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
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
22 October 2012
referral
Source: REFERRAL
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
22 October 2013
plenary amend
Source: PLENARY_AMEND
22 October 2013
Vote results
Source: PLENARY_VOTE_RESULTS
2 April 2014
Position adopted
Source: PLENARY_ADOPT_POSITION
2 April 2014
Vote results
Source: PLENARY_VOTE_RESULTS
16 March 2017
referral
Source: REFERRAL
5 April 2017
Vote results
Source: PLENARY_VOTE_RESULTS
5 April 2017
plenary approve council position
Source: PLENARY_APPROVE_COUNCIL_POSITION
5 April 2017
signature
Source: SIGNATURE
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
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
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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- Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2012%2F0266(COD)
- Open data entity: https://data.europarl.europa.eu/api/v2/procedures/2012-0266
- eu · 2012-0266 · source updated 5 May 2017