natgillin/translations-raw huggingface dataset:
In the case of class C devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 of for the device or devices concerned on the basis of further representative samples chosen in accordance with the rationale documented by the notified body in accordance with the third paragraph of Section 2.3.
informacije, ki se zagotovijo s pripomočkom na njegovi oznaki in v navodilih za uporabo.
Notified bodies shall ensure that the composition of the assessment team is such that there is sufficient experience with the evaluation of the devices, systems and processes concerned, continuous objectivity and neutrality; this shall include a rotation of the members of the assessment team at appropriate intervals.
Priglašeni organ lahko zahteva, naj se vloga dopolni z izvedbo nadaljnjih preskusov ali predložitvijo nadaljnjih dokazov, da se omogoči ugotavljanje skladnosti z zahtevami iz te uredbe.
As a general rule, a lead auditor shall neither lead nor attend audits for more than three consecutive years in respect of the same manufacturer.
Priglašeni organ preveri skladnost pripomočka z ustreznimi zahtevami iz Priloge I k tej uredbi.
If the notified body finds a divergence between the sample taken from the devices produced or from the market and the specifications laid down in the technical documentation or the approved design, it shall suspend or withdraw the relevant certificate or impose restrictions on it.
Priglašeni organ za oceno vloge zaposli osebje z dokazanim znanjem in izkušnjami v zvezi z zadevno tehnologijo in predvidenim namenom pripomočka ter proizvajalcu pošlje poročilo o ocenjevanju tehnične dokumentacije.
ASSESSMENT OF THE TECHNICAL DOCUMENTATION
Certifikat vključuje zaključke ocene, pogoje njegove veljavnosti, podatke, potrebne za identifikacijo odobrenih pripomočkov, in, kjer je ustrezno, opis predvidenega namena pripomočka.
Assessment of the technical documentation of class B, C and D devices and batch verification applicable to class D devices
Kadar namerava proizvajalec vpeljati katere koli od zgoraj navedenih sprememb, o tem obvesti priglašeni organ, ki je izdal certifikat EU o oceni tehnične dokumentacije.
In addition to the obligation laid down in Section 2, the manufacturer of devices shall lodge with the notified body an application for the assessment of the technical documentation relating to the device which it plans to place on the market or put into service and which is covered by the quality management system referred to in Section 2.
Ocenjevanje tehnične dokumentacije pripomočkov za dopolnilno diagnostiko
The application shall describe the design, manufacture and performance of the device in question.
Proizvajalec pripomočka za dopolnilno diagnostiko pri priglašenem organu vloži vlogo za ocenjevanje tehnične dokumentacije.
It shall include the technical documentation as referred to in Annexes II and III.
Priglašeni organ oceni vlogo v skladu s postopkom, določenim v oddelkih 4.1. do 4.8. te priloge.
In the case of devices for self-testing or near-patient testing, the application shall also include the aspects referred to in point (b) of Section 5.1.
Vloga omogoči razumevanje značilnosti in učinkovitosti pripomočka in oceno skladnosti z zahtevami iz te uredbe, povezanimi z zasnovo, zlasti v zvezi s primernostjo pripomočka glede na zadevno zdravilo.
The notified body shall examine the application by using staff, employed by it, with proven knowledge and experience in the evaluation of the technology, and the devices concerned and the evaluation of clinical evidence.
Pred izdajo certifikata EU o oceni tehnične dokumentacije za dopolnilno diagnostiko ter na podlagi osnutka povzetka o varnosti in učinkovitosti in osnutka navodil za uporabo priglašeni organ v zvezi s primernostjo pripomočka glede na zadevno zdravilo pridobi znanstveno mnenje enega od pristojnih organov, ki jih imenujejo države članice v skladu z Direktivo 2001/83/ES ali EMA; tako pristojni organ kot EMA se v nadaljevanju štejeta za „organ za zdravila, ki je bil zaprošen za mnenje“, odvisno od tega, kateri je bil zaprošen za mnenje na podlagi te točke.
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.
Kadar zdravilo spada izključno v področje uporabe Priloge k Uredbi (ES) št. 726/2004 Evropskega parlamenta in Sveta [1], priglašeni organ pridobi mnenje EMA.
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.
Če je zadevno zdravilo že odobreno ali je bila vložena vloga za njegovo odobritev, se priglašeni organ posvetuje s organom za zdravila ali z EMA, ki je pristojen(a) za izdajo dovoljenja.
