natgillin/translations-raw huggingface dataset:
In accordance with Article 8 of Regulation (EU) 2016/425, in order to place PPE products on the market, manufacturers shall carry out the applicable conformity assessment procedures and, where compliance with the applicable essential health and safety requirements has been demonstrated by the appropriate procedure, affix the CE marking.
V skladu s členom 8 Uredbe (EU) 2016/425 proizvajalci za dajanje proizvodov osebne varovalne opreme na trg izvajajo veljavne postopke ugotavljanja skladnosti in, kadar je bilo z ustreznim postopkom dokazano, da je skladnost z veljavnimi bistvenimi zdravstvenimi in varnostnimi zahtevami dokazana, namestijo oznako CE.
Thus, devices manufactured in accordance with the Council Directive 93/42/EEC and Regulation (EU) 2017/745 can circulate freely throughout the internal market and Member States may not introduce additional and diverging requirements regarding the manufacturing and placement on the market of such products.
Tako lahko pripomočki, proizvedeni v skladu z Direktivo Sveta 93/42/EGS in Uredbo (EU) 2017/745, prosto krožijo po celotnem notranjem trgu, države članice pa ne smejo uvesti dodatnih in različnih zahtev v zvezi s proizvodnjo in dajanjem takih izdelkov na trg.
Article 19 of Regulation (EU) 2016/425 lays down the specific conformity assessment procedures, which apply to the different categories of PPE.
Člen 19 Uredbe (EU) 2016/425 določa posebne postopke ugotavljanja skladnosti, ki se uporabljajo za različne kategorije osebne varovalne opreme.
Thus, items of PPE manufactured in accordance with the Regulation (EU) 2016/425 can circulate freely throughout the internal market and Member States may not introduce additional and diverging requirements regarding the manufacturing and placement on the market of such products.
Tako lahko proizvodi osebne varovalne opreme, proizvedeni v skladu z Uredbo (EU) 2016/425, prosto krožijo po celotnem notranjem trgu, države članice pa ne smejo uvesti dodatnih in različnih zahtev v zvezi s proizvodnjo in dajanjem takih proizvodov na trg.
Notified bodies should exchange such information through the coordination of notified bodies group established under Article 36 of Regulation (EU) 2016/425.
Priglašeni organi bi si morali take informacije izmenjevati prek skupine za usklajevanje priglašenih organov, ustanovljene na podlagi člena 36 Uredbe (EU) 2016/425.
Notified bodies which issue certificates to PPE products manufactured following other technical solutions than harmonised standards, should immediately inform the relevant notifying authority as well as the other notified bodies under Regulation (EU) 2016/425 of the certificates issued and the specific technical solution followed.
Priglašeni organi, ki izdajo certifikate za proizvode osebne varovalne opreme, proizvedene v skladu z drugimi tehničnimi rešitvami, ki niso harmonizirani standardi, bi morali o izdanih certifikatih in upoštevani specifični tehnični rešitvi nemudoma obvestiti ustrezen priglasitveni organ in druge priglašene organe v skladu z Uredbo (EU) 2016/425.
Article 5 of Directive 93/42/EEC and Article 8 of Regulation (EU) 2017/745 offer the possibility for manufacturers to rely on specific technical solutions, which are detailed in harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union.
Člen 5 Direktive 93/42/EGS in člen 8 Uredbe (EU) 2017/745 proizvajalcem omogočata, da se sklicujejo na posebne tehnične rešitve, ki so podrobno navedene v harmoniziranih standardih ali njihovih delih, sklicevanja nanje pa so bila objavljena v Uradnem listu Evropske unije.
Accordingly, to address the shortage of PPE necessary in the context of the COVID-19 outbreak, where non-CE marked PPE are intended to enter the EU market, the relevant market surveillance authorities should evaluate the products and, if they are found to be compliant with the essential health and safety requirements laid down by the relevant Regulation should take measures allowing the placing of such PPE on the Union market for a limited period of time or while the conformity assessment procedure with the notified body is being carried out.
Zato bi morali ustrezni organi za nadzor trga za rešitev pomanjkanja osebne varovalne opreme, potrebne v okviru izbruha COVID-19, ko bo osebna varovalna oprema brez nameščene oznake CE vstopila na trg EU, oceniti proizvode in, če ugotovijo, da je osebna varovalna oprema skladna z bistvenimi zdravstvenimi in varnostnimi zahtevami iz zadevne uredbe, sprejeti ukrepe, ki omogočajo dajanje take osebne varovalne opreme na trg Unije za omejeno obdobje ali med izvajanjem postopka ugotavljanja skladnosti s priglašenim organom.
