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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 PMS and PMCF 5 min read

Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices

In July 2021, Regulation (EU) 2019/1020 on market surveillance and product compliance, issued by the European Parliament and Council, came into force.…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

Clinical Evaluation Assessment Report Rubric: What Does It Mean For Your MDR Submissions?

MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR)…

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

Literature Review 6 min read

Fundamentals of a Literature Review: A Beginner’s Guide

The medical device industry is fueled by innovation. Research and development are the blood that keeps it going. Each day, we advance…

By CiteMed Author

20 Nov 2025

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