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) |
If PMCF identifies a previously unknown or significantly underestimated risk that was not adequately addressed in the pre-market clinical evaluation, the manufacturer must: (1) immediately notify MHRA and the UKAB; (2) assess whether the risk affects the benefit-risk determination; (3) determine whether an FSCA, risk management revision, or device modification is required; (4) update the clinical evaluation report and risk management file; (5) consider whether continued market distribution is justified pending risk assessment.
PMCF plan approval and submission
The PMCF plan should be agreed with the UKAB (for UKAB-certified devices) before the device is placed on the market. UKABs will assess the adequacy of the PMCF plan as part of the conformity assessment. The plan should be reviewed and updated if:
- The device undergoes a significant design change
- New safety signals emerge that require additional clinical monitoring
- Long-term follow-up data reveals previously unknown risks
- The device is extended to a new clinical indication or patient population
For devices approved under the transitional period (CE marked devices), PMCF plans should align with any existing EU PMCF commitments documented in the clinical evaluation report.