EU MDR

EU MDR 5 min read

What Is a Legacy Device, and What Do Manufacturers Need to Know About It?

The MDR is a sweeping reform of medical device regulation in Europe that aims to strengthen safety and quality. Recently, the provisions…

By CiteMed Author

20 Nov 2025

EU MDR 11 min read

EU IVDR Regulation: A Brief

IVDR is a separate regulation compared to the European medical devices regulation. However, it is closely associated with the regulatory authority. The…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

The Top 5 Regulatory Requirements for the Medical Device Industry

Being in the regulatory industry is not as cut and dry as most people think. Sure, you do have to read a…

By CiteMed Author

20 Nov 2025

EU MDR 18 min read

Navigating Global Medical Device Regulations

Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device regulations is as diverse as it is complex.…

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

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 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 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