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2021/0323(COD)

Amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices

adoptedEuropean Union· European Parliament· EN

Introduced

18 October 2021

Last action

28 January 2022 · publication official journal

Status

PLENARY_ADOPT_POSITION

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Source updated

28 January 2022

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23 official languages

  • Bulgarian

    Изменение на Регламент (ЕС) 2017/746 по отношение на преходните разпоредби за някои медицински изделия за инвитро диагностика и отложеното прилагане на изискванията към изделията в самите лечебни заведения

  • Czech

    Změna nařízení (EU) 2017/746, pokud jde o přechodná ustanovení pro některé diagnostické zdravotnické prostředky in vitro a odklad použitelnosti požadavků v případě prostředků vyráběných a používaných v rámci zdravotnických zařízení

  • Danish

    Ændring af forordning (EU) 2017/746 for så vidt angår overgangsbestemmelser for visse former for medicinsk udstyr til in vitro-diagnostik og udskydelse af anvendelsen af krav til internt udstyr

  • German

    Änderung der Verordnung (EU) 2017/746 hinsichtlich der Übergangsbestimmungen für bestimmte In-vitro-Diagnostika und des späteren Geltungsbeginns der Anforderungen an hausinterne Produkte

  • Greek

    Τροποποίηση του κανονισμού (ΕΕ) 2017/746 όσον αφορά τις μεταβατικές διατάξεις για ορισμένα in vitro διαγνωστικά ιατροτεχνολογικά προϊόντα και την αναβολή της εφαρμογής των απαιτήσεων για τα εσωτερικά τεχνολογικά προϊόντα

  • Spanish

    Modificación del Reglamento (UE) 2017/746 en lo que respecta a las disposiciones transitorias para determinados productos sanitarios para diagnóstico in vitro y la aplicación diferida de los requisitos aplicables a los productos internos

  • Estonian

    Määruse (EL) 2017/746 muutmine teatavaid in vitro diagnostika meditsiiniseadmeid käsitlevate üleminekusätete osas ja seoses asutusesiseseid seadmeid käsitlevate nõuete kohaldamise edasilükkamisega

  • Finnish

    Asetuksen (EU) 2017/746 muuttaminen siltä osin kuin on kyse tiettyjä in vitro -diagnostiikkaan tarkoitettuja lääkinnällisiä laitteita koskevista siirtymäsäännöksistä ja omaan käyttöön valmistettuja laitteita koskevien vaatimusten soveltamisen lykkäämisestä

  • French

    Modifiant le règlement (UE) 2017/746 en ce qui concerne les dispositions transitoires relatives à certains dispositifs médicaux de diagnostic in vitro et l’application différée des exigences en matière de dispositifs internes

  • Irish

    Leasú a dhéanamh ar Rialachán (AE) 2017/746 a mhéid a bhaineann le forálacha idirthréimhseacha le haghaidh feistí leighis diagnóiseacha in vitro áirithe agus le haghaidh chur i bhfeidhm iarchurtha na gceanglas maidir le feistí intí

  • Croatian

    Izmjena Uredbe (EU) 2017/746 u pogledu prijelaznih odredaba za određene in vitro dijagnostičke medicinske proizvode i odgode primjene zahtjeva za interne proizvode

  • Hungarian

    Az (EU) 2017/746 rendelet módosítása az egyes in vitro diagnosztikai orvostechnikai eszközökre vonatkozó átmeneti rendelkezések vonatkozásában és a házon belüli eszközökre vonatkozó követelmények késleltetett alkalmazása tekintetében

  • Italian

    Modifica del regolamento (UE) 2017/746 per quanto riguarda le disposizioni transitorie per determinati dispositivi medico-diagnostici in vitro e l'applicazione differita delle prescrizioni per i dispositivi fabbricati internamente

  • Lithuanian

    Reglamento (ES) 2017/746 dalinis keitimas dėl pereinamojo laikotarpio nuostatų taikymo tam tikroms in vitro diagnostikos medicinos priemonėms ir atidėto reikalavimų taikymo viduje pagamintoms priemonėms

  • Latvian

    Grozījumu izdarīšana Regulā (ES) 2017/746 attiecībā uz pārejas noteikumiem, kas piemērojami noteiktām in vitro diagnostikas medicīniskajām ierīcēm, un prasību atliktu piemērošanu iestādes iekšējai lietošanai paredzētām ierīcēm

