natgillin/translations-raw huggingface dataset:
in the case of investigational class I devices or in the case of non-invasive class IIa and class IIb devices, unless otherwise stated by national law, immediately after the validation date of the application pursuant to paragraph 5, 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 clinical investigation;
Države članice zavrnejo odobritev klinične raziskave, če:
in the case of investigational devices, other than those referred to in point (a), 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 clinical investigation.
je dosje vloge, predložen v skladu s členom 70(1), še vedno pomanjkljiv;
The Member State shall notify the sponsor of the authorisation within 45 days of the validation date referred to in paragraph 5.
pripomoček ali predloženi dokumenti, zlasti načrt raziskave in brošura za raziskovalca, ne ustrezajo najnovejšim znanstvenim dognanjem, klinična raziskava pa ni primerna, da bi z njo zagotovili dokaze o varnosti, učinkovitosti ali koristi pripomočka za udeležence ali paciente,
The Member State may extend this period by a further 20 days for the purpose of consulting with experts.
zahteve iz člena 62 niso izpolnjene, ali
The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress and global regulatory developments, the requirements laid down in Chapter II of Annex XV.
je kakršna koli ocena na podlagi odstavka 3 negativna.
In order to ensure the uniform application of the requirements laid down in Chapter II of Annex XV, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application.
Država članica poskrbi, da je v zvezi z zavrnitvijo na podlagi prvega pododstavka omogočen postopek pritožbe.
Article 71
Člen 72
Assessment by Member States
Izvajanje klinične raziskave
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 clinical investigation, as well as free of any other undue influence.
Sponzor in raziskovalec zagotovita, da se klinična raziskava izvaja v skladu z odobrenim načrtom klinične raziskave.
Member States shall ensure that the assessment is done jointly by an appropriate number of persons who collectively have the necessary qualifications and experience.
Da se preveri, da so pravice, varnost in dobro počutje udeležencev zaščiteni, da so sporočeni podatki zanesljivi in ponovljivi ter da so pri izvajanju klinične raziskave upoštevane zahteve te uredbe, sponzor zagotovi, da se izvajanje klinične raziskave ustrezno spremlja.
Member States shall assess whether the clinical investigation 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.
Sponzor obseg in naravo spremljanja določi na podlagi ocene, pri kateri so upoštevane vse značilnosti klinične raziskave, vključno z naslednjimi:
They shall, while taking into account applicable CS or harmonised standards, examine in particular:
cilji in metodologija klinične raziskave ter
the demonstration of compliance of the investigational device(s) with the applicable general safety and performance requirements, apart from the aspects covered by the clinical investigation, and whether, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects.
stopnja odstopanja posega od običajne klinične prakse.
This includes, where appropriate, assurance of technical and biological safety testing and pre-clinical evaluation;
Sponzor ali raziskovalec, kot je ustrezno, vse informacije o klinični raziskavi evidentira, obdeluje, obravnava in shranjuje tako, da omogoči njihovo natančno sporočanje, razlaganje in preverjanje, zaupnost evidenc in osebnih podatkov udeležencev pa je še vedno zagotovljena v skladu z veljavnim pravom o varstvu osebnih podatkov.
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;
Izvedejo se ustrezni tehnični in organizacijski ukrepi, da se obdelane informacije in osebni podatki zaščitijo pred nepooblaščenim ali nezakonitim dostopanjem, razkritjem, razširjanjem, spreminjanjem, uničenjem ali nenamerno izgubo, zlasti kadar obdelava zajema prenos prek omrežja.
whether the measures planned for the safe installation, putting into service and maintenance of the investigational device are adequate;
Države članice na ustrezni ravni pregledajo mesto ali mesta raziskave, da preverijo, ali se klinične raziskave izvajajo v skladu z zahtevami te uredbe in odobrenim načrtom raziskave.
the reliability and robustness of the data generated in the clinical investigation, taking account of statistical approaches, design of the investigation and methodological aspects, including sample size, comparator and endpoints;
Sponzor določi postopek za nujne primere, ki omogoča takojšnjo identifikacijo in po potrebi takojšen odpoklic pripomočkov, uporabljenih v raziskavi.
whether the requirements of Annex XV are met;
Člen 73
in the case of devices for sterile use, evidence of the validation of the manufacturer's sterilisation procedures or information on the reconditioning and sterilisation procedures which have to be conducted by the investigation site;
Elektronski sistem za klinične raziskave
the demonstration of the safety, quality and usefulness of any components of animal or human origin or of substances, which may be considered medicinal products in accordance with Directive 2001/83/EC.
