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

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

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Versions

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Documents

280 official files

Meditsiiniseadmed ***II

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Meditsiiniseadmed ***II
TEXT_ADOPTED · ET · 9 November 2017
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Meditsiiniseadmed ***II
TEXT_ADOPTED · ET · 9 November 2017
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Productos sanitarios ***II
TEXT_ADOPTED · ES · 9 November 2017
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Productos sanitarios ***II
TEXT_ADOPTED · ES · 9 November 2017
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Productos sanitarios ***II
TEXT_ADOPTED · ES · 9 November 2017
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Ιατροτεχνολογικά προϊόντα ***II
TEXT_ADOPTED · EL · 9 November 2017
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Ιατροτεχνολογικά προϊόντα ***II
TEXT_ADOPTED · EL · 9 November 2017
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Ιατροτεχνολογικά προϊόντα ***II
TEXT_ADOPTED · EL · 9 November 2017
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Medical devices ***II
TEXT_ADOPTED · EN · 9 November 2017
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Medical devices ***II
TEXT_ADOPTED · EN · 9 November 2017
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Medical devices ***II
TEXT_ADOPTED · EN · 9 November 2017
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Medizinprodukte ***II
TEXT_ADOPTED · DE · 9 November 2017
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Medizinprodukte ***II
TEXT_ADOPTED · DE · 9 November 2017
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Medizinprodukte ***II
TEXT_ADOPTED · DE · 9 November 2017
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Medicinsk udstyr ***II
TEXT_ADOPTED · DA · 9 November 2017
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Medicinsk udstyr ***II
TEXT_ADOPTED · DA · 9 November 2017
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Medicinsk udstyr ***II
TEXT_ADOPTED · DA · 9 November 2017
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Zdravotnické prostředky ***II
TEXT_ADOPTED · CS · 9 November 2017
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Zdravotnické prostředky ***II
TEXT_ADOPTED · CS · 9 November 2017
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Zdravotnické prostředky ***II
TEXT_ADOPTED · CS · 9 November 2017
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Медицински изделия ***II
TEXT_ADOPTED · BG · 9 November 2017
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ПРЕПОРЪКА ЗА ВТОРО ЧЕТЕНЕ относно позицията на Съвета на първо четене с оглед на приемането на регламент на Европейския парламент и на Съвета за медицинските изделия, за изменение на Директива 2001/83/ЕО, Регламент (ЕО) № 178/2002 и Регламент (ЕО) № 1223/2009 и за отмяна на директиви 90/385/ЕИО и 93/42/ЕИО на Съвета
REPORT_PLENARY · BG · 31 March 2017
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ПРЕПОРЪКА ЗА ВТОРО ЧЕТЕНЕ относно позицията на Съвета на първо четене с оглед на приемането на регламент на Европейския парламент и на Съвета за медицинските изделия, за изменение на Директива 2001/83/ЕО, Регламент (ЕО) № 178/2002 и Регламент (ЕО) № 1223/2009 и за отмяна на директиви 90/385/ЕИО и 93/42/ЕИО на Съвета
