Council Directive 90/385/EEC on active implantable medical devices
E460823
Council Directive 90/385/EEC on active implantable medical devices was an EU legal framework that set essential safety and performance requirements for active implantable medical devices such as pacemakers and implantable defibrillators.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Council Directive 90/385/EEC on active implantable medical devices canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T4617058 — 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: Council Directive 90/385/EEC on active implantable medical devices Context triple: [European Union medical device regulations, replaced, Council Directive 90/385/EEC on active implantable medical devices]
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A.
Council Directive 93/42/EEC on medical devices
Council Directive 93/42/EEC on medical devices was a key European Union legislative framework that set essential safety and performance requirements for medical devices marketed within the EU.
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B.
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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C.
European Union medical device regulations
European Union medical device regulations are a comprehensive set of legal and technical requirements governing the safety, performance, quality management, and market approval of medical devices within EU member states.
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D.
Council Directive 92/43/EEC
Council Directive 92/43/EEC is a key European Union law on the conservation of natural habitats and wild fauna and flora, forming one of the main pillars of EU nature protection policy.
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E.
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.
- 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: Council Directive 90/385/EEC on active implantable medical devices Target entity description: Council Directive 90/385/EEC on active implantable medical devices was an EU legal framework that set essential safety and performance requirements for active implantable medical devices such as pacemakers and implantable defibrillators.
-
A.
Council Directive 93/42/EEC on medical devices
Council Directive 93/42/EEC on medical devices was a key European Union legislative framework that set essential safety and performance requirements for medical devices marketed within the EU.
-
B.
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.
-
C.
European Union medical device regulations
European Union medical device regulations are a comprehensive set of legal and technical requirements governing the safety, performance, quality management, and market approval of medical devices within EU member states.
-
D.
Council Directive 92/43/EEC
Council Directive 92/43/EEC is a key European Union law on the conservation of natural habitats and wild fauna and flora, forming one of the main pillars of EU nature protection policy.
-
E.
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.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
EU medical devices legislation
ⓘ
European Union directive ⓘ |
| adoptedBy | Council of the European Communities NERFINISHED ⓘ |
| adoptionYear | 1990 ⓘ |
| aimsTo |
ensure a high level of protection of patients and users
ⓘ
ensure free movement of active implantable medical devices within the internal market ⓘ |
| amendedBy |
Directive 2007/47/EC
NERFINISHED
ⓘ
Directive 93/42/EEC NERFINISHED ⓘ |
| appliesTo | EU Member States NERFINISHED ⓘ |
| complements | general product safety rules in the EU ⓘ |
| defines | active implantable medical device ⓘ |
| enteredIntoForceYear | 1990 ⓘ |
| establishes |
essential requirements for design and manufacture of active implantable medical devices
ⓘ
obligations for manufacturers of active implantable medical devices ⓘ obligations for notified bodies ⓘ |
| EULawArea |
internal market
ⓘ
public health ⓘ |
| fullName | Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices NERFINISHED ⓘ |
| harmonises | national laws of EU Member States on active implantable medical devices ⓘ |
| jurisdiction | European Union ⓘ |
| language | all official languages of the European Union ⓘ |
| legalBasis | Treaty establishing the European Economic Community NERFINISHED ⓘ |
| legalForm | directive ⓘ |
| policyObjective | approximation of laws of the Member States relating to active implantable medical devices ⓘ |
| publishedIn | Official Journal of the European Communities NERFINISHED ⓘ |
| regulates |
active implantable medical devices for diagnostic purposes
ⓘ
active implantable medical devices for therapeutic purposes ⓘ implantable cardioverter defibrillators ⓘ pacemakers ⓘ |
| relatedTo |
Council Directive 93/42/EEC on medical devices
NERFINISHED
ⓘ
Directive 98/79/EC on in vitro diagnostic medical devices NERFINISHED ⓘ |
| repealedBy | Regulation (EU) 2017/745 on medical devices NERFINISHED ⓘ |
| repealEffectiveDate | 26 May 2021 ⓘ |
| requires |
CE marking for compliant active implantable medical devices
ⓘ
information and labelling for safe use of active implantable medical devices ⓘ protection against electrical, mechanical and thermal risks ⓘ reliability of power sources for active implantable medical devices ⓘ risk analysis and risk reduction for active implantable medical devices ⓘ |
| scope |
placing on the market of active implantable medical devices
ⓘ
putting into service of active implantable medical devices ⓘ |
| setsRequirementsFor |
clinical investigation of active implantable medical devices
ⓘ
conformity assessment of active implantable medical devices ⓘ performance of active implantable medical devices ⓘ safety of active implantable medical devices ⓘ |
| shortName | AIMDD NERFINISHED ⓘ |
| subjectMatter | active implantable medical devices ⓘ |
| typeOfStandard | New Approach directive NERFINISHED ⓘ |
| usesConcept | conformity assessment by notified bodies ⓘ |
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: Council Directive 90/385/EEC on active implantable medical devices Description of subject: Council Directive 90/385/EEC on active implantable medical devices was an EU legal framework that set essential safety and performance requirements for active implantable medical devices such as pacemakers and implantable defibrillators.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.
European Union medical device regulations
→
replaced
→
Council Directive 90/385/EEC on active implantable medical devices
ⓘ