Solar System Union supplied sealThe Solar System UnionPublic institutions
Shared rights across worlds
My local casesDocumentsAccessibility
Medical device review identity
HLT.05.02 / office
Medical device review
UnionMedical device reviewMedical device review

HLT.05.02 / PUBLIC SERVICE NETWORK

Medical device review

Assess a medical device's claimed function, intended users and supported receiving setting.

HLT.05.02officeUnion-wide competence

Medical device review / public remit

Assess a medical device's claimed function, intended users and supported receiving setting.

Receiving role
Medical device review assessment lead
Public counterpart
Medicines & Devices

Choose your route

Office output: Medical-device use finding

Assessment file: Medical-device use finding

  • device tests
  • intended use
  • clinical hazards

Read the medical-device use finding specification →

A difficult medical device review case

Illustrative case / HLT.05.02

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

Reporting and specialist powers

Competent parent
Medicines & Devices
Local public authority
Health & Biomedical Commission
Receiving evidence
device tests; intended use; clinical hazards
Assessment question
A device tested in one environment is proposed for a materially different care setting

Public records and accountability

HLT.05.02/REG
Records and reasoned determinations

Medical-device use finding

HLT.05.02/CONTACT
Contact the competent office

Accessible assistance, evidence alternatives, institutional handoffs and review.