The notified body shall review the clinical evidence presented by the manufacturer in the performance evaluation report and the related performance evaluation that was conducted.
Organ za zdravila, ki je bil zaprošen za mnenje, priglašenemu organu v 60 dneh od prejema vse potrebne dokumentacije sporoči svoje mnenje.
The notified body shall use employed device reviewers with sufficient clinical expertise and including external clinical experts with direct and current experience relating to the clinical application of the device in question for the purposes of that review.
To 60-dnevno obdobje se lahko iz utemeljenih razlogov podaljša enkrat za nadaljnjih 60 dni.
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.
Mnenje in morebitne spremembe tega mnenja se vključijo v dokumentacijo priglašenega organa o pripomočku.
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 pri sprejemanju odločitev ustrezno upošteva znanstveno mnenje iz točke (d).
The notified body shall verify that the clinical evidence and the performance 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 svojo končno odločitev sporoči organu za zdravila, ki je bil zaprošen za mnenje.
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 PMPF plan proposed, where applicable.
Certifikat EU o oceni tehnične dokumentacije se izda v skladu s točko (e) oddelka 5.1.
Based on its assessment of the clinical evidence, the notified body shall consider the performance 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 PMPF data.
Pred uvedbo sprememb, ki vplivajo na učinkovitost in/ali predvideno uporabo in/ali primernost pripomočka glede na zadevno zdravilo, proizvajalec o spremembah obvesti priglašeni organ.
The notified body shall clearly document the outcome of its assessment in the performance evaluation assessment report.
V slednjem primeru priglašeni organ oceni spremembe in zaprosi za mnenje organ za zdravila, ki je bil zaprošen za mnenje.
Before issuing an EU technical documentation assessment certificate, the notified body shall request an 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.
Organ za zdravila, ki je bil zaprošen za mnenje, da svoje mnenje v 30 dneh od prejema vse potrebne dokumentacije v zvezi s spremembami.
The verification shall include laboratory tests by the EU reference laboratory as referred to in Article 48(5).
Dopolnilo certifikata EU o oceni tehnične dokumentacije se izda v skladu s točko (f) oddelka 5.1.
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 in accordance with the procedure laid down in Article 48(6) of this Regulation on the performance evaluation report of the manufacturer.
UPRAVNE DOLOČBE
The EU reference laboratory shall provide a scientific opinion within 60 days.
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:
The scientific opinion of the EU reference laboratory and, where applicable, the views of the experts consulted, pursuant to the procedure laid down in Article 48(6), and any possible updates shall be included in the documentation of the notified body concerning the device.
izjavo EU o skladnosti;
The notified body shall, when making its decision, 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 pursuant to Article 48(6).
dokumentacijo iz pete alineje oddelka 2.1 ter zlasti podatke in evidence, ki izhajajo iz postopkov iz točke (c) drugega odstavka oddelka 2.2;
The notified body shall not deliver the certificate if the scientific opinion of the EU reference laboratory is unfavourable.
informacije o spremembah iz oddelka 2.4;
The notified body shall provide the manufacturer with a report on the technical documentation assessment, including a performance evaluation assessment report.
dokumentacijo iz oddelka 4.2 in točke (b) oddelka 5.1 ter
If the device conforms to the relevant provisions of this Regulation, the notified body shall issue an EU technical documentation assessment certificate.
odločitve in poročila priglašenega organa iz te priloge.
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 device, and, where appropriate, a description of the intended purpose of the device.
Vsaka država članica zagotovi, da je dokumentacija iz oddelka 6 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.
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.
Uredba (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila (UL L 136, 30.4.2004, str. 1).
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.
PRILOGA X
The notified body shall assess the planned changes and decide whether the planned changes require a new conformity assessment in accordance with Article 48 or whether they could be addressed by means of a supplement to the EU technical documentation assessment certificate.
UGOTAVLJANJE SKLADNOSTI NA PODLAGI PREGLEDA TIPA
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.
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, izpolnjuje ustrezne določbe iz te uredbe.
Where the changes could affect compliance with the CS or with other solutions chosen by the manufacturer which were approved through the EU technical documentation assessment 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 or with other solutions chosen by the manufacturer, to ensure a level of safety and performance that is at least equivalent, is maintained.