When delivering the conformity assessment certificates, notified bodies are required to inform their notifying authorities and may also be required to inform other notified bodies of the certificates they have issued, as set out in Article 34 of Regulation (EU) 2016/425.
Priglašeni organi morajo pri izdaji certifikatov o skladnosti obvestiti svoje priglasitvene organe, od njih pa se lahko tudi zahteva, da obvestijo druge priglašene organe o izdanih certifikatih, kot je določeno v členu 34 Uredbe (EU) 2016/425.
Directive 93/42/EEC and Regulation (EU) 2017/745 fully harmonise the rules for the design, manufacturing and placing the Union market of medical devices, and set up a number of essential requirements and of general safety and performance requirements, based on a classification of medical devices depending on specific rules governed by the intended purpose of the devices.
Direktiva 93/42/EGS in Uredba (EU) 2017/745 v celoti harmonizirata pravila za načrtovanje, proizvodnjo in dajanje medicinskih pripomočkov na trg Unije ter določata več bistvenih zahtev ter splošnih zahtev glede varnosti in učinkovitosti na podlagi razvrstitve medicinskih pripomočkov glede na posebna pravila, ki jih ureja predvideni namen pripomočkov.
Manufacturers are free to choose other technical solutions provided that the specific solution which is retained ensures that the medical device complies with the applicable essential health and safety requirements.
Proizvajalci lahko izberejo druge tehnične rešitve, če je ohranjena posebna rešitev, ki zagotavlja, da je medicinski pripomoček skladen z veljavnimi bistvenimi zdravstvenimi in varnostnimi zahtevami.
Regulation (EU) 2016/425 fully harmonises the rules for the design, manufacturing and placing on the Union market of PPE and sets out a number of essential health and safety requirements for PPE based on a classification of PPE depending on the risk against which it is intended to protect users.
Uredba (EU) 2016/425 v celoti harmonizira pravila za načrtovanje, proizvodnjo in dajanje osebne varovalne opreme na trg Unije ter določa več bistvenih zdravstvenih in varnostnih zahtev za osebno varovalno opremo na podlagi razvrstitve osebne varovalne opreme glede na tveganje, pred katerim naj bi ščitila uporabnike.
Instead, Annex I to Directive 93/42/EEC sets the essential requirements, and Annex I to Regulation (EU) 2017/745 sets the general safety and performance requirements, which medical devices should meet in order to be able to be placed on the market and to circulate freely across the entire EU market.
Namesto tega Priloga I k Direktivi 93/42/EGS določa bistvene zahteve, Priloga I k Uredbi (EU) 2017/745 pa določa splošne zahteve glede varnosti in učinkovitosti, ki jih morajo izpolnjevati medicinski pripomočki, da se lahko dajo na trg in prosto krožijo po celotnem trgu EU.
In accordance with this Article, should a manufacturer choose to adopt such a technical solution, the PPE is presumed to be in conformity with the essential health and safety requirements covered by the said harmonised standard or parts thereof.
Če se proizvajalec odloči sprejeti takšno tehnično rešitev v skladu s tem členom, se domneva, da je osebna varovalna oprema v skladu z bistvenimi zdravstvenimi in varnostnimi zahtevami, zajetimi v navedenem harmoniziranem standardu ali njegovih delih.
In accordance with Article 11 of Directive 93/42/EEC and with Article 52 of Regulation (EU) 2017/745, once the latter becomes applicable, in order to place medical devices on the market, manufacturers shall carry out the applicable conformity assessment procedures and, where compliance with the applicable essential requirements or general safety and performance requirements has been demonstrated by the appropriate procedure, affix the CE marking.
V skladu s členom 11 Direktive 93/42/EGS in členom 52 Uredbe (EU) 2017/745, ko se ta začne uporabljati, proizvajalci za dajanje medicinskih pripomočkov na trg, izvajajo postopke ugotavljanja skladnosti, ki se uporabljajo, in, kadar je bilo z ustreznim postopkom dokazano, da je skladnost z veljavnimi bistvenimi zahtevami ali splošnimi zahtevami glede varnosti in učinkovitosti dokazana, namestijo oznako CE. Odstopanja od postopkov ugotavljanja skladnosti lahko države članice na podlagi ustrezno utemeljene zahteve odobrijo za dajanje na trg in v uporabo na ozemlju zadevne države članice posameznih pripomočkov, katerih uporaba je v interesu varovanja zdravja.
