What are typical data sources manufacturers use to satisfy PMPF requirements?

Common PMPF data sources include participation in clinical or disease registries and reflex-testing agreements with clinical laboratories that provide ongoing real-world performance data. These sources are often more practical than dedicated new PMPF studies for established analytes with wide clinical use.

How does PMPF connect to the periodic safety reporting cycle?

Results from PMPF activities are documented in a PMPF Evaluation Report that feeds into the overall Performance Evaluation Report and, for Class C and D devices, into the Periodic Safety Update Report (PSUR), or into the PMS Report for Class A and B devices. This creates a closed loop where post-market findings continuously update the pre-market evidence base.

Is PMPF the same activity as the MDR's PMCF?

PMPF is the IVDR's direct analogue to the MDR's Post-Market Clinical Follow-up (PMCF), serving the same lifecycle purpose of confirming performance continues to hold in real-world use, but it is scoped to analytical and clinical performance of IVDs rather than clinical safety and performance of therapeutic or implantable devices. Manufacturers with combined MDR and IVDR portfolios should not assume identical templates work for both without adaptation.

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RegulatoryRegulated Pathways Global MarketsPMPF

Post-Market Performance Follow-Up (IVDR)

Continuous process of proactively collecting and evaluating performance data on an IVD after CE marking, analogous to MDR PMCF.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026

Definition

Annex XIII Part B of the IVDR defines PMPF as a continuous process that updates the performance evaluation and is addressed in the manufacturer's post-market surveillance plan. Its objectives include confirming safety and performance throughout the expected lifetime, identifying previously unknown risks, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse.

What the regulation says

Annex XIII Part B Section 5.1 states that PMPF shall be understood to be a continuous process that updates the performance evaluation referred to in Article 56 and Part A of this Annex.

What this means in practice

PMPF is not optional: where a manufacturer justifies that PMPF is not applicable, that justification itself must be documented and defended in the Performance Evaluation Report. Common PMPF activities include real-world performance studies, registry participation, external quality assessment (EQA) programme data, and structured user surveys.

Examples

A manufacturer of a diagnostic test for an infectious disease implements a PMPF study to track the test's positive predictive value in different patient populations over several years.
For a blood glucose monitoring system, PMPF activities could include analyzing data from external quality assessment programs and conducting structured surveys with laboratories and patients to gather feedback on usability and accuracy.
A manufacturer of a genetic screening panel participates in an international registry that collects anonymized performance data, allowing for ongoing monitoring of the assay's sensitivity and specificity against evolving scientific understanding.

Common pitfalls

•A common mistake is treating PMPF as a one-time activity or an optional requirement; manufacturers must have a continuous process and justify its inapplicability if not pursued.
•Manufacturers often fail to adequately integrate PMPF into their overall quality management system, leading to fragmented data collection and evaluation processes.
•Another misconception is limiting PMPF activities to only complaint data, overlooking proactive measures like real-world studies or user surveys that provide richer performance insights.

Frequently asked questions

PMPF is not optional by default for any class; Annex XIII Part B requires manufacturers to plan and conduct it as a continuous process. If a manufacturer concludes PMPF is not applicable to a specific device, that conclusion must be explicitly documented and justified rather than simply omitted.

Grouped by theme

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Regulatory

EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

Regulatory

IVDR Performance Evaluation

Continuous, systematic process to generate, collect, analyse, and assess data demonstrating an IVD's performance under IVDR Article 56.

Regulatory

Post-Market Surveillance Plan (IVDR)

Manufacturer-maintained plan under Article 79 describing how safety and performance data are systematically collected once an IVD is on the market.

Post-Market

PSUR (IVDR Specific)

Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81.

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Category: Regulatory
Acronym: PMPF
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Updated: 7/25/2026

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Continuous process of proactively collecting and evaluating performance data on an IVD after CE marking, analogous to MDR PMCF.

·PMPF is not optional: where a manufacturer justifies that PMPF is not applicable, that justification itself must be documented and defended in the Performance Evaluation Report.
·Common PMPF activities include real-world performance studies, registry participation, external quality assessment (EQA) programme data, and structured user surveys.

Remember this

Watch out: A common mistake is treating PMPF as a one-time activity or an optional requirement; manufacturers must have a continuous process and justify its inapplicability if not pursued.

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