natgillin/translations-raw huggingface dataset:
To avoid shortages of vitally important medical devices, it is therefore essential that notified bodies currently designated under Directives 90/385/EEC and 93/42/EEC are able to continue to operate until the new regulatory framework for medical devices under Regulation (EU) 2017/745 becomes applicable. 
Da bi se izognili pomanjkanju nujnih medicinskih pripomočkov, je zato nujno, da priglašeni organi, ki so trenutno imenovani v skladu z direktivama 90/385/EGS in 93/42/EGS, lahko še naprej delujejo, dokler se ne začne uporabljati novi regulativni okvir za medicinske pripomočke v skladu z Uredbo (EU) 2017/745.
That assessment should include a review of documents and activities related to the notified body, which enable the designating authority to verify the criteria for designation as set out in Directives 90/385/EEC and 93/42/EEC and Implementing Regulation (EU) No 920/2013. 
Navedena ocena bi morala vključevati pregled dokumentov in dejavnosti, povezanih s priglašenim organom, ki organu za imenovanje omogočajo, da preveri merila za imenovanje, kot je določeno v direktivah 90/385/EGS in 93/42/EGS ter Izvedbeni uredbi (EU) št. 920/2013.
Commission Implementing Regulation (EU) No 920/2013 (3) sets out a common interpretation of the main elements of the criteria for designation of notified bodies laid down in Directives 90/385/EEC and 93/42/EEC. 
Izvedbena uredba Komisije (EU) št. 920/2013 (3) določa enotno razlago glavnih elementov meril za imenovanje priglašenih organov, navedenih v direktivah 90/385/EGS in 93/42/EGS.
They should automatically become void at the latest on the date of repeal of Directives 90/385/EEC and 93/42/EEC. 
Najpozneje na datum razveljavitve direktiv 90/385/EGS in 93/42/EGS bi morale samodejno postati neveljavne.
The deferral of the application of Regulation (EU) 2017/745 and the deferral of the repeal of Directives 90/385/EEC and 93/42/EEC make it necessary to renew designations of notified bodies that would otherwise expire before the new regulatory framework for medical devices under Regulation (EU) 2017/745 becomes applicable. 
Zaradi odloga uporabe Uredbe (EU) 2017/745 ter odloga razveljavitve direktiv 90/385/EGS in 93/42/EGS je treba obnoviti imenovanja priglašenih organov, ki bi se sicer iztekla, preden se bo začel uporabljati novi regulativni okvir za medicinske pripomočke v skladu z Uredbo (EU) 2017/745.
Implementing Regulation (EU) No 920/2013 sets out procedural rules and obligations for the renewal of the designation as notified body to be complied with by the designating authorities of Member States under Directives 90/385/EEC and 93/42/EEC. 
Izvedbena uredba (EU) št. 920/2013 določa postopkovna pravila in obveznosti za obnovitev imenovanja za priglašeni organ, ki jih morajo organi za imenovanje iz držav članic izpolnjevati v skladu z direktivama 90/385/EGS in 93/42/EGS.
The maximum amount of financial assistance shall not exceed EUR 100 000 000 000 for all Member States. 
Najvišji znesek finančne pomoči ne sme preseči 100 000 000 000 EUR za vse države članice.
The Council implementing decision referred to in paragraph 1 shall contain: 
Izvedbeni sklep Sveta iz odstavka 1 vsebuje:
The Commission shall inform the Council when the Instrument becomes available. 
Komisija obvesti Svet, ko Instrument postane razpoložljiv.
Control and audits 
Kontrola in revizija
The Commission shall establish the necessary arrangements for the administration of the loans with the European Central Bank. 
Komisija določi potrebne ureditve za upravljanje posojil z Evropsko centralno banko.
Such agreements shall set out the payment conditions. 
V takšnem sporazumu so določeni plačilni pogoji.
This Regulation shall not be applicable to or in the United Kingdom. 
