PMS and PMCF Archives

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 CiteMed Author

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 CiteMed Author

07 Oct 2026

PMS and PMCF 18 min read

CiteMed Evidence Cloud V6.0.6: Post Market Surveillance Software Release That Closes the Loop

Summary Altus, released in May 2026, made every stage of CiteMed Evidence Cloud faster. AI screening got a visible reasoning trail, PDF…

By CiteMed Author

18 Aug 2026

PMS and PMCF 9 min read

The Post-Market Surveillance Document: Which Ones Do you Need?

Under EU MDR, PMS documentation comes down to four core documents: a PMS plan for every device (Article 84), a PMCF plan…

By CiteMed Author

20 Nov 2025

Post-market Clinical Follow-up (PMCF) What you Need and How to Get It

PMS and PMCF 9 min read

PMCF Plan EU MDR: What You Need and How to Create It

Post-market clinical follow-up, or PMCF, is the proactive, ongoing collection of clinical data on a device after it reaches the EU market, used…

By CiteMed Author

20 Nov 2025

Post Market Clinical Follow-Up (PMCF) – Understanding MDCG’s Latest Guidance

PMS and PMCF 11 min read

Post Market Clinical Follow Up Medical Devices: Requirements and Key Methods Under EU MDR

The core PMCF templates, MDCG 2020-7 for the plan and MDCG 2020-8 for the evaluation report, are still current as of this…

By CiteMed Author

20 Nov 2025

PMS and PMCF 7 min read

Building Your PMS Templates

This document intends to cover a comprehensive framework for each of your products. Use it as a guide to direct your staff…

By CiteMed Author

20 Nov 2025

Post-Market Surveillance, Market Surveillance, and Vigilance

PMS and PMCF 9 min read

PMS vs Vigilance: What Is the Difference?

Post-market surveillance (PMS) is the manufacturer's proactive, always-running system for collecting and reviewing data on its devices once they are on the…

By CiteMed Author

20 Nov 2025

EU MDR PMS and PMCF 8 min read

Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices

For medical devices specifically, the 2022 Blue Guide doesn't add much that MDR and IVDR don't already cover in more detail. It updated the market surveillance…

By CiteMed Author

20 Nov 2025

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