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EU MDR 7 min read

EU MDR: Combination Products – An Overview

We all know and love (ahem) the EU MDR (2017/745). And although it is defined as the EU Medical Device Regulation, it…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

Understanding Global Regulatory Authorities in the Medical Device Industry

You know what is common in all countries? No matter the geographical position, the culture, the people or religion? No one wants…

By CiteMed Author

20 Nov 2025

PMS and PMCF 7 min read

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…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

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…

By CiteMed Author

20 Nov 2025

EU MDR 7 min read

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…

By CiteMed Author

20 Nov 2025

EU MDR 5 min read

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…

By CiteMed Author

20 Nov 2025

CER Writing 8 min read

Managing Clinical Evaluation Report (CER) and Literature Review Teams

Being a medical device manufacturer involves more than the actual manufacturing of the medical devices. A manufacturer's job is not only to…

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