natgillin/translations-raw huggingface dataset:
The notified body shall examine the planned changes, notify the manufacturer of its decision and provide him with a supplement to the EU type-examination report.
Certifikat se pripravi v skladu s Prilogo XII.
The approval of any change to the approved type shall take the form of a supplement to the EU type-examination certificate.
Certifikatu se priložijo ustrezni deli dokumentacije, en izvod pa hrani priglašeni organ.
Changes to the intended purpose and conditions of use of the approved device, with the exception of limitations of the intended purpose and conditions of use, shall necessitate a new application for a conformity assessment.
Spremembe tipa
Section 5 of Annex IX shall apply with the proviso that any reference to an EU technical documentation assessment certificate shall be understood as a reference to an EU type-examination certificate.
Vložnik priglašeni organ, ki je izdal certifikat o EU-pregledu tipa, obvesti o načrtovanih spremembah odobrenega tipa ali njegovega predvidenega namena in pogojev uporabe.
Administrative provisions
Spremembe odobrenega pripomočka, vključno z omejitvami njegovega predvidenega namena in pogojev uporabe, odobri priglašeni organ, ki je izdal certifikat o EU-pregledu tipa, kadar bi te spremembe lahko vplivale na skladnost s splošnimi zahtevami glede varnosti in učinkovitosti ali pogoji, določenimi za uporabo izdelka.
the documentation referred to in the second indent of Section 2,
Priglašeni organ pregleda načrtovane spremembe, proizvajalca uradno obvesti o svoji odločitvi in mu predloži dopolnilo poročila o EU-pregledu tipa.
information on the changes referred to in Section 5, and
Odobritev morebitne spremembe odobrenega tipa je v obliki dopolnila certifikata o EU-pregledu tipa.
copies of EU type-examination certificates, scientific opinions and reports and their additions/supplements.
Ob spremembah predvidenega namena in pogojev uporabe odobrenega pripomočka – razen ob omejitvah predvidenega namena in pogojev uporabe – je potrebna nova vloga za ugotavljanje skladnosti.
Section 8 of Annex IX shall apply.
Oddelek 5 Priloge IX se uporablja pod pogojem, da se vsako sklicevanje na certifikat EU o oceni tehnične dokumentacije razume kot sklicevanje na certifikat o EU-pregledu tipa.
ANNEX XI
Upravne določbe
CONFORMITY ASSESSMENT BASED ON PRODUCT CONFORMITY VERIFICATION
dokumentacijo iz druge alineje oddelka 2;
The objective of the conformity assessment based on product conformity verification is to ensure that devices conform to the type for which an EU type-examination certificate has been issued, and that they meet the provisions of this Regulation which apply to them.
informacije o spremembah iz oddelka 5 in
Where an EU type-examination certificate has been issued in accordance with Annex X, the manufacturer may either apply the procedure set out in Part A (production quality assurance) or the procedure set out in Part B (product verification) of this Annex.
izvode certifikatov o EU-pregledu tipa, znanstvenih mnenj in poročil ter njihovih dodatkov/dopolnil.
By way of derogation from Sections 1 and 2 above, the procedures in this Annex coupled with the drawing up of technical documentation as set out in Annexes II and III may also be applied by manufacturers of class IIa devices.
Uporablja se oddelek 8 Priloge IX.
PRODUCTION QUALITY ASSURANCE
PRILOGA XI
The manufacturer shall ensure that the quality management system approved for the manufacture of the devices concerned is implemented, shall carry out a final verification, as specified in Section 6, and shall be subject to the surveillance referred to in Section 7.
UGOTAVLJANJE SKLADNOSTI NA PODLAGI PREVERJANJA SKLADNOSTI IZDELKA
When the manufacturer fulfils the obligations laid down in Section 4, it shall draw up and keep an EU declaration of conformity in accordance with Article 19 and Annex IV for the device covered by the conformity assessment procedure.
Cilj ugotavljanja skladnosti na podlagi preverjanja skladnosti izdelka je zagotoviti, da so pripomočki skladni s tipom, za katerega je bil izdan certifikat o EU-pregledu tipa, in da izpolnjujejo določbe iz te uredbe, ki se uporabljajo zanje.
By issuing an EU declaration of conformity, the manufacturer shall be deemed to ensure and to declare that the device concerned conforms to the type described in the EU type-examination certificate and meets the requirements of this Regulation which apply to the device.
Kadar je bil izdan certifikat o EU-pregledu tipa v skladu s Prilogo X, lahko proizvajalec uporabi bodisi postopek iz dela A (zagotavljanje kakovosti proizvodnje) bodisi postopek iz dela B (preverjanje izdelka) te priloge.
