natgillin/translations-raw huggingface dataset:
Before changes affecting the performance and/or the intended use and/or the suitability of the device in relation to the medicinal product concerned are made, the manufacturer shall inform the notified body of the changes.
Kadar zdravilo spada izključno v področje uporabe Priloge k Uredbi (ES) št. 726/2004, se priglašeni organ posvetuje z EMA.
In the latter case, the notified body shall assess the changes and seek the opinion of the medicinal products authority consulted.
Če je zadevno zdravilo že odobreno ali je bila predložena vloga za njegovo odobritev, se priglašeni organ posvetuje s pristojnim organom za zdravila ali EMA, ki je pristojen(a) za izdajo dovoljenja.
The medicinal products authority consulted shall give its opinion within 30 days of receipt of the all the necessary documentation regarding the changes.
Organ za zdravila, ki je bil zaprošen za mnenje, priglašenemu organu v 60 dneh od prejema vse potrebne dokumentacije sporoči svoje mnenje.
A supplement to the EU technical documentation assessment certificate shall be issued in accordance with point (f) of Section 5.1.
Mnenje organa za zdravila, ki je bil zaprošen za mnenje, in vse morebitne spremembe se vključijo v dokumentacijo priglašenega organa v zvezi s pripomočkom.
ADMINISTRATIVE PROVISIONS
Priglašeni organ pri sprejemanju odločitve ustrezno upošteva mnenje organa za zdravila, ki je bil zaprošen za mnenje.
The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, it's 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:
Končno odločitev sporoči organu za zdravila, ki je bil zaprošen za mnenje, in
the EU declaration of conformity,
pripravi poročilo o EU-pregledu tipa, ki vsebuje rezultate ocen in opravljenih preskusov ter znanstvena mnenja iz točk (a) do (k), vključno s poročilom o vrednotenju ocene učinkovitosti za pripomočke razreda C ali razreda D ali pripomočke, zajete v tretji alineji oddelka 2.
the documentation referred to in the fifth indent of Section 2.1. and, in particular, the data and records arising from the procedures referred to in point (c) of the second paragraph of Section 2.2.,
Certifikat
information on the changes referred to in Section 2.4.,
Če je tip skladen s to uredbo, priglašeni organ izda certifikat o EU-pregledu tipa.
the documentation referred to in Sections 4.2. and point (b) of Section 5.1., and
Certifikat vključuje ime in naslov proizvajalca, sklepe ocene pregleda tipa, pogoje veljavnosti certifikata in potrebne podatke za identifikacijo odobrenega tipa.
the decisions and reports from the notified body as referred to in this Annex.
Certifikat se pripravi v skladu s Prilogo XII.
Each Member State shall require that the documentation referred to in Section 6 is kept at the disposal of competent authorities for the period indicated in that Section in case a manufacturer, or its authorised representative, established within its territory goes bankrupt or ceases its business activity prior to the end of that period.
Certifikatu se priložijo ustrezni deli dokumentacije, en izvod pa hrani priglašeni organ.
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p.
Spremembe tipa
1).
Vložnik priglašeni organ, ki je izdal certifikat o EU-pregledu tipa, obvesti o načrtovanih spremembah odobrenega tipa ali njegovega predvidenega namena in pogojev uporabe.
ANNEX X
Spremembe odobrenega pripomočka, vključno z omejitvami njegovega predvidenega namena in pogojev uporabe, nadalje 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.
CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
Priglašeni organ pregleda načrtovane spremembe, proizvajalca uradno obvesti o svoji odločitvi in mu predloži dopolnilo poročila o EU-pregledu tipa.
EU type-examination is the procedure whereby a notified body ascertains and certifies that a device, including its technical documentation and relevant life cycle processes and a corresponding representative sample of the device production envisaged, fulfils the relevant provisions of this Regulation.
Odobritev morebitne spremembe odobrenega tipa je v obliki dopolnila certifikata o EU-pregledu tipa.
