natgillin/translations-raw huggingface dataset:
The practical implementation of these guidelines and principles should be taken into account in the decision process towards lifting travel restrictions and internal border controls.
Pri odločanju glede procesa na poti k odpravi omejitev potovanj in kontrol na notranjih mejah bi bilo treba upoštevati praktično izvajanje teh smernic in načel.
The timing of the process will also be influenced by citizens' compliance with physical distancing measures.
Na njegov časovni potek bodo vplivali tudi državljani in državljanke sami, in sicer z upoštevanjem ukrepov za omejevanje socialnih stikov.
III.2.
II.
It should in particular outline the following information:
Vsebovati bi morala zlasti naslednje informacije:
There is a lack of suitable substitutes available;
Na voljo ni dovolj ustreznih nadomestkov.
In those cases, the stricter conditions should prevail.
V teh primerih bi morali prevladati strožji pogoji.
In this case, the national notifications should be submitted to the central repository mentioned above.
V tem primeru bi bilo treba nacionalna obvestila predložiti v zgoraj navedeni centralni register.
In the event of the committee delivering a negative opinion, the Commission will immediately repeal the implementing act.
Če odbor poda negativno mnenje, bo Komisija takoj razveljavila izvedbeni akt.
This new regulatory framework sets high standards of quality and safety for medical devices and aims at ensuring the smooth functioning of the internal market.
Ta novi regulativni okvir določa visoke standarde kakovosti in varnosti medicinskih pripomočkov, njegov cilj pa je zagotoviti nemoteno delovanje notranjega trga.
There is no legal obligation to inform the Commission and other Member States of national derogations adopted prior to 24 April 2020.
Ni nobene pravne obveznosti glede obveščanja Komisije in drugih držav članic o nacionalnih odstopanjih, sprejetih pred 24. aprilom 2020.
Those implementing acts shall be adopted in accordance with the examination procedure established under Regulation (EU) No 182/2011 of the European Parliament and of the Council (8) .
Navedeni izvedbeni akti se sprejmejo v skladu s postopkom pregleda, določenim v Uredbi (EU) št. 182/2011 Evropskega parlamenta in Sveta (8) .
Unless determined otherwise, Union-wide derogations should remain in force for a period not exceeding six months.
Če ni določeno drugače, bi morala odstopanja na ravni Unije ostati v veljavi največ šestih mesecev.
In those cases, at the latest 14 days after its adoption, the Commission will submit the implementing act to the relevant committee in order to obtain its opinion taking into account the information referred to in section 3.
V teh primerih bo Komisija izvedbeni akt najpozneje 14 dni po njegovem sprejetju predložila ustreznemu odboru, da pridobi njegovo mnenje, pri čemer bo upoštevala informacije iz oddelka 3.
In such cases, the Commission may propose to amend or, where appropriate, repeal the implementing act by which it established the Union-wide derogation.
V takih primerih lahko Komisija predlaga spremembo ali, kadar je to ustrezno, razveljavitev izvedbenega akta, s katerim je uvedla odstopanje na ravni Unije.
The measure enables the Commission and Member States to address potential shortages Union wide of vitally important medical devices in an effective manner.
Ukrep Komisiji in državam članicam omogoča, da na ravni Unije učinkovito odpravijo morebitno pomanjkanje nujnih medicinskih pripomočkov.
This is necessary to ensure patient safety or health or the protection of public health, while safeguarding the smooth functioning of the internal market.
To je potrebno zaradi zagotavljanja varnosti ali zdravja pacientov oz. varovanja javnega zdravja ob hkratnem zagotavljanju nemotenega delovanja notranjega trga.
An explanation of the vital importance of the use of the medical device in the respective Member State should be supported by statement(s) of health institution(s), including the reasons for why the device cannot be substituted.
obrazložitev bistvenega pomena uporabe medicinskega pripomočka v zadevni državi članici bi morala biti podprta z izjavami zdravstvenih ustanov, vključno z razlogi, zakaj naprave ni mogoče nadomestiti.
This document also provides information on the adoption process and the general conditions that the Commission should set for Union-wide derogations by means of implementing acts.
Ta dokument vsebuje tudi informacije o postopku sprejetja in splošnih pogojih, ki bi jih morala Komisija za odstopanja na ravni Unije določiti z izvedbenimi akti.
To facilitate this process and to strengthen coordination between the Member States, the Commission will set up and administer a central repository (6) allowing national competent authorities to share with the Commission and each other information on the derogations they have granted.
