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Mapping to governance frameworks

This taxonomy supplies technical vocabulary for describing model changes. It is not legal advice and does not determine whether a change is a substantial modification, a significant change, or a reportable device change. Those determinations rest with manufacturers, regulators, and notified or auditing bodies under the applicable framework.

What each dimension can document

DimensionQuestion it answers
D1 MechanismWhat changes?
D2 GoalWhy adapt?
D3 Data RequirementsWhat data is needed?
D4 PersistenceHow long does the change last?
D5 ScopeHow much of the model structure is modified?
D6 Model TypeWhat model is being adapted?

Four frameworks

NIST AI RMF

Its lifecycle stages and core functions may be mapped to adaptation goals: the operate-and-monitor stage invokes drift remediation and continual adaptation, which can be separated by persistence (D4) and structural scope (D5). Data-stage obligations connect to D3.

EU AI Act

Risk-based requirements and post-market obligations may be informed by goal, persistence, and scope. A compute threshold can identify large fine-tuning events but may not capture low-compute interventions that materially alter behaviour. Derived artifacts with fused composition may heighten the need for provenance documentation.

EU MDR / IVDR

Post-market surveillance obligations may draw on D1, D4, and D5 for technical documentation, and on D2 and D3 for benefit-risk and clinical evaluation. A change driven by drift remediation can be distinguished from one driven by task specialisation even where mechanism and persistence are identical.

FDA PCCP

Modification description may map to D1, D4, D5 and D6; the modification protocol to D3 plus separately stated validation criteria; impact assessment to D2 and D4 alongside intended-purpose analysis conducted outside this framework.

Start from a technique

Every technique page carries its full profile, so the documentation dimensions above can be read off directly.

Find a technique Describe a change Why this matters