IVDR Archives - CiteMed

IVDR 21 min read

IVDR Performance Evaluation: Requirements, PEP and PER Guide

Executive Summary IVDR performance evaluation is the continuous process of collecting, appraising, and analysing data to demonstrate the scientific validity, analytical performance,…

By CiteMed Author

03 Nov 2026

IVDR 20 min read

IVDR Consulting 2026: Key Developments, Milestones and Compliance Strategy

Executive Summary The In Vitro Diagnostic Medical Devices Regulation (IVDR), Regulation (EU) 2017/746, governs in vitro diagnostic medical devices placed on the…

By CiteMed Author

23 Sep 2026

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