EU MDR

EU MDR 9 min read

Software as a Medical Device (SaMD): EU MDR and FDA Regulatory Overview

Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical devices, tele-health, and digital health solutions. Most modern…

By CiteMed Author

20 Nov 2025

EU MDR 5 min read

Unexpected Documents You Might Need for Your Clinical Evaluation Report

Medical device regulation is important. Not just because we work with them. But because they control and regulate devices that diagnose, treat,…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

Your MDR Readiness Checklist

The new EU MDR Regulations Everything you needed to know in 2020 The final period for compliance with EU medical device regulation…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

MEDDEV 2.7.1 Revision 4: Guidelines for Clinical Evaluation

In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof of and document the performance and safety of…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

Annual Safety Report: Clinical Trial Reporting Requirements in EU Countries – CiteMed

Introduction Clinical trials are a fundamental component of medical product development, providing a controlled environment to evaluate the safety and performance of…

By CiteMed Author

20 Nov 2025

EU MDR 4 min read

Publishing Clinical Trials Results in Journals

Clinical trials are a crucial piece of launching a medical device. Publishing the data you have gathered regarding the safety and effectiveness…

By CiteMed Author

20 Nov 2025

EU MDR 7 min read

Analyzing the Differences between CERs for MDR versus MDD

Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent post-market compliance requirements.…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

CER Medical Writer Qualifications for EU MDR: 7 Essential Skills

Medical writers make up much of the medical device regulatory industry. In fact, they are one of the largest contributors behind the…

By CiteMed Author

20 Nov 2025