Each additional deployment jurisdiction requires a structured pre-deployment checklist. The eight steps, each completed before deployment, are: identify national competent authority and market surveillance authority; review jurisdiction-specific guidance for conflicts with existing compliance posture; translate Instructions for Use into the member state’s official language; translate Declaration of Conformity if required; verify EU database registration covers the new jurisdiction; pre-identify serious incident reporting channel; pre-translate incident report template if the authority requires the national language; and confirm data residency and sovereignty compliance.

At deployment, two additional steps: brief deployers in the new jurisdiction on their Article 26 obligations, and add the jurisdiction to the quarterly guidance monitoring cycle.

The checklist is maintained by the Conformity Assessment Coordinator and completed per jurisdiction. Completed checklists are retained as Module 10 evidence.

Key outputs

• Ten-step per-jurisdiction deployment checklist
• Completed before and at deployment
• Conformity Assessment Coordinator responsibility
• Module 10 AISDP evidence