PMS requirements by device class
Post-market surveillance obligations derive from Schedule 1 (Essential Requirements) of the UK MDR 2002, the conformity assessment surveillance obligations in Schedule 3, and MHRA's post-market surveillance guidance. PMS is an ongoing lifecycle obligation for all device classes.
What is post-market surveillance?
Post-market surveillance (PMS) is the systematic, proactive process of collecting and reviewing experience gained from devices placed on the market, in order to:
- Confirm the safety and performance of the device in real-world use
- Identify previously unknown risks or adverse events
- Detect any systematic changes in device performance
- Provide data for the clinical evaluation / performance evaluation update
- Inform the risk management file
PMS is not the same as vigilance reporting — vigilance is reactive (reporting events after they occur); PMS is proactive (actively seeking and analysing data before events occur).
PMS obligations by device class
| Class | PMS plan required? | PMS report required? | PSUR required? | PSUR frequency |
|---|---|---|---|---|
| Class I | Yes | Yes (periodic) | No | N/A |
| Class IIa | Yes | Yes | Yes | At least every 2 years |
| Class IIb | Yes | Yes | Yes | At least annually |
| Class III | Yes | Yes | Yes | At least annually |
| AIMD | Yes | Yes | Yes | At least annually |
| IVD General | Yes | Yes | No | N/A |
| IVD List B | Yes | Yes | Yes | At least every 2 years |
| IVD List A | Yes | Yes | Yes | At least annually |
The PMS plan
Every device must have a documented PMS plan prepared before the device is placed on the market. The plan specifies:
- The methods for proactively collecting post-market data
- The types of data sources to be monitored
- The frequency of data collection and analysis
- Thresholds or criteria for triggering a trend report
- The person(s) responsible for PMS
- How PMS data flows into the risk management file, CER/PER, and PSUR
PMS data sources
| Data source | What it captures |
|---|---|
| Complaint and adverse event records | User-reported failures, malfunctions, and adverse events |
| MHRA Yellow Card reports | Healthcare professional and patient reports to MHRA |
| Distributor and customer feedback | Field issues, user concerns, service records |
| Post-market clinical follow-up (PMCF) studies | Structured clinical data collection from post-market use |
| Post-market performance follow-up (PMPF) for IVDs | Ongoing analytical and clinical performance monitoring |
| Published literature | Studies, case reports, review articles on the device or equivalent devices |
| Registries | National implant registries, disease registries with device data |
| International vigilance databases | FDA MAUDE, EUDAMED (EU), TGA databases |
| Regulatory authority communications | MHRA device alerts, other regulator warnings |
The PMS report
The PMS report documents the conclusions of PMS data analysis over the reporting period. It must confirm:
- PMS activities conducted and data collected
- Analysis of complaint and adverse event trends
- Results of PMCF / PMPF activities
- Comparison of observed adverse event rates with clinical data and IFU disclosures
- Any new risks identified or existing risk estimates changed
- Actions taken (CAPAs, FSCA initiation, technical file updates, CER updates)
- Overall conclusion on the device's continued safety and performance
The PMS report feeds directly into the PSUR for classes requiring PSURs.
Related pages
- Periodic Safety Update Reports (PSURs)
- Post-market clinical follow-up (PMCF)
- Distribution records
- What must be reported to MHRA
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Schedule 1 | Essential Requirements including PMS |
| UK MDR 2002, Schedule 3 | Conformity assessment surveillance obligations |
| MHRA: Post-market surveillance guidance | MHRA's PMS guidance |
| ISO 13485:2016, Clause 8.2 | Post-production monitoring and measurement |