natgillin/translations-raw huggingface dataset:
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.
OCENJEVANJE TEHNIČNE DOKUMENTACIJE
The notified body shall review the clinical evidence presented by the manufacturer in the clinical evaluation report and the related clinical evaluation that was conducted.
Ocenjevanje tehnične dokumentacije, ki se uporablja za pripomočke razreda III in za pripomočke razreda IIb iz drugega pododstavka člena 52(4)
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 the clinical condition in which it is utilised, for the purposes of that review.
Proizvajalec poleg izpolnjevanja obveznosti iz oddelka 2 pri priglašenem organu vloži vlogo za oceno tehnične dokumentacije pripomočka, ki ga namerava dati na trg ali v uporabo in za katerega se uporablja sistem vodenja kakovosti iz oddelka 2.
The notified body shall, in circumstances in which the clinical evidence is based partly or totally on data from devices which are claimed to be equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation.
V vlogi so opisani zasnova, izdelava in učinkovitost zadevnega pripomočka.
The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity.
Vloga vključuje tehnično dokumentacijo iz prilog II in III.
For any characteristic of the device claimed as innovative by the manufacturer or for new indications, the notified body shall assess to what extent specific claims are supported by specific pre-clinical and clinical data and risk analysis.
Pregled vloge opravlja pri priglašenem organu zaposleno osebje z dokazanim poznavanjem zadevne tehnologije, izkušnjami z njo in njeno klinično uporabo.
The notified body shall verify that the clinical evidence and the clinical evaluation are adequate and shall verify the conclusions drawn by the manufacturer on the conformity with the relevant general safety and performance requirements.
Priglašeni organ lahko zahteva, da se vloga dopolni z izvedbo nadaljnjih preskusov ali s predložitvijo nadaljnjih dokazov, da se omogoči ugotavljanje skladnosti z zadevnimi zahtevami iz uredbe.
That verification shall include consideration of the adequacy of the benefit-risk determination, the risk management, the instructions for use, the user training and the manufacturer's post-market surveillance plan, and include a review of the need for, and the adequacy of, the PMCF plan proposed, where applicable.
Priglašeni organ opravi ustrezne fizikalne ali laboratorijske preskuse v zvezi s pripomočkom ali od proizvajalca zahteva, da take preskuse opravi.
Based on its assessment of the clinical evidence, the notified body shall consider the clinical evaluation and the benefit-risk determination, and whether specific milestones need to be defined to allow the notified body to review updates to the clinical evidence that result from post-market surveillance and PMCF data.
Priglašeni organ pregleda klinične dokaze, ki jih predloži proizvajalec v poročilu o klinični oceni, in s tem povezano izvedeno klinično oceno.
The notified body shall clearly document the outcome of its assessment in the clinical evaluation assessment report.
Priglašeni organ ima za namene tega pregleda zaposlenih dovolj pregledovalcev pripomočkov z zadostnim kliničnim strokovnim znanjem, če je potrebno, pa lahko sodeluje tudi z zunanjimi kliničnimi strokovnjaki z neposrednimi in aktualnimi izkušnjami z zadevnim pripomočkom ali kliničnim stanjem, pri katerem se uporablja.
The notified body shall provide the manufacturer with a report on the technical documentation assessment, including a clinical evaluation assessment report.
Kadar klinični dokazi v celoti ali delno temeljijo na podatkih o pripomočkih, ki naj bi bili enakovredni pripomočku, ki se ocenjuje, priglašeni organ oceni primernost uporabe takih podatkov, pri čemer upošteva dejavnike, kot so nove indikacije in inovacije.
If the device conforms to the relevant provisions of this Regulation, the notified body shall issue an EU technical documentation assessment certificate.
Priglašeni organ jasno dokumentira svoje ugotovitve o navedeni enakovrednosti ter o ustreznosti in primernosti podatkov pri dokazovanju skladnosti.
The certificate shall contain the conclusions of the technical documentation assessment, the conditions of the certificate's validity, the data needed for identification of the approved design, and, where appropriate, a description of the intended purpose of the device.
