An IVD's PMPF plan has eight required parts

MDR's post-market clinical follow-up plan already has its own place on this blog, governed by Annex XIV Part B for medical devices generally. In vitro diagnostics run a parallel obligation under a different regulation entirely — IVDR's own Annex XIII Part B, covering post-market performance follow-up, or PMPF. The two annexes ask a similar underlying question and share much of their structure. They are not the same document, and a PMPF plan built by copying an MDR-side PMCF template and swapping the acronym has copied a shape from a regulation this device isn't actually reviewed under.

A separate annex, for a different kind of evidence

IVDR Article 10(9) requires every manufacturer to run a post-market surveillance system that includes, as one of its components, post-market performance follow-up — the mechanism for confirming, once a diagnostic is actually in use, that its performance holds up the way the performance evaluation behind its CE mark concluded it would. Annex XIII Part B structures what a PMPF plan has to contain. Nothing in it points back to MDR's Annex XIV, and nothing in MDR's Annex XIV points forward to it — a manufacturer that also markets devices under MDR is working two separate regulatory obligations, not one obligation filed under two names.

Eight elements, not a narrative summary

The plan has to include: the general methods and procedures of PMPF to be applied, such as gathering clinical experience already in use, user feedback, and screening of relevant literature and other performance or scientific data; the specific methods and procedures to be applied where the general ones aren't enough, including ring trials and other quality assurance activities, epidemiological studies, evaluation of suitable patient or disease registries, genetic databanks, or post-market clinical performance studies; a rationale for why those methods and procedures are appropriate; a reference to the relevant parts of the performance evaluation report and of the risk management file; the specific objectives the PMPF activity is meant to address; an evaluation of performance data relating to equivalent or similar devices and the current state of the art; a reference to relevant common specifications, harmonised standards, and guidance; and a detailed, justified time schedule for the activities themselves. A plan that states an intent to do PMPF without walking through these eight in order hasn't demonstrated the reasoning Annex XIII Part B is actually structured to require.

Ring trials are the detail an MDR-side template doesn't have

A ring trial — the same sample set tested across multiple laboratories, operators, or instruments to check whether an assay's result holds up independent of who's running it — addresses a failure mode specific to diagnostics: a test that performs consistently on the bench where it was validated but drifts once it's running on different equipment, under different lab conditions, in different hands. A device-side PMCF method list has no real equivalent to this, because an implant or an instrument doesn't raise the same question a diagnostic assay does about whether a different lab reproduces the same result. A PMPF plan that lists literature review and registries but never asks whether inter-laboratory reproducibility needs its own check hasn't actually engaged the annex's own logic for what makes a diagnostic's performance fail in the field.

PMPF updates a document that already exists

Annex XIII Part B is explicit that PMPF is to be understood as a continuous process that updates the performance evaluation referred to in Article 56 and Part A of the same annex, and has to be addressed within the manufacturer's post-market surveillance plan. A PMPF report that gets filed and never routed back into the performance evaluation report it's supposed to update has produced a document, not the update the annex actually asks for — the same way new evidence can reopen a risk file's own overall conclusion once it exists.

Silence isn't the exemption here either

The same discipline MDR's Annex XIV Part A applies to PMCF applies to PMPF: where a manufacturer determines PMPF isn't appropriate for a given device, that conclusion needs a documented justification, filed within the performance evaluation report, not an absence of any mention at all. A notified body reading the technical documentation is checking for one of two outcomes — a plan built to the eight-element structure, or a reasoned justification for skipping it — the same binary this blog has already traced on the device side, running through a different annex.

Where this meets the rest of the file

A PMPF-plan worksheet built around Annex XIII Part B's own eight elements, distinct from the device-side Annex XIV Part B this blog already covers, is previewed in the launch catalog. If your program's IVD post-market plan draws this structure differently, the shelf takes that correction directly.