Da bi olajšala ta postopek in izboljšala usklajevanje med državami članicami, bo Komisija vzpostavila in upravljala centralni register (6) , ki bo pristojnim nacionalnim organom omogočil, da si med sabo in s Komisijo izmenjujejo informacije o odobrenih odstopanjih.
The Commission may adopt Union-wide derogations only in response to national derogations notified to the Commission by a Member State.
Komisija lahko sprejme odstopanja na ravni Unije samo kot odziv na nacionalna odstopanja, o katerih je država članica obvestila Komisijo.
Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745
Smernice za sprejetje odstopanj na ravni Unije za medicinske pripomočke v skladu s členom 59 Uredbe (EU) 2017/745
This additional documentation will complement the information initially notified to the Commission as part of the national derogation(s) concerned.
Ta dodatna dokumentacija bo dopolnila informacije, ki so bile prvotno priglašene Komisiji v okviru zadevnih nacionalnih odstopanj.
An explanation why the conformity assessment has not been initiated or completed before the placing on the market; an explanation of the vital importance of the use of the medical device; a detailed plan on how to ensure compliance or withdrawal of the device from the market after the temporary derogation expired;
pojasnilo, zakaj se ugotavljanje skladnosti ni začelo ali ni bilo dokončano pred dajanjem na trg; obrazložitev bistvenega pomena uporabe medicinskega pripomočka; podroben načrt, kako zagotoviti skladnost ali umik pripomočka s trga po izteku začasnega odstopanja;
Any substantial change in circumstances or the information referred to in section 3, or information otherwise available to the Commission or the Member States, in particular through market surveillance, should warrant a re-assessment of the Union-wide derogation and its conditions.
Vsaka bistvena sprememba okoliščin ali informacij iz oddelka 3 ali informacij, ki so sicer na voljo Komisiji ali državam članicam, zlasti v okviru nadzora trga, bi morala upravičiti ponovno oceno odstopanja na ravni Unije in njegovih pogojev.
Conversely, Member States, by means of national measures, should be able to introduce conditions that are stricter than those laid down in Union-wide derogations.
Nasprotno pa bi morale imeti države članice možnost, da z nacionalnimi ukrepi uvedejo strožje pogoje od tistih, ki so določeni v odstopanjih na ravni Unije.
The Medical Devices Regulation (EU) 2017/745 of the European Parliament and of the Council was adopted on 5 April 2017 (1) .
Uredba (EU) 2017/745 Evropskega parlamenta in Sveta o medicinskih pripomočkih je bila sprejeta 5. aprila 2017 (1) .
Each notified national derogation clearly identifies the medical device for which it is granted, including a description of the device, the intended purpose, and the manufacturer's information;
V vsakem priglašenem nacionalnem odstopanju je jasno navedeno, za kateri medicinski pripomoček je odobreno, vključno z opisom pripomočka, njegovim predvidenim namenom in informacijami proizvajalca.
The documentation referred to in sub-section A demonstrates that the manufacturer has done what can be reasonably expected in order to complete the conformity assessment without delay or, where applicable, there is sufficient evidence that the manufacturer has been prevented from completing, or initiating, the conformity assessment due to exceptional and unforeseeable circumstances;
Iz dokumentacije, navedene v pododdelku A, je razvidno, da je proizvajalec naredil, kar je razumno mogoče pričakovati, da bi lahko nemudoma dokončal postopek ugotavljanja skladnosti, ali, kadar je ustrezno, da obstajajo zadostni dokazi, da proizvajalec zaradi izjemnih in nepredvidljivih okoliščin ni mogel dokončati ali začeti postopka ugotavljanja skladnosti.
Those Union-wide derogations should be regarded as a measure of last resort, only to be considered in exceptional cases to ensure patient health or safety or to protect public health.
Navedena odstopanja na ravni Unije bi bilo treba obravnavati kot skrajni ukrep, ki se upošteva le v izjemnih primerih, da se zagotovi zdravje ali varnost pacientov oz. varovanje javnega zdravja.
COMMUNICATION FROM THE COMMISSION
Postopek sprejetja
The content of each notified national derogation in terms of validity period, specific conditions or requirements, as well as the outcome of any surveillance or monitoring activities, has been made available to the Commission and all other Member States;
Vsebina vsakega priglašenega nacionalnega odstopanja v smislu obdobja veljavnosti, posebnih pogojev ali zahtev ter rezultati kakršnih koli dejavnosti nadzora ali spremljanja so bili dani na voljo Komisiji in vsem drugim državam članicam.
At the same time, Regulation (EU) 2020/561 also defers the application of the provision repealing Council Directive 90/385/EEC on active implantable medical devices (3) and Council Directive 93/42/EEC on medical devices (4) .