Application
Ob spremembah predvidenega namena in pogojev uporabe odobrenega pripomočka – razen ob omejitvah predvidenega namena in pogojev uporabe – je potrebna nova vloga za ugotavljanje skladnosti.
The manufacturer shall lodge an application for assessment with a notified body.
Kadar bi spremembe lahko vplivale na učinkovitost, kot jo navaja proizvajalec, ali skladnost s skupnimi specifikacijami ali drugimi rešitvami, ki jih izbere proizvajalec in so bile odobrene s certifikatom o EU-pregledu tipa, se priglašeni organ posvetuje z referenčnim laboratorijem EU, ki je bil vključen v začetno posvetovanje, da se potrdi ohranjanje skladnosti s skupnimi specifikacijami, kadar so te na voljo, ali drugimi rešitvami, ki jih izbere proizvajalec za zagotovitev vsaj enakovredne ravni varnosti in učinkovitosti.
the name of the manufacturer and the address of its registered place of business and, if the application is lodged by the authorised representative, the name of the authorised representative and the address of its registered place of business,
Kadar spremembe vplivajo na učinkovitost ali predvideno uporabo pripomočka za dopolnilno diagnostiko, odobrenega s certifikatom o EU-pregledu tipa, ali njegovo primernost glede na zdravilo, se priglašeni organ posvetuje s pristojnim organom za zdravila, ki je bil vključen v začetno posvetovanje, ali Agencijo.
the technical documentation referred to in Annexes II and III.
Organ za zdravila, ki je bil zaprošen za mnenje, poda svoje morebitno mnenje v 30 dneh po prejemu veljavne dokumentacije v zvezi s spremembami.
The applicant shall make a representative sample of the device production envisaged (‘type’) available to the notified body.
Odobritev morebitne spremembe odobrenega tipa je v obliki dopolnila prvotnega certifikata o EU-pregledu tipa.
The notified body may request other samples as necessary,
Upravne določbe
in the case of devices for self-testing or near-patient testing, test reports, including results of studies carried out with intended users, and data showing the handling suitability of the device in relation to its intended purpose for self-testing or near patient-testing,
Proizvajalec ali, če ta nima registriranega kraja poslovanja v državi članici, njegov pooblaščeni predstavnik vsaj deset let po tem, ko je bil na trg dan zadnji pripomoček, za nacionalne organe hrani:
where practicable, an example of the device.
dokumentacijo iz druge alineje oddelka 2;
If required, the device shall be returned on completion of the technical documentation assessment;
informacije o spremembah iz oddelka 5;
data showing the suitability of the device in relation to its intended purpose for self-testing or near-patient testing,
izvode certifikatov o EU-pregledu tipa, znanstvenih mnenj in poročil ter njihovih dodatkov/dopolnil.
the information to be provided with the device on its label and its instructions for use, and
Uporablja se oddelek 7 Priloge IX.
a written declaration that no application has been lodged with any other notified body for the same type, or information about any previous application for the same type that was refused by another notified body or was withdrawn by the manufacturer or its authorised representative before that other notified body made its final assessment.
PRILOGA XI
Assessment
UGOTAVLJANJE SKLADNOSTI NA PODLAGI ZAGOTAVLJANJA KAKOVOSTI PROIZVODNJE
examine the application, by using staff with proven knowledge and experience in the evaluation of the technology, and the devices concerned and the evaluation of clinical evidence.
Proizvajalec zagotovi, da se uporabi sistem vodenja kakovosti, odobren za izdelavo zadevnih pripomočkov, in opravi končno preverjanje, kot je opredeljen v oddelku 3, in je predmet nadzora iz oddelka 4.
