qanastek/ELRC-Medical-V2 huggingface dataset:
English: Taking into account the COVID-19 outbreak and the associated public health crisis, the Commission should be able to adopt Union-wide derogations in response to national derogations in order to address potential shortages Union wide of vitally important medical devices in an effective manner.
Translation (en-hr): Uzimajući u obzir pandemiju bolesti COVID-19 i povezanu javnozdravstvenu krizu, Komisija bi trebala moći donijeti odstupanja na razini Unije kao odgovor na nacionalna odstupanja kako bi se učinkovito reagiralo na problem potencijalne nestašice životno važnih medicinskih proizvoda u Uniji.
English: Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices placed on the market from 26 May 2021 pursuant to paragraph 3 of this Article, may continue to be made available on the market or put into service until 26 May 2025.
Translation (en-hr): „4. Proizvodi koji su zakonito stavljeni na tržište u skladu s direktivama 90/385/EEZ i 93/42/EEZ prije 26. svibnja 2021. te proizvodi stavljeni na tržište od 26. svibnja 2021. na temelju stavka 3. ovog članka mogu se i dalje stavljati na raspolaganje na tržištu ili u uporabu do 26. svibnja 2025.",
English: Regulation (EU) 2017/745 significantly reinforces key elements of the existing regulatory approach in Council Directive 90/385/EEC and Council Directive 93/42/EEC, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance, whilst introducing provisions ensuring transparency and traceability regarding medical devices, to improve health and safety.
Translation (en-hr): Uredbom (EU) 2017/745 znatno se poboljšavaju ključni elementi postojećeg regulatornog pristupa iz Direktive Vijeća 90/385/EEZ i Direktive Vijeća 93/42/EEZ, kao što su nadzor prijavljenih tijela, postupci ocjenjivanja sukladnosti, klinička ispitivanja i klinička procjena, vigilancija i nadzor tržišta, te se istodobno uvode odredbe za osiguravanje transparentnosti i sljedivosti u pogledu medicinskih proizvoda radi poboljšanja zdravlja i sigurnosti.
English: To ensure the continuous availability of medical devices on the Union market, including medical devices that are vitally important in the context of the COVID-19 outbreak and the associated public health crisis, it is also necessary to adapt certain transitional provisions of Regulation (EU) 2017/745 that would otherwise no longer apply as from the date of application of those provisions.
Translation (en-hr): Kako bi se osigurala stalna dostupnost medicinskih proizvoda na tržištu Unije, uključujući medicinske proizvode koji su od životne važnosti u kontekstu pandemije bolesti COVID-19 i povezane javnozdravstvene krize, potrebno je prilagoditi i određene prijelazne odredbe Uredbe (EU) 2017/745 koje se inače više ne bi primjenjivale od datuma primjene tih odredaba.
English: In order to take account of the fact that the possibility to adopt Union-wide derogations must, for a transitional period, be given to the Commission in relation to national derogations from Directives 90/385/EEC and 93/42/EEC, certain amendments to the relevant provisions of Regulation (EU) 2017/745 are necessary.
Translation (en-hr): Kako bi se u obzir uzela činjenica da se Komisiji za prijelazno razdoblje mora dati mogućnost donošenja odstupanja na razini Unije u vezi s nacionalnim odstupanjima od direktiva 90/385/EEZ i 93/42/EEZ, potrebne su određene izmjene odgovarajućih odredaba Uredbe (EU) 2017/745.
English: "- Article 11(13) of Directive 93/42/EEC and Article 9(9) of Directive 90/385/EEC which are repealed with effect from [insert date - date of entry into force of this Regulation]";
Translation (en-hr): „- članak 11. stavak 13. Direktive 93/42/EEZ i članak 9. stavak 9. Direktive 90/385/EEZ koji se stavljaju izvan snage s učinkom od [umetnuti datum - datum stupanja na snagu ove Uredbe]";
English: At the same time, Regulation (EU) 2017/745 sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such devices.
Translation (en-hr): Istovremeno, Uredbom (EU) 2017/745 utvrđuju se visoki standardi kvalitete i sigurnosti za medicinske proizvode u svrhu rješavanja općih sigurnosnih problema povezanih s tim proizvodima.
English: The COVID-19 crisis has created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of Regulation (EU) 2017/745.
Translation (en-hr): Zbog krize uzrokovane bolešću COVID-19 došlo je do izvanrednih okolnosti koje zahtijevaju znatna dodatna sredstva i povećanu dostupnost životno važnih medicinskih proizvoda, a koje nisu bile razumno predvidljive u vrijeme donošenja Uredbe (EU) 2017/745.