  • Maltese

    Emenda tar-Regolament (UE) 2017/746 fir-rigward ta' dispożizzjonijiet tranżizzjonali għal ċertu apparat mediku dijanjostiku in vitro u applikazzjoni differita tar-rekwiżiti għall-apparat intern

  • Dutch

    Wijziging van Verordening (EU) 2017/746 wat betreft overgangsbepalingen voor bepaalde medische hulpmiddelen voor in-vitrodiagnostiek en uitgestelde toepassing van de voorschriften voor intern vervaardigde hulpmiddelen

  • Polish

    Zmiana rozporządzenia (UE) 2017/746 w odniesieniu do przepisów przejściowych dotyczących niektórych wyrobów medycznych do diagnostyki in vitro oraz odroczonego stosowania wymogów dotyczących wyrobów na własny użytek

  • Portuguese

    Alteração do Regulamento (UE) 2017/746 no que diz respeito às disposições transitórias aplicáveis a determinados dispositivos médicos para diagnóstico in vitro e à aplicação diferida dos requisitos aplicáveis aos dispositivos internos

  • Romanian

    Modificarea Regulamentului (UE) 2017/746 în ceea ce privește dispozițiile tranzitorii pentru anumite dispozitive medicale pentru diagnostic in vitro și amânarea aplicării cerințelor pentru dispozitivele dezvoltate intern

  • Slovak

    Zmena nariadenia (EÚ) 2017/746, pokiaľ ide o prechodné ustanovenia pre určité diagnostické zdravotnícke pomôcky in vitro a odklad uplatňovania požiadaviek na interné pomôcky

  • Slovenian

    Sprememba Uredbe (EU) 2017/746 v zvezi s prehodnimi določbami za nekatere in vitro diagnostične medicinske pripomočke in odloženo uporabo zahtev za interne pripomočke

  • Swedish

    Ändring av förordning (EU) 2017/746 vad gäller övergångsbestämmelser för vissa medicintekniska produkter för in vitro-diagnostik och senarelagd tillämpning av kraven för egentillverkade produkter

Records

Official bill 2021/0323(COD) from European Union at European Parliament. Dated 18 October 2021. Status: PLENARY_ADOPT_POSITION.

Timeline

  1. 18 October 2021

    referral

    Source: REFERRAL

  2. 18 October 2021

    Introduced

    Amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices

    Source: COD

  3. 14 December 2021

    Plenary vote

    Source: PLENARY_VOTE

  4. 15 December 2021

    Position adopted

    Source: PLENARY_ADOPT_POSITION

  5. 15 December 2021

    Plenary vote

    Source: PLENARY_VOTE

  6. 25 January 2022

    signature

    Source: SIGNATURE

  7. 28 January 2022

    publication official journal

    Source: PUBLICATION_OFFICIAL_JOURNAL

Votes

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Versions

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Documents

72 official files

Disposizioni transitorie per determinati dispositivi medico-diagnostici in vitro e applicazione differita delle prescrizioni per i dispositivi fabbricati internamente ***I

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  • Disposizioni transitorie per determinati dispositivi medico-diagnostici in vitro e applicazione differita delle prescrizioni per i dispositivi fabbricati internamente ***I

    TEXT_ADOPTED · IT · 21 February 2022

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  • Disposizioni transitorie per determinati dispositivi medico-diagnostici in vitro e applicazione differita delle prescrizioni per i dispositivi fabbricati internamente ***I

    TEXT_ADOPTED · IT · 21 February 2022

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  • Übergangsbestimmungen für bestimmte In-vitro-Diagnostika und späterer Geltungsbeginn der Anforderungen an hausinterne Produkte ***I

    TEXT_ADOPTED · DE · 21 February 2022

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  • Übergangsbestimmungen für bestimmte In-vitro-Diagnostika und späterer Geltungsbeginn der Anforderungen an hausinterne Produkte ***I

    TEXT_ADOPTED · DE · 21 February 2022

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  • Forálacha idirthréimhseacha le haghaidh feistí leighis diagnóiseacha in vitro áirithe agus le haghaidh chur i bhfeidhm iarchurtha na gceanglas maidir le feistí intí ***I

