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Link to original content: http://dbpedia.org/resource/Medical_Devices_Directive
About: Medical Devices Directive
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The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010.

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  • Die Richtlinie 93/42/EWG des Rates vom 14. Juni 1993 über Medizinprodukte ist eine von insgesamt drei Medizinprodukte-EU-Richtlinien und wird in Deutschland und Österreich kurz als Medizinprodukterichtlinie bezeichnet. International spricht man von der Richtlinie als Medical Device Directive (MDD), oder Directive 93/42/EEC. Sie ist das wichtigste Regelungsinstrument zum Nachweis der Sicherheit und der medizinisch-technischen Leistungsfähigkeit von Medizinprodukten im Europäischen Wirtschaftsraum. Sie wurde zuletzt im Jahr 2007 über die Änderungsrichtlinie 2007/47/EG in großen Teilen modifiziert. Diese Änderungen wurden am 21. März 2010 in der EU national rechtswirksam. Am 25. Mai 2017 ist die neue Verordnung (EU) 2017/745 über Medizinprodukte in Kraft getreten. Diese wird auch als Medical Device Regulation (MDR) bezeichnet und ist ohne Umsetzung in nationale Gesetze gültig. Mit einer Übergangsfrist von 3 Jahren wird sie die Medizinprodukterichtlinie 93/42/EWG ersetzen. Wie bei allen europäischen Richtlinien ist es vorrangiges Ziel der Medizinprodukterichtlinie, den freien Warenverkehr zu ermöglichen. Dies belegt Artikel 2 der Richtlinie 93/42/EWG, der fordert: „Die Mitgliedstaaten treffen alle erforderlichen Maßnahmen, damit die Produkte nur in Verkehr gebracht und/oder in Betrieb genommen werden dürfen, wenn sie bei sachgemäßer Lieferung, Installation, Instandhaltung und ihrer Zweckbestimmung entsprechender Verwendung die Anforderungen dieser Richtlinie erfüllen.“ Die weiteren Artikel behandeln die verwaltungsmäßige Umsetzung und verweisen auf weitere rechtliche Verknüpfungen. Die Umsetzung der Medizinprodukterichtlinie in jeweils nationales Recht erfolgt durch nationale Gesetze, in Deutschland und Österreich durch das Medizinproduktegesetz (Gesetz über Medizinprodukte). Die Schweiz, obschon weder Mitglied der Europäischen Union noch des Europäischen Wirtschaftsraumes, bezieht sich im Heilmittelgesetz (Bundesgesetz über Arzneimittel und Medizinprodukte) ebenfalls auf diese Richtlinie und hat sie mit der (MepV) im April 1996 praktisch übernommen und in Schweizer Recht umgesetzt. (de)
  • The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010. The Medical Devices Directive is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745), effective on 26 May 2021. (en)
  • 유럽 의료기기 지침(Medical Device Directive, MDD)은 1993년 6월 14일 만들어진 의료 기기에 관한 위원회 지침 93/42/EEC, OJ No L 169/1 of 1993-07-12)는 유럽 연합 내의 의료 장비와 관련된 법률을 조화시키기 위한 것이다. 의료기기 지침서는 '새로운 접근법'지침이며 따라서 제조업체가 합법적으로 유럽 시장에 를 설치하려면 의료기기 지침의 요구 사항을 충족시켜야한다. '조화 된 표준'을 충족하는 제조업체의 제품은 지침에 대한 적합성을 가정한다. 의료기기 지침을 준수하는 제품에는 CE 마크가 적용되어야한다. MDD가 나오고 난뒤 25년뒤에 새로운 유럽 의료기기법인 유럽 의료기기 규칙(MDR = EU regulation 2017/745)[1]이 나왔다. 이 법은 2021년 5월 26일부터 강제적용된다. (ko)
