natgillin/translations-raw huggingface dataset:
However, the applicant shall make available all the documentation referred to in the first subparagraph to demonstrate compliance with those requirements upon request.
Vendar vložnik na zahtevo omogoči dostop do vse dokumentacije iz prvega pododstavka, da dokaže skladnost s temi zahtevami.
The notified body shall update the documentation referred to in paragraph 2 whenever relevant changes occur, in order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements set out in Annex VII.
Priglašeni organ posodobi dokumentacijo iz odstavka 2 vsakič, kadar pride do pomembnih sprememb, da bi organu, pristojnemu za priglašene organe, omogočil spremljanje in preverjanje, ali se vse zahteve, določene v Prilogi VII, stalno upoštevajo.
The authority responsible for notified bodies shall within 30 days check that the application referred to in Article 34 is complete and shall request the applicant to provide any missing information.
Organ, pristojen za priglašene organe, v 30 dneh preveri, ali je vloga iz člena 34 popolna, ter od vložnika zahteva, da predloži morebitne manjkajoče informacije.
Once the application is complete that national authority shall send it to the Commission.
Potem ko je vloga popolna, jo ta organ pošlje Komisiji.
The authority responsible for notified bodies shall review the application and supporting documentation in accordance with its own procedures and shall draw up a preliminary assessment report.
Organ, pristojen za priglašene organe, pregleda vlogo in pripadajočo dokumentacijo v skladu z lastnimi postopki in sestavi predhodno ocenjevalno poročilo.
The authority responsible for notified bodies shall submit the preliminary assessment report to the Commission which shall immediately transmit it to the MDCG.
Organ, pristojen za priglašene organe, predhodno ocenjevalno poročilo predloži Komisiji, ki ga nemudoma posreduje Koordinacijski skupini za medicinske pripomočke.
Within 14 days of the submission referred to in paragraph 2 of this Article, the Commission, in conjunction with the MDCG, shall appoint a joint assessment team made up of three experts, unless the specific circumstances require a different number of experts, chosen from the list referred to in Article 36.
Komisija v sodelovanju s Koordinacijsko skupino za medicinske pripomočke v 14 dneh od predložitve iz odstavka 2 tega člena imenuje skupno ocenjevalno ekipo, ki jo sestavljajo trije strokovnjaki s seznama iz člena 36, razen če je zaradi posebnih okoliščin potrebno drugačno število strokovnjakov.
One of the experts shall be a representative of the Commission who shall coordinate the activities of the joint assessment team.
Eden od strokovnjakov je predstavnik Komisije in usklajuje dejavnosti skupne ocenjevalne ekipe.
The other two experts shall come from Member States other than the one in which the applicant conformity assessment body is established.
Druga dva strokovnjaka sta iz držav članic, različnih kot država članica, v kateri ima sedež organ za ugotavljanje skladnosti, ki je vložil vlogo.
The joint assessment team shall be comprised of competent experts who are competent to assess the conformity assessment activities and the types of devices which are the subject of the application or, in particular when the assessment procedure is initiated in accordance with Article 43(3) to ensure that the specific concern can be appropriately assessed.
Skupno ocenjevalno ekipo sestavljajo kompetentni strokovnjaki, ki so usposobljeni za ocenjevanje dejavnosti ugotavljanja skladnosti in vrst pripomočkov, za katere je vložena vloga, ali, zlasti kadar je bil postopek ocenjevanja začet v skladu s členom 43(3), za zagotovitev ustrezne obravnave specifičnih pomislekov.
Within 90 days of its appointment, the joint assessment team shall review the documentation submitted with the application in accordance with Article 34.
Skupna ocenjevalna ekipa v 90 dneh od imenovanja pregleda dokumentacijo, predloženo z vlogo v skladu s členom 34.
The joint assessment team may provide feedback to, or require clarification from, the authority responsible for notified bodies on the application and on the planned on-site assessment.
Skupna ocenjevalna ekipa lahko o vlogi in načrtovanem ocenjevanju na kraju samem poroča organu, pristojnemu za priglašene organe, ali ga zaprosi za pojasnila v zvezi z vlogo in načrtovanim ocenjevanjem na kraju samem.
The authority responsible for notified bodies together with the joint assessment team shall plan and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor, located inside or outside the Union, to be involved in the conformity assessment process.
