In Vitro Diagnostic Devices Regulation (IVDR) and How It Relates to CE markings
CE marking indicates compliance with an EU directive so that you can market your products in the EU. It's that simple. CE…
20 Nov 2025
In Vitro Diagnostic Regulation (IVDR) Device Risk Management Challenges
All medical devices have their merit since all of them are used in the medical field. However, the In vitro diagnostic tools…
20 Nov 2025
Performance Plan Evaluation Under the EU IVDR 2017/746
Most of us are familiar with clinical evaluations for medical devices. Easy peasy. But when it comes to the equivalent for in vitro…
20 Nov 2025
EU In Vitro Diagnostic Regulation (IVDR): Frequently Asked Questions
The regulatory landscape in Europe is changing. In 2021, the new medical device regulation was implemented; in 2022, it was time for…
20 Nov 2025
IVDR: State-of-the-Art for In Vitro Diagnostic Medical Devices
With the updates to the European Medical Device and In Vitro Diagnostic Device Regulations (MDR 2017/745 and IVDR 2017/746, respectively), the requirements…
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
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
How Literature Review Automation Improves Performance Evaluation Reports (PER) Program Management for the IVDR
A literature review is a formal collection of scientific studies published in peer-reviewed journals or conference proceedings that are relevant to the…
20 Nov 2025