natgillin/translations-raw huggingface dataset:
Article 66
Sponzor študije učinkovitosti iz člena 58(1) in (2) vnese in vloži vlogo v državah članicah, v katerih se bo študija učinkovitosti izvajala (v tem členu imenovana: zadevna država članica), ter ji priloži dokumentacijo iz oddelkov 2 in 3 Priloge XIII in iz Priloge XIV.
Application for performance studies
Vlogo se vloži prek elektronskega sistema iz člena 69 za to študijo učinkovitosti ustvari enotno identifikacijsko številko, ki je edinstvena za celotno Unijo in se uporablja za vso komunikacijo v zvezi s to študijo učinkovitosti.
The sponsor of a performance study referred to in Article 58(1) and (2) shall enter and submit an application to the Member State(s) in which the performance study is to be conducted (referred to for the purposes of this Article as ‘Member State concerned’) accompanied by the documentation referred to in Sections 2 and 3 of Annex XIII and in Annex XIV.
Zadevna država članica v desetih dneh po prejemu vloge uradno obvesti sponzorja, ali študija učinkovitosti spada v področje uporabe te uredbe in ali je v skladu s poglavjem I Priloge XIV dosje popoln.
The application shall be submitted by means of the electronic system referred to in Article 69, which shall generate a Union-wide unique single identification number for the performance study which shall be used for all relevant communication in relation to that performance study.
Sponzor v enem tednu po vsaki spremembi dokumentacije iz poglavja I Priloge XIV v elektronskem sistemu iz člena 69 posodobi ustrezne podatke in poskrbi, da je zadevna sprememba dokumentacije jasno prepoznavna.
Within 10 days of receiving the application, the Member State concerned shall notify the sponsor as to whether the performance study falls within the scope of this Regulation and as to whether the application dossier is complete in accordance with Chapter I of Annex XIV.
Zadevna država članica je o posodobitvi uradno obveščena prek navedenega elektronskega sistema.
Within one week of any change occurring in relation to the documentation referred to in Chapter I of Annex XIV, the sponsor shall update the relevant data in the electronic system referred to in Article 69 and make that change to the documentation clearly identifiable.
Če zadevna država članica ugotovi, da študija učinkovitosti, za katero je bila vložena vloga, ne spada v področje uporabe te uredbe ali da vloga ni popolna, o tem obvesti sponzorja in določi rok največ deset dni, v katerih lahko sponzor prek elektronskega sistema iz člena 69 predloži pripombe ali dopolni vlogo.
The Member State concerned shall be notified of the update by means of that electronic system.
Zadevne države članice lahko ta rok podaljšajo za največ 20 dni, kadar je to ustrezno.
Where the Member State concerned finds that the performance study applied for does not fall within the scope of this Regulation or that the application is not complete, it shall inform the sponsor thereof and shall set a time limit of maximum 10 days for the sponsor to comment or to complete the application by means of the electronic system referred to in Article 69.
Če sponzor v roku iz prvega pododstavka ne predloži nobenih pripomb in ne dopolni vloge, se šteje, da je vloga zapadla.
The Member State concerned may extend this period by a maximum of 20 days where appropriate.
Če sponzor meni, da vloga spada v področje uporabe te uredbe in/ali da je popolna, zadevna država članica pa se s tem ne strinja, se šteje, da je vloga zavrnjena.
Where the sponsor has not provided comments nor completed the application within the time limit referred to in the first subparagraph, the application shall be deemed to have lapsed.
Zadevna država članica poskrbi, da je v zvezi s takšno zavrnitvijo omogočen postopek pritožbe.
Where the sponsor considers that the application falls under the scope of this Regulation and/or is complete but the Member State concerned does not agree, the application shall be considered to have been rejected.
Zadevna država članica sponzorja v petih dneh po prejemu pripomb ali zahtevanih dodatnih informacij uradno obvesti, ali se šteje, da študija učinkovitosti spada v področje uporabe te uredbe in da je vloga popolna.
The Member State concerned shall provide for an appeal procedure in respect of such refusal.
Zadevna država članica lahko roka iz odstavkov 1 in 3 podaljša za dodatnih pet dni.
The Member State concerned shall notify the sponsor within five days of receipt of the comments or of the requested additional information, whether the performance study is considered as falling within the scope of this Regulation and the application is complete.
