IVDR
E458513
IVDR is the European Union’s regulatory framework governing the safety, performance, and market approval of in vitro diagnostic medical devices.
All labels observed (1)
| Label | Occurrences |
|---|---|
| IVDR canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T4617062 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: IVDR Context triple: [European Union medical device regulations, hasAbbreviation, IVDR]
-
A.
UDI
UDI (Union des Démocrates et Indépendants) is a French centrist political party that brings together various moderate, pro-European right and center-right groups.
-
B.
IVDP
IVDP is the Portuguese regulatory and certification body responsible for overseeing the production, quality, and appellation of Port and Douro wines from the Douro Demarcated Region.
-
C.
IRDT
IRDT is the daylight saving time observed in Iran, advancing clocks one hour ahead of Iran Standard Time.
-
D.
EIDR
EIDR (Entertainment Identifier Registry) is a global unique identifier system used by the entertainment industry to reliably track and reference film, television, and other audiovisual content.
-
E.
CIDI
CIDI is a specialized body of the Organization of American States that promotes integral development and cooperation among its member states in the Americas.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: IVDR Target entity description: IVDR is the European Union’s regulatory framework governing the safety, performance, and market approval of in vitro diagnostic medical devices.
-
A.
UDI
UDI (Union des Démocrates et Indépendants) is a French centrist political party that brings together various moderate, pro-European right and center-right groups.
-
B.
IVDP
IVDP is the Portuguese regulatory and certification body responsible for overseeing the production, quality, and appellation of Port and Douro wines from the Douro Demarcated Region.
-
C.
IRDT
IRDT is the daylight saving time observed in Iran, advancing clocks one hour ahead of Iran Standard Time.
-
D.
EIDR
EIDR (Entertainment Identifier Registry) is a global unique identifier system used by the entertainment industry to reliably track and reference film, television, and other audiovisual content.
-
E.
CIDI
CIDI is a specialized body of the Organization of American States that promotes integral development and cooperation among its member states in the Americas.
- F. None of above. chosen
Statements (53)
| Predicate | Object |
|---|---|
| instanceOf |
European Union regulation
ⓘ
medical device regulation ⓘ |
| adoptionDate | 2017-04-05 ⓘ |
| appliesTo |
EU distributors of in vitro diagnostic medical devices
ⓘ
EU importers of in vitro diagnostic medical devices ⓘ EU reference laboratories for in vitro diagnostic medical devices ⓘ authorised representatives of non-EU manufacturers ⓘ manufacturers of in vitro diagnostic medical devices ⓘ notified bodies for in vitro diagnostic medical devices ⓘ |
| classificationRule |
Class A
ⓘ
Class B ⓘ Class C ⓘ Class D ⓘ |
| contains |
Annex I General Safety and Performance Requirements
ⓘ
Annex II Technical Documentation ⓘ Annex III Technical Documentation on Post-market Surveillance ⓘ Annex IX Conformity Assessment based on a Quality Management System and on Assessment of Technical Documentation ⓘ Annex X Conformity Assessment based on Type-examination ⓘ Annex XI Conformity Assessment based on Production Quality Assurance ⓘ |
| dateOfApplication | 2022-05-26 ⓘ |
| defines | risk-based classification rules for in vitro diagnostic medical devices ⓘ |
| enforcedBy | competent authorities of EU Member States ⓘ |
| enteredIntoForce | 2017-05-26 ⓘ |
| establishes | EUDAMED database for in vitro diagnostic medical devices ⓘ |
| fullName | In Vitro Diagnostic Medical Devices Regulation NERFINISHED ⓘ |
| governs | in vitro diagnostic medical devices ⓘ |
| harmonisedWith | Medical Devices Regulation (EU) 2017/745 NERFINISHED ⓘ |
| jurisdiction | European Union ⓘ |
| language | all official languages of the European Union ⓘ |
| legalBasis |
Article 114 of the Treaty on the Functioning of the European Union
NERFINISHED
ⓘ
Article 168(4)(c) of the Treaty on the Functioning of the European Union NERFINISHED ⓘ |
| monitoredBy | European Commission NERFINISHED ⓘ |
| objective |
ensure high level of health protection for patients and users
ⓘ
ensure safety and performance of in vitro diagnostic medical devices ⓘ ensure smooth functioning of the internal market for in vitro diagnostic medical devices ⓘ |
| publicationDate | 2017-05-05 ⓘ |
| regulationNumber | Regulation (EU) 2017/746 ⓘ |
| replaced |
Directive 98/79/EC
NERFINISHED
ⓘ
In Vitro Diagnostic Medical Devices Directive NERFINISHED ⓘ |
| requires |
clinical evidence for in vitro diagnostic medical devices
ⓘ
conformity assessment procedures based on risk class ⓘ performance evaluation of in vitro diagnostic medical devices ⓘ post-market surveillance system ⓘ quality management system for manufacturers ⓘ unique device identification for in vitro diagnostic medical devices ⓘ vigilance reporting of serious incidents and field safety corrective actions ⓘ |
| scopeIncludes |
companion diagnostics
ⓘ
devices for blood grouping and tissue typing ⓘ devices for detection of transmissible agents in blood and tissues ⓘ near-patient testing in vitro diagnostic medical devices ⓘ self-testing in vitro diagnostic medical devices ⓘ |
| sets | rules for in-house devices manufactured and used within health institutions ⓘ |
| typeOfAct | directly applicable regulation ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: IVDR Description of subject: IVDR is the European Union’s regulatory framework governing the safety, performance, and market approval of in vitro diagnostic medical devices.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.