    TEXT_ADOPTED · GA · 18 February 2022

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  • Forálacha idirthréimhseacha le haghaidh feistí leighis diagnóiseacha in vitro áirithe agus le haghaidh chur i bhfeidhm iarchurtha na gceanglas maidir le feistí intí ***I

    TEXT_ADOPTED · GA · 18 February 2022

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  • Dispositions transitoires relatives à certains dispositifs médicaux de diagnostic in vitro et application différée des conditions en matière de dispositifs fabriqués et utilisés en interne ***I

    TEXT_ADOPTED · FR · 18 February 2022

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  • Dispositions transitoires relatives à certains dispositifs médicaux de diagnostic in vitro et application différée des conditions en matière de dispositifs fabriqués et utilisés en interne ***I

    TEXT_ADOPTED · FR · 18 February 2022

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  • Disposiciones transitorias para determinados productos sanitarios para diagnóstico in vitro y aplicación diferida de los requisitos aplicables a los productos internos ***I

    TEXT_ADOPTED · ES · 18 February 2022

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  • Disposiciones transitorias para determinados productos sanitarios para diagnóstico in vitro y aplicación diferida de los requisitos aplicables a los productos internos ***I

    TEXT_ADOPTED · ES · 18 February 2022

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  • Přechodná ustanovení pro některé diagnostické zdravotnické prostředky in vitro a odklad použitelnosti požadavků v případě prostředků vyráběných a používaných v rámci zdravotnických zařízení ***I

    TEXT_ADOPTED · CS · 18 February 2022

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  • Přechodná ustanovení pro některé diagnostické zdravotnické prostředky in vitro a odklad použitelnosti požadavků v případě prostředků vyráběných a používaných v rámci zdravotnických zařízení ***I

    TEXT_ADOPTED · CS · 18 February 2022

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  • Prechodné ustanovenia pre určité diagnostické zdravotnícke pomôcky in vitro a odklad uplatňovania požiadaviek na interné pomôcky ***I

    TEXT_ADOPTED · SK · 18 February 2022

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  • Prechodné ustanovenia pre určité diagnostické zdravotnícke pomôcky in vitro a odklad uplatňovania požiadaviek na interné pomôcky ***I

    TEXT_ADOPTED · SK · 18 February 2022

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  • Prehodne določbe za nekatere in vitro diagnostične medicinske pripomočke in odloženo uporabo zahtev za interne pripomočke ***I

    TEXT_ADOPTED · SL · 18 February 2022

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  • Prehodne določbe za nekatere in vitro diagnostične medicinske pripomočke in odloženo uporabo zahtev za interne pripomočke ***I

    TEXT_ADOPTED · SL · 18 February 2022

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  • Overgangsbestemmelser for visse former for medicinsk udstyr til in vitro-diagnostik og udskydelse af anvendelsen af krav til internt udstyr ***I

    TEXT_ADOPTED · DA · 18 February 2022

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  • Overgangsbestemmelser for visse former for medicinsk udstyr til in vitro-diagnostik og udskydelse af anvendelsen af krav til internt udstyr ***I

    TEXT_ADOPTED · DA · 18 February 2022

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  • Egyes in vitro diagnosztikai orvostechnikai eszközökre vonatkozó átmeneti rendelkezések és a házon belüli eszközökre vonatkozó követelmények késleltetett alkalmazása ***I

    TEXT_ADOPTED · HU · 18 February 2022

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  • Egyes in vitro diagnosztikai orvostechnikai eszközökre vonatkozó átmeneti rendelkezések és a házon belüli eszközökre vonatkozó követelmények késleltetett alkalmazása ***I

    TEXT_ADOPTED · HU · 18 February 2022

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  • Övergångsbestämmelser för vissa medicintekniska produkter för in vitro-diagnostik och senarelagd tillämpning av kraven för egentillverkade produkter ***I

    TEXT_ADOPTED · SV · 17 February 2022

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  • Övergångsbestämmelser för vissa medicintekniska produkter för in vitro-diagnostik och senarelagd tillämpning av kraven för egentillverkade produkter ***I

    TEXT_ADOPTED · SV · 17 February 2022

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