Post-Market Performance Follow-up (PMPF) is the IVDR requirement to actively and continuously collect and evaluate performance data for a CE-marked in vitro diagnostic (IVD) device throughout its lifecycle. Manufacturers must build PMPF into their Quality Management System (QMS), document it in a dedicated PMPF Plan, and feed the findings into the Performance Evaluation Report (PER) and, for higher-risk devices, the Periodic Safety Update Report (PSUR).
This is the second part of a two-part series on IVDR post-market obligations. Is your Post-Market Surveillance system IVDR-ready? covered the wider PMS system this guide sits inside. PMPF has been mandatory since 26 May 2022 for every IVD device from Class A through D, including legacy devices that haven't yet transitioned from the IVDD. Many manufacturers of those legacy devices don't realize the obligation already applies to them.
How does PMPF differ from general Post-Market Surveillance (PMS)?
PMPF is one specific activity within the broader PMS system that the IVDR requires, not a synonym for it. PMS is the continuous process that every manufacturer goes through over a device's lifetime: complaint handling, vigilance, and market data collection. PMPF is the mechanism inside that system for actively generating new performance evidence, and its findings must flow directly into the PER and, for Class C and D devices, the PSUR.
Within that role, PMPF specifically exists to:
- Confirm the device's safety, performance, and scientific validity
- Detect emerging risks
- Identify potential systematic misuse
Getting started: integrating PMPF into your QMS.
Integrating PMPF into a QMS means writing procedures that align with IVDR Annex XIII, Part B, and explicitly connect PMPF to risk management, CAPA, performance evaluation, and the Summary of Safety and Performance (SSP), rather than treating it as a document that nobody else's process touches.
Key deliverables:
- PMS Plan (including or referencing a PMPF Plan)
- PMS Report (Class A and B)
- Periodic Safety Update Report — PSUR (Class C and D)
- PMPF Plan
- PMPF Evaluation Report
If PMPF genuinely doesn't apply to a device, that has to be justified in the PER, not simply left blank. In practice, this is rare. Any residual risk, open uncertainty, or plausible change in performance over time is enough to trigger the requirement.
How do you design a PMPF plan?
A PMPF Plan sets out the general and specific methods a manufacturer will use to collect and evaluate post-market performance data for a device. It has to be built from that device's own PER and its residual gaps, rather than assembled from a generic template — Notified Bodies assess whether the chosen methods actually address the device's specific uncertainties.
Methods commonly used include:
- User feedback
- Clinical experience
- Scientific literature reviews
- Ring trials
- Epidemiological studies
- Registry evaluations
- Dedicated PMPF studies, often run through IVD clinical performance studies
Start from the PER: its indications for use, intended population, clinical safety and performance requirements, and clinical claims and benefits. Identify where the clinical data has gaps, then turn each gap into a specific question PMPF needs to answer. Any outstanding residual risk should point to a concrete follow-up activity, such as a user survey or an additional usability study, rather than a general commitment to "monitor."
Literature searches feeding into PMPF must follow a systematic, documented methodology to meet IVDR expectations; an ad hoc search doesn't satisfy the requirement. Watch too for signs of systematic misuse, such as off-label use, and keep that distinct from ordinary use error, since the two call for different corrective actions. Where a healthcare institution modifies a device itself, that may fall under the in-house exemption at IVDR Article 5(5), but only if the institution meets every condition the exemption sets. It isn't a blanket carve-out.
What are the PMPF reporting and update-frequency requirements?
Every IVD device requires a PMPF Evaluation Report, and its findings must be summarised in the PMS Report for Class A and B devices, or in the PSUR for Class C and D devices. Update frequency is risk-based: Class C and D devices should be updated annually as a baseline, since Notified Bodies scrutinize adherence to PMPF commitments closely during surveillance audits.
|
Process |
Deliverable |
Class A |
Class B |
Class C |
Class D |
|
Performance Evaluation |
Performance Evaluation Plan (PEP) |
Yes |
Yes |
Yes |
Yes |
|
|
Performance Evaluation Report (PER) |
Yes |
Yes |
Annually |
Annually |
|
Post-Market Performance Follow-up |
PMPF Plan |
Yes |
Yes |
Yes |
Yes |
|
|
PMPF Evaluation Report |
Yes |
Yes |
Annually* |
Annually* |
|
Post-Market Surveillance |
PMS Plan |
Yes |
Yes |
Yes |
Yes |
|
|
PMS Report |
Yes |
Yes |
No |
No |
|
|
Periodic Safety Update Report (PSUR) |
No |
No |
Annually |
Annually |
Beyond that scheduled cadence, update the PMPF Evaluation Report whenever new signals emerge:
- Serious adverse events
- Complaint trends
- Emerging risks
- Newly identified performance issues and limitations
It's falling behind on these triggers, not just the calendar, that erodes a Notified Body's confidence when a certificate comes up for renewal.
What about legacy IVDD devices?
Devices that still hold a valid IVDD certificate or Declaration of Conformity aren't exempt from PMS and PMPF; most of the obligations already apply to them. Under MDCG 2022-8, legacy devices don't need a premarket SSP or PER. A PMS Report is still required; a PSUR remains optional (manufacturers can prepare one voluntarily); and the PMPF Plan must define the update frequency and methodology based on device risk.
Final thoughts
PMPF isn't a document you file once and forget. It's a live evidence stream that has to keep pace with the device across its life on the market. Getting the plan, the methods, and the reporting cadence right the first time saves rework later, particularly ahead of a Notified Body audit.
Qserve's IVD regulatory and clinical performance specialists build PMPF plans, run the underlying studies, and support continuous performance evaluation for IVDR compliance. Talk to our IVD team to scope your next PMPF cycle, or revisit Part 1 of this series for the broader PMS picture.