REPORT_PLENARY · BG · 31 March 2017
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ПРЕПОРЪКА ЗА ВТОРО ЧЕТЕНЕ относно позицията на Съвета на първо четене с оглед на приемането на регламент на Европейския парламент и на Съвета за медицинските изделия, за изменение на Директива 2001/83/ЕО, Регламент (ЕО) № 178/2002 и Регламент (ЕО) № 1223/2009 и за отмяна на директиви 90/385/ЕИО и 93/42/ЕИО на Съвета
REPORT_PLENARY · BG · 31 March 2017
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ПРЕПОРЪКА ЗА ВТОРО ЧЕТЕНЕ относно позицията на Съвета на първо четене с оглед на приемането на регламент на Европейския парламент и на Съвета за медицинските изделия, за изменение на Директива 2001/83/ЕО, Регламент (ЕО) № 178/2002 и Регламент (ЕО) № 1223/2009 и за отмяна на директиви 90/385/ЕИО и 93/42/ЕИО на Съвета
REPORT_PLENARY · BG · 31 March 2017
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ΣΥΣΤΑΣΗ ΓΙΑ ΤΗ ΔΕΥΤΕΡΗ ΑΝΑΓΝΩΣΗ σχετικά με τη θέση του Συμβουλίου σε πρώτη ανάγνωση ενόψει της έκδοσης κανονισμού του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για τα ιατροτεχνολογικά προϊόντα, για την τροποποίηση της οδηγίας 2001/83/EΚ, του κανονισμού (EΚ) αριθ. 178/2002 και του κανονισμού (EΚ) αριθ. 1223/2009 και για την κατάργηση των οδηγιών 90/385/ΕΟΚ και 93/42/ΕΟΚ του Συμβουλίου
REPORT_PLENARY · EL · 31 March 2017
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ΣΥΣΤΑΣΗ ΓΙΑ ΤΗ ΔΕΥΤΕΡΗ ΑΝΑΓΝΩΣΗ σχετικά με τη θέση του Συμβουλίου σε πρώτη ανάγνωση ενόψει της έκδοσης κανονισμού του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για τα ιατροτεχνολογικά προϊόντα, για την τροποποίηση της οδηγίας 2001/83/EΚ, του κανονισμού (EΚ) αριθ. 178/2002 και του κανονισμού (EΚ) αριθ. 1223/2009 και για την κατάργηση των οδηγιών 90/385/ΕΟΚ και 93/42/ΕΟΚ του Συμβουλίου
REPORT_PLENARY · EL · 31 March 2017
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ΣΥΣΤΑΣΗ ΓΙΑ ΤΗ ΔΕΥΤΕΡΗ ΑΝΑΓΝΩΣΗ σχετικά με τη θέση του Συμβουλίου σε πρώτη ανάγνωση ενόψει της έκδοσης κανονισμού του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για τα ιατροτεχνολογικά προϊόντα, για την τροποποίηση της οδηγίας 2001/83/EΚ, του κανονισμού (EΚ) αριθ. 178/2002 και του κανονισμού (EΚ) αριθ. 1223/2009 και για την κατάργηση των οδηγιών 90/385/ΕΟΚ και 93/42/ΕΟΚ του Συμβουλίου
REPORT_PLENARY · EL · 31 March 2017
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ΣΥΣΤΑΣΗ ΓΙΑ ΤΗ ΔΕΥΤΕΡΗ ΑΝΑΓΝΩΣΗ σχετικά με τη θέση του Συμβουλίου σε πρώτη ανάγνωση ενόψει της έκδοσης κανονισμού του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου για τα ιατροτεχνολογικά προϊόντα, για την τροποποίηση της οδηγίας 2001/83/EΚ, του κανονισμού (EΚ) αριθ. 178/2002 και του κανονισμού (EΚ) αριθ. 1223/2009 και για την κατάργηση των οδηγιών 90/385/ΕΟΚ και 93/42/ΕΟΚ του Συμβουλίου
REPORT_PLENARY · EL · 31 March 2017
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PREPORUKA ZA DRUGO ČITANJE o stajalištu Vijeća u prvom čitanju s ciljem donošenja Uredbe Europskog parlamenta i Vijeća o medicinskim proizvodima, o izmjeni Direktive 2001/83/EZ, Uredbe (EZ) br. 178/2002 i Uredbe (EZ) br. 1223/2009 te o stavljanju izvan snage direktiva Vijeća 90/385/EEZ i 93/42/EEZ
REPORT_PLENARY · HR · 31 March 2017
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PREPORUKA ZA DRUGO ČITANJE o stajalištu Vijeća u prvom čitanju s ciljem donošenja Uredbe Europskog parlamenta i Vijeća o medicinskim proizvodima, o izmjeni Direktive 2001/83/EZ, Uredbe (EZ) br. 178/2002 i Uredbe (EZ) br. 1223/2009 te o stavljanju izvan snage direktiva Vijeća 90/385/EEZ i 93/42/EEZ
