eIFU Compliance Starts with Validation

How IFUcare helps medical device and IVD manufacturers stay compliant

Offering electronic Instructions for Use (eIFUs) is not just about going digital: it’s about regulatory compliance! Once your eIFU goes live, your website becomes part of your medical device, and is therefore subject to the same stringent compliance requirements under the MDR and IVDR.

In our previous blog (Expanded eIFU Eligibility under EU Regulation 2025/1234 – IFUcare), we explored the expanded eligibility for eIFUs under Commission Implementing Regulation (EU) 2025/1234. Now, one critical question remains for many manufacturers:

“How do we validate our eIFU environment in a way that satisfies Notified Bodies?”

This post explains why eIFU validation is essential, what manufacturers are asking, and how IFUcare — QbD Group’s dedicated eIFU solution — provides a secure, validated, and compliant platform tailored for the life sciences industry.

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Why validation matters more than ever

With the new regulation expanding the scope for eIFUs, more manufacturers are looking to offer digital IFUs to save costs, improve accessibility, and streamline logistics.

But there’s a catch: once an eIFU is published, your online platform becomes a regulated extension of your product. To remain compliant, your eIFU platform must:

Ensure that the correct version is always available
Prevent unauthorised changes or data breaches
Log every change through a complete audit trail
Be validated as part of your Quality Management System (QMS)

In short, digital alone is not enough. Your eIFU system must be proven reliable, secure, and fully controlled — just like any other component of your regulated device.

What manufacturers are asking — and how IFUcare answers

At IFUcare, we work closely with medical device and IVD manufacturers who are transitioning to eIFUs. Here are some of the most common questions we receive, and how our platform addresses them.

“How should we validate the website?”

IFUcare is a pre-validated platform, developed in accordance with GAMP 5. We deliver:

A full validation package
Risk assessments
Integration-ready templates

All tailored for direct implementation in your QMS.

“Is it secure enough for our Notified Body?”

Yes. IFUcare is ISO 13485 and ISO 27001 certified, and follows a Software Development Life Cycle (SDLC) approach aligned with IEC 62304. The platform includes robust security measures to safeguard against hardware and software intrusions.

“Do we need to re-validate annually?”

Yes — and we help you stay ahead. Our team provides ongoing validation support and change impact assessments to ensure your environment remains compliant over time.

“Can we use this in an audit?”

Absolutely. IFUcare is designed with audits in mind. We deliver and update the full set of documentation needed to demonstrate compliance, including:

Validation reports
Change control records
Risk assessments
Traceability matrices

This ensures you’re fully prepared to answer any Notified Body questions with confidence.

Why IFUcare makes the difference

Not all platforms are created equal. IFUcare was designed specifically for medical device and IVD manufacturers, with compliance, traceability, and validation at its core. Here’s what sets it apart:

Compliance-by-design
Built to meet MDR/IVDR and Notified Body expectations from the ground up.
Fully validated platform
No need to start from scratch — full validation documentation is included.
24/7 multilingual access
Users can access the correct eIFU in the right language, from anywhere in the world.
Full version control & audit trail
Every change is logged. A complete history is always available.
Seamless integration
Easily connect IFUcare with your existing systems (PLM, DMS, ERP…) for smooth workflows.
Backed by experts
As part of The QbD Group, IFUcare clients benefit from expert support in quality, regulatory affairs, and software validation — from implementation to audit.

Conclusion: eIFU compliance doesn’t end with going digital

Going digital is a great start — but it’s only step one. Without proper validation, documentation, and audit readiness, your eIFU platform may not meet regulatory expectations, exposing you to compliance risks. IFUcare helps medical device and IVD manufacturers:

Stay compliant with MDR/IVDR
Eliminate the need to build and validate their own platform
Confidently pass audits with full documentation and expert support

Need help validating your eIFU system?

Get in touch with IFUcare, part of QbD Group, for a consultation or live demo. We’ll help you streamline your eIFU compliance — without starting from zero.

Contact us today.