Using the IMDRF Classification to Apply Rule 11
The MDCG Guidelines recommend the application of the International Medical Device Regulators Forum (IMDRF) risk categorization framework to help with risk classification…
20 Nov 2025
Classifying In Vitro Diagnostic Medical Devices Under The MDR
May 26, 2022, marks the start of the 5-year staggered implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746). Unlike…
20 Nov 2025
Is MDR Compliance Expensive?
The short answer is, yes, it can be. MDR compliance may not have been expensive in the past, but as the regulations…
20 Nov 2025
PMCF for IVDR and MDR – A Case Study and How-To
By now, most of us have struggled through at least one successful submission for MDR/IVDR, and we know they take time. Very…
20 Nov 2025
Market Surveillance of Medical Devices Under the EU MDR
The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed…
20 Nov 2025
Post-Market Surveillance and Vigilance: MDR vs IVDR
The Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR) are two sides of the same regulatory coin…
20 Nov 2025
5 Major Concerns for Software As a Medical Device and AI Companies
Move over, Dr House, there’s a new diagnostician in town, and it’s not human! Thanks to the power of AI, medical devices…
20 Nov 2025
Unpacking State-of-the-art: Why Does It Matter to My Medical Device Clinical Evaluation?
The European Medical Device Regulation (EU MDR, 2017/745) has been called many things since it was first drafted, some of which cannot…
20 Nov 2025