Medical device review amendments and continuing conditions

HLT.05.02officeUnion-wide competence

Purpose and competence

Medical device review amendments and continuing conditions 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/R3
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

A change that may reopen the medical-device use finding

A device tested in one environment is proposed for a materially different care setting; require relevant evidence.

Instrument affected: Medical-device use finding
Receiving custodian: Medical device review assessment lead

Access to this record

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