qanastek/ELRC-Medical-V2 huggingface dataset:
English: (9) To ensure the continuous presence of a functioning and effective regulatory framework for medical devices it is necessary to also defer the application of the provision repealing Directives 90/385/EEC and 93/42/EEC.
Translation (en-sl): (9) Za zagotovitev stalnega obstoja delujočega in učinkovitega regulativnega okvira za medicinske pripomočke je treba prav tako odložiti začetek uporabe določbe o razveljavitvi direktiv 90/385/EGS in 93/42/EGS.
English: ‘(g) with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to:
Translation (en-sl): „(g) se za pripomočke za večkratno uporabo, za katere se zahteva, da je zapis UDI naveden na samem pripomočku, člen 27(4) uporablja:
English: (6) The application should be deferred for provisions of Regulation (EU) 2017/745 that would otherwise start to apply from 26 May 2020.
Translation (en-sl): (6) Začetek uporabe bi bilo treba odložiti za določbe Uredbe (EU) 2017/745, ki bi se sicer začele uporabljati 26. maja 2020.
English: To attain the intended effect of amending Regulation (EU) 2017/745 as regards the dates of application of certain provisions, it is necessary for this Regulation to enter into force before 26 May 2020.
Translation (en-sl): Da bi se dosegel predvideni učinek spremembe Uredbe (EU) 2017/745 glede datumov začetka uporabe nekaterih določb, mora ta uredba začeti veljati pred 26. majem 2020.
English: It is for this reason appropriate that the relevant provision of Regulation (EU) 2017/745 applies at the earliest date possible and that the corresponding provisions of Directives 90/385/EEC and 93/42/EEC are repealed from that same date.
Translation (en-sl): 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.
English: Devices lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices placed on the market from 26 May 2021 pursuant to paragraph 3 of this Article, may continue to be made available on the market or put into service until 26 May 2025.
Translation (en-sl): Pripomočki, ki so bili zakonito dani na trg v skladu z direktivama 90/385/EGS in 93/42/EGS pred 26. majem 2021, in pripomočki, ki so bili dani na trg od 26. maja 2021 v skladu z odstavkom 3 tega člena, so lahko še naprej dostopni na trgu ali dani v uporabo do 26. maja 2025.
English: "- Article 11(13) of Directive 93/42/EEC and Article 9(9) of Directive 90/385/EEC which are repealed with effect from [insert date - date of entry into force of this Regulation]";
Translation (en-sl): „- člena 11(13) Direktive 93/42/EGS in člena 9(9) Direktive 90/385/EGS, ki se razveljavita z učinkom od [vstaviti datum - datum začetka veljavnosti te uredbe]";
English: ][3: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p.
Translation (en-sl): ][3: Direktiva Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih (UL L 169, 12.7.1993, str.
English: At the same time, it is necessary to defer the date of repeal of Directives 90/385/EEC and 93/42/EEC.
Translation (en-sl): Hkrati je treba odložiti tudi datum razveljavitve direktiv 90/385/EGS in 93/42/EGS.
English: Regulation (EU) 2017/745 significantly reinforces key elements of the existing regulatory approach in Council Directive 90/385/EEC and Council Directive 93/42/EEC, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance, whilst introducing provisions ensuring transparency and traceability regarding medical devices, to improve health and safety.
Translation (en-sl): Uredba (EU) 2017/745 znatno krepi ključne elemente obstoječega regulativnega pristopa iz Direktive Sveta 90/385/EGS in Direktive Sveta 93/42/EGS, kot so nadzor priglašenih organov, postopki ugotavljanja skladnosti, klinične raziskave in klinične ocene, vigilanca in nadzor trga, hkrati pa uvaja določbe, ki zagotavljajo preglednost in sledljivost medicinskih pripomočkov, z namenom izboljšanja zdravja in varnosti.
English: Taking into account the COVID-19 outbreak and the associated public health crisis, the Commission should be able to adopt Union-wide derogations in response to national derogations in order to address potential shortages Union wide of vitally important medical devices in an effective manner.