Priglašeni organ za vse značilnosti pripomočka, za katere proizvajalec trdi, da so inovativne, ali za nove indikacije oceni, v kakšnem obsegu so posamezne trditve potrjene s specifičnimi predkliničnimi in kliničnimi podatki ter analizo tveganja.
Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device.
Priglašeni organ preuči ustreznost kliničnih dokazov in klinične ocene ter preveri proizvajalčeve ugotovitve glede skladnosti z ustreznimi splošnimi zahtevami glede varnosti in učinkovitosti.
Where the manufacturer plans to introduce any of the above-mentioned changes it shall inform the notified body which issued the EU technical documentation assessment certificate thereof.
Pri tem preuči tudi ustreznost določitve razmerja med koristmi in tveganji, upravljanje tveganja, navodila za uporabo, usposabljanje uporabnikov in načrt proizvajalca za nadzor po dajanju na trg, preveri pa tudi, ali je potreben predlagani načrt kliničnega spremljanja po dajanju na trg, in primernost takšnega načrta, kjer je ustrezno.
The notified body shall assess the planned changes and decide whether the planned changes require a new conformity assessment in accordance with Article 52 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate.
Priglašeni organ na podlagi svoje ocene kliničnih dokazov preuči klinično oceno in določitev razmerja med koristmi in tveganji, pa tudi, ali je treba določiti specifične mejnike, da bo lahko pregledal posodobitve kliničnih dokazov, temelječih na podatkih iz nadzora po dajanju na trg in kliničnega spremljanja po dajanju na trg.
In the latter case, the notified body shall assess the changes, notify the manufacturer of its decision and, where the changes are approved, provide it with a supplement to the EU technical documentation assessment certificate.
Priglašeni organ v poročilu o vrednotenju klinične ocene jasno dokumentira rezultat svojega ocenjevanja.
Specific additional procedures
Priglašeni organ proizvajalcu predloži poročilo o oceni tehnične dokumentacije, vključno s poročilom o vrednotenju klinične ocene.
Assessment procedure for certain class III and class IIb devices
Če je pripomoček skladen z ustreznimi določbami iz te uredbe, priglašeni organ izda certifikat EU o oceni tehnične dokumentacije.
For class III implantable devices, and for class IIb active devices intended to administer and/or remove a medicinal product as referred to in Section 6.4. of Annex VIII (Rule 12), the notified body shall, having verified the quality of clinical data supporting the clinical evaluation report of the manufacturer referred to in Article 61(12), prepare a clinical evaluation assessment report which sets out its conclusions concerning the clinical evidence provided by the manufacturer, in particular concerning the benefit-risk determination, the consistency of that evidence with the intended purpose, including the medical indication or indications and the PMCF plan referred to in Article 10(3) and Part B of Annex XIV.
Certifikat vključuje zaključke ocene tehnične dokumentacije, pogoje veljavnosti certifikata, podatke, potrebne za identifikacijo odobrene zasnove, in, kjer je ustrezno, opis predvidenega namena pripomočka.
The notified body shall transmit its clinical evaluation assessment report, along with the manufacturer's clinical evaluation documentation, referred to in points (c) and (d) of Section 6.1 of Annex II, to the Commission.
Kadar bi spremembe odobrenega pripomočka lahko vplivale na varnost in učinkovitost pripomočka ali pogoje, predpisane za uporabo pripomočka, mora te spremembe odobriti priglašeni organ, ki je izdal certifikat EU o oceni tehnične dokumentacije.
The Commission shall immediately transmit those documents to the relevant expert panel referred to in Article 106.
Kadar proizvajalec namerava vključiti katere koli od zgoraj navedenih sprememb, o tem obvesti priglašeni organ, ki je izdal certifikat EU o oceni tehnične dokumentacije.
The notified body may be requested to present its conclusions as referred to in point (a) to the expert panel concerned.
Priglašeni organ oceni načrtovane spremembe in odloči, ali je zaradi njih potrebno novo ugotavljanje skladnosti v skladu s členom 52 ali pa bi zadostovala dopolnitev certifikata EU o oceni tehnične dokumentacije.
