natgillin/translations-raw huggingface dataset:
Article 36
Priloge VII, ki ga po možnosti zaposluje priglašeni organ sam.
Requirements relating to notified bodies
Osebje iz oddelkov 3.2.3. in 3.2.7.
Notified bodies shall fulfil the tasks for which they are designated in accordance with this Regulation.
Priloge VII zaposluje priglašeni organ sam in ne smejo biti zunanji strokovnjaki ali podizvajalci.
They shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil those tasks.
Da se organu, pristojnemu za priglašene organe, omogoči izvajanje dejavnosti ocenjevanja, imenovanja, priglasitve ter spremljanja in nadzora ter da se olajša ocenjevanje, opisano v tem poglavju, mu priglašeni organi omogočijo dostop do vse zadevne dokumentacije, vključno z dokumentacijo proizvajalca, ter mu jo na zahtevo predložijo.
In particular, notified bodies shall comply with Annex VII.
Da se zagotovi enotna uporaba zahtev, določenih v Prilogi VII, lahko Komisija sprejme izvedbene akte, če je to potrebno za rešitev vprašanj različne razlage in praktične uporabe.
In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent availability of sufficient administrative, technical and scientific personnel in accordance with Section 3.1.1 of Annex VII and personnel with relevant clinical expertise in accordance with Section 3.2.4 of Annex VII, where possible employed by the notified body itself.
Člen 37
The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified body itself and shall not be external experts or subcontractors.
Odvisne družbe in oddaja naročil podizvajalcem
Notified bodies shall make available and submit upon request all relevant documentation, including the manufacturer's documentation, to the authority responsible for notified bodies to allow it to conduct its assessment, designation, notification, monitoring and surveillance activities and to facilitate the assessment outlined in this Chapter.
Kadar priglašeni organ naročilo za posebne naloge, povezane z ugotavljanjem skladnosti, odda podizvajalcu ali za posebne naloge, povezane z ugotavljanjem skladnosti, pritegne odvisno družbo, preveri, ali podizvajalec oziroma odvisna družba izpolnjuje veljavne zahteve, določene v Prilogi VII, in o tem ustrezno obvesti organ, pristojen za priglašene organe.
In order to ensure the uniform application of the requirements set out in Annex VII, the Commission may adopt implementing acts, to the extent necessary to resolve issues of divergent interpretation and of practical application.
Priglašeni organi prevzamejo polno odgovornost za naloge, ki jih v njihovem imenu opravijo podizvajalci ali odvisne družbe.
Article 37
Priglašeni organi omogočijo javni dostop do seznama svojih odvisnih družb.
Subsidiaries and subcontracting
Naročilo za izvedbo dejavnosti ugotavljanja skladnosti se lahko odda podizvajalcu ali jih lahko opravi odvisna družba pod pogojem, da je bila pravna ali fizična oseba, ki je oddala vlogo za ugotavljanje skladnosti, o tem ustrezno obveščena.
Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the applicable requirements set out in Annex VII and shall inform the authority responsible for notified bodies accordingly.
Priglašeni organi hranijo vse zadevne dokumente v zvezi s preverjanjem kvalifikacij podizvajalca ali odvisne družbe ter delom, ki so ga ti izvedli v skladu s to uredbo, tako da so na voljo organu, pristojnemu za priglašene organe.
Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontractors or subsidiaries.
Člen 38
Notified bodies shall make publicly available a list of their subsidiaries.
Vloga za imenovanje, ki jo predložijo organi za ugotavljanje skladnosti
Conformity assessment activities may be subcontracted or carried out by a subsidiary provided that the legal or natural person that applied for conformity assessment has been informed accordingly.
Organi za ugotavljanje skladnosti vložijo vlogo za imenovanje pri organu, pristojnem za priglašene organe.
Notified bodies shall keep at the disposal of the authority responsible for notified bodies all relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.
V vlogi se opredelijo dejavnosti ugotavljanja skladnosti, kot so opredeljene v tej uredbi, in vrste pripomočkov, za katere organ zaprosi za imenovanje, priložena pa ji je dokumentacija, ki dokazuje skladnost z vsemi zahtevami iz Priloge VII.
Article 38
Pri dokazovanju skladnosti z organizacijskimi in splošnimi zahtevami ter zahtevami glede vodenja kakovosti, določenimi v oddelkih 1 in 2 Priloge VII, se lahko predložita veljaven certifikat o akreditaciji in ustrezno poročilo o oceni, ki ga izda nacionalni akreditacijski organ v skladu z Uredbo (ES) št. 765/2008, ter se upoštevata pri ocenjevanju iz člena 39.
Application by conformity assessment bodies for designation
Vendar vložnik na zahtevo omogoči dostop do vse dokumentacije iz prvega pododstavka, da dokaže skladnost s temi zahtevami.
Conformity assessment bodies shall submit an application for designation to the authority responsible for notified bodies.