‘According to Article 26(4) and point 7(f) of Annex V of Regulation (EU) 2016/425',
„v skladu s členom 26(4) in točko 7(f) Priloge V k Uredbi (EU) 2016/425"
Corrigendum to Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
Popravek Priporočila Komisije (EU) 2020/403 z dne 13. marca 2020 o postopkih ugotavljanja skladnosti in nadzora trga v okviru grožnje COVID-19
of 8 April 2020
z dne 8. aprila 2020
REPORTING AND REVIEW
POROČANJE IN PREGLED
The effectiveness of these applications has generally not been evaluated.
Učinkovitost teh aplikacij na splošno še ni bila ocenjena.
Their impact can be boosted by a strategy supporting wider testing.
Njihov učinek je mogoče izboljšati s strategijo, ki bi podpirala širše testiranje.
The effectiveness of these mobile applications depends on a number of factors.
Učinkovitost teh mobilnih aplikacij je odvisna od več dejavnikov.
Certain Member States have taken measures to simplify access to necessary data.
Nekatere države članice so sprejele ukrepe za poenostavitev dostopa do potrebnih podatkov.
The Member State concerned should take utmost account of such observations.
Zadevna država članica bi morala te pripombe čim bolj upoštevati.
The eHealth Network should meet immediately to operationalize this Recommendation.
Mreža e-zdravje bi se morala nemudoma sestati za operacionalizacijo tega priporočila.
Within one week, Member States and the Commission may submit observations on these measures.
Države članice in Komisija lahko v enem tednu podajo pripombe o teh ukrepih.
However, the EU's common efforts combating the virus are hampered by the current fragmentation of approaches.
Toda skupna prizadevanja EU za boj proti virusu ovira sedanja razdrobljenost pristopov.
Such reports should continue on regular basis for as long as the COVID-19 crisis persists.
Taka poročila bi se morala nadaljevati redno, dokler traja kriza zaradi COVID-19.
deletion of the data in principle after a period of 90 days, or in any event no later than when the pandemic is declared under control; and
izbris podatkov načeloma po obdobju 90 dni, v vsakem primeru pa najpozneje tedaj, ko se razglasi, da je pandemija pod nadzorom, ter
While these applications are of evident usefulness for Member States, they also potentially add value to the work of the ECDC.
Te aplikacije so nedvomno koristne za države članice, dodajajo pa lahko tudi vrednost delu ECDC.
The forum for coordination of efforts in the context of serious cross-border threats to health is the Health Security Committee, set up by the Article 17 of the aforementioned Decision.
Forum za usklajevanje dejavnosti v okviru resnih čezmejnih nevarnosti za zdravje je odbor za zdravstveno varnost, ustanovljen s členom 17 navedenega sklepa.
The Commission may make further recommendations to Member States, including on the timing of the measures applied in the areas covered by this Recommendation.
Komisija lahko izda nadaljnja priporočila državam članicam, tudi glede časovnega razporeda ukrepov, ki se izvajajo na področjih iz tega priporočila.
An exceptional crisis of such magnitude requires determined action of all Member States and EU institutions and bodies working together in a genuine spirit of solidarity.
V izjemni krizi take razsežnosti je potrebno odločno ukrepanje vseh držav članic ter institucij in organov EU, ki sodelujejo skupaj v pristnem duhu solidarnosti.
Certain applications are available to the general public, while others only to closed user groups directed at tracing contacts in the workplace.
Nekatere aplikacije so na voljo širši javnosti, druge pa samo zaprtim skupinam uporabnikom z namenom sledenja stikom na delovnem mestu.
In addition, Article 15(1) of the Directive allows Member States to adopt legislative measures to restrict the scope of certain rights and obligations established by the Directive, including those set out in Article 5, when such restriction constitutes a necessary, appropriate and proportionate measure within a democratic society to achieve certain objectives.
Poleg tega člen 15(1) Direktive državam članicam omogoča sprejemanje zakonodajnih ukrepov za omejevanje področja uporabe nekaterih pravic in obveznosti, določenih z Direktivo, vključno s tistimi iz člena 5, če taka omejitev pomeni potreben, primeren in ustrezen ukrep znotraj demokratične družbe za doseganje določenih ciljev.
The Toolbox will consist of practical measures for making effective use of technologies and data, with a focus on two areas in particular:
Nabor orodij bodo sestavljali praktični ukrepi za učinkovito uporabo tehnologij in podatkov s posebnim poudarkom na dveh področjih:
Any such restrictions should, in particular, be temporary, in that they remain strictly limited to what is necessary to combat the crisis and do not continue to exist, without an adequate justification, after the crisis has passed.
Zlasti bi morale biti vse takšne omejitve začasne, tj. strogo omejene na tisto, kar je potrebno za boj proti krizi, in brez ustrezne utemeljitve po koncu krize ne bi smele obstajati še naprej.
