Describe the intended role in the care process.
Record what the system does, who relies on its output and how it may affect care. Separate an administrative drafting tool from a feature used for diagnosis, treatment or a safety function. Product-related high-risk classification requires assessment of the applicable Article 6 criteria and relevant product legislation.
A supplier's broad healthcare description is not enough. Review the actual intended purpose, instructions, configuration and limitations of the proposed deployment.
Identify what needs clinical and technical review.
Connect the supplier's evidence to the setting in which the system will be used. Ask which patient groups, workflows and limitations were considered, what information is missing and who is qualified to assess it. Keep claims about performance distinct from the organisation's decision to use the system.
An evidence record can index evaluations and approvals without unnecessarily copying patient information. Agree privacy, confidentiality and access arrangements before collecting sensitive material.
Plan intervention and escalation before use.
Define the responsible professional or operational reviewer, the information they need and the action they can take. Consider how uncertainty, unexpected outputs or a service interruption will be handled. A workflow should support a clear escalation path rather than leaving staff to improvise during a concern.
- Intended-purpose and workflow descriptions.
- Supplier instructions and evidence references.
- Named review, escalation and change owners.
- Approval conditions and monitoring questions.
Scope governance around an accountable service.
An EUAIC engagement can begin with one service, supplier or family of use cases. Map existing clinical, information-governance and technology processes, then agree the additional record and review work needed. Reviewers should be able to see which decision belongs to which accountable body.
EUAIC does not provide clinical approval or substitute for medical-device, safety or professional assessments. A website enquiry should describe the governance requirement without including identifiable patient records.