Organ, pristojen za priglašene organe, in skupna ocenjevalna ekipa načrtujeta in opravita ocenjevanje organa za ugotavljanje skladnosti, ki je vložil vlogo, na kraju samem ter po potrebi vsake odvisne družbe ali podizvajalca v Uniji ali zunaj nje, ki bo sodeloval v postopku ugotavljanja skladnosti.
The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies.
Ocenjevanje organa, ki je vložil vlogo, na kraju samem vodi organ, pristojen za priglašene organe.
Findings regarding non-compliance of an applicant conformity assessment body with the requirements set out in Annex VII shall be raised during the assessment process and discussed between the authority responsible for notified bodies and the joint assessment team with a view to reaching consensus and resolving any diverging opinions, with respect to the assessment of the application.
Ugotovitve o neskladnosti organa za ugotavljanje skladnosti, ki je vložil vlogo, z zahtevami, določenimi v Prilogi VII, se navedejo med postopkom ocenjevanja, zatem pa o njih razpravljata organ, pristojen za priglašene organe, in skupna ocenjevalna ekipa, da bi našla sporazumno rešitev in razrešila morebitna različna mnenja glede ocenjevanja vloge.
At the end of the on-site assessment, the authority responsible for notified bodies shall list for the applicant conformity assessment body the non-compliances resulting from the assessment and summarise of the assessment by the joint assessment team.
Ob koncu ocenjevanja na kraju samem organ, pristojen za priglašene organe, organu za ugotavljanje skladnosti, ki je vložil vlogo, navede primere neskladnosti, ugotovljenih pri ocenjevanju, in povzetek ocene, ki jo je predložila skupna ocenjevalna ekipa.
Within a specified timeframe, the applicant conformity assessment body shall submit to the national authority a corrective and preventive action plan to address the non-compliances.
V določenem časovnem okviru organ za ugotavljanje skladnosti, ki je vložil vlogo, nacionalnemu organu predloži načrt korektivnih in preventivnih ukrepov za odpravo primerov neskladnosti.
The joint assessment team shall document any remaining diverging opinions with respect to the assessment within 30 days of completion of the on-site assessment and send them to the authority responsible for notified bodies.
Skupna ocenjevalna ekipa v 30 dneh od zaključka ocene na kraju samem zabeleži vsa preostala različna mnenja glede ocene in jih pošlje organu, pristojnemu za priglašene organe.
The authority responsible for notified bodies shall, following receipt of a corrective and preventive action plan from the applicant body, assess whether non-compliances identified during the assessment have been appropriately addressed.
Ko organ, pristojen za priglašene organe, od organa, ki je vložil vlogo, prejme načrt korektivnih in preventivnih ukrepov, oceni, ali so bile neskladnosti, odkriti med oceno, ustrezno odpravljene.
This plan shall indicate the root cause of the identified non-compliances and shall include a timeframe for implementation of the actions therein.
V načrtu sta navedena osnovni vzrok za ugotovljene neskladnosti in časovni razpored za izvedbo ukrepov, navedenih v načrtu.
The authority responsible for notified bodies shall, having confirmed the corrective and preventive action plan, forward it and its opinion thereon to the joint assessment team.
Potem ko organ, pristojen za priglašene organe, potrdi načrt korektivnih in preventivnih ukrepov, ga skupaj s svojim mnenjem o tem načrtu pošlje skupni ocenjevalni ekipi.
The joint assessment team may request of the authority responsible for notified bodies further clarification and modifications.
Skupna ocenjevalna ekipa lahko organ, pristojen za priglašene organe, zaprosi za dodatna pojasnila in spremembe.
The authority responsible for notified bodies shall draw up its final assessment report which shall include:
Organ, pristojen za priglašene organe, sestavi končno ocenjevalno poročilo, ki vključuje:
the result of the assessment,
rezultat ocenjevanja,
confirmation that the corrective and preventive actions have been appropriately addressed and, where required, implemented,
potrditev, da so bili korektivni in preventivni ukrepi ustrezno obravnavani in po potrebi izvedeni,
any remaining diverging opinion with the joint assessment team, and, where applicable,
vsa preostala mnenja, ki se razlikujejo od mnenja skupne ocenjevalne ekipe in, kadar je to ustrezno,
the recommended scope of designation.
priporočilo glede obsega imenovanja.
The authority responsible for notified bodies shall submit its final assessment report and, if applicable, the draft designation to the Commission, the MDCG and the joint assessment team.
Organ, pristojen za priglašene organe, predloži Komisiji, Koordinacijski skupini za medicinske pripomočke in skupni ocenjevalni ekipi končno ocenjevalno poročilo in po potrebi osnutek imenovanja.
