natgillin/translations-raw huggingface dataset:
(4) Under Article 8(2) read in conjunction with Article 10(2) of Council Regulation (EEC) No 95/93, the failure by an air carrier to operate 80% of a series of slots which it has been allocated at a coordinated airport threatens the historic precedence for these slots.
(4) Če letalski prevoznik ne uporabi 80 % zaporedja slotov, ki so mu bili dodeljeni na koordiniranem letališču, s tem v skladu s členom 8(2) v povezavi s členom 10(2) Uredbe Sveta (EGS) št. 95/93 ogrozi svojo prednostno razvrstitev teh slotov.
The Commission should base any such decisions on the latest available information, published by the EU Network Manager at the European Organisation for the Safety of Air Navigation (‘Eurocontrol'), and on relevant scientific advice.
Zato je predlagano, da se na Komisijo prenese pooblastilo za podaljšanje obdobja, v katerem veljajo ukrepi, po potrebi z delegiranimi akti. Komisija bi morala vsako tako odločitev utemeljiti na podlagi najnovejših razpoložljivih informacij, ki jih objavi upravitelj omrežja EU pri Eurocontrolu, in ustreznega znanstvenega mnenja.
Proposal for a
Predlog
The proposal does not have a budgetary impact for the EU institutions.
Ta predlog ne vpliva na proračun institucij EU.
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
V skladu z načelom sorazmernosti iz navedenega člena ta uredba ne presega tistega, kar je potrebno za doseganje navedenih ciljev.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).
Navedeni izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 114(3).
According to the principle of subsidiarity, Union action may only be taken if the envisaged aims cannot be achieved by Member States alone.
V skladu z načelom subsidiarnosti se lahko ukrepi na ravni Unije sprejmejo samo, če države članice predvidenih ciljev ne morejo doseči same.
Subsidiarity
Subsidiarnost
Reasons for and objectives of the proposal
Razlogi za predlog in njegovi cilji
In this regard, the legislation, that is being amended, is adopted in full compliance with the principle of subsidiarity and any amendment thereto must be made through a Commission proposal.
V zvezi s tem se zakonodaja, ki se spreminja, sprejme ob doslednem upoštevanju načela subsidiarnosti, vsaka njena sprememba pa mora biti narejena na podlagi predloga Komisije.
Legal basis
Pravna podlaga
Proportionality
Sorazmernost
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4)(c) thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije, zlasti člena 114 in člena 168(4)(c) Pogodbe,
"(j) Article 59 shall apply from [insert date - date of entry into force of this Regulation]';
„(j) se člen 59 uporablja od [vstaviti datum - datum začetka veljavnosti te uredbe].
Those deferrals safeguard the presence of a functioning regulatory framework on medical devices from 26 May 2020.
Navedeni odlogi zagotavljajo obstoj delujočega regulativnega okvira za medicinske pripomočke od 26. maja 2020.
It was therefore considered to be appropriate to provide for an exception to the eight-week period referred to in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the Treaty on European Union, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community.
Zato velja, da je primerno uporabiti izjemo od roka osmih tednov iz člena 4 Protokola št. 1 o vlogi nacionalnih parlamentov v Evropski uniji, ki je priložen Pogodbi o Evropski uniji, Pogodbi o delovanju Evropske unije in Pogodbi o ustanovitvi Evropske skupnosti za atomsko energijo.
This proposal is not accompanied by a separate impact assessment, as an impact assessment for Regulation (EU) 2017/745 has already been undertaken.
Tega predloga ne spremlja ločena ocena učinka, saj je bila ocena učinka za Uredbo (EU) 2017/745 že izvedena.
After consulting the European Economic and Social Committee,
po posvetovanju z Evropskim ekonomsko-socialnim odborom,
The proposal is based on Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union (TFEU).
Predlog temelji na členu 114 in členu 168(4)(c) Pogodbe o delovanju Evropske unije (PDEU).
(12) The adoption of this Regulation takes place under exceptional circumstances arising from the COVID-19 outbreak and the associated public health crisis.
(12) Sprejetje te uredbe poteka v izjemnih okoliščinah, ki so posledica izbruha COVID-19 in z njim povezane krize na področju javnega zdravja.
This proposal does not alter Regulation (EU) 2017/745 on substance and does not impose new obligations on the concerned parties.
Ta predlog ne spreminja vsebine Uredbe (EU) 2017/745 in zadevnim stranem ne nalaga novih obveznosti.
It primarily aims at providing, for exceptional reasons in the context of the current COVID-19 outbreak, a one-year deferral as regards the date of application of certain provisions of that Regulation.
