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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

RECOMMANDATION POUR LA DEUXIÈME LECTURE sur la position du Conseil en première lecture en vue de l'adoption du règlement du Parlement européen et du Conseil relatif aux dispositifs médicaux, modifiant la directive 2001/83/CE, le règlement (CE) n° 178/2002 et le règlement (CE) n° 1223/2009 et abrogeant les directives 90/385/CEE et 93/42/CEE du Conseil

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  • RECOMMANDATION POUR LA DEUXIÈME LECTURE sur la position du Conseil en première lecture en vue de l'adoption du règlement du Parlement européen et du Conseil relatif aux dispositifs médicaux, modifiant la directive 2001/83/CE, le règlement (CE) n° 178/2002 et le règlement (CE) n° 1223/2009 et abrogeant les directives 90/385/CEE et 93/42/CEE du Conseil

    REPORT_PLENARY · FR · 29 March 2017

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  • SUOSITUS TOISEEN KÄSITTELYYN neuvoston ensimmäisen käsittelyn kannasta Euroopan parlamentin ja neuvoston antamiseksi lääkinnällisistä laitteista sekä direktiivin 2001/83/EY, asetuksen (EY) N:o 178/2002 ja asetuksen (EY) N:o 1223/2009 muuttamisesta sekä neuvoston direktiivien 90/385/ETY ja 93/42/ETY kumoamisesta

    REPORT_PLENARY · FI · 29 March 2017

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  • SUOSITUS TOISEEN KÄSITTELYYN neuvoston ensimmäisen käsittelyn kannasta Euroopan parlamentin ja neuvoston antamiseksi lääkinnällisistä laitteista sekä direktiivin 2001/83/EY, asetuksen (EY) N:o 178/2002 ja asetuksen (EY) N:o 1223/2009 muuttamisesta sekä neuvoston direktiivien 90/385/ETY ja 93/42/ETY kumoamisesta

    REPORT_PLENARY · FI · 29 March 2017

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  • SUOSITUS TOISEEN KÄSITTELYYN neuvoston ensimmäisen käsittelyn kannasta Euroopan parlamentin ja neuvoston antamiseksi lääkinnällisistä laitteista sekä direktiivin 2001/83/EY, asetuksen (EY) N:o 178/2002 ja asetuksen (EY) N:o 1223/2009 muuttamisesta sekä neuvoston direktiivien 90/385/ETY ja 93/42/ETY kumoamisesta

    REPORT_PLENARY · FI · 29 March 2017

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  • SUOSITUS TOISEEN KÄSITTELYYN neuvoston ensimmäisen käsittelyn kannasta Euroopan parlamentin ja neuvoston antamiseksi lääkinnällisistä laitteista sekä direktiivin 2001/83/EY, asetuksen (EY) N:o 178/2002 ja asetuksen (EY) N:o 1223/2009 muuttamisesta sekä neuvoston direktiivien 90/385/ETY ja 93/42/ETY kumoamisesta

    REPORT_PLENARY · FI · 29 March 2017

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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 · 24 March 2017

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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 · 24 March 2017

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  • Suite donnée au T7-0266/2014

    ACT_FOLLOWUP · FR · 9 October 2014

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  • Follow up to T7-0266/2014

    ACT_FOLLOWUP · EN · 6 October 2014

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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 · 9 October 2013

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  • VERSLAG over het voorstel voor een verordening van het Europees Parlement en de Raad betreffende medische hulpmiddelen en tot wijziging van Richtlijn 2001/83/EG, Verordening (EG) nr. 178/2002 en Verordening (EG) nr. 1223/2009

    REPORT_PLENARY · NL · 9 October 2013

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  • ZPRÁVA o návrhu nařízení Evropského parlamentu a Rady o zdravotnických prostředcích a o změně směrnice 2001/83/ES, nařízení (ES) č. 178/2002 a nařízení (ES) č. 1223/2009.

