natgillin/translations-raw huggingface dataset:
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.
Z odstopanjem od člena 52 te uredbe ali, v primeru obdobja od [vstaviti datum - datum začetka veljavnosti te uredbe] do 25. maja 2021, z odstopanjem od člena 9(1) in (2) Direktive 90/385/EGS ali člena 11(1) do (6) Direktive 93/42/EGS lahko vsak pristojni organ na podlagi ustrezno utemeljene zahteve na ozemlju zadevne države članice odobri dajanje določenega pripomočka, za katerega niso bili opravljeni ustrezni postopki iz navedenih členov, vendar je njegova uporaba v interesu javnega zdravja ali pa varnosti ali zdravja pacientov, na trg ali v uporabo.
(7) in Article 122, the first paragraph is amended as follows:
(7) v členu 122 se prvi odstavek spremeni:
(9) in point (h) of point 5.1 of Annex IX,'26 May 2020' is replaced by '26 May 2021'.
(9) v točki (h) točke 5.1 Priloge IX se datum „26.
‘(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;',
„(f) se za pripomočke razredov IIa in IIb člen 27(4) uporablja od 26. maja 2023, za pripomočke razreda I pa od 26. maja 2025;";
(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.
(4) Glede na to, da se zdaj soočamo z izzivi, katerih razsežnost še nikoli ni bila tako velika, in ob upoštevanju kompleksnosti Uredbe (EU) 2017/745 je zelo verjetno, da države članice, zdravstvene ustanove, gospodarski subjekti in druge zadevne strani ne bodo mogle zagotoviti ustreznega izvajanja in uporabe navedene uredbe od 26. maja 2020, kakor je določeno.
(b) in paragraph 2, the following subparagraph is added:
(b) v odstavku 2 se doda naslednji pododstavek:
(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.
(5) Da bi zagotovili nemoteno delovanje notranjega trga, visoko raven varovanja javnega zdravja in varnosti pacientov ter pravno varnost in se izognili morebitnim motnjam na trgu, je treba odložiti začetek uporabe nekaterih določb Uredbe (EU) 2017/745.
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.
Uredba (EU) 2017/745 Evropskega parlamenta in Sveta, sprejeta 5. aprila 2017, vzpostavlja nov regulativni okvir za zagotovitev nemotenega delovanja notranjega trga v zvezi z medicinskimi pripomočki, zajetimi v navedeni uredbi, pri čemer je izhodišče visoka raven varovanja zdravja pacientov in uporabnikov, ob upoštevanju malih in srednjih podjetij, ki delujejo v tem sektorju.
(iii) class I devices from 26 May 2027;',
(iii) za pripomočke razreda I od 26. maja 2027;";
(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.
(1) Uredba (EU) 2017/745 Evropskega parlamenta in Sveta vzpostavlja nov regulativni okvir za zagotovitev nemotenega delovanja notranjega trga v zvezi z medicinskimi pripomočki, zajetimi v navedeni uredbi, pri čemer je izhodišče visoka raven varovanja zdravja pacientov in uporabnikov, ob upoštevanju malih in srednjih podjetij, ki delujejo v tem sektorju.
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.
Da bi zagotovili nemoteno delovanje notranjega trga, visoko raven varovanja javnega zdravja in varnosti pacientov, pravno varnost in se izognili morebitnim motnjam na trgu, je treba odložiti začetek uporabe nekaterih določb Uredbe (EU) 2017/745 za eno leto.
(ii) class IIa and class IIb devices from 26 May 2025;
(ii) za pripomočke razredov IIa in IIb od 26. maja 2025;
(8) Article 123 is amended as follows:
(8) člen 123 se spremeni:
(2) Article 17 is amended as follows:
(2) člen 17 se spremeni:
(c) in paragraph 3, the first subparagraph is replaced by the following:
(c) v odstavku 3 se prvi pododstavek nadomesti z naslednjim:
(4) Article 59 is amended as follows:
(4) člen 59 se spremeni:
(6) Article 120 is amended as follows:
(6) člen 120 se spremeni:
(1) in Article 1(2), the second subparagraph is amended as follows:
(1) v členu 1(2) se drugi pododstavek spremeni:
(iv) point (g) is replaced by the following:
(iv) točka (g) se nadomesti z naslednjim:
(i) implantable devices and class III devices from 26 May 2023;
(i) za pripomočke za vsaditev in pripomočke razreda III od 26. maja 2023;
(f) paragraph 11 is amended as follows:
(f) odstavek 11 se spremeni:
(5) in Article 113, '25 February 2020' is replaced by '25 February 2021';
(5) v členu 113 se datum „25.
