A model that scored well in evaluation can still fail on the ward if nobody is trained to use it, nobody watches its performance and nobody is responsible for switching it off. Before you deploy, check both technical and organisational readiness.
Prerequisites¶
| Prerequisite | Importance | Level |
|---|---|---|
| Completed evaluation phase (clinical utility demonstrated) | Necessary | |
| Regulatory route settled: CE marking after conformity assessment, or documented use of the MDR in-house exemption (Art. 5(5)) for a tool made and used only within your institution | Necessary | |
| Clinical integration design reviewed with IT and clinical leads | Necessary | |
| Training programme prepared | Necessary | |
| Governance and accountability structures agreed | Necessary |