Hkrati se z Uredbo (EU) 2020/561 odloži tudi začetek uporabe določbe o razveljavitvi Direktive Sveta 90/385/EGS (3) o aktivnih medicinskih pripomočkih za vsaditev in Direktive Sveta 93/42/EGS (4) o medicinskih pripomočkih.
In response to the COVID-19 pandemic, and with patient health and safety as a guiding principle, following the proposal of the Commission, the European Parliament and the Council on 23 April 2020 adopted Regulation (EU) 2020/561 (2) , which defers by one year the date of application of Regulation (EU) 2017/745 to 26 May 2021.
V odziv na pandemijo COVID-19 ter ob upoštevanju zdravja in varnosti pacientov kot vodilnega načela sta Evropski parlament in Svet 23. aprila 2020 na predlog Komisije sprejela Uredbo (EU) 2020/561 (2) , s katero se začetek uporabe Uredbe (EU) 2017/745 odloži za eno leto na 26. maj 2021.
These Guidelines provide information on the adoption of those Union-wide derogations, in particular the criteria that the Commission will take into account to determine whether the extension to the territory of the Union of a national derogation is necessary and justified for a medical device.
Te smernice podajajo informacije o sprejetju navedenih odstopanj na ravni Unije, zlasti merila, ki jih bo Komisija upoštevala pri ugotavljanju, ali je za medicinski pripomoček razširitev nacionalnega odstopanja na ozemlje Unije potrebno in utemeljeno.
The Commission may also consider any other comments submitted to it, for example, from Member States in the MDCG.
Komisija lahko upošteva vse druge pripombe, na primer pripombe, ki jih predložijo države članice v okviru Koordinacijske skupine za medicinske pripomočke.
Each notified national derogation is of temporary nature and its period of validity is limited to what can be reasonably expected necessary to complete the applicable conformity assessment procedure or, alternatively, to ensure patient safety or health or the protection of public health;
Vsako priglašeno nacionalno odstopanje je začasno, njegovo obdobje veljavnosti pa je omejeno na časovno obdobje, ki je po razumnem pričakovanju nujno za dokončanje veljavnega postopka ugotavljanja skladnosti ali za zagotovitev varnosti ali zdravja pacientov oz. varovanja javnega zdravja.
The information referred to in points 1 to 5 of sub-section B is required to allow the Commission to assess whether the adoption of a Union-wide derogation would be duly justified.
Informacije iz odstavkov od 1 do 5 pododdelka B so obvezne, da lahko Komisija oceni, ali bi bilo sprejetje odstopanja na ravni Unije ustrezno utemeljeno.
However, Article 59(2), second subparagraph, sets out that Member States may submit a notification to the Commission in order to ensure that those national derogations can be considered for the purpose of adopting Union-wide derogations.
Vendar drugi pododstavek člena 59(2) določa, da lahko države članice Komisijo obvestijo o odobrenih odstopanjih in tako zagotovijo, da se lahko ta nacionalna odstopanja upoštevajo pri sprejetju odstopanj na ravni Unije.
Any (technical) documentation submitted by manufacturer(s) related to the medical device benefiting from the notified national derogation(s), as well as the outcome of the national competent authority's assessment of that submission, have been made available to the Commission and all other Member States.
Vsa (tehnična) dokumentacija, ki jo predložijo proizvajalci o medicinskem pripomočku, za katerega velja priglašeno nacionalno odstopanje, ter rezultat ocene te vloge, ki jo pripravi pristojni nacionalni organ, so dani na voljo Komisiji in vsem drugim državam članicam.
For the purpose of point 6 of sub-section B, the Commission intends to consult the Member States by means of the MDCG.
Komisija se za namene točke 6 pododdelka B namerava posvetovati z državami članicami v okviru Koordinacijske skupine za medicinske pripomočke.
In considering the adoption of a Union-wide derogation, in a first step the Commission will consult the Member States, by means of the Medical Device Coordination Group (MDCG) established under Regulation (EU) 2017/745, to identify whether a notified national derogation for a certain medical device could be of Union relevance.
Komisija se bo pri odločanju o sprejetju odstopanja na ravni Unije v prvem koraku posvetovala z državami članicami, in sicer v okviru Koordinacijske skupine za medicinske pripomočke, ustanovljene na podlagi Uredbe (EU) 2017/745, da bi ugotovila, ali bi priglašeno nacionalno odstopanje za določen medicinski pripomoček lahko bilo pomembno za Unijo.