They can provide guidance to citizens and facilitate the organisation of the medical follow-up of patients.
Državljanom lahko dajejo napotke in omogočajo lažje organiziranje zdravstvenega spremljanja bolnikov.
Certain companies including telecommunications providers and major technology platforms have published or made available to public authorities anonymised and aggregated location data.
Nekatera podjetja, vključno s ponudniki telekomunikacij in velikimi tehnološkimi platformami, so objavila ali dala javnim organom na voljo anonimizirane podatke o lokaciji v zbirni obliki.
The European Data Protection Board and the European Data Protection supervisor will be associated to the process.
V ta proces bosta vključena Evropski odbor za varstvo podatkov in Evropski nadzornik za varstvo podatkov.
A PAN-EUROPEAN APPROACH FOR COVID-19 MOBILE APPLICATIONS
VSEEVROPSKI PRISTOP ZA MOBILNE APLIKACIJE V ZVEZI S COVID-19
Member States should, by 31 May 2020, report to the Commission on the actions taken pursuant to this Recommendation.
Države članice bi morale do 31. maja 2020 poročati Komisiji o ukrepih, sprejetih na podlagi tega priporočila.
The Toolbox should be shared with the European Union's international partners to exchange best practices and help address the virus spread worldwide.
Nabor orodij bi bilo treba deliti z mednarodnimi partnerji Evropske unije za izmenjavo dobrih praks in pomoč pri obravnavanju širjenja virusa po vsem svetu.
transparency requirements on the privacy settings to ensure trust into the applications.
zahteve po preglednosti glede nastavitev zasebnosti, da se zagotovi zaupanje v aplikacije.
However, a fragmented and uncoordinated approach risks hampering the effectiveness of measures aimed at combating the COVID-19 crisis, whilst also causing serious harm to the single market and to fundamental rights and freedoms.
Toda razdrobljen in neusklajen pristop utegne okrniti učinkovitost ukrepov za boj proti krizi zaradi COVID-19, povzročil pa bi tudi hudo škodo enotnemu trgu ter temeljnim pravicam in svoboščinam.
Given the functions of smartphone applications as described above, their use is capable of affecting the exercise of certain fundamental rights such as inter alia the right to respect for private and family life.
Glede na opisane funkcije pametnih telefonov je mogoče z njihovo uporabo vplivati na uresničevanje nekaterih temeljnih pravic, kot je med drugim pravica do spoštovanja zasebnega in družinskega življenja.
USE OF MOBILITY DATA TO INFORM MEASURES AND EXIT STRATEGY
UPORABA PODATKOV O MOBILNOSTI ZA PRIPRAVO UKREPOV IN IZHODNE STRATEGIJE
The Commission will, starting in June 2020, on the basis of these Member States reports, assess the progress made and the effect of this Recommendation.
Komisija bo od junija 2020 dalje na podlagi teh poročil držav članic ocenjevala doseženi napredek in učinek tega priporočila.
As any interference with those rights should be in accordance with the law, Member States' laws which would set out or permit limitations to the exercise of certain fundamental rights should be in line with the general principles of Union law as stated in Article 6 of the Treaty on the European Union, their constitutional traditions and their obligations under international law.
Ker bi moralo biti kakršno koli poseganje v te pravice skladno z zakonodajo, bi morali biti zakoni držav članic, ki bi določali ali dovoljevali omejevanje uresničevanja nekaterih temeljnih pravic, v skladu s splošnimi načeli prava Unije, določenimi v členu 6 Pogodbe o Evropski uniji, njihovo ustavno tradicijo in obveznostmi v skladu z mednarodnim pravom.
Regulation (EU) 2016/679 of the European Parliament and of the Council (3) on the protection of natural persons with regard to the processing of personal data and on the free movement of such data lays down the conditions for processing personal data, including data concerning health.
Uredba (EU) 2016/679 Evropskega parlamenta in Sveta (3) o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov določa pogoje za obdelavo osebnih podatkov, tudi podatkov o zdravju.
Member States should take these actions as a matter of urgency and in close coordination with other Member States, the Commission and other relevant stakeholders, and without prejudice to the competences of the Member States in the domain of public health.
Države članice bi morale te ukrepe sprejeti nemudoma in v tesnem sodelovanju z drugimi državami članicami, Komisijo in drugimi ustreznimi zainteresiranimi stranmi ter brez poseganja v pristojnosti držav članic na področju javnega zdravja.
