MDR

Official standard

Full Name

Medical Device Regulation (EU) 2017/745

Region

European Union

Codes

Crosswalk Edges

Authority

European Parliament and Council

Data Provenance

Manual TranscriptionLicense: Public Domain (EUR-Lex)Source

Hierarchy Explorer

Hierarchy ExplorerClick to expand - equivalences appear inline

ch_1Chapter I - Scope and Definitions

ch_2Chapter II - Making Available and Putting into Service

ch_3Chapter III - Identification and Traceability (UDI)

ch_4Chapter IV - Notified Bodies

ch_5Chapter V - Classification and Conformity Assessment

ch_6Chapter VI - Clinical Evaluation and Investigation

ch_7Chapter VII - Post-Market Surveillance and Vigilance

ch_8Chapter VIII - Market Surveillance