natgillin/translations-raw huggingface dataset:
Procedure in the case of devices manufactured utilising, or incorporating, tissues or cells of human or animal origin, or their derivatives, that are non-viable or rendered non-viable
Ta priglašeni organ zaprosi za mnenje organa za zdravila, ki je bil zaprošen za mnenje, da potrdi, da kakovost in varnost pomožne snovi ostajata nespremenjeni.
Tissues or cells of human origin or their derivatives
Organ za zdravila, ki je bil zaprošen za mnenje, upošteva podatke o koristnosti vključitve snovi v pripomoček, kot jo določa priglašeni organ, in tako zagotovi, da spremembe ne vplivajo negativno na ugotovljena tveganja ali koristi, povezane z vključitvijo snovi v pripomoček.
For devices manufactured utilising derivatives of tissues or cells of human origin that are covered by this Regulation in accordance with point (g) of Article 1(6) and for devices that incorporate, as an integral part, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, that have an action ancillary to that of the device, the notified body shall, prior to issuing an EU technical documentation assessment certificate, seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2004/23/EC (‘human tissues and cells competent authority’) on the aspects relating to the donation, procurement and testing of tissues or cells of human origin or their derivatives.
Organ za zdravila, ki je bil zaprošen za mnenje, da svoje mnenje v 60 dneh od prejema vse potrebne dokumentacije v zvezi s spremembami.
The notified body shall submit a summary of the preliminary conformity assessment which provides, among other things, information about the non-viability of the human tissues or cells in question, their donation, procurement and testing and the risk or benefit of the incorporation of the tissues or cells of human origin or their derivatives into the device.
Priglašeni organ dopolnila certifikata EU o oceni tehnične dokumentacije ne izda, če je znanstveno mnenje organa za zdravila, ki je bil zaprošen za mnenje, negativno.
Within 120 days of receipt of all the necessary documentation, the human tissues and cells competent authority shall provide to the notified body its opinion.
Priglašeni organ svojo končno odločitev sporoči organu za zdravila, ki je bil zaprošen za mnenje.
The scientific opinion of the human tissues and cells competent authority, and any possible update, shall be included in the documentation of the notified body concerning the device.
Kadar organ za zdravila, ki je bil zaprošen za mnenje, prejme informacije o pomožni snovi, ki bi lahko vplivale ugotovljena tveganja ali koristi, povezane z vključitvijo snovi v pripomoček, priglašenemu organu svetuje o tem, ali te informacije vplivajo na ugotovljena tveganja ali koristi, povezane z vključitvijo snovi v pripomoček.
The notified body shall give due consideration to the views expressed in the scientific opinion of the human tissues and cells competent authority when making its decision.
Priglašeni organ to mnenje upošteva pri ponovni preučitvi svoje ocene postopka ugotavljanja skladnosti.
The notified body shall not deliver the certificate if that scientific opinion is unfavourable.
Postopek v primeru pripomočkov, ki so bili izdelani z uporabo človeških ali živalskih tkiv ali celic ali njihovih derivatov, ki so neviabilni ali so postali neviabilni, ali ki taka tkiva ali celice ali njihove derivate vsebujejo
It shall convey its final decision to the human tissues and cells competent authority concerned.
Tkiva ali celice človeškega izvora ali njihovi derivati
Before any change is made with respect to non-viable tissues or cells of human origin or their derivatives incorporated in a device, in particular relating to their donation, testing or procurement, the manufacturer shall inform the notified body of the intended changes.
Za pripomočke, izdelane z uporabo derivatov človeških tkiv ali celic, ki so zajeti s to uredbo v skladu s točko (g) člena 1(6), in za pripomočke, ki kot sestavni del vsebujejo človeška tkiva ali celice ali njihove derivate, zajete z Direktivo 2004/23/ES, ki dopolnjujejo učinek pripomočka, priglašeni organ pred izdajo certifikata EU o oceni tehnične dokumentacije pridobi znanstveno mnenje enega od pristojnih organov, ki jih imenujejo države članice v skladu z Direktivo 2004/23/ES (v nadaljnjem besedilu: pristojni organ za človeška tkiva in celice), o vidikih, povezanih z darovanjem, pridobivanjem in preskušanjem človeških tkiv ali celic ali njihovih derivatov.
The notified body shall consult the authority that was involved in the initial consultation, in order to confirm that the quality and safety of the tissues or cells of human origin or their derivatives incorporated in the device are maintained.
