CE marking for medical devices
GPTKB entity
Statements (67)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:Certification
|
| gptkbp:bfsLayer |
6
|
| gptkbp:bfsParent |
gptkb:European_Medical_Device_Regulation
|
| gptkbp:applies_to |
In vitro diagnostic devices
Active implantable medical devices Non-active medical devices |
| gptkbp:appointed_by |
Notified bodies
|
| gptkbp:based_on |
European standards
|
| gptkbp:enforces |
National authorities
|
| gptkbp:ensures |
Compliance with EU legislation
|
| https://www.w3.org/2000/01/rdf-schema#label |
CE marking for medical devices
|
| gptkbp:indication |
Conformity with health, safety, and environmental protection standards
|
| gptkbp:involves |
Risk assessment
|
| gptkbp:is_associated_with |
Regulatory updates
User safety Market access strategies User instructions Market research activities |
| gptkbp:is_considered |
Specific device types
|
| gptkbp:is_influenced_by |
gptkb:standard
|
| gptkbp:is_involved_in |
Market entry strategy
Regulatory submissions Device classification Device lifecycle assessment Device risk management plans |
| gptkbp:is_linked_to |
Regulatory compliance
Labeling requirements Clinical evaluation Regulatory guidance documents User training requirements Safety and efficacy assessments |
| gptkbp:is_part_of |
Quality management systems
Risk management process Quality assurance processes Product lifecycle management EU regulatory framework Market surveillance activities Regulatory compliance audits Regulatory training programs Regulatory strategy |
| gptkbp:is_recognized_by |
European Union member states
|
| gptkbp:is_related_to |
Post-market surveillance
Device innovation Device performance evaluation |
| gptkbp:is_subject_to |
Legal obligations
Periodic audits |
| gptkbp:recognizes |
Quality assurance
|
| gptkbp:regulates |
Medical devices in the European Economic Area
|
| gptkbp:requires |
Technical documentation
Medical software Clinical evaluation reports Clinical trials in the EU Device design validation Device labeling compliance Device market analysis. Device performance testing Device quality control Device registration in the EU Exporting medical devices from the EU Importing medical devices into the EU Market access in the EU Medical devices sold in the EU Post-market clinical follow-up Technical file preparation |
| gptkbp:symbol |
Consumer trust
Product safety |
| gptkbp:updates |
Regulatory changes
|