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…
12 May 2026
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…
05 May 2026
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…
21 Apr 2026
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…
15 Apr 2026
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…
29 Mar 2026
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…
17 Mar 2026
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…
11 Mar 2026
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…
03 Mar 2026