Regulation (EU) 2017/746 on in vitro diagnostic medical devices
E460822
Regulation (EU) 2017/746 on in vitro diagnostic medical devices is the European Union’s comprehensive legal framework governing the safety, performance, and market access of in vitro diagnostic medical devices.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Regulation (EU) 2017/746 on in vitro diagnostic medical devices canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T4617056 — 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: Regulation (EU) 2017/746 on in vitro diagnostic medical devices Context triple: [European Union medical device regulations, hasCoreInstrument, Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
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A.
Directive 98/79/EC on in vitro diagnostic medical devices
Directive 98/79/EC on in vitro diagnostic medical devices was an EU legal framework that set safety, performance, and conformity requirements for in vitro diagnostic medical devices placed on the European market.
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B.
Regulation (EU) 2018/1727
Regulation (EU) 2018/1727 is the EU legal act that establishes and governs the functioning, mandate, and powers of Eurojust in supporting and coordinating cross-border criminal investigations and prosecutions among Member States.
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C.
Regulation (EU) 2016/794
Regulation (EU) 2016/794 is an EU legal act that modernised and strengthened the mandate, structure, and operational framework of Europol as the Union’s law enforcement agency.
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D.
Regulation (EU) No 1151/2012
Regulation (EU) No 1151/2012 is a European Union law that establishes the quality schemes and protection framework for agricultural products and foodstuffs, including designations such as Protected Designation of Origin and Protected Geographical Indication.
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E.
Regulation (EU) 2019/787
Regulation (EU) 2019/787 is a European Union law that harmonizes the rules for the production, labeling, and protection of spirit drinks, including geographical indications such as Protected Designations of Origin.
- 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: Regulation (EU) 2017/746 on in vitro diagnostic medical devices Target entity description: Regulation (EU) 2017/746 on in vitro diagnostic medical devices is the European Union’s comprehensive legal framework governing the safety, performance, and market access of in vitro diagnostic medical devices.
-
A.
Directive 98/79/EC on in vitro diagnostic medical devices
Directive 98/79/EC on in vitro diagnostic medical devices was an EU legal framework that set safety, performance, and conformity requirements for in vitro diagnostic medical devices placed on the European market.
-
B.
Regulation (EU) 2018/1727
Regulation (EU) 2018/1727 is the EU legal act that establishes and governs the functioning, mandate, and powers of Eurojust in supporting and coordinating cross-border criminal investigations and prosecutions among Member States.
-
C.
Regulation (EU) 2016/794
Regulation (EU) 2016/794 is an EU legal act that modernised and strengthened the mandate, structure, and operational framework of Europol as the Union’s law enforcement agency.
-
D.
Regulation (EU) No 1151/2012
Regulation (EU) No 1151/2012 is a European Union law that establishes the quality schemes and protection framework for agricultural products and foodstuffs, including designations such as Protected Designation of Origin and Protected Geographical Indication.
-
E.
Regulation (EU) 2019/787
Regulation (EU) 2019/787 is a European Union law that harmonizes the rules for the production, labeling, and protection of spirit drinks, including geographical indications such as Protected Designations of Origin.
- F. None of above. chosen
Statements (51)
| Predicate | Object |
|---|---|
| instanceOf |
EU legislative act
ⓘ
European Union regulation ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| aimsTo |
ensure high level of protection of health for patients and users
ⓘ
ensure smooth functioning of the internal market for in vitro diagnostic medical devices ⓘ |
| classificationRule |
Class A
ⓘ
Class B ⓘ Class C ⓘ Class D ⓘ |
| contains |
general safety and performance requirements
ⓘ
provisions on clinical evidence and performance evaluation ⓘ provisions on companion diagnostics ⓘ provisions on devices for near-patient testing ⓘ provisions on devices for self-testing ⓘ provisions on in-house devices manufactured by health institutions ⓘ provisions on market surveillance by competent authorities ⓘ provisions on notified bodies designation and oversight ⓘ provisions on performance studies ⓘ |
| dateOfAdoption | 2017-04-05 ⓘ |
| dateOfApplication | 2022-05-26 ⓘ |
| dateOfEntryIntoForce | 2017-05-26 ⓘ |
| dateOfPublication | 2017-05-05 ⓘ |
| defines |
obligations of authorised representatives
ⓘ
obligations of distributors ⓘ obligations of importers ⓘ obligations of manufacturers of in vitro diagnostic medical devices ⓘ requirements for safety and performance of in vitro diagnostic medical devices ⓘ |
| establishes | Eudamed database for in vitro diagnostic medical devices NERFINISHED ⓘ |
| introduces |
Unique Device Identification system for in vitro diagnostic medical devices
ⓘ
risk-based classification system for in vitro diagnostic medical devices ⓘ |
| jurisdiction | European Union ⓘ |
| languageVersion | all official EU languages ⓘ |
| legalBasis | Treaty on the Functioning of the European Union ⓘ |
| OJReference | OJ L 117, 5.5.2017, p. 176–332 ⓘ |
| policyArea |
internal market
ⓘ
public health ⓘ |
| publishedIn | Official Journal of the European Union NERFINISHED ⓘ |
| relatedTo | Regulation (EU) 2017/745 on medical devices NERFINISHED ⓘ |
| repeals | Directive 98/79/EC on in vitro diagnostic medical devices NERFINISHED ⓘ |
| requires |
CE marking for compliant in vitro diagnostic medical devices
ⓘ
conformity assessment procedures for in vitro diagnostic medical devices ⓘ post-market surveillance system ⓘ quality management system for manufacturers ⓘ vigilance reporting of serious incidents and field safety corrective actions ⓘ |
| setsOut |
rules for making in vitro diagnostic medical devices available on the EU market
ⓘ
rules for placing in vitro diagnostic medical devices on the EU market ⓘ rules for putting in vitro diagnostic medical devices into service ⓘ |
| shortName |
IVDR
NERFINISHED
ⓘ
In Vitro Diagnostic Medical Devices Regulation NERFINISHED ⓘ |
| subjectMatter | in vitro diagnostic medical devices ⓘ |
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: Regulation (EU) 2017/746 on in vitro diagnostic medical devices Description of subject: Regulation (EU) 2017/746 on in vitro diagnostic medical devices is the European Union’s comprehensive legal framework governing the safety, performance, and market access of in vitro diagnostic medical devices.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.
European Union medical device regulations
→
hasCoreInstrument
→
Regulation (EU) 2017/746 on in vitro diagnostic medical devices
ⓘ