Since July 2025 Regulation (EU) 2025/1234 has made it possible to provide instructions for use for all medical devices intended for professional use in electronic form. The advantages are clear: printing, storage, and logistics costs disappear. Instructions for use are always up to date and available worldwide in all languages via QR code.
The requirements, however, are more specific than many initially expect. Those who underestimate them end up creating more work than they save. Here is where tracekey comes in. We enable you to seamlessly and compliantly link your eIFUs to your EUDAMED entries. You retain control over your data at all times and reduce complexity.
An eIFU is more than just a document on a website. Anyone wishing to comply with the requirements of the regulation must meet the following criteria:
Link to EUDAMED
The eIFU must be linked to the correct Basic UDI-DI or UDI-DI in EUDAMED. These links must remain up to date, even if product data changes.
Version Control & Audit Trail
Every change made to a document must be fully documented. Withdrawn versions must be archived and remain available upon request.
Multilingual
eIFUs must be available in the official languages of all markets where the product is sold.
Availability Guarantee
Access to the solution must be available at all times. The manufacturer is responsible for any technical failures.
GDPR-compliant hosting
Data must be processed in European data centers.
Product Restrictions
The use of eIFUs is limited to medical devices used by healthcare professionals.
We don’t treat eIFU as a separate tool, but rather as an integral part of UDI management.
In practice, this means that our eIFU tool uses existing EUDAMED data to determine which documents are required for which product. Links are not created through manual assignment, but by comparing the data you have already entered in our UDI Manager.
The result for you is not an additional system, but one less process.
Everything in one place — for all product types, documents, and languages, with automatic versioning and audit trail.
Hosting included on EU infrastructure, with a service level agreement. Upon request, it can be hosted on a separate, CI-compliant manufacturer website.
It’s not an IT project, because the solution runs in a browser without installation or the need for your own server infrastructure.
Are you currently exploring how to implement eIFU in your organization? We’ll show you exactly how it works with your EUDAMED data.
An electronic instruction for use (eIFU) replaces the printed leaflet included in the product packaging. Users can access the latest version via QR code or web link. The legal basis in the EU is Implementing Regulation (EU) 2021/2226, as last amended by (EU) 2025/1234.
Effective July 2025, this applies to all medical devices and their accessories that are intended exclusively for use by healthcare professionals. Products that are reasonably expected to be used by the general public will still require a paper version.
Regulation (EU) 2025/1234 applies to MDR devices. For IVDs, the separate Regulation (EU) 2017/746 (IVDR), Annex I, Chapter III, 20.1.f, applies.
No. eIFU is voluntary. However, anyone planning to make the switch should factor in the lead time required for EUDAMED linkage, risk analysis, and validation documentation.
You can provide the user manual, declaration of conformity, reuse instructions, disposal instructions, and safety instructions as an eIFU.