EU In Vitro Diagnostic Regulation
GPTKB entity
Statements (58)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:municipality
|
| gptkbp:bfsLayer |
6
|
| gptkbp:bfsParent |
gptkb:European_Medical_Device_Regulation
|
| gptkbp:addresses |
software as a medical device
|
| gptkbp:aims_to |
ensure safety and performance of in vitro diagnostic devices
|
| gptkbp:applies_to |
in vitro diagnostic medical devices
companion diagnostics |
| gptkbp:effective_date |
May 26, 2022
|
| gptkbp:enacted_by |
gptkb:legislation
|
| gptkbp:enhances |
patient safety
|
| gptkbp:established |
gptkb:European_Database_on_Medical_Devices_(EUDAMED)
|
| gptkbp:examines |
legal experts
|
| gptkbp:facilitates |
market access for innovative diagnostics
|
| https://www.w3.org/2000/01/rdf-schema#label |
EU In Vitro Diagnostic Regulation
|
| gptkbp:includes |
provisions for economic operators
rules for labelling and instructions for use |
| gptkbp:influence |
stricter requirements for high-risk devices
|
| gptkbp:is_analyzed_in |
gptkb:academic_research
|
| gptkbp:is_challenged_by |
some manufacturers
|
| gptkbp:is_cited_in |
policy papers
|
| gptkbp:is_connected_to |
healthcare delivery
health technology assessment |
| gptkbp:is_criticized_for |
complexity of compliance
|
| gptkbp:is_designed_to |
protect public health
|
| gptkbp:is_discussed_in |
gptkb:EU_Parliament
medical conferences regulatory forums |
| gptkbp:is_evaluated_by |
stakeholder feedback
regulatory authorities regulatory impact |
| gptkbp:is_implemented_in |
member states of the EU
|
| gptkbp:is_influenced_by |
international standards
scientific advancements |
| gptkbp:is_linked_to |
patient outcomes
|
| gptkbp:is_monitored_by |
Notified Bodies
|
| gptkbp:is_part_of |
EU health policy
EU Medical Device Regulation framework EU regulatory landscape |
| gptkbp:is_promoted_by |
healthcare organizations
|
| gptkbp:is_referenced_in |
gptkb:document
|
| gptkbp:is_related_to |
gptkb:municipality
healthcare regulations diagnostic innovation in vitro diagnostics market |
| gptkbp:is_reviewed_by |
gptkb:legislation
|
| gptkbp:is_subject_to |
EU law
public consultation |
| gptkbp:is_supported_by |
industry stakeholders
patient advocacy groups |
| gptkbp:mandates |
post-market surveillance
|
| gptkbp:promotes |
transparency in the market
|
| gptkbp:provides |
guidelines for clinical performance studies
|
| gptkbp:replaced_by |
IVD Directive 98/79/ EC
|
| gptkbp:requires |
risk classification of devices
vigilance reporting clinical evidence for device performance |
| gptkbp:supports |
patient access to diagnostics
|
| gptkbp:updates |
amendments and guidelines
|