Priglašeni organ dokumentacijo iz odstavka 2 posodobi 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 application shall specify the conformity assessment activities as defined in this Regulation, and the types of devices for which the body is applying to be designated, and shall be supported by documentation demonstrating compliance with Annex VII.
Člen 39
In respect of the organisational and general requirements and the quality management requirements set out in Sections 1 and 2 of Annex VII, a valid accreditation certificate and the corresponding evaluation report delivered by a national accreditation body in accordance with Regulation (EC) No 765/2008 may be submitted and shall be taken into consideration during the assessment described in Article 39.
Ocenjevanje vloge
However, the applicant shall make available all the documentation referred to in the first subparagraph to demonstrate compliance with those requirements upon request.
Organ, pristojen za priglašene organe, v 30 dneh preveri, ali je vloga iz člena 38 popolna, ter vložnika zahteva, da predloži morebitne manjkajoče informacije.
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.
Potem ko je vloga popolna, jo ta organ pošlje Komisiji.
Article 39
Organ, pristojen za priglašene organe, pregleda vlogo in pripadajočo dokumentacijo v skladu z lastnimi postopki in sestavi predhodno ocenjevalno poročilo.
Assessment of the application
Organ, pristojen za priglašene organe, predhodno ocenjevalno poročilo predloži Komisiji, ki ga nemudoma posreduje Koordinacijski skupini za medicinske pripomočke.
The authority responsible for notified bodies shall within 30 days check that the application referred to in Article 38 is complete and shall request the applicant to provide any missing information.
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 40(2), razen če je zaradi posebnih okoliščin potrebno drugačno število strokovnjakov.
Once the application is complete that authority shall send it to the Commission.
Eden od strokovnjakov je predstavnik Komisije in usklajuje dejavnosti skupne ocenjevalne ekipe.
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.
Druga dva strokovnjaka sta iz držav članic, ki niso država članica, v kateri ima sedež organ za ugotavljanje skladnosti, ki je vložil vlogo.
The authority responsible for notified bodies shall submit the preliminary assessment report to the Commission which shall immediately transmit it to the MDCG.
Skupno ocenjevalno ekipo sestavljajo strokovnjaki, ki so usposobljeni, da ocenjujejo dejavnosti ugotavljanja skladnosti in vrste pripomočkov, za katere je vložena vloga, ali, zlasti kadar je bil postopek ocenjevanja uveden v skladu s členom 47(3), da zagotovijo ustrezno obravnavo specifičnih pomislekov.
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 40(2).
Skupna ocenjevalna ekipa v 90 dneh od imenovanja pregleda dokumentacijo, predloženo z vlogo v skladu s členom 38.
One of the experts shall be a representative of the Commission who shall coordinate the activities of the joint assessment team.
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 other two experts shall come from Member States other than the one in which the applicant conformity assessment body is established.
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 joint assessment team shall be comprised of 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 47(3), to ensure that the specific concern can be appropriately assessed.
Ocenjevanje organa, ki je vložil vlogo, na kraju samem vodi organ, pristojen za priglašene organe.
Within 90 days of its appointment, the joint assessment team shall review the documentation submitted with the application in accordance with Article 38.
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.
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.
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.
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.
V določenem časovnem okviru organ za ugotavljanje skladnosti, ki je vložil vlogo, nacionalnemu organu predloži načrt korektivnih in preventivnih ukrepov za odpravo neskladnosti.
The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies.
Skupna ocenjevalna ekipa v 30 dneh od zaključka ocenjevanja na kraju samem zabeleži vsa preostala različna mnenja glede ocene in jih pošlje organu, pristojnemu 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.
Ko organ, pristojen za priglašene organe, od organa, ki je vložil vlogo, prejme načrt korektivnih in preventivnih ukrepov, oceni, ali so bile neskladnosti, odkrite med ocenjevanjem, ustrezno odpravljene.
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 the assessment by the joint assessment team.
V načrtu je naveden osnovni vzrok za ugotovljene neskladnosti in časovni razpored za izvedbo ukrepov, navedenih v načrtu.
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.
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 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 lahko organ, pristojen za priglašene organe, zaprosi za dodatna pojasnila in spremembe.
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.
Organ, pristojen za priglašene organe, sestavi končno ocenjevalno poročilo, ki vključuje:
This plan shall indicate the root cause of the identified non-compliances and shall include a timeframe for implementation of the actions therein.
rezultat ocenjevanja,
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.
potrditev, da so bili korektivni in preventivni ukrepi ustrezno obravnavani in po potrebi izvedeni,
The joint assessment team may request of the authority responsible for notified bodies further clarification and modifications.
vsa preostala mnenja, ki se razlikujejo od mnenja skupne ocenjevalne ekipe, in, kjer je to ustrezno,
The authority responsible for notified bodies shall draw up its final assessment report which shall include:
priporočilo glede obsega imenovanja.
the result of the assessment,
Organ, pristojen za priglašene organe, končno ocenjevalno poročilo in po potrebi osnutek imenovanja predloži Komisiji, Koordinacijski skupini za medicinske pripomočke in skupni ocenjevalni ekipi.
confirmation that the corrective and preventive actions have been appropriately addressed and, where required, implemented,
Skupna ocenjevalna ekipa Komisiji predloži končno mnenje o ocenjevalnem poročilu, ki ga je pripravil 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.
any remaining diverging opinion with the joint assessment team, and, where applicable,
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 recommended scope of designation.