The expert panel shall decide, under the supervision of the Commission, on the basis of all of the following criteria:
V primeru slednjega priglašeni organ oceni spremembe, uradno obvesti proizvajalca o svoji odločitvi in mu, če so spremembe odobrene, predloži dopolnilo certifikata EU o oceni tehnične dokumentacije.
the novelty of the device or of the related clinical procedure involved, and the possible major clinical or health impact thereof;
Posebni dodatni postopki
a significantly adverse change in the benefit-risk profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in the case of failure of the device;
Ocenjevalni postopek za nekatere pripomočke razredov III in IIb
a significantly increased rate of serious incidents reported in accordance with Article 87 in respect of a specific category or group of devices,
Za pripomočke razreda III za vsaditev in aktivne pripomočke razreda IIb, namenjene dajanju in/ali odstranjevanju zdravil iz oddelka 6.4 Priloge VIII (pravilo 12), priglašeni organ, potem ko preveri kakovost kliničnih podatkov, na katerih temelji proizvajalčevo poročilo o klinični oceni iz člena 61(12), pripravi poročilo o vrednotenju klinične ocene, v katerem poda svoje ugotovitve o kliničnih dokazih, ki jih predloži proizvajalec, zlasti kar zadeva določitev razmerja med koristmi in tveganji, skladnost teh dokazov s predvidenim namenom, vključno z medicinsko indikacijo ali indikacijami ter načrtom kliničnega spremljanja po dajanju na trg iz člena 10(3) in dela B Priloge XIV.
whether to provide a scientific opinion on the clinical evaluation assessment report of the notified body based on the clinical evidence provided by the manufacturer, in particular concerning the benefit-risk determination, the consistency of that evidence with the medical indication or indications and the PMCF plan.
Priglašeni organ Komisiji skupaj pošlje svoje poročilo o vrednotenju klinične ocene in dokumentacijo proizvajalca o klinični oceni iz točk (c) in (d) oddelka 6.1 Priloge II.
That scientific opinion shall be provided within a period of 60 days, starting on the day of receipt of the documents from the Commission as referred to in point (a).
Komisija te dokumente nemudoma predloži zadevnemu strokovnemu odboru iz člena 106.
The reasons for the decision to provide a scientific opinion on the basis of the criteria in points (i), (ii) and (iii) shall be included in the scientific opinion.
Priglašeni organ je lahko zaprošen, da zadevnemu strokovnemu odboru predstavi svoje ugotovitve iz točke (a).
Where the information submitted is not sufficient for the expert panel to reach a conclusion, this shall be stated in the scientific opinion.
Strokovni odbor pod nadzorom Komisije in na podlagi naslednjih meril:
The expert panel may decide, under the supervision of the Commission, on the basis of the criteria laid down in point (c) not to provide a scientific opinion, in which case it shall inform the notified body as soon as possible and in any event within 21 days of receipt of the documents as referred to in point (a) from the Commission.
novost pripomočka ali z njim povezanega kliničnega postopka ter njegovi morebitni pomembni klinični učinki ali vpliv na zdravje;
The expert panel shall within that time limit provide the notified body and the Commission with the reasons for its decision, whereupon the notified body may proceed with the certification procedure of that device.
pomembna neželena sprememba profila koristi in tveganj, ki velja za specifično kategorijo ali skupino pripomočkov, nastala zaradi znanstveno utemeljenih zdravstvenih pomislekov v zvezi s sestavnimi deli ali izvornim materialom ali v zvezi z učinkom na zdravje v primeru nedelovanja pripomočka;
The expert panel shall within 21 days of receipt of the documents from the Commission notify the Commission, through Eudamed whether it intends to provide a scientific opinion, pursuant to point (c), or whether it intends not to provide a scientific opinion, pursuant to point (d).
bistveno višja stopnja resnih zapletov, o katerih se poroča v skladu s členom 87, v zvezi s specifično kategorijo ali skupino pripomočkov,
Where no opinion has been delivered within a period of 60 days, the notified body may proceed with the certification procedure of the device in question.
odloči, ali se predloži znanstveno mnenje o poročilu o vrednotenju klinične ocene, ki ga je priglašeni organ pripravil na osnovi kliničnih dokazov proizvajalca, zlasti o določanju razmerja med koristmi in tveganji, skladnosti teh dokazov z zdravstveno indikacijo ali indikacijami ter o načrtu kliničnega spremljanja po dajanju na trg.