The notified body shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests;
Kadar proizvajalec izpolnjuje obveznosti iz oddelka 1, za model pripomočka, zajetega v postopek ugotavljanja skladnosti, pripravi in shrani izjavo EU o skladnosti v skladu s členom 17 in Prilogo IV.
examine and assess the technical documentation for conformity with the requirements of this Regulation that are applicable to the device and verify that the type has been manufactured in conformity with that documentation; it shall also record the items designed in conformity with the applicable standards referred to in Article 8 or with applicable CS, and record items not designed on the basis of the relevant standards referred to in Article 8 or of the relevant CS;
Šteje se, da proizvajalec z izdajo izjave EU o skladnosti zagotovi in izjavlja, da zadevni pripomoček izpolnjuje zahteve iz te uredbe, ki se uporabljajo za ta pripomoček, in da so pripomočki razreda C in razreda D, za katere se opravi pregled tipa, skladni s tipom, opisanim v certifikatu o EU-pregledu tipa.
review the clinical evidence presented by the manufacturer in the performance evaluation report in accordance with Section 1.3.2 of Annex XIII.
Sistem upravljanja kakovosti
The notified body shall employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical experts with direct and current experience relating to the clinical application of the device in question for the purposes of that review;
vse elemente iz oddelka 2.1 Priloge IX;
in circumstances in which the clinical evidence is partly or totally based on data from devices which are claimed to be similar or equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation.
tehnično dokumentacijo iz prilog II in III za odobrene tipe;
The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity;
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.
clearly document the outcome of its assessment in the performance evaluation assessment report referred to in Section 4.8 of Annex IX;
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 pripomoček v posamezni fazi.
carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether the solutions adopted by the manufacturer meet the general safety and performance requirements laid down in this Regulation in the event that the standards referred to in Article 8 or the CS have not been applied.
Ta dokumentacija zlasti vključuje ustrezen opis vseh elementov iz točk (a), (b), (d) in (e) oddelka 2.2 Priloge IX.
Where the device has to be connected to another device or devices in order to operate as intended, proof shall be provided that it conforms to the general safety and performance requirements when connected to any such device or devices having the characteristics specified by the manufacturer;
Uporabljata se prvi in drugi odstavek oddelka 2.3 Priloge IX.
carry out or arrange for the appropriate assessments and the physical or laboratory tests necessary to verify whether, in the event that the manufacturer has chosen to apply the relevant harmonised standards, those standards have actually been applied;
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 zagotavljanju kakovosti proizvodnje.
agree with the applicant on the place where the necessary assessments and tests are to be carried out;
Priglašeni organ proizvajalca uradno obvesti o svoji odločitvi, da izda certifikat.
draw up an EU type-examination report on the results of the assessments and tests carried out under points (a) to (g);
V tej odločitvi navede ugotovitve svoje presoje in obrazloženo oceno.
in the case of class D devices, request the EU reference laboratory, where designated in accordance with Article 100, to verify the performance claimed by the manufacturer and the compliance of the device with the CS, where available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.
Uporablja se oddelek 2.4 Priloge IX.
The verification shall include laboratory tests by the EU reference laboratory in accordance with Article 48(5).
Nadzor
In addition, the notified body shall, in the cases referred to in Article 48(6) of this Regulation, consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 following the procedure laid down in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer.
Uporabljajo se oddelek 3.1, prva, druga in četrta alineja oddelka 3.2 ter oddelki 3.3, 3.4, 3.6 in 3.7 Priloge IX.
The scientific opinion of the EU reference laboratory and, where the procedure laid down in Article 48(6) is applicable, the views of the experts consulted, and any possible updates shall be included in the documentation of the notified body concerning the device.
Preverjanje izdelanih pripomočkov razreda D
The notified body shall give due consideration to the views expressed in the scientific opinion of the EU reference laboratory, and, where applicable, to the views expressed by the experts consulted in accordance with Article 48(6), when making its decision.
Proizvajalec za preverjanje skladnosti izdelanih pripomočkov razreda D preskusi vsako izdelano serijo pripomočkov.
The notified body shall not deliver the certificate if the scientific opinion of the EU reference laboratory is unfavourable;
Po opravljenih kontrolah in preskusih priglašenemu organu nemudoma pošlje zadevna poročila o teh preskusih.
for companion diagnostics, seek the opinion, on the basis of the draft summary of safety and performance and the draft instructions for use, of one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMA (either of which to be hereinafter referred to as ‘the medicinal products authority consulted’ depending on which has been consulted under this point) on the suitability of the device in relation to the medicinal product concerned.