Komisija lahko z izvedbenimi akti sprejme ukrepe, s katerimi določi podrobno ureditev postopkov in poročil glede vloge za imenovanje iz člena 38 ter ocene vloge, določeno v tem členu.
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.
Člen 40
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.
Imenovanje strokovnjakov za skupno ocenjevanje vlog za priglasitev
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.
Države članice in Komisija imenujejo strokovnjake, usposobljene za ocenjevanje organov za ugotavljanje skladnosti na področju medicinskih pripomočkov, za sodelovanje pri dejavnostih iz členov 39 in 48.
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 38 and the assessment of the application set out in this Article.
Komisija vodi seznam strokovnjakov, imenovanih v skladu z odstavkom 1 tega člena, ter informacije o njihovi specifični usposobljenosti in strokovnem znanju.
Article 40
Ta seznam je prek elektronskega sistema iz člena 57 na voljo pristojnim organom držav članic.
Nomination of experts for joint assessment of applications for notification
Člen 41
The Member States and the Commission shall nominate experts qualified in the assessment of conformity assessment bodies in the field of medical devices to participate in the activities referred to in Articles 39 and 48.
Jezikovne zahteve
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.
Vsi dokumenti, zahtevani na podlagi členov 38 in 39, se sestavijo v jeziku ali jezikih, ki jih določi zadevna država članica.
That list shall be made available to Member States competent authorities through the electronic system referred to in Article 57.
Države članice pri uporabi prvega odstavka preučijo, ali naj se za celotno zadevno dokumentacijo ali za del nje sprejme in uporablja splošno razumljiv jezik na zdravstvenem področju.
Article 41
Komisija zagotovi prevode dela ali celotne dokumentacije v skladu s členoma 38 in 39 v enega izmed uradnih jezikov Unije, tako da bo dokumentacija brez težav razumljiva skupni ocenjevalni ekipi, imenovani v skladu s členom 39(3).
Language requirements
Člen 42
All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages which shall be determined by the Member State concerned.
Postopek imenovanja in priglasitve
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 lahko imenujejo le organe za ugotavljanje skladnosti, v zvezi s katerimi je bilo zaključeno ocenjevanje v skladu s členom 39 in ki izpolnjujejo zahteve, določene v Prilogi VII.
The Commission shall provide translations of the documentation pursuant to Articles 38 and 39, 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 39(3).
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.
Article 42
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 vrsta pripomočka, za ocenjevanje katerega je priglašeni organ pooblaščen, brez poseganja v člen 44 pa tudi vsi pogoji, povezani z imenovanjem.
Designation and notification procedure
Priglasitvi se priloži končno ocenjevalno poročilo, ki ga pripravi organ, pristojen za priglašene organe, končno mnenje skupne ocenjevalne ekipe iz člena 39(9) in priporočilo Koordinacijske skupine za medicinske pripomočke.
Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 39 was completed and which comply with Annex VII.
Če država članica priglasiteljica ne upošteva priporočila Koordinacijske skupine za medicinske pripomočke, to ustrezno obrazloži.
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).
Država članica priglasiteljica brez poseganja v člen 44 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.
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 44, any conditions associated with the designation.
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 v zvezi s spremljanjem organa, pristojnega za priglašene organe.
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 39(9) and the recommendation of the MDCG.
Če ugovorov ni, Komisija v 42 dneh v NANDO objavi obvestilo, da ji je bila sporočena priglasitev iz odstavka 2.
Where the notifying Member State does not follow the recommendation of the MDCG, it shall provide a duly substantiated justification.
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.
The notifying Member State shall, without prejudice to Article 44, 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.
Koordinacijska skupina za medicinske pripomočke po posvetovanju z udeleženimi stranmi sporoči svoje mnenje, in sicer najpozneje v 40 dneh po tem, ko ji je bila zadeva predložena.
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.
Če Koordinacijska skupina za medicinske pripomočke meni, da se priglasitev lahko sprejme, Komisija v 14 dneh v NANDO objavi priglasitev.
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 Koordinacijska skupina za medicinske pripomočke po posvetovanju v skladu z odstavkom 7 obstoječe ugovore potrdi ali navede nove, država članica priglasiteljica v 40 dneh po prejemu mnenja skupine predloži pisni odgovor nanj.