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European Union · Bill · COD

2012/0266(COD)

Regulation on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

adoptedEuropean Union· European Parliament· EN

Introduced

22 October 2012

Last action

5 May 2017 · publication official journal

Status

PLENARY_ADOPT_POSITION

Sponsors

—

Subjects

Discovery layer

Source updated

5 May 2017

Official titles

Authentic titles published by the source. The stored canonical title is not replaced.

22 official languages
  • Bulgarian

    Регламент за медицинските изделия и за изменение на Директива 2001/83/ЕО, Регламент (ЕО) № 178/2002 и Регламент (ЕО) № 1223/2009

  • Czech

    Nařízení o zdravotnických prostředcích a změně směrnice 2001/83/ES, nařízení (ES) č. 178/2002 a nařízení (ES) č. 1223/2009

  • Danish

    Forordning om medicinsk udstyr og om ændring af direktiv 2001/83/EF, forordning (EF) nr. 178/2002 og forordning (EF) nr. 1223/2009

  • German

    Verordnung über Medizinprodukte und zur Änderung der Richtlinie 2001/83/EG, der Verordnung (EG) Nr. 178/2002 und der Verordnung (EG) Nr. 1223/2009

  • Greek

    Κανονισμός για τα ιατροτεχνολογικά προϊόντα και για την τροποποίηση της οδηγίας 2001/83/EΚ, του κανονισμού (EΚ) αριθ. 178/2002 και του κανονισμού (EΚ) αριθ. 1223/2009

  • Spanish

    Reglamento sobre los productos sanitarios y por el que se modifican la Directiva 2001/83/CE, el Reglamento (CE) nº 178/2002 y el Reglamento (CE) nº 1223/2009

  • Estonian

    Määrus, milles käsitletakse meditsiiniseadmeid ja millega muudetakse direktiivi 2001/83/EÜ, määrust (EÜ) nr 178/2002 ja määrust (EÜ) nr 1223/2009

  • Finnish

    Asetus lääkinnällisistä laitteista sekä direktiivin 2001/83/EY, asetuksen (EY) N:o 178/2002 ja asetuksen (EY) N:o 1223/2009 muuttamisesta

  • French

    Règlement relatif aux dispositifs médicaux, et modifiant la directive 2001/83/CE, le règlement (CE) n° 178/2002 et le règlement (CE) n° 1223/2009

  • Croatian

    Uredba o medicinskim proizvodima i o izmjeni Direktive 2001/83/EZ, Uredbe (EZ) br. 178/2002 i Uredbe (EC) br. 1223/2009

  • Hungarian

    Az orvostechnikai eszközökről, valamint a 2001/83/EK irányelv, a 178/2002/EK rendelet és az 1223/2009/EK rendelet módosításáról szóló rendelet

  • Italian

    Regolamento relativo ai dispositivi medici e recante modifica della direttiva 2001/83/CE, del regolamento (CE) n. 178/2002 e del regolamento (CE) n. 1223/2009

  • Lithuanian

    Reglamentas dėl medicinos priemonių, kuriuo iš dalies keičiama Direktyva 2001/83/EB, Reglamentas (EB) Nr. 178/2002 ir Reglamentas (EB) Nr. 1223/2009

  • Latvian

    Regula, kas attiecas uz medicīniskām ierīcēm un ar ko groza Direktīvu 2001/83/EK, Regulu (EK) Nr. 178/2002 un Regulu (EK) Nr. 1223/2009

  • Maltese

    Regolament dwar l-apparati mediċi, u li jemenda d-Direttiva 2001/83/KE, ir-Regolament (KE) Nru 178/2002 u r-Regolament (KE) Nru 1223/2009

  • Dutch

    Verordening inzake medische producten en tot wijziging van Richtlijn 2001/83/EG, Verordening (EG) nr. 178/2002 en Verordening (EG) nr. 1223/2009

  • Polish

    Rozporządzenie w sprawie wyrobów medycznych, zmieniające dyrektywę 2001/83/WE, rozporządzenie (WE) nr 178/2002 i rozporządzenie (WE) nr 1223/2009

  • Portuguese

    Regulamento relativo aos dispositivos médicos e que altera a Diretiva 2001/83/CE, o Regulamento (CE) n.º 178/2002 e o Regulamento (CE) n.º 1223/2009

  • Romanian

    Regulament privind dispozitivele medicale și de modificare a Directivei 2001/83/CE, a Regulamentului (CE) nr. 178/2002 și a Regulamentului (CE) nr. 1223/2009

  • Slovak

    Nariadenie o zdravotníckych pomôckach, ktorým sa mení a dopĺňa smernica2001/83/ES, nariadenie (ES) č. 178/2002 a nariadenie (ES) č. 1223/2009

  • Slovenian

    Uredba o medicinskih pripomočkih in spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009

  • Swedish

    Förordning om medicintekniska produkter och om ändring av direktiv 2001/83/EG, förordning (EG) nr 178/2002 och förordning (EG) nr 1223/2009

Records

Official bill 2012/0266(COD) from European Union at European Parliament. Dated 22 October 2012. Status: PLENARY_ADOPT_POSITION.