Quality management system
Z odstopanjem od oddelkov 1 in 2 zgoraj lahko tudi proizvajalci pripomočkov razreda IIa uporabljajo postopke iz te uredbe, skupaj s pripravo tehnične dokumentacije iz prilog II in III.
all elements listed in Section 2.1 of Annex IX,
ZAGOTAVLJANJE KAKOVOSTI PROIZVODNJE
the technical documentation referred to in Annexes II and III for the types approved, and
Proizvajalec zagotovi, da se uporabi sistem vodenja kakovosti, odobren za izdelavo zadevnih pripomočkov, opravi končno preverjanje, kot je opredeljeno v oddelku 6, in je predmet nadzora iz oddelka 7.
a copy of the EU type-examination certificates referred to in Section 4 of Annex X; if the EU type-examination certificates have been issued by the same notified body with which the application is lodged, a reference to the technical documentation and its updates and the certificates issued shall also be included in the application.
Kadar proizvajalec izpolnjuje obveznosti iz oddelka 4, za model pripomočka, zajetega v postopek ugotavljanja skladnosti, pripravi in shrani izjavo EU o skladnosti v skladu s členom 19 in Prilogo IV.
Implementation of the quality management system shall be such as to ensure that there is compliance with the type described in the EU type-examination certificate and with the provisions of this Regulation which apply to the devices at each stage.
Šteje se, da proizvajalec z izdajo izjave EU o skladnosti zagotovi in izjavlja, da je zadevni pripomoček skladen s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjuje zahteve iz te uredbe, ki se uporabljajo za ta pripomoček.
All the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be documented in a systematic and orderly manner in the form of a quality manual and written policies and procedures, such as quality programmes, quality plans and quality records.
Sistem vodenja kakovosti
That documentation shall, in particular, include an adequate description of all elements listed in points (a), (b), (d) and (e) of Section 2.2 of Annex IX.
vse elemente iz oddelka 2.1 Priloge IX,
The first and second paragraph of Section 2.3 of Annex IX shall apply.
tehnično dokumentacijo iz prilog II in III za odobrene tipe in
If the quality management system is such that it ensures that the devices conform to the type described in the EU type-examination certificate and that it conforms to the relevant provisions of this Regulation, the notified body shall issue an EU quality assurance certificate.
izvod certifikatov o EU-pregledu tipa iz oddelka 4 Priloge X; če je certifikate o EU-pregledu tipa izdal priglašeni organ, pri katerem je bila vložena vloga, se v vlogo vključi tudi sklicevanje na tehnično dokumentacijo in njene posodobitve in izdane certifikate.
That decision shall contain the conclusions of the notified body's audit and a reasoned assessment.
Izvajanje sistema vodenja kakovosti je tako, da je zagotovljena skladnost s tipom, opisanim v certifikatu o EU-pregledu tipa, in določbami iz te uredbe, ki se uporabljajo za pripomočke v posamezni fazi.
Section 2.4 of Annex IX shall apply.
Vsi elementi, zahteve in določbe, ki jih sprejme proizvajalec za svoj sistem vodenja kakovosti, so sistematično in urejeno dokumentirani v priročniku kakovosti ter zapisanih politikah in postopkih, kot so programi kakovosti, načrti kakovosti in evidenca kakovosti.
Surveillance
Ta dokumentacija zlasti vključuje ustrezen opis vseh elementov iz točk (a), (b), (d) in (e) oddelka 2.2 Priloge IX.
Section 3.1, the first, second and fourth indents of Section 3.2, Sections 3.3, 3.4, 3.6 and 3.7 of Annex IX shall apply.
Uporabljata se prvi in drugi odstavek oddelka 2.3 Priloge IX.
In the case of class III devices, surveillance shall also include a check that the quantities of produced or purchased raw material or crucial components approved for the type and correspond to the quantities of finished devices.
Če se s sistemom vodenja kakovosti zagotavlja, da so pripomočki skladni s tipom, opisanim v certifikatu o EU-pregledu tipa, in so izpolnjene ustrezne določbe iz te uredbe, priglašeni organ izda certifikat EU za zagotavljanje kakovosti.
Batch verification in the case of devices incorporating, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in Article 1(8).
V tej odločitvi navede ugotovitve svoje presoje in obrazloženo oceno.
Upon completing the manufacture of each batch of devices that incorporate, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the notified body of the release of the batch of devices and send it the official certificate concerning the release of the batch of human blood or plasma derivative used in the device, issued by a Member State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.
