natgillin/translations-raw huggingface dataset:
The notified body shall examine the technical documentation for the subsystem or the safety component and shall carry out the appropriate examinations and tests, as set out in the relevant harmonised standards and/or technical specifications, or equivalent tests, to ensure its conformity with the applicable requirements of this Regulation, or have them carried out.
Priglašeni organ pregleda tehnično dokumentacijo za podsistem ali varnostni element ter izvede ali naroči ustrezne preglede in preskuse, kot so določeni v ustreznih harmoniziranih standardih in/ali tehničnih specifikacijah, ali enakovredne preskuse, s čimer se preveri njihova skladnost z veljavnimi zahtevami iz te uredbe.
The notified body shall fill in the corresponding pages in the logbook referred to in Annex I, Section Point 6.2.
Priglašeni organ izpolni ustrezne strani v kontrolni knjigi, navedeni v oddelku točki 6.2 Priloge I.
The notified body shall fill in the corresponding pages of the logbook referred to in Section Point 6.2 of Annex I.
Priglašeni organ izpolni ustrezne strani v kontrolni knjigi, navedeni v oddelku točki 6.2 Priloge I.
The notified body shall give due consideration to any comments received when making its decision.”
Priglašeni organ ob odločanju ustrezno upošteva vse prejete pripombe.“
The notified body shall hold a copy of the EC design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer for a period up to the end of the validity of the certificate74.
Priglašeni organ ima izvod certifikata o ES-pregledu oblikovanja, njegovih prilog in dodatkov ter tehnični spis, vključno z dokumentacijo, ki jo predloži proizvajalec za obdobje do konca veljavnosti certifikata74.
The notified body shall hold a copy of the EC-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer for a period up to the end of the validity of the certificate27.
Priglašeni organ ima izvod certifikata o ES-pregledu tipa, njegovih prilog in dodatkov ter tehnični spis, vključno z dokumentacijo, ki jo predloži proizvajalec, za obdobje do konca veljavnosti certifikata27.
The notified body shall inform the other notified bodies concerning the EU type-examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.
Priglašeni organ obvesti druge priglašene organe o zavrnjenih, umaknjenih, začasno preklicanih ali drugače omejenih potrdilih o atestu EU ter jih na zahtevo obvesti o izdanih takih potrdilih in/ali dodatkih.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and affix its identification number to the approved product, or have it affixed under its responsibility.
Priglašeni organ izda certifikat o skladnosti ob upoštevanju izvedenih pregledov in preskusov ter namesti svojo identifikacijsko številko na odobren izdelek ali jo da namestiti na svojo odgovornost.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved appliance, or have it affixed under its responsibility.
Priglašeni organ izda potrdilo o skladnosti v zvezi z izvedenimi pregledi in preskusi ter namesti ali da v okviru svoje odgovornosti namestiti svojo identifikacijsko številko na odobreno napravo.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved instrument, or have it affixed under its responsibility.
Priglašeni organ izda potrdilo o skladnosti v zvezi z izvedenimi pregledi in preskusi ter namesti ali v okviru svoje odgovornosti da namestiti svojo identifikacijsko številko na odobreno tehtnico.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved product, or have it affixed under its responsibility.
Priglašeni organ izda potrdilo o skladnosti ob upoštevanju izvedenih pregledov in preskusov ter namesti svojo identifikacijsko številko na odobren proizvod ali jo da namestiti na svojo odgovornost.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved subsystem or the safety component, or have it affixed under its responsibility.
Priglašeni organ izda potrdilo o skladnosti ob upoštevanju izvedenih pregledov in preskusov ter namesti svojo identifikacijsko številko na vsak odobren podsistem ali varnostni element ali jo da namestiti na svojo odgovornost.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility.
Priglašeni organ izda certifikat o skladnosti ob upoštevanju izvedenih pregledov in preskusov ter namesti svojo identifikacijsko številko na vsak odobren izdelek ali jo da namestiti na svojo odgovornost.
The notified body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall affix its identification number to each approved appliance or fitting, or have it affixed under its responsibility.
Priglašeni organ izda potrdilo o skladnosti v zvezi z izvedenimi pregledi in preskusi ter namesti ali da v okviru svoje odgovornosti namestiti svojo identifikacijsko številko na vsako odobreno napravo ali opremo.
The notified body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility.
Priglašeni organ izda certifikat o skladnosti ob upoštevanju izvedenih pregledov in preskusov ter namesti svojo identifikacijsko številko na vsak odobren izdelek ali jo da namestiti na svojo odgovornost.
The notified body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility.
Priglašeni organ izda potrdilo o skladnosti ob upoštevanju izvedenih pregledov in preskusov ter namesti svojo identifikacijsko številko na vsak odobren proizvod ali jo da namestiti na svojo odgovornost.