English: Taking into account the COVID-19 outbreak and the associated public health crisis, its epidemiological development, as well as the additional resources required in the Member States, health institutions, economic operators and other relevant parties, it is appropriate to defer the application of the relevant provisions of Regulation (EU) 2017/745 by one year.
Translation (en-hr): Uzimajući u obzir pandemiju bolesti COVID-19 i s njom povezanu javnozdravstvenu krizu, njezin epidemiološki razvoj te dodatna sredstva koja su potrebna državama članicama, zdravstvenim institucijama, gospodarskim subjektima i drugim relevantnim stranama, primjereno je odgoditi primjenu relevantnih odredaba Uredbe (EU) 2017/745 za jednu godinu.
English: (v) the following point (j) is added:
Translation (en-hr): v. dodaje se sljedeća točka (j):
English: ‘The Member State may inform the Commission and the other Member States of any authorisation granted in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC before [insert date - date of entry into force of this Regulation].
Translation (en-hr): „Država članica može obavijestiti Komisiju i druge države članice o svakom odobrenju dodijeljenom u skladu s člankom 9. stavkom 9. Direktive 90/385/EEZ ili člankom 11. stavkom 13. Direktive 93/42/EEZ prije [umetnuti datum - datum stupanja na snagu ove Uredbe].",
English: [1: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 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 (OJ L 117, 5.5.2017, p.
Translation (en-hr): [1: Uredba (EU) 2017/745 Europskog parlamenta i Vijeća od 5. travnja 2017. 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 (SL L 117, 5.5.2017., str. 1.).][2: Direktiva Vijeća 90/385/EEZ od 20. lipnja 1990. o usklađivanju zakonodavstva država članica koja se odnose na aktivne medicinske proizvode za ugradnju (SL L 189, 20.7.1990., str. 17.).][3: Direktiva Vijeća 93/42/EEZ od 14. lipnja 1993. o medicinskim proizvodima (SL L 169, 12.7.1993., str. 1.).]
English: (7) Both Directives 90/385/EEC and 93/42/EEC, as well as Regulation (EU) 2017/745, empower national competent authorities, on a duly justified request, to authorise the placing on the market of medical devices for which the relevant conformity assessment procedures have not been carried out, but the use of which is in the interest of protection of health, or in the interest of public health or patient safety or health respectively (‘national derogation').
Translation (en-hr): (7) Direktivama 90/385/EEZ i 93/42/EEZ te Uredbom (EU) 2017/745 ovlašćuju se nacionalna nadležna tijela da, na propisno utemeljen zahtjev, odobre stavljanje na tržište medicinskih proizvoda za koje nisu provedeni relevantni postupci ocjenjivanja sukladnosti, ali čija je uporaba u interesu zaštite zdravlja, od interesa za javno zdravlje ili sigurnost odnosno zdravlje pacijenata („nacionalno odstupanje").
English: The proposed amendment aims to ensure that the intended purpose of Regulation (EU) 2017/745, that is, to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which guarantees a high level of protection of public health and patient safety and the smooth functioning of the internal market for such devices, can be attained.
Translation (en-hr): Predloženom izmjenom nastoji se postići predviđeni cilj Uredbe (EU) 2017/745, odnosno uspostava čvrstog, transparentnog, predvidljivog i održivog regulatornog okvira za medicinske proizvode kojim se jamči visoka razina zaštite javnog zdravlja i sigurnosti pacijenata te neometano funkcioniranje unutarnjeg tržišta za te proizvode.
English: ‘Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article or, when granted before [insert date - date of entry into force of this Regulation], in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC to the territory of the Union and set the conditions under which the device may be placed on the market or put into service.
Translation (en-hr): „Slijedom obavijesti u skladu sa stavkom 2. ovog članka, Komisija može, u iznimnim slučajevima u vezi s javnim zdravljem ili sigurnošću odnosno zdravljem pacijenata, provedbenim aktima na ograničeni rok proširiti valjanost odobrenja koje je dodijelila država članica u skladu sa stavkom 1. ovog članka ili, ako je dodijeljeno prije [umetnuti datum - datum stupanja na snagu ove Uredbe], u skladu s člankom 9. stavkom 9. Direktive 90/385/EEZ ili člankom 11. stavkom 13. Direktive 93/42/EEZ, na područje Unije i utvrditi uvjete pod kojima se proizvod može staviti na tržište ili u uporabu.
