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.
Observed surface forms (1)
| Surface form | Occurrences |
|---|---|
| Council Directive 93/42/EEC | 0 |
Statements (63)
| Predicate | Object |
|---|---|
| instanceOf |
European Union directive
ⓘ
medical device regulation ⓘ |
| abbreviation | MDD NERFINISHED ⓘ |
| adoptedBy | Council of the European Communities NERFINISHED ⓘ |
| 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
NERFINISHED
ⓘ
Directive 2001/104/EC NERFINISHED ⓘ Directive 2003/12/EC NERFINISHED ⓘ Directive 2007/47/EC NERFINISHED ⓘ Directive 98/79/EC NERFINISHED ⓘ Regulation (EC) No 1882/2003 NERFINISHED ⓘ 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 NERFINISHED ⓘ |
| harmonisedWith |
Directive 90/385/EEC on active implantable medical devices
NERFINISHED
ⓘ
Directive 98/79/EC on in vitro diagnostic medical devices NERFINISHED ⓘ |
| implementedBy | national laws of EU Member States ⓘ |
| jurisdiction | European Union ⓘ |
| languageVersions | all official EU languages ⓘ |
| legalBasis | Treaty establishing the European Economic Community NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| repealedBy | Regulation (EU) 2017/745 NERFINISHED ⓘ |
| repealEffectiveDate | 2021-05-26 ⓘ |
| repealPostponedBy | Regulation (EU) 2020/561 NERFINISHED ⓘ |
| replacedBy | Regulation (EU) 2017/745 on medical devices NERFINISHED ⓘ |
| 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 NERFINISHED ⓘ |
| status | repealed ⓘ |
| subjectMatter | medical devices ⓘ |
| wasInForceUntil | 2021-05-25 ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.
European Union medical device regulations
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replaced
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Council Directive 93/42/EEC on medical devices
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