  • La Direttiva CEE 93/42 sui dispositivi medici (abbreviata in DDM 93/42), pubblicata sulla GUCE nel giugno del 1993, è un documento che riporta i criteri generali da utilizzare nella progettazione e realizzazione di alcune categorie di dispositivi medici, vigente negli stati dell'Unione europea. Essa impone l'obbligo della marcatura CE per la commercializzazione di tali dispositivi (DM); per ottenere il marchio CE occorre rispettare dei requisiti essenziali.I requisiti citati nel documento «devono essere interpretati e applicati in modo da tener conto della tecnologia e delle pratiche esistenti nella fase di progettazione». La DDM 93/42 è un documento di validità sovranazionale ed è stata recepita in Italia nel febbraio del 1997 con il Decreto Legislativo 24 febbraio 1997, n. 46 ("Attuazione della direttiva 93/42/CEE, concernente i dispositivi medici"). (it)
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dbp:amends
  • Directive 84/539/EEC, Directive 90/385/EEC (en)
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  • 1993-07-12 (xsd:date)
dbp:implementation
  • 1994-07-01 (xsd:date)
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  • 1993-06-14 (xsd:date)
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  • Art. 100a TEEC (en)
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  • 93 (xsd:integer)
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  • 0001-07-12 (xsd:gMonthDay)
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  • Directive 76/764/EEC (en)
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  • Current (en)
dbp:title
  • Council Directive concerning medical devices (en)
dbp:type
  • Directive (en)
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  • 유럽 의료기기 지침(Medical Device Directive, MDD)은 1993년 6월 14일 만들어진 의료 기기에 관한 위원회 지침 93/42/EEC, OJ No L 169/1 of 1993-07-12)는 유럽 연합 내의 의료 장비와 관련된 법률을 조화시키기 위한 것이다. 의료기기 지침서는 '새로운 접근법'지침이며 따라서 제조업체가 합법적으로 유럽 시장에 를 설치하려면 의료기기 지침의 요구 사항을 충족시켜야한다. '조화 된 표준'을 충족하는 제조업체의 제품은 지침에 대한 적합성을 가정한다. 의료기기 지침을 준수하는 제품에는 CE 마크가 적용되어야한다. MDD가 나오고 난뒤 25년뒤에 새로운 유럽 의료기기법인 유럽 의료기기 규칙(MDR = EU regulation 2017/745)[1]이 나왔다. 이 법은 2021년 5월 26일부터 강제적용된다. (ko)
  • Die Richtlinie 93/42/EWG des Rates vom 14. Juni 1993 über Medizinprodukte ist eine von insgesamt drei Medizinprodukte-EU-Richtlinien und wird in Deutschland und Österreich kurz als Medizinprodukterichtlinie bezeichnet. International spricht man von der Richtlinie als Medical Device Directive (MDD), oder Directive 93/42/EEC. Wie bei allen europäischen Richtlinien ist es vorrangiges Ziel der Medizinprodukterichtlinie, den freien Warenverkehr zu ermöglichen. Dies belegt Artikel 2 der Richtlinie 93/42/EWG, der fordert: (de)
  • The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on 21 March 2010. (en)
  • La Direttiva CEE 93/42 sui dispositivi medici (abbreviata in DDM 93/42), pubblicata sulla GUCE nel giugno del 1993, è un documento che riporta i criteri generali da utilizzare nella progettazione e realizzazione di alcune categorie di dispositivi medici, vigente negli stati dell'Unione europea. La DDM 93/42 è un documento di validità sovranazionale ed è stata recepita in Italia nel febbraio del 1997 con il Decreto Legislativo 24 febbraio 1997, n. 46 ("Attuazione della direttiva 93/42/CEE, concernente i dispositivi medici"). (it)
rdfs:label
  • Richtlinie 93/42/EWG über Medizinprodukte (de)
  • Direttiva CEE 93/42 sui dispositivi medici (it)
  • 유럽 의료기기 지침 (ko)
  • Medical Devices Directive (en)
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