Regulation (EU) 2017/746 on in vitro diagnostic medical devices
E460822
Regulation (EU) 2017/746 on in vitro diagnostic medical devices is the European Union’s comprehensive legal framework governing the safety, performance, and market access of in vitro diagnostic medical devices.
Statements (51)
| Predicate | Object |
|---|---|
| instanceOf |
EU legislative act
ⓘ
European Union regulation ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| aimsTo |
ensure high level of protection of health for patients and users
ⓘ
ensure smooth functioning of the internal market for in vitro diagnostic medical devices ⓘ |
| classificationRule |
Class A
ⓘ
Class B ⓘ Class C ⓘ Class D ⓘ |
| contains |
general safety and performance requirements
ⓘ
provisions on clinical evidence and performance evaluation ⓘ provisions on companion diagnostics ⓘ provisions on devices for near-patient testing ⓘ provisions on devices for self-testing ⓘ provisions on in-house devices manufactured by health institutions ⓘ provisions on market surveillance by competent authorities ⓘ provisions on notified bodies designation and oversight ⓘ provisions on performance studies ⓘ |
| dateOfAdoption | 2017-04-05 ⓘ |
| dateOfApplication | 2022-05-26 ⓘ |
| dateOfEntryIntoForce | 2017-05-26 ⓘ |
| dateOfPublication | 2017-05-05 ⓘ |
| defines |
obligations of authorised representatives
ⓘ
obligations of distributors ⓘ obligations of importers ⓘ obligations of manufacturers of in vitro diagnostic medical devices ⓘ requirements for safety and performance of in vitro diagnostic medical devices ⓘ |
| establishes | Eudamed database for in vitro diagnostic medical devices NERFINISHED ⓘ |
| introduces |
Unique Device Identification system for in vitro diagnostic medical devices
ⓘ
risk-based classification system for in vitro diagnostic medical devices ⓘ |
| jurisdiction | European Union ⓘ |
| languageVersion | all official EU languages ⓘ |
| legalBasis | Treaty on the Functioning of the European Union ⓘ |
| OJReference | OJ L 117, 5.5.2017, p. 176–332 ⓘ |
| policyArea |
internal market
ⓘ
public health ⓘ |
| publishedIn | Official Journal of the European Union NERFINISHED ⓘ |
| relatedTo | Regulation (EU) 2017/745 on medical devices NERFINISHED ⓘ |
| repeals | Directive 98/79/EC on in vitro diagnostic medical devices NERFINISHED ⓘ |
| requires |
CE marking for compliant in vitro diagnostic medical devices
ⓘ
conformity assessment procedures for in vitro diagnostic medical devices ⓘ post-market surveillance system ⓘ quality management system for manufacturers ⓘ vigilance reporting of serious incidents and field safety corrective actions ⓘ |
| setsOut |
rules for making in vitro diagnostic medical devices available on the EU market
ⓘ
rules for placing in vitro diagnostic medical devices on the EU market ⓘ rules for putting in vitro diagnostic medical devices into service ⓘ |
| shortName |
IVDR
NERFINISHED
ⓘ
In Vitro Diagnostic Medical Devices Regulation NERFINISHED ⓘ |
| subjectMatter | in vitro diagnostic medical devices ⓘ |
Referenced by (1)
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European Union medical device regulations
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Regulation (EU) 2017/746 on in vitro diagnostic medical devices
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