The notified body shall issue a certificate of conformity in respect to the examinations and tests carried out, and shall affix its identification number to each approved subsystem or safety component or have it affixed under its responsibility.
Priglašeni organ izda potrdilo o skladnosti ob upoštevanju izvedenih pregledov in preskusov ter namesti svojo identifikacijsko številko na vsak odobren podsistem ali varnostni element ali jo da namestiti na svojo odgovornost.
the notified body shall issue the certificate of conformity of the FPC on the basis of:
Priglašeni organ izda izjavo o skladnosti KTP na podlagi:
the notified body shall issue the certificate of conformity of the product on the basis of:
Priglašeni organ izda izjavo o skladnosti proizvoda na podlagi:
The notified body shall keep a copy of the approval decision(s) issued, its annexes and additions, as well as the technical file for a period of 15 years from the date of their issue.
Priglašeni organ hrani izvod odločitev o odobritvi, njenih prilog in dodatkov ter tehnično dokumentacijo za obdobje 15 let od datuma njihove izdaje.
The notified body shall keep a copy of the approval decision(s) issued, its annexes and additions, as well as the technical file for a period of 15 years from the date of their issue.
Priglašeni organ hrani izvode odločitev o odobritvi, njenih prilog in dodatkov ter tehnično dokumentacijo za obdobje 15 let od datuma njihove izdaje.
The notified body shall keep a copy of the EU design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer until the expiry of the validity of the certificate.
Priglašeni organ hrani izvod potrdila o EU-pregledu oblikovanja, njegovih prilog in dodatkov ter tehnični dosje, vključno z dokumentacijo, ki jo predloži proizvajalec, do izteka veljavnosti potrdila.
The notified body shall keep a copy of the EU type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
Priglašeni organ ima izvod potrdila o EU-pregledu tipa, njegovih prilog in dodatkov ter tehnični spis, vključno z dokumentacijo, ki jo predloži proizvajalec, do izteka veljavnosti potrdila.
The notified body shall keep a copy of the EU type-examination certificate, its annexes and additions, as well as the technical file and the evaluation report for a period of 15 years from the date of issue of the certificate.
Priglašeni organ hrani izvod potrdila o EU-pregledu tipa, njegovih prilog in dodatkov ter tehnično dokumentacijo in poročilo o vrednotenju za obdobje 15 let od datuma izdaje potrdila.
The notified body shall keep a copy of the EU type-examination certificate, its annexes and additions, as well as the technical file and the evaluation report, for a period of 15 years from the date of issue of the certificate.
Priglašeni organ hrani izvod potrdila o EU-pregledu tipa, njegovih prilog in dodatkov ter tehnično dokumentacijo in poročilo o vrednotenju, za obdobje 15 let od datuma izdaje potrdila.
The notified body shall keep a copy of the EU type-examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until 5 years after the expiry of the validity of that certificate.
Priglašeni organ izvod hrani izvod potrdila o atestu EU, njegovih prilog in dodatkov ter tehnične dokumentacije, vključno z dokumentacijo, ki jo je predložil proizvajalec, še pet let po izteku veljavnosti navedenega potrdila.
The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
Priglašeni organ hrani izvod certifikata o tipskem pregledu EU, njegovih prilog in dodatkov ter tehnično mapo, vključno z dokumentacijo, ki jo predloži proizvajalec, do izteka veljavnosti tega certifikata.
The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
Priglašeni organ hrani izvod potrdila o atestu EU, njegovih prilog in dodatkov ter tehnični dosje, vključno z dokumentacijo, ki jo predloži proizvajalec, do izteka veljavnosti potrdila.
The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.
Priglašeni organ hrani izvod potrdila o EU-pregledu tipa, njegovih prilog in dodatkov ter tehnični dosje, vključno z dokumentacijo, ki jo predloži proizvajalec, do izteka veljavnosti potrdila.
The notified body shall keep at the disposal of the national authorities the relevant documents concerning the assessment of the subcontractor’s or subsidiary’s qualifications and the work carried out by the subcontractor or the subsidiary under Annex V.
Priglašeni organ hrani za nacionalne organe zadevne dokumente v zvezi z ocenjevanjem kvalifikacij podizvajalca ali hčerinskega podjetja ter z delom, ki ga podizvajalec ali hčerinsko podjetje izvaja v skladu s Prilogo V.
The notified body shall keep itself appraised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation.
Priglašeni organ oceni kakršne koli spremembe splošno sprejetih najnovejših dosežkov, ki kažejo, da odobreni tip ne izpolnjuje več veljavnih zahtev te direktive, ter določi, ali take spremembe zahtevajo nadaljnje preiskave.
The notified body shall keep itself appraised of any changes of the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigations.
