natgillin/translations-raw huggingface dataset:
the name and address of the manufacturer and the name and address of the authorised representative, where the manufacturer does not have a registered place of business in the Community,’;
ime in naslov proizvajalca ter ime in naslov pooblaščenega zastopnika, če proizvajalec v Skupnosti nima registrirane poslovne enote,“;
in the case of a device within the meaning of Article 1(4a), an indication that the device contains a human blood derivative.’;
v primeru pripomočka v smislu člena 1(4a) navedba, da pripomoček vsebuje derivat človeške krvi.“;
the following indent shall be added to the second paragraph of Section 15:
doda se naslednja alinea v drugi odstavek oddelka 15:
date of issue or the latest revision of the instructions for use.’;
datum izdaje ali zadnjega popravka navodil za uporabo.“;
Annex 2 shall be amended as follows:
Priloga 2 se spremeni:
in Section 2, the third paragraph shall be replaced by the following:
v oddelku 2 se tretji pododstavek nadomesti z naslednjim:
‘This declaration shall cover one or more clearly identified devices by means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’;
„Ta izjava navaja enega ali več jasno opredeljenih pripomočkov, in sicer ime proizvoda, njegovo kodo ali drugo nedvoumno oznako, hrani pa jo proizvajalec.“;
in the second paragraph of Section 3.1, the first sentence of the fifth indent shall be replaced by the following:
v drugem odstavku oddelka 3.1 se prvi stavek pete alinee nadomesti z:
an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7.’;
jamstvo proizvajalca, da bo vpeljal in sproti dopolnjeval sistem poprodajnega nadzora, vključno z določbami iz Priloge 7.“;
Section 3.2 shall be amended as follows:
oddelek 3.2 se spremeni:
the following sentence shall be added to the second subparagraph:
v drugemu pododstavku se doda naslednji stavek:
‘It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).’;
„Vključuje zlasti ustrezno dokumentacijo, podatke in evidence, ki izhajajo iz postopkov iz točke (c).“;
the following indent shall be added to point (b):
točki (b) se doda naslednja alinea:
where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is 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 načrtovanje, izdelavo in/ali končen nadzor ter preskušanje izdelkov ali njihovih elementov izvaja tretja oseba, metod spremljanja učinkovitega delovanja sistema kakovosti ter zlasti vrste in obsega nadzora tretje osebe.“;
the following indents shall be added to point (c):
točki (c) se dodajo naslednje alinee:
a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,
izjave, ali pripomoček, kot sestavni del, vključuje snov ali derivat človeške krvi iz oddelka 10 Priloge 1, ter podatkov o preskusih, opravljenih v zvezi s tem, ki so potrebni za oceno varnosti, kakovosti in uporabnosti te snovi ali derivata človeške krvi, ob upoštevanju predvidenega namena pripomočka,
the pre-clinical evaluation,
predklinično vrednotenje,
the clinical evaluation referred to in Annex 7.’;
klinično vrednotenje, iz Priloge 7.“;
in Section 3.3, the last sentence of the second subparagraph shall be replaced by the following:
v oddelku 3.3 se zadnji stavek drugega pododstavka nadomesti z:
‘The evaluation procedure shall include an inspection on the manufacturer's premises and, in duly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.’;
„Postopek vrednotenja vključuje obisk inšpekcije v prostorih proizvajalca in, v utemeljenih primerih, v prostorih proizvajalčevih dobaviteljev in/ali podizvajalcev, da se preveri proizvodni postopek.“;
Section 4.2 shall be amended as follows:
oddelek 4.2 se spremeni:
‘The application shall describe the design, manufacture and performances of the product in question, and it must include the documents needed to assess whether the product conforms to the requirements of this Directive, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;
„V vlogi so opisani načrt, izdelava in delovanje zadevnega izdelka, poleg tega so vključeni dokumenti, potrebni za oceno, ali izdelek ustreza zahtevam te direktive in zlasti točkama (c) in (d) tretjega odstavka oddelka 3.2 Priloge 2.“;
in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;
v četrti alinei drugega odstavka se besedi „klinične podatke“ nadomestita z „klinično vrednotenje.“;
in Section 4.3, the following paragraphs shall be added:
v oddelku 4.3 se dodata pododstavka:
‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the competent 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 10 Priloge 1 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 EMEA.
The opinion of the competent national authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation.
Mnenje pristojnega nacionalnega organa ali EMEA se pripravi v 210 dneh po prejemu popolne dokumentacije.
The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device.