Vloga
To verify conformity of manufactured class D devices, the manufacturer shall carry out tests on each manufactured batch of devices.
Proizvajalec pri priglašenem organu vloži vlogo za ugotavljanje skladnosti.
After the conclusion of the controls and tests, it shall forward to the notified body, without delay, the relevant reports on those tests.
ime proizvajalca in naslov njegovega registriranega kraja poslovanja ter, če vlogo vloži pooblaščeni predstavnik, ime pooblaščenega predstavnika in naslov njegovega registriranega kraja poslovanja;
Furthermore, the manufacturer shall make the samples of manufactured batches of devices available to the notified body in accordance with pre-agreed conditions and detailed arrangements which shall include that the notified body or the manufacturer shall send samples of the manufactured batches of devices to the EU reference laboratory, where such a laboratory has been designated in accordance with Article 100, to carry out appropriate tests.
tehnično dokumentacijo iz prilog II in III.
The EU reference laboratory shall inform the notified body about its findings.
Vložnik priglašenemu organu omogoči dostop do reprezentativnega vzorca predvidene proizvodnje pripomočka („tip“).
The manufacturer may place the devices on the market, unless the notified body communicates to the manufacturer within the agreed timeframe, but not later than 30 days after reception of the samples, any other decision, including in particular any condition of validity of delivered certificates.
Priglašeni organ lahko po potrebi zahteva druge vzorce;
Assessment of the technical documentation of specific types of devices
v primeru pripomočkov za samotestiranje ali testiranje ob pacientu poročila o preskusih, vključno z rezultati študij, opravljenih s predvidenimi uporabniki, in podatke, ki kažejo primernost ravnanja s pripomočkom glede na predvideni namen za samotestiranje ali testiranje ob pacientu;
Assessment of the technical documentation of class B, C and D devices for self-testing and near-patient testing
kjer je izvedljivo, primerek pripomočka.
The manufacturer of class B, C and D devices for self-testing and near-patient testing shall lodge with the notified body an application for the assessment of the technical documentation.
Po potrebi se pripomoček vrne po opravljenem ocenjevanju tehnične dokumentacije;
The application shall enable the design of the device characteristics and performance(s) to be understood and shall enable conformity with the design-related requirements of this Regulation to be assessed.
podatke, ki kažejo primernost pripomočka glede na njegov predvideni namen za samotestiranje ali testiranje ob pacientu;
It shall include:
informacije, ki se zagotovijo s pripomočkom na njegovi oznaki in v navodilih za uporabo in
test reports, including results of studies carried out with intended users;
pisno izjavo, da vloga ni bila vložena pri nobenem drugem priglašenem organu za isti tip, ali informacije o morebitni predhodni vlogi za isti tip, ki jo je drug priglašeni organ zavrnil ali ki jo je proizvajalec ali njegov pooblaščeni predstavnik umaknil, preden je ta drug priglašeni organ izvedel končno oceno.
where practicable, an example of the device; if required, the device shall be returned on completion of the technical documentation assessment;
Ocenjevanje
data showing the suitability of the device in view of its intended purpose for self-testing or near patient-testing;
opravi pregled vloge s pomočjo osebja z dokazanim znanjem in izkušnjami pri ocenjevanju zadevne tehnologije in pripomočkov ter ocenjevanju kliničnih dokazov.
the information to be provided with the device on its label and its instructions for use.
Priglašeni organ opravi ustrezne fizikalne ali laboratorijske preskuse v zvezi s pripomočkom ali proizvajalcu naroči, da take preskuse opravi;
The notified body may require the application to be completed by carrying out further tests or by providing further proof to allow assessment of conformity with the requirements of this Regulation.
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;
The notified body shall verify the compliance of the device with the relevant requirements set out in Annex I of this Regulation.
pregleda klinične dokaze, ki jih predstavi proizvajalec v poročilu o oceni učinkovitosti v skladu z oddelkom 1.3.2 Priloge XIII.
The notified body shall assess the application, by using staff, employed by it, with proven knowledge and experience regarding the technology concerned and the intended purpose of the device and provide the manufacturer with a technical documentation assessment report.
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 uporabo zadevnega pripomočka;
The certificate shall contain the conclusions of the assessment, the conditions of its validity, the data needed for the identification of the approved devices and, where appropriate, a description of the intended purpose of the device.
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.
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.
