MDACS Technical References (TR Series)

HK-unique · TR series are the primary compliance reference

Technical References are MDD's normative documents — the equivalent of regulations in a statutory framework.

Reference	Title
TR-001	Essential Principles of Safety and Performance
TR-002	Conformity Assessment
TR-003	Classification of General Medical Devices
TR-004	Classification of IVD Medical Devices
TR-005	Adverse Event Reporting
TR-006	Field Safety Corrective Actions
TR-007	Labelling
TR-008	Clinical Evidence

Guidance Notes (GN Series)

Reference	Title
GN-01 (2024)	Overview of MDACS

All TRs and GNs are published on the MDD official website. Always use the current version.