Glossary · EU in vitro diagnostics: IVDR
Post-market performance follow-up (PMPF)
Also known as: PMPF, PMPF plan, PMPF evaluation report
Under the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, post-market performance follow-up is a continuous process that updates the performance evaluation, in which the manufacturer proactively collects and evaluates performance and relevant scientific data from the use of a CE-marked device within its intended purpose. It is planned in a PMPF plan and reported in a PMPF evaluation report under Annex XIII Part B.
- EU
- IVDR
In one sentence
PMPF under IVDR Annex XIII Part B: continuous, proactive collection of performance data on a CE-marked IVD to update its performance evaluation.
Example
A manufacturer of a class C hepatitis assay collects external quality assessment results, user feedback and new literature on assay performance, and reports them in a PMPF evaluation report that feeds the annual PSUR.
How it applies
- Aims: PMPF confirms safety, performance and scientific validity over the device’s lifetime, identifies previously unknown risks or limits of performance, and detects systematic misuse.
- Methods: General methods such as literature review, user feedback and data from external quality assessment schemes; specific methods such as registries or post-market performance studies.
- Not needed? Where PMPF is considered unnecessary for a device, the manufacturer justifies this in the PMS plan.
- Reporting: The PMPF evaluation report updates the performance evaluation. For class C and D devices its findings go into the PSUR and the summary of safety and performance.
- Technical documentation: The PMPF plan belongs to the technical documentation on post-market surveillance (Annex III IVDR); the report is kept with the performance evaluation report.
PMPF vs. PMCF
PMPF is the IVDR term and follows up the performance of a diagnostic, including scientific validity and analytical performance. PMCF is the MDR term and follows up clinical safety and performance of a device used on patients. A manufacturer with both product types runs two processes with different templates and outputs.