.
The MDR, via GSPR 23.4.s, requires that residual risks be made known to the user and patient. This covers :
possible failures,
performance variations,
external influences,
interference with other equipment,
restrictions related to any drugs or biological materials incorporated,
risks associated with materials.
ISO 20417 completes this objective by listing the categories of information to be provided in the leaflet, including limitations, precautions, contraindications and warnings. The convergence is clear: everything that remains after risk control must be communicated.
7. Clarification of terms: limitations, contraindications, precautions, warnings
This distinction is often misunderstood. In practice :
Limitations: limits on use inherent in the device's performance or design (ranges, compatibilities, service life, environmental conditions).
Contraindications: situations in which the device should not be used, as the benefit/risk balance becomes unfavorable.
Precautions: operating measures or behaviors expected to maintain an acceptable level of risk.
Warnings: major risks requiring immediate attention, which could lead to serious harm if ignored.
Clarifying these terms at the outset of a project avoids piling up inconsistent statements in IFUs.
8. MDR vs ISO 20417 harmonization: convergences, differences and priorities
Priority is still given to MDR, but ISO 20417 structures make compliance easier.
Points of convergence :
identification requirement,
need to communicate residual risks,
alignment with UDI,
consistency with ISO 15223-1 symbols.
Differing points :
safety vocabulary (limitations/warnings/precautions vs. warnings/required actions),
completeness of risks for MDR, broader than list 20417,
linguistic approach, detailed in the MDR and absent from the standards.
This double reading is useful for building robust documentation.
9. Mandatory languages: an essential reminder
Member States impose their own languages for labels and IFUs. This obligation applies from the moment they are made available on the market.
ISO 15223-1 symbols can reduce the translation burden, but never dispense with the need to provide critical safety information in the required language.
For further information: the CSDmed article dedicated to MDR/IVDR language requirements.
10. Case studies
Case study A: orthopedic implant
IFU rich in warnings and precautions relating to materials, mechanics and external influences.
Numerous residual risks: mechanical failure, allergic rejection, MRI interference.
Importance of consistency between label, IFU and clinical documentation.
Case study B: medical software (SaMD)
Electronic IFU authorized according to applicable rules.
Residual risks linked to the user interface, input errors, cybersecurity.
Precautions linked to the IT environment, updates and interoperability.
11. Mini-FAQ
When can an IFU be supplied in electronic form?
In cases covered by European eIFU regulations, and if the device is not intended for the patient.
What symbols are required on the label?
ISO 15223-1 symbols relevant to the device: manufacturer, date, UDI, sterility, storage conditions, etc.
Is it necessary to list all residual risks in the IFU?
Yes, when they are relevant to safety or performance (GSPR 23.4).
How do I choose between warning, precaution and limitation?
Depending on the level of risk, potential severity and the user's role in control.
How do I manage IFU updates?
They must be available on the manufacturer's website and kept up to date as stipulated in GSPR 23.1.
Conclusion
Consistent documentation, well aligned between MDR, ISO 20417 and ISO 15223-1, remains one of the pillars of European conformity. Behind the symbols, dates and warnings, transparency to the user and risk management are paramount.
This is an area where expert support is often decisive, particularly when it comes to harmonizing a range of products, rationalizing IFUs and avoiding inconsistencies that slow down regulatory dossiers.
CSDmed brings its expertise and a methodical approach to its customers, start-ups, manufacturers, importers and distributors of medical devices, thanks to a team of experts and specialized consultants, who can handle your R&D dossier, your QMS, and your MDR technical dossier in their entirety.
🔗 Contact us and find out how we can help you.