V tem poglavju se datum, ko je sponzor uradno obveščen v skladu z odstavkom 1 ali 3, šteje za datum potrditve vloge.
The Member State concerned may also extend the period referred to in paragraphs 1 and 3 each by a further five days.
Če sponzor ni uradno obveščen, se za datum potrditve šteje zadnji dan rokov iz odstavkov 1, 3 oziroma 4.
For the purposes of this Chapter, the date on which the sponsor is notified in accordance with paragraph 1 or 3 shall be the validation date of the application.
V obdobju, v katerem se vloga ocenjuje, lahko država članica od sponzorja zahteva dodatne informacije.
Where the sponsor is not notified, the validation date shall be the last day of the periods referred to in paragraphs 1, 3 and 4 respectively.
Tek roka iz točke (b) odstavka 7 se od datuma prvega zahtevka do prejema dodatnih informacij prekine.
During the period when the application is being assessed the Member State may request additional information from the sponsor.
Sponzor lahko začne izvajati študijo učinkovitosti v naslednjih okoliščinah:
The expiry of the deadline pursuant to the point (b) of paragraph 7 shall be suspended from the date of the first request until such time as the additional information has been received.
v primeru študij učinkovitosti, izvedenih v skladu s točko (a) člena 58(1), in če odvzem vzorca ne pomeni večjega kliničnega tveganja za udeleženca v študiji, razen če nacionalno pravo ne določa drugače, takoj po datumu potrditve vloge iz odstavka 5 tega člena, in sicer pod pogojem, da pristojni odbor za etiko v zadevni državi članici v zvezi s študijo učinkovitosti ni dal negativnega mnenja, ki bi v skladu z njenim nacionalnim pravom veljalo za to državo članico kot celoto;
The sponsor may start the performance study in the following circumstances:
v primeru študij učinkovitosti, izvedenih na podlagi točk (b) in (c) člena 58(1) in člena 58(2), ali študij učinkovitosti, razen študij učinkovitosti iz točke (a) tega odstavka, takoj ko zadevna država članica sponzorja uradno obvesti o dovoljenju in pod pogojem, da pristojni odbor za etiko v zadevni državi članici v zvezi s študijo učinkovitosti ni dal negativnega mnenja, ki bi v skladu z njenim nacionalnim pravom veljalo za to državo članico kot celoto.
in the case of performance studies carried out pursuant to point (a) of Article 58(1) and where the specimen collection does not represent a major clinical risk to the subject of the study, unless otherwise stated by national law, immediately after the validation date of application described in paragraph 5 of this Article, provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study;
Država članica uradno obvesti sponzorja o dovoljenju v 45 dneh po datumu potrditve vloge iz odstavka 5.
in the case of performance studies carried out pursuant to points (b) and (c) of Article 58(1) and Article 58(2) or performance studies other than those referred to in point (a) of this paragraph, as soon as the Member State concerned has notified the sponsor of its authorisation and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the performance study.
Država članica lahko ta rok podaljša za dodatnih 20 dni zaradi posvetovanja s strokovnjaki.
The Member State shall notify the sponsor of the authorisation within 45 days of the validation date of the application referred to in paragraph 5.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 108, s katerimi zaradi tehničnega napredka in razvoja v mednarodnem ureditvenem okviru spremeni zahteve iz poglavja I Priloge XIV.
The Member State may extend this period by a further 20 days for the purpose of consulting with experts.
Da bi se zagotovila enotna uporaba zahtev, določenih v poglavju I Priloge XIV, lahko Komisija sprejme izvedbene akte, če je to potrebno za rešitev vprašanj različne razlage in praktične uporabe.
The Commission is empowered to adopt delegated acts in accordance with Article 108 amending, in the light of technical progress and global regulatory developments, the requirements laid down in Chapter I of Annex XIV.
Člen 67
In order to assure the uniform application of the requirements laid down in Chapter I of Annex XIV, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and practical application.
Ocena s strani držav članic
Article 67
Države članice zagotovijo, da osebe, ki preverjajo in ocenjujejo vlogo ali o njej odločajo, nimajo nasprotnih interesov, so neodvisne od sponzorja, raziskovalcev, ki sodelujejo pri študiji, ter fizičnih ali pravnih oseb, ki financirajo študijo učinkovitosti, ter tudi sicer niso izpostavljene nobenemu nedovoljenemu vplivu.