Translation (en-sl): Ob upoštevanju izbruha COVID-19 in z njim povezane krize na področju javnega zdravja bi bilo treba Komisiji omogočiti, da sprejme odstopanja na ravni Unije kot odziv na nacionalna odstopanja, da bi učinkovito obravnavala morebitno pomanjkanje nujnih medicinskih pripomočkov v Uniji.
English: In order to take account of the fact that the possibility to adopt Union-wide derogations must, for a transitional period, be given to the Commission in relation to national derogations from Directives 90/385/EEC and 93/42/EEC, certain amendments to the relevant provisions of Regulation (EU) 2017/745 are necessary.
Translation (en-sl): Da bi se upoštevalo dejstvo, 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.
English: The COVID-19 crisis has created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of Regulation (EU) 2017/745.
Translation (en-sl): Kriza zaradi COVID-19 je ustvarila izredne razmere, zaradi katerih so potrebni precejšnji dodatni viri in tudi večja razpoložljivost nujnih medicinskih pripomočkov, česar ob sprejetju Uredbe (EU) 2017/745 ni bilo mogoče razumno predvideti.
English: (8) In order to cover any national derogations granted by the Member States in accordance with Directives 90/385/EEC or 93/42/EEC in the context of the COVID-19 outbreak before the entry into force of this Regulation, it is also necessary to provide for the possibility for the Member States to notify those national derogations and for the Commission to extend their validity to the territory of the Union.
Translation (en-sl): (8) 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 tudi možnost, da države članice priglasijo navedena nacionalna odstopanja in da Komisija razširi njihovo veljavnost na ozemlje Unije.
English: ][2: 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 (OJ L 189, 20.7.1990, p.
Translation (en-sl): ][2: Direktiva Sveta 90/385/EGS z dne 20. junija 1990 o približevanju zakonodaje držav članic o aktivnih medicinskih pripomočkih za vsaditev (UL L 189, 20.7.1990, str.
English: To ensure the continuous availability of medical devices on the Union market, including medical devices that are vitally important in the context of the COVID-19 outbreak and the associated public health crisis, it is also necessary to adapt certain transitional provisions of Regulation (EU) 2017/745 that would otherwise no longer apply as from the date of application of those provisions.
Translation (en-sl): Za zagotovitev neprekinjene razpoložljivosti medicinskih pripomočkov na trgu Unije, vključno z medicinskimi pripomočki, ki so nujno potrebni v okviru izbruha COVID-19 in z njim povezane krize na področju javnega zdravja, je treba tudi prilagoditi nekatere prehodne določbe Uredbe (EU) 2017/745, ki se sicer od datuma začetka uporabe navedenih določb ne bi več uporabljale.
English: The proposed amendment aims to ensure that the intended purpose of Regulation (EU) 2017/745, that is, to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which guarantees a high level of protection of public health and patient safety and the smooth functioning of the internal market for such devices, can be attained.
Translation (en-sl): Namen predlagane spremembe je zagotoviti, da je mogoče doseči predvideni namen Uredbe (EU) 2017/745, tj. vzpostavitev trdnega, preglednega, predvidljivega in trajnostnega regulativnega okvira za medicinske pripomočke, ki zagotavlja visoko raven varovanja javnega zdravja in varnosti pacientov ter nemoteno delovanje notranjega trga za take pripomočke.
English: 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.
Translation (en-sl): Navedene 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 Unije.
English: (v) the following point (j) is added:
Translation (en-sl): (v) doda se naslednja točka (j):
English: (11) Since the objectives of this Regulation, namely to defer the application of certain provisions of Regulation (EU) 2017/745 and to allow for the extension of the validity of national derogations, authorised under Directives 90/385/EEC or 93/42/EEC, to the territory of the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
Translation (en-sl): (11) Ker ciljev te uredbe, tj. 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 obsega in učinkov lažje dosežeta na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
English: Taking into account the COVID-19 outbreak and the associated public health crisis, its epidemiological development, as well as the additional resources required in the Member States, health institutions, economic operators and other relevant parties, it is appropriate to defer the application of the relevant provisions of Regulation (EU) 2017/745 by one year.
