natgillin/translations-raw huggingface dataset:
(1) Council Joint Action 2008/124/CFSP of 4 February 2008 on the European Union Rule of Law Mission in Kosovo, EULEX KOSOVO ( OJ L 42, 16.2.2008, p. 92 ).
(1) Skupni ukrep Sveta 2008/124/SZVP z dne 4. februarja 2008 o misiji Evropske unije za krepitev pravne države na Kosovem (EULEX KOSOVO) ( UL L 42, 16.2.2008, str. 92 ).
(3) Political and Security Committee Decision (CFSP) 2019/1991 of 28 November 2019 on the appointment of the Head of Mission of the European Union Rule of Law Mission in Kosovo (EULEX KOSOVO) (EULEX KOSOVO/2/2019) ( OJ L 308, 29.11.2019, p. 105 ).
(3) Sklep Političnega in Varnostnega Odbora (SZVP) 2019/1991 z dne 28. novembra 2019 o imenovanju vodje misije Evropske unije za krepitev pravne države na Kosovu (EULEX KOSOVO) (EULEX KOSOVO/2/2019) ( UL L 308, 29.11.2019, str. 105 ).
(2) Council Decision (CFSP) 2018/856 of 8 June 2018 amending Joint Action 2008/124/CFSP on the European Union Rule of Law Mission in Kosovo (EULEX KOSOVO) ( OJ L 146, 11.6.2018, p. 5 ).
(2) Sklep Sveta (SZVP) 2018/856 z dne 8. junija 2018 o spremembi Skupnega ukrepa 2008/124/SZVP o misiji Evropske unije za krepitev pravne države na Kosovu (EULEX KOSOVO) ( UL L 146, 11.6.2018, str. 5 ).
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However, compliance with the harmonised standards is not mandatory.
Vendar skladnost s harmoniziranimi standardi ni obvezna.
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije in zlasti člena 292 Pogodbe,
In addition, the global supply chain of such products has also sustained significant disruptions, which have induced repercussions on the EU market as well.
Poleg tega je svetovna dobavna veriga takih izdelkov tudi utrpela znatne motnje, ki so prav tako povzročile posledice za trg EU.
For PPE, this should be done through the Information and Communication System for Market Surveillance (ICSMS).
Za osebno varovalno opremo bi bilo to treba storiti prek informacijskega in komunikacijskega sistema za nadzor trga (ICSMS).
In order to mitigate the effects of the various disruptive factors, the economic operators are redesigning their supply chains by launching new manufacturing lines and/or diversifying their supplier base.
Da bi ublažili posledice različnih motečih dejavnikov, gospodarski subjekti preoblikujejo svoje dobavne verige z uvajanjem novih proizvodnih linij in/ali diverzifikacijo svoje baze dobaviteljev.
They shall also inform the Commission and other Member State of the results of the evaluation and the actions which they have required the economic operator to take.
Komisijo in drugo državo članico obvestijo tudi o rezultatih ocene in ukrepih, ki so jih zahtevali od gospodarskega subjekta.
These efforts by the industrial stakeholders would not be able to produce their full effects if the increased supply cannot feed into the market without any undue delays.
Navedena prizadevanja deležnikov v industriji ne bi imela polnega učinka, če večja ponudba ne more prispevati k trgu brez nepotrebnega odlašanja.
Notified bodies need to carry out this assessment not only where the manufacturer has applied the harmonised standards, but also in a situation where the manufacturer has followed other technical solutions.
Priglašeni organi morajo to oceno izvesti ne le, kadar je proizvajalec uporabil harmonizirane standarde, ampak tudi v primeru, ko je proizvajalec sledil drugim tehničnim rešitvam.
Economic operators active across the EU are working relentlessly to increase their respective manufacturing and distribution capacity.
Gospodarski subjekti, ki delujejo po vsej EU, si neutrudno prizadevajo za povečanje svojih proizvodnih in distribucijskih zmogljivosti.
CONFORMITY ASSESSMENT PROCEDURES
Postopki nadzora trga
on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
o postopkih ugotavljanja skladnosti in nadzora trga v okviru grožnje COVID-19
Relevant medical devices as non-invasive devices are in Class I, unless specific rules apply.
Ustrezni medicinski pripomočki, kot so neinvazivni pripomočki, spadajo v razred I, razen če se uporabljajo posebna pravila.
Each of the different conformity assessment procedures, which may be used, require the mandatory involvement of a third party conformity assessment body.
