natgillin/translations-raw huggingface dataset:
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;
podatke, predpisane kot del sistema kakovosti v zvezi z načrtom, kot so rezultati analiz, izračuni, preskusi, rešitve, sprejete v skladu z oddelkom 2 poglavja I Priloge I, predklinično in klinično vrednotenje, poprodajni načrt kliničnega spremljanja in poprodajni rezultati kliničnega spremljanja itd., kadar je to ustrezno.“;
Section 6.1 shall be amended as follows:
oddelek 6.1 se spremeni:
the introductory part shall be replaced by the following:
uvodni del se nadomesti z:
‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, keep at the disposal of the national authorities:’;
„Proizvajalec ali njegov pooblaščeni zastopnik mora za obdobje vsaj petih let ali v primeru pripomočkov za vsaditev vsaj petnajstih let po izdelavi zadnjega proizvoda hraniti na voljo nacionalnim organom:“;
the following phrase shall be added to the second indent:
drugi alinei se doda naslednji stavek:
‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;
„in zlasti dokumentacijo, podatke in evidence iz drugega odstavka oddelka 3.2,“;
Section 7 shall be replaced by the following:
oddelek 7 se nadomesti z:
Application to devices in Classes IIa and IIb.
Uporaba pri pripomočkih v razredih IIa in IIb
In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb.
V skladu s členom 11(2) in (3) lahko ta priloga velja tudi za izdelke iz razredov IIa in IIb.
Section 4, however, does not apply.
Oddelek 4 se v tem primeru ne uporablja.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.
V okviru ocenjevanja, navedenega v oddelku 3.3, priglašeni organ za vsaj en reprezentativni vzorec v vsaki podskupini naprav oceni, ali je za pripomočke iz razreda IIa tehnična dokumentacija, kot je opredeljena v oddelku 3.2(c), skladna z določbami te direktive.
For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive.
V okviru ocenjevanja, navedenega v oddelku 3.3, priglašeni organ za vsaj en reprezentativni vzorec v vsaki skupini generičnih pripomočkov oceni, ali je za pripomočke iz razreda IIb tehnična dokumentacija, kot je opredeljena v oddelku 3.2(c), skladna z določbami te direktive.
In choosing representative sample(s) 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 or biological properties) that have been carried out in accordance with this Directive.
Pri izbiri reprezentativnega(-ih) vzorca(-ev) priglašeni organ upošteva tehnološke novosti, podobnost med načini zasnove, tehnologije, proizvodnje in metod sterilizacije, predvideno uporabo in izide vseh prejšnjih relevantnih ocen (na primer v zvezi z fizikalnimi, kemijskimi ali biološkimi lastnostmi), ki so bile izvedene v skladu s to direktivo.
The notified body shall document and keep available to the competent authority its rationale for the sample(s) taken.
Priglašeni organ dokumentira svoje ugotovitve o odvzetih vzorcih in jih hrani na voljo pristojnemu organu.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 5.’;
Priglašeni organ oceni nadaljnje vzorce kot del ocene nadzora iz oddelka 5.“;
in Section 8, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;
v oddelku 8 se besede „členu 4(3) Direktive 89/381/EGS“ nadomestijo s „členu 114(2) Direktive 2001/83/ES“;
Section 3 shall be replaced by the following:
oddelek 3 se nadomesti z:
The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular:
Dokumentacija mora omogočati razumevanje načrta, izdelave in delovanja izdelka, zlasti pa mora vključevati:
a general description of the type, including any variants planned, and its intended use(s),
splošni opis tipa, vključno z vsemi predvidenimi različicami, in njegovo predvideno uporabo/uporabami,
design drawings, methods of manufacture envisaged, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc.,
tehnične risbe, predvidene metode proizvodnje, zlasti v zvezi z metodami sterilizacije, in diagrame komponent, sestavnih delov, vezij itd.,
the descriptions and explanations necessary to understand the abovementioned drawings and diagrams and the operation of the product,
opise in razlage, ki so potrebni za razumevanje omenjenih risb in diagramov ter delovanja izdelka,
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards referred to in Article 5 have not been applied in full,
seznam standardov iz člena 5, ki so uveljavljeni v celoti ali delno, ter opise rešitev, sprejetih za izpolnjevanje bistvenih zahtev te direktive, če standardi iz člena 5 niso bili v celoti uveljavljeni,
the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,
rezultate opravljenih izračunov načrta, analiz tveganja, preiskav, tehničnih preskusov ipd.,
a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device,
izjavo z navedbami, ali pripomoček kot sestavni del vsebuje snov, derivat človeške krvi ali izdelek iz človeških tkiv iz oddelka 7.4 Priloge I, ter podatke preskusov, ki so bili opravljeni v zvezi s tem in ki so potrebni za oceno varnosti, kakovosti in uporabnosti te snovi, derivata človeške krvi ali izdelka iz človeških tkiv, ob upoštevanju predvidenega namena pripomočka,
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,
izjavo o tem, ali je pripomoček izdelan z uporabo tkiv živalskega izvira iz Direktive 2003/32/ES,
the solutions adopted as referred to in Annex I, Chapter I, Section 2,
rešitve, sprejete v skladu z oddelkom 2 poglavja I Priloge I,
the draft label and, where appropriate, instructions for use.’;
osnutek nalepke in, če je primerno, navodila za uporabo.“;
in Section 5, the second and third paragraphs shall be replaced by the following:
v oddelku 5 se drugi in tretji odstavek nadomestita z:
‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMEA before taking a decision.