The joint assessment team shall provide a final opinion regarding the assessment report prepared by the authority responsible for notified bodies and, if applicable, the draft designation within 21 days of receipt of those documents to the Commission which shall immediately submit that final opinion to the MDCG.
Skupna ocenjevalna ekipa Komisiji predloži končno mnenje o ocenjevalnem poročilu, ki ga pripravi organ, pristojen za priglašene organe, in po potrebi osnutek imenovanja v 21 dneh od prejema navedenih dokumentov, Komisija pa to končno mnenje nemudoma predloži Koordinacijski skupini za medicinske pripomočke.
Within 42 days of receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft designation, which the authority responsible for notified bodies shall duly take into consideration for its decision on the designation of the notified body.
Koordinacijska skupina za medicinske pripomočke v 42 dneh po prejemu mnenja skupne ocenjevalne ekipe izda priporočilo glede osnutka imenovanja, ki ga organ, pristojen za priglašene organe, ustrezno upošteva pri svoji odločitvi o imenovanju priglašenega organa.
The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements specifying procedures and reports for the application for designation referred to in Article 34 and the assessment of the application set out in this Article.
Komisija lahko z izvedbenimi akti sprejme ukrepe, ki določajo podrobno ureditev postopkov in poročil za vlogo za imenovanje iz člena 34 ter oceno vloge, določeno v tem členu.
Nomination of experts for joint assessment of applications for notification
Imenovanje strokovnjakov za skupno ocenjevanje vlog za priglasitev
The Member States and the Commission shall nominate experts qualified in the assessment of conformity assessment bodies in the field of in vitro diagnostic medical devices to participate in the activities referred to in Articles 35 and 44.
Države članice in Komisija imenujejo strokovnjake, usposobljene za ocenjevanje organov za ugotavljanje skladnosti na področju in vitro diagnostičnih medicinskih pripomočkov, za sodelovanje pri dejavnostih iz členov 35 in 44.
The Commission shall maintain a list of the experts nominated pursuant to paragraph 1 of this Article, together with information on their specific field of competence and expertise.
Komisija vodi seznam strokovnjakov, imenovanih v skladu z odstavkom 1 tega člena, ter informacije o njihovi usposobljenosti na posebnem področju in strokovnem znanju.
That list shall be made available to Member States competent authorities through the electronic system referred to in Article 52.
Ta seznam je prek elektronskega sistema iz člena 52 na voljo pristojnim organom držav članic.
All documents required pursuant to Articles 34 and 35 shall be drawn up in a language or languages which shall be determined by the Member State concerned.
Vsi dokumenti, zahtevani na podlagi členov 34 in 35, se sestavijo v jeziku ali jezikih, ki jih določi zadevna država članica.
Member States, in applying the first paragraph, shall consider accepting and using a commonly understood language in the medical field, for all or part of the documentation concerned.
Države članice pri uporabi prvega odstavka preučijo, ali naj se za del ali celotno zadevno dokumentacijo sprejme in uporablja splošno razumljiv jezik na zdravstvenem področju.
The Commission shall provide translations of the documentation pursuant to Articles 34 and 35, or parts thereof into an official Union language, such as is necessary for that documentation to be readily understood by the joint assessment team appointed in accordance with Article 35(3).
Komisija zagotovi prevode dela ali celotne dokumentacije v skladu s členoma 34 in 35 v enega izmed uradnih jezikov Unije, tako da bo dokumentacija brez težav razumljiva skupni ocenjevalni ekipi, imenovani v skladu s členom 35(3).
Designation and notification procedure
Postopek imenovanja in priglasitve
Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 35 was completed and which comply with Annex VII.
Države članice lahko imenujejo le organe za ugotavljanje skladnosti, v zvezi s katerimi je bilo zaključeno ocenjevanje v skladu s členom 35 in ki izpolnjujejo zahteve, določene v Prilogi VII.
Member States shall notify the Commission and the other Member States of the conformity assessment bodies they have designated, using the electronic notification tool within the database of notified bodies developed and managed by the Commission (NANDO).
Države članice Komisiji in drugim državam članicam z elektronskim orodjem za priglasitev v okviru podatkovne zbirke priglašenih organov, ki jo je razvila in jo upravlja Komisija (NANDO), priglasijo imenovane organe za ugotavljanje skladnosti.