English: (11) Since the objectives of this Regulation, namely to defer the application of certain provisions of Regulation (EU) 2017/745 and to allow for the extension of the validity of national derogations, authorised under Directives 90/385/EEC or 93/42/EEC, to the territory of the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Translation (en-hr): S obzirom na to da ciljeve ove Uredbe, odnosno odgodu primjene određenih odredaba Uredbe (EU) 2017/745 i dopuštanje proširenja valjanosti nacionalnih odstupanja odobrenih na temelju Direktive 90/385/EEZ ili Direktive 93/42/EEZ na područje Unije, ne mogu dostatno ostvariti države članice, nego se zbog svojeg opsega i učinaka oni na bolji način mogu ostvariti na razini Unije, Unija može donijeti mjere u skladu s načelom supsidijarnosti utvrđenim u članku 5. Ugovora o Europskoj uniji.
English: (2) The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to the Member States and is a high burden for national authorities, health institutions, EU citizens, and economic operators.
Translation (en-hr): (2) Pandemija bolesti COVID-19 i s njom povezana javnozdravstvena kriza nezapamćeni je izazov za države članice i veliko opterećenje za nacionalna tijela, zdravstvene institucije, građane EU-a i gospodarske subjekte.
English: The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to the Member States and is a high burden for national authorities, health institutions, EU citizens and economic operators.
Translation (en-hr): Pandemija bolesti COVID-19 i s njom povezana javnozdravstvena kriza nezapamćeni je izazov za države članice i veliko opterećenje za nacionalna tijela, zdravstvene institucije, građane EU-a i gospodarske subjekte.
English: Those extraordinary circumstances have a significant impact on various areas covered by Regulation (EU) 2017/745 and therefore it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as it provides for.
Translation (en-hr): Te izvanredne okolnosti imaju znatan utjecaj na različita područja obuhvaćena Uredbom (EU) 2017/745 te je stoga vrlo vjerojatno da države članice, zdravstvene ustanove, gospodarski subjekti i druge relevantne strane neće moći osigurati pravilnu provedbu i primjenu te uredbe od 26. svibnja 2020., datuma predviđenog za početak njezine primjene.
English: (4) Given the unprecedented magnitude of the current challenges, and taking into account the complexity of Regulation (EU) 2017/745, it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as it provides for.
Translation (en-hr): (4) S obzirom na aktualnu krizu neviđenih razmjera i uzimajući u obzir složenost Uredbe (EU) 2017/745 vrlo je vjerojatno da države članice, zdravstvene ustanove, gospodarski subjekti i druge relevantne strane neće moći osigurati pravilnu provedbu i primjenu te uredbe od 26. svibnja 2020., datuma predviđenog za početak njezine primjene.
English: (5) In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty, and to avoid potential market disruption, it is necessary to defer the application of certain provisions of Regulation (EU) 2017/745.
Translation (en-hr): (5) Kako bi se osiguralo neometano funkcioniranje unutarnjeg tržišta i visoka razina zaštite javnog zdravlja i sigurnosti pacijenata te pružila pravna sigurnost i izbjegli mogući poremećaji na tržištu, nužno je odgoditi primjenu određenih odredaba Uredbe (EU) 2017/745.
English: (5) in Article 113, '25 February 2020' is replaced by '25 February 2021';
Translation (en-hr): (5) u članku 113. datum „25. veljače 2020." zamjenjuje se datumom „25. veljače 2021.";
English: It primarily aims at providing, for exceptional reasons in the context of the current COVID-19 outbreak, a one-year deferral as regards the date of application of certain provisions of that Regulation.
Translation (en-hr): Prvenstveni je cilj ovog prijedloga jednogodišnja odgoda datuma primjene određenih odredaba te uredbe zbog iznimnih razloga u kontekstu aktualne pandemije bolesti COVID-19.
English: By way of derogation from Article 52 of this Regulation or, for the period from [insert date - date of entry into force of this Regulation] to 25 May 2021, by way of derogation from Article 9(1) and (2) of Directive 90/385/EEC or from Article 11(1) to (6) of Directive 93/42/EEC, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the applicable procedures referred to in those Articles have not been carried out but use of which is in the interest of public health or patient safety or health.
