Resources

All regulatory process charts are available to download in Regulatory Affairs Management Suite (RAMS). Get your first chart for free when you create a RAMS account.

LOG INTO RAMS

Understanding the EU IVDR white paper by Emergo by UL
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
Read More
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
Read More
Understanding the EU IVDR white paper by Emergo by UL
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
Read More
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
Read More
EU IVDR readiness checklist from Emergo by UL
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
Read More
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
Read More
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
Read More
The Role of Eudamed under the MDR and IVDR
The European Database for Medical Devices, or Eudamed, is a major part of Europe's new medical device and IVD regulations. Eudamed is a database that
Read More