Priglašeni organ predloži povzetek predhodnega ugotavljanja skladnosti, ki med drugim vključuje informacije o neviabilnosti zadevnih človeških tkiv ali celic, njihovem darovanju, pridobivanju in preskušanju ter tveganji ali koristmi vgraditve človeških tkiv ali celic ali njihovih derivatov v pripomoček.
The human tissues and cells competent authority concerned shall take into account the data relating to the usefulness of incorporation of the tissues or cells of human origin or their derivatives into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit-risk ratio of the addition of the tissues or cells of human origin or their derivatives in the device.
Pristojni organ za človeška tkiva in celice priglašenemu organu v 120 dneh od prejema vse potrebne dokumentacije sporoči svoje mnenje.
Tissues or cells of animal origin or their derivatives
Priglašeni organ certifikata ne izda, če je to znanstveno mnenje negativno.
In the case of devices manufactured utilising animal tissue which is rendered non-viable or utilising non-viable products derived from animal tissue, as referred to in Regulation (EU) No 722/2012, the notified body shall apply the relevant requirements laid down in that Regulation.
Končno odločitev sporoči zadevnemu pristojnemu organu za človeška tkiva in celice.
Procedure in the case of devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body
Pred vsako spremembo, ki se nanaša na neviabilna človeška tkiva ali celice ali njihove derivate, vgrajene v pripomoček, zlasti v zvezi z njihovim darovanjem, preskušanjem ali pridobivanjem, proizvajalec obvesti priglašeni organ o načrtovanih spremembah.
The quality and safety of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by, or locally dispersed in, the human body, shall be verified where applicable and only in respect of the requirements not covered by this Regulation, in accordance with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions.
Priglašeni organ se posvetuje z organom, ki je bil vključen v prvotno posvetovanje, da potrdi, da kakovost in varnost človeških tkiv ali celic ali njihovih derivatov, vgrajenih v pripomoček, ostajata nespremenjeni.
In addition, for devices, or their products of metabolism, that are systemically absorbed by the human body in order to achieve their intended purpose, the notified body shall seek a scientific opinion from one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as ‘the medicinal products authority consulted’ depending on which has been consulted under this point, on the compliance of the device with the relevant requirements laid down in Annex I to Directive 2001/83/EC.
Zadevni pristojni organ za človeška tkiva in celice upošteva podatke o koristnosti vgraditve človeških tkiv ali celic ali njihovih derivatov v pripomoček, kot jo določa priglašeni organ, in tako zagotovi, da spremembe ne vplivajo negativno na ugotovljeno razmerje med koristmi in tveganji vgraditve človeških tkiv ali celic ali njihovih derivatov v pripomoček.
The opinion of the medicinal products authority consulted shall be drawn up within 150 days of receipt of all the necessary documentation.
Mnenje predloži v 60 dneh od prejema vse potrebne dokumentacije v zvezi z načrtovanimi spremembami.
The scientific opinion of the medicinal products authority consulted, and any possible update, shall be included in the documentation of the notified body concerning the device.
Priglašeni organ v primeru negativnega znanstvenega mnenja ne izda dopolnila certifikata EU o oceni tehnične dokumentacije in o dokončni odločitvi obvesti zadevni organ za človeška tkiva in celice.
The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision and shall convey its final decision to the medicinal products authority consulted.
Tkiva ali celice živalskega izvora ali njihovi derivati
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 as referred to in Article 1(8)
V primeru pripomočkov, izdelanih z uporabo živalskih tkiv, ki so postali neviabilni, ali z uporabo neviabilnih izdelkov iz živalskih tkiv, kot je navedeno v Uredbi (EU) št. 722/2012, priglašeni organ uporabi ustrezne zahteve iz navedene uredbe.
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 as 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.
Postopek pri pripomočkih, sestavljenih iz snovi ali kombinacij snovi, ki jih človeško telo absorbira ali se lokalno razpršijo po človeškem telesu
ADMINISTRATIVE PROVISIONS
Kakovost in varnost pripomočkov, sestavljenih iz snovi ali kombinacij snovi, ki so namenjene vnosu v človeško telo skozi telesno odprtino ali nanosu na kožo in ki jih človeško telo absorbira ali se lokalno razpršijo po človeškem telesu, se, kjer je ustrezno, preverja – pri čemer je to preverjanje omejeno le na zahteve, ki niso zajete v tej uredbi – v skladu z ustreznimi zahtevami iz Priloge I k Direktivi 2001/83/ES za oceno absorpcije, porazdelitve, presnove, izločanja, lokalne tolerance, toksičnosti, interakcije z drugimi pripomočki, zdravili ali drugimi snovmi ter možnosti neželenih reakcij.