Uporablja se oddelek 2.4 Priloge IX.
the documentation referred to in the fifth indent of Section 2.1 of Annex IX,
Nadzor
the documentation referred to in the eighth indent of Section 2.1 of Annex IX, including the EU type-examination certificate referred to in Annex X,
Uporabljajo se oddelek 3.1, prva, druga in četrta alineja oddelka 3.2, oddelki 3.3, 3.4, 3.6 in 3.7 Priloge IX.
information on the changes referred to in Section 2.4 of Annex IX, and
Kar zadeva pripomočke razreda III, nadzor vključuje tudi preverjanje, da količine proizvedenih ali kupljenih surovin ali bistvenih sestavnih delov, odobrenih za tip, ustrezajo količinam končnih pripomočkov.
the decisions and reports from the notified body as referred to in Sections 2.3, 3.3 and 3.4 of Annex IX.
Preverjanje serij v primeru pripomočkov, ki kot sestavni del vsebujejo zdravilno učinkovino, ki bi se ob ločeni uporabi štela za zdravilo, pridobljeno iz človeške krvi ali človeške plazme iz člena 1(8)
Application to class IIa devices
Po končani izdelavi vsake serije pripomočkov, ki kot sestavni del vsebujejo zdravilno učinkovino, ki bi se ob ločeni uporabi štela za zdravilo, pridobljeno iz človeške krvi ali človeške plazme iz prvega pododstavka člena 1(8), proizvajalec priglašeni organ obvesti o sprostitvi serije pripomočkov in mu pošlje uradni certifikat o sprostitvi serije derivatov človeške krvi ali plazme, uporabljenih v pripomočku, ki ga izda laboratorij države članice ali laboratorij, ki ga za ta namen določi država članica v skladu s členom 114(2) Direktive 2001/83/ES.
By way of derogation from Section 5, by virtue of the EU declaration of conformity the manufacturer shall be deemed to ensure and to declare that the class IIa devices in question are manufactured in conformity with the technical documentation referred to in Annexes II and III and meet the requirements of this Regulation which apply to them.
dokumentacijo iz pete alineje oddelka 2.1 Priloge IX;
For class IIa devices the notified body shall assess, as part of the assessment referred to in Section 6.3, whether the technical documentation as referred to in Annexes II and III for the devices selected on a representative basis is compliant with this Regulation.
dokumentacijo iz osme alineje oddelka 2.1 Priloge IX, vključno s certifikatom o EU-pregledu tipa iz Priloge X;
In choosing a representative sample or samples of devices, the notified body shall take into account the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended use and the results of any previous relevant assessments (e.g. with regard to physical, chemical, biological or clinical properties) that have been carried out in accordance with this Regulation.
informacije o spremembah iz oddelka 2.4 Priloge IX ter
The notified body shall document its rationale for the sample or samples of devices taken.
odločitve in poročila priglašenega organa iz oddelkov 2.3, 3.3 in 3.4 Priloge IX.
Where the assessment under Section 10.2. confirms that the class IIa devices in question conform to the technical documentation referred to in Annexes II and III and meet the requirements of this Regulation which apply to them, the notified body shall issue a certificate pursuant to this Part of this Annex.
Uporaba za pripomočke razreda IIa
Samples additional to those taken for the initial conformity assessment of devices shall be assessed by the notified body as part of the surveillance assessment referred to in Section 7.
Z odstopanjem od oddelka 5 se šteje, da proizvajalec z izjavo EU o skladnosti zagotovi in izjavlja, da so zadevni pripomočki razreda IIa izdelani v skladu s tehnično dokumentacijo iz prilog II in III ter da izpolnjujejo zahteve iz te uredbe, ki se uporabljajo zanje.
By way of derogation from Section 6, the manufacturer or its authorised representative shall, for a period ending no sooner than 10 years after the last device has been placed on the market, keep at the disposal of the competent authorities:
Priglašeni organ za pripomočke razreda IIa v okviru ocenjevanja iz oddelka 6.3 oceni, ali je tehnična dokumentacija iz prilog II in III za pripomočke, izbrane na reprezentativni podlagi, skladna s to uredbo.
the technical documentation referred to in Annexes II and III, and
Priglašeni organ pri izbiri enega ali več reprezentativnih vzorcev pripomočkov upošteva tehnološke novosti, podobnosti v zasnovi, tehnologijo, metode izdelave in sterilizacije, predvideno uporabo in rezultate morebitnih prejšnjih relevantnih ocen (na primer v zvezi s fizikalnimi, kemičnimi, biološkimi ali kliničnimi lastnostmi), ki so bile opravljene v skladu s to uredbo.
the certificate referred to in Section 10.3.
Priglašeni organ dokumentira svojo utemeljitev za enega ali več odvzetih vzorcev pripomočkov.
