Medical device review evidence and source custody

HLT.05.02officeUnion-wide competence

Purpose and competence

Medical device review evidence and source custody is maintained for Medical device review. Its scope follows the office’s mandate: Assess a medical device's claimed function, intended users and supported receiving setting.

A device tested in one environment is proposed for a materially different care setting

Record specification

Record identifier: HLT.05.02/R2
Responsible custodian: Medical device review
Source evidence: device tests; intended use; clinical hazards
Decision output: Medical-device use finding
Publication status: Draft record specification / no signed decision
Review route: Union Ombudsman / Union Court of Justice

Custodian and access

Medical device review assessment lead → · Public records access procedure

Source catalogue for Medical device review

Source 1: device tests
Source 2: intended use
Source 3: clinical hazards
Receiving purpose: Medical-device use finding

Access to this record

Medical device review assessment lead / contact · Public records procedure · Common custody and accessible-format rules