Resources
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Applying Human Factors Engineering (HFE) to in vitro diagnostic (IVD) products under the European IVD Regulation (IVDR)
Yvonne Limpens and Brenda van Geel from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights about the upcoming
Performance Evaluation – When, What and How to Prepare for EU IVDR
This webinar explains the Performance Evaluation concept introduced by IVDR 2017/746 and focuses on the interaction of elements required for
EU IVDR Readiness Assessment Checklist
Is your company ready for the implementation of the European In Vitro Diagnostics Regulation (IVDR)? Under the IVDR, in vitro diagnostic (IVD) device
Countdown to IVDR Date of Application – Key Requirements and Challenges
Preparing for the In Vitro Diagnostic Device Regulation (EU) 2017/746 (IVDR) will require manufacturers to develop new practices, apply new concepts
IVD Medical Devices Clinical Performance Evaluation Studies
In Europe, certain in vitro diagnostic (IVD) devices must undergo clinical performance (CP) evaluation studies conducted in accordance with current
European IVD Regulatory Approval Process
IVD devices (In Vitro Diagnostics) are a subset of medical devices primarily used for to testing human fluids such as blood, tissue or urine in a
Understanding Europe's New IVDR 2017/746
It's finally here. The European Commission's new In Vitro Diagnostic Regulation (IVDR 2017/746) will address several weaknesses of the IVDD and bring
Europe In Vitro Diagnostic Devices Regulation (IVDR) CE Marking Regulatory Process
In order to commercialize in vitro diagnostic (IVD) devices in the European Union , a CE Mark certificate is needed. This certification verifies that
EU IVDR Conformity Assessment Options for In Vitro Diagnostic Medical Devices
Beginning on May 26, 2022, new in vitro diagnostic (IVD) medical devices intended to be marketed in the European Union (EU) must comply with the In