Regulation (EU) 2017/746 on in vitro diagnostic medical devices

E460822

EU legislative act European Union regulation

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.

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All labels observed (2)

Label	Occurrences
In Vitro Diagnostic Medical Devices Regulation	2
Regulation (EU) 2017/746 on in vitro diagnostic medical devices canonical	2

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]

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
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 ⓘ European Parliament ⓘ
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 ⓘ linked to: European database on medical devices (EUDAMED)
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 ⓘ
relatedTo	Regulation (EU) 2017/745 on medical devices ⓘ linked to: Regulation (EU) 2017/745
repeals	Directive 98/79/EC on in vitro diagnostic medical devices ⓘ
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 ⓘ In Vitro Diagnostic Medical Devices Regulation ⓘ linked to: Regulation (EU) 2017/746 on in vitro diagnostic medical devices
subjectMatter	in vitro diagnostic medical devices ⓘ

How these facts were elicited

Referenced by (4)

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 ⓘ

Directive 98/79/EC on in vitro diagnostic medical devices → repealedBy → Regulation (EU) 2017/746 on in vitro diagnostic medical devices ⓘ

IVDR → fullName → In Vitro Diagnostic Medical Devices Regulation ⓘ

linked to: Regulation (EU) 2017/746 on in vitro diagnostic medical devices

Regulation (EU) 2017/746 on in vitro diagnostic medical devices → shortName → In Vitro Diagnostic Medical Devices Regulation ⓘ