Poleg tega proizvajalec vzorce izdelanih pripomočkov ali serij pripomočkov da na voljo priglašenemu organu v skladu s predhodno dogovorjenimi pogoji in podrobnimi ureditvami, vključno s pogojem, da priglašeni organ ali proizvajalec pošilja vzorce izdelanih pripomočkov ali serij pripomočkov referenčnemu laboratoriju EU, kadar je bil ta laboratorij imenovan v skladu s členom 100, ki opravi ustrezne laboratorijske preskuse.
Where the medicinal product falls exclusively within the scope of the Annex of Regulation (EC) No 726/2004, the notified body shall consult the EMA.
Proizvajalec ali, če ta nima registriranega kraja poslovanja v državi članici, njegov pooblaščeni predstavnik vsaj deset let po tem, ko je bil na trg dan zadnji pripomoček, za nacionalne organe hrani:
If the medicinal product concerned is already authorised, or if an application for its authorisation has been submitted, the notified body shall consult the medicinal products competent authority, or the EMA, that is responsible for the authorisation.
dokumentacijo iz pete alineje oddelka 2.1 Priloge IX;
The medicinal products authority consulted shall deliver its opinion within 60 days of receipt of all the necessary documentation.
dokumentacijo iz osme alineje oddelka 2.1 Priloge IX, vključno s certifikatom o EU-pregledu tipa iz Priloge X;
The opinion of the medicinal products authority consulted and any possible update shall be included in the documentation of the notified body concerning the device.
informacije o spremembah iz oddelka 2.4 Priloge IX ter
The notified body shall give due consideration to the opinion expressed by the medicinal products authority consulted when making its decision.
odločitve in poročila priglašenega organa iz oddelkov 2.3, 3.3 in 3.4 Priloge IX.
It shall convey its final decision to the medicinal products authority consulted; and
PRILOGA XII
draw up an EU type-examination report on the results of the assessments and tests carried out, and scientific opinions provided under, points (a) to (k), including a performance evaluation assessment report for class C or class D devices or covered by the third indent of Section 2.
CERTIFIKATI, KI JIH IZDA PRIGLAŠENI ORGAN
Certificate
Certifikati se sestavijo v enem od uradnih jezikov Unije.
If the type conforms to this Regulation, the notified body shall issue an EU type-examination certificate.
Vsak certifikat se nanaša na samo en postopek ugotavljanja skladnosti.
The certificate shall contain the name and address of the manufacturer, the conclusions of the type examination assessment, the conditions of certificate's validity and the data needed for identification of the type approved.
Certifikati se izdajo samo za enega proizvajalca.
The certificate shall be drawn up in accordance with Annex XII.
Ime in naslov proizvajalca, vključena v certifikat, sta enaka kot ime in naslov, registrirana v elektronskem sistemu iz člena 27.
The relevant parts of the documentation shall be annexed to the certificate and a copy kept by the notified body.
Področje uporabe certifikatov nedvoumno opisuje pripomoček ali pripomočke, na katere se certifikati nanašajo:
Changes to the type
certifikati EU o oceni tehnične dokumentacije in certifikati o EU-pregledu tipa vključujejo jasno identifikacijo pripomočka ali pripomočkov, vključno z imenom, modelom in vrsto, predvideni namen, kot ga proizvajalec navaja v navodilih za uporabo v zvezi s katerim je bil pripomoček ocenjen s postopkom ocene skladnosti, razred tveganja in osnovni UDI-DI P iz člena 24(6);
The applicant shall inform the notified body which issued the EU type-examination certificate of any planned change to the approved type or of its intended purpose and conditions of use.
certifikati EU o sistemu vodenja kakovosti in certifikati EU za zagotavljanje kakovosti proizvodnje vključujejo identifikacijo pripomočka ali skupin pripomočkov, razred tveganja in predvideni namen.
Changes to the approved device including limitations of its intended purpose and conditions of use shall require further approval from the notified body which issued the EU type-examination certificate where such changes may affect conformity with the general safety and performance requirements or with the conditions prescribed for use of the product.
