European Medical Device Regulation
GPTKB entity
Statements (74)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:municipality
|
| gptkbp:bfsLayer |
5
|
| gptkbp:bfsParent |
gptkb:ISO_14971
|
| gptkbp:aims_to |
ensure safety and performance of medical devices
|
| gptkbp:applies_to |
gptkb:hospital
in vitro diagnostic devices manufacturers in the EU |
| gptkbp:collaborated_with |
research projects
stakeholder consultations |
| gptkbp:effective_date |
May 26, 2021
|
| gptkbp:enforces |
gptkb:legislation
|
| gptkbp:established |
rules for notified bodies
|
| gptkbp:examines |
gptkb:academic_research
policy debates |
| gptkbp:facilitates |
market access for medical devices
|
| https://www.w3.org/2000/01/rdf-schema#label |
European Medical Device Regulation
|
| gptkbp:includes |
post-market surveillance requirements
provisions for clinical investigations |
| gptkbp:influence |
vigilance reporting obligations
|
| gptkbp:is_analyzed_in |
regulatory impact assessments
|
| gptkbp:is_associated_with |
market surveillance activities
|
| gptkbp:is_challenged_by |
advocacy groups
legal disputes small manufacturers |
| gptkbp:is_connected_to |
patient safety initiatives
digital health initiatives innovation in medical technology health technology assessment. |
| gptkbp:is_criticized_for |
complexity of compliance
|
| gptkbp:is_discussed_in |
gptkb:international_forums
policy papers media articles regulatory forums medical device conferences |
| gptkbp:is_evaluated_by |
regulatory bodies
compliance audits impact studies independent reviews |
| gptkbp:is_implemented_in |
gptkb:EU_member_states
|
| gptkbp:is_influenced_by |
international standards
public health concerns |
| gptkbp:is_informed_by |
stakeholder feedback
scientific evidence |
| gptkbp:is_linked_to |
sustainability efforts
post-market clinical follow-up |
| gptkbp:is_monitored_by |
competent authorities
|
| gptkbp:is_part_of |
EU regulatory framework
EU health policy global regulatory landscape |
| gptkbp:is_promoted_by |
training programs
public awareness campaigns healthcare organizations professional associations |
| gptkbp:is_reflected_in |
industry standards
national laws |
| gptkbp:is_related_to |
gptkb:EU_In_Vitro_Diagnostic_Regulation
gptkb:EU_Medical_Device_Coordination_Group General Safety and Performance Requirements |
| gptkbp:is_reviewed_by |
gptkb:legislation
legal experts regulatory experts |
| gptkbp:is_subject_to |
gptkb:Constitution
legal challenges transitional provisions |
| gptkbp:is_supported_by |
technical committees
industry stakeholders guidance documents |
| gptkbp:mandates |
gptkb:CE_marking_for_medical_devices
|
| gptkbp:provides |
guidelines for risk management
|
| gptkbp:replaced_by |
gptkb:Medical_Device_Directive_(MDD)
|
| gptkbp:requires |
gptkb:document
clinical evaluation labeling and instructions for use |
| gptkbp:updates |
subsequent regulations
|