(a) paragraph 1 is replaced by the following:
(a) odstavek 1 se nadomesti z naslednjim:
(iii) point (f) is replaced by the following:
(iii) točka (f) se nadomesti z naslednjim:
(3) in Article 34(1), ‘25 March 2020' is replaced by '25 March 2021';
(3) v členu 34(1) se datum „25.
(b) paragraph 4 is replaced by the following:
(b) odstavek 4 se nadomesti z naslednjim:
Such eligible expenditure shall not exceed EUR 200 000.
Taki upravičeni izdatki ne presegajo 200 000 EUR.
13 Regional and Urban Policy
13 Regionalna in mestna politika
[XX.YY.YY.YY] NO NO NO NO
[XX YY YY YY] NE NE NE NE
There was no consultation of external stakeholders.
Posvetovanja z zunanjimi zainteresiranimi stranmi ni bilo.
These current limited and targeted changes do not require a separate impact assessment.
Te trenutno omejene in ciljno usmerjene spremembe ne zahtevajo ločene ocene učinka.
4 Employment, Social affairs and Inclusion
4 Zaposlovanje, socialne zadeve in vključevanje
from candidate countries[13: Candidate countries and, where applicable, potential candidate countries from the Western Balkans.]
držav kandidatk[13: Države kandidatke in po potrebi potencialne države kandidatke z Zahodnega Balkana.]
These measures are complementary and additional to the legislative modifications proposed on 13 March 2020.
Ti ukrepi dopolnjujejo zakonodajne spremembe, predlagane 13. marca 2020.
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.
S prvim svežnjem ukrepov, ki ga je Komisija predlagala 13. marca 2020, je bilo uvedenih več pomembnih sprememb, ki omogočajo učinkovitejši odziv na trenutne razmere.
Equally, the Commission will display the same flexibility in assessing the compliance of Member States with their obligations.
Prav tako bo Komisija pokazala enako prožnost pri ocenjevanju izpolnjevanja obveznosti s strani držav članic.
Furthermore, certain procedural requirements linked to audits and financial instruments will be simplified.
Poenostavljene bodo tudi nekatere postopkovne zahteve v povezavi z revizijami in finančnimi instrumenti.
(3) However, the serious negative effects on EU economies and societies are becoming worse.
(3) Vendar postajajo resni negativni učinki na gospodarstva in družbe EU vedno hujši.
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.
V skladu z načelom sorazmernosti iz navedenega člena ta uredba ne presega tistega, kar je potrebno za doseganje navedenega cilja.
[10: Details of management modes and references to the Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html]
[10: Pojasnila o načinih upravljanja in sklici na finančno uredbo so na voljo na spletišču BudgWeb: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html]
Such operations may be selected even before the necessary programme amendment is approved by the Commission.
Take operacije se lahko izberejo, še preden Komisija odobri potrebne spremembe programa.
The direct and indirect effects of the COVID-19 outbreak continue to increase in all Member States.
Neposredni in posredni učinki izbruha COVID-19 se v vseh državah članicah še naprej povečujejo.
In order to contribute to an effective response to the current crisis, the scope of support from the ERDF was considerably expanded.
Da bi prispevali k učinkovitemu odzivu na sedanjo krizo, je bil obseg podpore iz ESRR precej razširjen.
from EFTA countries[12: EFTA: European Free Trade Association. ]
držav Efte[12: Efta: Evropsko združenje za prosto trgovino. ]
DG: EMPL, REGIO 2020 2021 2022 2023 2024 2025 TOTAL
GD: EMPL, REGIO 2020 2021 2022 2023 2024 2025 SKUPAJ
In the meantime, the effects on our economies and societies become ever more serious.
Medtem pa se posledice za naša gospodarstva in družbe še zaostrujejo.
This has created an exceptional situation which needs to be addressed with specific measures.
Zaradi tega so nastale izredne razmere, ki jih je treba reševati s specifičnimi ukrepi.
Financial impact in 2020 - 2025
finančne posledice med letoma 2020 in 2025
Based on an assessment of the application of this exceptional co-financing rate, the Commission may propose an extension of this measure.
Na podlagi ocene uporabe te izredne stopnje sofinanciranja lahko Komisija predlaga razširitev tega ukrepa.
