natgillin/translations-raw huggingface dataset:
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 on the day of its publication in the Official Journal of the European Union. 
Glede na nujno potrebo po takojšnji obravnavi javnozdravstvene krize, povezane z izbruhom COVID-19, bi morala ta uredba nujno začeti veljati na dan objave v Uradnem listu Evropske unije.
amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions 
o spremembi Uredbe (EU) 2017/745 o medicinskih pripomočkih glede datumov začetka uporabe nekaterih njenih določb
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 necessary medical treatment to patients who are urgently in need of such treatment. 
Medicinski pripomočki, kot so medicinske rokavice, kirurške maske, oprema za intenzivno nego in druga medicinska oprema, imajo v okviru izbruha COVID-19 in s tem povezane javnozdravstvene krize ključno vlogo pri zagotavljanju zdravja in varnosti državljanov Unije ter omogočanju državam članicam, da zagotovijo ustrezno zdravljenje pacientom, ki ga nujno potrebujejo.
The application should be deferred for provisions of Regulation (EU) 2017/745 that would otherwise start to apply from 26 May 2020. 
Začetek uporabe bi bilo treba odložiti za določbe Uredbe (EU) 2017/745, ki bi se sicer začele uporabljati 26. maja 2020.
To ensure the continuous presence of a functioning and effective regulatory framework for medical devices, it is necessary to defer the application of the provision repealing Directives 90/385/EEC and 93/42/EEC. 
Za zagotovitev stalnega obstoja delujočega in učinkovitega regulativnega okvira za medicinske pripomočke je treba odložiti začetek uporabe določbe o razveljavitvi direktiv 90/385/EGS in 93/42/EGS.
Furthermore, Regulation (EU) 2017/745 significantly reinforces key elements of the existing regulatory approach in Council Directives 90/385/EEC (3) and 93/42/EEC (4) , 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. 
Poleg tega Uredba (EU) 2017/745 znatno krepi ključne elemente obstoječega regulativnega pristopa iz direktiv Sveta 90/385/EGS (3) in 93/42/EGS (4) , kot so nadzor priglašenih organov, postopki ugotavljanja skladnosti, klinične raziskave in klinične ocene, vigilanca in nadzor trga, hkrati pa uvaja določbe za zagotovitev preglednosti in sledljivosti glede medicinskih pripomočkov, z namenom izboljšanja zdravja in varnosti.
It is for that 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 date. 
Zato je primerno, da se ustrezna določba Uredbe (EU) 2017/745 začne uporabljati na najzgodnejši možni datum in da se ustrezne določbe direktiv 90/385/EGS in 93/42/EGS razveljavijo z istim datumom.
Regulation (EU) 2017/745 of the European Parliament and of the Council (2) 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 (2) vzpostavlja nov regulativni okvir za zagotovitev nemotenega delovanja notranjega trga za medicinske pripomočke, zajete v navedeni uredbi, temelječ na visoki ravni varovanja zdravja pacientov in uporabnikov ter upoštevajoč mala in srednja podjetja, dejavna v tem sektorju.
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 izredne razmere pomembno vplivajo na različna področja, ki jih zajema Uredba (EU) 2017/745, kot so imenovanje in delo priglašenih organov ter dajanje medicinskih pripomočkov na trg in omogočanje njihove dostopnosti na trgu v Uniji.
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. 
Uredba (EU) 2017/745 določa tudi visoke standarde kakovosti in varnosti medicinskih pripomočkov, da bi se tako zadostilo skupnim potrebam po varnosti teh pripomočkov.
The public health 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. 
Javnozdravstvena kriza je ustvarila izredne razmere, zaradi katerih so potrebni precejšnji dodatni viri in tudi večja razpoložljivost nujno potrebnih medicinskih pripomočkov, česar ob sprejetju Uredbe (EU) 2017/745 ni bilo mogoče razumno predvideti.
