EU PMS (Post-Market Surveillance) is the systematic, proactive and continuous monitoring system that manufacturers must establish under the EU Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746). It is used to track the safety and performance of medical devices throughout their time on the market, identify unknown risks and ensure that risk control measures remain effective.
MDR Articles 83–86 set out the PMS requirements in detail: all medical device manufacturers (both inside and outside the EU) must establish and maintain an effective PMS system. It is the systematic process a manufacturer establishes to collect and evaluate data on the safety and performance of a medical device throughout its life cycle.
When establishing a complete PMS (post-market surveillance) system and maintaining the related documentation, manufacturers of MDR Class I devices and IVDR Class A and B devices must actively and systematically collect, record and analyse quality, performance and safety data across the device’s entire life cycle. This is a core activity.
EVERBIZ Certification Services has found that many companies need a reference template for PMS data collection when collecting and recording data. In practice, data collection has two main aspects: proactive collection and reactive collection:
Proactive data collection
Notes: (1) SOTA is short for State of the Art (the current/latest level of technology)
(2) Scientific literature and professional database websites:
EUDAMED – European Database on Medical Devices
https://ec.europa.eu/tools/eudamed/eudamed#/screen/home
MDCG 2025-10 (PMS guidance), which guides data collection methods and processes
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed- documents-and-other-guidance_en
PubMed/MEDLINE – US National Library of Medicine database
https://pubmed.ncbi.nlm.nih.gov/
Embase – core European biomedical database
https://www.elsevier.com/en-in/products/embase
Europe PMC – biomedical literature repository
https://europepmc.org/2
Cochrane Library – authoritative medical evidence database
https://www.cochranelibrary.com/
ClinicalTrials.gov – US clinical trial registry (run by the US National Library of Medicine)
https://clinicaltrials.gov/
EU Clinical Trials Register – EU clinical trial registry
https://www.clinicaltrialsregister.eu/
IEEE Xplore – for searching literature on medical device technical specifications, performance parameters and software, supporting SOTA technology comparisons
https://ieeexplore.ieee.org/Xplore/home.jsp
EUDAMED vigilance module
https://webgate.ec.europa.eu/eudamed/
MAUDE (US FDA database)
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- assistance/manufacturer-and-user-facility-device-experience-maude-database
IMDRF (International Medical Device Regulators Forum) – provides global PMS best-practice guidance, including SOTA assessment methods and data collection standards
https://www.imdrf.org/
IQWiG (Institute for Quality and Efficiency in Health Care, Germany) – provides medical device health technology assessment reports covering long-term safety and performance data, useful for PMS trend analysis
https://www.iqwig.de/
Reactive data collection
The reference template generated from proactive and reactive data collection is as follows:
(EU) 2017/745 (ANNEX XIV CLINICAL EVALUATION AND POST-MARKET CLINICAL FOLLOW-UP)3
Proactive data collection
Reactive data collection
Read more:
Introduction to the ISO/IEC 27701 Standard
The Relationship Between ISO 27701 and Regulation (EU) 2016/679
Introduction to the GDPR (General Data Protection Regulation) for EU Medical Devices
How Can Manufacturers Hedge Risk Through Insurance Under the MDR?