Vsak od različnih postopkov ugotavljanja skladnosti, ki se lahko uporabijo, zahteva obvezno vključitev organa za ugotavljanje skladnosti tretje osebe.
The requirements for the design, manufacturing and placing on the market of medical devices are laid down by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (2) .
Zahteve za zasnovo, proizvodnjo in dajanje na trg medicinskih pripomočkov so določene v Direktivi Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih (2) .
Bearing in mind that the health and safety of the EU citizens is of upmost priority, it is of paramount importance to ensure that the most appropriate PPE and medical devices ensuring adequate protection are swiftly made available to those who need it most.
Ob upoštevanju, da sta zdravje in varnost državljanov EU najpomembnejši prednostni področji, je izjemno pomembno zagotoviti, da so najprimernejša osebna varovalna oprema in medicinski pripomočki, ki zagotavljajo ustrezno zaščito, hitro dostopni tistim, ki jih najbolj potrebujejo.
Surgical masks, examination gloves and some types of gowns are products falling within the scope of Directive 93/42/EEC and of Regulation (EU) 2017/745.
Kirurške maske, rokavice za preskušanje in nekatere vrste halj so izdelki, ki spadajo na področje uporabe Direktive 93/42/EGS in Uredbe (EU) 2017/745.
In the context of the COVID-19 threat, such PPE and medical devices are essential for healthcare workers, first responders and other personnel involved in the efforts to contain the virus and avoid its further spread.
V okviru grožnje COVID-19 so taka osebna varovalna oprema in medicinski pripomočki bistvenega pomena za zdravstvene delavce, osebe, ki se prve odzovejo, in drugo osebje, ki sodeluje pri prizadevanjih za zajezitev virusa in preprečevanju njegovega nadaljnjega širjenja.
That Directive is repealed by 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 (3) , with effect from 26 May 2020.
Navedena direktiva je razveljavljena z Uredbo (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 (3) z učinkom od 26. maja 2020.
In particular, the supply chain of certain types of PPE such as the disposable face masks is under severe strain, due to the exponential growth of the demand both via existing as well as via new channels.
Zlasti je zelo obremenjena dobavna veriga nekaterih vrst osebne varovalne opreme, kot so obrazne maske za enkratno uporabo, zaradi eksponentne rasti povpraševanja tako po obstoječih kot tudi po novih poteh.
Market surveillance authorities should inform immediately the Commission and other Member States of any temporary arrangement they have granted to specific PPE or medical devices.
Organi za nadzor trga bi morali nemudoma obvestiti Komisijo in druge države članice o vsaki začasni ureditvi, ki jo odobrijo za specifično osebno varovalno opremo ali medicinske pripomočke.
In order to ensure that such products can be made available in other Member States and in view of the importance to ensure an efficient exchange of information as well as a coordinated response to all threats to the citizens' health and safety, it is appropriate that the market surveillance authority carrying out such an evaluation communicates its decision to other Member States authorities and to the Commission through the regular market surveillance information exchange channels.
Za zagotovitev, da se taki proizvodi lahko dajo na voljo v drugih državah članicah, in glede na pomen zagotavljanja učinkovite izmenjave informacij ter usklajenega odziva na vse nevarnosti za zdravje in varnost državljanov, je primerno, da organ za nadzor trga, ki izvaja takšno ocenjevanje, svojo odločitev sporoči organom drugih držav članic in Komisiji prek rednih kanalov za izmenjavo informacij o tržnem nadzoru.
Such measures should nevertheless not have a detrimental effect on the overall level of health and safety and all relevant stakeholders should ensure that any PPE or medical devices, which is being placed on the EU market, continues to provide an adequate level of protection of the users' health and safety.
Takšni ukrepi kljub temu ne bi smeli škodljivo vplivati na splošno raven zdravja in varnosti, vsi zadevni deležniki pa bi morali zagotoviti, da vsa osebna varovalna oprema ali medicinski pripomočki, ki se dajejo na trg EU, še naprej zagotavljajo ustrezno raven varovanja zdravja in varnosti uporabnikov.
The relevant market surveillance authorities in the Member States should as a matter of priority focus on non-compliant PPE or medical devices raising serious risks as to the health and safety of their intended users.
Ustrezni organi za nadzor trga v državah članicah bi se morali prednostno osredotočiti na neustrezno osebno varovalno opremo ali medicinske pripomočke, ki povzročajo resna tveganja za zdravje in varnost njihovih predvidenih uporabnikov.