„V primeru pripomočkov iz drugega odstavka oddelka 7.4 Priloge I se priglašeni organ v zvezi z vidiki iz tega oddelka, pred odločitvijo posvetuje z enim od pristojnih organov, ki jih določijo države članice v skladu z Direktivo 2001/83/ES, ali z EMEA.
Section 7.3 shall be replaced by the following:
oddelek 7.3 se nadomesti z:
In the case of implantable devices, the period shall be at least 15 years after the last product has been manufactured.’;
Proizvajalec ali njegov pooblaščeni zastopnik mora s tehnično dokumentacijo hraniti tudi izvode potrdil o ES-tipskem preskusu in njihovih dodatkov najmanj pet let po proizvodnji zadnjega pripomočka, v primeru pripomočkov za vsaditev pa za najmanj 15 let po proizvodnji zadnjega pripomočka.“;
in Section 1, the words ‘established in the Community’ shall be deleted;
v oddelku 1 se črtajo besede „s sedežem v Skupnosti“;
in Section 3, the first paragraph shall be replaced by the following:
v oddelku 3 se prvi odstavek nadomesti z:
The manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action.
Proizvajalec mora jamčiti, da bo uporabljal in ohranjal ažurne sistematične postopke za pregledovanje izkušenj, pridobljenih iz pripomočkov v fazi po proizvodnji, vključno z določbami iz Priloge X, in da bo uporabljal ustrezna sredstva za uveljavljanje vseh potrebnih korektivnih postopkov.
in Section 7, the introductory part shall be replaced by the following:
v oddelku 7 se uvodni del nadomesti z:
‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:’;
„Proizvajalec ali njegov pooblaščeni zastopnik mora za obdobje vsaj petih let ali v primeru pripomočkov za vsaditev vsaj 15 let po izdelavi zadnjega proizvoda hraniti na voljo nacionalnim organom:“;
in the introductory part of Section 8 the word ‘exemptions’ shall be deleted;
v uvodnem delu oddelka 8 se črta beseda „izjemah“;
in Section 9, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;
v oddelku 9 se besede „člena 4(3) Direktive 89/381/EGS“ nadomestijo z besedami „člena 114(2) Direktive 2001/83/ES“;
Annex V shall be amended as follows:
Priloga V se spremeni:
The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by Section 1 ensures and declares that the products concerned conform to the type described in the EC type-examination certificate and meet the provisions of this Directive which apply to them.
Izjava ES o skladnosti je del postopka, v katerem proizvajalec, ki izpolnjuje obveznosti iz oddelka 1, zagotovi in izjavi, da zadevni proizvodi ustrezajo tipu, opisanemu v certifikatu o ES-tipskem pregledu, in izpolnjujejo določbe direktive, ki se nanašajo nanje.
This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and must be kept by the manufacturer.’;
V izjavi morajo biti navedeni in jasno opredeljeni eden ali več proizvedenih medicinskih pripomočkov, in sicer z imenom proizvoda, njegovo kodo ali drugo nedvoumno oznako. Proizvajalec mora izjavo hraniti.“;
in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by the following:
v osmi alinei odstavka 2 oddelka 3.1 se uvodni del nadomesti z:
This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them;’;
To jamstvo mora zajemati tudi obveznost proizvajalca, da obvešča pristojne organe o naslednjih dogodkih, takoj ko zanje izve:“;
in point (b) of the third paragraph of Section 3.2, the following indent shall be added:
v točki (b) tretjega odstavka oddelka 3.2 se doda alinea:
where the manufacture and/or final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
če izdelavo in/ali končen nadzor ter preskušanje izdelkov, ali njihovih elementov, izvaja tretja oseba, metod spremljanja učinkovitosti delovanja sistema kakovosti ter zlasti vrste in obsega nadzora tretje osebe;“;
in Section 5.1, the introductory part shall be replaced by the following:
v oddelku 5.1 se uvodni del nadomesti z:
Section 6 shall be replaced by the following:
oddelek 6 se nadomesti z:
Application to devices in Class IIa
Uporaba pri pripomočkih razreda IIa
In line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:
V skladu s členom 11(2) lahko ta priloga velja tudi za izdelke iz razreda IIa, in sicer ob naslednjih pogojih:
By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity the manufacturer ensures and declares that the products in Class IIa are manufactured in conformity with the technical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directive which apply to them.