PRODUCT VERIFICATION
Kadar ocena iz oddelka 10.2 potrjuje, da so zadevni pripomočki razreda IIa skladni s tehnično dokumentacijo iz prilog II in III ter da izpolnjujejo zahteve iz te uredbe, ki se uporabljajo zanje, priglašeni organ izda certifikat v skladu s tem delom te priloge.
Product verification shall be understood to be the procedure whereby after examination of every manufactured device, the manufacturer, by issuing an EU declaration of conformity in accordance with Article 19 and Annex IV, shall be deemed to ensure and to declare that the devices which have been subject to the procedure set out in Sections 14 and 15 conform to the type described in the EU type-examination certificate and meet the requirements of this Regulation which apply to them.
Vzorce, ki so bili odvzeti poleg tistih za prvotno ugotavljanje skladnosti, priglašeni organ oceni kot del ocene nadzora iz oddelka 7.
The manufacturer shall take all the measures necessary to ensure that the manufacturing process produces devices which conform to the type described in the EU type-examination certificate and to the requirements of the Regulation which apply to them.
Z odstopanjem od oddelka 6 proizvajalec ali njegov pooblaščeni predstavnik vsaj deset let po tem, ko je bil na trg dan zadnji pripomoček, za pristojne organe hrani:
Prior to the start of manufacture, the manufacturer shall prepare documents defining the manufacturing process, in particular as regards sterilisation where necessary, together with all routine, pre-established procedures to be implemented to ensure homogeneous production and, where appropriate, conformity of the devices with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to them.
tehnično dokumentacijo iz priloge II in III ter
In addition, for devices placed on the market in a sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer shall apply the provisions of Sections 6 and 7.
certifikat iz oddelka 10.3.
The manufacturer shall undertake to institute and keep up to date a post-market surveillance plan, including a PMCF plan, and the procedures ensuring compliance with the obligations of the manufacturer resulting from the provisions on vigilance and post-market surveillance system set out in Chapter VII.
PREVERJANJE IZDELKA
The notified body shall carry out the appropriate examinations and tests in order to verify the conformity of the device with the requirements of the Regulation by examining and testing every product as specified in Section 15.
Razume se, da je preverjanje izdelka postopek, pri katerem se šteje, da proizvajalec po pregledu vsakega izdelanega pripomočka z izdajo izjave EU o skladnosti v skladu s členom 19 in Prilogo IV zagotovi in izjavlja, da so pripomočki, ki so bili predmet postopka iz oddelkov 14 in 15, skladni s tipom, opisanim v certifikatu o EU-pregledu tipa, in da izpolnjujejo zahteve iz te uredbe, ki se uporabljajo zanje.
The examinations and tests referred to in the first paragraph of this Section shall not apply to aspects of the manufacturing process designed to secure sterility.
Proizvajalec sprejme vse potrebne ukrepe, da bodo pripomočki, nastali v postopku izdelave, skladni s tipom, opisanim v certifikatu o EU-pregledu tipa, in z zahtevami iz te uredbe, ki se uporabljajo zanje.
Every device shall be examined individually and the appropriate physical or laboratory tests as defined in the relevant standard or standards referred to in Article 8, or equivalent tests and assessments, shall be carried out in order to verify, where appropriate, the conformity of the devices with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to them.
Proizvajalec pred začetkom izdelave pripravi dokumente z opredelitvijo postopka izdelave, po potrebi zlasti glede sterilizacije, skupaj z vsemi rutinskimi, vnaprej opredeljenimi postopki, ki jih je treba izvesti za zagotovitev homogene proizvodnje in, kjer je to ustrezno, skladnosti pripomočkov s tipom, opisanim v certifikatu o EU-pregledu tipa, in z zahtevami iz te uredbe, ki se uporabljajo zanje.
The notified body shall affix, or have affixed, its identification number to each approved device and shall draw up an EU product verification certificate relating to the tests and assessments carried out.
Za pripomočke, ki se dajo na trg v sterilnem stanju, in le za tiste vidike postopka izdelave, ki so namenjeni zagotavljanju in ohranjanju sterilnosti, proizvajalec poleg tega uporablja določbe iz oddelkov 6 in 7.
