natgillin/translations-raw huggingface dataset:
The proposal does not go beyond what is necessary to achieve the objective of alleviating the impact of the current SARS-CoV-2 outbreak for the purposes of the operation of Regulation (EEC) No 95/93. 
Ovaj prijedlog ne prelazi ono što je potrebno za ostvarivanje cilja ublažavanja posljedica pojave virusa SARS-CoV-2 u svrhu funkcioniranja Uredbe (EEZ) br. 95/93. Predložena mjera stoga je proporcionalna, među ostalim i zbog pravovremene provedbe za različite vrste odredišta.
Regulation (EEC) No 95/93 does not address the problems that air carriers are facing due to the outbreak of SARS-CoV-2 in relation to their possibilities to maintain their slots for following scheduling periods. 
Uredba (EEZ) br. 95/93 ne odnosi se na probleme povezane s mogućnošću zadržavanja slotova u sljedećim razdobljima reda letenja s kojima se suočavaju zračni prijevoznici zbog pojave virusa SARS-CoV-2.
Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. 
Delegirani akti doneseni na temelju ovog članka stupaju na snagu bez odgode i primjenjuju se sve dok nije podnesen nikakav prigovor u skladu sa stavkom 2. Prilikom priopćenja delegiranog akta Europskom parlamentu i Vijeću navode se razlozi za primjenu hitnog postupka.
EN 8 EN 
HR 8 HR
EN EN 
I VIJEĆA
For the purposes of Articles 8(2) and 10(2), coordinators shall consider slots allocated for the period from 1 March 2020 until 30 June 2020 as having been operated by the air carrier to which they had initially been allocated. 
Za potrebe članka 8. stavka 2. i članka 10. stavka 2. koordinatori smatraju da je zračni prijevoznik kojem su slotovi prvotno dodijeljeni za razdoblje od 1. ožujka 2020. do 30. lipnja 2020. iskoristio te slotove.
• Choice of the instrument 
• Odabir instrumenta
Reasons for and objectives of the proposal 
Razlozi i ciljevi prijedloga
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. 
U skladu s načelom proporcionalnosti utvrđenim u tom članku, ova Uredba ne prelazi ono što je potrebno za ostvarivanje tih ciljeva.
The proposal does not have a budgetary impact for the EU institutions. 
Prijedlog ne utječe na proračun institucija EU-a.
Proportionality 
Proporcionalnost
According to the principle of subsidiarity, Union action may only be taken if the envisaged aims cannot be achieved by Member States alone. 
U skladu s načelom supsidijarnosti djelovanje na razini Unije može se poduzeti samo ako države članice predviđene ciljeve ne mogu ostvariti same.
"(j) Article 59 shall apply from [insert date - date of entry into force of this Regulation]'; 
„(j) članak 59. primjenjuje se od [umetnuti datum - datum stupanja na snagu ove Uredbe]";
In this regard, the legislation, that is being amended, is adopted in full compliance with the principle of subsidiarity and any amendment thereto must be made through a Commission proposal. 
U tom pogledu, zakonodavstvo koje se izmjenjuje donosi se u potpunosti u skladu s načelom supsidijarnosti i svaka njegova izmjena mora se provesti na temelju Komisijina prijedloga.
After consulting the European Economic and Social Committee, 
nakon savjetovanja s Europskim gospodarskim i socijalnim odborom,
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). 
Ti se provedbeni akti donose u skladu s postupkom ispitivanja iz članka 114. stavka 3.";
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof, 
uzimajući u obzir Ugovor o funkcioniranju Europske unije, a posebno njegov članak 114. i članak 168. stavak 4. točku (c),
Those deferrals safeguard the presence of a functioning regulatory framework on medical devices from 26 May 2020. 
Tim se odgodama postiže postojanje funkcionirajućeg regulatornog okvira za medicinske proizvode i nakon 26. svibnja 2020.
It was therefore considered to be appropriate to provide for an exception to the eight-week period referred to in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the Treaty on European Union, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community. 
