Council Directive 90/385/EEC on active implantable medical devices

E460823

EU medical devices legislation European Union directive

Council Directive 90/385/EEC on active implantable medical devices was an EU legal framework that set essential safety and performance requirements for active implantable medical devices such as pacemakers and implantable defibrillators.

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Observed surface forms (1)

Surface form	Occurrences
Council Directive 90/385/EEC	0

Statements (48)

Predicate	Object
instanceOf	EU medical devices legislation ⓘ European Union directive ⓘ
adoptedBy	Council of the European Communities NERFINISHED ⓘ
adoptionYear	1990 ⓘ
aimsTo	ensure a high level of protection of patients and users ⓘ ensure free movement of active implantable medical devices within the internal market ⓘ
amendedBy	Directive 2007/47/EC NERFINISHED ⓘ Directive 93/42/EEC NERFINISHED ⓘ
appliesTo	EU Member States NERFINISHED ⓘ
complements	general product safety rules in the EU ⓘ
defines	active implantable medical device ⓘ
enteredIntoForceYear	1990 ⓘ
establishes	essential requirements for design and manufacture of active implantable medical devices ⓘ obligations for manufacturers of active implantable medical devices ⓘ obligations for notified bodies ⓘ
EULawArea	internal market ⓘ public health ⓘ
fullName	Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices NERFINISHED ⓘ
harmonises	national laws of EU Member States on active implantable medical devices ⓘ
jurisdiction	European Union ⓘ
language	all official languages of the European Union ⓘ
legalBasis	Treaty establishing the European Economic Community NERFINISHED ⓘ
legalForm	directive ⓘ
policyObjective	approximation of laws of the Member States relating to active implantable medical devices ⓘ
publishedIn	Official Journal of the European Communities NERFINISHED ⓘ
regulates	active implantable medical devices for diagnostic purposes ⓘ active implantable medical devices for therapeutic purposes ⓘ implantable cardioverter defibrillators ⓘ pacemakers ⓘ
relatedTo	Council Directive 93/42/EEC on medical devices NERFINISHED ⓘ Directive 98/79/EC on in vitro diagnostic medical devices NERFINISHED ⓘ
repealedBy	Regulation (EU) 2017/745 on medical devices NERFINISHED ⓘ
repealEffectiveDate	26 May 2021 ⓘ
requires	CE marking for compliant active implantable medical devices ⓘ information and labelling for safe use of active implantable medical devices ⓘ protection against electrical, mechanical and thermal risks ⓘ reliability of power sources for active implantable medical devices ⓘ risk analysis and risk reduction for active implantable medical devices ⓘ
scope	placing on the market of active implantable medical devices ⓘ putting into service of active implantable medical devices ⓘ
setsRequirementsFor	clinical investigation of active implantable medical devices ⓘ conformity assessment of active implantable medical devices ⓘ performance of active implantable medical devices ⓘ safety of active implantable medical devices ⓘ
shortName	AIMDD NERFINISHED ⓘ
subjectMatter	active implantable medical devices ⓘ
typeOfStandard	New Approach directive NERFINISHED ⓘ
usesConcept	conformity assessment by notified bodies ⓘ

Referenced by (1)

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European Union medical device regulations → replaced → Council Directive 90/385/EEC on active implantable medical devices ⓘ