In order to cover any national derogations granted by Member States in accordance with Directive 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 necessary to provide for the possibility for Member States to notify those national derogations and for the Commission to extend their validity to the territory of the Union. 
Da se zajamejo vsa nacionalna odstopanja, ki so jih države članice odobrile v skladu z Direktivo 90/385/EGS ali Direktivo 93/42/EGS v okviru izbruha COVID-19 pred začetkom veljavnosti te uredbe, je treba zagotoviti možnost, da države članice priglasijo ta nacionalna odstopanja in da Komisija razširi njihovo veljavnost na ozemlje Unije.
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. 
Za zagotovitev nemotenega delovanja notranjega trga, visoke ravni varovanja javnega zdravja in varnosti pacientov ter pravne varnosti in v izogib morebitnim motnjam na trgu, je treba odložiti začetek uporabe nekaterih določb Uredbe (EU) 2017/745.
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. 
Za zagotovitev neprekinjene razpoložljivosti medicinskih pripomočkov na trgu Unije, vključno z medicinskimi pripomočki, ki so nujno potrebni v okviru izbruha COVID-19 in s tem povezane javnozdravstvene krize, je treba prilagoditi tudi nekatere prehodne določbe Uredbe (EU) 2017/745, ki se sicer ne bi več uporabljale.
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 laid down therein. 
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 v njej določeno.
Taking into account that the possibility to adopt Union-wide derogations, for a transitional period, is to 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. 
Ob upoštevanju, da mora imeti Komisija v prehodnem obdobju možnost, da sprejme odstopanja na ravni Unije v zvezi z nacionalnimi odstopanji od direktiv 90/385/EGS in 93/42/EGS, so potrebne nekatere spremembe ustreznih določb 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 by Member States, health institutions, economic operators and other relevant parties, it is appropriate to defer the application of those provisions of Regulation (EU) 2017/745 by one year. 
Ob upoštevanju izbruha COVID-19 in s tem povezane javnozdravstvene krize, epidemiološkega razvoja ter dodatnih virov, ki jih potrebujejo države članice, zdravstvene ustanove, gospodarski subjekti in druge zadevne strani, je primerno, da se začetek uporabe teh določb Uredbe (EU) 2017/745 odloži za eno leto.
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 Directive 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 their 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 (‘TEU'). 
Ker ciljev te uredbe, in sicer odložiti začetek uporabe nekaterih določb Uredbe (EU) 2017/745 in omogočiti razširitev veljavnosti nacionalnih odstopanj, odobrenih v skladu z Direktivo 90/385/EGS ali Direktivo 93/42/EGS, na ozemlje Unije, države članice ne morejo zadovoljivo doseči, temveč se zaradi njunega obsega in učinkov lažje dosežeta na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji (PEU).
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'). 
Direktivi 90/385/EGS in 93/42/EGS ter Uredba (EU) 2017/745 nacionalne pristojne organe pooblaščajo, da na podlagi ustrezno utemeljene zahteve odobrijo dajanje na trg medicinskih pripomočkov, za katere niso bili opravljeni ustrezni postopki ugotavljanja skladnosti, vendar je njihova uporaba v interesu varovanja zdravja ali v interesu javnega zdravja ali pa varnosti ali zdravja pacientov (v nadaljnjem besedilu: nacionalno odstopanje).
Regulation (EU) 2020/402, and its amendment, apply for a limited period of 6 weeks. 
Uredba (EU) 2020/402 in njena sprememba se uporabljata za omejeno obdobje šestih tednov.
This is the case notably for the Principality of Monaco (4) . 
To velja zlasti za Kneževino Monako (4) .
The main objective of such system would be to protect public health within the Union. 
Glavni cilj takega sistema bi bil varovanje javnega zdravja v Uniji.
Pursuant to Article 127(3) of the Withdrawal Agreement, during the transition period, the United Kingdom of Great Britain and Northern Ireland is to be considered as a Member State, and not as a third country. 