The proposal is based on Articles 177, 178 and 322 of the Treaty on the Functioning of the European Union.
Predlog temelji na členih 177, 178 in 322 Pogodbe o delovanju Evropske unije.
Payments =5+ 6
plačila = 5 + 6
The Commission will assess and may propose on that basis an extension of this measure.
Komisija bo izvedla oceno in lahko na tej podlagi predlaga razširitev tega ukrepa.
The COVID-19 outbreak is also likely to have serious impacts on the implementation of ongoing operations.
Izbruh COVID-19 bo verjetno imel resne posledice tudi za izvajanje tekočih operacij.
SPECIFIC OBJECTIVE No 1…[17: As described in point 1.4.2.
SPECIFIČNI CILJ št. 1 …[17: Kakor je opisan v točki 1.4.2 „Specifični cilji …". ]
National authorities could also consider the possibility to select new operations or to launch new or additional calls for proposals if necessary.
Nacionalni organi bi lahko po potrebi razmislili tudi o možnosti izbire novih operacij ali uvedbi novih ali dodatnih razpisov za zbiranje predlogov.
[8: ABM: activity-based management; ABB: activity-based budgeting.]
[8: ABM: upravljanje po dejavnostih, ABB: oblikovanje proračuna po dejavnostih.]
1b Smart and Inclusive Growth: European Regional Development Fund, the European Social Fund, the Cohesion Fund 4 Employment, social affairs and inclusion 13 Regional and Urban Policy Diff. NO NO NO NO
1b Pametna in vključujoča rast: Evropski sklad za regionalni razvoj, Evropski socialni sklad, Kohezijski sklad 4 Zaposlovanje, socialne zadeve in vključevanje 13 Regionalna in mestna politika dif. NE NE NE NE
The transmission of the summary report prepared by the Commission in 2020, in accordance with Article 53(1), may be postponed accordingly.
Predložitev zbirnega poročila, ki ga je leta 2020 pripravila Komisija v skladu s členom 53(1), se lahko v skladu s tem preloži na pozneje.
Furthermore, it is also proposed to allow for additional flexibility at the closure of programmes to ensure that available resources are used to the largest extent (Article 1(3)).
Predlaga se tudi, da se ob zaključku programov omogoči dodatna prožnost, da se zagotovi čim večja uporaba razpoložljivih virov (člen 1(3)).
It provides clarity on the eligibility of expenditure affected by the measures put in place as a response to the public health crisis.
Zagotavlja jasnost glede upravičenosti izdatkov, na katere vplivajo ukrepi, ki se izvajajo v odziv na javnozdravstveno krizo.
The total annual breakdown of commitment appropriations for the European Regional Development Fund, the European Social Fund and the Cohesion Fund remains unchanged.
Skupna letna razdelitev odobritev za prevzem obveznosti za Evropski sklad za regionalni razvoj, Evropski socialni sklad in Kohezijski sklad ostaja nespremenjena.
"Article [25a]
Člen [25a]
However, the proposal follows extensive consultations with Member States and the European Parliament over recent weeks, and takes account of the more than 200 clarification and advice questions received from national authorities concerning their handling of crisis response measures through the Coronavirus Response Investment Initiative Task Force.
Vendar predlog temelji na obsežnih posvetovanjih z državami članicami in Evropskim parlamentom v zadnjih tednih ter upošteva več kot 200 pojasnjevalnih vprašanj in vprašanj glede nasvetov, ki jih je prejela od nacionalnih organov v zvezi z njihovim ravnanjem pri ukrepih za odzivanje na krizo prek delovne skupine v okviru naložbene pobude v odziv na koronavirus.
A Regulation is the appropriate instrument to introduce the additional flexibilities needed to address these unprecedented circumstances.
Uredba je ustrezen instrument za uvedbo dodatne prožnosti, ki je potrebna za obravnavo teh okoliščin brez primere.
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 177, 178 and 322(1)(a) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije ter zlasti členov 177, 178 in 322(1)(a) Pogodbe,
They result from the close cooperation with Member States through the Coronavirus Response Investment Initiative Task Force where over 200 questions have already been addressed.
Izhajajo iz tesnega sodelovanja z državami članicami prek delovne skupine v okviru naložbene pobude v odziv na koronavirus, ki je obravnavala že več kot 200 vprašanj.
The deadline for the submission of the annual implementation reports for the year 2019 should be postponed, as should be the transmission of the Commission's summary report based on those annual implementation reports.