The notified body shall give due consideration to the views expressed in the scientific opinion of the expert panel.
To znanstveno mnenje se predloži v 60 dneh od dneva prejema dokumentov od Komisije, kakor je navedeno v točki (a).
Where the expert panel finds that the level of clinical evidence is not sufficient or otherwise gives rise to serious concerns about the benefit-risk determination, the consistency of that evidence with the intended purpose, including the medical indication(s), and with the PMCF plan, the notified body shall, if necessary, advise the manufacturer to restrict the intended purpose of the device to certain groups of patients or certain medical indications and/or to impose a limit on the duration of validity of the certificate, to undertake specific PMCF studies, to adapt the instructions for use or the summary of safety and performance, or to impose other restrictions in its conformity assessment report, as appropriate.
V znanstvenem mnenju navede tudi razloge, na podlagi katerih je sprejel odločitev o predložitvi znanstvenega mnenja na podlagi meril iz točk (i), (ii) in (iii).
The notified body shall provide a full justification where it has not followed the advice of the expert panel in its conformity assessment report and the Commission shall without prejudice to Article 109 make both the scientific opinion of the expert panel and the written justification provided by the notified body publicly available via Eudamed.
Če strokovni odbor zaradi nezadostnih predloženih informacij zaključka ni mogel sprejeti, to navede v znanstvenem mnenju.
The Commission, after consultation with the Member States and relevant scientific experts shall provide guidance for expert panels for consistent interpretation of the criteria in point (c) before 26 May 2020.
Strokovni odbor se lahko pod nadzorom Komisije in na podlagi meril iz točke (c) odloči, da ne predloži znanstvenega mnenja, in v tem primeru o tem priglašeni organ čim prej uradno obvesti, vsekakor pa v 21 dneh od prejema dokumentov iz točke (a) od Komisije.
Procedure in the case of devices incorporating a medicinal substance
V navedenem roku priglašenemu organu in Komisiji navede razloge za svojo odločitev, priglašeni organ pa lahko nato začne postopek certificiranja tega pripomočka.
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma and that has an action ancillary to that of the device, the quality, safety and usefulness of the substance shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.
Strokovni odbor Komisijo v 21 dneh od prejema dokumentov, ki jih je prejel od nje, prek Eudameda obvesti, da namerava predložiti znanstveno mnenje, v skladu s točko (c), ali da znanstvenega mnenja ne namerava predložiti, v skladu s točko (d).
Before issuing an EU technical documentation assessment certificate, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, 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 quality and safety of the substance including the benefit or risk of the incorporation of the substance into the device.
Če mnenje v 60 dneh ni predloženo, lahko priglašeni organ začne postopek certificiranja zadevnega pripomočka.
Where the device incorporates a human blood or plasma derivative or a substance that, if used separately, may be considered to be a medicinal product falling exclusively within the scope of the Annex to Regulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA.
Priglašeni organ ustrezno upošteva stališča, izražena v znanstvenem mnenju strokovnega odbora.
When issuing its opinion, the medicinal products authority consulted shall take into account the manufacturing process and the data relating to the usefulness of incorporation of the substance into the device as determined by the notified body.
Kadar strokovni odbor ugotovi, da raven kliničnih dokazov ni zadostna ali da na kakršen koli drug način vzbuja resne pomisleke glede določitve razmerja med koristmi in tveganji, skladnosti teh dokazov s predvidenim namenom, vključno z zdravstveno indikacijo ali indikacijami in načrtom kliničnega spremljanja po dajanju na trg, priglašeni organ po potrebi proizvajalcu svetuje, naj omeji predvideni namen pripomočka na določene skupine pacientov ali določene zdravstvene indikacije in/ali omeji trajanje veljavnosti certifikata, opravi specifične študije kliničnega spremljanja po dajanju na trg, prilagodi navodila za uporabo ali zbirno poročilo o varnosti in učinkovitosti ali uvede druge omejitve v svojem poročilu o ugotavljanju skladnosti, kot je ustrezno.
The medicinal products authority consulted shall provide its opinion to the notified body within 210 days of receipt of all the necessary documentation.
