Directive 98/79/EC on in vitro diagnostic medical devices
E458511
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.
All labels observed (4)
How this entity was disambiguated
This entity first appeared as the object of triple T4617059 — 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: Directive 98/79/EC on in vitro diagnostic medical devices Context triple: [European Union medical device regulations, replaced, Directive 98/79/EC on in vitro diagnostic medical devices]
-
A.
Regulation (EC) No 726/2004
Regulation (EC) No 726/2004 is an EU law that establishes the centralized procedure for the authorization and supervision of medicinal products and defines the role and powers of the European Medicines Agency.
-
B.
Directive 2009/147/EC
Directive 2009/147/EC is a key European Union law on the conservation of wild birds, forming one of the main legal pillars of the Natura 2000 protected areas network.
-
C.
Regulation (EC) No 45/2001
Regulation (EC) No 45/2001 is an EU law that sets out data protection rules for the processing of personal data by EU institutions and bodies.
-
D.
Council Directive 2001/86/EC
Council Directive 2001/86/EC is a European Union legal act that supplements the Statute for a European Company (Societas Europaea) by establishing rules on employee involvement in such companies.
-
E.
Regulation (EC) No 851/2004
Regulation (EC) No 851/2004 is the EU law that established the European Centre for Disease Prevention and Control and defined its mandate, structure, and functions in coordinating infectious disease surveillance and control across member states.
- 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: Directive 98/79/EC on in vitro diagnostic medical devices Target entity description: 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.
-
A.
Regulation (EC) No 726/2004
Regulation (EC) No 726/2004 is an EU law that establishes the centralized procedure for the authorization and supervision of medicinal products and defines the role and powers of the European Medicines Agency.
-
B.
Directive 2009/147/EC
Directive 2009/147/EC is a key European Union law on the conservation of wild birds, forming one of the main legal pillars of the Natura 2000 protected areas network.
-
C.
Regulation (EC) No 45/2001
Regulation (EC) No 45/2001 is an EU law that sets out data protection rules for the processing of personal data by EU institutions and bodies.
-
D.
Council Directive 2001/86/EC
Council Directive 2001/86/EC is a European Union legal act that supplements the Statute for a European Company (Societas Europaea) by establishing rules on employee involvement in such companies.
-
E.
Regulation (EC) No 851/2004
Regulation (EC) No 851/2004 is the EU law that established the European Centre for Disease Prevention and Control and defined its mandate, structure, and functions in coordinating infectious disease surveillance and control across member states.
- F. None of above. chosen
Statements (50)
| Predicate | Object |
|---|---|
| instanceOf |
EU legal act
ⓘ
European Union directive ⓘ |
| adoptedBy |
Council of the European Union
ⓘ
European Parliament ⓘ |
| adoptionDate | 1998-10-27 ⓘ |
| aimsTo |
ensure a high level of protection of health and safety for patients, users and others
ⓘ
ensure the free movement of in vitro diagnostic medical devices within the internal market ⓘ |
| applicationDate | 2003-12-07 ⓘ |
| appliesTo | in vitro diagnostic medical devices intended for use in the European Union ⓘ |
| citation | Directive 98/79/EC ⓘ |
| establishes |
classification rules for certain in vitro diagnostic medical devices
ⓘ
conformity assessment procedures for in vitro diagnostic medical devices ⓘ essential requirements for in vitro diagnostic medical devices ⓘ specific provisions for devices for performance evaluation ⓘ specific provisions for devices for self-testing ⓘ |
| excludes | devices for general laboratory use unless specifically intended by the manufacturer for in vitro diagnostic examination ⓘ |
| geographicalScope | European Economic Area ⓘ |
| harmonises | national laws on in vitro diagnostic medical devices within the EU internal market ⓘ |
| implementedBy | EU Member States through national legislation ⓘ |
| jurisdiction | European Union ⓘ |
| languageVersions | all official languages of the European Union ⓘ |
| legalBasis |
Treaty establishing the European Community
ⓘ
linked to:
Treaty of Rome
|
| legalForm | directive ⓘ |
| officialName | Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices ⓘ |
| OJNumber | 331 ⓘ |
| OJPublicationDate | 1998-12-07 ⓘ |
| OJSeries | L ⓘ |
| policyArea | public health ⓘ |
| providesFor |
designation of notified bodies by Member States
ⓘ
safeguard clause procedures for unsafe devices ⓘ vigilance system for in vitro diagnostic medical devices ⓘ |
| publishedIn |
Official Journal of the European Communities
ⓘ
linked to:
Official Journal of the European Union
|
| regulates |
placing on the market of in vitro diagnostic medical devices
ⓘ
putting into service of in vitro diagnostic medical devices ⓘ |
| relatedTo |
Directive 90/385/EEC on active implantable medical devices
ⓘ
Directive 93/42/EEC concerning medical devices ⓘ |
| repealedBy | Regulation (EU) 2017/746 on in vitro diagnostic medical devices ⓘ |
| repealEffectiveDate | 2022-05-26 ⓘ |
| requires |
CE marking for compliant in vitro diagnostic medical devices
ⓘ
manufacturers to implement quality assurance systems ⓘ manufacturers to issue an EC declaration of conformity ⓘ manufacturers to prepare technical documentation ⓘ manufacturers to report serious incidents and field safety corrective actions ⓘ |
| sector | medical devices law ⓘ |
| setsRequirementFor |
conformity assessment of in vitro diagnostic medical devices
ⓘ
performance of in vitro diagnostic medical devices ⓘ safety of in vitro diagnostic medical devices ⓘ |
| shortName | IVD Directive ⓘ |
| subjectMatter | in vitro diagnostic medical devices ⓘ |
| transpositionDeadline | 2000-12-07 ⓘ |
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: Directive 98/79/EC on in vitro diagnostic medical devices Description of subject: 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.
Referenced by (7)
Full triples — surface form annotated when it differs from this entity's canonical label.
European Union medical device regulations
→
replaced
→
Directive 98/79/EC on in vitro diagnostic medical devices
ⓘ
Council Directive 93/42/EEC
→
harmonisedWith
→
Directive 98/79/EC on in vitro diagnostic medical devices
ⓘ
subject linked to:
Council Directive 93/42/EEC on medical devices
Directive 98/79/EC on in vitro diagnostic medical devices
→
officialName
→
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
ⓘ
linked to: Directive 98/79/EC on in vitro diagnostic medical devices
linked to: Directive 98/79/EC on in vitro diagnostic medical devices
linked to: Directive 98/79/EC on in vitro diagnostic medical devices
Regulation (EU) 2017/746 on in vitro diagnostic medical devices
→
repeals
→
Directive 98/79/EC on in vitro diagnostic medical devices
ⓘ
Council Directive 90/385/EEC
→
relatedTo
→
Directive 98/79/EC on in vitro diagnostic medical devices
ⓘ
subject linked to:
Council Directive 90/385/EEC on active implantable medical devices