Znanstveno mnenje pristojnega nacionalnega organa ali EMEA je treba vključiti v dokumentacijo o pripomočku.
The notified body will give due consideration to the views expressed in this consultation when making its decision.
Priglašeni organ ob odločanju ustrezno upošteva stališča, izražena v teh posvetovanjih.
It will convey its final decision to the competent body concerned.
Končno odločitev predloži zadevnemu pristojnemu organu.
In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEA must be included in the documentation concerning the device.
V primeru pripomočkov iz tretjega odstavka oddelka 10 Priloge 1 je treba znanstveno mnenje EMEA vključiti v dokumentacijo o pripomočku.
The opinion shall be drawn up within 210 days after receipt of valid documentation.
Mnenje se pripravi v 210 dneh po prejemu popolne dokumentacije.
The notified body will give due consideration to the opinion of the EMEA when making its decision.
Priglašeni organ ob sprejemanju odločitve na primeren način upošteva mnenje EMEA.
The notified body may not deliver the certificate if the EMEA's scientific opinion is unfavourable.
Priglašenemu organu ni treba izdati potrdila, če je znanstveno mnenje EMEA neugodno.
It will convey its final decision to the EMEA.’;
Končno odločitev predloži agenciji EMEA.“;
in Section 5.2, the second indent shall be replaced by the following:
v oddelku 5.2 se druga alinea nadomesti z:
the data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, 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, predklinično in klinično vrednotenje, poprodajni načrt kliničnega spremljanja in poprodajni rezultati kliničnega spremljanja itd., kadar je to ustrezno.“;
Section 6.1 shall be replaced by the following:
oddelek 6.1 se nadomesti z:
For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorised representative shall keep available for the national authorities:
Proizvajalec ali njegov pooblaščeni zastopnik najmanj petnajst let od zadnjega datuma proizvodnje izdelka hrani na voljo nacionalnim organom:
the declaration of conformity,
izjavo o skladnosti,
the documentation referred to in the second indent of Section 3.1, and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,
dokumentacijo iz druge alinee oddelka 3.1 in zlasti dokumentacijo, podatke in evidence iz drugega odstavka oddelka 3.2,
the amendments referred to in Section 3.4,
spremembe iz oddelka 3.4,
the documentation referred to in Section 4.2,
dokumentacijo iz oddelka 4.2,
the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;
odločitve in poročila priglašenega organa iz oddelkov 3.4, 4.3, 5.3 in 5.4.“;
Section 6.3 shall be deleted;
oddelek 6.3 se črta;
the following Section shall be added:
doda se naslednji oddelek:
Application to the devices referred to in Article 1(4a):
Uporaba za pripomočke iz člena 1(4a):
Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturer shall inform the notified body of the release of the batch of devices and send to it the official certificate concerning the release of the batch of human blood derivative used in the device, issued by a State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.’;
Po dokončani proizvodnji vsake serije pripomočkov iz člena 1(4a) proizvajalec obvesti priglašeni organ o sprostitvi serije pripomočkov in mu pošlje uradno potrdilo o sprostitvi serije človeške krvi, uporabljenega v pripomočku, ki ga izda državni laboratorij ali laboratorij, ki ga v skladu s členom 114(2) Direktive 2001/83/ES za ta namen določi država članica.“;
Annex 3 shall be amended as follows:
Priloga 3 se spremeni:
Section 3 shall be amended as follows:
oddelek 3 se spremeni:
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,“;
the fifth to eighth indents shall be replaced by the following:
peta do osma alinea se nadomestijo z:
the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,
rezultate opravljenih načrtovalnih izračunov, analiz tveganja, preiskav, tehničnih preskusov itd.,
a declaration stating whether or not the device incorporates, as an integral part, a substance or a human blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection 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, ali pripomoček, kot sestavni del, vključuje snov ali derivat človeške krvi iz oddelka 10 Priloge 1, ter podatke o preskusih, opravljenih v zvezi s tem, ki so potrebni za oceno varnosti, kakovosti in uporabnosti te snovi ali derivata človeške krvi, ob upoštevanju predvidenega namena pripomočka,
the clinical evaluation referred to in Annex 7,
klinično vrednotenje iz Priloge 7,
the draft instruction leaflet.’;
osnutek prospekta z navodili.“;
the following paragraphs shall be added to Section 5:
oddelku 5 se dodajo naslednji pododstavki:
in Section 7.3, the words ‘five years from the manufacture of the last appliance’ shall be replaced by the words ‘15 years from the manufacture of the last product’;
v oddelku 7.3 se besede „pet let od izdelave zadnje naprave“ nadomestijo s „petnajst let od izdelave zadnjega izdelka“;
Section 7.4 shall be deleted;
oddelek 7.4 se črta;
Annex 4 shall be amended as follows:
Priloga 4 se spremeni:
in Section 4, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;
v oddelku 4 se besede „poprodajni sistem nadzora“ nadomestijo s „poprodajni sistem nadzora, vključno z določbami iz Priloge 7“;
Section 6.3 shall be replaced by the following:
oddelek 6.3 se nadomesti z:
Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.’;
Statistično nadzorovanje izdelkov bo temeljilo na lastnostih in/ali spremenljivkah ter bo zahtevalo programe vzorčenja z operativnimi značilnostmi, ki zagotavljajo visoko raven varnosti in zmogljivosti v skladu s tehničnim razvojem. Programi vzorčenja bodo določeni z usklajenimi standardi iz člena 5, ob upoštevanju posebne narave zadevnih kategorij izdelka.“;
Annex 5 shall be amended as follows:
Priloga 5 se spremeni:
in Section 2, second paragraph, the words ‘identified specimens of the product and shall be kept by the manufacturer’ shall be replaced by the words ‘devices manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer’;
v drugem odstavku oddelka 2 se besede „identificiranih primerkov izdelka in se hranijo pri proizvajalcu“ nadomestijo s „proizvedenih pripomočkov, jasno identificiranih z imenom proizvoda, njegovo kodo ali drugo nedvoumno oznako in se hranijo pri proizvajalcu“;
in the sixth indent of Section 3.1, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketing surveillance system including the provisions referred to in Annex 7’;
v šesti alinei oddelka 3.1 se besede „poprodajni sistem nadzora“ nadomestijo s „poprodajni sistem nadzora, vključno z določbami iz Priloge 7“;
in Section 3.2(b), the following indent shall be added:
v oddelku 3.2(b) 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.’;
v primeru, da izdelavo in/ali končen nadzor ter preskušanje izdelkov, ali njihovih elementov, izvaja tretja oseba, metod spremljanja učinkovitega delovanja sistema kakovosti ter zlasti vrste in obsega nadzora tretje osebe.“;
in Section 4.2, the following indent shall be inserted after the first indent:
v členu 4.2 se za prvo alineo vstavi alinea:
the technical documentation,’;
tehnično dokumentacijo,“;
Annex 6 shall be amended as follows:
Priloga 6 se spremeni:
Section 2.1 shall be amended as follows:
oddelek 2.1 se spremeni:
the first indent shall be replaced by the following two indents:
prva alinea se nadomesti z naslednjima alineama:
the name and address of the manufacturer,
ime in naslov proizvajalca,
the information necessary for the identification of the product in question,’;
podatke, ki so nujni za prepoznavanje zadevnega pripomočka,“;
in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner’;
v tretji alinei se beseda „zdravnika“ nadomesti z „ustrezno usposobljenega zdravnika“;
the fourth indent shall be replaced by the following:
četrta alinea se nadomesti z:
the specific characteristics of the product revealed by the prescription,’;
posebne značilnosti pripomočkov, ki izhajajo iz recepta,“;
Section 2.2 shall be replaced by the following:
oddelek 2.2 se nadomesti z:
For devices intended for clinical investigations covered in Annex 7:
Za pripomočke, namenjene za klinične preiskave, ki jih ureja Priloga 7:
data allowing the devices in question to be identified,
podatke, ki omogočajo prepoznavanje pripomočka,
the clinical investigation plan,
načrt klinične preiskave,
the investigator's brochure,
brošuro raziskovalca,
the confirmation of insurance of subjects,
potrdilo o zavarovanju oseb,
the documents used to obtain informed consent,
dokumente, ki se uporabljajo za pridobitev prostovoljnega soglasja,
a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,
izjavo, ali pripomoček, kot sestavni del, vključuje snov ali derivat človeške krvi iz oddelka 10 Priloge 1,
the opinion of the ethics committee concerned and details of the aspects covered by its opinion,
mnenje zadevnega etičnega odbora in podatke o vidikih, zajetih v mnenju,
the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,
ime ustrezno usposobljenega zdravnika ali druge pooblaščene osebe ter ustanove, odgovorne za preiskave,
the place, date of commencement and duration scheduled for the investigations,
kraj, začetek in predvideno trajanje preiskav,
a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.’;
izjavo, ki potrjuje, da zadevni pripomoček izpolnjuje bistvene zahteve, razen vidikov, ki sestavljajo cilj preiskave, in da so glede na te vidike sprejeti vsi varnostni ukrepi za zaščito zdravja in varnosti pacienta.“;