Translation (en-hr): „1. Odstupajući od članka 52. ove Uredbe, ili za razdoblje od [umetnuti datum - datum stupanja na snagu ove Uredbe] do 25. svibnja 2021., odstupajući od članka 9. stavaka 1. i 2. Direktive 90/385/EEZ ili članka 11. stavaka od 1. do 6. Direktive 93/42/EEZ, svako nadležno tijelo može, na propisno utemeljen zahtjev, odobriti stavljanje na tržište ili u uporabu, na državnom području predmetne države članice, određenog proizvoda za koji nisu provedeni primjenjivi postupci iz tih članaka, ali čija je uporaba u interesu javnog zdravlja ili sigurnosti odnosno zdravlja pacijenata.",
English: In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty, and to avoid potential market disruption, it is necessary to defer the application of certain provisions of Regulation (EU) 2017/745 by one year.
Translation (en-hr): Kako bi se osiguralo neometano funkcioniranje unutarnjeg tržišta i visoka razina zaštite javnog zdravlja i sigurnosti pacijenata te pružila pravna sigurnost i izbjegli mogući poremećaji na tržištu, nužno je odgoditi primjenu određenih odredaba Uredbe (EU) 2017/745 za jednu godinu.
English: (1) Regulation (EU) 2017/745 of the European Parliament and of the Council establishes a new regulatory framework to ensure the smooth functioning of the internal market as regards medical devices covered by that Regulation, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector.
Translation (en-hr): (1) Uredbom (EU) 2017/745 Europskog parlamenta i Vijeća uspostavlja se novi regulatorni okvir za osiguravanje neometanog funkcioniranja unutarnjeg tržišta u pogledu medicinskih proizvoda obuhvaćenih tom uredbom, polazeći od visoke razine zaštite zdravlja pacijenata i korisnika te uzimajući u obzir mala i srednja poduzeća koja djeluju u tom sektoru.
English: (2) Article 17 is amended as follows:
Translation (en-hr): (2) članak 17. mijenja se kako slijedi:
English: (8) Article 123 is amended as follows:
Translation (en-hr): (8) članak 123. mijenja se kako slijedi:
English: Regulation (EU) 2017/745 of the European Parliament and of the Council, adopted on 5 April 2017, establishes a new regulatory framework to ensure the smooth functioning of the internal market as regards medical devices covered by that Regulation, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises that are active in this sector.
Translation (en-hr): Uredbom (EU) 2017/745 Europskog parlamenta i Vijeća donesenom 5. travnja 2017. uspostavlja se novi regulatorni okvir za osiguravanje neometanog funkcioniranja unutarnjeg tržišta u pogledu medicinskih proizvoda obuhvaćenih tom uredbom, polazeći od visoke razine zaštite zdravlja pacijenata i korisnika te uzimajući u obzir mala i srednja poduzeća koja djeluju u tom sektoru.
English: ‘(f) Article 27(4) shall apply to class IIa and class IIb devices from 26 May 2023 and to class I devices from 26 May 2025;',
Translation (en-hr): „(f) Na proizvode II.a klase i II.b klase članak 27. stavak 4. primjenjuje se od 26. svibnja 2023., a na proizvode I. klase od 26. svibnja 2025.;",
English: (iii) class I devices from 26 May 2027;',
Translation (en-hr): iii. proizvodi I. klase: od 26. svibnja 2027.;",
English: (4) Article 59 is amended as follows:
Translation (en-hr): (4) članak 59. mijenja se kako slijedi:
English: (7) in Article 122, the first paragraph is amended as follows:
Translation (en-hr): (7) u članku 122. prvi stavak mijenja se kako slijedi:
English: (1) in Article 1(2), the second subparagraph is amended as follows:
Translation (en-hr): (1) u članku 1. stavku 2. drugi podstavak mijenja se kako slijedi:
English: (b) in paragraph 2, the following subparagraph is added:
Translation (en-hr): (b) u stavku 2. dodaje se sljedeći podstavak:
English: (iv) point (g) is replaced by the following:
Translation (en-hr): iv. točka (g) zamjenjuje se sljedećim:
English: (3) in Article 34(1), ‘25 March 2020' is replaced by '25 March 2021';
Translation (en-hr): (3) u članku 34. stavku 1. datum „25. ožujka 2020." zamjenjuje se datumom „25. ožujka 2021.";
English: (ii) class IIa and class IIb devices from 26 May 2025;
Translation (en-hr): ii. proizvodi II.a i II.b klase: od 26. svibnja 2025.;
English: (iii) point (f) is replaced by the following:
Translation (en-hr): iii. točka (f) zamjenjuje se sljedećim:
English: (6) Article 120 is amended as follows:
Translation (en-hr): (6) članak 120. mijenja se kako slijedi:
English: (9) in point (h) of point 5.1 of Annex IX,'26 May 2020' is replaced by '26 May 2021'.