Timeline

  1. 22 October 2012

    referral

    Source: REFERRAL

  2. 22 October 2012

    Introduced

    Regulation on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

    Source: COD

  3. 22 October 2013

    plenary amend

    Source: PLENARY_AMEND

  4. 22 October 2013

    Vote results

    Source: PLENARY_VOTE_RESULTS

  5. 2 April 2014

    Position adopted

    Source: PLENARY_ADOPT_POSITION

  6. 2 April 2014

    Vote results

    Source: PLENARY_VOTE_RESULTS

  7. 16 March 2017

    referral

    Source: REFERRAL

  8. 5 April 2017

    Vote results

    Source: PLENARY_VOTE_RESULTS

  9. 5 April 2017

    plenary approve council position

    Source: PLENARY_APPROVE_COUNCIL_POSITION

  10. 5 April 2017

    signature

    Source: SIGNATURE

  11. 5 May 2017

    publication official journal

    Source: PUBLICATION_OFFICIAL_JOURNAL

Votes

No vote records are attached yet.

Versions

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Documents

280 official files

RECOMMENDATION FOR SECOND READING on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

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  • RECOMMENDATION FOR SECOND READING on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

    REPORT_PLENARY · EN · 18 March 2019

    DownloadOpen at official source

  • RECOMMENDATION FOR SECOND READING on the Council position at first reading with a view to the adoption of a regulation of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

    REPORT_PLENARY · EN · 18 March 2019

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  • Medicintekniska produkter ***II

    TEXT_ADOPTED · SV · 29 June 2018

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  • Medicinski pripomočki ***II

    TEXT_ADOPTED · SL · 29 June 2018

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  • Zdravotnícke pomôcky ***II

    TEXT_ADOPTED · SK · 29 June 2018

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  • Dispozitivele medicale ***II

    TEXT_ADOPTED · RO · 29 June 2018

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  • Dispositivos médicos ***II

    TEXT_ADOPTED · PT · 29 June 2018

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  • Wyroby medyczne ***II

    TEXT_ADOPTED · PL · 29 June 2018

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  • Medische hulpmiddelen ***II

    TEXT_ADOPTED · NL · 29 June 2018

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  • Apparati mediċi ***II

    TEXT_ADOPTED · MT · 29 June 2018

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  • Medicīniskas ierīces ***II

    TEXT_ADOPTED · LV · 29 June 2018

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  • Dispositivi medici ***II

    TEXT_ADOPTED · IT · 29 June 2018

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  • Medicinos priemonės ***II

    TEXT_ADOPTED · LT · 29 June 2018

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  • Medicinski proizvodi ***II

    TEXT_ADOPTED · HR · 29 June 2018

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  • Orvostechnikai eszközök ***II

    TEXT_ADOPTED · HU · 29 June 2018

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  • Feistí leighis ***II

    TEXT_ADOPTED · GA · 29 June 2018

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  • Dispositifs médicaux ***II

    TEXT_ADOPTED · FR · 29 June 2018

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  • Lääkinnälliset laitteet ***II

    TEXT_ADOPTED · FI · 29 June 2018

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  • Meditsiiniseadmed ***II

    TEXT_ADOPTED · ET · 29 June 2018

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  • Ιατροτεχνολογικά προϊόντα ***II

    TEXT_ADOPTED · EL · 29 June 2018

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  • Productos sanitarios ***II

    TEXT_ADOPTED · ES · 29 June 2018

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  • Medical devices ***II

    TEXT_ADOPTED · EN · 29 June 2018

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  • Medicinsk udstyr ***II

    TEXT_ADOPTED · DA · 29 June 2018

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  • Medizinprodukte ***II

    TEXT_ADOPTED · DE · 29 June 2018

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  • Zdravotnické prostředky ***II

    TEXT_ADOPTED · CS · 29 June 2018

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  • Медицински изделия ***II

    TEXT_ADOPTED · BG · 29 June 2018

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  • Medicinski proizvodi ***II

    TEXT_ADOPTED · HR · 4 June 2018

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  • Medicinski proizvodi ***II

    TEXT_ADOPTED · HR · 4 June 2018

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  • Медицински изделия ***II

    TEXT_ADOPTED · BG · 4 June 2018

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  • Медицински изделия ***II