The notification shall clearly specify, using the codes referred to in paragraph 13 of this Article, the scope of the designation indicating the conformity assessment activities as defined in this Regulation, and the types of devices which the notified body is authorised to assess and, without prejudice to Article 40, any conditions associated with the designation.
V priglasitvi so z uporabo kod iz odstavka 13 tega člena jasno določeni področje uporabe imenovanja ter navedene dejavnosti ugotavljanja skladnosti, kot so opredeljene v tej uredbi, in vrste pripomočkov, za ocenjevanje katerih je priglašeni organ pooblaščen, brez poseganja v člen 40 pa tudi vsi pogoji, povezani z imenovanjem.
The notification shall be accompanied by the final assessment report of the authority responsible for notified bodies, the final opinion of the joint assessment team referred to in Article 35(9) and the recommendation of the MDCG.
Priglasitvi se priloži končno ocenjevalno poročilo, ki ga pripravi organ, pristojen za priglašene organe, končno mnenje skupne ocenjevalne ekipe iz člena 35(9) in priporočilo Koordinacijske skupine za medicinske pripomočke.
Where the notifying Member State does not follow the recommendation of the MDCG, it shall provide a duly substantiated justification.
Če država članica priglasiteljica ne upošteva priporočila Koordinacijske skupine za medicinske pripomočke, to ustrezno utemeljeno obrazloži.
The notifying Member State shall, without prejudice to Article 40, inform the Commission and the other Member States of any conditions associated with the designation and provide documentary evidence regarding the arrangements in place to ensure that the notified body will be monitored regularly and will continue to satisfy the requirements set out in Annex VII.
Država članica priglasiteljica brez poseganja v člen 40 Komisijo in druge države članice obvesti o vseh pogojih, povezanih z imenovanjem, in predloži dokumentarna dokazila o veljavni ureditvi, s katero se zagotavlja redno spremljanje priglašenega organa in njegovo nadaljnje izpolnjevanje zahtev, določenih v Prilogi VII.
Within 28 days of the notification referred to in paragraph 2, a Member State or the Commission may raise written objections, setting out its arguments, with regard either to the notified body or to its monitoring by the authority responsible for notified bodies.
Država članica ali Komisija lahko v 28 dneh od priglasitve iz odstavka 2 vloži pisne ugovore, v katerih navede svoje utemeljitve bodisi v zvezi s priglašenim organom bodisi s spremljanjem organa, pristojnega za priglašene organe.
Where no objection is raised, the Commission shall publish in NANDO the notification within 42 days of its having been notified as referred to in paragraph 2.
Če ugovorov ni, Komisija v 42 dneh v NANDO objavi obvestilo, da ji je bila sporočena priglasitev iz odstavka 2.
When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall bring the matter before the MDCG within 10 days of the expiry of the period referred to in paragraph 6.
Kadar država članica ali Komisija ugovarja v skladu z odstavkom 6, Komisija zadevo v 10 dneh po izteku obdobja iz odstavka 6 predloži Koordinacijski skupini za medicinske pripomočke.
After consulting the parties involved, the MDCG shall give its opinion at the latest within 40 days of the matter having been brought before it.
Koordinacijska skupina za medicinske pripomočke po posvetovanju z udeleženimi stranmi sporoči svoje mnenje najpozneje v 40 dneh po tem, ko ji je bila zadeva predložena.
Where the MDCG is of the opinion that the notification can be accepted, the Commission shall publish in NANDO the notification within 14 days.
Če Koordinacijska skupina za medicinske pripomočke meni, da se priglasitev lahko sprejme, Komisija v 14 dneh v NANDO objavi priglasitev.
Where the MDCG, after having been consulted in accordance with paragraph 7, confirms the existing objection or raises another objection, the notifying Member State shall provide a written response to the MDCG opinion within 40 days of its receipt.
Če Koordinacijska skupina za medicinske pripomočke po posvetovanju v skladu z odstavkom 7 obstoječe ugovore potrdi ali navede nove ugovore, država članica priglasiteljica v 40 dneh po prejemu mnenja Koordinacijske skupine za medicinske pripomočke predloži pisni odgovor nanj.
The response shall address the objections raised in the opinion, and set out the reasons for the notifying Member State's decision to designate or not designate the conformity assessment body.
V njem se odzove na ugovore iz mnenja in navede razloge, zakaj namerava imenovati organ za ugotavljanje skladnosti oziroma zakaj ga ne namerava imenovati.
Where the notifying Member State decides to uphold its decision to designate the conformity assessment body, having given its reasons in accordance with paragraph 8, the Commission shall publish in NANDO the notification within 14 days of being informed thereof.
