European Database on Medical Devices (EUDAMED)
GPTKB entity
Statements (55)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:Data
|
| gptkbp:aims_to |
enhance market access
support innovation improve device safety |
| gptkbp:complies_with |
gptkb:EU_Medical_Device_Regulation_(MDR)
gptkb:EU_In_Vitro_Diagnostic_Regulation_(IVDR) |
| gptkbp:contains |
data on medical devices
|
| gptkbp:developed_by |
gptkb:European_Commission
|
| gptkbp:enables |
data sharing
|
| gptkbp:enhances |
transparency in the medical device market
|
| gptkbp:facilitates |
adverse event reporting
device traceability |
| https://www.w3.org/2000/01/rdf-schema#label |
European Database on Medical Devices (EUDAMED)
|
| gptkbp:improves |
patient safety
|
| gptkbp:includes |
post-market surveillance data
clinical investigations registration of devices |
| gptkbp:is_accessible_by |
gptkb:Public
gptkb:Web |
| gptkbp:is_funded_by |
EU budget
|
| gptkbp:is_integrated_with |
national databases
|
| gptkbp:is_part_of |
gptkb:EU_Digital_Single_Market
EU regulatory framework |
| gptkbp:is_related_to |
regulatory compliance
data interoperability patient registries clinical evaluation safety alerts market authorization medical device regulation health technology assessment post-market monitoring device recalls |
| gptkbp:is_subject_to |
data protection regulations
|
| gptkbp:is_updated_by |
gptkb:automotive_industry
regulatory authorities |
| gptkbp:is_used_by |
gptkb:healthcare_professionals
gptkb:researchers patients |
| gptkbp:launched |
gptkb:2020
|
| gptkbp:managed_by |
gptkb:European_Commission
|
| gptkbp:promotes |
harmonization of data
|
| gptkbp:provides |
data analytics tools
|
| gptkbp:provides_access_to |
gptkb:automotive_industry
notified bodies authorized representatives competent authorities |
| gptkbp:purpose |
to provide a comprehensive database for medical devices in the European Union
|
| gptkbp:reduces |
administrative burden
|
| gptkbp:regulates |
gptkb:medical_devices
|
| gptkbp:supports |
risk management
market surveillance |
| gptkbp:bfsParent |
gptkb:EU_In_Vitro_Diagnostic_Regulation
gptkb:MDR_(Medical_Device_Regulation)_EU_2017/745 |
| gptkbp:bfsLayer |
8
|