Post-Market Clinical Follow-up (PMCF)
Post-Market Clinical Follow-up (PMCF) is part of the ongoing clinical evaluation obligation under Schedule 1 (Essential Requirements) of the UK MDR 2002 — specifically the requirement to maintain a current clinical evaluation. MHRA expects PMCF for all Class IIa, IIb, III, and AIMD devices, and for IVDs through Post-Market Performance Follow-up (PMPF).
What is PMCF?
Post-Market Clinical Follow-up (PMCF) is the proactive collection of clinical data from the marketed device to:
- Confirm the continued clinical safety and performance of the device over its intended lifetime
- Identify previously unknown or underestimated risks
- Identify emerging risks based on new clinical evidence or adverse event data
- Detect changes in clinical practice or patient population that affect the benefit-risk ratio
- Provide evidence that the clinical evaluation remains current
PMCF is distinct from general PMS — it specifically collects clinical data (patient outcomes, adverse events in patients) rather than just complaint and failure data.
When is PMCF required?
PMCF is expected for:
- Class IIa, IIb, III, AIMD devices — as part of maintaining a current clinical evaluation
- Devices where the initial clinical evidence was based primarily on equivalent device data rather than direct clinical investigation data
- Devices with novel technologies or materials where long-term performance data was limited at time of market entry
- Devices where post-market signals suggest the pre-market clinical evidence may not have fully captured real-world risk
PMCF plan
Before a device is placed on the market, the manufacturer should prepare a PMCF plan documenting:
- Objectives of the PMCF programme
- Methods to be used (see below)
- Patient population to be studied
- Endpoints (clinical outcomes, safety events, device longevity)
- Data collection schedule
- Statistical approach
- How data will feed into the CER update
PMCF methods
PMCF can be conducted through various methods, individually or in combination:
| Method | Description | Best suited for |
|---|---|---|
| Registry participation | Enrolment in a national or international disease or device registry | Implants, high-volume devices, long-term follow-up |
| Post-market clinical study | Prospective observational study of patients using the device | Novel devices; devices where equivalent data was limited |
| Long-term follow-up study | Structured follow-up of a cohort of patients over a defined period | Implants; devices requiring longevity confirmation |
| Survey-based data collection | Structured questionnaires to healthcare professionals on real-world use | Usability, user satisfaction, complaint data |
| Systematic literature monitoring | Ongoing literature search and appraisal for new publications on the device or equivalents | All devices |
| Real-world data analysis | Analysis of anonymised healthcare records, claims databases | Where feasible and ethics-approved |
PMCF report
The results of PMCF activities must be documented in a PMCF report that covers:
- PMCF activities conducted during the reporting period
- Data collected and analysed
- Clinical outcomes observed
- Adverse events identified
- Conclusions on device safety and performance in real-world use
- Impact on the benefit-risk assessment
- Any actions required (risk management update, CER update, CAPA, FSCA)
The PMCF report feeds directly into the CER update and, for classes requiring PSURs, into the PSUR.
Post-Market Performance Follow-up (PMPF) for IVDs
The IVD equivalent of PMCF is Post-Market Performance Follow-up (PMPF). For IVDs, PMPF focuses on:
- Ongoing analytical performance monitoring (quality control data, proficiency testing/EQA participation)
- Emerging literature on the analyte and clinical application
- Real-world clinical performance data
- Post-market comparison with other available diagnostic methods
Related pages
- PMS requirements by class
- Periodic Safety Update Reports (PSURs)
- Clinical evaluation requirements
- Clinical evaluation summary in the technical file
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Schedule 1 (ERs 1–3) | Clinical evaluation and PMCF obligations |
| MEDDEV 2.12/2 Rev.2 | PMCF studies guidance (reference) |
| MHRA: Clinical evaluation guidance | MHRA's position on PMCF |
| EU MDR 2017/745, Annex XIV Part B | Detailed EU PMCF requirements (applies in NI) |