Regulatory mapping (informative)¶
This page shows where MedAgentRx touches each regulatory element. It is informative only. Whether a plan meets a regulation is for the manufacturer and the reviewer to decide.
FDA PCCP (final guidance, 4 December 2024)¶
| PCCP component | Plan section | Checks |
|---|---|---|
| Description of Modifications | modifications, max_updates, update_frequency |
PLAN-002, PLAN-004 |
| Modification Protocol: data management | data_management |
DATA-001 to DATA-006 |
| Modification Protocol: re-training | modifications[].type |
PLAN-002, recorded architecture fingerprint |
| Modification Protocol: performance evaluation | performance |
PERF-001 to PERF-006, LIFE-001, LIFE-002 |
| Modification Protocol: update procedures | update_procedures |
DOC-001; card and release records in the decision ledger |
| Impact Assessment | impact_assessment |
rendered in the PCCP document |
FDA, Health Canada and MHRA published five guiding principles for PCCPs: focused and bounded, risk-based, evidence-based, transparent, and total product lifecycle. The plan's closed list of modifications and fixed intended use keep it focused and bounded. Pre-specified criteria and the locked test set make it evidence-based. The ledger and reports make it transparent. The bio-creep guard and alpha spending cover the lifecycle.
EU AI Act and MDR¶
| Requirement | How it is reflected |
|---|---|
| Article 43(4): pre-determined changes are not a substantial modification | The plan file is the record of pre-determined changes; OUTSIDE_PLAN marks anything else |
| Annex IV point 2(f): description of pre-determined changes in the technical documentation | medagentrx render-plan writes that description from the same file the gate runs |
| Article 10: data governance | DATA-002 and DATA-003 |
| Article 15: accuracy | PERF-001 to PERF-004 |
| MDCG 2025-6 | Predetermined changes are not substantial under the AI Act; MDR significant change is still assessed separately and is outside this tool |
What MedAgentRx does not do¶
- It does not decide whether a change is significant under the MDR.
- It does not replace a quality management system, design controls or clinical evaluation.
- Its output is not itself a regulatory submission.