Assessment by Member States
Države članice zagotovijo, da pri oceni sodeluje ustrezno število oseb, ki imajo skupaj potrebne kvalifikacije in izkušnje.
Member States shall ensure that the persons validating and assessing the application, or deciding on it, do not have conflicts of interest, are independent of the sponsor, the investigators involved and of natural or legal persons financing the performance study, as well as free of any other undue influence.
Države članice ocenijo, ali je študija učinkovitosti zasnovana tako, da so po zmanjšanju tveganj morebitna preostala tveganja za udeležence ali tretje osebe upravičena v primerjavi s pričakovanimi kliničnimi koristmi.
Member States shall ensure that the assessment is done jointly by a reasonable number of persons who collectively have the necessary qualifications and experience.
Ob upoštevanju veljavnih skupnih specifikacij ali harmoniziranih standardov preučijo zlasti:
Member States shall assess whether the performance study is designed in such a way that potential remaining risks to subjects or third persons, after risk minimization, are justified, when weighed against the clinical benefits to be expected.
dokaz o skladnosti pripomočkov za študijo učinkovitosti z veljavnimi splošnimi zahtevami glede varnosti in učinkovitosti, razen vidikov, zajetih v študiji učinkovitosti, in ali so bili v zvezi s temi vidiki sprejeti vsi previdnostni ukrepi za zaščito zdravja in varnosti udeležencev.
They shall, while taking into account applicable CS or harmonised standards, examine in particular:
To v primeru študij učinkovitosti vključuje oceno analitske učinkovitosti in v primeru intervencijskih študij klinične učinkovitosti oceno analitske in klinične učinkovitosti ter znanstvene veljavnosti, ob upoštevanju zadnjega stanja tehničnega razvoja;
the demonstration of compliance of the device(s) for performance study with the applicable general safety and performance requirements, apart from the aspects covered by the performance study, and whether, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects.
ali so rešitve za zmanjšanje tveganja, ki jih uporablja sponzor, opisane v harmoniziranih standardih, ter v primerih, ko sponzor ne uporablja harmoniziranih standardov, ali so rešitve za minimizacijo tveganj zagotavljajo raven zaščite, ki je enakovredna tisti, ki jo zagotavljajo harmonizirani standardi;
This includes, in case of performance studies, the evaluation of the analytical performance, and in case of interventional clinical performance studies, the evaluation of the analytical performance, clinical performance and scientific validity, taking into consideration the state of the art;
ali so ukrepi, načrtovani za varno montažo, dajanje v uporabo in vzdrževanje pripomočka za študijo učinkovitosti, ustrezni;
whether the risk-minimisation solutions employed by the sponsor are described in harmonised standards and, in those cases where the sponsor does not use harmonised standards, whether the risk-minimisation solutions provide a level of protection that is equivalent to that provided by harmonised standards;
zanesljivost in ponovljivost podatkov, pridobljenih v okviru študije učinkovitosti, ob upoštevanju statistične obdelave, zasnove študije učinkovitosti in metodoloških vidikov, vključno z velikostjo vzorca, primerjalnim pripomočkom in merili učinkovitosti;
whether the measures planned for the safe installation, putting into service and maintenance of the device for performance study are adequate;
izpolnjevanje zahtev iz Priloge XIV.
the reliability and robustness of the data generated in the performance study, taking account of statistical approaches, design of the performance study and methodological aspects, including sample size, comparator and endpoints;
Države članice zavrnejo dovoljenje za študijo učinkovitosti, če:
whether the requirements of Annex XIV are met.
je vloga, predložena v skladu s členom 66(3), še vedno pomanjkljiva;
Member States shall refuse the authorisation of the performance study if:
pripomoček ali predloženi dokumenti, zlasti načrt študije učinkovitosti in brošura za raziskovalca, ne ustrezajo znanstvenim dognanjem, študija učinkovitosti kot takšna pa ni ustrezna za zagotavljanje dokazov o lastnostih glede varnosti in učinkovitosti ali koristnosti pripomočka za udeležence ali paciente;
the application dossier submitted pursuant to Article 66(3) remains incomplete;
zahteve iz člena 58 niso izpolnjene, ali
the device or the submitted documents, especially the performance study plan and the investigator's brochure, do not correspond to the state of scientific knowledge, and the performance study, in particular, is not suitable for providing evidence for the safety, performance characteristics or benefit of the device on subjects or patients;
je kakršna koli ocena na podlagi odstavka 3 negativna.
the requirements of Article 58 are not met; or
Država članica omogoči postopek pritožbe v zvezi z zavrnitvijo na podlagi prvega pododstavka.
any assessment under paragraph 3 is negative.
