natgillin/translations-raw huggingface dataset:
To ensure that decisions by notified bodies are not influenced by non-legitimate circumstances the organisation and operation of the bodies should ensure full impartiality.
Za zagotovitev, da na odločitve priglašenih organov ne vplivajo nelegitimne okoliščine, bi morala organizacija in upravljanje organov zagotavljati popolno nepristranskost.
To be able to carry out their tasks in a coherent and systematic manner the bodies should possess a satisfactory management system including provisions on professional secrecy.
Organi bi morali imeti zadovoljiv sistem vodenja, vključno z določbami o poslovni molčečnosti, da bi lahko skladno in sistematično opravljali svoje naloge.
In order to allow notified bodies to perform their work properly, the level of knowledge and competence of the personnel should be guaranteed at all times.
Da bi lahko priglašeni organi ustrezno opravljali svoje delo, bi morala biti vedno zagotovljena raven znanja in kompetence osebja.
The measures provided for in this Regulation are in accordance with the opinion of the Committee set up by Article 6(2) of Directive 90/385/EEC,
Ukrepi iz te uredbe so v skladu z mnenjem odbora, ustanovljenega s členom 6(2) Direktive 90/385/EGS –
‘device’ means active implantable medical devices as defined in Article 1(2)(c) of Directive 90/385/EEC or medical devices and their accessories as defined in Article 1(2) of Directive 93/42/EEC;
„pripomoček“ pomeni aktivne medicinske pripomočke za vsaditev, kot so opredeljeni v členu 1(2)(c) Direktive 90/385/EGS, ali medicinske pripomočke in njihove dodatke, kot so opredeljeni v členu 1(2) Direktive 93/42/EGS;
‘conformity assessment body’ means a body which performs calibration, testing, certification and inspection activities under Article R1(13) in Annex I to Decision No 768/2008/EC of the European Parliament and of the Council [4];
„organ za ugotavljanje skladnosti“ pomeni organ, ki umerja opremo, izvaja testiranje, izdaja certifikate in izvaja inšpekcijske preglede v skladu s členom R1(13) Sklepa št. 768/2008/ES Evropskega parlamenta in Sveta [4];
‘notified body’ means a conformity assessment body which has been notified by a Member State in accordance with Article 11 of Directive 90/385/EEC or Article 16 of Directive 93/42/EEC;
„priglašeni organ“ pomeni organ za ugotavljanje skladnosti, ki ga je v skladu s členom 11 Direktive 90/385/EGS ali členom 16 Direktive 93/42/EGS priglasila država članica;
‘accreditation body’ means the sole body in a Member State that performs accreditation with authority derived from the State as laid down by Article 2(10) of Regulation (EC) No 765/2008;
„akreditacijski organ“ pomeni edini organ v državi članici, ki opravlja akreditacijo v skladu s pooblastili, ki mu jih dodeli država, kot je navedeno v členu 2(10) Uredbe (ES) št. 765/2008;
‘designating authority’ means the authority(ies) entrusted by a Member State to assess, designate, notify and monitor notified bodies under Directive 90/385/EEC or Directive 93/42/EEC;
„organ za imenovanje“ pomeni organe, ki jim države članice zaupajo ocenitev, imenovanje, priglasitev in nadzor priglašenih organov v skladu z direktivama 90/385/EGS in 93/42/EGS;
‘competent authority’ means the authority(ies) in charge of market surveillance and/or of vigilance for devices;
„pristojni organ“ pomeni organ, ki je zadolžen za nadzor trga in/ali vigilanco pripomočkov;
‘on-site assessment’ means a verification in the premises of the body or of one of its subcontractors or subsidiaries by the designating authority;
„pregled na kraju samem“ pomeni preverjanje, ki ga opravi organ za imenovanje v prostorih organa za ugotavljanje skladnosti ali enega izmed njegovih podizvajalcev ali pomožnih organov;
‘surveillance on-site assessment’ means a periodic routine on-site assessment which is neither the on-site assessment undertaken for the initial designation, nor the on-site assessment undertaken for the renewal of the designation;
„nadzorni pregled na kraju samem“ pomeni reden rutinski pregled na kraju samem, ki ni pregled, opravljen za prvo imenovanje, niti pregled, ki se izvaja za obnovitev imenovanja;
‘observed audit’ means a designating authority's assessment of the performance of a notified body’s audit team in the premises of the body's client;
„opazovana revizija“ pomeni ocenjevanje uspešnosti revizijske skupine priglašenega organa v prostorih njegove stranke, ki ga izvede organ za imenovanje;
‘functions’ means the tasks to be fulfilled by the body’s staff and its external experts, namely: auditing of the quality systems, product related technical documentation review, review of clinical evaluations and investigations, device testing and, for each of the previously mentioned items, the final review and decision making thereon;
„funkcije“ pomenijo naloge, ki jih mora izpolniti osebje organa in njegovi zunanji strokovnjaki, in sicer: revizija sistemov kakovosti, pregled tehnične dokumentacije proizvoda, pregled kliničnega ocenjevanja in preiskav, testiranje pripomočkov, in za vsako od prej navedenih postavk končni pregled in odločanje v zvezi z njimi;
‘subcontracting’ means the transfer of tasks to one of the following:
„podizvajanje“ pomeni prenos nalog na eno od naslednjih oseb:
a natural person who further delegates these tasks or parts thereof;
fizično osebo, ki te naloge ali del njih odda naprej;
several natural or legal persons who jointly perform these tasks.