Ta uredba se ne uporablja za Združeno kraljestvo ali v njem.
References to ‘Member States' in this Regulation shall not be understood to include the United Kingdom. 
Sklicevanja na države članice v tej uredbi se ne razumejo, kot da vključujejo Združeno kraljestvo.
The period of availability of the Instrument during which a decision referred to in Article 6(1) may be adopted shall end on 31 December 2022. 
Obdobje razpoložljivosti Instrumenta, v katerem se lahko sprejme sklep iz člena 6(1), se konča 31. decembra 2022.
Contributions to the Instrument in the form of guarantees from Member States 
Prispevki držav članic k Instrumentu v obliki jamstev
Financial assistance shall be made available by means of a Council implementing decision adopted on the basis of a proposal from the Commission. 
Finančna pomoč se da na voljo z izvedbenim sklepom Sveta, ki se sprejme na podlagi predloga Komisije.
In addition, the Commission shall verify compliance with the prudential rules laid down in Article 9. 
Poleg tega Komisija preveri skladnost z bonitetnimi pravili iz člena 9.
(2) Council Regulation (EC) No 332/2002 of 18 February 2002 establishing a facility providing medium-term financial assistance for Member States' balances of payments ( OJ L 53, 23.2.2002, p. 1 ). 
(2) Uredba Sveta (ES) št. 332/2002 z dne 18. februarja 2002 o ustanovitvi aranžmaja za zagotavljanje srednjeročne finančne pomoči za plačilne bilance držav članic ( UL L 53, 23.2.2002, str. 1 ).
Member States may contribute to the Instrument by counter-guaranteeing the risk borne by the Union. 
Države članice lahko prispevajo k Instrumentu tako, da posredno jamčijo za tveganje, ki ga nosi Unija.
Prudential rules applicable to the portfolio of loans 
Bonitetna pravila, ki se uporabljajo za portfelj posojil
(1) Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 ( OJ L 193, 30.7.2018, p. 1 ). 
(1) Uredba (EU, Euratom) 2018/1046 Evropskega parlamenta in Sveta z dne 18. julija 2018 o finančnih pravilih, ki se uporabljajo za splošni proračun Unije, spremembi uredb (EU) št. 1296/2013, (EU) št. 1301/2013, (EU) št. 1303/2013, (EU) št. 1304/2013, (EU) št. 1309/2013, (EU) št. 1316/2013, (EU) št. 223/2014, (EU) št. 283/2014 in Sklepa št. 541/2014/EU ter razveljavitvi Uredbe (EU, Euratom) št. 966/2012 ( UL L 193, 30.7.2018, str. 1 ).
the amount of the loan, its maximum average maturity, its pricing formula, its maximum number of instalments, its availability period and the other detailed rules needed for the granting of the financial assistance; 
znesek posojila, največjo povprečno zapadlost posojila, formulo za izračun cene posojila, največje število obrokov, obdobje razpoložljivosti posojila in druga podrobna pravila, potrebna za odobritev finančne pomoči;
In order to address the impact of the COVID-19 outbreak and respond to its socio‐economic consequences, this Regulation establishes the European instrument for temporary support to mitigate unemployment risks in an emergency (SURE) (the ‘Instrument'). 
Za obravnavanje posledic izbruha COVID-19 in odzivanje na njegove socialnoekonomske posledice ta uredba vzpostavlja evropski instrument za začasno podporo za ublažitev tveganj za brezposelnost v izrednih razmerah (SURE) (v nadaljnjem besedilu: Instrument).
The share of loans granted to the three Member States representing the largest share of the loans granted shall not exceed 60 per cent of the maximum amount referred to in Article 5. 
Delež posojil, odobrenih trem državam članicam, ki predstavljajo največji delež odobrenih posojil, ne sme preseči 60 odstotkov najvišjega zneska iz člena 5.
The financial assistance shall take the form of a loan granted by the Union to the Member State concerned. 
