A clinical evaluation plan sets what the report has to prove

Two documents in a technical file share almost the same name, and it's an easy pair to conflate. A clinical investigation plan, built to ISO 14155, is the protocol a specific new study runs on — it exists only when a manufacturer decides to generate new clinical data directly. A clinical evaluation plan is a different document with a different job: MDR Article 61 and Annex XIV Part A require it for every device, whether or not a new investigation ever runs, and it has to exist before any clinical evidence — literature, registry data, a prior investigation, or a new one — gets weighed against the device's conformity claims. Skip straight to gathering the evidence, and there's no plan on record establishing what that evidence was supposed to prove in the first place.

Article 61 puts the plan before the evidence

Article 61(1) requires manufacturers to plan, conduct and document a clinical evaluation in accordance with Article 61 and Annex XIV Part A, confirming conformity with the relevant general safety and performance requirements under normal conditions of use and assessing whether the device's benefit-risk ratio is acceptable. Annex XIV Part A establishes the plan as the document that has to exist first, before the evaluation's own data collection and analysis begins — a plan drafted after the evidence has already been gathered, to justify a conclusion the manufacturer already reached, has the sequence backwards from what the annex requires.

What the plan has to name

Annex XIV Part A, Section 1 requires the plan to identify, at minimum, the general safety and performance requirements that need support from clinical data; describe the device's intended clinical benefits with specified, measurable outcome parameters; and specify the methods to be used for examining the benefit-risk determination, including reference to any relevant common specifications, harmonized standards, or guidance. The plan is the document that turns ‘this device has to be safe and effective’ into a named list of GSPRs, benefits, and outcome parameters a reviewer can actually check the eventual evidence against — a technical file with a report but no plan behind it has no fixed record of what that report was supposed to demonstrate.

Depth is proportionate — and that judgment sits with the manufacturer

Annex XIV Part A also states that the clinical evaluation's depth and extent has to be proportionate to the device's nature, classification, intended purpose and risks, and to the manufacturer's own claims for it. That's not a lighter standard for lower-risk devices so much as a different burden of justification: a novel, higher-class device needs a plan that reasons through why the depth chosen is adequate, not just one that asserts it. The equivalence route this blog has already covered is one way that proportionality plays out in practice — a plan that leans on equivalence still has to justify why comparison to an existing device answers the GSPRs the plan itself identified as needing clinical support.

The plan decides whether an investigation plan gets written at all

Where the clinical evaluation plan finds a GSPR that existing literature and prior data can't support, that gap is what triggers a new clinical investigation under Article 62 — and only at that point does the separate ISO 14155 investigation plan come into the picture, built to answer the specific gap the evaluation plan already named. The evaluation plan is the parent document that decides whether a new study is even necessary; the investigation plan is what gets written once that decision has already been made. Treating the two as interchangeable, or skipping the evaluation plan's own gap analysis and jumping straight to designing a study, loses the record of why that study was the right response.

Where this meets the file

The clinical evaluation itself doesn't end with one report: Annex XIV Part A requires updating both the plan and the resulting clinical evaluation report throughout the device's lifecycle, on a schedule proportionate to risk — the same ongoing-evidence discipline a PMCF plan runs on the post-market side. A clinical evaluation plan worksheet built around Annex XIV Part A's named elements — the GSPRs in scope, the outcome parameters, and the proportionality justification — is previewed in the launch catalog. If your program scopes this differently, the shelf takes that correction directly.