Stoga se smatra primjerenim predvidjeti iznimku od osmotjednog roka iz članka 4. Protokola br. 1 o ulozi nacionalnih parlamenata u Europskoj uniji, priloženog Ugovoru o Europskoj uniji, Ugovoru o funkcioniranju Europske unije i Ugovoru o osnivanju Europske zajednice za atomsku energiju.
The proposal is based on Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union (TFEU). 
Prijedlog je utemeljen na članku 114. i članku 168. stavku 4. točki (c) Ugovora o funkcioniranju Europske unije (UFEU).
This proposal is not accompanied by a separate impact assessment, as an impact assessment for Regulation (EU) 2017/745 has already been undertaken. 
Ovom prijedlogu nije priložena zasebna procjena učinka jer je ona već provedena za Uredbu (EU) 2017/745.
(12) The adoption of this Regulation takes place under exceptional circumstances arising from the COVID-19 outbreak and the associated public health crisis. 
(12) Ova se Uredba donosi u iznimnim okolnostima koje su posljedica pandemije bolesti COVID-19 i povezane javnozdravstvene krize.
Regulation (EU) 2017/745 also allows the Commission to extend, in exceptional cases, the validity of a national derogation for a limited period of time to the territory of the Union (‘Union-wide derogation'). 
Uredbom (EU) 2017/745 također se omogućuje Komisiji da, u iznimnim slučajevima, valjanost nacionalnih odstupanja proširi na područje Unije na ograničeni rok („odstupanje na razini Unije").
Regulation (EU) 2017/745 is amended as follows: 
Uredba (EU) 2017/745 mijenja se kako slijedi:
(13) In light of the overriding need to immediately address the public health crisis associated with the COVID-19 outbreak, this Regulation should enter into force as a matter of urgency, 
(13) S obzirom na to da je potrebno odmah reagirati na javnozdravstvenu krizu povezanu s pandemijom bolesti COVID-19, ova bi Uredba trebala hitno stupiti na snagu,
This proposal does not alter Regulation (EU) 2017/745 on substance and does not impose new obligations on the concerned parties. 
Ovim se prijedlogom ne mijenja sadržaj Uredbe (EU) 2017/745 niti se njime uvode nove obveze predmetnih strana.
(6) The application should be deferred for provisions of Regulation (EU) 2017/745 that would otherwise start to apply from 26 May 2020. 
(6) Primjenu bi trebalo odgoditi za odredbe Uredbe (EU) 2017/745 koje bi se inače počele primjenjivati od 26. svibnja 2020.
‘(g) with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to: 
„(g) u pogledu proizvoda za višekratnu uporabu koji sami nose oznaku nosača jedinstvene identifikacije proizvoda članak 27. stavak 4. primjenjuje se na sljedeće:
After consulting the Committee of the Regions, 
nakon savjetovanja s Odborom regija,
This Union action is necessary to achieve the objective of the proper implementation and application of Regulation (EU) 2017/745 by all involved parties, taking into account the magnitude of the current COVID-19 outbreak and the associated public health crisis. 
To djelovanje Unije nužno je za postizanje cilja pravilne provedbe i primjene Uredbe (EU) 2017/745 od strane svih uključenih strana, uzimajući u obzir razmjere aktualne pandemije bolesti COVID-19 i s njom povezane javnozdravstvene krize.
In addition, the proposed amendment seeks to ensure that the Commission is able to adopt, in exceptional cases, Union-wide derogations in response to national derogations at the earliest date possible in order to address potential shortages Union wide of vitally important medical devices in an effective manner. 
Osim toga, predloženom izmjenom nastoji se osigurati da Komisija u iznimnim slučajevima može u najkraćem mogućem roku 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.
(10) Regulation (EU) 2017/745 should therefore be amended accordingly. 
(10) Uredbu (EU) 2017/745 trebalo bi stoga na odgovarajući način izmijeniti.
amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions 
o izmjeni Uredbe (EU) 2017/745 o medicinskim proizvodima u pogledu datuma primjene određenih njezinih odredaba
Those extraordinary circumstances have a significant impact on various areas covered by Regulation (EU) 2017/745, such as the designation and work of notified bodies and the placing on the market and making available on the market of medical devices in the Union. 
