European Union MDR - Complete Guide | Cite Medical Solutions

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 CiteMed Author

15 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 CiteMed Author

13 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 CiteMed Author

07 Oct 2026

EU MDR 19 min read

How Often Should a CER Be Updated Under EU MDR? A Practical Guide

Executive Summary Guidance on how often to update a Clinical Evaluation Report (CER) can vary, with manufacturers encountering recommendations for annual, two-year,…

By CiteMed Author

29 Sep 2026

EU MDR 13 min read

ISO 14971 and EU MDR: Integrating Risk Management with Clinical Evaluation

Summary Most manufacturers have a risk management file. Far fewer have a risk management process that stays current, connects meaningfully to clinical…

By CiteMed Author

11 Sep 2026

EU MDR 16 min read

PSUR vs PMSR: Understanding Post-Market Surveillance Reporting Under EU MDR

Summary Under EU MDR 2017/745, post-market surveillance is no longer a passive requirement. It is an active, continuous process of collecting, analysing,…

By CiteMed Author

01 Sep 2026

EU MDR Literature Review 11 min read

PRISMA and EU MDR Literature Review: A Guide to Structured Evidence Methodology

How PRISMA Principles Support Transparent and Defensible Medical Device Literature Reviews Literature reviews play an increasingly important role in demonstrating the safety…

By CiteMed Author

15 Jul 2026

EU MDR Literature Review 22 min read

How to Conduct an EU MDR Literature Review: A Step-by-Step Guide to Submission-Ready Evidence

An EU MDR literature review is the systematic, documented search and appraisal of published clinical data that supports a device's clinical evaluation.…

By CiteMed Author

03 Jul 2026

EU MDR 10 min read

Why Mendeley and Citation Managers Are Not Enough for EU MDR Literature Review

Mendeley and Reference Management Software: Why They Fall Short for EU MDR Clinical Evaluation Introduction The use of reference management software and…

By CiteMed Author

03 Jun 2026

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