Blog

EU MDR 12 min read

CER Rejection: Common Reasons Clinical Evaluation Reports Fail EU MDR Review

Why Clinical Evaluation Reports Are Rejected Under EU MDR - and How to Avoid It Introduction Clinical Evaluation Reports (CERs) play a…

By CiteMed Author

12 May 2026

CER Writing 15 min read

CER Writing: Common Literature Review Challenges Affecting Clinical Evaluation Reports

CER Writing and Literature Review: Common Challenges Affecting Clinical Evaluation Reports Under EU MDR Literature review forms a central component in clinical…

By CiteMed Author

05 May 2026

EU MDR 10 min read

EU MDR Clinical Evaluation Consultant Selection Guide

EU MDR Consultant Selection: What Matters Most   Selecting the right EU MDR consultant is often more challenging than expected. Many manufacturers…

By CiteMed Author

21 Apr 2026

EU MDR 11 min read

FDA’s RWE Guidance Updates: What Manufacturers Need to Know

Introduction In early 2026, the U.S. Food and Drug Administration (FDA) signaled a meaningful shift in how real-world evidence (RWE) can be…

By CiteMed Author

15 Apr 2026

EU MDR Systematic Review 15 min read

Living Systematic Reviews for Medical Devices: Enabling Continuous Clinical Evaluation Under EU MDR

  Introduction: The Continuous Problem   Under the European Medical Device Regulation (EU MDR 2017/745), clinical evaluation is defined as a continuous process (Article…

By CiteMed Author

29 Mar 2026

EU MDR 11 min read

Navigating Appraisal and Weighting Under MDR 2017/745

  A Comprehensive Guide for Medical Device Evidence Assessment   Introduction   Appraisal and weighting of clinical data are among the most…

By CiteMed Author

17 Mar 2026

EU MDR 13 min read

CER Writing Strategy Guide: How to Write a Compliant EU MDR CER

How to Write a Compliant Clinical Evaluation Report Under EU MDR 2017/745 Introduction The Clinical Evaluation Report (CER) is the central regulatory…

By CiteMed Author

11 Mar 2026

EU MDR 7 min read

In-House vs Outsourced CER Writing Under EU MDR: Strategic Considerations for Medical Device Manufacturers

Introduction Under the European Union Medical Device Regulation (EU MDR), the Clinical Evaluation Report (CER) has become one of the most scrutinised…

By CiteMed Author

03 Mar 2026