A PMCF plan is optional, but only in writing

A narrower question than the PMS plan asks

A post-market surveillance plan under Article 84 has to cover the device's full safety and performance picture — complaints, vigilance data, trend reporting, the whole system Article 83 requires to run actively rather than wait for problems to arrive. PMCF, defined in Annex XIV Part B, is narrower and more specifically clinical: its objectives, set out in Part B point 6.1, are to confirm the device's safety and performance throughout its expected lifetime, identify previously unknown side effects, monitor known side effects and contraindications, identify and analyze emergent risks, and confirm that the benefit-risk conclusion reached during clinical evaluation still holds once the device is actually in use. A PMS plan can be broad and still miss this piece if it never asks the narrower clinical question PMCF exists to answer on its own.

Two ways to satisfy Part A, not a third

Annex XIV Part A is specific about what a PMS plan owes on this point: either a PMCF plan built to Part B's structure, or a documented justification for why PMCF isn't applicable to the device. Both are acceptable outcomes. What isn't acceptable is a PMS plan that simply doesn't address the question — silence isn't the same as a reasoned justification, and a notified body reviewing the technical documentation is checking for one of the two, not for the absence of either. A justification tends to hold up when it points to a device with a long, stable clinical history and no open questions about its safety or performance profile; it tends not to hold up for a device whose clinical evaluation already leaned on equivalence to another device, or whose technology is new enough that the lifetime safety and performance picture Part B point 6.1 asks for hasn't actually been observed yet.

What the methods section actually has to choose

Part B point 6.2 splits PMCF methods into two tiers. General methods — screening and evaluating relevant clinical literature, gathering user feedback, reviewing registries — apply broadly and often overlap with data the wider PMS system is already collecting. Specific methods, including PMCF studies and device-specific registries, come into play when the general methods can't answer a stated objective on their own. A plan that lists only the general methods, without a stated reason those methods are sufficient to meet each objective in 6.1, hasn't actually worked through Part B's own logic — it's copied the section headings without doing the analysis the headings are there to prompt. MDCG 2020-7 lays out the template notified bodies expect a PMCF plan to follow, which standardizes what a reasoned method choice actually has to show rather than leaving each manufacturer to invent its own shape for the same objectives. A notified body reviewing the technical documentation is reading the plan for that reasoning specifically — not just whether a method is named, but whether the plan explains why that method, at that scale, is the right instrument for the objective it's assigned to.

Where the results have to land

A PMCF report, built to the MDCG 2020-8 template, isn't a standalone deliverable that gets filed and forgotten. Its conclusions feed back into the clinical evaluation report, updating the safety and performance evidence the device's CE mark rests on, and into the risk management file's own overall-residual-risk conclusion — new post-market clinical evidence is exactly the kind of input that can reopen a judgment the risk file already closed. A PMCF plan built around this chain — the Part B objectives, the general-versus-specific method choice, and a stated path for feeding results back into clinical evaluation and risk management — is previewed in the launch catalog. If your program draws the necessity justification differently, the shelf takes that correction directly.