MDR
E458512
MDR is the European Union’s comprehensive regulatory framework governing the safety, performance, and market approval of medical devices.
All labels observed (1)
| Label | Occurrences |
|---|---|
| MDR canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T4617061 — 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: MDR Context triple: [European Union medical device regulations, hasAbbreviation, MDR]
-
A.
MDE
MDE is the state agency in Maryland responsible for protecting and restoring the environment and public health through regulation, monitoring, and enforcement of environmental laws.
-
B.
MDC
MDC is a Zimbabwean opposition political party known as the Movement for Democratic Change, which has played a major role in challenging the long-standing rule of ZANU–PF.
-
C.
MDAR
MDAR is the Massachusetts state agency responsible for promoting agriculture, supporting farmers, and overseeing agricultural policy, food safety, and related environmental resources.
-
D.
MCD
MCD is a system of urban and suburban commuter rail lines in Moscow designed to function like an express metro, connecting the city with its surrounding regions.
-
E.
MDA
MDA (Monochrome Display Adapter) is IBM's original text-only video display standard for early IBM PCs, providing high-resolution monochrome output without graphics capabilities.
- 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: MDR Target entity description: MDR is the European Union’s comprehensive regulatory framework governing the safety, performance, and market approval of medical devices.
-
A.
MDE
MDE is the state agency in Maryland responsible for protecting and restoring the environment and public health through regulation, monitoring, and enforcement of environmental laws.
-
B.
MDC
MDC is a Zimbabwean opposition political party known as the Movement for Democratic Change, which has played a major role in challenging the long-standing rule of ZANU–PF.
-
C.
MDAR
MDAR is the Massachusetts state agency responsible for promoting agriculture, supporting farmers, and overseeing agricultural policy, food safety, and related environmental resources.
-
D.
MCD
MCD is a system of urban and suburban commuter rail lines in Moscow designed to function like an express metro, connecting the city with its surrounding regions.
-
E.
MDA
MDA (Monochrome Display Adapter) is IBM's original text-only video display standard for early IBM PCs, providing high-resolution monochrome output without graphics capabilities.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
European Union regulation
ⓘ
medical device regulation ⓘ |
| adoptionDate | 2017-04-05 ⓘ |
| alsoKnownAs |
Medical Device Regulation
ⓘ
linked to:
European Union medical device regulations
|
| appliesTo |
authorised representatives of manufacturers
ⓘ
distributors of medical devices ⓘ importers of medical devices ⓘ manufacturers of medical devices ⓘ |
| classificationSystem | risk-based classification into classes I, IIa, IIb, III ⓘ |
| contains |
Annex I General Safety and Performance Requirements
ⓘ
Annex IX Conformity Assessment based on a Quality Management System and on Assessment of Technical Documentation ⓘ Annex VIII Classification Rules ⓘ Annex X Clinical Evaluation ⓘ Annex XIV Clinical Evaluation and Post-market Clinical Follow-up ⓘ |
| effectiveDate | 2017-05-25 ⓘ |
| establishes | European database on medical devices (EUDAMED) ⓘ |
| fullApplicationDate | 2021-05-26 ⓘ |
| fullName | Regulation (EU) 2017/745 ⓘ |
| governs |
market approval of medical devices in the EU
ⓘ
performance of medical devices in the EU market ⓘ safety of medical devices in the EU market ⓘ |
| introduces |
increased transparency through EUDAMED database
ⓘ
more stringent rules for notified bodies ⓘ person responsible for regulatory compliance ⓘ stricter requirements for clinical evidence ⓘ unique device identification system ⓘ |
| jurisdiction | European Union ⓘ |
| legalBasis | Article 114 of the Treaty on the Functioning of the European Union ⓘ |
| objective |
ensure high level of protection of health for patients and users
ⓘ
ensure smooth functioning of the internal market for medical devices ⓘ |
| publicationDate | 2017-05-05 ⓘ |
| regulates |
clinical evaluation of medical devices
ⓘ
conformity assessment of medical devices ⓘ market surveillance of medical devices ⓘ post-market surveillance of medical devices ⓘ registration of devices and economic operators ⓘ vigilance and incident reporting for medical devices ⓘ |
| replaces |
Active Implantable Medical Devices Directive 90/385/EEC
ⓘ
Medical Devices Directive 93/42/EEC ⓘ |
| requires |
CE marking for medical devices
ⓘ
implant cards for patients with implantable devices ⓘ periodic safety update reports for certain devices ⓘ post-market clinical follow-up where appropriate ⓘ quality management system for manufacturers ⓘ risk management system for medical devices ⓘ |
| scope |
accessories for medical devices
ⓘ
certain groups of products without an intended medical purpose ⓘ 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: MDR Description of subject: MDR is the European Union’s comprehensive regulatory framework governing the safety, performance, and market approval of medical devices.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.