Translation (en-hr): (9) u točki 5.1. podtočki (h) Priloga IX. datum „26. svibnja 2020." zamjenjuje se datumom „26. svibnja 2021.".
English: (c) in paragraph 3, the first subparagraph is replaced by the following:
Translation (en-hr): (c) u stavku 3. prvi podstavak zamjenjuje se sljedećim:
English: (f) paragraph 11 is amended as follows:
Translation (en-hr): (f) stavak 11. mijenja se kako slijedi:
English: (a) paragraph 1 is replaced by the following:
Translation (en-hr): (a) stavak 1. zamjenjuje se sljedećim:
English: Proposal for a
Translation (en-hr): Prijedlog
English: (i) implantable devices and class III devices from 26 May 2023;
Translation (en-hr): i. proizvodi za ugradnju i proizvodi III. klase: od 26. svibnja 2023.;
English: 13 Regional and Urban Policy
Translation (en-hr): 13 Regionalna i urbana politika
English: [XX.YY.YY.YY] NO NO NO NO
Translation (en-hr): [XX.YY.YY.YY] NE NE NE NE
English: framework Number 1b Smart and Inclusive Growth
Translation (en-hr): okvira Broj 1b Pametan i uključiv rast
English: Such eligible expenditure shall not exceed EUR 200 000.
Translation (en-hr): Takvi prihvatljivi izdaci ne smiju prelaziti 200 000 EUR.
English: In the meantime, the effects on our economies and societies become ever more serious.
Translation (en-hr): U međuvremenu posljedice za naša gospodarstva i društva postaju sve ozbiljnije.
English: There was no consultation of external stakeholders.
Translation (en-hr): Nije bilo savjetovanja s vanjskim dionicima.
English: These current limited and targeted changes do not require a separate impact assessment.
Translation (en-hr): Za te trenutačne ograničene i ciljane promjene nije potrebna zasebna procjena učinka.
English: The first package of measures proposed by the Commission on 13 March 2020 introduced a number of important changes that allow for a more effective response in the current situation.
Translation (en-hr): U prvom paketu mjera koji je Komisija predložila 13. ožujka 2020. uveden je niz važnih promjena koje omogućuju djelotvorniji odgovor u trenutačnoj situaciji.
English: Furthermore, certain procedural requirements linked to audits and financial instruments will be simplified.
Translation (en-hr): Nadalje, pojednostavnit će se određeni postupovni zahtjevi povezani s revizijama i financijskim instrumentima.
English: In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary to achieve those objectives.
Translation (en-hr): U skladu s načelom proporcionalnosti utvrđenim u tom članku, ova Uredba ne prelazi ono što je potrebno za ostvarivanje tih ciljeva.
English: These measures are complementary and additional to the legislative modifications proposed on 13 March 2020.
Translation (en-hr): Te su dodatne mjere nadopuna zakonodavnim izmjenama predloženima 13. ožujka 2020.
English: Such operations may be selected even before the necessary programme amendment is approved by the Commission.
Translation (en-hr): Te se operacije mogu odabrati čak i prije nego što Komisija odobri potrebnu izmjenu programa.
English: Equally, the Commission will display the same flexibility in assessing the compliance of Member States with their obligations.
Translation (en-hr): Komisija će iskazati jednaku fleksibilnost kad bude procjenjivala jesu li države članice ispunile svoje obveze.
English: (3) However, the serious negative effects on EU economies and societies are becoming worse.
Translation (en-hr): (3) Međutim, pogoršavaju se ozbiljni negativni učinci na gospodarstva i društva EU-a.
English: framework 5 ‘Administrative expenditure'
Translation (en-hr): okvira 5 „Administrativni rashodi"
English: National authorities could also consider the possibility to select new operations or to launch new or additional calls for proposals if necessary.
Translation (en-hr): Nacionalna tijela mogu razmotriti i mogućnost odabira novih operacija ili pokretanja novih ili dodatnih poziva na podnošenje prijedloga ako je to potrebno.
English: Financial impact in 2020 - 2025
Translation (en-hr): financijski učinak od 2020. do 2025.
English: 4 Employment, Social affairs and Inclusion
Translation (en-hr): 4 Zapošljavanje, socijalna pitanja i uključivanje