več fizičnih ali pravnih oseb, ki te naloge opravljajo skupaj.
Interpretation of designation criteria
Razlaga meril za imenovanje
The criteria set out in Annex 8 to Directive 90/385/EEC or in Annex XI to Directive 93/42/EEC shall be applied as laid down in Annex I.
Merila, navedena v Prilogi 8 k Direktivi 90/385/EGS ali v Prilogi XI k Direktivi 93/42/EGS, se uporabljajo, kot je določeno v Prilogi I.
Procedure for the designation of notified bodies
Postopek za imenovanje priglašenih organov
When applying for designation as a notified body, a conformity assessment body shall use the application form set out in Annex II.
Ob predložitvi vloge za imenovanje za priglašeni organ uporabi organ za ugotavljanje skladnosti obrazec iz Priloge II.
If the conformity assessment body submits the application and documents annexed to the application on paper, it shall also submit an electronic copy of the application and its annexes.
Če organ za ugotavljanje skladnosti predloži vlogo in dokumente, priložene k vlogi, na papirju, predloži tudi elektronsko različico vloge in njenih prilog.
The application shall specify the conformity assessment activities, the conformity assessment procedures and the fields of competence for which the conformity assessment body wishes to be notified, the latter by indicating the codes used in the ‘New Approach Notified and Designated Organisations’ Information System [5] and subdivisions of those fields.
V vlogi so opredeljene dejavnosti za ugotavljanje skladnosti, postopki ugotavljanja skladnosti ter področja pristojnosti, za katere želi biti organ za ugotavljanje skladnosti priglašen, pri čemer za slednje navede kode, ki se uporabljajo v informacijskem sistemu „NANDO“ [5], in pododdelke v okviru teh področij.
The designating authority of the Member State where the conformity assessment body is established shall assess that body in accordance with an assessment check-list that covers at least the items listed in Annex II.
Organ za imenovanje v državi članici, kjer ima sedež organ za ugotavljanje skladnosti, navedeni organ oceni v skladu s kontrolnim seznamom za ocenjevanje, ki zajema vsaj postavke iz Priloge II.
The assessment shall include an on-site assessment.
Ocenjevanje vključuje pregled na kraju samem.
Representatives of designating authorities of two other Member States shall, in coordination with the designating authority of the Member State in which the conformity assessment body is established and together with a representative of the Commission, participate to the assessment of the conformity assessment body, including the on-site assessment.
Predstavniki organa za imenovanje v dveh drugih državah članicah v sodelovanju z organom za imenovanje v državi članici, kjer ima sedež organ za ugotavljanje skladnosti, in skupaj s predstavnikom Komisije sodelujejo pri ocenjevanju organa za ugotavljanje skladnosti, vključno s pregledom na kraju samem.
The designating authority of the Member State where the conformity assessment body is established shall give those representatives timely access to the documents necessary to assess the conformity assessment body.
Organ za imenovanje v državi članici, kjer ima sedež organ za ugotavljanje skladnosti, navedenim predstavnikom omogoči pravočasen dostop do dokumentov, potrebnih za ocenjevanje organa za ugotavljanje skladnosti.
They shall produce within 45 days after the on-site assessment a report, which shall contain at least a summary of identified non-compliances with the criteria set out in Annex I and recommendation with regard to the designation of the notified body.
Ti v 45 dneh po pregledu na kraju samem pripravijo poročilo, ki vsebuje vsaj povzetek ugotovljenih neskladnosti z merili iz Priloge I in priporočilo glede imenovanja priglašenega organa.
The Member States shall make available a pool of assessors for the Commission to call upon for each assessment.