Translation (en-sl): Ob upoštevanju izbruha COVID-19 in z njim povezane krize na področju javnega zdravja, epidemiološkega razvoja ter dodatnih virov, ki jih potrebujejo države članice, zdravstvene ustanove, gospodarski subjekti in druge zadevne strani, je primerno, da se začetek uporabe ustreznih določb Uredbe (EU) 2017/745 odloži za eno leto.
English: 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.
Translation (en-sl): Uredba (EU) 2017/745 določa tudi visoke standarde kakovosti in varnosti medicinskih pripomočkov, da bi upoštevali skupno skrb za varnost takih pripomočkov.
English: ‘The Member State may inform the Commission and the other Member States of any authorisation granted in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC before [insert date - date of entry into force of this Regulation].
Translation (en-sl): „Država članica lahko obvesti Komisijo in druge države članice o vseh odobritvah v skladu s členom 9(9) Direktive 90/385/EGS ali členom 11(13) Direktive 93/42/EGS pred [vstaviti datum - datum začetka veljavnosti te uredbe].
English: The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to the Member States and is a high burden for national authorities, health institutions, EU citizens and economic operators.
Translation (en-sl): Izbruh COVID-19 in z njim povezana kriza na področju javnega zdravja za države članice pomenita izziv brez primere in sta veliko breme za nacionalne organe, zdravstvene ustanove, državljane EU in gospodarske subjekte.
English: (2) The COVID-19 outbreak and the associated public health crisis presents an unprecedented challenge to the Member States and is a high burden for national authorities, health institutions, EU citizens, and economic operators.
Translation (en-sl): (2) Izbruh COVID-19 in z njim povezana kriza na področju javnega zdravja za države članice pomenita izziv brez primere in sta veliko breme za nacionalne organe, zdravstvene ustanove, državljane EU in gospodarske subjekte.
English: (7) Both Directives 90/385/EEC and 93/42/EEC, as well as Regulation (EU) 2017/745, empower national competent authorities, on a duly justified request, to authorise the placing on the market of medical devices for which the relevant conformity assessment procedures have not been carried out, but the use of which is in the interest of protection of health, or in the interest of public health or patient safety or health respectively (‘national derogation').
Translation (en-sl): (7) 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).
English: ‘Following a notification pursuant to paragraph 2 of this Article, the Commission, in exceptional cases relating to public health or patient safety or health, may, by means of implementing acts, extend for a limited period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 of this Article or, when granted before [insert date - date of entry into force of this Regulation], in accordance with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC to the territory of the Union and set the conditions under which the device may be placed on the market or put into service.
Translation (en-sl): „Po obvestilu iz odstavka 2 tega člena lahko Komisija v izjemnih primerih, povezanih z javnim zdravjem ali pa varnostjo ali zdravjem pacientov, z izvedbenimi akti za omejen čas razširi veljavnost odobritve, ki jo je dala država članica v skladu z odstavkom 1 tega člena ali, v primeru odobritve pred [vstaviti datum - datum začetka veljavnosti te uredbe], v skladu s členom 9(9) Direktive 90/385/EGS ali členom 11(13) Direktive 93/42/EGS, na ozemlje Unije in določi pogoje, pod katerimi se lahko pripomoček daje na trg ali v uporabo.
English: Those extraordinary circumstances have a significant impact on various areas covered by Regulation (EU) 2017/745 and therefore 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.
Translation (en-sl): Navedene izredne razmere pomembno vplivajo na različna področja, ki jih zajema Uredba (EU) 2017/745, zato je zelo verjetno, da države članice, zdravstvene ustanove, gospodarski subjekti in druge zadevne strani ne bodo mogli zagotoviti ustreznega izvajanja in uporabe navedene uredbe od 26. maja 2020, kakor je določeno.
English: 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.
Translation (en-sl): 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.
English: (7) in Article 122, the first paragraph is amended as follows:
Translation (en-sl): (7) v členu 122 se prvi odstavek spremeni:
English: (9) in point (h) of point 5.1 of Annex IX,'26 May 2020' is replaced by '26 May 2021'.