Člen 68
Member States shall provide for an appeal procedure in respect of a refusal pursuant to the first subparagraph.
Izvedba študije učinkovitosti
Article 68
Sponzor in raziskovalec zagotovita, da se študija učinkovitosti izvaja v skladu z odobrenim načrtom študije učinkovitosti.
Conduct of a performance study
Da se preveri ustrezna zaščita pravic, varnosti in dobrega počutja udeležencev, zanesljivost in ponovljivosti podatkov ter skladnost študije učinkovitosti z zahtevami te uredbe, sponzor zagotovi ustrezno spremljanje izvajanja študije učinkovitosti.
The sponsor and the investigator shall ensure that the performance study is conducted in accordance with the approved performance study plan.
Sponzor določi obseg in naravo spremljanja na podlagi ocene, ki upošteva vse značilnosti študije učinkovitosti, vključno z naslednjimi:
In order to verify that the rights, safety and well-being of subjects are protected, that the reported data are reliable and robust, and that the conduct of the performance study is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a performance study.
cilj in metodologija študije učinkovitosti ter
The extent and nature of the monitoring shall be determined by the sponsor on the basis of an assessment that takes into consideration all characteristics of the performance study including the following:
stopnja odstopanja intervencije od običajne študije učinkovitosti.
the objective and methodology of the performance study; and
Sponzor ali raziskovalec, kot je ustrezno, evidentira, obdeluje, obravnava in shranjuje vse informacije o študiji učinkovitosti tako, da omogoči natančno poročanje, razlago in preverjanje informacij, zaupnost evidenc in osebnih podatkov udeležencev pa je še vedno zagotovljena v skladu z veljavno zakonodajo o varstvu osebnih podatkov.
the degree of deviation of the intervention from normal clinical practice.
Izvedejo se ustrezni tehnični in organizacijski ukrepi za zaščito obdelanih informacij in osebnih podatkov pred nepooblaščenim ali nezakonitim dostopanjem, razkritjem, razširjanjem, spreminjanjem, uničenjem ali nenamerno izgubo, zlasti kadar obdelava zajema prenos prek omrežja.
All performance study information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable law on personal data protection.
Države članice na ustrezni ravni pregledajo mesto oziroma mesta študije učinkovitosti, da preverijo, ali se študije učinkovitosti izvajajo v skladu z zahtevami te uredbe in odobrenim načrtom raziskave.
Appropriate technical and organisational measures shall be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss, in particular where the processing involves transmission over a network.
Sponzor določi postopek za nujne primere, ki omogoča takojšnjo identifikacijo in po potrebi takojšnji odpoklic pripomočkov, uporabljenih v študiji.
Member States shall inspect, at an appropriate level, performance study site(s) to check that performance studies are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.
Člen 69
The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the study.
Elektronski sistem za študije učinkovitosti
Article 69
Komisija v sodelovanju z državami članicami vzpostavi, upravlja in vzdržuje elektronski sistem:
Electronic system on performance studies
za ustvarjanje v členu 66(1) navedenih enotnih identifikacijskih številk za študije učinkovitosti;
The Commission shall, in collaboration with the Member States, set up, manage and maintain an electronic system:
ki se uporablja kot vstopna točka za predložitev vseh vlog ali uradnih obvestil za študije učinkovitosti iz členov 66, 70, 71 in 74 ter za vse druge predložitve podatkov ali obdelave podatkov v zvezi s tem;
to create the single identification numbers for performance studies referred to in Article 66(1);
za izmenjavo informacij v zvezi s študijami učinkovitosti v smislu te uredbe, in sicer med državami članicami ter med njimi in Komisijo, vključno z izmenjavo informacij iz členov 72 in 74;
to be used as an entry point for the submission of all applications or notifications for performance studies referred to in Articles 66, 70, 71 and 74 and for all other submission of data, or processing of data in this context;
za informacije, ki jih predloži sponzor v skladu s členom 73, vključno s poročilom o študiji učinkovitosti in njegovim povzetkom, kakor je predpisano v odstavku 5 navedenega člena;
for the exchange of information relating to performance studies in accordance with this Regulation between the Member States and between them and the Commission including the exchange of information referred to in to Articles 72 and 74;
za poročanje o resnih neželenih dogodkih in pomanjkljivostih pripomočka ter s tem povezanih posodobitvah v skladu s členom 76.