4.4. Priglašeni organ odobri kakršne koli spremembe splošno sprejetih najnovejših dosežkov, ki kažejo, da odobreno oblikovanje ne izpolnjuje več veljavnih zahtev zakonodajnega instrumenta, ter določi, ali te spremembe zahtevajo nadaljnje preiskave.
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the essential health and safety requirements set out in Annex I, and shall determine whether such changes require further investigation.
Priglašeni organ oceni kakršne koli spremembe splošno sprejetih najnovejših dosežkov, ki kažejo, da odobreni načrt ne izpolnjuje več bistvenih zdravstvenih in varnostnih zahtev iz Priloge I, ter določi, ali take spremembe zahtevajo nadaljnje preiskave.
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation.
1.7. Priglašeni organ oceni kakršne koli spremembe splošno sprejetih najnovejših dosežkov, ki kažejo, da odobreni tip ne izpolnjuje več veljavnih zahtev iz te direktive, ter določi, ali take spremembe zahtevajo nadaljnje preiskave.
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Regulation, and shall determine whether such changes require further investigation.
1.7 Priglašeni organ spremlja kakršne koli spremembe splošno sprejetih najnovejših dosežkov, ki kažejo, da odobreni tip ne izpolnjuje več veljavnih zahtev iz te uredbe, ter določi, ali take spremembe zahtevajo nadaljnje preiskave.
The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the requirements of this Regulation and shall determine whether such changes require further investigation.
Priglašeni organ mora biti  seznanjen s kakršnimi koli spremembami splošne narave, ki kažejo, da odobreni tip morda ne izpolnjuje več zahtev iz te uredbe, ter odloči, ali take spremembe zahtevajo nadaljnje preiskave.
The notified body shall keep itself informed of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of this Directive, and shall determine whether such changes require further investigation.
Priglašeni organ pridobi podatke o kakršnih koli spremembah splošno sprejetih najnovejših dosežkov, ki kažejo, da odobreni tip ne izpolnjuje več veljavnih zahtev iz te direktive, ter določi, ali take spremembe zahtevajo nadaljnje preiskave.
The notified body shall participate in, or ensure that its assessment personnel is informed of, the relevant standardisation activities and the activities of the notified body co-ordination group established pursuant to Article 29 and apply as general guidance the administrative decisions and documents produced as a result of the work of that group.
Priglašeni organ sodeluje pri ustreznih dejavnostih standardizacije in dejavnostih skupine za usklajevanje priglašenih organov, ustanovljene po členu 29, oziroma poskrbi, da je njegovo osebje za ugotavljanje skladnosti obveščeno o omenjenih dejavnostih ter da se upravne odločbe in dokumenti, ki izhajajo iz rezultatov dela te skupine, uporabljajo kot splošne smernice.
The notified body shall participate in, or ensure that its assessment personnel is informed of, the relevant standardisation activities and the activities of the notified body co-ordination group established under this Regulation and apply as general guidance the administrative decisions and documents produced as a work result of that group.
Priglašeni organ sodeluje v ustreznih dejavnostih standardizacije in dejavnostih skupine priglašenega organa za usklajevanje, ustanovljene v skladu s to uredbo, ali zagotovi, da je njegovo osebje za ocenjevanje obveščeno o teh dejavnostih, ter uporablja upravne odločbe in dokumente, ki so rezultat dela navedene skupine, kot splošne smernice.
The notified body shall periodically carry out audits in order to ensure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report.
Priglašeni organ periodično izvaja presoje, da se prepriča, ali proizvajalec vzdržuje in uporablja sistem kakovosti; proizvajalcu poda poročilo o presoji.
The notified body shall provide the manufacturer with a visit report and, if a test has taken place, with a test report.
Priglašeni organ izda proizvajalcu poročilo o obisku in, če je opravil preskuse, poročilo o preskusih.
The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
Priglašeni organ proizvajalcu pošlje poročilo o obisku, če so bili izvedeni testi, pa tudi poročilo o njih.
The notified body shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the assessment and/or the verification performed.
Priglašeni organ sklene zavarovanje odgovornosti, razen če odgovornost prevzame država v skladu z nacionalno zakonodajo ali če je država članica sama neposredno pristojna za ocenjevanje in/ali preverjanje.
The notified body shall, having verified the usefulness of the product as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from the [Committee of Advanced Therapies] on the quality and safety of the product.
Priglašeni organ zahteva, potem ko preveri uporabnost izdelka kot dela medicinskega pripomočka in ob upoštevanju predvidenega namena pripomočka, od [Odbora za napredne terapije] znanstveno mnenje o kakovosti in varnosti izdelka.
the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from the European Medicines Agency (EMEA) on the quality and safety of the substance.
zahteva priglašeni organ, potem ko preveri uporabnost snovi kot dela medicinskega pripomočka in ob upoštevanju predvidenega namena pripomočka, od Evropske agencije za zdravila (EMEA) znanstveno mnenje o kakovosti in varnosti snovi.