Finančna pomoč je v obliki posojila, ki ga Unija odobri zadevni državi članici.
Conditions for using the Instrument 
Pogoji za uporabo Instrumenta
At the request of the beneficiary Member State and where circumstances permit an improvement in the interest rate on the loan, the Commission may refinance all or part of its initial borrowing or restructure the corresponding financial conditions. 
Na prošnjo države članice upravičenke in kadar okoliščine dovoljujejo ugodnejšo obrestno mero posojila, lahko Komisija refinancira vsa ali del svojih prvotnih posojil ali prestrukturira ustrezne finančne pogoje.
It shall also transfer the principal and the interest due under the loan agreement to an account with the European System of Central Banks 20 TARGET2 business days prior to the corresponding due date. 
Poleg tega glavnico in zapadle obresti v okviru sporazuma o posojilu prenese na račun pri Evropskem sistemu centralnih bank 20 delovnih dni TARGET2 pred ustreznim rokom za plačilo.
The amounts due by the Union in a given year shall not exceed 10 per cent of the maximum amount referred to in Article 5. 
Zneski, ki jih dolguje Unija v danem letu, ne smejo preseči 10 odstotkov najvišjega zneska iz člena 5.
Where a request for financial assistance submitted in accordance with Article 3(1) is, fully or in part, based on planned public expenditure, the beneficiary Member State shall, every six months, inform the Commission about the implementation of such planned public expenditure. 
Če prošnja za finančno pomoč, predložena v skladu s členom 3(1), v celoti ali delno temelji na načrtovanih javnofinančnih odhodkih, država članica upravičenka vsakih šest mesecev obvesti Komisijo o izvrševanju takšnih načrtovanih javnofinančnih odhodkov.
Complementary nature of the Instrument 
Dopolnilna narava Instrumenta
Where the Commission concludes in the report referred to in Article 14 that the severe economic disturbance caused by the COVID-19 outbreak affecting the financing of measures referred to in Article 1 continues to exist, the Council, on a proposal from the Commission, may decide to extend the period of availability of the Instrument, each time for an additional period of six months. 
Kadar Komisija v poročilu iz člena 14 ugotovi, da hude gospodarske motnje, ki jih je povzročil izbruh COVID-19 in ki vplivajo na financiranje ukrepov iz člena 1, še vedno obstajajo, se lahko Svet na predlog Komisije odloči, da podaljša obdobje razpoložljivosti Instrumenta, vsakič za dodatno obdobje šest mesecev.
When adopting an implementing decision as referred to in paragraph 1, the Council shall consider existing and expected needs of the requesting Member State, as well as requests for financial assistance pursuant to this Regulation already submitted or planned to be submitted by other Member States, while applying the principles of equal treatment, solidarity, proportionality and transparency. 
Svet pri sprejemanju izvedbenega sklepa iz odstavka 1 upošteva obstoječe in pričakovane potrebe države članice prosilke ter prošnje za finančno pomoč na podlagi te uredbe, ki so jih že predložile ali jih nameravajo predložiti druge države članice, ter pri tem spoštuje načela enake obravnave, solidarnosti, sorazmernosti in preglednosti.
To that end, and in accordance with a Council implementing decision adopted pursuant to Article 6(1), the Commission shall be empowered to borrow on the capital markets or with financial institutions on behalf of the Union at the most appropriate time so as to optimise the cost of funding and preserve its reputation as the Union's issuer in the markets. 
V ta namen in v skladu z izvedbenim sklepom Sveta, sprejetim na podlagi člena 6(1), se na Komisijo prenese pooblastilo, da na kapitalskih trgih ali pri finančnih institucijah najema posojila v imenu Unije v najugodnejšem času, da tako optimizira stroške financiranja in ohrani svoj ugled izdajatelja Unije na teh trgih.
The borrowing and lending operations under the Instrument shall be carried out in euros. 
Najemanja in dajanja posojil v okviru Instrumenta se izvajajo v eurih.