V skladu s členom 127(3) sporazuma o izstopu se v prehodnem obdobju Združeno kraljestvo Velika Britanija in Severna Irska šteje kot država članica in ne kot tretja država.
These initiatives are proving successful, and equipment is planned to be made available 2 weeks after the Member States sign the contracts with the bidders. 
Te pobude so se izkazale za uspešne, oprema pa naj bi bila na voljo dva tedna po tem, ko države članice podpišejo pogodbe s ponudniki.
On that basis, a need may arise to review the scope of Annex I and products covered by this Regulation. 
Na podlagi tega bi se lahko pojavila potreba po pregledu področja uporabe Priloge I in izdelkov, ki jih zajema ta uredba.
These measures, aimed at protecting health and impacting on trade, should be targeted, proportionate, transparent and temporary. 
Ti ukrepi, katerih cilj je varovati zdravje in vplivati na trgovino, bi morali biti ciljno usmerjeni, sorazmerni, pregledni in začasni.
This concerns the territories of Büsingen, Heligoland, Livigno, Ceuta and Melilla. 
To zadeva naslednja ozemlja: Büsingen, Helgoland, Livigno ter Ceuta in Melilla.
This is particularly the case of the member States of the European Free Trade Association, and the Western Balkans which are engaged in a process of deep integration with the Union. 
To še zlasti velja za države članice Evropskega združenja za prosto trgovino in države Zahodnega Balkana, ki sodelujejo v procesu tesnega povezovanja z Unijo.
It is therefore appropriate to exclude such countries from the scope of application of this Regulation. 
Zato je primerno, da se te države izključijo iz področja uporabe te uredbe.
The Commission finalised a joint procurement for personal protective equipment, in which 25 Member States took part. 
Komisija je zaključila skupno javno naročilo za osebno zaščitno opremo, pri katerem je sodelovalo 25 držav članic.
A review of the scope should be based on a continuous assessment of needs of critical equipment related to the fight against COVID-19 and their potential shortages. 
Pregled področja uporabe bi moral temeljiti na stalnem ocenjevanju potreb po kritični opremi za boj proti COVID-19 in njenega morebitnega pomanjkanja.
Continuous efforts are being made to help ensuring urgent and adequate provision of protective equipment throughout the EU. 
Po vsej EU potekajo stalna prizadevanja za pomoč pri zagotavljanju nujne in ustrezne zaščitne opreme.
The measures provided for in this Regulation should not apply to trade between the EU Member States. 
Ukrepi iz te uredbe se ne bi smeli uporabljati za trgovino med državami članicami EU.
The production capacities of personal protective equipment have been ramped-up. 
Proizvodne zmogljivosti za osebno zaščitno opremo so se močno povečale.
An export authorisation system should remedy or prevent a situation of a shortage of essential products within the borders of the Union. 
Sistem izvoznih dovoljenj bi moral odpraviti ali preprečiti pomanjkanje bistvenih izdelkov znotraj meja Unije.
Union measures should therefore be proportionate and ensure that exports remain possible, subject to a prior authorisation. 
Ukrepi Unije bi morali zato biti sorazmerni in zagotoviti, da izvoz ostane mogoč s predhodnim dovoljenjem.
This Regulation should apply to exports of Union goods from the customs territory of the Union. 
Ta uredba bi se morala uporabljati za izvoz blaga Unije s carinskega območja Unije.
The single market for medical and personal protective equipment is closely integrated beyond the boundaries of the Union, and so are its production value chains and distribution networks. 
Enotni trg za zdravstveno in osebno zaščitno opremo je tesno povezan onkraj meja Unije, kot tudi njegove proizvodne vrednostne verige in distribucijska omrežja.
Entirely financed by the Commission via direct grants, this reserve will be hosted in one or several Member States. 
Te zaloge v celoti financira Komisija z neposrednimi nepovratnimi sredstvi in se bodo skladiščile v eni ali več državah članicah.
In a Joint Statement of 26 March the members of the European Council underlined that the adoption of the decision on the authorisation for export of PPE should lead to the full and effective lifting of all forms of internal bans or restrictions. 