    TEXT_ADOPTED · BG · 4 June 2018

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  • Lääkinnälliset laitteet ***II

    TEXT_ADOPTED · FI · 14 May 2018

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  • Lääkinnälliset laitteet ***II

    TEXT_ADOPTED · FI · 14 May 2018

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  • Orvostechnikai eszközök ***II

    TEXT_ADOPTED · HU · 14 May 2018

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  • Orvostechnikai eszközök ***II

    TEXT_ADOPTED · HU · 14 May 2018

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  • Feistí leighis ***II

    TEXT_ADOPTED · GA · 26 April 2018

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  • Feistí leighis ***II

    TEXT_ADOPTED · GA · 26 April 2018

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  • BETÄNKANDE över förslaget till Europaparlamentets och rådets förordning om medicintekniska produkter och om ändring av direktiv 2001/83/EG, förordning (EG) nr 178/2002 och förordning (EG) nr 1223/2009

    REPORT_PLENARY · SV · 31 January 2018

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  • BETÄNKANDE över förslaget till Europaparlamentets och rådets förordning om medicintekniska produkter och om ändring av direktiv 2001/83/EG, förordning (EG) nr 178/2002 och förordning (EG) nr 1223/2009

    REPORT_PLENARY · SV · 31 January 2018

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  • BETÄNKANDE över förslaget till Europaparlamentets och rådets förordning om medicintekniska produkter och om ändring av direktiv 2001/83/EG, förordning (EG) nr 178/2002 och förordning (EG) nr 1223/2009

    REPORT_PLENARY · SV · 31 January 2018

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  • POROČILO o predlogu uredbe Evropskega parlamenta in Sveta o medicinskih pripomočkih in spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009

    REPORT_PLENARY · SL · 31 January 2018

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  • POROČILO o predlogu uredbe Evropskega parlamenta in Sveta o medicinskih pripomočkih in spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009

    REPORT_PLENARY · SL · 31 January 2018

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  • POROČILO o predlogu uredbe Evropskega parlamenta in Sveta o medicinskih pripomočkih in spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009

    REPORT_PLENARY · SL · 31 January 2018

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  • SPRÁVA k návrhu nariadenia Európskeho parlamentu a Rady o zdravotníckych pomôckach a ktorým sa mení smernica 2001/83/ES, nariadenie (ES) č. 178/2002 a nariadenie (ES) č. 1223/2009

    REPORT_PLENARY · SK · 31 January 2018

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  • SPRÁVA k návrhu nariadenia Európskeho parlamentu a Rady o zdravotníckych pomôckach a ktorým sa mení smernica 2001/83/ES, nariadenie (ES) č. 178/2002 a nariadenie (ES) č. 1223/2009

    REPORT_PLENARY · SK · 31 January 2018

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  • SPRÁVA k návrhu nariadenia Európskeho parlamentu a Rady o zdravotníckych pomôckach a ktorým sa mení smernica 2001/83/ES, nariadenie (ES) č. 178/2002 a nariadenie (ES) č. 1223/2009

    REPORT_PLENARY · SK · 31 January 2018

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  • RAPORT referitor la propunerea de regulament al Parlamentului European și al Consiliului privind dispozitivele medicale și de modificare a Directivei 2001/83/CE, a Regulamentului (CE) nr. 178/2002 și a Regulamentului (CE) nr. 1223/2009

    REPORT_PLENARY · RO · 31 January 2018

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  • RAPORT referitor la propunerea de regulament al Parlamentului European și al Consiliului privind dispozitivele medicale și de modificare a Directivei 2001/83/CE, a Regulamentului (CE) nr. 178/2002 și a Regulamentului (CE) nr. 1223/2009

    REPORT_PLENARY · RO · 31 January 2018

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  • RAPORT referitor la propunerea de regulament al Parlamentului European și al Consiliului privind dispozitivele medicale și de modificare a Directivei 2001/83/CE, a Regulamentului (CE) nr. 178/2002 și a Regulamentului (CE) nr. 1223/2009

    REPORT_PLENARY · RO · 31 January 2018

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  • RELATÓRIO sobre a proposta de Regulamento do Parlamento Europeu e do Conselho relativo aos dispositivos médicos e que altera a Diretiva 2001/83/CE, o Regulamento (CE) n.º 178/2002 e o Regulamento (CE) n.º 1223/2009

    REPORT_PLENARY · PT · 31 January 2018

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  • RELATÓRIO sobre a proposta de Regulamento do Parlamento Europeu e do Conselho relativo aos dispositivos médicos e que altera a Diretiva 2001/83/CE, o Regulamento (CE) n.º 178/2002 e o Regulamento (CE) n.º 1223/2009

    REPORT_PLENARY · PT · 31 January 2018

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