natgillin/translations-raw huggingface dataset:
(22) Commission Regulation (EC) No 748/2008 of 30 July 2008 on the opening and administration of an import tariff quota for frozen thin skirt of bovine animals falling within CN code 0206 29 91 ( OJ L 202, 31.7.2008, p. 28 ).
(22) Uredba Komisije (ES) št. 748/2008 z dne 30. julija 2008 o odprtju in upravljanju uvoznih tarifnih kvot za zamrznjene rebrne dele trebušnih prepon govejih živali, ki spadajo v tarifno oznako KN 0206 29 91 ( UL L 202, 31.7.2008, str. 28 ).
(11) Commission Regulation (EC) No 1979/2006 of 22 December 2006 opening and providing for the administration of tariff quotas for preserved mushrooms imported from third countries ( OJ L 368, 23.12.2006, p. 91 ).
(11) Uredba Komisije (ES) št. 1979/2006 z dne 22. decembra 2006 o odprtju in zagotavljanju upravljanja tarifnih kvot za konzervirane gobe, uvožene iz tretjih držav ( UL L 368, 23.12.2006, str. 91 ).
(15) Commission Regulation (EC) No 539/2007 of 15 May 2007 opening and providing for the administration of tariff quotas in the egg sector and for egg albumin ( OJ L 128, 16.5.2007, p. 19 ).
(15) Uredba Komisije (ES) št. 539/2007 z dne 15. maja 2007 o odprtju in upravljanju tarifnih kvot v sektorju za jajca in jajčni albumin ( UL L 128, 16.5.2007, str. 19 ).
(9) Commission Regulation (EC) No 1918/2006 of 20 December 2006 opening and providing for the administration of tariff quota for olive oil originating in Tunisia ( OJ L 365, 21.12.2006, p. 84 ).
(9) Uredba Komisije (ES) št. 1918/2006 z dne 20. decembra 2006 o odprtju in zagotavljanju upravljanja tarifnih kvot za olivno olje s poreklom iz Tunizije ( UL L 365, 21.12.2006, str. 84 ).
(14) Commission Regulation (EC) No 536/2007 of 15 May 2007 opening and providing for the administration of a tariff quota for poultrymeat allocated to the United States of America ( OJ L 128, 16.5.2007, p. 6 ).
(14) Uredba Komisije (ES) št. 536/2007 z dne 15. maja 2007 o odprtju in upravljanju tarifne kvote za perutninsko meso, dodeljene Združenim državam Amerike ( UL L 128, 16.5.2007, str. 6 ).
(21) Commission Regulation (EC) No 431/2008 of 19 May 2008 opening and providing for the administration of an import tariff quota for frozen meat of bovine animals covered by CN code 0202 and products covered by CN code 0206 29 91 ( OJ L 130, 20.5.2008, p. 3 ).
(21) Uredba Komisije (ES) št. 431/2008 z dne 19. maja 2008 o odprtju in upravljanju uvozne tarifne kvote za zamrznjeno goveje meso z oznako KN 0202 in proizvode z oznako KN 0206 29 91 ( UL L 130, 20.5.2008, str. 3 ).
of 18 May 2020
z dne 18. maja 2020
Where there is doubt about the competence of the notified body, the Commission should have the possibility to investigate the individual case.
Kadar obstaja dvom glede kompetence priglašenega organa, bi morala imeti Komisija možnost, da preišče posamezen primer.
Having regard to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (2) , and in particular Article 16(2) thereof,
ob upoštevanju Direktive Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih (2) in zlasti člena 16(2) Direktive,
However, for a significant number of those notified bodies the designations will expire between 26 May 2020 and 25 May 2021.
Vendar se bodo imenovanja številnih navedenih priglašenih organov iztekla med 26. majem 2020 in 25. majem 2021.
This responsibility also extends to a decision on the renewal of designation, including such that a Member State might carry out in accordance with this amending Implementing Regulation.
Ta odgovornost velja tudi za odločitev o obnovitvi imenovanja, vključno s tako, ki jo lahko sprejme država članica v skladu s to izvedbeno uredbo.
Implementing Regulation (EU) No 920/2013 should therefore be amended accordingly.
Izvedbeno uredbo (EU) št. 920/2013 bi bilo zato treba ustrezno spremeniti.
As a result, notified bodies designated under those Directives are able to certify medical devices for one additional year, until 25 May 2021.
Posledično lahko priglašeni organi, imenovani v skladu z navedenima direktivama, certificirajo medicinske pripomočke še dodatno leto, in sicer do 25. maja 2021.
Those renewals of designations should be of temporary nature and adopted before the end of the validity period of the respective preceding designation.
Navedene obnovitve imenovanj bi morale biti začasne, sprejeti pa bi jih bilo treba pred koncem obdobja veljavnosti zadevnega prejšnjega imenovanja.
The adoption of those renewals of designations has to take place under considerable time constraints.