The other Member States shall be reimbursed for additional contributions from the amounts recovered by the Commission from the Member State concerned. 
Druge države članice prejmejo za dodatne prispevke povračilo iz zneskov, ki jih Komisija izterja od zadevne države članice.
The characteristics of the loan shall be agreed in a loan agreement between the beneficiary Member State and the Commission (the ‘loan agreement'). 
Značilnosti posojila se določijo v sporazumu o posojilu, ki ga skleneta država članica upravičenka in Komisija (v nadaljnjem besedilu: sporazum o posojilu).
The Member State which failed to honour the call shall remain liable to honour it. 
Država članica, ki ni izvedla unovčenja, ga je še vedno obvezana izvesti.
Where necessary, the Commission may roll over the associated borrowings contracted on behalf of the Union. 
Komisija lahko po potrebi obnovi povezana posojila, najeta v imenu Unije.
The Instrument shall only become available after all Member States have contributed to the Instrument in accordance with Article 11 for an amount representing at least 25 per cent of the maximum amount referred to in Article 5, provided that the relative shares of contributions of each Member State of the overall amount of Member States' contributions correspond to the relative shares of Member States in the total gross national income of the Union, as resulting from column (1) of Table 3 of Part A (‘Introduction and financing of the general budget') of the revenue part of the budget for 2020 set out in the general budget of the Union for the financial year 2020, as adopted on 27 November 2019 (4) . 
Instrument postane razpoložljiv šele, ko vse države članice prispevajo v Instrument v skladu s členom 11 v znesku, ki predstavlja vsaj 25 odstotkov najvišjega zneska iz člena 5, pod pogojem, da relativni deleži prispevkov posameznih držav članic v skupnem znesku prispevkov držav članic ustrezajo relativnim deležem držav članic v skupnem bruto nacionalnem dohodku Unije, kot izhaja iz stolpca (1) tabele 3 v delu A („Uvod in financiranje splošnega proračuna") v prihodkovnem delu proračuna za leto 2020, določenem v splošnem proračunu Unije za proračunsko leto 2020, kot je bil sprejet 27. novembra 2019 (4) .
Contributions from Member States shall be provided in the form of irrevocable, unconditional and on-demand guarantees. 
Prispevki držav članic se zagotovijo v obliki jamstev, ki so nepreklicna, brezpogojna in na zahtevo.
The guarantee called from a Member State shall be limited, in all circumstances, by the overall amount of guarantee contributed by that Member State under the agreement referred to in paragraph 3. 
Jamstvo vsake države članice, ki se unovči, je v vsakem primeru omejeno s skupnim zneskom jamstva, ki ga je ta država članica prispevala v skladu s sporazumom iz odstavka 3.
Disbursement of the loan granted under the Instrument 
Izplačevanje posojila, odobrenega v okviru Instrumenta
Before calling on guarantees provided by the Member States, the Commission, at its sole discretion and responsibility as the Union institution entrusted with the implementation of the general budget of the Union in accordance with Article 317 TFEU, is expected to examine the scope for drawing on the margin available under the own-resources ceiling for payment appropriations to the extent that it is deemed sustainable by the Commission, having regard, inter alia, to the total contingent liabilities of the Union, including under the balance of payments facility established by Regulation (EC) No 332/2002, and the sustainability of the general budget of the Union. 
Preden Komisija unovči jamstva, ki jih zagotovijo države članice, se od nje pričakuje, da po lastni presoji in v okviru odgovornosti, ki jo ima kot institucija Unije, pristojna za izvrševanje splošnega proračuna Unije v skladu s členom 317 PDEU, preuči obseg črpanja sredstev iz kritja, razpoložljivega za odobritve plačil v okviru zgornje meje lastnih sredstev, pri čemer presodi, kakšen obseg je vzdržen, med drugim ob upoštevanju skupnih pogojnih obveznosti Unije, vključno v okviru aranžmaja za plačilne bilance, ustanovljenega z Uredbo Sveta (ES) št. 332/2002, ter vzdržnosti splošnega proračuna Unije.
