IVDR Compliance

IVDR Requirements: What You Need To Become Compliant

The Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR) sets the framework and requirements for - obviously - diagnostic medical devices....

IVDR Compliance Sebastian Skorka Updated 7 months ago

Nov 12, 2025

How Do We Ensure the Post-Market Surveillance Under the IVDR?

Question: We are a manufacturer of in-vitro diagnostic medical device software. How do we ensure the post-market surveillance under the IVDR? Short answer:...

IVDR Compliance Sebastian Skorka Updated 7 months ago

Nov 13, 2025

Clinical Evidence for In-Vitro Diagnostic Medical Devices

Clinical evidence - What is this? Clinical evidence for in-vitro diagnostic devices (IVDs) is gathered through performance evaluations, assessing scientific...

IVDR Compliance Sebastian Skorka Updated 7 months ago

Dec 09, 2025

IVDR Classification: Classification Of In-Vitro Diagnostic Devices

In this article, we'll walk you through the basic IVDR classification concepts for software as an IVD and look at some examples. The Regulation (EU) 2017/746...

IVDR Compliance Sebastian Skorka Updated over 1 year ago

Oct 01, 2024