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, 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:
Poleg tega priglašeni organ za pripomočke ali njihove produkte presnove, ki jih človeško telo sistematično absorbira, da bi bil dosežen njihov predvideni namen, pridobi znanstveno mnenje enega od pristojnih organov, ki jih imenujejo države članice v skladu z Direktivo 2001/83/ES, ali EMA (za namene tega oddelka se tako pristojni organ kot EMA štejeta za „organ za zdravila, ki je bil zaprošen za mnenje“, odvisno od tega, kateri je bil zaprošen za mnenje v skladu s to točko), o skladnosti pripomočka z zadevnimi zahtevami iz Priloge I k Direktivi 2001/83/ES.
the EU declaration of conformity,
Organ za zdravila, ki je bil zaprošen za mnenje, da svoje mnenje v 150 dneh od prejema vse potrebne dokumentacije.
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,
Znanstveno mnenje organa za zdravila, ki je bil zaprošen za mnenje, in vse morebitne spremembe se vključijo v dokumentacijo priglašenega organa o pripomočku.
information on the changes referred to in Section 2.4,
Priglašeni organ pri sprejemanju odločitev ustrezno upošteva stališča, izražena v znanstvenem mnenju, in o dokončni odločitvi obvesti organ za zdravila, ki je bil zaprošen za mnenje.
the documentation referred to in Section 4.2, and
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)
the decisions and reports from the notified body as referred to in this Annex.
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.
Each Member State shall require that the documentation referred to in Section 7 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.
UPRAVNE DOLOČBE
ANNEX X
Proizvajalec ali, če ta nima registriranega kraja poslovanja v državi članici, 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:
CONFORMITY ASSESSMENT BASED ON TYPE-EXAMINATION
izjavo EU o skladnosti;
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.
dokumentacijo iz pete alineje oddelka 2.1 ter zlasti podatke in evidence, ki izhajajo iz postopkov iz točke (c) drugega odstavka oddelka 2.2;
Application
informacije o spremembah iz oddelka 2.4;
The manufacturer shall lodge an application for assessment with a notified body.
dokumentacijo iz oddelka 4.2 in
the name of the manufacturer and address of the registered place of business of the manufacturer 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,
odločitve in poročila priglašenega organa iz te priloge.
the technical documentation referred to in Annexes II and III.
Vsaka država članica zahteva, da je dokumentacija iz oddelka 7 na voljo pristojnim organom za obdobje iz navedenega oddelka, če proizvajalec ali njegov pooblaščeni predstavnik, ki ima sedež na njenem ozemlju, gre v stečaj ali preneha opravljati svojo poslovno dejavnost pred koncem tega obdobja.
The applicant shall make a representative sample of the device production envisaged (‘type’) available to the notified body.
PRILOGA X
The notified body may request other samples as necessary, and
UGOTAVLJANJE SKLADNOSTI NA PODLAGI PREGLEDA TIPA
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.
EU-pregled tipa je postopek, s katerim priglašeni organ ugotovi in potrdi, da pripomoček, vključno z njegovo tehnično dokumentacijo in zadevnimi procesi v življenjski dobi, in ustrezen reprezentativni vzorec predvidene proizvodnje pripomočka, izpolnjujeta ustrezne določbe iz te uredbe.
Assessment
Vloga
examine the application by using staff with proven knowledge and experience regarding the technology concerned and its clinical application.
Proizvajalec pri priglašenem organu vloži vlogo za ugotavljanje skladnosti.
The notified body may require the application to be completed by having further tests carried out or requesting further evidence to be provided to allow assessment of conformity with the relevant requirements of this Regulation.
ime proizvajalca in naslov njegovega registriranega kraja poslovanja ter, če vlogo vloži pooblaščeni predstavnik, ime pooblaščenega predstavnika in naslov njegovega registriranega kraja poslovanja;
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;
tehnično dokumentacijo iz prilog II in III.
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 the items not designed on the basis of the relevant standards referred to in Article 8 or of the relevant CS;
Vložnik priglašenemu organu omogoči dostop do reprezentativnega vzorca predvidene proizvodnje pripomočka („tip“).
review the clinical evidence presented by the manufacturer in the clinical evaluation report in accordance with Section 4 of Annex XIV.
Ocenjevanje
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 device in question or to the clinical condition in which it is utilised, for the purposes of that review;
opravi pregled vloge s pomočjo osebja z dokazanim znanjem in izkušnjami v zvezi z zadevno tehnologijo in njeno klinično uporabo.
in circumstances in which the clinical evidence is based partly or totally 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.