Rok za predložitev letnih poročil o izvajanju za leto 2019 bi bilo treba preložiti na pozneje, tako kot tudi predložitev zbirnega poročila Komisije na podlagi teh letnih poročil o izvajanju.
[4: OJ C 91 I, 20.3.2020, p.
[4: UL C 91 I, 20.3.2020, str.
Proposal/initiative in effect from 1/7/2020 to 30/6/2021
trajanje predloga/pobude od 1. 7. 2020 do 30. 6. 2021
The Commission considers that all necessary flexibility should be deployed in dealing with failure by beneficiaries to fulfil obligations in a timely manner for reasons related to the COVID-19 outbreak (for example, the unavailability of staff).
Komisija meni, da bi bilo treba uporabiti vso potrebno prožnost pri obravnavanju nepravočasnega izpolnjevanja obveznosti s strani upravičencev iz razlogov, povezanih z izbruhom COVID-19 (npr. zaradi nerazpoložljivosti osebja).
By way of derogation from Article 125(3)(b), such operations may be selected for support by the ERDF or the ESF prior to the approval of the amended programme.
Z odstopanjem od člena 125(3)(b) se lahko take operacije izberejo za podporo iz ESRR ali ESS pred odobritvijo spremenjenega programa.
(2) in Article 130, the following paragraph 3 is added:
(2) v členu 130 se doda naslednji odstavek 3:
It finally alleviates some requirements for Member States where these create administrative burdens that could delay implementation of measures to respond to the COVID-19 outbreak.
Nazadnje odpravlja nekatere zahteve za države članice, če te ustvarjajo upravna bremena, ki bi lahko povzročila zamudo pri izvajanju ukrepov za odziv na izbruh COVID-19.
[9: As referred to in Article 54(2)(a) or (b) of the Financial Regulation.]
[9: Po členu 54(2)(a) oz. (b) finančne uredbe.]
Additionally, it is proposed to exempt Member States from the need to comply with thematic concentration requirements, to enable a redirection of resources to the areas most impacted by the current crisis.
Predlaga se tudi, da se države članice izvzamejo iz obveznosti izpolnjevanja zahtev glede tematske osredotočenosti, da se omogoči preusmeritev virov na območja, ki so najbolj prizadeta zaradi trenutne krize.
(1) the following new Chapter is added in Title II of Part Two:
(1) v naslovu II drugega dela se doda naslednje novo poglavje:
(15) Given the urgency of the situation related to the COVID-19 outbreak, it is appropriate that this Regulation enters into force on the date of its publication in the Official Journal of the European Union.
(15) Zaradi resnosti razmer v povezavi z izbruhom COVID-19 je primerno, da začne ta uredba veljati na dan objave v Uradnem listu Evropske unije.
It is necessary therefore to provide exceptional additional flexibility to Member States to enable them to respond to this unprecedented crisis by enhancing the possibility to mobilise all non-utilised support from the Funds.
Zato je treba državam članicam zagotoviti izredno dodatno prožnost, da se bodo lahko odzvale na to krizo brez primere, in sicer z razširitvijo možnosti uporabe celotne neporabljene podpore iz skladov.
These exceptional changes shall be without prejudice to the rules that should apply under regular circumstances.
Te izredne spremembe ne posegajo v pravila, ki bi se morala uporabljati v običajnih okoliščinah.
The implementation of the measures will be monitored and reported upon in the framework of the general reporting mechanisms established in Regulation (EU) No 1303/2013.
Spremljanje izvajanja ukrepov in poročanje o tem bosta potekala v okviru splošnih mehanizmov poročanja, določenih v Uredbi (EU) št. 1303/2013.
Member States and regions will be able to mobilise more resources for scaling up and extending short-time work schemes, for support to SMEs working capital and for immediate expenditure in the healthcare sector.
Države članice in regije bodo lahko mobilizirale več sredstev za okrepitev in razširitev shem skrajšanega delovnega časa, podporo MSP v obliki obratnega kapitala in takojšnje izdatke v zdravstvenem sektorju.
In order to ensure continued focus on less developed regions, the Member States should first examine other possibilities for transferring funding before considering transfers from the budget for the less developed regions given the potential negative implications of such transfers for the essential investments in the region of origin or for the completion of operations selected prior to the request for transfer (Article 25a(3) and (4)).
