PMS and PMCF

PMS and PMCF 5 min read

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

It's not enough to make a device and put it on the market—you must know how people use your product. Therefore, the…

By CiteMed Author

20 Nov 2025

PMS and PMCF 6 min read

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

One of the new aspects introduced in the European Medical Device Regulation 2017/745 (MDR) is post-market clinical follow-up (PMCF). While PMCF is…

By CiteMed Author

20 Nov 2025

PMS and PMCF 9 min read

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

Under the European Medical Device Regulation (EU MDR 2017/745), manufacturers are required to conduct post-market clinical follow-up (PMCF) as part of their…

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

PMS and PMCF 6 min read

Post-Market Surveillance, Market Surveillance, and Vigilance – What is the Difference?

Most regulatory staff can define post-market surveillance relatively succinctly. Perhaps also vigilance. But when it comes to market surveillance, what exactly makes…

By CiteMed Author

20 Nov 2025

EU MDR PMS and PMCF 5 min read

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

In July 2021, Regulation (EU) 2019/1020 on market surveillance and product compliance, issued by the European Parliament and Council, came into force.…

By CiteMed Author

20 Nov 2025

PMS and PMCF 7 min read

PMCF for IVDR and MDR – A Case Study and How-To

By now, most of us have struggled through at least one successful submission for MDR/IVDR, and we know they take time. Very…

By CiteMed Author

20 Nov 2025

EU MDR PMS and PMCF 6 min read

Market Surveillance of Medical Devices Under the EU MDR

The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed…

By CiteMed Author

20 Nov 2025

PMS and PMCF 9 min read

Post Market Surveillance EU MDR – CiteMed

Post-market surveillance (PMS) under the EU MDR (2017/745) is a systematic and proactive process through which medical device manufacturers collect, analyze, and…

By CiteMed Author

20 Nov 2025