The notified body shall:
1.4 Priglašeni organ:
The notified body shall:
1.4. Priglašeni organ:
The notified body which refuses to issue or withdraws, suspends or otherwise restricts an EU type-examination certificate shall inform its notifying authorities and the other notified bodies accordingly, giving the reasons for its decision.
Priglašeni organ, ki zavrne izdajo ali prekliče, začasno odvzame ali drugače omeji potrdilo o atestu EU, priglasitvene organe in tudi druge priglašene organe o tem obvesti ter navede razloge za svojo odločitev.
The notified body which refuses to issue or withdraws, suspends or otherwise restricts an EU-type examination certificate must inform its notifying authorities and the other notified bodies accordingly, giving the reasons for its decision.
Priglašeni organ, ki zavrne izdajo ali umakne, začasno prekliče ali drugače omeji potrdilo o atestu EU, mora o tem obvestiti priglasitvene organe in tudi druge priglašene organe ter navesti razloge za svojo odločitev.
The notified body will give due consideration to the opinion of the [Committee of Advanced Therapies] when making its decision.
Priglašeni organ ob odločanju ustrezno upošteva mnenje [Odbora za napredne terapije].
The notified body will give due consideration to the opinion of the EMEA when making its decision.
Priglašeni organ ob odločanju ustrezno upošteva mnenje EMEA.
The notified Competent Authority shall take all appropriate measures available under its domestic law to address the errors described in the notice.
Obveščeni Pristojni organ sprejme vse ustrezne ukrepe, ki so mu na voljo v skladu z njegovo nacionalno zakonodajo, da obravnava napake, opisane v obvestilu.
The notified Competent Authority will take all appropriate measures available under its domestic law to address the errors described in the notice.
Obveščeni Pristojni organ bo sprejel vse ustrezne ukrepe, ki so na voljo v skladu z njegovo nacionalno zakonodajo, da odpravi napake, opisane v obvestilu.
The notified concentration was part of a wider operation including the transfer of the gas transmission network, owned by GDP, to REN, the Portuguese electricity grid operator within a given time frame.
Priglašena koncentracija je bila del širše transakcije, ki je vključevala prenos omrežja za transmisijo plina v lasti družbe GDP na družbo REN, portugalskega operaterja elektroenergetskega omrežja, v določenem časovnem okviru.
The notified drafts were examined in the light of Directive 1999/45/EC16 relating to the classification, packaging and labeling of dangerous preparations and Regulation (EC) No 1272/200817 on classification, labelling and packaging of substances and mixtures.
Priglašeni osnutki so bili proučeni ob upoštevanju Direktive 1999/45/ES16 v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih pripravkov in Uredbe (ES) št. 1272/200817 o razvrščanju, označevanju in pakiranju snovi ter zmesi.
The notified events have been rarely ‘closed’ by an official message.
Uradno sporočeni dogodki so bili redko „zaprti“ z uradnim obvestilom.
The notified measures were adopted by the Hungarian authorities over the period from 1995 to 2003 to assist the restructuring of Postabank and to facilitate its privatisation.
Madžarski organi so priglašene ukrepe sprejeli v obdobju med letoma 1995 in 2003, da bi pomagali pri prestrukturiranju družbe Postabank in pospešili njeno privatizacijo.
The notifiers shall inform the Agency accordingly.
Prijavitelji o tem obvestijo Agencijo.
The notifying authority shall be organised in such a way that each decision relating to notification of a performance assessment body is taken by competent persons different from those who carried out the assessment.
Priglasitveni organ je organiziran tako, da vsako odločitev v zvezi s priglasitvijo organa za ocenjevanje zmogljivosti sprejmejo pristojne osebe, ki niso tiste, ki so izvedle ocenjevanje.
The notifying authority shall be organised in such a way that each decision relating to notification of the notified bodies is taken by competent persons different from those who carried out the assessment.
Priglasitveni organ mora biti organiziran tako, da vsak sklep glede priglasitve priglašenih organov sprejme pristojna oseba, ki ni ista kot osebe, ki so izvedle ocenjevanje.
The notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.
Priglasitveni organ ima na voljo zadostno število strokovnega osebja za pravilno izvajanje svojih nalog.
The notifying authority shall immediately inform the Commission and the other Member States accordingly.
Priglasitveni organ o tem nemudoma obvesti Komisijo in druge države članice.
The notifying authority shall not offer or provide any activities that notified bodies perform, or consultancy services on a commercial or competitive basis.
Priglasitveni organ ne ponuja ali izvaja nobenih dejavnosti, ki jih izvajajo priglašeni organi, ali svetovalnih storitev na tržni ali konkurenčni osnovi.