in Section 3.1, the first paragraph shall be replaced by the following:
prvi odstavek oddelka 3.1 se nadomesti z:
‘For custom-made devices, documentation, indicating manufacturing site(s) and enabling the design, manufacture and performances of the product, including the expected performances, to be understood, so as to allow conformity with the requirements of this Directive to be assessed.’;
„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.“;
in Section 3.2, the first paragraph shall be amended as follows:
v oddelku 3.2 se prvi odstavek spremeni:
a general description of the product and its intended use,’;
splošen opis izdelka in njegovo predvideno uporabo,“;
in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the risk analysis and a list of the standards’;
v četrti alinei se besede „seznam standardov“ nadomestijo z besedami „rezultati analize tveganja in seznam standardov“;
the following indent shall be inserted after the fourth indent:
za četrto alineo se doda naslednja alinea:
if the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1, 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, vključuje snov ali derivat človeške krvi iz oddelka 10 Priloge 1, podatke o preskusih, opravljenih v zvezi s tem, ki so potrebni za oceno varnosti, kakovosti in uporabnosti te snovi ali derivata človeške krvi, ob upoštevanju predvidenega namena pripomočka.“;
the following two sections shall be added:
dodata se naslednja oddelka:
The information included in the declarations covered by this Annex shall be kept for a period of at least 15 years from the date of manufacture of the last product.
Podatki, ki se v okviru te priloge navajajo v izjavi, se hranijo za obdobje najmanj petnajst let od datuma proizvodnje zadnjega izdelka.
For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, 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 7, in da bo uporabljal ustrezna sredstva za uveljavljanje vseh potrebnih korektivnih ukrepov.
This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them and the relevant corrective actions:
To jamstvo mora vključevati tudi obveznost proizvajalca, da obvešča pristojne organe o naslednjih dogodkih in obvesti tudi o ustreznih korektivnih postopkih:
any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
vsaka okvara ali poslabšanje lastnosti in/ali delovanja pripomočka ter vsaka neustreznost v označevanju ali v navodilih za uporabo, ki bi lahko povzročila ali je morda povzročila smrt bolnika ali uporabnika ali resno poslabšanje njegovega zdravstvenega stanja;
any technical or medical reason connected with the characteristics or performance of a device for the reasons referred to in point (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 točke (i), ki povzroči sistematični odpoklic pripomočkov istega tipa s strani proizvajalca.“;
Annex 7 shall be amended as follows:
Priloga 7 se spremeni:
Section 1 shall be replaced by the following:
oddelek 1 se nadomesti z:
As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of the device and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 5 of Annex 1, must be based on clinical data.
Po splošnem pravilu morajo potrditev skladnosti z zahtevami v zvezi z lastnostmi in delovanjem iz oddelkov 1 in 2 Priloge 1 v normalnih pogojih uporabe pripomočka ter ovrednotenje stranskih učinkov in sprejemljivosti razmerja med koristmi in tveganjem iz oddelka 5 Priloge 1 temeljiti na kliničnih podatkih.
The evaluation of this data (hereinafter referred to as clinical evaluation), where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:
Vrednotenje teh podatkov, v nadaljevanju klinično vrednotenje, pri katerem se ustrezno upošteva vsak ustrezno usklajen standard, mora upoštevati opredeljen in metodološko dober postopek, ki temelji na:
Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device where:
kritičnem vrednotenju ustrezne sodobne znanstvene literature, ki je zdaj na voljo v zvezi z varnostjo, delovanjem, značilnostmi načrta in predvidenim namenom pripomočka, če:
there is demonstration of equivalence of the device to the device to which the data relates and,
obstaja dokazilo o enakovrednosti pripomočka s pripomočkom, za katerega veljajo podatki, in
the data adequately demonstrate compliance with the relevant essential requirements;
podatki ustrezno dokazujejo skladnost z ustreznimi bistvenimi zahtevami;
Or a critical evaluation of the results of all the clinical investigations made,
ali kritičnem vrednotenju rezultatov vseh opravljenih kliničnih preiskav;
Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.
ali kritičnem vrednotenju združenih kliničnih podatkov iz 1.1.1 in 1.1.2.
Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.
Klinične preiskave se opravijo, razen če se ustrezno utemelji, da temeljijo na obstoječih kliničnih podatkih.