Shifting expectations around sustainability, advances in digital delivery, and updated regulatory guidance are changing not only how IFUs are provided, but how they need to be designed, governed and operationalized across the medical device lifecycle. For manufacturers, the implications reach well beyond documentation teams.
Instructions for Use (IFUs) have long been treated as a necessary output of medical device development: carefully controlled, heavily regulated, but often considered separate from the device itself. That view is becoming increasingly outdated.
From paper inserts to system-level considerations
Traditional paper IFUs carry an inherent operational and environmental burden. Every update, whether driven by regulatory change, usability feedback or post-market surveillance, can trigger knock-on effects across packaging, inventory and validation activities.
The growing interest in electronic IFUs (eIFUs) reflects a broader desire to decouple instructions from physical product where appropriate. Done well, this can support faster updates, reduce waste and enable more flexible supply chains. However, medical devices are not consumer products. IFUs remain a regulated risk control measure, not an optional onboarding aid.
That distinction matters. Decisions about whether IFUs are delivered electronically or in paper form must account for who is using the device, under what conditions, and with what level of training. What may be appropriate for a professional-use device in a controlled clinical environment may not be suitable for patient or lay users, where accessibility, equity and correct use remain critical.
IFU decisions don’t stop at design
Even small IFU-related changes can have disproportionate downstream effects. Removing a multi-page paper IFU from sterile packaging, for example, can alter pack density, palletization or transport performance, which can trigger requalification or revalidation.
As device manufacturers place greater emphasis on intuitive design and Human Factors engineering, there is a natural desire to reduce reliance on lengthy instructions altogether. In principle, making devices easier to use should simplify IFUs.
In practice, those design decisions need to be carried all the way through into manufacturing systems.
Even small IFU-related changes can have disproportionate downstream effects. Label space constraints, additional symbols or pictograms, access indicators or jurisdiction-specific requirements can force label redesigns, introduce new packaging configurations, and increase validation or change control burden. Removing a multi-page paper IFU from sterile packaging, for example, can alter pack density, palletization or transport performance, which in some cases can trigger requalification activities that affect production schedules.
This is why IFUs cannot be treated as a late-stage documentation task. They are tightly coupled to how products are manufactured, labeled, distributed and released.
eIFUs: regulatory permission is only the starting point
Regulatory frameworks governing labeling have evolved to reflect advances in technology and use environments. The FDA permits electronic delivery for specific prescription and professional-use devices as part of 21 CFR Part 801². In the EU, Commission Implementing Regulation (EU) 2025/1234¹ allows electronic IFUs for certain professional-use devices, subject to risk assessment and defined safeguards.
What these frameworks provide is permission, not simplification.
Electronic IFUs introduce new compliance challenges that must be actively managed. These include robust digital version control aligned with physical manufacturing releases, validated linkage between device configurations and IFU access, jurisdiction-specific availability controls, and ongoing post-market maintenance. Access reliability, version mismatches and foreseeable misuse become part of the risk analysis.
Without robust infrastructure and processes in place to manage these risks, the perceived benefits of eIFUs can quickly be eroded by operational complexity.
Where manufacturers often get caught out
A recurring issue across the industry is treating IFUs as standalone documentation rather than as an integral part of the device system.
This typically shows up as:
- IFUs being finalized after key design and process decisions are already locked
- Limited consideration of real-world clinical workflows during usability validation
- Underestimating the manufacturing impact of seemingly minor IFU changes
- For electronic delivery, it can also include insufficient planning for post-market updates and lifecycle management
The result is often late-stage rework, increased validation burden, or avoidable regulatory friction.
Integrating IFUs into compliant production systems
IFUs increasingly shape how devices are packaged, validated, distributed and used in the real world.
By integrating IFU strategy early alongside device design, Human Factors engineering and manufacturing planning, medical device companies can manage complexity more proactively. The goal is not simply reduced operational and environmental burden, but IFU solutions that support safe use while remaining operationally robust and compliant across the full device lifecycle.
Are you looking to evolve your IFU strategy but want guidance on the design and manufacturing implications?
Get in touch to see how our integrated design, Human Factors, engineering and manufacturing experts can help.
References:
[1] European Commission. Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic form.
Official Journal of the European Union (EUR‑Lex): Implementing regulation – EU – 2025/1234 – EN – EUR-Lex
[2] United States – FDA labelling regulation (binding requirement)
U.S. Food and Drug Administration. Title 21, Code of Federal Regulations (CFR), Part 801 – Labeling. Electronic Code of Federal Regulations (eCFR): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801
