Blog

Expert insights on eIFU compliance, regulatory updates, and digital transformation in the medical device industry.

7 articles

Topics:

Compliance

EU MDR

EUDAMED

IVD

IVDR

Medical Devices

Sustainability

UDI

Usability

Featured

Jul 22, 20266 min read

Your eIFU Link and EUDAMED: What the 28 November 2026 Deadline Means for Your Device Registrations

With EUDAMED registration deadlines approaching, manufacturers must ensure their eIFU links are stable, accurate, and aligned with UDI device registration requirements.

Jul 17, 20266 min read

Human Factors and Usability: The Part of eIFU Compliance Teams Still Underestimate

Discover why usability engineering and human factors are now essential to eIFU compliance, and how IEC 62366-1 supports safer digital instructions for use.

Article: Beyond the QR Code: Where Digital Labeling Is Actually Heading

Blog

Jul 17, 20267 min read

Beyond the QR Code: Where Digital Labeling Is Actually Heading

Discover how eIFU is evolving beyond QR codes through UDI, EUDAMED, GS1 Digital Link, NFC, and connected digital labeling ecosystems.

Article: Why Early-Stage MedTech Companies Should Decide on eIFU Before Their First Submission

Blog

Jul 17, 20266 min read

Why Early-Stage MedTech Companies Should Decide on eIFU Before Their First Submission

Discover why early-stage MedTech companies should make eIFU part of their regulatory strategy before their first submission to avoid costly redesigns and delays.

Article: IFU packaging best practices: the environmental case for eIFU

Blog

Jul 17, 20266 min read

IFU packaging best practices: the environmental case for eIFU

Discover how eIFU helps MedTech and IVD manufacturers reduce packaging waste, support PPWR compliance, and strengthen sustainability credentials.

Article: Where eIFU Is Heading for IVDs: What Manufacturers Should Watch Next

Blog

Jul 17, 20266 min read

Where eIFU Is Heading for IVDs: What Manufacturers Should Watch Next

Discover the current eIFU rules for IVDs, the near-patient testing exception, and the regulatory developments manufacturers should monitor next.

Article: MedTech Europe Pushes for Wider Adoption of eIFU – Now Across Both Lay-Use Devices and Near-Patient Tests

Blog

Oct 15, 20258 min read

MedTech Europe Pushes for Wider Adoption of eIFU – Now Across Both Lay-Use Devices and Near-Patient Tests

MedTech Europe has taken another significant step in its push for digital healthcare, publishing new guidance on eIFU for near-patient tests following its position paper on lay-use devices.