qms_version 2.2.0 sop_id CSC PR.001 sop_version 2.0.1 template_id CSC F.018 template_version 2.0.1 record_version record_id MDR-001 title Medical Device Regulation Classification Medical Device Classification General Template ID CSC F.018 Template Version 2.0.1 QMS Version 2.2.0 SOP ID CSC PR.001 SOP Version 2.0.1 Regulatory References Author Approval Purpose This document describes the medical device classification for {{device.name}} release {{device.version}}. Scope This document applies to {{device.name}} release {{device.version}}. Definitions Item Definition Roles and Responsibilities Role Responsibilities MHRA Classification and rationale MHRA Classification {{device.mhra_class}} Medical software classification and rationale - BS EN 62304:2020 62304 Classification {{device.BS62304_class}}