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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

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Subjects

Discovery layer

Source updated

5 May 2017

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Official titles

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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

No version snapshots stored. Document URLs remain at the source.

Documents

280 official files

ДОКЛАД относно предложението за регламент на Европейския парламент и на Съвета за медицинските изделия и за изменение на Директива 2001/83/ЕО, Регламент (ЕО) № 178/2002 и Регламент (ЕО) № 1223/2009

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  • ДОКЛАД относно предложението за регламент на Европейския парламент и на Съвета за медицинските изделия и за изменение на Директива 2001/83/ЕО, Регламент (ЕО) № 178/2002 и Регламент (ЕО) № 1223/2009

    REPORT_PLENARY · BG · 31 January 2018

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  • ДОКЛАД относно предложението за регламент на Европейския парламент и на Съвета за медицинските изделия и за изменение на Директива 2001/83/ЕО, Регламент (ЕО) № 178/2002 и Регламент (ЕО) № 1223/2009

    REPORT_PLENARY · BG · 31 January 2018

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  • REPORT on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

    REPORT_PLENARY · EN · 29 January 2018

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  • REPORT on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

    REPORT_PLENARY · EN · 29 January 2018

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  • REPORT on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

    REPORT_PLENARY · EN · 29 January 2018

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  • REPORT on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

    REPORT_PLENARY · EN · 29 January 2018

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  • IETEIKUMS OTRAJAM LASĪJUMAM par Padomes nostāju pirmajā lasījumā, lai pieņemtu Eiropas Parlamenta un Padomes regulu, kas attiecas uz medicīniskām ierīcēm, ar ko groza Direktīvu 2001/83/EK, Regulu (EK) Nr. 178/2002 un Regulu (EK) Nr. 1223/2009 un atceļ Padomes Direktīvas 90/385/EK un 93/428/EEK

    REPORT_PLENARY · LV · 14 December 2017

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  • IETEIKUMS OTRAJAM LASĪJUMAM par Padomes nostāju pirmajā lasījumā, lai pieņemtu Eiropas Parlamenta un Padomes regulu, kas attiecas uz medicīniskām ierīcēm, ar ko groza Direktīvu 2001/83/EK, Regulu (EK) Nr. 178/2002 un Regulu (EK) Nr. 1223/2009 un atceļ Padomes Direktīvas 90/385/EK un 93/428/EEK

    REPORT_PLENARY · LV · 14 December 2017

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  • IETEIKUMS OTRAJAM LASĪJUMAM par Padomes nostāju pirmajā lasījumā, lai pieņemtu Eiropas Parlamenta un Padomes regulu, kas attiecas uz medicīniskām ierīcēm, ar ko groza Direktīvu 2001/83/EK, Regulu (EK) Nr. 178/2002 un Regulu (EK) Nr. 1223/2009 un atceļ Padomes Direktīvas 90/385/EK un 93/428/EEK

    REPORT_PLENARY · LV · 14 December 2017

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  • IETEIKUMS OTRAJAM LASĪJUMAM par Padomes nostāju pirmajā lasījumā, lai pieņemtu Eiropas Parlamenta un Padomes regulu, kas attiecas uz medicīniskām ierīcēm, ar ko groza Direktīvu 2001/83/EK, Regulu (EK) Nr. 178/2002 un Regulu (EK) Nr. 1223/2009 un atceļ Padomes Direktīvas 90/385/EK un 93/428/EEK

    REPORT_PLENARY · LV · 14 December 2017

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  • Medicintekniska produkter ***II

    TEXT_ADOPTED · SV · 9 November 2017

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  • Medicintekniska produkter ***II

    TEXT_ADOPTED · SV · 9 November 2017

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  • Medicintekniska produkter ***II

    TEXT_ADOPTED · SV · 9 November 2017

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  • Medicinski pripomočki ***II

    TEXT_ADOPTED · SL · 9 November 2017

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  • Medicinski pripomočki ***II

    TEXT_ADOPTED · SL · 9 November 2017

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  • Medicinski pripomočki ***II

    TEXT_ADOPTED · SL · 9 November 2017

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  • Zdravotnícke pomôcky ***II

    TEXT_ADOPTED · SK · 9 November 2017

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  • Zdravotnícke pomôcky ***II

    TEXT_ADOPTED · SK · 9 November 2017

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  • Zdravotnícke pomôcky ***II

    TEXT_ADOPTED · SK · 9 November 2017

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  • Dispozitivele medicale ***II

    TEXT_ADOPTED · RO · 9 November 2017

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  • Dispozitivele medicale ***II

    TEXT_ADOPTED · RO · 9 November 2017

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  • Dispozitivele medicale ***II

    TEXT_ADOPTED · RO · 9 November 2017

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  • Dispositivos médicos ***II

    TEXT_ADOPTED · PT · 9 November 2017

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  • Dispositivos médicos ***II

    TEXT_ADOPTED · PT · 9 November 2017

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  • Dispositivos médicos ***II

    TEXT_ADOPTED · PT · 9 November 2017

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  • Wyroby medyczne ***II

    TEXT_ADOPTED · PL · 9 November 2017

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  • Wyroby medyczne ***II

    TEXT_ADOPTED · PL · 9 November 2017

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  • Wyroby medyczne ***II

    TEXT_ADOPTED · PL · 9 November 2017

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  • Medische hulpmiddelen ***II

    TEXT_ADOPTED · NL · 9 November 2017

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  • Medische hulpmiddelen ***II

    TEXT_ADOPTED · NL · 9 November 2017

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  • Medische hulpmiddelen ***II

    TEXT_ADOPTED · NL · 9 November 2017

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  • Apparati mediċi ***II

    TEXT_ADOPTED · MT · 9 November 2017

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  • Apparati mediċi ***II

    TEXT_ADOPTED · MT · 9 November 2017

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    TEXT_ADOPTED · MT · 9 November 2017

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  • Medicīniskas ierīces ***II

    TEXT_ADOPTED · LV · 9 November 2017

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  • Medicīniskas ierīces ***II

    TEXT_ADOPTED · LV · 9 November 2017

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  • Medicīniskas ierīces ***II

    TEXT_ADOPTED · LV · 9 November 2017

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  • Medicinos priemonės ***II

    TEXT_ADOPTED · LT · 9 November 2017

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    TEXT_ADOPTED · LT · 9 November 2017

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    TEXT_ADOPTED · LT · 9 November 2017

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  • Dispositivi medici ***II

    TEXT_ADOPTED · IT · 9 November 2017

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  • Dispositivi medici ***II

    TEXT_ADOPTED · IT · 9 November 2017

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    TEXT_ADOPTED · IT · 9 November 2017

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  • Medicinski proizvodi ***II

    TEXT_ADOPTED · HR · 9 November 2017

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  • Orvostechnikai eszközök ***II

    TEXT_ADOPTED · HU · 9 November 2017

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  • Dispositifs médicaux ***II

    TEXT_ADOPTED · FR · 9 November 2017

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  • Dispositifs médicaux ***II

    TEXT_ADOPTED · FR · 9 November 2017

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  • Dispositifs médicaux ***II

    TEXT_ADOPTED · FR · 9 November 2017

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  • Lääkinnälliset laitteet ***II

    TEXT_ADOPTED · FI · 9 November 2017

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  • Meditsiiniseadmed ***II

    TEXT_ADOPTED · ET · 9 November 2017

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