Z odstopanjem od oddelkov 2, 3.1 in 3.2 in na podlagi izjave o skladnosti proizvajalec zagotovi in izjavi, da so bili proizvodi iz razreda IIa izdelani v skladu s tehnično dokumentacijo iz oddelka 3 Priloge VII in da izpolnjujejo določbe te direktive, ki se uporabljajo zanje.
For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3 of Annex VII for at least one representative sample for each device subcategory for compliance with the provisions of this Directive.
V okviru ocenjevanja, navedenega v oddelku 3.3, priglašeni organ za vsaj en reprezentativni vzorec v vsaki podskupini naprav oceni, ali je za pripomočke iz razreda IIa tehnična dokumentacija, kot je opredeljena v oddelku 3 Priloge VII, skladna z določbami te direktive.
Further samples shall be assessed by the notified body as part of the surveillance assessment referred to in Section 4.3.’;
Priglašeni organ oceni nadaljnje vzorce kot del ocene nadzora iz oddelka 4.3.“;
in Section 7, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) of Directive 2001/83/EC’;
v oddelku 7 se besede „člena 4(3) Direktive 89/381/EGS“ nadomestijo z besedami „člena 114(2) Direktive 2001/83/ES“;
The manufacturer affixes the CE marking in accordance with Article 17 and draws up a written declaration of conformity.
Proizvajalec pritrdi oznako CE v skladu s členom 17 in izda pisno izjavo o skladnosti.
This declaration must cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference, and be kept by the manufacturer.
V izjavi morajo biti navedeni in jasno opredeljeni eden ali več proizvedenih medicinskih pripomočkov, in sicer z imenom proizvoda, njegovo kodo ali drugo nedvoumno oznako.
The CE marking must be accompanied by the identification number of the notified body which performs the tasks referred to in this Annex.’;
Proizvajalec mora izjavo hraniti. Oznako CE mora spremljati identifikacijska številka priglašenega organa, ki izvaja naloge iz te priloge.“;
in Section 3.2, the following indent shall be added:
v oddelek 3.2 se doda alinea:
where the final inspection and testing of the products, or elements thereof, are carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;’
če končen nadzor in preskušanje izdelkov, ali njihovih elementov, izvaja tretja oseba, metod spremljanja učinkovitosti delovanja sistema kakovosti ter zlasti vrste in obsega nadzora tretje osebe.“;
Annex VII shall be amended as follows:
Priloga VII se spremeni:
Sections 1 and 2 shall be replaced by the following:
oddelka 1 in 2 se nadomestita z naslednjim:
The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.
Izjava ES o skladnosti je postopek, v katerem proizvajalec ali njegov pooblaščeni zastopnik, ki izpolnjuje obveznosti iz oddelka 2 in v primeru izdelkov, ki se dajejo na trg v sterilnem stanju, in pripomočkov z merilno funkcijo, obveznosti iz oddelka 5, zagotovi in izjavi, da zadevni izdelki izpolnjujejo določbe te direktive, ki se uporabljajo zanje.
a general description of the product, including any variants planned and its intended use(s),’;
splošni opis izdelka, skupaj z vsemi predvidenimi različicami in predvideno uporabo,“;
the fifth indent shall be replaced by the following:
peta alinea se nadomesti z:
in the case of products placed on the market in a sterile condition, description of the methods used and the validation report,’;
v primeru izdelkov, ki se dajejo na trg v sterilnem stanju, opis uporabljenih metod in validacijsko poročilo,“;
the seventh indent shall be replaced by the following indents:
sedma alinea se nadomesti z alineama:
the pre-clinical evaluation,’;
predklinično vrednotenje,“;
the following indent shall be inserted after the seventh indent:
za sedmo alineo se vstavi alinea:
the clinical evaluation in accordance with Annex X,’;
klinično vrednotenje v skladu s Prilogo X,“;
in Section 4, the introductory part shall be replaced by the following:
v oddelku 4 se uvodni del nadomesti z:
The manufacturer shall institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective actions, taking account of the nature and risks in relation to the product.
