IVDR

IVDR 6 min read

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…

By CiteMed Author

20 Nov 2025

IVDR 7 min read

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…

By CiteMed Author

20 Nov 2025

IVDR 5 min read

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…

By CiteMed Author

20 Nov 2025

IVDR 9 min read

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…

By CiteMed Author

20 Nov 2025

IVDR 6 min read

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…

By CiteMed Author

20 Nov 2025

IVDR 6 min read

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…

By CiteMed Author

20 Nov 2025

IVDR 6 min read

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…

By CiteMed Author

20 Nov 2025

EU MDR IVDR 6 min read

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…

By CiteMed Author

20 Nov 2025