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

Official titles

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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

18 October 2021
referral
Source: REFERRAL
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
14 December 2021
Plenary vote
Source: PLENARY_VOTE
15 December 2021
Position adopted
Source: PLENARY_ADOPT_POSITION
15 December 2021
Plenary vote
Source: PLENARY_VOTE
25 January 2022
signature
Source: SIGNATURE
28 January 2022
publication official journal
Source: PUBLICATION_OFFICIAL_JOURNAL

Votes

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Documents

72 official files

Pereinamojo laikotarpio nuostatų taikymas tam tikroms in vitro diagnostikos medicinos priemonėms ir atidėtas reikalavimų taikymas viduje pagamintoms priemonėms ***I

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Pereinamojo laikotarpio nuostatų taikymas tam tikroms in vitro diagnostikos medicinos priemonėms ir atidėtas reikalavimų taikymas viduje pagamintoms priemonėms ***I
TEXT_ADOPTED · LT · 23 March 2022
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Transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices ***I
TEXT_ADOPTED · EN · 23 March 2022
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Μεταβατικές διατάξεις για ορισμένα in vitro διαγνωστικά ιατροτεχνολογικά προϊόντα και αναβολή της εφαρμογής των απαιτήσεων για τα εσωτερικά τεχνολογικά προϊόντα ***I
TEXT_ADOPTED · EL · 23 March 2022
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Pereinamojo laikotarpio nuostatų taikymas tam tikroms in vitro diagnostikos medicinos priemonėms ir atidėtas reikalavimų taikymas viduje pagamintoms priemonėms ***I
TEXT_ADOPTED · LT · 22 March 2022
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Pereinamojo laikotarpio nuostatų taikymas tam tikroms in vitro diagnostikos medicinos priemonėms ir atidėtas reikalavimų taikymas viduje pagamintoms priemonėms ***I
TEXT_ADOPTED · LT · 22 March 2022
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Μεταβατικές διατάξεις για ορισμένα in vitro διαγνωστικά ιατροτεχνολογικά προϊόντα και αναβολή της εφαρμογής των απαιτήσεων για τα εσωτερικά τεχνολογικά προϊόντα ***I
TEXT_ADOPTED · EL · 22 March 2022
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Μεταβατικές διατάξεις για ορισμένα in vitro διαγνωστικά ιατροτεχνολογικά προϊόντα και αναβολή της εφαρμογής των απαιτήσεων για τα εσωτερικά τεχνολογικά προϊόντα ***I
TEXT_ADOPTED · EL · 22 March 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 · 22 March 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 · 22 March 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 · 22 March 2022
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Dispozițiile tranzitorii pentru anumite dispozitive medicale pentru diagnostic in vitro și amânarea aplicării condițiilor pentru dispozitivele produse intern ***I
TEXT_ADOPTED · RO · 22 March 2022
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Disposições transitórias aplicáveis a determinados dispositivos médicos para diagnóstico in vitro e à aplicação diferida das condições aplicáveis aos dispositivos fabricados e utilizados na própria instituição de saúde ***I
TEXT_ADOPTED · PT · 22 March 2022
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Przepisy przejściowe dotyczące niektórych wyrobów medycznych do diagnostyki in vitro oraz odroczonego stosowania wymogów dotyczących wyrobów na własny użytek ***I
TEXT_ADOPTED · PL · 22 March 2022
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Overgangsbepalingen voor bepaalde medische hulpmiddelen voor in-vitrodiagnostiek en uitgestelde toepassing van de voorschriften voor intern vervaardigde hulpmiddelen ***I
TEXT_ADOPTED · NL · 22 March 2022
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Dispożizzjonijiet tranżizzjonali għal ċertu apparat mediku dijanjostiku in vitro u applikazzjoni differita tar-rekwiżiti għall-apparat intern ***I
TEXT_ADOPTED · MT · 22 March 2022
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Pārejas noteikumi, kas piemērojami noteiktām in vitro diagnostikas medicīniskajām ierīcēm, un prasību atlikta piemērošana iestādes iekšējai lietošanai paredzētām ierīcēm ***I
TEXT_ADOPTED · LV · 22 March 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 · 22 March 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 · 22 March 2022
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Prijelazne odredbe za određene in vitro dijagnostičke medicinske proizvode i odgoda primjene zahtjeva za interne proizvode ***I
TEXT_ADOPTED · HR · 22 March 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 · 22 March 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 · 22 March 2022
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Tiettyjä in vitro -diagnostiikkaan tarkoitettuja lääkinnällisiä laitteita koskevat siirtymäsäännökset ja omaan käyttöön valmistettuja laitteita koskevien vaatimusten soveltamisen lykkääminen ***I
TEXT_ADOPTED · FI · 22 March 2022
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Teatavaid in vitro diagnostika meditsiiniseadmeid käsitlevad üleminekusätted ja asutusesiseseid seadmeid käsitlevate nõuete kohaldamise edasilükkamine ***I
TEXT_ADOPTED · ET · 22 March 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 · 22 March 2022
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Übergangsbestimmungen für bestimmte In-vitro-Diagnostika und späterer Geltungsbeginn der Anforderungen an hausinterne Produkte ***I
TEXT_ADOPTED · DE · 22 March 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 · 22 March 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 · 22 March 2022
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Преходни разпоредби за някои медицински изделия за инвитро диагностика и отложено прилагане на изискванията към изделията в самите лечебни заведения ***I