Priglašeni organ jasno dokumentira svoje ugotovitve o navedeni enakovrednosti ter o relevantnosti in primernosti podatkov za dokazovanje skladnosti;
Assessment of the technical documentation of companion diagnostics
jasno dokumentira rezultat svojega ocenjevanja v poročilu o vrednotenju ocene učinkovitosti iz oddelka 4.8 Priloge IX;
The manufacturer of a companion diagnostic shall lodge with the notified body an application for the assessment of the technical documentation.
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.
The notified body shall assess that application in accordance with the procedure laid down in Sections 4.1 to 4.8 of this Annex.
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 navede proizvajalec;
The application shall enable the characteristics and performance of the device to be understood, and shall enable conformity with the design-related requirements of this Regulation to be assessed, in particular, with regard to the suitability of the device in relation to the medicinal product concerned.
opravi ali naroči ustrezne ocene in fizikalne ali laboratorijske preskuse, da preveri, ali so bili ustrezni harmonizirani standardi, če se je proizvajalec odločil, da jih uporabi, dejansko tudi uporabljeni;
The notified body shall, before issuing an EU technical documentation assessment certificate for the companion diagnostic and on the basis of the draft summary of safety and performance and the draft instructions for use, 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, regarding the suitability of the device in relation to the medicinal product concerned.
se z vložnikom dogovori o kraju, kjer bodo opravljene potrebne ocene in preskusi;
Where the medicinal product falls exclusively within the scope of the Annex to Regulation (EC) No 726/2004 of the European Parliament and of the Council [1], the notified body shall seek the opinion of the EMA.
pripravi poročilo o EU-pregledu tipa, z rezultati ocen in preskusov, izvedenih na podlagi točk (a) do (g);
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 authority, or the EMA, that is responsible for the authorisation.
za pripomočke razreda D od referenčnega laboratorija EU, določenega v skladu s členom 100, zahteva, da preveri učinkovitost, kot jo navaja proizvajalec, in skladnost pripomočka s skupnimi specifikacijami, kadar so na voljo, ali z drugimi rešitvami, ki jih izbere proizvajalec, da zagotovi vsaj enakovredno raven varnosti in učinkovitosti.
The medicinal products authority consulted shall provide its opinion, within 60 days of receipt of all the necessary documentation.
Preverjanje vključuje laboratorijske preskuse v referenčnem laboratoriju v skladu s členom 48(5).
This 60-day period may be extended once for a further 60 days on justified grounds.
V primerih iz člena 48(6) te uredbe se priglašeni organ posvetuje tudi z ustreznimi strokovnjaki iz člena 106 Uredbe (EU) 2017/745, pri čemer uporablja postopek iz člena 48(6) te uredbe o poročilu proizvajalca o oceni učinkovitosti.
The opinion and any possible update shall be included in the documentation of the notified body concerning the device.
Znanstveno mnenje referenčnega laboratorija EU in, kadar se uporablja postopek iz člena 48(6), mnenja strokovnjakov, s katerimi so bila opravljena posvetovanja, ter morebitne spremembe teh mnenj se vključijo v dokumentacijo pripomočka, ki jo pripravi priglašeni organ.
The notified body shall give due consideration to the scientific opinion referred to in point (d) when making its decision.
Priglašeni organ pri sprejemanju odločitev ustrezno upošteva stališča, izražena v znanstvenem mnenju referenčnega laboratorija EU, in, kjer je ustrezno, strokovnjakov, s katerimi so bila v skladu s členom 48(6) opravljena posvetovanja.
The notified body shall convey its final decision to the medicinal products authority consulted.
Priglašeni organ certifikata ne izda, če je znanstveno mnenje referenčnega laboratorija EU negativno.
The EU technical documentation assessment certificate shall be delivered in accordance with point (e) of Section 5.1.
v primeru pripomočkov za dopolnilno diagnostiko enega od pristojnih organov, ki jih imenujejo države članice v skladu z Direktivo 2001/83/ES ali EMA (tako pristojni organ kot EMA se v nadaljevanju štejeta za „organ za zdravila, ki je bil zaprošen za mnenje“, odvisno od tega, kateri je bil zaprošen za mnenje na podlagi te točke) zaprosi, naj na podlagi osnutka povzetka varnosti in učinkovitosti in osnutka navodil za uporabo da mnenje v zvezi s primernostjo pripomočka glede na zadevno zdravilo.