Translation (en-sl): (9) v točki (h) točke 5.1 Priloge IX se datum „26.
English: ‘(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;',
Translation (en-sl): „(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;";
English: (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.
Translation (en-sl): (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.
English: (b) in paragraph 2, the following subparagraph is added:
Translation (en-sl): (b) v odstavku 2 se doda naslednji pododstavek:
English: (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.
Translation (en-sl): (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.
English: 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.
Translation (en-sl): 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.
English: (iii) class I devices from 26 May 2027;',
Translation (en-sl): (iii) za pripomočke razreda I od 26. maja 2027;";
English: (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.
Translation (en-sl): (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.
English: 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.
Translation (en-sl): 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.
English: (ii) class IIa and class IIb devices from 26 May 2025;
Translation (en-sl): (ii) za pripomočke razredov IIa in IIb od 26. maja 2025;
English: (8) Article 123 is amended as follows:
Translation (en-sl): (8) člen 123 se spremeni:
English: (2) Article 17 is amended as follows:
Translation (en-sl): (2) člen 17 se spremeni:
English: (c) in paragraph 3, the first subparagraph is replaced by the following:
Translation (en-sl): (c) v odstavku 3 se prvi pododstavek nadomesti z naslednjim:
English: (4) Article 59 is amended as follows:
Translation (en-sl): (4) člen 59 se spremeni:
English: (6) Article 120 is amended as follows:
Translation (en-sl): (6) člen 120 se spremeni:
English: (1) in Article 1(2), the second subparagraph is amended as follows:
Translation (en-sl): (1) v členu 1(2) se drugi pododstavek spremeni:
English: (iv) point (g) is replaced by the following:
Translation (en-sl): (iv) točka (g) se nadomesti z naslednjim:
English: (i) implantable devices and class III devices from 26 May 2023;
Translation (en-sl): (i) za pripomočke za vsaditev in pripomočke razreda III od 26. maja 2023;
English: (f) paragraph 11 is amended as follows:
Translation (en-sl): (f) odstavek 11 se spremeni:
English: (5) in Article 113, '25 February 2020' is replaced by '25 February 2021';
Translation (en-sl): (5) v členu 113 se datum „25.
English: (a) paragraph 1 is replaced by the following:
Translation (en-sl): (a) odstavek 1 se nadomesti z naslednjim:
English: (iii) point (f) is replaced by the following:
Translation (en-sl): (iii) točka (f) se nadomesti z naslednjim:
English: (3) in Article 34(1), ‘25 March 2020' is replaced by '25 March 2021';
Translation (en-sl): (3) v členu 34(1) se datum „25.
English: (b) paragraph 4 is replaced by the following:
Translation (en-sl): (b) odstavek 4 se nadomesti z naslednjim:
English: Such eligible expenditure shall not exceed EUR 200 000.
Translation (en-sl): Taki upravičeni izdatki ne presegajo 200 000 EUR.
English: 13 Regional and Urban Policy
Translation (en-sl): 13 Regionalna in mestna politika
English: [XX.YY.YY.YY] NO NO NO NO
Translation (en-sl): [XX YY YY YY] NE NE NE NE
English: There was no consultation of external stakeholders.
Translation (en-sl): Posvetovanja z zunanjimi zainteresiranimi stranmi ni bilo.
English: These current limited and targeted changes do not require a separate impact assessment.
Translation (en-sl): Te trenutno omejene in ciljno usmerjene spremembe ne zahtevajo ločene ocene učinka.
English: 4 Employment, Social affairs and Inclusion
Translation (en-sl): 4 Zaposlovanje, socialne zadeve in vključevanje
English: from candidate countries[13: Candidate countries and, where applicable, potential candidate countries from the Western Balkans.]
Translation (en-sl): držav kandidatk[13: Države kandidatke in po potrebi potencialne države kandidatke z Zahodnega Balkana.]
English: These measures are complementary and additional to the legislative modifications proposed on 13 March 2020.
Translation (en-sl): Ti ukrepi dopolnjujejo zakonodajne spremembe, predlagane 13. marca 2020.