In the context of the current COVID-19 global outbreak as well as the rapid spread of the virus across various regions of the EU, the demand for personal protective equipment (hereinafter ‘PPE') such as face masks, gloves, protective coveralls or eyewear protection, as well as for medical devices such as surgical masks, exploration gloves and some gowns, has seen an exponential growth.
Zaradi aktualnega svetovnega izbruha COVID-19 ter hitrega širjenja virusa v različnih regijah EU povpraševanje po osebni varovalni opremi, kot so obrazne maske, rokavice, varovalni kombinezoni ali očala, ter po medicinskih pripomočkih, kot so kirurške maske, rokavice za raziskovanje in nekatere halje, eksponentno narašča.
Pursuant to this Article, items of PPE of category III, such as the ones designed protect against harmful biological agents should be subjected to specific combination of conformity assessment procedures, which are described respectively in Annexes V, VII and VIII of the same Regulation.
V skladu s tem členom bi bilo treba za proizvode osebne varovalne opreme kategorije III, na primer tiste za zaščito pred škodljivimi biološkimi dejavniki, opraviti posebno kombinacijo postopkov ugotavljanja skladnosti, ki so opisani v prilogah V, VII in VIII iste uredbe.
PPE intended to protect against harmful biological agents, such as viruses are listed in Annex I of Regulation (EU) 2016/425 as category III, which includes exclusively the risks that may cause ‘very serious consequences such as death or irreversible damage to health'.
Osebna varovalna oprema, namenjena zaščiti pred škodljivimi biološkimi dejavniki, kot so virusi, je v Prilogi I k Uredbi (EU) 2016/425 navedena kot kategorija III, ki vključuje izključno tveganja, ki lahko povzročijo „zelo hude posledice, kot je smrt ali trajna okvara zdravja".
The requirements for the design, manufacturing and placing on the market of personal protective equipment are laid down by Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (1) .
Zahteve za načrtovanje, proizvodnjo in dajanje na trg osebne varovalne opreme so določene v Uredbi (EU) 2016/425 Evropskega parlamenta in Sveta z dne 9. marca 2016 o osebni varovalni opremi in razveljavitvi Direktive Sveta 89/686/EGS (1) .
PPE or medical devices not bearing the CE marking could also be assessed and part of a purchase organised by the relevant Member State authorities provided that is ensured that such products are only available for the healthcare workers for the duration of the current health crisis and that they are not entering the regular distribution channels and made available to other users.
Osebna varovalna oprema ali medicinski pripomočki, ki nimajo oznake CE, so prav tako lahko predmet ocene in nakupa, ki ga organizirajo ustrezni organi držav članic, če se zagotovi, da so taki izdelki na voljo samo zdravstvenim delavcem med trajanjem aktualne zdravstvene krize ter da ne vstopajo v redne distribucijske kanale in se ne dajejo na voljo drugim uporabnikom.
Disposable and re-usable face masks ensuring protection against particulate hazards, disposable and re-usable coveralls, gloves and eyewear protection, which are used for prevention and protection against harmful biological agents such as viruses are products falling within the scope of the Regulation (EU) 2016/425.
Obrazne maske za enkratno uporabo in za ponovno uporabo, ki ščitijo pred nevarnimi delci, kombinezoni za enkratno uporabo in za ponovno uporabo, ki se uporabljajo za preprečevanje in zaščito pred škodljivimi biološkimi dejavniki, kot so virusi, so proizvodi, ki spadajo na področje uporabe Uredbe (EU) 2016/425.
Considering that certain types of PPE or medical devices that are used in the context of the COVID-19 outbreak, may also be used for other purposes, it is necessary that Member States take all appropriate measures to ensure that PPE or medical devices not bearing the CE marking, which may be placed on the Union market in accordance with paragraph 8 of the present Recommendation are only made available to healthcare workers,
Ker se nekatere vrste osebne varovalne opreme ali medicinskih pripomočkov, ki se uporabljajo v okviru izbruha COVID-19, lahko uporabijo tudi za druge namene, je nujno, da države članice sprejmejo vse ustrezne ukrepe za zagotovitev, da se osebna varovalna oprema ali medicinski pripomočki brez nameščene oznake CE, ki se lahko dajo na trg Unije v skladu z odstavkom 8 tega priporočila, dajo na voljo samo zdravstvenim delavcem -
In the case of medical devices, the possibility for Member States to authorise derogations from conformity assessment procedures should also be considered, according to Article 11(13) of Directive 93/42/EEC and Article 59 of Regulation (EU) 2017/745 once the latter becomes applicable, also when the intervention of a notified body is not required.