Te izvanredne okolnosti imaju znatan utjecaj na različita područja obuhvaćena Uredbom (EU) 2017/745, kao što su imenovanje i rad prijavljenih tijela te stavljanje na tržište i stavljanje na raspolaganje na tržištu medicinskih proizvoda u Uniji.
(9) To ensure the continuous presence of a functioning and effective regulatory framework for medical devices it is necessary to also defer the application of the provision repealing Directives 90/385/EEC and 93/42/EEC. 
(9) Kako bi se osiguralo neprekinuto važenje funkcionirajućeg i djelotvornog regulatornog okvira za medicinske proizvode, potrebno je odgoditi i primjenu odredbe o stavljanju izvan snage direktiva 90/385/EEZ i 93/42/EEZ.
Union intervention is required to ensure a high level of protection of health for patients and users, the smooth functioning of the internal market and avoid potential market disruption. 
Djelovanje Unije potrebno je kako bi se osigurala visoka razina zaštite zdravlja pacijenata i korisnika i neometano funkcioniranje unutarnjeg tržišta te izbjegli mogući poremećaji na tržištu.
To attain the intended effect of amending Regulation (EU) 2017/745 as regards the dates of application of certain provisions, it is necessary for this Regulation to enter into force before 26 May 2020. 
Kako bi se postigao predviđeni učinak izmjene Uredbe (EU) 2017/745 u pogledu datuma primjene određenih odredaba, potrebno je da ova Uredba stupi na snagu prije 26. svibnja 2020.
It is for this reason appropriate that the relevant provision of Regulation (EU) 2017/745 applies at the earliest date possible and that the corresponding provisions of Directives 90/385/EEC and 93/42/EEC are repealed from that same date. 
Iz tog je razloga primjereno da se relevantna odredba Uredbe (EU) 2017/745 počne primjenjivati na najraniji mogući datum i da se odgovarajuće odredbe direktiva 90/385/EEZ i 93/42/EEZ stave izvan snage od istog tog datuma.
At the same time, it is necessary to defer the date of repeal of Directives 90/385/EEC and 93/42/EEC. 
Istodobno je potrebno odgoditi datum stavljanja izvan snage direktiva 90/385/EEZ i 93/42/EEZ.
(8) In order to cover any national derogations granted by the Member States in accordance with Directives 90/385/EEC or 93/42/EEC in the context of the COVID-19 outbreak before the entry into force of this Regulation, it is also necessary to provide for the possibility for the Member States to notify those national derogations and for the Commission to extend their validity to the territory of the Union. 
(8) Kako bi se obuhvatila sva nacionalna odstupanja koja su države članice odobrile u skladu s Direktivom 90/385/EEZ ili Direktivom 93/42/EEZ u kontekstu pandemije bolesti COVID-19 prije stupanja na snagu ove Uredbe, također je potrebno predvidjeti mogućnost da države članice obavijeste Komisiju o tim nacionalnim odstupanjima i da Komisija proširi njihovu valjanost na područje Unije.
(3) Medical devices, such as medical gloves, surgical masks, equipment for intensive care and other medical equipment, play a crucial role in the context of the COVID-19 outbreak and the associated public health crisis to ensure the health and safety of Union citizens and to enable Member States to give patients urgently in need the necessary medical treatment. 
(3) Medicinski proizvodi kao npr. medicinske rukavice, kirurške maske, oprema za intenzivnu njegu i ostala medicinska oprema imaju ključnu ulogu u osiguravanju zdravlja i sigurnosti građana Unije i omogućavanju liječenja najhitnijih pacijenata u državama članicama u kontekstu pandemije bolesti COVID-19 i s njom povezane javnozdravstvene krize.
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. 
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.
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. 
„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.",
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. 
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.
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. 
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.
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. 
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.
"- 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]"; 
„- 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]";
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. 
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.
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. 
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.
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. 
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.
(v) the following point (j) is added: 
v. dodaje se sljedeća točka (j):
‘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]. 
„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].",
[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. 
[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.).]
(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'). 
(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").
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. 
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.
‘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. 
„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.
(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. 
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.
(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. 
(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.
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. 
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.