Where appropriate, the report referred to in paragraph 1 shall be accompanied by a proposal for a Council implementing decision extending the period of availability of the Instrument. 
Po potrebi se poročilu iz odstavka 1 Komisije priloži predlog izvedbenega sklepa Sveta o podaljšanju obdobja razpoložljivosti Instrumenta iz člena 12(4).
Such calls shall be made pro rata to the relative share of each of the other Member States in the gross national income of the Union as referred to in Article 12(1) and adapted without taking into account the relative share of the Member State concerned. 
Takšno unovčenje se izvede sorazmerno z relativnim deležem vsake druge države članice v bruto nacionalnem dohodku Unije iz člena 12(1), kot je prilagojen brez upoštevanja relativnega deleža zadevne države članice.
a description of the national short-time work schemes or similar measures, as well as, where appropriate, of the relevant health-related measures, that may be financed. 
opis nacionalne sheme oziroma shem skrajšanega delovnega časa ali podobnih ukrepov in, kjer je ustrezno, ustreznih ukrepov, povezanih z zdravjem, ki jih je mogoče financirati.
Within six months of the day on which the Instrument becomes available in accordance with Article 12 and every six months thereafter in the context of Article 250 of Regulation (EU, Euratom) 2018/1046, the Commission shall forward to the European Parliament, the Council, the Economic and Financial Committee and the Employment Committee a report on the use of financial assistance, including outstanding amounts and the applicable repayment schedule under the Instrument, and on the continuation of the exceptional occurrences that justify the application of this Regulation. 
Komisija Evropskemu parlamentu, Svetu, Ekonomsko-finančnemu odboru in Odboru za zaposlovanje v šestih mesecih po dnevu, ko Instrument v skladu s členom 12 postane razpoložljiv, in nato vsakih šest mesecev v okviru člena 250 Uredbe (EU, Euratom) 2018/1046 posreduje poročilo o uporabi finančne pomoči, vključno z neporavnanimi zneski in veljavnim načrtom odplačevanja v okviru Instrumenta, ter o nadaljevanju izjemnih okoliščin, ki upravičujejo uporabo te uredbe.
This Regulation lays down the conditions and procedures enabling the Union to provide financial assistance to a Member State which is experiencing, or is seriously threatened with, a severe economic disturbance caused by the COVID-19 outbreak for the financing, primarily, of short-time work schemes or similar measures aimed at protecting employees and the self‐employed and thus reducing the incidence of unemployment and loss of income, as well as for the financing, as an ancillary, of some health-related measures, in particular in the workplace. 
Ta uredba določa pogoje in postopke, ki Uniji omogočajo zagotavljanje finančne pomoči državi članici, ki se zaradi izbruha COVID-19 sooča z resnimi gospodarskimi motnjami ali jo takšne motnje resno ogrožajo, in sicer v prvi vrsti za financiranje shem skrajšanega delovnega časa ali podobnih ukrepov za zaščito zaposlenih in samozaposlenih, da se tako zmanjša obseg brezposelnosti in izgube dohodka, poleg tega pa tudi za financiranje nekaterih ukrepov, povezanih z zdravjem, zlasti na delovnem mestu.
Beneficiary Member States shall use financial assistance primarily in support of their national short-time work schemes or similar measures, and, where applicable, in support of relevant health-related measures. 
Države članice upravičenke uporabijo finančno pomoč v prvi vrsti za podporo svojim shemam skrajšanega delovnega časa ali podobnim ukrepom in, kjer je ustrezno, za podporo ustreznim ukrepom, povezanim z zdravjem.
Where a Member State fails, in full or in part, to honour a call in time, the Commission, in order to cover for the part corresponding to the Member State concerned, shall have the right to make additional calls on guarantees to other Member States. 