Če se država članica priglasiteljica odloči, da bo vztrajala pri svoji odločitvi o imenovanju organa za ugotavljanje skladnosti, potem ko je za to navedla razloge v skladu z odstavkom 8, Komisija v 14 dneh po tem, ko je bila o tem obveščena, v NANDO objavi priglasitev.
When publishing the notification in NANDO, the Commission shall add to the electronic system referred to in Article 52 the information relating to the notification of the notified body along with the documents mentioned in paragraph 4 of this Article and the opinion and response referred to in paragraphs 7 and 8 of this Article.
Komisija pri objavi priglasitve v NANDO vnese v elektronski sistem iz člena 52 tudi informacije v zvezi s priglasitvijo priglašenega organa, dokumente iz odstavka 4 tega člena ter mnenje in odgovor iz odstavkov 7 in 8 tega člena.
The designation shall become valid the day after the notification is published in NANDO.
Imenovanje začne veljati dan po tem, ko je priglasitev objavljena v NANDO.
The published notification shall state the scope of lawful conformity assessment activity of the notified body.
Objavljena priglasitev navaja obseg zakonite dejavnosti priglašenega organa v zvezi z ugotavljanjem skladnosti.
The conformity assessment body concerned may perform the activities of a notified body only after the designation has become valid in accordance with paragraph 11.
Zadevni organ za ugotavljanje skladnosti lahko izvaja dejavnosti priglašenega organa šele po tem, ko imenovanje postane veljavno v skladu z odstavkom 11.
13 The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of codes and corresponding types of devices for the purpose of specifying the scope of the designation of notified bodies.
Komisija do 26. novembra 2017 z izvedbenimi akti sestavi seznam kod in ustreznih vrst pripomočkov, da opredeli področje uporabe imenovanja priglašenih organov.
The Commission, after consulting the MDCG, may update this list based, inter alia, on information arising from the coordination activities described in Article 44.
Komisija lahko ta seznam po posvetovanju s Koordinacijsko skupino za medicinske pripomočke posodobi, med drugim na podlagi informacij, pridobljenih pri usklajevalnih dejavnostih iz člena 44.
Identification number and list of notified bodies
Identifikacijska številka in seznam priglašenih organov
The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with Article 38(11).
Komisija dodeli identifikacijsko številko vsakemu priglašenemu organu, za katerega začne veljati priglasitev v skladu s členom 38(11).
It shall assign a single identification number even when the body is notified under several Union acts.
Dodeli mu enotno identifikacijsko številko, tudi če je organ priglašen v skladu z več akti Unije.
If they are successfully designated in accordance with this Regulation, bodies notified pursuant to Directive 98/79/EC shall retain the identification number assigned to them pursuant to that Directive.
Če so uspešno imenovani v skladu s to uredbo, organi, priglašeni v skladu z Direktivo 98/79/ES, ohranijo identifikacijsko številko, ki jim je bila dodeljena v skladu z navedeno direktivo.
The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the conformity assessment activities as defined in this Regulation and the types of devices for which they have been notified, accessible to the public in NANDO.
Komisija v NANDO javnosti omogoči dostop do seznama organov, priglašenih v skladu s to uredbo, pa tudi do identifikacijskih številk, ki so jim bile dodeljene, in dejavnosti ugotavljanja skladnosti, kot so opredeljene v tej uredbi, ter vrst pripomočkov, za katere so bili priglašeni.
It shall also make this list available on the electronic system referred to in Article 52.
Ta seznam da na voljo tudi prek elektronskega sistema iz člena 52.
The Commission shall ensure that the list is kept up to date.
Komisija poskrbi za posodabljanje seznama.
Monitoring and re-assessment of notified bodies
Spremljanje in ponovno ocenjevanje priglašenih organov
Notified bodies shall, without delay, and at the latest within 15 days, inform the authority responsible for notified bodies of relevant changes which may affect their compliance with the requirements set out in Annex VII or their ability to conduct the conformity assessment activities relating to the devices for which they have been designated.
Priglašeni organi nemudoma in najpozneje v 15 dneh obvestijo organ, pristojen za priglašene organe, o pomembnih spremembah, ki bi lahko vplivale na njihovo izpolnjevanje zahtev, določenih v Prilogi VII, ali na njihovo zmožnost opravljanja dejavnosti ugotavljanja skladnosti, povezanih s pripomočki, za katere so bili imenovani.