This process will be subject to consultation of Member States in the MDCG.
O tem postopku se bodo posvetovale države članice v okviru Koordinacijske skupine za medicinske pripomočke.
Union-wide derogations may lay down stricter conditions for the temporary placing on the market of a medical device than those established by means of national derogations already in place for a device.
Z odstopanji na ravni Unije se lahko določijo pogoji za začasno dajanje na trg medicinskega pripomočka, ki so strožji od tistih, določenih z nacionalnimi odstopanji, ki veljajo za pripomoček.
Regulation (EU) 2017/745 also empowers 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 Komisijo pooblašča tudi, da v izjemnih primerih veljavnost nacionalnega odstopanja za omejeno obdobje razširi na ozemlje Unije (v nadaljnjem besedilu: odstopanje na ravni Unije).
Pursuant to Article 59(3) of Regulation (EU) 2017/745, the Commission, in exceptional cases relating to public health or patient safety or health, may, by means of an implementing act, extend for a limited period of time the validity of a national derogation granted by a Member State in accordance with the above-mentioned provisions, to the territory of the Union and set the conditions under which the device may be placed on the market or put into service.
V skladu s členom 59(3) Uredbe (EU) 2017/745 lahko Komisija v izjemnih primerih, povezanih z javnim zdravjem oz. varnostjo ali zdravjem pacientov, z izvedbenim aktom za omejen čas razširi veljavnost nacionalnega odstopanja, ki ga je odobrila država članica v skladu z zgoraj navedenimi določbami, na ozemlje Unije in določi pogoje, pod katerimi se lahko pripomoček daje na trg ali v uporabo.
In setting those conditions, the Commission will base its decision in particular on the information submitted in accordance with sub-section A of section 3.
Komisija se bo pri določanju teh pogojev oprla zlasti na informacije, predložene v skladu s pododdelkom A oddelka 3.
Article 59 of Regulation (EU) 2017/745 provides that national competent authorities may authorise, on duly justified request, the placing on the market and putting into service within the territory of the Member State concerned, of a specific device for which the conformity assessment procedures referred to in Article 52 of Regulation (EU) 2017/745 or, for the period from 24 April 2020 to 25 May 2021, Article 9(1) and (2) of Directive 90/385/EEC or Article 11(1) to (6) of Directive 93/42/EEC, have not been carried out but use of which is in the interest of public health or patient safety or health (5) .
Člen 59 Uredbe (EU) 2017/745 določa, da lahko pristojni nacionalni organi na podlagi ustrezno utemeljene zahteve na ozemlju zadevne države članice odobrijo dajanje določenega pripomočka na trg in v uporabo, za katerega niso bili opravljeni postopki ugotavljanja skladnosti iz člena 52 Uredbe (EU) 2017/745 ali - za obdobje od 24. aprila 2020 do 25. maja 2021 - iz člena 9(1) in (2) Direktive 90/385/EGS ali člena 11(1) do (6) Direktive 93/42/EGS, vendar je njegova uporaba v interesu javnega zdravja ali varnosti ali zdravja pacientov (5) .
At least one national derogation has been granted and notified to the Commission for the medical device in question;
Za zadevni medicinski pripomoček je bilo odobreno vsaj eno nacionalno odstopanje in Komisija je bila o tem obveščena.
Pursuant to Article 59(2) of Regulation (EU) 2017745, Member States shall inform the Commission and other Member States of any national derogation granted for a medical device.
Države članice v skladu s členom 59(2) Uredbe (EU) 2017/745 obvestijo Komisijo in druge države članice o vsakem nacionalnem odstopanju, odobrenem za medicinski pripomoček.
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 public health or patient safety or health (‘national derogation').
Direktivi 90/385/EGS in 93/42/EGS ter Uredba (EU) 2017/745 pristojne nacionalne 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 javnega zdravja oz. varnosti ali zdravja pacientov (v nadaljnjem besedilu: nacionalno odstopanje).
Where applicable, there are no indications in the technical dossier, or from vigilance or market surveillance activities, concerning devices of previous generations or with similar characteristics, that the device could be harmful for patient health or safety or public health;
Kadar je ustrezno, v tehnični dokumentaciji nič ne kaže na to, da bi lahko pripomoček ogrožal zdravje ali varnost pacientov ali škodoval javnemu zdravju, niti to ni razvidno iz dejavnosti vigilance ali nadzora trga v zvezi s pripomočki prejšnjih generacij ali s podobnimi značilnostmi.