Priglašeni organ v svojem poročilu o ugotavljanju skladnosti ustrezno utemelji primere, pri katerih ni upošteval mnenja strokovnega odbora, Komisija pa brez poseganja v člen 109 prek Eudameda omogoči javni dostop do znanstvenega mnenja strokovnega odbora in pisne utemeljitve priglašenega organa.
The scientific opinion of the medicinal products authority consulted, and any possible update of that opinion, shall be included in the documentation of the notified body concerning the device.
Komisija – po posvetovanju z državami članicami in ustreznimi znanstvenimi strokovnjaki – strokovnim odborom zagotovi smernice za usklajeno razlago meril iz točke (c) pred 26. majem 2020.
The notified body shall give due consideration to the views expressed in the scientific opinion when making its decision.
Postopek v primeru pripomočkov, ki vsebujejo zdravilne učinkovine
The notified body shall not deliver the certificate if the scientific opinion is unfavourable and shall convey its final decision to the medicinal products authority consulted.
Kadar pripomoček kot sestavni del vsebuje učinkovino, ki se ob ločeni uporabi lahko šteje za zdravilo v smislu točke 2 člena 1 Direktive 2001/83/ES, vključno z zdravilom, pridobljenim iz človeške krvi ali človeške plazme, in ki dopolnjujejo učinek pripomočkov, se kakovost, varnost in uporabnost učinkovine preverijo po analogiji z metodami, opredeljenimi v Prilogi I k Direktivi 2001/83/ES.
Before any change is made with respect to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the manufacturer shall inform the notified body of the changes.
Potem ko preveri uporabnost učinkovine kot dela pripomočka in ob upoštevanju predvidenega namena 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 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 kakovosti in varnosti učinkovine, vključno o koristih ali tveganjih, povezanih z vključitvijo učinkovine v pripomoček.
That notified body shall seek the opinion of the medicinal products authority consulted, in order to confirm that the quality and safety of the ancillary substance remain unchanged.
Kadar pripomoček vsebuje derivat človeške krvi ali plazme ali učinkovino, ki se ob ločeni uporabi lahko šteje za zdravilo, ki spada izključno v področje uporabe Priloge k Uredbi (ES) št. 726/2004, priglašeni organ zaprosi za mnenje EMA.
The medicinal products authority consulted shall take into account the data relating to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the risk or benefit previously established concerning the incorporation of the substance into the device.
Organ za zdravila, ki je bil zaprošen za mnenje, ob izdaji mnenja upošteva postopek izdelave in podatke o koristnosti vključitve učinkovine v pripomoček, kot jo določa priglašeni organ.
The medicinal products authority consulted shall provide its opinion within 60 days after receipt of all the necessary documentation regarding the changes.
Organ za zdravila, ki je bil zaprošen za mnenje, priglašenemu organu v 210 dneh od prejema vse potrebne dokumentacije sporoči svoje mnenje.
The notified body shall not deliver the supplement to the EU technical documentation assessment certificate if the scientific opinion provided by the medicinal products authority consulted is unfavourable.
Znanstveno mnenje organa za zdravila, ki je bil zaprošen za mnenje, in vse morebitne spremembe tega mnenja se vključijo v dokumentacijo priglašenega organa o pripomočku.
The notified body shall convey its final decision to the medicinal products authority consulted.
Priglašeni organ pri sprejemanju odločitev ustrezno upošteva stališča, izražena v znanstvenem mnenju.
Where the medicinal products authority consulted obtains information on the ancillary substance, which could have an impact on the risk or benefit previously established concerning the incorporation of the substance into the device, it shall advise the notified body as to whether this information has an impact on the risk or benefit previously established concerning the incorporation of the substance into the device.
V primeru negativnega znanstvenega mnenja ne izda certifikata in o dokončni odločitvi obvesti organ za zdravila, ki je bil zaprošen za mnenje.
The notified body shall take that advice into account in reconsidering its assessment of the conformity assessment procedure.
Pred vsako spremembo, ki se nanaša na pomožno snov, vključeno v pripomoček, zlasti v zvezi z njegovim postopkom izdelave, proizvajalec o spremembah obvesti priglašeni organ.