EU MDR Articles & Clinical Evaluation Resources

IVDR 21 min read

IVDR Performance Evaluation: Requirements, PEP and PER Guide

Executive Summary IVDR performance evaluation is the continuous process of collecting, appraising, and analysing data to demonstrate the scientific validity, analytical performance,…

By Dr Alyssa Charles, MBChB

03 Nov 2026

Post-market surveillance and PMCF under EU MDR

EU MDR 21 min read

Post-Market Surveillance and PMCF: A Complete Guide for EU MDR

Executive Summary Under EU MDR 2017/745, post-market surveillance and Post-Market Clinical Follow-Up are not supplementary activities. They are core lifecycle obligations that…

By Dr Alyssa Charles, MBChB

15 Oct 2026

Miscellaneous 19 min read

Post-Market Surveillance Plan: What to Include Under EU MDR

Executive Summary The Post-Market Surveillance Plan (PMSP) is the document that defines how a medical device manufacturer collects, analyses, and acts on…

By Dr Alyssa Charles, MBChB

15 Oct 2026

Literature Review 19 min read

CiteMed Evidence Cloud 6.0.8: Software for Literature Review Updates and New Features

Executive Summary CiteMed Evidence Cloud 6.0.8 is the latest release of CiteMed's systematic literature review software platform, designed for regulatory affairs, quality…

By Alicia Baron

14 Oct 2026

PMS and PMCF 22 min read

What Is a PMCF Plan? Post-Market Surveillance Software, Requirements and EU MDR Structure

Executive Summary Post-Market Clinical Follow-Up (PMCF) is the structured process through which medical device manufacturers proactively collect clinical data on their device…

By Dr Alyssa Charles, MBChB

13 Oct 2026

EU MDR 18 min read

Go Live Fast: How CiteMed Gets Teams Up and Running in Three Weeks

Executive Summary Signing the contract is exciting. Then comes the question every regulatory team asks: what happens next?For teams managing active EU…

By Priscilla Murphy

13 Oct 2026

PMS and PMCF 21 min read

Post-Market Surveillance for High-Risk Devices: Class IIb and Class III Requirements Under EU MDR

Executive Summary Under EU MDR 2017/745, post-market surveillance is an active, continuous obligation for all medical device manufacturers. For Class IIb and…

By Dr Alyssa Charles, MBChB

07 Oct 2026

EU MDR 21 min read

CER Template Guide: What a Clinical Evaluation Report Contains

Executive Summary A Clinical Evaluation Report (CER) brings together the clinical evidence used to support the safety, clinical performance, and clinical benefits…

By Dr Alyssa Charles, MBChB

07 Oct 2026

CER Writing 19 min read

CER Writers: Clinical Evaluation Report Cost Guide 2026

Executive Summary Several factors affect the overall cost of preparing a Clinical Evaluation Report (CER), including the type of medical device, the…

By Dr Alyssa Charles, MBChB

04 Oct 2026

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