Obnovitve imenovanj bodo morale biti sprejete z velikimi časovnimi omejitvami.
amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies
o spremembi Izvedbene uredbe (EU) št. 920/2013 glede obnovitve imenovanj ter nadzora in spremljanja priglašenih organov
The public health crisis has created extraordinary circumstances that have a significant impact on various areas covered by the Union regulatory framework for medical devices, such as the designation and work of notified bodies, as well as the availability of vitally important medical devices in the Union.
Kriza v javnem zdravju je povzročila izredne razmere, ki pomembno vplivajo na različna področja, ki jih zajema regulativni okvir Unije za medicinske pripomočke, kot so imenovanje in delo priglašenih organov ter razpoložljivost nujnih medicinskih pripomočkov v Uniji.
In light of the overriding need to immediately address the public health crisis associated with the COVID-19 pandemic, this Implementing Regulation should enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union,
Glede na nujno potrebo po takojšnji obravnavi krize v javnem zdravju, povezane s pandemijo COVID-19, bi morala ta izvedbena uredba nujno začeti veljati na dan objave v Uradnem listu Evropske unije -
The measures provided for in this Regulation are in accordance with the opinion of the Medical Devices Committee set up by Article 6(2) of Directive 90/385/EEC.
Ukrepi iz te uredbe so v skladu z mnenjem odbora za medicinske pripomočke, ustanovljenega s členom 6(2) Direktive 90/385/EGS.
This should allow designating authorities, in the context of the COVID-19 pandemic and the associated public health crisis, to derogate from the procedures laid down in Article 3 of that Regulation in order to guarantee the smooth and timely renewal of a designation before its expiry.
To bi moralo organom za imenovanje v okviru pandemije COVID-19 in z njo povezane krize v javnem zdravju omogočiti odstopanje od postopkov iz člena 3 navedene uredbe, da se zagotovi nemotena in pravočasna obnovitev imenovanja pred njegovim iztekom.
Having regard to Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (1) , and in particular Article 11(2) thereof,
ob upoštevanju Direktive Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev (1) in zlasti člena 11(2) Direktive,
Those notifications should include the reasons for decisions on the renewal taken by a designating authority.
Navedene priglasitve bi morale vključevati razloge za odločitve o obnovitvi, ki jih je sprejel organ za imenovanje.
Without valid designation, those notified bodies would no longer be able to issue certificates, and ensure their continuous validity, which is a necessary requirement for the lawful placing on the market or putting into service of medical devices.
Brez veljavnega imenovanja navedeni priglašeni organi ne bi več mogli izdajati certifikatov in zagotavljati njihove neprekinjene veljavnosti, kar je nujno potrebno za zakonito dajanje medicinskih pripomočkov na trg ali v uporabo.
In accordance with Directives 90/385/EEC and 93/42/EEC, Member States are responsible for a decision on designation as notified body.
V skladu z direktivama 90/385/EGS in 93/42/EGS so države članice odgovorne za odločitev o imenovanju za priglašeni organ.
Those constraints could not reasonably have been anticipated at the time of adoption of Implementing Regulation (EU) No 920/2013.
Navedenih omejitev ob sprejetju Izvedbene uredbe (EU) št. 920/2013 ni bilo mogoče razumno predvideti.
The COVID-19 pandemic and the associated public health crisis presents an unprecedented challenge to Member States and other actors active in the field of medical devices.
Pandemija COVID-19 in z njo povezana kriza v javnem zdravju pomenita izziv brez primere za države članice in druge akterje, ki so dejavni na področju medicinskih pripomočkov.
In particular, travel restrictions and public health measures, such as social distancing requirements, imposed by Member States, as well as the increased demand for resources to fight the COVID-19 pandemic and the associated public health crisis, prevent the relevant actors from carrying out the designation process in accordance with the procedural rules and obligations set out in Implementing Regulation (EU) No 920/2013.
Zlasti omejitve potovanj in javnozdravstveni ukrepi, kot so zahteve po omejevanju socialnih stikov, ki so jih uvedle države članice, ter povečano povpraševanje po virih za boj proti pandemiji COVID-19 in z njo povezani krizi v javnem zdravju zadevnim akterjem preprečujejo izvajanje postopka imenovanja v skladu s postopkovnimi pravili in obveznostmi iz Izvedbene uredbe (EU) št. 920/2013.
The Commission should be able to require a designating authority to provide it with the results of the assessment supporting the decision to renew the designation of a notified body, as well as the outcome of related surveillance and monitoring activities, including those referred to in Article 5 of that Implementing Regulation.
Komisija bi morala imeti možnost, da od organa za imenovanje zahteva, da ji predloži rezultate ocene, ki podpira odločitev o obnovitvi imenovanja priglašenega organa, ter rezultate povezanih dejavnosti nadzora in spremljanja, vključno s tistimi iz člena 5 navedene izvedbene uredbe.
Taking into account the unprecedented challenges caused by the COVID-19 pandemic, the complexity of the tasks regarding the renewal of the designation of notified bodies, as well as the need to prevent potential shortages of vitally important medical devices in the Union, it is appropriate to amend Implementing Regulation (EU) No 920/2013 as regards the renewal of designations as notified bodies.