Države članice dajo Komisiji na voljo skupino ocenjevalcev, ki jih slednja lahko pokliče za vsako ocenjevanje.
The designating authority of the Member State where the conformity assessment body is established shall upload into a data storage system managed by the Commission, the assessment report drafted by the representatives referred to in paragraph 2, its own assessment report and, if not contained therein, an on-site assessment report.
Organ za imenovanje v državi članici, kjer ima sedež organ za ugotavljanje skladnosti, v sistem za shranjevanje podatkov, ki ga upravlja Komisija, prenese poročilo o ocenjevanju, ki so ga pripravili predstavniki iz odstavka 2, lastno poročilo o ocenjevanju in tudi poročilo o pregledu na kraju samem, če ni zajeto v prej navedenih dokumentih.
The designating authorities of all the other Member States shall be informed of the application and may request to get access to certain or all the documents referred to in paragraph 4.
Organi za imenovanje v vseh drugih državah članicah so obveščeni o uporabi, lahko pa zahtevajo tudi dostop do nekaterih ali vseh dokumentov iz odstavka 4.
Those authorities and the Commission may review all the documents referred to in paragraph 4, may raise questions or concerns and may request further documentation within one month after the last upload of one of those documents.
Ti organi in Komisija lahko pregledajo vse dokumente iz odstavka 4, postavljajo vprašanja ali izrazijo pomisleke in v roku enega meseca po zadnjem prenosu enega od navedenih dokumentov zahtevajo dodatno dokumentacijo.
Within the same period of time, they may request an exchange of views on the application, organised by the Commission.
V tem času lahko zahtevajo izmenjavo mnenj o vlogi, ki jo pripravi Komisija.
The designating authority of the Member State where the conformity assessment body is established shall respond to the questions, concerns and requests for further documentation within four weeks following their receipt.
Organ za imenovanje v državi članici, kjer ima sedež organ za ugotavljanje skladnosti, odgovori na vprašanja, pomisleke in zahteve po dodatni dokumentaciji v štirih tednih po njihovem prejemu.
The designating authorities of the other Member States or the Commission may individually or jointly address recommendations to the designating authority of the Member State where the conformity assessment body is established within four weeks following the receipt of the response.
Organi za imenovanje v drugih državah članicah ali Komisija lahko v štirih tednih po prejemu odgovora posamično ali skupno obravnavajo priporočila organa za imenovanje v državi članici, kjer ima sedež organ za ugotavljanje skladnosti.
That designating authority shall take account of the recommendations when it takes the decision on the designation of the conformity assessment body.
Organ za imenovanje upošteva priporočila, ko se odloča o imenovanju organa za ugotavljanje skladnosti.
If it does not follow the recommendations, it shall give the reasons therefor within two weeks after its decision.
Če ne upošteva priporočil, poda razloge za to v dveh tednih po sprejetju odločitve.
The Member State shall notify to the Commission its decision on the designation of a conformity assessment body by means of the ‘New Approach Notified and Designated Organisations’ Information System.
Država članica sporoči Komisiji svojo odločitev o imenovanju organa za ugotavljanje skladnosti prek informacijskega sistema „NANDO“.
The validity of the designation shall be limited up to a maximum of five years.
Veljavnost imenovanja je omejena na največ pet let
Extension and renewal of designation
Podaljšanje in obnovitev imenovanja
An extension of the scope of the notified body's designation may be granted in accordance with Article 3.
Podaljšanje veljavnosti imenovanja priglašenega organa se lahko odobri v skladu s členom 3.
A designation as notified body may be renewed in accordance with Article 3 before the end of the validity period of the previous designation.
Imenovanje za priglašeni organ se lahko pred koncem obdobja veljavnosti prejšnjega imenovanja obnovi v skladu s členom 3.
For the purposes of paragraph 2, the procedure set out in Article 3(2) shall include, where appropriate, an observed audit.
Za namene odstavka 2 postopek, določen v členu 3(2), vključuje opazovano revizijo, če je to primerno.
Extension and renewal procedures may be combined.
Postopki za podaljšanje in obnovitev se lahko kombinirajo.
Notified bodies already designated before the entry into force of this Regulation and for which the designation does not have a stated validity period or has a validity period exceeding five years, shall be subject to renewal at least within three years of entry into force of this Regulation.
Priglašeni organi, ki so bili imenovani že pred začetkom veljavnosti te uredbe, njihovo imenovanje pa je časovno neomejeno ali velja več kot 5 let, morajo v 3 letih po začetku veljavnosti te uredbe opraviti postopek podaljšanja.