TEXT_ADOPTED · BG · 22 March 2022
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Teatavaid in vitro diagnostika meditsiiniseadmeid käsitlevad üleminekusätted ja asutusesiseseid seadmeid käsitlevate nõuete kohaldamise edasilükkamine ***I
TEXT_ADOPTED · ET · 23 February 2022
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Teatavaid in vitro diagnostika meditsiiniseadmeid käsitlevad üleminekusätted ja asutusesiseseid seadmeid käsitlevate nõuete kohaldamise edasilükkamine ***I
TEXT_ADOPTED · ET · 23 February 2022
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Przepisy przejściowe dotyczące niektórych wyrobów medycznych do diagnostyki in vitro oraz odroczonego stosowania wymogów dotyczących wyrobów na własny użytek ***I
TEXT_ADOPTED · PL · 23 February 2022
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Przepisy przejściowe dotyczące niektórych wyrobów medycznych do diagnostyki in vitro oraz odroczonego stosowania wymogów dotyczących wyrobów na własny użytek ***I
TEXT_ADOPTED · PL · 23 February 2022
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Overgangsbepalingen voor bepaalde medische hulpmiddelen voor in-vitrodiagnostiek en uitgestelde toepassing van de voorschriften voor intern vervaardigde hulpmiddelen ***I
TEXT_ADOPTED · NL · 22 February 2022
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Overgangsbepalingen voor bepaalde medische hulpmiddelen voor in-vitrodiagnostiek en uitgestelde toepassing van de voorschriften voor intern vervaardigde hulpmiddelen ***I
TEXT_ADOPTED · NL · 22 February 2022
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Dispozițiile tranzitorii pentru anumite dispozitive medicale pentru diagnostic in vitro și amânarea aplicării condițiilor pentru dispozitivele produse intern ***I
TEXT_ADOPTED · RO · 22 February 2022
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Dispozițiile tranzitorii pentru anumite dispozitive medicale pentru diagnostic in vitro și amânarea aplicării condițiilor pentru dispozitivele produse intern ***I
TEXT_ADOPTED · RO · 22 February 2022
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Pārejas noteikumi, kas piemērojami noteiktām in vitro diagnostikas medicīniskajām ierīcēm, un prasību atlikta piemērošana iestādes iekšējai lietošanai paredzētām ierīcēm ***I
TEXT_ADOPTED · LV · 22 February 2022
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Pārejas noteikumi, kas piemērojami noteiktām in vitro diagnostikas medicīniskajām ierīcēm, un prasību atlikta piemērošana iestādes iekšējai lietošanai paredzētām ierīcēm ***I
TEXT_ADOPTED · LV · 22 February 2022
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Disposições transitórias aplicáveis a determinados dispositivos médicos para diagnóstico in vitro e à aplicação diferida das condições aplicáveis aos dispositivos fabricados e utilizados na própria instituição de saúde ***I
TEXT_ADOPTED · PT · 21 February 2022
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Disposições transitórias aplicáveis a determinados dispositivos médicos para diagnóstico in vitro e à aplicação diferida das condições aplicáveis aos dispositivos fabricados e utilizados na própria instituição de saúde ***I
TEXT_ADOPTED · PT · 21 February 2022
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Tiettyjä in vitro -diagnostiikkaan tarkoitettuja lääkinnällisiä laitteita koskevat siirtymäsäännökset ja omaan käyttöön valmistettuja laitteita koskevien vaatimusten soveltamisen lykkääminen ***I
TEXT_ADOPTED · FI · 21 February 2022
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Tiettyjä in vitro -diagnostiikkaan tarkoitettuja lääkinnällisiä laitteita koskevat siirtymäsäännökset ja omaan käyttöön valmistettuja laitteita koskevien vaatimusten soveltamisen lykkääminen ***I
TEXT_ADOPTED · FI · 21 February 2022
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Dispożizzjonijiet tranżizzjonali għal ċertu apparat mediku dijanjostiku in vitro u applikazzjoni differita tar-rekwiżiti għall-apparat intern ***I
TEXT_ADOPTED · MT · 21 February 2022
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Dispożizzjonijiet tranżizzjonali għal ċertu apparat mediku dijanjostiku in vitro u applikazzjoni differita tar-rekwiżiti għall-apparat intern ***I
TEXT_ADOPTED · MT · 21 February 2022
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Prijelazne odredbe za određene in vitro dijagnostičke medicinske proizvode i odgoda primjene zahtjeva za interne proizvode ***I
TEXT_ADOPTED · HR · 21 February 2022
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Prijelazne odredbe za određene in vitro dijagnostičke medicinske proizvode i odgoda primjene zahtjeva za interne proizvode ***I
TEXT_ADOPTED · HR · 21 February 2022
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Transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices ***I
TEXT_ADOPTED · EN · 21 February 2022
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Transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices ***I
TEXT_ADOPTED · EN · 21 February 2022
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Преходни разпоредби за някои медицински изделия за инвитро диагностика и отложено прилагане на изискванията към изделията в самите лечебни заведения ***I
TEXT_ADOPTED · BG · 21 February 2022
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Преходни разпоредби за някои медицински изделия за инвитро диагностика и отложено прилагане на изискванията към изделията в самите лечебни заведения ***I
TEXT_ADOPTED · BG · 21 February 2022
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Official source: https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?lang=en&reference=2021%2F0323(COD)
Open data entity: https://data.europarl.europa.eu/api/v2/procedures/2021-0323
eu · 2021-0323 · source updated 28 January 2022