Free self-assessment tool
EU eIFU regulation readiness checklist
Assess your organization's compliance readiness for switching to electronic Instructions for Use under the expanded EU regulation.
1. Product eligibility
Do you have devices intended only for professional use (not for laypersons)?
Have you identified all eligible products in your portfolio for eIFU conversion?
2. Risk assessment & compliance
Have you documented a risk assessment as required by Article 4 of Regulation (EU) 2021/2226?
Does it cover user profiles, emergency access needs, and hardware/software compatibility?
3. eIFU access & website setup
Is there a dedicated, multilingual eIFU website?
Are IFUs available in a tamper-resistant format?
Is the platform GDPR-compliant and protected against unauthorized access?
4. Paper access requirements
Can paper copies be provided within 7 days of request or at delivery when needed?
Is product labeling updated to indicate eIFU availability?
5. Version control & updates
Are historical versions retained and available upon request?
Can users be alerted when critical updates are made?
6. Validation & audit readiness
Has your eIFU system been technically validated (e.g. IQ/OQ documentation)?
Are you prepared for Notified Body review under EU MDR or IVDR?
At Risk
0% completeSeveral key compliance areas require immediate action.
Want to reduce risk and save time in a compliant way? Host your instructions for use on a platform that is pre-configured to support rapid validation.
This checklist is intended as general guidance and does not constitute regulatory or legal advice. Always consult the applicable regulation and your Notified Body.