REPORT_PLENARY · HR · 31 March 2017
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PREPORUKA ZA DRUGO ČITANJE o stajalištu Vijeća u prvom čitanju s ciljem donošenja Uredbe Europskog parlamenta i Vijeća o medicinskim proizvodima, o izmjeni Direktive 2001/83/EZ, Uredbe (EZ) br. 178/2002 i Uredbe (EZ) br. 1223/2009 te o stavljanju izvan snage direktiva Vijeća 90/385/EEZ i 93/42/EEZ
REPORT_PLENARY · HR · 31 March 2017
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PREPORUKA ZA DRUGO ČITANJE o stajalištu Vijeća u prvom čitanju s ciljem donošenja Uredbe Europskog parlamenta i Vijeća o medicinskim proizvodima, o izmjeni Direktive 2001/83/EZ, Uredbe (EZ) br. 178/2002 i Uredbe (EZ) br. 1223/2009 te o stavljanju izvan snage direktiva Vijeća 90/385/EEZ i 93/42/EEZ
REPORT_PLENARY · HR · 31 March 2017
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PRIPOROČILO ZA DRUGO OBRAVNAVO o stališču Sveta v prvi obravnavi z namenom sprejetja Uredbe Evropskega parlamenta in Sveta o medicinskih pripomočkih, spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009 ter razveljavitvi direktiv Sveta 90/385/EGS in 93/42/EGS
REPORT_PLENARY · SL · 31 March 2017
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PRIPOROČILO ZA DRUGO OBRAVNAVO o stališču Sveta v prvi obravnavi z namenom sprejetja Uredbe Evropskega parlamenta in Sveta o medicinskih pripomočkih, spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009 ter razveljavitvi direktiv Sveta 90/385/EGS in 93/42/EGS
REPORT_PLENARY · SL · 31 March 2017
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PRIPOROČILO ZA DRUGO OBRAVNAVO o stališču Sveta v prvi obravnavi z namenom sprejetja Uredbe Evropskega parlamenta in Sveta o medicinskih pripomočkih, spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009 ter razveljavitvi direktiv Sveta 90/385/EGS in 93/42/EGS
REPORT_PLENARY · SL · 31 March 2017
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PRIPOROČILO ZA DRUGO OBRAVNAVO o stališču Sveta v prvi obravnavi z namenom sprejetja Uredbe Evropskega parlamenta in Sveta o medicinskih pripomočkih, spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009 ter razveljavitvi direktiv Sveta 90/385/EGS in 93/42/EGS
REPORT_PLENARY · SL · 31 March 2017
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ANDRABEHANDLINGS-REKOMMENDATION om rådets ståndpunkt vid första behandlingen inför antagandet av Europaparlamentets och rådets förordning om medicintekniska produkter, om ändring av direktiv 2001/83/EG, förordning (EG) nr 178/2002 och förordning (EG) nr 1223/2009 och om upphävande av rådets direktiv 90/385/EEG och 93/428/EEG
REPORT_PLENARY · SV · 31 March 2017
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ANDRABEHANDLINGS-REKOMMENDATION om rådets ståndpunkt vid första behandlingen inför antagandet av Europaparlamentets och rådets förordning om medicintekniska produkter, om ändring av direktiv 2001/83/EG, förordning (EG) nr 178/2002 och förordning (EG) nr 1223/2009 och om upphävande av rådets direktiv 90/385/EEG och 93/428/EEG
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ANDRABEHANDLINGS-REKOMMENDATION om rådets ståndpunkt vid första behandlingen inför antagandet av Europaparlamentets och rådets förordning om medicintekniska produkter, om ändring av direktiv 2001/83/EG, förordning (EG) nr 178/2002 och förordning (EG) nr 1223/2009 och om upphävande av rådets direktiv 90/385/EEG och 93/428/EEG