The second priority for the Toolbox should be a common approach for the use of anonymised and aggregated mobility data necessary for:
Druga prednostna naloga za nabor orodij bi moral biti skupen pristop k uporabi anonimiziranih in zbirnih podatkov o mobilnosti, potrebnih za:
In order to detect proximity encounters between users of different contact tracing applications (a scenario most likely to happen among people moving across national/regional borders), interoperability between applications should be envisaged.
Za odkrivanje stikov med uporabniki različnih aplikacij za sledenje stikom (do tega scenarija bi zelo verjetno prišlo pri gibanju ljudi prek nacionalnih/regionalnih meja) bi bilo treba razmisliti o interoperabilnosti.
The pan-European approach for COVID-19 mobile applications will be published on 15 April and will be complemented by Commission guidance on privacy and data protection.
Vseevropski pristop za mobilne aplikacije v zvezi s COVID-19 bo objavljen 15. aprila, dopolnjevale pa ga bodo s smernice Komisije o varstvu zasebnosti in podatkov.
Digital technologies and data have a valuable role to play in combating the COVID-19 crisis, given that many people in Europe are connected to the internet via mobile devices.
Digitalne tehnologije in podatki imajo pomembno vlogo v boju s krizo zaradi COVID-19, saj se veliko ljudi v Evropi povezuje v internet z mobilnimi telefoni.
‘Health Security Committee' means the body composed of representatives of the Member States, established under the Article 17 of the Decision No 1082/2013/EU.
„odbor za zdravstveno varnost" pomeni organ, ki ga sestavljajo predstavniki držav članic, ustanovljen na podlagi člena 17 Sklepa št. 1082/2013/EU;
Consultation with data protection authorities, in accordance with the requirements set out in Union law on the protection of personal data, is essential to ensure that personal data is processed lawfully and that the rights of the individuals concerned are respected.
Posvetovanje z organi za varstvo podatkov v skladu z zahtevami zakonodaje Unije o varstvu osebnih podatkov je bistveno za zagotovitev, da se osebni podatki obdelujejo zakonito in da se spoštujejo pravice zadevnih posameznikov.
In particular, the Commission stated it would consider the need for legislative action to foster business-to-government data sharing for the public interest.
Komisija je poudarila zlasti, da bo preučila potrebo po zakonodajnih ukrepih za spodbujanje souporabe podatkov med podjetji in državnimi upravami v javnem interesu.
The Commission may consult the European Data Protection Supervisor and the European Data Protection Board, in accordance with Article 42 of Regulation (EU) 2018/1725 of the European Parliament and of the Council (4) and Article 70 of Regulation (EU) 2016/679.
Komisija se lahko posvetuje z evropskim nadzornikom za varstvo podatkov in evropskim odborom za varstvo podatkov v skladu s členom 42 Uredbe (EU) 2018/1725 Evropskega parlamenta in Sveta (4) in členom 70 Uredbe (EU) 2016/679.
restricting processing of the data exclusively for the purposes stated above and exclude sharing of the data with any third party.
omejitev obdelave podatkov izključno za zgoraj navedene namene in izključitev souporabe podatkov s katero koli tretjo osebo.
measures to prevent proliferation of applications that are not compatible with Union law, to support requirements for accessibility for persons with disabilities, and for interoperability and promotion of common solutions, not excluding a potential pan-European application;
ukrepe za preprečevanje širjenja aplikacij, ki niso združljive s pravom Unije, da se podprejo zahteve glede dostopnosti za invalide, ter za interoperabilnost in spodbujanje skupnih rešitev, kar ne bi izključevalo potencialne vseevropske aplikacije;
Pursuant to Article 5(3) of the Directive, such storage or gaining of access is only permitted in narrowly defined circumstances or on the basis of consent of the user or subscriber, after having been provided with clear and comprehensive information, in accordance with the requirements of Regulation (EU) 2016/679.
V skladu s členom 5(3) Direktive je tako shranjevanje ali dostopanje dovoljeno samo v ozko opredeljenih okoliščinah ali na podlagi privolitve uporabnika ali naročnika, potem ko je bil jasno in izčrpno obveščen, v skladu z zahtevami iz Uredbe (EU) 2016/679.
The public health crisis caused by the current COVID-19 pandemic (hereinafter, ‘COVID-19 crisis') is compelling the Union and the Member States to face an unprecedented challenge to its health care systems, way of life, economic stability and values.
Zaradi krize javnega zdravja, ki jo je povzročila sedanja pandemija bolezni COVID-19 (v nadaljnjem besedilu: kriza zaradi COVID-19) se Unija in države članice soočajo z izzivom brez primere za svoje zdravstvene sisteme, način življenja, gospodarsko stabilnost in vrednote.