for information to be provided by the sponsor in accordance with Article 73, including the performance study report and its summary as required in paragraph 5 of that Article;
Komisija pri vzpostavljanju elektronskega sistema iz odstavka 1 tega člena zagotovi, da je ta – kar zadeva študije učinkovitosti za dopolnilno diagnostiko – povezljiv s podatkovno zbirko EU za klinična preskušanja zdravil za uporabo v humani medicini, ustanovljeno v skladu s členom 81 Uredbe (EU) št. 536/2014 Evropskega parlamenta in Sveta [26].
for reporting on serious adverse events and device deficiencies, and related updates referred to in Article 76.
Informacije iz točke (c) odstavka 1 so dostopne le državam članicam in Komisiji.
When setting up the electronic system referred to in paragraph 1 of this Article, the Commission shall ensure that it is interoperable with the EU database for clinical trials on medicinal products for human use set up in accordance with Article 81 of Regulation (EU) No 536/2014 of the European Parliament and of the Council [26] as concerns performance studies of companion diagnostics.
Informacije iz drugih točk navedenega odstavka so javno dostopne, razen če je vse te informacije ali njihove dele upravičeno treba obravnavati zaupno zaradi:
The information referred to in point (c) of paragraph 1 shall only be accessible to the Member States and the Commission.
varstva osebnih podatkov v skladu z Uredbo (ES) št. 45/2001;
The information referred to in the other points of that paragraph shall be accessible to the public, unless, for all or parts of that information, confidentiality of the information is justified on any of the following grounds:
varstva zaupnih poslovnih informacij, predvsem v brošuri za raziskovalce, pri čemer se zlasti upošteva status ugotavljanja skladnosti pripomočka, razen če ne prevlada javni interes za razkritje;
protection of personal data in accordance with Regulation (EC) No 45/2001;
učinkovitega nadzora poteka študije učinkovitosti, ki ga opravljajo zadevna država članica oziroma zadevne države članice.
protection of commercially confidential information, especially in the investigators brochure, in particular through taking into account the status of the conformity assessment for the device, unless there is an overriding public interest in disclosure;
Nobeni osebni podatki udeležencev niso javno dostopni.
effective supervision of the conduct of the performance study by the Member State(s) concerned.
Uporabniški vmesnik elektronskega sistema iz odstavka 1 je na voljo v vseh uradnih jezikih Unije.
No personal data of subjects shall be publicly available.
Člen 70
The user interface of the electronic system referred to in paragraph 1 shall be available in all official languages of the Union.
Študije učinkovitosti v zvezi s pripomočki z oznako CE
Article 70
Kadar je treba izvesti študijo učinkovitosti za dodatno oceno pripomočka, ki že ima oznako CE v skladu s členom 18(1), in sicer v okviru njegovega predvidenega namena (v nadaljnjem besedilu: študija v sklopu spremljanja učinkovitosti po dajanju na trg), in morajo zaradi te študije učinkovitosti udeleženci sodelovati tudi pri drugih, invazivnih ali obremenjujočih postopkih poleg tistih, ki se izvajajo pri običajnih pogojih uporabe pripomočka, sponzor najmanj 30 dni pred začetkom raziskave prek elektronskega sistema iz člena 69 uradno obvesti zadevne države članice.
Performance studies regarding devices bearing the CE marking
Sponzor v uradno obvestilo vključi dokumentacijo iz oddelka 2 dela A Priloge XIII in iz Priloge XIV.
Where a performance study is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 18(1) (‘PMPF study’), and where the performance study would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome, the sponsor shall notify the Member States concerned at least 30 days prior to its commencement by means of the electronic system referred to in Article 69.
Za študije v sklopu spremljanja učinkovitosti po dajanju na trg se uporabljajo točke (b) do (l) in točka (p) člena 58(5) ter členi 71, 72 in 73, člen 76(5) ter ustrezne določbe prilog XIII in XIV.