Statements (51)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
gptkb:legislation
|
| gptkbp:affects |
manufacturers
distributors importers |
| gptkbp:appliesTo |
medical devices
|
| gptkbp:basisFor |
gptkb:510(k)_clearance_in_US
gptkb:Premarket_Approval_(PMA)_in_US CE marking in EU |
| gptkbp:class |
Class I, II, III (US)
Class I, IIa, IIb, III (EU) |
| gptkbp:dateEnacted |
2017 (EU MDR)
2021 (full application of EU MDR) |
| gptkbp:enforcedBy |
gptkb:Australia
gptkb:Canada gptkb:China gptkb:European_Union gptkb:Japan gptkb:United_States regulatory authorities |
| gptkbp:example |
gptkb:EU_MDR
gptkb:US_FDA_regulations |
| https://www.w3.org/2000/01/rdf-schema#label |
Medical Device Regulation
|
| gptkbp:purpose |
ensure safety and performance of medical devices
|
| gptkbp:relatedTo |
gptkb:drug
gptkb:In_Vitro_Diagnostic_Regulation_(IVDR) |
| gptkbp:replacedBy |
gptkb:Medical_Device_Directive_(MDD)_in_EU
|
| gptkbp:requires |
gptkb:Good_Manufacturing_Practice_(GMP)
gptkb:Unique_Device_Identification_(UDI) manual labeling requirements risk management clinical evaluation clinical data market surveillance traceability conformity assessment corrective actions incident reporting post-market surveillance device registration recall procedures vigilance reporting authorized representative (for non-EU manufacturers in EU) Notified Body assessment (EU) clinical investigation for high-risk devices periodic safety update reports post-market clinical follow-up quality management system (QMS) registration with competent authority |
| gptkbp:bfsParent |
gptkb:MDR
|
| gptkbp:bfsLayer |
6
|