Council Directive 93/42/EEC on medical devices
E458510
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.
All labels observed (5)
How this entity was disambiguated
This entity first appeared as the object of triple T4617057 — 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 93/42/EEC on medical devices Context triple: [European Union medical device regulations, replaced, Council Directive 93/42/EEC on medical devices]
-
A.
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.
-
B.
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.
-
C.
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.
-
D.
Council Regulation (EEC) No 1210/90
Council Regulation (EEC) No 1210/90 is the European Union legal act that established the European Environment Agency and set out its mandate and operational framework.
-
E.
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.
- 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 93/42/EEC on medical devices Target entity description: 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.
-
A.
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.
-
B.
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.
-
C.
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.
-
D.
Council Regulation (EEC) No 1210/90
Council Regulation (EEC) No 1210/90 is the European Union legal act that established the European Environment Agency and set out its mandate and operational framework.
-
E.
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.
- F. None of above. chosen
Statements (63)
| Predicate | Object |
|---|---|
| instanceOf |
European Union directive
ⓘ
medical device regulation ⓘ |
| abbreviation | MDD ⓘ |
| adoptedBy |
Council of the European Communities
ⓘ
linked to:
Council of the European Union
|
| aimsTo |
ensure free movement of medical devices within the internal market
ⓘ
ensure high level of protection of health and safety for patients, users and others ⓘ |
| amendedBy |
Directive 2000/70/EC
ⓘ
Directive 2001/104/EC ⓘ Directive 2003/12/EC ⓘ Directive 2007/47/EC ⓘ Directive 98/79/EC ⓘ Regulation (EC) No 1882/2003 ⓘ Regulation (EC) No 596/2009 ⓘ |
| appliesTo |
placing on the market of medical devices in the European Union
ⓘ
putting into service of medical devices in the European Union ⓘ |
| cameIntoForce | 1993-06-14 ⓘ |
| classificationSystem |
Class I
ⓘ
Class III ⓘ Class IIa ⓘ Class IIb ⓘ |
| covers |
active medical devices
ⓘ
non-active medical devices ⓘ |
| dateAdopted | 1993-06-14 ⓘ |
| defines |
accessory to a medical device
ⓘ
medical device ⓘ |
| effectiveFrom | 1993-06-14 ⓘ |
| establishes |
classification rules for medical devices
ⓘ
conformity assessment procedures for medical devices ⓘ |
| EULegislationArea |
internal market
ⓘ
public health ⓘ |
| excludes |
active implantable medical devices covered by Directive 90/385/EEC
ⓘ
in vitro diagnostic medical devices covered by Directive 98/79/EC ⓘ |
| fullName | Council Directive 93/42/EEC of 14 June 1993 concerning medical devices ⓘ |
| harmonisedWith |
Directive 90/385/EEC on active implantable medical devices
ⓘ
Directive 98/79/EC on in vitro diagnostic medical devices ⓘ |
| implementedBy | national laws of EU Member States ⓘ |
| jurisdiction | European Union ⓘ |
| languageVersions | all official EU languages ⓘ |
| legalBasis |
Treaty establishing the European Economic Community
ⓘ
linked to:
Treaty of Rome
|
| OJPagination | page 1–43 ⓘ |
| providesFor |
competent authorities in Member States
ⓘ
designation of notified bodies by Member States ⓘ safeguard clause procedures ⓘ |
| publicationDate | 1993-07-12 ⓘ |
| publishedIn |
Official Journal of the European Communities L 169
ⓘ
linked to:
Official Journal of the European Union
|
| repealedBy | Regulation (EU) 2017/745 ⓘ |
| repealEffectiveDate | 2021-05-26 ⓘ |
| repealPostponedBy | Regulation (EU) 2020/561 ⓘ |
| replacedBy |
Regulation (EU) 2017/745 on medical devices
ⓘ
linked to:
Regulation (EU) 2017/745
|
| requires |
CE marking for compliant medical devices
ⓘ
appropriate labeling and instructions for use ⓘ clinical evaluation of medical devices ⓘ manufacturer to implement quality management systems for certain device classes ⓘ manufacturers to draw up an EC declaration of conformity ⓘ post-market surveillance by manufacturers ⓘ risk analysis and risk management for medical devices ⓘ technical documentation for medical devices ⓘ vigilance reporting of serious incidents and field safety corrective actions ⓘ |
| sets | essential requirements for safety and performance of medical devices ⓘ |
| shortName | Medical Devices Directive ⓘ |
| status | repealed ⓘ |
| subjectMatter | medical devices ⓘ |
| wasInForceUntil | 2021-05-25 ⓘ |
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 93/42/EEC on medical devices Description of subject: 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.
Referenced by (6)
Full triples — surface form annotated when it differs from this entity's canonical label.
European Union medical device regulations
→
replaced
→
Council Directive 93/42/EEC on medical devices
ⓘ
Council Directive 93/42/EEC
→
fullName
→
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
ⓘ
subject linked to:
Council Directive 93/42/EEC on medical devices
linked to: Council Directive 93/42/EEC on medical devices
subject linked to:
Council Directive 93/42/EEC on medical devices
linked to: Council Directive 93/42/EEC on medical devices
Directive 98/79/EC on in vitro diagnostic medical devices
→
relatedTo
→
Directive 93/42/EEC concerning medical devices
ⓘ
linked to: Council Directive 93/42/EEC on medical devices
linked to: Council Directive 93/42/EEC on medical devices
subject linked to:
Council Directive 90/385/EEC on active implantable medical devices