Njegov glavni namen je zaradi izjemnih razlogov v okviru sedanjega izbruha COVID-19 zagotoviti enoletni odlog datuma začetka uporabe nekaterih določb navedene uredbe.
(13) 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,
(13) Glede na nujno potrebo po takojšnji obravnavi krize na področju javnega zdravja, povezane z izbruhom COVID-19, bi morala ta uredba začeti veljati čim prej -
(10) Regulation (EU) 2017/745 should therefore be amended accordingly.
(10) Uredbo (EU) 2017/745 bi bilo zato treba ustrezno spremeniti.
(3) 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 patients urgently in need the necessary medical treatment.
(3) Medicinski pripomočki, kot so medicinske rokavice, kirurške maske, oprema za intenzivno nego in druga medicinska oprema, imajo v okviru izbruha COVID-19 in z njim povezane krize na področju javnega zdravja ključno vlogo pri zagotavljanju zdravja in varnosti državljanov Unije ter omogočanju državam članicam, da se pacienti, ki to nujno potrebujejo, ustrezno zdravijo.
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
Union intervention is required to ensure a high level of protection of health for patients and users, the smooth functioning of the internal market and avoid potential market disruption.
Ukrepanje Unije je potrebno za zagotovitev visoke ravni varovanja zdravja pacientov in uporabnikov, nemotenega delovanja notranjega trga in preprečevanja morebitnih motenj na trgu.
In addition, the proposed amendment seeks to ensure that the Commission is able to adopt, in exceptional cases, Union-wide derogations in response to national derogations at the earliest date possible in order to address potential shortages Union wide of vitally important medical devices in an effective manner.
Poleg tega je namen predlagane spremembe zagotoviti, da lahko Komisija v izjemnih primerih sprejme odstopanja na ravni Unije kot odgovor na nacionalna odstopanja na najzgodnejši možni datum, da bi učinkovito obravnavala morebitno pomanjkanje nujnih medicinskih pripomočkov v Uniji.
Regulation (EU) 2017/745 is amended as follows:
Uredba (EU) 2017/745 se spremeni:
Regulation (EU) 2017/745 also allows the Commission to extend, in exceptional cases, the validity of a national derogation for a limited period of time to the territory of the Union (‘Union-wide derogation').
Uredba (EU) 2017/745 Komisiji omogoča tudi, da v izjemnih primerih veljavnost nacionalnega odstopanja za omejeno obdobje razširi na ozemlje Unije (v nadaljnjem besedilu: odstopanje na ravni Unije).
This Union action is necessary to achieve the objective of the proper implementation and application of Regulation (EU) 2017/745 by all involved parties, taking into account the magnitude of the current COVID-19 outbreak and the associated public health crisis.
Ta ukrep Unije je potreben za dosego cilja ustreznega izvajanja in uporabe Uredbe (EU) 2017/745, kar zadeva vse zadevne strani, ob upoštevanju obsega sedanjega izbruha COVID-19 in z njim povezane krize na področju javnega zdravja.
[1: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p.
[1: Uredba (EU) 2017/745 Evropskega parlamenta in Sveta z dne 5. aprila 2017 o medicinskih pripomočkih, spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009 ter razveljavitvi direktiv Sveta 90/385/EGS in 93/42/EGS (UL L 117, 5.5.2017, str.
(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.
(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.
‘(g) with regard to reusable devices that are required to bear the UDI carrier on the device itself, Article 27(4) shall apply to:
„(g) se za pripomočke za večkratno uporabo, za katere se zahteva, da je zapis UDI naveden na samem pripomočku, člen 27(4) uporablja:
(6) The application should be deferred for provisions of Regulation (EU) 2017/745 that would otherwise start to apply from 26 May 2020.
(6) Začetek uporabe bi bilo treba odložiti za določbe Uredbe (EU) 2017/745, ki bi se sicer začele uporabljati 26. maja 2020.
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.
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.
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.
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.
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.
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.
"- 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]";
„- 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]";
][3: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p.
][3: Direktiva Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih (UL L 169, 12.7.1993, str.
At the same time, it is necessary to defer the date of repeal of Directives 90/385/EEC and 93/42/EEC.
Hkrati je treba odložiti tudi datum razveljavitve direktiv 90/385/EGS in 93/42/EGS.
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.
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.
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.
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.
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.
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.
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.
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.
(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.
(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.
][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.
][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.
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.
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.
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.
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.
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.
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.
(v) the following point (j) is added:
(v) doda se naslednja točka (j):
(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.
(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.
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.
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.
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 upoštevali skupno skrb za varnost takih pripomočkov.
‘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].
„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].
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.
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.
(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.
(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.
(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').
(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).
‘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.
„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.
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.
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.