IVDR
E458513
IVDR is the European Union’s regulatory framework governing the safety, performance, and market approval of in vitro diagnostic medical devices.
Statements (53)
| Predicate | Object |
|---|---|
| instanceOf |
European Union regulation
ⓘ
medical device regulation ⓘ |
| adoptionDate | 2017-04-05 ⓘ |
| appliesTo |
EU distributors of in vitro diagnostic medical devices
ⓘ
EU importers of in vitro diagnostic medical devices ⓘ EU reference laboratories for in vitro diagnostic medical devices ⓘ authorised representatives of non-EU manufacturers ⓘ manufacturers of in vitro diagnostic medical devices ⓘ notified bodies for in vitro diagnostic medical devices ⓘ |
| classificationRule |
Class A
ⓘ
Class B ⓘ Class C ⓘ Class D ⓘ |
| contains |
Annex I General Safety and Performance Requirements
ⓘ
Annex II Technical Documentation ⓘ Annex III Technical Documentation on Post-market Surveillance ⓘ Annex IX Conformity Assessment based on a Quality Management System and on Assessment of Technical Documentation ⓘ Annex X Conformity Assessment based on Type-examination ⓘ Annex XI Conformity Assessment based on Production Quality Assurance ⓘ |
| dateOfApplication | 2022-05-26 ⓘ |
| defines | risk-based classification rules for in vitro diagnostic medical devices ⓘ |
| enforcedBy | competent authorities of EU Member States ⓘ |
| enteredIntoForce | 2017-05-26 ⓘ |
| establishes | EUDAMED database for in vitro diagnostic medical devices ⓘ |
| fullName | In Vitro Diagnostic Medical Devices Regulation NERFINISHED ⓘ |
| governs | in vitro diagnostic medical devices ⓘ |
| harmonisedWith | Medical Devices Regulation (EU) 2017/745 NERFINISHED ⓘ |
| jurisdiction | European Union ⓘ |
| language | all official languages of the European Union ⓘ |
| legalBasis |
Article 114 of the Treaty on the Functioning of the European Union
NERFINISHED
ⓘ
Article 168(4)(c) of the Treaty on the Functioning of the European Union NERFINISHED ⓘ |
| monitoredBy | European Commission NERFINISHED ⓘ |
| objective |
ensure high level of health protection for patients and users
ⓘ
ensure safety and performance of in vitro diagnostic medical devices ⓘ ensure smooth functioning of the internal market for in vitro diagnostic medical devices ⓘ |
| publicationDate | 2017-05-05 ⓘ |
| regulationNumber | Regulation (EU) 2017/746 ⓘ |
| replaced |
Directive 98/79/EC
NERFINISHED
ⓘ
In Vitro Diagnostic Medical Devices Directive NERFINISHED ⓘ |
| requires |
clinical evidence for in vitro diagnostic medical devices
ⓘ
conformity assessment procedures based on risk class ⓘ performance evaluation of in vitro diagnostic medical devices ⓘ post-market surveillance system ⓘ quality management system for manufacturers ⓘ unique device identification for in vitro diagnostic medical devices ⓘ vigilance reporting of serious incidents and field safety corrective actions ⓘ |
| scopeIncludes |
companion diagnostics
ⓘ
devices for blood grouping and tissue typing ⓘ devices for detection of transmissible agents in blood and tissues ⓘ near-patient testing in vitro diagnostic medical devices ⓘ self-testing in vitro diagnostic medical devices ⓘ |
| sets | rules for in-house devices manufactured and used within health institutions ⓘ |
| typeOfAct | directly applicable regulation ⓘ |
Referenced by (1)
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