Da se zagotovi nadaljnja osredotočenost na manj razvite regije, bi morale države članice najprej proučiti druge možnosti za prenos finančnih sredstev, preden uporabijo sredstva iz proračuna za manj razvite regije, saj bi taki prenosi lahko imeli negativne posledice za bistvene naložbe v regiji izvora ali za dokončanje operacij, izbranih pred zahtevkom za prenos (člen 25a(3) in (4)).
The proposal complements the Commission's proposal COM(2020) 113 of 13 March 2020 as regards specific measures to mobilise investments in the health care systems of the Member States and in other sectors of their economies in response to the COVID-19 outbreak (Coronavirus Response Investment Initiative) as well as all other measures aimed at addressing the current unprecedented situation.
Dopolnjuje predlog Komisije COM(2020) 113 z dne 13. marca 2020 glede posebnih ukrepov za mobilizacijo naložb v zdravstvenih sistemih držav članic in v drugih sektorjih njihovih gospodarstev v odziv na izbruh COVID-19 (Naložbena pobuda v odziv na koronavirus) ter vse druge ukrepe za reševanje trenutnih razmer brez primere.
N [18: Year N is the year in which implementation of the proposal/initiative starts.]
N [18: Leto N je leto začetka izvajanja predloga/pobude.]
By way of derogation from Articles 26(1), 27(1), 30(1) and 30(2), as from [date of entry into force of this Regulation] the consistency of programmes and of their implementation with the Partnership Agreement shall not be verified.
Z odstopanjem od členov 26(1), 27(1), 30(1) in 30(2) se od [datum začetka veljavnosti te uredbe] ne preverja skladnost programov in njihovega izvajanja s sporazumom o partnerstvu.
The crisis hampers growth in Member States, which in turn aggravates the serious liquidity shortages due to the sudden and important increase in public investments needed in their health care systems and other sectors of their economies.
Kriza ovira rast v državah članicah, kar še poslabšuje resne težave s pomanjkanjem likvidnosti zaradi nenadnega velikega povečanja javnih naložb, ki so potrebne v zdravstvenih sistemih in drugih sektorjih gospodarstev.
In particular, Partnership Agreements should no longer be amended until the end of the programming period neither to reflect prior changes in operational programmes nor to introduce any other changes.
Sporazumi o partnerstvu se do konca programskega obdobja ne bi smeli več spreminjati niti zaradi upoštevanja predhodnih sprememb operativnih programov niti zaradi uvajanja kakršnih koli drugih sprememb.
The proposal is a limited and targeted change not going beyond what is necessary to achieve the objective of providing additional flexibility and legal certainty to mobilise investments in response to the widespread public health crises affecting the growth potential of regions and enterprises and the well-being of the general public.
Predlog pomeni omejeno in usmerjeno spremembo, ki ne presega tistega, kar je potrebno za zagotovitev dodatne prožnosti in pravne varnosti za mobilizacijo naložb v odziv na obsežno javnozdravstveno krizo, ki vpliva na potencial regij in podjetij za rast ter blaginjo širše javnosti.
National authorities may thus consider adjusting operations (e.g. deliverables, time limit for execution, etc.) in accordance with their national rules where necessary and justified, in a way to minimise the impact of the COVID-19 outbreak on the programmes.
Nacionalni organi lahko zato razmislijo o prilagoditvi operacij (npr. rezultatov, rokov za izvršitev itd.) v skladu s svojimi nacionalnimi pravili, če je to potrebno in upravičeno, in sicer tako, da se čim bolj zmanjša vpliv izbruha COVID-19 na programe.
Type[16: Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).]
vrsta[16: Realizacije so dobavljeni proizvodi in opravljene storitve (npr. število financiranih izmenjav študentov, število kilometrov novozgrajenih cest …).]
For the purpose of these transfers, the requirements laid down in Article 92(4) shall not apply.
Za namen teh prenosov se zahteve iz člena 92(4) ne uporabljajo.
This derogation will allow all available resources from the ERDF, the Cohesion Fund and the ESF to be mobilised to overcome the unprecedented challenges the Member States are facing because of the COVID-19 outbreak.
To odstopanje bo omogočilo uporabo vseh razpoložljivih sredstev iz ESRR, Kohezijskega sklada in ESS za premagovanje izzivov brez primere, s katerimi se države članice spoprijemajo zaradi izbruha COVID-19.
N[15: Year N is the year in which implementation of the proposal/initiative starts.]
N[15: Leto N je leto začetka izvajanja predloga/pobude.]