Surveillance and monitoring
Nadzor in spremljanje
For the purpose of surveillance, the designating authority of the Member State where the notified body is established shall assess an appropriate number of notified body’s reviews of the manufacturer’s clinical evaluations and shall carry out an appropriate number of file reviews, surveillance on-site assessments and observed audits at the following intervals:
Za namene nadzora oceni organ za imenovanje v državi članici, kjer ima sedež priglašeni organ, ustrezno število pregledov kliničnega ocenjevanja proizvajalca, ki jih je opravil priglašeni organ, ter izvede ustrezno število pregledov dokumentacije, nadzorni pregled na kraju samem in opazovane revizije v naslednjih intervalih:
at least every 12 months for notified bodies with more than 100 clients;
najmanj vsakih 12 mesecev za priglašene organe, ki imajo več kot 100 strank;
at least every 18 months for all other notified bodies.
najmanj vsakih 18 mesecev za vse druge priglašene organe.
That designating authority shall, in particular, examine changes which have occurred since the last assessment and the work the notified body has performed since that assessment.
Navedeni organ za imenovanje prouči zlasti spremembe, ki so nastale od zadnjega ocenjevanja, in delo, ki ga je priglašeni organ od takrat opravil.
Surveillance and monitoring conducted by the designating authorities shall appropriately address subsidiaries.
Pri nadzoru in spremljanju, ki ju izvajajo organi za imenovanje, se ustrezno upoštevajo pomožni organi.
The designating authority of the Member State where the notified body is established shall continuously monitor that body to ensure ongoing compliance with the applicable requirements.
Organ za imenovanje v državi članici, kjer ima sedež priglašeni organ, za zagotovitev neprekinjene skladnosti z veljavnimi zahtevami redno spremlja navedeni organ.
That authority shall provide for a systematic follow-up of complaints, vigilance reports and other information, including from other Member States, which might indicate the non-fulfilment of the obligations by a notified body or its deviation from common or best practice.
Navedeni organ zagotovi sistematično spremljanje pritožb, poročil o vigilanci in drugih informacij, vključno s tistimi iz drugih držav članic, ki bi lahko kazale, da priglašeni organ ne izpolnjuje obveznosti ali odstopa od skupne ali najboljše prakse.
In addition to surveillance or renewal on-site assessments, the designating authority of the Member State where the notified body is established shall initiate unannounced or short-notice on-site assessments if those on-site assessments are needed to verify compliance.
Poleg nadzora in pregledov za obnovitev na kraju samem organ za imenovanje v državi članici, kjer ima sedež priglašeni organ, začne nenapovedan ali na kratek rok napovedan pregled na kraju samem, če je ta potreben za preverjanje skladnosti.
Investigation of the competence of a notified body
Preiskava kompetenc priglašenega organa
The Commission may investigate cases regarding the competence of a notified body or the fulfilment of the requirements and responsibilities to which a notified body is subject under Directive 90/385/EEC and Directive 93/42/EEC.
Komisija lahko preišče primere v zvezi s kompetencami priglašenega organa ali izpolnjevanjem zahtev in pristojnosti, v zvezi s katerimi se za priglašeni organ uporabljata direktivi 90/385/EGS in 93/42/EGS.
Investigations will start with a consultation of the designating authority of the Member State where the notified body is established.
Preiskave se bodo začele s posvetovanjem organa za imenovanje v državi članici, kjer ima sedež priglašeni organ.
Upon request, that designating authority shall, within four weeks, provide the Commission with all relevant information concerning the relevant notified body.
Organ za imenovanje na zahtevo Komisije slednji v štirih tednih predloži vse ustrezne informacije, ki se nanašajo na zadevni priglašeni organ.
The Commission will ensure that all sensitive information obtained in the course of its investigations is treated confidentially.
Komisija zagotovi, da se vse informacije občutljive narave, pridobljene med njenim preiskovanjem, obravnavajo zaupno.
When the notified body no longer meets the requirements for its notification, the Commission will inform the Member State where that body is established and may request the Member State to take the necessary corrective measures.
Ko priglašeni organ ne izpolnjuje več zahtev za priglasitev, Komisija o tem obvesti državo članico, kjer je sedež tega organa, in od države članice lahko zahteva, da sprejme potrebne popravljalne ukrepe.
Exchange of experience on designation and supervision of conformity assessment bodies
Izmenjava izkušenj o imenovanju in nadzoru organov za ugotavljanje skladnosti
Designating authorities shall consult each other and the Commission on questions with general relevance with regard to the implementation of this Regulation and the interpretation of the provisions of Directive 90/385/EEC and of Directive 93/42/EEC in relation with conformity assessment bodies.