    REPORT_PLENARY · CS · 9 October 2013

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  • BETÆNKNING om forslag til Europa-Parlamentets og Rådets forordning om medicinsk udstyr og om ændring af direktiv 2001/83/EF, forordning (EF) nr. 178/2002 og forordning (EF) nr. 1223/2009

    REPORT_PLENARY · DA · 9 October 2013

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  • PRANEŠIMAS dėl pasiūlymo dėl Europos Parlamento ir Tarybos reglamento dėl medicinos prietaisų, kuriuo iš dalies keičiami Direktyva 2001/83/EB, Reglamentas (EB) Nr. 178/2002 ir Reglamentas (EB) Nr. 1223/2009

    REPORT_PLENARY · LT · 9 October 2013

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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 · 9 October 2013

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  • JELENTÉS az orvostechnikai eszközökről, valamint a 2001/83/EK irányelv, a 178/2002/EK rendelet és az 1223/2009/EK rendelet módosításáról szóló európai parlamenti és tanácsi rendeletre irányuló javaslatról

    REPORT_PLENARY · HU · 9 October 2013

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  • MIETINTÖ ehdotuksesta Euroopan parlamentin ja neuvoston asetukseksi lääkinnällisistä laitteista sekä direktiivin 2001/83/EY, asetuksen (EY) N:o 178/2002 ja asetuksen (EY) N:o 1223/2009 muuttamisesta

    REPORT_PLENARY · FI · 9 October 2013

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  • INFORME sobre la propuesta de Reglamento del Parlamento Europeo y del Consejo 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

    REPORT_PLENARY · ES · 9 October 2013

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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 · 9 October 2013

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  • SPRAWOZDANIE w sprawie wniosku dotyczącego rozporządzenia Parlamentu Europejskiego i Rady w sprawie wyrobów medycznych, zmieniającego dyrektywę 2001/83/WE, rozporządzenie (WE) nr 178/2002 i rozporządzenie (WE) nr 1223/2009

    REPORT_PLENARY · PL · 9 October 2013

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  • RELAZIONE sulla proposta di regolamento del Parlamento europeo e del Consiglio 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

    REPORT_PLENARY · IT · 9 October 2013

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  • RAPPORT dwar il-proposta għal regolament tal-Parlament Ewropew u tal-Kunsill dwar l-apparati mediċi, li jemenda d-Direttiva 2001/83/KE, ir-Regolament (KE) Nru 178/2002 u r-Regolament (KE) Nru 1223/2009

    REPORT_PLENARY · MT · 9 October 2013

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  • ΕΚΘΕΣΗ σχετικά με την πρόταση κανονισμού του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για τα ιατροτεχνολογικά προϊόντα και για την τροποποίηση της οδηγίας 2001/83/ΕΚ, του κανονισμού (ΕΚ) αριθ. 178/2002 και του κανονισμού (ΕΚ) αριθ. 1223/2009

    REPORT_PLENARY · EL · 9 October 2013

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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 · 9 October 2013

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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 · 9 October 2013

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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 · 9 October 2013

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  • RAPORT Ettepanek võtta vastu Euroopa Parlamendi ja nõukogu määrus, milles käsitletakse meditsiiniseadmeid ja millega muudetakse direktiivi 2001/83/EÜ, määrust (EÜ) nr 178/2002 ja määrust (EÜ) nr 1223/2009

    REPORT_PLENARY · ET · 9 October 2013

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  • IZVJEŠĆE o prijedlogu Uredbe Europskog parlamenta i Vijeća o medicinskim proizvodima i o izmjeni Direktive 2001/83/EZ, Uredbe (EZ) br. 178/2002 i Uredbe (EZ) br. 1223/2009

    REPORT_PLENARY · HR · 9 October 2013

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  • ZIŅOJUMS par priekšlikumu Eiropas Parlamenta un Padomes regulai, kas attiecas uz medicīniskām ierīcēm un ar ko groza Direktīvu 2001/83/EK, Regulu (EK) Nr. 178/2002 un Regulu (EK) Nr. 1223/2009

    REPORT_PLENARY · LV · 9 October 2013

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  • RAPPORT sur la proposition de règlement du Parlement européen et du Conseil relatif aux dispositifs médicaux, et modifiant la directive 2001/83/CE, le règlement (CE) n° 178/2002 et le règlement (CE) n° 1223/2009

    REPORT_PLENARY · FR · 9 October 2013

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