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ISO 20417 checklist

ISO 20417 checklist

Standardize your medical device labeling process with this checklist template. It covers required fields—from manufacturer info to clinical evaluation—so you can document details clearly.

Use this template
or download pdf
ISO 20417 checklist

Standardize your medical device labeling process with this checklist template. It covers required fields—from manufacturer info to clinical evaluation—so you can document details clearly.

Use this template
or download pdf

About the ISO 20417 checklist

Accurate medical device labeling is a regulatory requirement. Whether you’re a quality manager in a medical device company or part of a regulatory affairs team, you know that the ISO 20417 checklist plays a key role in standardizing what information needs to go on labels and instructions for use. This template helps you align every product with global documentation standards—without missing details.

Key elements of the ISO 20417 checklist

This ISO 20417 checklist gives you a clear structure for compiling the mandatory information medical device manufacturers must provide. Here are its core components:

  • Device identification and traceability – This section collects core product data, ensuring you can reliably trace every device, especially in field actions or recalls.
  • Labeling content and format – Beyond what’s printed, this covers how labeling content is presented. You track elements like UDI, warnings, and language requirements to stay aligned with both ISO and local regulations.
  • User context – You’ll clarify what the device is for, who it’s for, and under what conditions it should be used. This prevents misuse and supports clearer clinical communication.
  • Performance and safety validation – This focuses on what “working correctly” means for the device. You define essential functions and link them to test data that proves the device performs safely and as expected.
  • Risk and usability controls – Next, you’ll capture known risks, how they’re mitigated, and whether the design supports user-friendly, error-resistant operation. This combines risk management with human factors insights.
  • Post-market and lifecycle oversight – Finally, you’ll track how device performance is monitored after release, including complaints, clinical data, and any product changes that could affect labeling or use instructions.

Best practices to get the most out of your ISO 20417 checklist

ISO 20417 is a detailed map for what information must accompany a medical device. These best practices can help you maximize template in your day-to-day work.

Start building your checklist early in the development process. Don’t wait until labeling is due. Instead, use it as a working document from the beginning to guide documentation decisions across departments. This keeps teams aligned and avoids retroactive edits.

Don’t forget to involve your cross-functional teams. Get input from regulatory, R&D, and quality to avoid overlooking important information. Everyone sees different risks and gaps, so this collaboration saves you rework later.

Tailor the checklist to the complexity of each device. For low-risk products, a lean version might do. For complex or high-risk devices, you can expand sections for deeper documentation needs, especially around performance and risk.

Start using the ISO 20417 checklist to simplify compliance

Bring structure and consistency to your medical device documentation with this template. It’s built to guide you through the standard’s requirements, so you can work more confidently and keep audits stress-free. Assign roles, track progress, and document updates with ease!. You’ll save time while keeping your data organized—whether you’re reviewing with your team as well as presenting to an auditor.

Related categories

  • Operational excellence templates
  • Risk management and compliance templates
  • Health care templates
  • ISO templates
  • Quality assurance templates
Preview of the template
entity_item!!!
Page 1
General Information
Name of Medical Device
Manufacturer Name
Model Number
Serial Number
Date of Manufacture
Labeling Requirements
Device label includes name and address of manufacturer
Device label includes unique device identifier (UDI)
Instructions for use are provided
Warnings and precautions are clearly stated
Intended Use
Intended medical purpose is clearly defined
Intended patient population is specified
Intended user profile is described
Essential Performance
Essential performance characteristics are identified
Acceptable performance criteria are established
Verification and validation activities demonstrate performance meets criteria
Risk Management
Risk analysis has been conducted
Risks have been addressed and mitigated
Residual risks are acceptable
Usability
Usability engineering process has been implemented
User interface design minimizes use errors
Summative usability evaluation has been conducted
Clinical Evaluation
Clinical evidence supports intended use
Post-market clinical follow-up plan is in place
Clinical evaluation report documents findings
Production and Post-Production
Process validation demonstrates consistent manufacture
Changes to device are properly documented
Complaint handling system is implemented

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Related resources

Access a complete set of resources aimed at maximizing safety, quality, and operational excellence, including detailed guides, related templates, and real-world use cases.

Topic guides

Read in-depth guides covering key topics related to this article.

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Template collections

See comprehensive collections of best practice templates related to this topic.

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Frequently asked questions

What types of medical devices does ISO 20417 apply to?

ISO 20417 applies to nearly all medical devices, from surgical tools and implants to diagnostic equipment and even certain software. It’s relevant whether your device is Class I or Class III. The key factor is that it’s regulated as a medical device and needs accompanying information.

Can I use the exact same ISO 20417 checklist for all my products?

Not exactly. While the framework stays consistent, you’ll need to tailor each checklist to the specific device type, risk class, and market. A checklist for a wearable glucose monitor won’t work for a surgical implant. The checklist above can be your base template, then build in product-specific fields and requirements as needed.

What’s the difference between ISO 20417 and ISO 15223-1?

ISO 20417 covers what information must be supplied with a device, while ISO 15223-1 focuses on how to present that information using standardized symbols. If you’re labeling a device, you’ll probably be using both: one to guide your content, and the other to make it clear and consistent on the label.


This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
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