The manufacturer or its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the competent authorities:
Proizvajalec se zaveže, da bo pripravil in posodabljal načrt nadzora po dajanju na trg, vključno z načrtom kliničnega spremljanja po dajanju na trg, in postopke, ki zagotavljajo skladnost z obveznostmi proizvajalca, ki izhajajo iz določb o vigilanci in sistemu nadzora po dajanju na trg iz poglavja VII.
the documentation referred to in Section 12,
Priglašeni organ opravi ustrezne preglede in preskuse, da preveri skladnost pripomočka z zahtevami iz uredbe, tako da pregleda in preskusi vsak izdelek, kakor je določeno v oddelku 15.
the certificate referred to in Section 15.2, and
Pregledi in preskusi iz prvega odstavka tega oddelka se ne uporabljajo za tiste vidike postopka izdelave, ki so namenjeni zagotavljanju sterilnosti.
the EU type-examination certificate referred to in Annex X.
Vsak pripomoček se pregleda posebej in se opravijo ustrezni fizikalni ali laboratorijski preskusi, opredeljeni v ustreznem standardu ali standardih iz člena 8, ali enakovredni preskusi in ocene, da se, kjer je ustrezno, preveri skladnost pripomočkov s tipom, opisanim v certifikatu o EU-pregledu tipa, in zahtevami iz te uredbe, ki se uporabljajo zanje.
By way of derogation from Section 11, by virtue of the EU declaration of conformity the manufacturer shall be deemed to ensure and to declare that the class IIa devices in question are manufactured in conformity with the technical documentation referred to in Annexes II and III and meet the requirements of this Regulation which apply to them.
Priglašeni organ namesti ali naroči namestitev svoje identifikacijske številke na vsak odobreni pripomoček in pripravi certifikat EU o preverjanju izdelka v zvezi z opravljenimi preskusi in ocenami.
The verification conducted by the notified body in accordance with Section 14 is intended to confirm the conformity of the class IIa devices in question with the technical documentation referred to in Annexes II and III and with the requirements of this Regulation which apply to them.
Proizvajalec ali njegov pooblaščeni predstavnik vsaj deset let ali v primeru pripomočkov za vsaditev vsaj 15 let po tem, ko je bil na trg dan zadnji pripomoček, za nacionalne organe hrani:
If the verification referred to in Section 18.2 confirms that the class IIa devices in question conform to the technical documentation referred to in Annexes II and III and meet the requirements of this Regulation which apply to them, the notified body shall issue a certificate pursuant to this Part of this Annex.
dokumentacijo iz oddelka 12;
By way of derogation from Section 17, the manufacturer or its authorised representative shall, for a period ending no sooner than 10 years after the last device has been placed on the market, keep at the disposal of the competent authorities:
certifikat iz oddelka 15.2 in
the certificate referred to in Section 18.3.
certifikat o EU-pregledu tipa iz Priloge X.
ANNEX XII
Z odstopanjem od oddelka 11 se šteje, da proizvajalec z izjavo EU o skladnosti zagotovi in izjavlja, da so zadevni pripomočki razreda IIa izdelani v skladu s tehnično dokumentacijo iz prilog II in III ter da izpolnjujejo zahteve iz te uredbe, ki se uporabljajo zanje.
CERTIFICATES ISSUED BY A NOTIFIED BODY
Preverjanje, ki ga opravi priglašeni organ v skladu z oddelkom 14, je namenjeno potrjevanju skladnosti zadevnih pripomočkov razreda IIa s tehnično dokumentacijo iz prilog II in III ter zahtevami iz te uredbe, ki se uporabljajo zanje.
Certificates shall be drawn up in one of the official languages of the Union.
Če preverjanje v skladu z oddelkom 18.2 potrjuje, da so zadevni pripomočki razreda IIa skladni s tehnično dokumentacijo iz prilog II in III ter da izpolnjujejo zahteve iz te uredbe, ki se uporabljajo zanje, priglašeni organ izda certifikat v skladu s tem delom te priloge.
Each certificate shall refer to only one conformity assessment procedure.
Z odstopanjem od oddelka 17 proizvajalec ali njegov pooblaščeni predstavnik vsaj deset let po tem, ko je bil na trg dan zadnji pripomoček, za pristojne organe hrani:
Certificates shall only be issued to one manufacturer.
certifikat iz oddelka 18.3.
The name and address of the manufacturer included in the certificate shall be the same as that registered in the electronic system referred to in Article 30.
PRILOGA XII
The scope of the certificates shall unambiguously identify the device or devices covered:
CERTIFIKATI, KI JIH IZDA PRIGLAŠENI ORGAN
EU technical documentation assessment certificates, EU type-examination certificates and EU product verification certificates shall include a clear identification, including the name, model and type, of the device or devices, the intended purpose, as included by the manufacturer in the instructions for use and in relation to which the device has been assessed in the conformity assessment procedure, risk classification and the Basic UDI-DI as referred to in Article 27(6);
Certifikati se sestavijo v enem od uradnih jezikov Unije.