V primeru medicinskih pripomočkov bi bilo treba upoštevati tudi možnost držav članic, da odobrijo odstopanja od postopkov ugotavljanja skladnosti v skladu s členom 11(13) Direktive 93/42/EGS in členom 59 Uredbe (EU) 2017/745, ko se slednja začne uporabljati, tudi kadar posredovanje priglašenega organa ni potrebno.
With the objective to ensure availability of PPE and medical devices for adequate protection in the COVID-19 outbreak, the Commission invites all economic operators throughout the supply chain, as well as notified bodies and market surveillance authorities to deploy all the measures at their disposal to support the efforts aimed at ensuring that the supply of PPE and medical devices throughout the EU market will match the continuously increasing demand.
Da bi zagotovila razpoložljivost osebne varovalne opreme in medicinskih pripomočkov za ustrezno zaščito ob izbruhu COVID-19, Komisija poziva vse gospodarske subjekte v celotni dobavni verigi ter priglašene organe in organe za nadzor trga, naj uporabijo vse ukrepe, ki jih imajo na voljo, za podporo prizadevanjem za zagotovitev, da bo dobava osebne varovalne opreme in medicinskih pripomočkov na celotnem trgu EU ustrezala stalno naraščajočemu povpraševanju.
In view of the importance to ensure an efficient exchange of information between all stakeholders in the PPE supply chain, where notified bodies conclude that a PPE following another specific standard or technical solution is compliant with the essential health and safety requirements applicable to it, sharing this information will be instrumental in facilitating the assessment of other products manufactured according to the same specific standard or technical solution in a swift manner.
Glede na to, kako pomembno je zagotoviti učinkovito izmenjavo informacij med vsemi deležniki v dobavni verigi osebne varovalne opreme, kadar priglašeni organi ugotovijo, da je osebna varovalna oprema v skladu z drugim specifičnim standardom ali tehnično rešitvijo skladna z bistvenimi zdravstvenimi in varnostnimi zahtevami, ki se zanjo uporabljajo, bo izmenjava teh informacij ključna za lažjo oceno drugih proizvodov, proizvedenih v skladu z enakim specifičnim standardom ali tehnično rešitvijo.
Pursuant to these Articles, medical devices falling within Class I, other than custom-made or investigational devices, should be subjected to the conformity assessment procedure for the EC declaration of conformity, without the involvement of a third party conformity assessment body.
V skladu s tema členoma bi bilo treba za medicinske pripomočke iz razreda I, razen pripomočkov, izdelanih za posameznega uporabnika, ali pripomočkov, ki so predmet raziskave, opraviti postopek ugotavljanja skladnosti za izjavo ES o skladnosti brez sodelovanja organa za ugotavljanje skladnosti tretje osebe.
Notified bodies should thus assess whether products manufactured in line with other technical solutions, such as the ones contained in the WHO recommendations on the appropriate selection of PPE also meet the applicable essential health and safety requirements.
Priglašeni organi bi morali tako oceniti, ali proizvodi, proizvedeni v skladu z drugimi tehničnimi rešitvami, kot so tiste iz priporočil Svetovne zdravstvene organizacije o ustrezni izbiri osebne varovalne opreme, izpolnjujejo tudi veljavne bistvene zdravstvene in varnostne zahteve.
The notified bodies under Regulation (EU) 2016/425 should prioritise and swiftly conduct the conformity assessment activities in the framework of all newly submitted requests by economic operators of PPE necessary for protection in the context of the COVID-19 outbreak.
Priglašeni organi v skladu z Uredbo (EU) 2016/425 bi morali dati prednost in čim prej izvesti dejavnosti ugotavljanja skladnosti za vse na novo predložene zahteve gospodarskih subjektov v zvezi z osebno varovalno opremo, ki je potrebna za zaščito v okviru izbruha COVID-19.
In the case of PPE products manufactured following technical solutions other than harmonised standards, the WHO recommendations on the appropriate selection of PPE may be used as a potential source of reference for such technical solutions, provided that the said technical solutions ensure an adequate level of protection corresponding to the applicable essential health and safety requirements laid down in Regulation (EU) 2016/425.