Ob upoštevanju izzivov brez primere, ki jih je povzročila pandemija COVID-19, zapletenosti nalog v zvezi z obnovitvijo imenovanj priglašenih organov ter potrebe po preprečevanju morebitnega pomanjkanja nujnih medicinskih pripomočkov v Uniji je primerno spremeniti Izvedbeno uredbo (EU) št. 920/2013 glede obnovitve imenovanj za priglašene organe.
To ensure a minimum level of control and monitoring of notified bodies, during that period of time, designating authorities should still carry out any measures to ensure an adequate level of surveillance that remain possible under those circumstances in addition to the assessment of an appropriate number of the notified body's reviews of the manufacturer's clinical evaluations and an appropriate number of file reviews.
Da bi se zagotovila minimalna raven nadzora in spremljanja priglašenih organov v navedenem obdobju, bi morali organi za imenovanje še vedno izvajati vse ukrepe, s katerimi bi lahko v navedenih razmerah še vedno zagotovili ustrezno raven nadzora, poleg ocenjevanja ustreznega števila pregledov kliničnega ocenjevanja proizvajalca, ki jih opravi priglašeni organ, in ustreznega števila pregledov dokumentacije.
The extraordinary circumstances created by the COVID-19 pandemic also have an impact on the surveillance and monitoring activities related to notified bodies.
Izredne razmere, ki jih je povzročila pandemija COVID-19, vplivajo tudi na dejavnosti nadzora in spremljanja, povezane s priglašenimi organi.
Designating authorities should examine changes to the organisational and general requirements set out in Annex II to Implementing Regulation (EU) No 920/2013 that have occurred since the last on-site assessment and the activities the notified body has performed thereafter within the scope of its designation.
Organi za imenovanje bi morali proučiti spremembe organizacijskih in splošnih zahtev iz Priloge II k Izvedbeni uredbi (EU) št. 920/2013, ki so nastale od zadnjega pregleda na kraju samem, in dejavnosti, ki jih je priglašeni organ od takrat opravil v okviru svojega imenovanja.
In order to ensure transparency and increase mutual trust, designating authorities should also be required to notify the Commission and each other, by means of the ‘New Approach Notified and Designated Organisations' Information System (NANDO), of any decision on the renewal of a designation as notified body that was carried out without having recourse to the procedures laid down in Article 3 of Implementing Regulation (EU) No 920/2013.
Za zagotovitev preglednosti in povečanje medsebojnega zaupanja bi bilo treba od organov za imenovanje zahtevati tudi, da prek informacijskega sistema o priglašenih in določenih organih Novega pristopa (NANDO) Komisiji in drug drugemu sporočijo vse odločitve o obnovitvi imenovanja za priglašeni organ, ki so bile sprejete brez uporabe postopkov iz člena 3 Izvedbene uredbe (EU) št. 920/2013.
In deciding on a renewal of a designation, the designating authority should carry out an assessment of the notified body in order to verify its continuous competence and ability to accomplish the tasks for which it has been designated.
Organ za imenovanje bi moral pri odločanju o obnovitvi imenovanja izvesti oceno priglašenega organa, da preveri njegovo stalno kompetenco in zmožnost opravljanja nalog, za katere je bil imenovan.
In the context of the COVID-19 pandemic, Regulation (EU) 2020/561 of the European Parliament and of the Council (4) was adopted in order to defer by one year the application of those provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council (5) that would otherwise start to apply from 26 May 2020, including the provision repealing Directives 90/385/EEC and 93/42/EEC.
V okviru pandemije COVID-19 je bila sprejeta Uredba (EU) 2020/561 Evropskega parlamenta in Sveta (4) , da bi se za eno leto odložila uporaba tistih določb Uredbe (EU) 2017/745 Evropskega parlamenta in Sveta (5) , ki bi se sicer začele uporabljati 26. maja 2020, vključno z določbo o razveljavitvi direktiv 90/385/EGS in 93/42/EGS.
In particular, those circumstances may, for a certain period of time, prevent the designating authority of a Member State from carrying out surveillance on-site assessments or observed audits.
Predvsem lahko navedene razmere organu za imenovanje iz države članice za določeno obdobje preprečijo izvajanje nadzornih pregledov na kraju samem ali opazovanih revizij.
To ensure patient safety and health, those derogation measures should be limited to the renewal of already granted designations as notified bodies for which the designation process has previously been carried out, including a completed assessment of the notified body and the associated surveillance and monitoring activities.
Da bi se zagotovila varnost in zdravje pacientov, bi bilo treba navedene ukrepe odstopanja omejiti na obnovitev že odobrenih imenovanj za priglašene organe, za katere je bil postopek imenovanja že izveden, vključno z zaključeno oceno priglašenega organa ter povezanih dejavnosti nadzora in spremljanja.
The extraordinary circumstances created by the COVID-19 pandemic have a significant impact on the work of notified bodies, Member States and the Commission, regarding the renewal of the designation process.
Izredne razmere, ki jih je povzročila pandemija COVID-19, pomembno vplivajo na delo priglašenih organov, držav članic in Komisije v zvezi s postopkom obnovitve imenovanj.
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.