Kadar država članica celotnega ali delnega unovčenja ne izvede pravočasno, ima Komisija pravico, da za kritje ustreznega dela zadevne državne članice dodatno unovči jamstva drugih držav članic.
Calls on guarantees provided by Member States shall be made pro rata to the relative share of each Member State in the gross national income of the Union as referred to in Article 12(1). 
Unovčenje jamstev, ki jih zagotovijo države članice, je sorazmerno z relativnim deležem vsake države članice v bruto nacionalnem dohodku Unije iz člena 12(1).
The loan agreement shall contain the necessary provisions regarding controls and audits as required by Article 220(5) of Regulation (EU, Euratom) 2018/1046. 
Sporazum o posojilu vsebuje potrebne določbe o kontroli in revizijah, kot določa člen 220(5) Uredbe (EU, Euratom) 2018/1046.
Such agreements shall contain the provisions set out in Article 220(5) of Regulation (EU, Euratom) 2018/1046. 
Takšen sporazum vsebuje določbe iz člena 220(5) Uredbe (EU, Euratom) 2018/1046.
The loan granted under the Instrument (‘loan') shall be disbursed in instalments. 
Posojilo, odobreno v okviru Instrumenta (v nadaljnjem besedilu: posojilo), se izplačuje obročno.
Amounts resulting from calls on guarantees referred to in paragraph 2 shall constitute external assigned revenue for the Instrument in accordance with Article 21(5) of Regulation (EU, Euratom) 2018/1046. 
Zneski, ki izhajajo iz unovčenja jamstev iz odstavka 2, predstavljajo zunanje namenske prejemke za Instrument v skladu s členom 21(5) Uredbe (EU, Euratom) 2018/1046.
The Instrument shall complement the national measures taken by affected Member States by providing financial assistance to help those Member States cope with the sudden and severe increase in actual and possibly also planned public expenditure intended to mitigate the direct economic, social and health-related effects of the exceptional occurrence caused by the COVID‐19 outbreak. 
Instrument dopolnjuje nacionalne ukrepe, ki jih sprejmejo prizadete države članice, in sicer tako, da tem državam članicam zagotavlja finančno pomoč za obvladovanje nenadnega in močnega povečanja dejanskih in morda tudi načrtovanih javnofinančnih odhodkov, namenjenih ublažitvi neposrednih ekonomskih, socialnih in z zdravjem povezanih učinkov izjemnih okoliščin, ki jih je povzročil izbruh COVID-19.
In the call on guarantees, the Commission shall inform the Member States about the extent to which the margin has been drawn. 
Komisija ob unovčitvi jamstev obvesti države članice o obsegu sredstev, ki so bila črpana iz kritja v okviru zgornje meje.
The Commission shall conclude an agreement with a contributing Member State on the irrevocable, unconditional and on-demand guarantees referred to in paragraph 2. 
Komisija z državo članico, ki prispeva k Instrumentu, sklene sporazum o jamstvih, ki so nepreklicna, brezpogojna in na zahtevo, iz odstavka 2.
Before submitting a proposal to the Council, the Commission shall consult the Member State concerned without undue delay to verify the sudden and severe increase in actual and possibly also planned public expenditure directly related to short-time work schemes and similar measures, as well as, where appropriate, to relevant health-related measures, in the Member State requesting financial assistance which are linked to the exceptional occurrence caused by the COVID-19 outbreak. 
Preden Komisija predloži predlog Svetu, se brez nepotrebnega odlašanja posvetuje z zadevno državo članico, da bi preverila nenadno in močno povečanje dejanskih in morda tudi načrtovanih javnofinančnih odhodkov, neposredno povezanih s shemami skrajšanega delovnega časa in podobnimi ukrepi, ter, kjer je ustrezno, z ustreznimi ukrepi, povezanimi z zdravjem, ki so povezani z izjemnimi okoliščinami, ki jih je povzročil izbruh COVID-19, v državi članici, ki zaprosi za finančno pomoč.