Proizvajalec mora uporabljati in ohranjati ažurne sistematične postopke za pregledovanje izkušenj, pridobljenih iz pripomočkov v fazi po proizvodnji, vključno z določbami iz Priloge X, in uporabljati ustrezna sredstva za uveljavljanje vseh potrebnih korektivnih postopkov, ob upoštevanju narave in tveganja v povezavi z izdelkom.
He shall notify the competent authorities of the following incidents immediately on learning of them:’;
Pristojne organe mora obvestiti o naslednjih dogodkih, takoj ko zanje izve:“;
in Section 5, the words ‘Annex IV, V or VI’ shall be replaced by the words ‘Annex II, IV, V or VI’;
v oddelku 5 se besede „Prilog IV, V ali VI“ nadomestijo z besedami „prilog II, IV, V ali VI“;
Annex VIII shall be amended as follows:
Priloga VIII se spremeni:
the following indent shall be inserted after the introductory phrase:
za uvodnim stavkom se vstavi naslednja alinea:
the name and address of the manufacturer,’;
ime in naslov proizvajalca,“;
the specific characteristics of the product as indicated by the prescription,’;
posebne značilnosti izdelka, ki izhajajo iz pisnega navodila,“;
Section 2.2 shall be amended as follows:
oddelek 2.2 se spremeni z:
the second indent shall be replaced by the following:
druga alinea se nadomesti z:
the clinical investigation plan,’;
načrt klinične preiskave,“;
the following indents shall be inserted after the second indent:
za drugo alineo se vstavijo alinee:
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I,
izjavo, ali pripomoček, kot sestavni del, vključuje snov ali derivat človeške krvi iz oddelka 7.4 Priloge I,
a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,’;
izjavo o tem, ali je pripomoček izdelan z uporabo tkiv živalskega izvora iz Direktive 2003/32/ES,“;
For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.’;
za uporabniku prilagojene pripomočke, dokumentacijo, ki navaja proizvodno(-e) lokacijo(-e) in omogoča razumevanje načrta, izdelave in delovanja izdelka, skupaj s predvidenim delovanjem, tako da je mogoča ocena skladnosti z zahtevami te direktive.“;
Section 3.2 shall be replaced by the following:
oddelek 3.2 se nadomesti z:
For devices intended for clinical investigations, the documentation must contain:
za pripomočke, namenjene za klinične preiskave, mora dokumentacija vsebovati:
a general description of the product and its intended use,
splošni opis izdelka in njegovo predvideno uporabo,
the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of this Directive if the standards referred to in Article 5 have not been applied,
rezultate analize tveganja in seznam standardov iz člena 5, ki so uveljavljeni v celoti ali delno, ter opise rešitev, sprejetih za izpolnjevanje bistvenih zahtev te direktive, če standardi iz člena 5 niso bili uveljavljeni,
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 7.4 of Annex I, the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
če pripomoček, kot sestavni del, vsebuje snov, derivat človeške krvi iz oddelka 7.4 Priloge I, podatke preskusov, ki so bili opravljeni v zvezi s tem in ki so potrebni za oceno varnosti, kakovosti in uporabnosti te snovi ali derivata človeške krvi, ob upoštevanju predvidenega namena pripomočka,
if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk of infection,
če je pripomoček izdelan z uporabo tkiv živalskega izvora iz Direktive 2003/32/ES, ukrepe za obvladovanje s tem povezanega tveganja, ki so bili uporabljeni za zmanjšanje tveganja za okužbo,
the results of the design calculations, and of the inspections and technical tests carried out, etc.
rezultate opravljenih izračunov načrta, opravljenih inšpekcij in tehničnih preskusov itd.
The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section.
Proizvajalec mora sprejeti vse potrebne ukrepe za zagotovitev, da so v proizvodnem postopku izdelani izdelki, ki so v skladu z dokumentacijo iz prvega odstavka tega oddelka.
The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of these measures.’;
Proizvajalec mora dovoliti ocenjevanje ali, po potrebi, preverjanje učinkovitosti teh ukrepov.“;
the following section shall be added:
doda se oddelek 5:
For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action.
Za uporabniku prilagojene pripomočke mora proizvajalec jamčiti, da bo ocenil in dokumentiral izkušnje, pridobljene v fazi po proizvodnji, vključno z določbami iz Priloge X, in da bo uporabljal ustrezna sredstva za uveljavljanje vseh potrebnih korektivnih postopkov.
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type by the manufacturer.’;
vsak tehnični ali medicinski razlog, povezan z lastnostmi ali delovanjem pripomočka zaradi razlogov iz pododstavka (i), ki povzroči sistematični odpoklic pripomočkov istega tipa s strani proizvajalca.“;