Blog

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

23 articles

Topics:

Compliance

EU MDR

IVDR

Implementation

Security

Sustainability

Technical

Featured

Jan 20, 20256 min read

eIFU Compliance Starts with Validation

Learn why system validation is the foundation of eIFU compliance and how to ensure your electronic Instructions for Use platform meets regulatory requirements under EU MDR and IVDR.

Feb 2, 20265 min read

Summary of Commission Implementing Regulation (EU) 2025/1234

Learn how Commission Implementing Regulation (EU) 2025/1234 broadens electronic Instructions for Use (eIFUs) for professional medical devices, the compliance steps required, and how IFUcare can help.

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.

Article: The Future of Post-Market Surveillance in IVD and MD Industry: Leveraging eIFU

Blog

May 29, 20245 min read

The Future of Post-Market Surveillance in IVD and MD Industry: Leveraging eIFU

Post-market surveillance has become more critical than ever. Learn how eIFU can revolutionize PMS in the IVD and MD industry.

Article: New IVDR/MDR Overview of Language Requirements for Manufacturers of Medical Devices

Blog

Feb 28, 20244 min read

New IVDR/MDR Overview of Language Requirements for Manufacturers of Medical Devices

The European Commission published an overview of language requirements for medical device manufacturers. Learn what this means for eIFU.

Article: eIFU Versus Paper-Based IFU: What Are the Benefits of Going Digital?

Blog

Feb 23, 20245 min read

eIFU Versus Paper-Based IFU: What Are the Benefits of Going Digital?

Why do more and more manufacturers choose to move to eIFU? Learn about the range of benefits of replacing paper-based manuals with electronic instructions.

Article: What Do Notified Bodies Expect of Your eIFU Solution and Its Implementation?

Blog

Feb 7, 20248 min read

What Do Notified Bodies Expect of Your eIFU Solution and Its Implementation?

Implementing an eIFU solution has major implications on your QMS. Learn what Notified Bodies will review during the process.

Article: The Power of eIFU in a Product Recall Process

Blog

Oct 30, 20235 min read

The Power of eIFU in a Product Recall Process

Product recalls are a fact of life for Medical Device manufacturers. Learn how eIFU is helping to ease the pain and make recalls more efficient.

Article: Privacy and Compliance in the Medical Industry: How Firms Can Walk the Tightrope

Blog

Oct 30, 20236 min read

Privacy and Compliance in the Medical Industry: How Firms Can Walk the Tightrope

Recent changes in eIFU regulations have changed the way medical device firms operate. Learn how to balance privacy and compliance using eIFU innovations.

Article: The 6 Crucial Advantages of Software as a Service for eIFU

Blog

Oct 30, 20236 min read

The 6 Crucial Advantages of Software as a Service for eIFU

SaaS has taken software development by storm. Learn about the six key advantages of delivering eIFU as Software as a Service.

Blog

eIFU Compliance Starts with Validation

Summary of Commission Implementing Regulation (EU) 2025/1234

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

The Future of Post-Market Surveillance in IVD and MD Industry: Leveraging eIFU

New IVDR/MDR Overview of Language Requirements for Manufacturers of Medical Devices

eIFU Versus Paper-Based IFU: What Are the Benefits of Going Digital?

What Do Notified Bodies Expect of Your eIFU Solution and Its Implementation?

The Power of eIFU in a Product Recall Process

Privacy and Compliance in the Medical Industry: How Firms Can Walk the Tightrope

The 6 Crucial Advantages of Software as a Service for eIFU

We value your privacy