Člani Evropskega sveta so v skupni izjavi z dne 26. marca poudarili, da bi s sprejetjem sklepa o dovoljenjih za izvoz osebne zaščitne opreme moralo biti mogoče v celoti umakniti vse oblike notranjih prepovedi ali omejitev.
The CN codes should be given for information only. 
Oznake KN bi bilo treba navesti samo informativno.
The demand for certain types of PPE has especially led to shortages on the internal market. 
Predvsem povpraševanje po nekaterih vrstah osebne zaščitne opreme je povzročilo pomanjkanje na notranjem trgu.
As the epidemiological crisis caused by the COVID-19 disease continues, the demand within the Union for personal protective equipment (‘PPE'), which consists of protective masks (and surgical masks), gloves, goggles, face-shields, and overalls, remains very high and is even continuously increasing. 
Ker se epidemiološka kriza zaradi bolezni COVID-19 nadaljuje, je povpraševanje po osebni zaščitni opremi, ki zajema zaščitne (in kirurške) maske, rokavice, očala, zaščito za obraz in kombinezone, v Uniji še vedno zelo veliko in se celo še povečuje.
Special attention should be given to the products covered by the Joint Procurement as well as requested under the Union Civil Protection Mechanism such as other types of PPE, ventilators and laboratory products (test kits). 
Posebno pozornost bi bilo treba nameniti izdelkom, ki jih zajemajo skupna javna naročila, in tistim, ki se zahtevajo v okviru mehanizma Unije na področju civilne zaščite, kot so druge vrste osebne zaščitne opreme, ventilatorji in laboratorijski izdelki (kompleti za testiranje).
It is likewise appropriate to exclude from the export authorisation requirement the overseas countries and territories listed in Annex II to the Treaty, as well as the Faeroe Islands, Andorra, San Marino, the Vatican City and Gibraltar, since they have a particular dependency on the metropolitan supply chains of the Member States to which they are attached or on the supply chains of neighbouring Member States, respectively. 
Prav tako je primerno, da se iz obveznosti predložitve izvoznega dovoljenja izključijo čezmorske države in ozemlja iz Priloge II k Pogodbi kot tudi Ferski otoki, Andora, San Marino, Vatikanska mestna država in Gibraltar, saj so posebej odvisni od metropolitanskih dobavnih verig držav članic, ki jim pripadajo, oziroma od dobavnih verig sosednjih držav članic.
The administrative modalities for these authorisations should be left to the discretion of the Member States during the time of this temporary system. 
Odločitve glede upravnih ureditev za izdajo navedenih dovoljenj bi bilo treba v času tega začasnega sistema prepustiti državam članicam.
Therefore countries that form part of that customs territory need not be exempted in order to receive unrestricted shipments from within the Union. 
Zato je treba države, ki so del navedenega carinskega območja, izvzeti, da bi lahko prejemale neomejene pošiljke iz Unije.
In deciding whether to grant an export authorisation, the Member States should also take into consideration the fulfilment of a supply obligation under joint procurement or rescEU by the Union and the Member States, the support of the activities of the World Health Organization (WHO), the support of EU-level coordinated responses to crisis situations or the request for assistance by third countries or international organisations. 
Države članice bi morale pri odločanju, ali odobrijo izvozno dovoljenje, upoštevati tudi izpolnjevanje obveznosti glede dobave v okviru skupnega javnega naročanja ali rescEU Unije in držav članic, podporo dejavnostim Svetovne zdravstvene organizacije (WHO), podporo usklajenim odzivom na krizne razmere na ravni EU ali prošnjo za pomoč s strani tretjih držav ali mednarodnih organizacij.
Conversely, territories of Member States specifically excluded from the customs territory of the Union should not fall under the requirement of export authorisation and should therefore be exempted as well. 