On duly justified imperative grounds of urgency relating to the health and safety of humans, Article 59(3), second subparagraph, of Regulation (EU) 2017/745 stipulates that the Commission shall adopt immediately applicable implementing acts without its prior submission to the relevant Comitology committee as provided for in Article 8 in conjunction with Article 5 of Regulation (EU) No 182/2011.
V drugem pododstavku člena 59(3) Uredbe (EU) 2017/745 je določeno, da Komisija na podlagi ustrezno utemeljenih nujnih razlogov v zvezi z zdravjem in varnostjo ljudi sprejme izvedbene akte, ki se začnejo uporabljati takoj, brez njihove predhodne predložitve ustreznemu komitološkemu odboru, kot je določeno v členu 8 v povezavi s členom 5 Uredbe (EU) št. 182/2011.
Article 59(3) of Regulation (EU) 2017/745 requires that the Commission sets out the conditions of a Union-wide derogation adopted by means of an implementing act.
Člen 59(3) Uredbe (EU) 2017/745 zahteva, da Komisija določi pogoje odstopanja na ravni Unije, sprejetega z izvedbenim aktom.
Pursuant to Article 59(3), first subparagraph, of Regulation (EU) 2017/745, the Commission shall adopt Union-wide derogations by means of implementing acts.
V skladu s prvim pododstavkom člena 59(3) Uredbe (EU) 2017/745 Komisija z izvedbenimi akti sprejme odstopanja na ravni Unije.
For each notified national derogation, the complete set of justifications that were taken into account when granting the notified national derogation has been made available to the Commission and all other Member States;
Za vsako priglašeno nacionalno odstopanje je bil Komisiji in vsem drugim državam članicam dan na voljo celoten sklop utemeljitev, ki so bile upoštevane pri odobritvi priglašenega nacionalnega odstopanja.
Official Journal of the European Union
Pravna podlaga
Where it has been determined that there could be Union-relevance, in a second step the Commission will assess whether the procedural requirements referred to in sub-section A have been met.
Kadar je ugotovljeno, da bi odstopanje lahko bilo pomembno za Unijo, bo Komisija v drugem koraku ocenila, ali so bile izpolnjene postopkovne zahteve iz pododdelka A. V tretjem koraku bo Komisija na podlagi zahtev iz pododdelka B ugotovila, ali bi bilo v zadevnem primeru sprejetje odstopanja na ravni Unije ustrezno utemeljeno.
There is clear Union-relevance for extending the validity of the notified national derogation(s) to Union territory.
Razširitev veljavnosti priglašenih nacionalnih odstopanj na ozemlje Unije je očitno pomembno za Unijo.
Extension of period for the adoption of implementing acts
Podaljšanje roka za sprejetje izvedbenih aktov
The relevant notice was published on page number 55 of OJ C 64 of 27 February 2020.
Zadevno obvestilo je bilo objavljeno na strani 55 UL C 64 z dne 27. februarja 2020.
The final deadline therefore expires on 29 May 2020.
Končni rok se torej izteče 29. maja 2020.
This request, made by the Kingdom of Denmark concerns business to consumer parcel services in Denmark.
Ta zahtevek Kraljevine Danske se nanaša na storitve paketne pošte od podjetij do potrošnika na Danskem.
In the light of the current context and the effects of the COVID 19 pandemics, and with the agreement of the Kingdom of Denmark, the period available to the Commission for deciding on this request is hereby extended by 12 working days.
Glede na trenutne razmere in posledice pandemije COVID 19 ter v dogovoru s Kraljevino Dansko se rok, ki je na voljo Komisiji za odločanje o tem zahtevku, podaljša za 12 delovnih dni.
(1) Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC ( OJ L 94, 28.3.2014, p. 243 ).
(1) Direktiva 2014/25/EU Evropskega parlamenta in Sveta z dne 26. februarja 2014 o javnem naročanju naročnikov, ki opravljajo dejavnosti v vodnem, energetskem in prometnem sektorju ter sektorju poštnih storitev ter o razveljavitvi Direktive 2004/17/ES ( UL L 94, 28.3.2014, str. 243 ).
On 19 December 2019 the Commission received a request pursuant to Article 35 of Directive 2014/25/EU of the European Parliament and of the Council (1) .
Komisija je 19. decembra 2019 prejela zahtevek v skladu s členom 35 Direktive 2014/25/EU Evropskega parlamenta in Sveta (1) .
Notice of request concerning the applicability of Article 34 of Directive 2014/25/EU
Obvestilo o zahtevku glede uporabe člena 34 Direktive 2014/25/EU
The initial deadline was 11 May 2020.
Prvotni rok se izteče 11. maja 2020.