Directive 98/79/EC on in vitro diagnostic medical devices
E458511
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.
Statements (50)
| Predicate | Object |
|---|---|
| instanceOf |
EU legal act
ⓘ
European Union directive ⓘ |
| adoptedBy |
Council of the European Union
NERFINISHED
ⓘ
European Parliament NERFINISHED ⓘ |
| adoptionDate | 1998-10-27 ⓘ |
| aimsTo |
ensure a high level of protection of health and safety for patients, users and others
ⓘ
ensure the free movement of in vitro diagnostic medical devices within the internal market ⓘ |
| applicationDate | 2003-12-07 ⓘ |
| appliesTo | in vitro diagnostic medical devices intended for use in the European Union ⓘ |
| citation | Directive 98/79/EC NERFINISHED ⓘ |
| establishes |
classification rules for certain in vitro diagnostic medical devices
ⓘ
conformity assessment procedures for in vitro diagnostic medical devices ⓘ essential requirements for in vitro diagnostic medical devices ⓘ specific provisions for devices for performance evaluation ⓘ specific provisions for devices for self-testing ⓘ |
| excludes | devices for general laboratory use unless specifically intended by the manufacturer for in vitro diagnostic examination ⓘ |
| geographicalScope | European Economic Area NERFINISHED ⓘ |
| harmonises | national laws on in vitro diagnostic medical devices within the EU internal market ⓘ |
| implementedBy | EU Member States through national legislation ⓘ |
| jurisdiction | European Union ⓘ |
| languageVersions | all official languages of the European Union ⓘ |
| legalBasis | Treaty establishing the European Community NERFINISHED ⓘ |
| legalForm | directive ⓘ |
| officialName | Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices NERFINISHED ⓘ |
| OJNumber | 331 ⓘ |
| OJPublicationDate | 1998-12-07 ⓘ |
| OJSeries | L ⓘ |
| policyArea | public health ⓘ |
| providesFor |
designation of notified bodies by Member States
ⓘ
safeguard clause procedures for unsafe devices ⓘ vigilance system for in vitro diagnostic medical devices ⓘ |
| publishedIn | Official Journal of the European Communities NERFINISHED ⓘ |
| regulates |
placing on the market of in vitro diagnostic medical devices
ⓘ
putting into service of in vitro diagnostic medical devices ⓘ |
| relatedTo |
Directive 90/385/EEC on active implantable medical devices
NERFINISHED
ⓘ
Directive 93/42/EEC concerning medical devices NERFINISHED ⓘ |
| repealedBy | Regulation (EU) 2017/746 on in vitro diagnostic medical devices NERFINISHED ⓘ |
| repealEffectiveDate | 2022-05-26 ⓘ |
| requires |
CE marking for compliant in vitro diagnostic medical devices
ⓘ
manufacturers to implement quality assurance systems ⓘ manufacturers to issue an EC declaration of conformity ⓘ manufacturers to prepare technical documentation ⓘ manufacturers to report serious incidents and field safety corrective actions ⓘ |
| sector | medical devices law ⓘ |
| setsRequirementFor |
conformity assessment of in vitro diagnostic medical devices
ⓘ
performance of in vitro diagnostic medical devices ⓘ safety of in vitro diagnostic medical devices ⓘ |
| shortName | IVD Directive NERFINISHED ⓘ |
| subjectMatter | in vitro diagnostic medical devices ⓘ |
| transpositionDeadline | 2000-12-07 ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.
European Union medical device regulations
→
replaced
→
Directive 98/79/EC on in vitro diagnostic medical devices
ⓘ