Organi za imenovanje se v zvezi z organi za ugotavljanje skladnosti medsebojno ter s Komisijo posvetujejo o vprašanjih splošnega pomena glede izvajanja te uredbe in glede razlage določb v direktivah 90/385/EGS in 93/42/EGS.
Designating authorities shall communicate to each other and the Commission by 31 December 2013 the model assessment check-list used in accordance with Article 3(2) and thereafter the adaptations made to this check-list.
Organi za imenovanje drug drugemu in Komisiji do 31. decembra 2013 posredujejo model kontrolnega seznama za ocenjevanje, ki se uporablja v skladu s členom 3(2), po tem datumu pa drug drugega in Komisijo obveščajo o spremembah tega kontrolnega seznama.
When the assessment reports referred to in Article 3(4) indicate discrepancies in the general practice of designating authorities, Member States or the Commission may request an exchange of views, which will be organised by the latter.
Kadar poročila o ocenjevanju iz člena 3(4) kažejo razlike v splošni praksi organov za imenovanje, lahko države članice ali Komisija zaprosi za izmenjavo mnenj, ki jo organizira Komisija.
Operating of designating authorities
Delovanje organov za imenovanje
Designating authorities shall have a sufficient number of competent personnel at their disposal for the proper performance of their tasks.
Organi za imenovanje imajo na voljo zadostno število usposobljenega osebja za ustrezno opravljanje svojih nalog.
Those authorities shall be established, organised and operated so as to safeguard the objectivity and impartiality of their activities and to avoid any conflicts of interests with conformity assessment bodies.
Navedeni organi so imenovani, organizirani in delujejo tako, da ščitijo objektivnost in nepristranskost svojih dejavnosti ter preprečujejo navzkrižja interesov z organi za ugotavljanje skladnosti.
The designating authorities shall be organised so that each decision relating to a notification of a conformity assessment body is not taken by the same member of personnel who carried out the assessment of that body.
Organi za imenovanje so organizirani tako, da vseh odločitev v zvezi s priglasitvijo organa za ugotavljanje skladnosti ne sprejme tisti član osebja, ki je izvedel tudi njegovo ocenjevanje.
Where designating authorities are not in charge of market surveillance and vigilance for medical devices, they shall involve the competent authorities of that Member State for all tasks incumbent to them in accordance with this Regulation.
Kadar organi za imenovanje niso odgovorni za nadzor trga in vigilanco medicinskih pripomočkov, vključijo pristojne organe zadevne države članice v vse naloge, za katere so zadolženi v skladu s to uredbo.
They shall in particular consult the competent authorities of that Member State prior to taking decisions and invite them to attend all types of assessments.
Še zlasti se pred sprejetjem odločitve posvetujejo s pristojnimi organi zadevne države članice in jih povabijo, naj se udeležijo vseh vrst ocenjevanj.
Cooperation with accreditation bodies
Sodelovanje z akreditacijskimi organi
Where designation is based on accreditation in the meaning of Regulation (EC) No 765/2008, Member States shall ensure that the accreditation body that has accredited a particular notified body is kept informed by the competent authorities on incident reports and other information that relate to matters under the control of the notified body when the information may be relevant for the assessment of the performance of the notified body.
Kadar imenovanje temelji na akreditaciji v smislu Uredbe (ES) št. 765/2008, države članice zagotovijo, da pristojni organi obveščajo akreditacijski organ, ki je pooblastil določen priglašeni organ, o poročilih o incidentih in drugih informacijah, ki se nanašajo na zadeve pod nadzorom priglašenega organa, če so lahko te informacije pomembne za ocenjevanje uspešnosti priglašenega organa.
Member States shall ensure that the accreditation body in charge of the accreditation of a particular conformity assessment body is kept informed by the designating authority of the Member State where the conformity assessment body is established on findings relevant for the accreditation.
Države članice zagotovijo, da organ za imenovanje v državi članici, v kateri ima organ za ugotavljanje skladnosti sedež, obvešča akreditacijski organ, pristojen za pooblastitev določenega organa za ugotavljanje skladnosti, o ugotovitvah, ki so pomembne za akreditacijo.
The accreditation body shall inform the designating authority of the Member State where the conformity assessment body is established on its findings.
Akreditacijski organ o svojih ugotovitvah obvesti organ za imenovanje v državi članici, kjer ima sedež organ za ugotavljanje skladnosti.
It shall apply to extension of designations as from 25 December 2013.
V primeru podaljšanja imenovanja se začne uporabljati 25. decembra 2013.