Priglašeni organ je na zahtevo zmožen določiti, na katere (posamezne) pripomočke se certifikat nanaša.
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.
Priglašeni organ vzpostavi sistem, ki omogoča določitev pripomočkov, vključno z njihovo klasifikacijo, na katere se certifikat nanaša.
The approval of any change to the approved type shall take the form of a supplement to the EU type-examination certificate.
Certifikati po potrebi vključujejo opozorilo, da je za dajanje na trg pripomočka ali pripomočkov, na katere se ta certifikat nanaša, potreben drug certifikat, izdan v skladu s to uredbo.
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.
Certifikati EU o sistemu vodenja kakovosti in certifikati EU za zagotavljanje kakovosti proizvodnje za sterilne pripomočke razreda A vključujejo izjavo, da je bila presoja sistema vodenja kakovosti s strani priglašenega organa omejena na vidike proizvodnje, ki so povezani z zagotavljanjem in ohranjanjem sterilnih pogojev.
Where the changes could affect the performance claimed by the manufacturer or compliance with the CS or with other solutions chosen by the manufacturer which were approved through the EU type-examination certificate, the notified body shall consult the EU reference laboratory that was involved in the initial consultation, in order to confirm that compliance with the CS, when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent are maintained.
Kadar se certifikat dopolni, spremeni ali ponovno izda, novi certifikat vsebuje sklic na predhodni certifikat in datum njegove izdaje ter navedbo sprememb.
Where the changes affect the performance or the intended use of a companion diagnostic approved through the EU type-examination certificate or its suitability in relation to a medicinal product, the notified body shall consult the medicinal products competent authority that was involved in the initial consultation or the EMA.
MINIMALNA VSEBINA CERTIFIKATOV
The medicinal products authority consulted shall give its opinion, if any, within 30 days after receipt of the valid documentation regarding the changes.
Ime, naslov in identifikacijska številka priglašenega organa.
The approval of any change to the approved type shall take the form of a supplement to the initial EU type-examination certificate.
Ime in naslov proizvajalca in, kjer je ustrezno, pooblaščenega predstavnika.
Administrative provisions
Edinstvena identifikacijska številka certifikata.
The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, 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:
Enotna registrska številka proizvajalca iz člena 28(2), če je že bila dodeljena.
the documentation referred to in the second indent of Section 2,
Datum izdaje.
information on the changes referred to in Section 5,
Datum poteka veljavnosti.
copies of EU type-examination certificates, scientific opinions and reports and their additions/supplements.
Podatki, potrebni za nedvoumno identifikacijo pripomočka ali pripomočkov, kjer je ustrezno, kot je opredeljeno v oddelku 4 te priloge.
Section 7 of Annex IX shall apply.
Kjer je ustrezno, sklicevanje na vsak predhodni certifikat, kot je opredeljeno v oddelku 8 poglavja I.
ANNEX XI
Sklicevanje na to uredbo in zadevno prilogo, v skladu s katero je bilo opravljeno ugotavljanje skladnosti.
CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY ASSURANCE
Opravljeni pregledi in preskusi, npr. sklicevanje na ustrezne skupne specifikacije, harmonizirane standarde, poročila o preskusih in poročilo ali poročila o presoji.
The manufacturer shall ensure that the quality management system approved for the manufacture of the devices concerned is implemented, shall carry out final verification, as specified in Section 3, and shall be subject to the surveillance referred to in Section 4.
Kjer je ustrezno, sklicevanje na ustrezne dele tehnične dokumentacije ali druge certifikate, potrebne za dajanje pripomočka ali pripomočkov, na katere se certifikati nanašajo, na trg.
When the manufacturer fulfils the obligations laid down in Section 1, it shall draw up and keep an EU declaration of conformity in accordance with Article 17 and Annex IV for the device covered by the conformity assessment procedure.
Kjer je ustrezno, informacije o nadzoru, ki ga izvaja priglašeni organ.