Priglašeni organ lahko zahteva, da se vloga dopolni z nadaljnjimi preskusi ali predložijo dodatni dokazi, da se omogoči ugotavljanje skladnosti z zadevnimi zahtevami iz te uredbe.
The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity;
Priglašeni organ opravi ustrezne fizikalne ali laboratorijske preskuse v zvezi s pripomočkom ali proizvajalcu naroči, da take preskuse opravi;
clearly document the outcome of its assessment in a pre-clinical and clinical evaluation assessment report as part of the EU type examination report referred to in point (i);
pregleda in oceni, ali je tehnična dokumentacija skladna z zahtevami te uredbe, ki se uporabljajo za pripomoček, in preveri, ali je tip izdelan skladno z navedeno dokumentacijo; evidentira tudi izdelke, zasnovane v skladu z veljavnimi standardi iz člena 8 ali veljavnimi skupnimi specifikacijami, ter izdelke, ki niso zasnovani na podlagi ustreznih standardov iz člena 8 ali ustreznih splošnih specifikacij;
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.
pregleda klinične dokaze, ki jih predstavi proizvajalec v poročilu o klinični oceni v skladu z oddelkom 4 Priloge XIV.
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;
Priglašeni organ ima za namene tega pregleda zaposlenih dovolj pregledovalcev pripomočkov z zadostnim kliničnim strokovnim znanjem, sodeluje pa lahko tudi z zunanjimi kliničnimi strokovnjaki z neposrednimi in aktualnimi izkušnjami z zadevnim pripomočkom ali kliničnim stanjem, pri katerem se uporablja;
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;
kadar klinični dokazi delno ali v celoti temeljijo na podatkih o pripomočkih, ki naj bi bili podobni ali enakovredni pripomočku, ki se ocenjuje, oceni primernost uporabe teh podatkov, pri čemer upošteva dejavnike, kot so nove indikacije in inovacije.
agree with the applicant on the place where the necessary assessments and tests are to be carried out; and
Priglašeni organ jasno dokumentira svoje ugotovitve o navedeni enakovrednosti ter o relevantnosti in primernosti podatkov za dokazovanje skladnosti;
draw up an EU type-examination report on the results of the assessments and tests carried out under points (a) to (g).
jasno dokumentira rezultat svojega ocenjevanja v poročilu o vrednotenju predklinične in klinične ocene, ki je del poročila o EU-pregledu tipa iz točke (i);
Certificate
opravi ali naroči ustrezno oceno ter fizikalne ali laboratorijske preskuse, da preveri, ali rešitve, ki jih je sprejel proizvajalec, izpolnjujejo splošne zahteve glede varnosti in učinkovitosti iz te uredbe, kadar standardi iz člena 8 ali skupne specifikacije niso bili uporabljeni.
If the type conforms to this Regulation, the notified body shall issue an EU type-examination certificate.
Kadar mora biti pripomoček priključen na drug pripomoček ali pripomočke, da lahko deluje v skladu s predvidenim namenom, se predloži dokaz, da izpolnjuje splošne zahteve glede varnosti in učinkovitosti ob priključitvi na vsak tak pripomoček ali pripomočke z lastnostmi, kot jih opredeli proizvajalec;
The certificate shall contain the name and address of the manufacturer, the conclusions of the type examination assessment, the conditions of the certificate's validity and the data needed for identification of the type approved.
opravi ali naroči ustrezne ocene in fizikalne ali laboratorijske preskuse, da preveri, ali so bili ustrezni harmonizirani standardi, v primeru, da se je proizvajalec odločil, da jih uporabi, dejansko tudi uporabljeni;
The certificate shall be drawn up in accordance with Annex XII.
se z vložnikom dogovori o kraju, kjer bodo opravljene potrebne ocene in preskusi, ter
The relevant parts of the documentation shall be annexed to the certificate and a copy kept by the notified body.
pripravi poročilo o EU-pregledu tipa, z rezultati ocen in preskusov, izvedenih na podlagi točk (a) do (g).
Changes to the type
Certifikat
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.
Če je tip skladen s to uredbo, priglašeni organ izda certifikat o EU-pregledu tipa.
Changes to the approved device including limitations of its intended purpose and conditions of use shall require 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.
Certifikat vključuje ime in naslov proizvajalca, sklepe ocene pregleda tipa, pogoje veljavnosti certifikata in potrebne podatke za identifikacijo odobrenega tipa.