EU Medical Device Regulation (MDR)
GPTKB entity
Statements (70)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:municipality
|
| gptkbp:bfsLayer |
8
|
| gptkbp:bfsParent |
gptkb:European_Database_on_Medical_Devices_(EUDAMED)
|
| gptkbp:addresses |
safety and performance requirements
|
| gptkbp:aims_to |
ensure safety and performance of medical devices
|
| gptkbp:applies_to |
gptkb:hospital
manufacturers of medical devices |
| gptkbp:effective_date |
May 26, 2021
|
| gptkbp:enacted_by |
gptkb:legislation
|
| gptkbp:enforces |
national authorities
|
| gptkbp:enhances |
transparency in the market
|
| gptkbp:established |
EUDAMED database
|
| gptkbp:examines |
gptkb:hospital
regulatory bodies |
| gptkbp:facilitates |
market access for innovative devices
|
| gptkbp:governed_by |
gptkb:legislation
|
| https://www.w3.org/2000/01/rdf-schema#label |
EU Medical Device Regulation (MDR)
|
| gptkbp:includes |
labeling requirements
vigilance requirements |
| gptkbp:influence |
stricter requirements for notified bodies
|
| gptkbp:introduced |
new classification rules
|
| gptkbp:is_adopted_by |
gptkb:EU_member_states
|
| gptkbp:is_criticized_for |
complexity of compliance
|
| gptkbp:is_designed_to |
protect public health
|
| gptkbp:is_discussed_in |
gptkb:television_channel
conferences webinars public consultations academic literature policy forums |
| gptkbp:is_evaluated_by |
effectiveness
compliance costs implementation challenges impact on innovation impact on patients regulatory burden conformity assessment procedures |
| gptkbp:is_implemented_in |
national legislation
|
| gptkbp:is_influenced_by |
international standards
stakeholder feedback |
| gptkbp:is_informed_by |
scientific evidence
|
| gptkbp:is_linked_to |
gptkb:European_Medicines_Agency_(EMA)
gptkb:Company patient rights market surveillance |
| gptkbp:is_monitored_by |
gptkb:legislation
|
| gptkbp:is_part_of |
gptkb:EU_internal_market
EU regulatory framework healthcare regulation EU health policy global regulatory landscape |
| gptkbp:is_promoted_by |
industry associations
|
| gptkbp:is_related_to |
patient safety
health technology assessment In Vitro Diagnostic Regulation (IVDR) |
| gptkbp:is_reviewed_by |
stakeholders
legal experts |
| gptkbp:is_subject_to |
regular updates
legal challenges public scrutiny |
| gptkbp:is_supported_by |
training programs
advocacy groups research initiatives guidance documents |
| gptkbp:mandates |
post-market surveillance
|
| gptkbp:provides |
guidelines for clinical investigations
|
| gptkbp:replaced_by |
gptkb:Medical_Device_Directive_(MDD)
|
| gptkbp:requires |
gptkb:document
risk management processes clinical evaluation |