Glossary · EU medical devices: MDR
Post-market surveillance (MDR and IVDR)
Also known as: PMS, Post-market surveillance system, PMS plan
Under the EU Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, post-market surveillance is the set of activities by which manufacturers, together with other economic operators, proactively collect and review experience gained from devices they have placed on the market, in order to identify any need for corrective or preventive action. Every manufacturer must run a PMS system proportionate to the risk class, as part of its quality management system.
- EU
- MDR
- IVDR
In one sentence
Post-market surveillance under MDR Articles 83–86 and IVDR 78–81: the manufacturer’s system for proactively collecting and acting on field experience.
Example
A manufacturer of a class IIa infusion pump defines in its PMS plan which complaint, service and literature data it collects, how trends are analyzed and when the risk file, clinical evaluation and IFU are updated.
How it applies
- PMS plan: Each device has a PMS plan under Annex III that states the data sources (complaints, service reports, literature, registries, similar devices), the methods for analysis and trend detection, and the indicators that trigger action.
- Reports: Class I medical devices and class A and B IVDs need a PMS report (Article 85 MDR, Article 80 IVDR), updated when necessary. Higher classes need a periodic safety update report.
- Feedback loops: PMS results update the benefit-risk determination, risk management, design and manufacturing, the clinical evaluation or performance evaluation, the labeling and the SSCP.
- Actions: Where a need is identified, the manufacturer takes corrective or preventive action through its CAPA process and informs the competent authorities and notified body where required.
- Clinical data: PMCF (MDR) and PMPF (IVDR) are the clinical and performance parts of the PMS system.
- Technical documentation: Annex III defines the technical documentation on post-market surveillance, kept alongside the Annex II technical documentation.
PMS vs. vigilance
PMS is proactive and continuous: the manufacturer looks for signals in all available experience. Vigilance is the reactive reporting obligation for serious incidents and field safety corrective actions, with fixed deadlines. Vigilance is a part of PMS, not a synonym for it.
Compared with the USA
The FDA separates the pieces: adverse events are reported under Medical Device Reporting (21 CFR Part 803), complaint handling and CAPA sit in the QMSR, and the FDA can order postmarket surveillance studies for certain devices. There is no single PMS plan requirement comparable to Annex III.