V primeru proizvodov osebne varovalne opreme, proizvedenih v skladu s tehničnimi rešitvami, ki niso harmonizirani standardi, se lahko kot potencialni vir za take tehnične rešitve uporabljajo priporočila Svetovne zdravstvene organizacije o ustrezni izbiri osebne varovalne opreme, če navedene tehnične rešitve zagotavljajo ustrezno raven zaščite, ki ustreza veljavnim zdravstvenim in varnostnim zahtevam iz Uredbe (EU) 2016/425.
Where market surveillance authorities find that PPE or medical devices ensure an adequate level of health and safety in accordance with the essential requirements laid down in Regulation (EU) 2016/425 or the requirements of Directive 93/42/EEC or Regulation (EU) 2017/745, even though the conformity assessment procedures, including the affixing of CE marking have not been fully finalised according to the harmonised rules, they may authorise the making available of these products on the Union market for a limited period of time and while the necessary procedures are being carried out.
Kadar organi za nadzor trga ugotovijo, da osebna varovalna oprema ali medicinski pripomočki zagotavljajo ustrezno raven zdravja in varnosti v skladu z bistvenimi zahtevami iz Uredbe (EU) 2016/425 ali zahtevami iz Direktive 93/42/EGS ali Uredbe (EU) 2017/745, čeprav postopki ugotavljanja skladnosti, vključno z namestitvijo oznake CE, niso v celoti dokončani v skladu s harmoniziranimi pravili, lahko odobrijo razpoložljivost teh izdelkov na trgu Unije za omejeno obdobje, medtem ko se izvajajo potrebni postopki.
Regulation (EU) 2016/425 is technologically neutral and does not lay down any specific mandatory technical solutions for the design of PPE products.
Uredba (EU) 2016/425 je tehnološko nevtralna in ne določa posebnih obveznih tehničnih rešitev za načrtovanje proizvodov osebne varovalne opreme.
To that effect, notified bodies can make use of the existing channels for exchange of information in the framework of the coordination groups established in accordance with Article 36 of Regulation (EU) 2016/425.
V ta namen lahko priglašeni organi uporabijo obstoječe kanale za izmenjavo informacij v okviru skupin za usklajevanje, ustanovljenih v skladu s členom 36 Uredbe (EU) 2016/425.
According to Article 26(4) and point 7 (f) of Annex V of Regulation (EU) 2016/425, notified bodies are required to assess that a PPE product meets the applicable essential health and safety requirements.
Priglašeni organi morajo v skladu s členom 26(4) in točko 7(f) Priloge V k Uredbi (EU) 2016/425 oceniti, ali proizvod osebne varovalne opreme izpolnjuje veljavne bistvene zdravstvene in varnostne zahteve.
Directive 93/42/EEC and Regulation (EU) 2017/745 are technologically neutral and do not lay down any specific mandatory technical solutions for the design of medical devices.
Direktiva 93/42/EGS in Uredba (EU) 2017/745 sta tehnološko nevtralni in ne določata posebnih obveznih tehničnih rešitev za načrtovanje medicinskih pripomočkov.
Article 11 of Directive 93/42/EEC and Article 52 of Regulation (EU) 2017/745, once the latter becomes applicable, lay down the specific conformity assessment procedures, which apply to the different classes of medical devices.
Člen 11 Direktive 93/42/EGS in člen 52 Uredbe (EU) 2017/745, ko se ta začne uporabljati, določata posebne postopke ugotavljanja skladnosti, ki se uporabljajo za različne razrede medicinskih pripomočkov.
Notified bodies are the conformity assessment bodies designated by Member States and authorised to carry out third party conformity assessment tasks under Regulation (EU) 2016/425.
Priglašeni organi so organi za ugotavljanje skladnosti, ki jih imenujejo države članice in so pooblaščeni za izvajanje nalog ugotavljanja skladnosti tretjih oseb v skladu z Uredbo (EU) 2016/425.
In accordance with this Article, should a manufacturer choose to adopt such a technical solution, the medical device is presumed to be in conformity with the 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 medicinski pripomoček v skladu z zahtevami, zajetimi v navedenem harmoniziranem standardu ali njegovih delih.
Instead, Annex II to Regulation (EU) 2016/425 sets the essential health and safety requirements, which PPE 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 II k Uredbi (EU) 2016/425 določa bistvene zdravstvene in varnostne zahteve, ki jih mora izpolnjevati osebna varovalna oprema, da se lahko da na trg in prosto kroži po celotnem trgu EU.
Article 14 of Regulation (EU) 2016/425 offers 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 14 Uredbe (EU) 2016/425 proizvajalcem omogoča, 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.