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ANDRABEHANDLINGS-REKOMMENDATION om rådets ståndpunkt vid första behandlingen inför antagandet av Europaparlamentets och rådets förordning om medicintekniska produkter, om ändring av direktiv 2001/83/EG, förordning (EG) nr 178/2002 och förordning (EG) nr 1223/2009 och om upphävande av rådets direktiv 90/385/EEG och 93/428/EEG
REPORT_PLENARY · SV · 31 March 2017
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RAKKOMANDAZZJONI GĦAT-TIENI QARI dwar il-pożizzjoni tal-Kunsill fl-ewwel qari għall-adozzjoni tar-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 u li jħassar id-Direttivi tal-Kunsill 90/385/KEE u 93/428/KEE
REPORT_PLENARY · MT · 31 March 2017
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RAKKOMANDAZZJONI GĦAT-TIENI QARI dwar il-pożizzjoni tal-Kunsill fl-ewwel qari għall-adozzjoni tar-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 u li jħassar id-Direttivi tal-Kunsill 90/385/KEE u 93/428/KEE
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RAKKOMANDAZZJONI GĦAT-TIENI QARI dwar il-pożizzjoni tal-Kunsill fl-ewwel qari għall-adozzjoni tar-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 u li jħassar id-Direttivi tal-Kunsill 90/385/KEE u 93/428/KEE
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RAKKOMANDAZZJONI GĦAT-TIENI QARI dwar il-pożizzjoni tal-Kunsill fl-ewwel qari għall-adozzjoni tar-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 u li jħassar id-Direttivi tal-Kunsill 90/385/KEE u 93/428/KEE
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DOPORUČENÍ PRO DRUHÉ ČTENÍ k postoji Rady v prvním čtení k přijetí nařízení Evropského parlamentu a Rady o zdravotnických prostředcích, změně směrnice 2001/83/ES, nařízení (ES) č. 178/2002 a nařízení (ES) č. 1223/2009 a o zrušení směrnic Rady 90/385/EHS a 93/42/EHS
REPORT_PLENARY · CS · 31 March 2017
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DOPORUČENÍ PRO DRUHÉ ČTENÍ k postoji Rady v prvním čtení k přijetí nařízení Evropského parlamentu a Rady o zdravotnických prostředcích, změně směrnice 2001/83/ES, nařízení (ES) č. 178/2002 a nařízení (ES) č. 1223/2009 a o zrušení směrnic Rady 90/385/EHS a 93/42/EHS
REPORT_PLENARY · CS · 31 March 2017
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DOPORUČENÍ PRO DRUHÉ ČTENÍ k postoji Rady v prvním čtení k přijetí nařízení Evropského parlamentu a Rady o zdravotnických prostředcích, změně směrnice 2001/83/ES, nařízení (ES) č. 178/2002 a nařízení (ES) č. 1223/2009 a o zrušení směrnic Rady 90/385/EHS a 93/42/EHS
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DOPORUČENÍ PRO DRUHÉ ČTENÍ k postoji Rady v prvním čtení k přijetí nařízení Evropského parlamentu a Rady o zdravotnických prostředcích, změně směrnice 2001/83/ES, nařízení (ES) č. 178/2002 a nařízení (ES) č. 1223/2009 a o zrušení směrnic Rady 90/385/EHS a 93/42/EHS
REPORT_PLENARY · CS · 31 March 2017
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ZALECENIE DO DRUGIEGO CZYTANIA dotyczące stanowiska Rady w pierwszym czytaniu w sprawie przyjęcia rozporządzenia Parlamentu Europejskiego i Rady w sprawie wyrobów medycznych, zmiany dyrektywy 2001/83/WE, rozporządzenia (WE) nr 178/2002 i rozporządzenia (WE) nr 1223/2009 oraz uchylenia dyrektyw Rady 90/385/EWG i 93/42/EWG
REPORT_PLENARY · PL · 31 March 2017
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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