Nasprotno pa za ozemlja držav članic, ki so izrecno izključena s carinskega območja Unije, ne bi smela veljati obveznost izvoznega dovoljenja in bi jih bilo zato tudi treba izvzeti.
Based on the principle of international solidarity, Member States should authorise exports to enable the provisions of emergency supplies in the context of humanitarian aid. 
Države članice bi na podlagi načela mednarodne solidarnosti morale dovoliti izvoz, da omogočijo zagotavljanje nujne oskrbe v okviru humanitarne pomoči.
Under the Union Civil Protection Mechanism (UCPM), the European Commission has decided to create a strategic rescEU stockpile of medical equipment such as ventilators and protective masks to help EU countries in the context of the COVID-19 pandemic. 
Evropska komisija se je odločila, da v okviru mehanizma Unije na področju civilne zaščite oblikuje strateško zalogo medicinske opreme v okviru rescEU, kot so ventilatorji in zaščitne maske, da bi državam članicam EU pomagala v pandemiji COVID-19.
The degree of market integration for the products concerned between parts of the customs territory of the Union and other countries or territories, whether achieved under an arrangement establishing a free-trade area or for other reasons such as geographic proximity or historic ties, should also be considered. 
Upoštevati bi morale tudi stopnjo povezanosti trga za zadevne izdelke med deli carinskega območja Unije in drugimi državami in ozemlji, doseženo na podlagi dogovora o vzpostavitvi območja proste trgovine ali zaradi drugih razlogov kot so geografska bližina ali zgodovinske vezi.
The Commission also set up a Clearing House, including for PPE, with the objective to coordinate efforts to match supply and demand in the EU, and facilitate an adequate functioning of the internal market. 
Komisija je vzpostavila tudi posredovalni mehanizem, vključno za osebno zaščitno opremo, da bi koordinirala prizadevanja za uskladitev ponudbe in povpraševanja v EU ter pomagala pri ustreznem delovanju notranjega trga.
In contrast, Member States should not authorise exports that would create speculative distortion and serve stockpiling and hoarding of essential equipment by those with little or no objective need. 
Po drugi strani pa države članice ne bi smele dovoliti izvoza, ki bi ustvaril špekulativno izkrivljanje ter omogočil ustvarjanje in kopičenje nujne opreme, čeprav za to objektivno obstajajo majhne potrebe ali jih sploh ni.
In order to ensure coherence, the description of the types of PPE subject to this authorisation system laid down by this Regulation should be aligned with the corresponding specifications of the equipment subject to the Joint Procurement, which has identified the specific needs in the Union. 
Za zagotovitev skladnosti bi bilo treba opis nekaterih vrst osebne zaščitne opreme, za katere velja ta sistem dovoljenj, določen s to uredbo, uskladiti z ustreznimi specifikacijami za opremo, ki je predmet skupnega javnega naročila, v katerem so se opredelile posebne potrebe v Uniji.
Member States do however not have to contact the Clearing House in the case of authorisations for emergency supplies in the context of humanitarian aid. 
Vendar se državam članicam ni treba obrniti na posredovalni mehanizem v primeru dovoljenj za nujno oskrbo v okviru humanitarne pomoči.
Authorisations should be granted only to the extent that the volume of exports is not such that it poses a threat to the availability of PPE on the market of the Member State in question or elsewhere in the Union for the purpose of meeting the objective of this Regulation. 
Izvozna dovoljenja se lahko izdajo le, če obseg izvoza ne ogroža razpoložljivosti osebne zaščitne opreme na trgu zadevne države članice ali drugje v Uniji za namene izpolnjevanja cilja te uredbe.
Likewise, it would be counterproductive to disrupt closely integrated value chains and distribution networks established on the basis of those arrangements or otherwise, in particular in the case of neighbouring countries and economies. 
Motnje tesno povezanih vrednostnih verig in distribucijskih mrež, ki so vzpostavljene na podlagi teh dogovorov ali kako drugače, bi bile podobno kontraproduktivne, zlasti v primeru sosednjih držav in gospodarstev.