Komisija v sodelovanju z državami članicami vzpostavi, upravlja in vzdržuje elektronski sistem:
Member States shall refuse the authorisation of the clinical investigation if:
za ustvarjanje v členu 70(1) navedenih enotnih identifikacijskih številk za klinične raziskave;
the application dossier submitted pursuant to Article 70(1) remains incomplete;
ki se uporablja kot vstopna točka za predložitev vseh vlog ali uradnih obvestil za klinične raziskave iz členov 70, 74, 75 in 78 ter za vse druge predložitve podatkov ali obdelave podatkov v zvezi s tem;
the device or the submitted documents, especially the investigation plan and the investigator's brochure, do not correspond to the state of scientific knowledge, and the clinical investigation, in particular, is not suitable for providing evidence for the safety, performance characteristics or benefit of the device on subjects or patients,
za izmenjavo informacij v zvezi s kliničnimi raziskavami v smislu te uredbe, in sicer med državami članicami ter med njimi in Komisijo, vključno z izmenjavo informacij iz členov 70 in 76;
the requirements of Article 62 are not met, or
za informacije, ki jih predloži sponzor v skladu s členom 77, vključno s poročilom o klinični raziskavi in njegovim povzetkom, kakor je predpisano v odstavku 5 navedenega člena;
any assessment under paragraph 3 is negative.
za poročanje o resnih neželenih dogodkih in pomanjkljivostih pripomočka ter s tem povezanih posodobitvah v skladu s členom 80.
Member States shall provide for an appeal procedure in respect of a refusal pursuant to the first subparagraph.
Komisija pri vzpostavljanju elektronskega sistema iz odstavka 1 tega člena zagotovi, da je ta – kar zadeva kombiniranje kliničnih raziskav pripomočkov s kliničnim preskušanjem na podlagi Uredbe (EU) št. 536/2014 Evropskega parlamenta in Sveta [37] – povezljiv s podatkovno zbirko EU za klinična preskušanja zdravil za uporabo v humani medicini, ustanovljeno v skladu s členom 81 navedene uredbe.
Article 72
Informacije iz točke (c) odstavka 1 so dostopne le državam članicam in Komisiji.
Conduct of a clinical investigation
Informacije iz drugih točk navedenega odstavka so javno dostopne, razen če je vse te informacije ali njihove dele upravičeno treba obravnavati zaupno zaradi:
The sponsor and the investigator shall ensure that the clinical investigation is conducted in accordance with the approved clinical investigation plan.
varstva osebnih podatkov v skladu z Uredbo (ES) št. 45/2001, ali
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 clinical investigation is in compliance with the requirements of this Regulation, the sponsor shall ensure adequate monitoring of the conduct of a clinical investigation.
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, ali
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 clinical investigation including the following:
učinkovitega nadzora nad izvajanjem klinične raziskave s strani zadevne države članice ali zadevnih držav članic.
the objective and methodology of the clinical investigation; and
Nobeni osebni podatki udeležencev niso javno dostopni.
the degree of deviation of the intervention from normal clinical practice.
Uporabniški vmesnik elektronskega sistema iz odstavka 1 je na voljo v vseh uradnih jezikih Unije.
All clinical investigation 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.
Člen 74
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.
Klinične raziskave v zvezi s pripomočki z oznako CE
Member States shall inspect, at an appropriate level, investigation site(s) to check that clinical investigations are conducted in accordance with the requirements of this Regulation and with the approved investigation plan.
Kadar je treba izvesti klinično raziskavo za dodatno oceno pripomočka, ki že ima oznako CE v skladu s členom 20(1), in sicer v okviru njegovega predvidenega namena (v nadaljnjem besedilu: raziskava v sklopu kliničnega spremljanja po dajanju na trg), in morajo zaradi te raziskave 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 73 uradno obvesti zadevne države članice.
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 investigation.
Sponzor v uradno obvestilo vključi dokumentacijo iz poglavja II Priloge XV.
Article 73
Za raziskave v sklopu kliničnega spremljanja po dajanju na trg se uporabljajo točke (b) do (k) in točka (m) člena 62(4), člen 75, člen 76, člen 77, člen 80(5) in ustrezne določbe Priloge XV.
Electronic system on clinical investigations
Kadar je treba izvesti klinično raziskavo za dodatno oceno pripomočka, ki že ima oznako CE v skladu s členom 20(1), in sicer zunaj okvira njegovega predvidenega namena, se uporabljajo členi 62 do 81.
The Commission shall, in collaboration with the Member States, set up, manage and maintain an electronic system:
Člen 75
to create the single identification numbers for clinical investigations referred to in Article 70(1);
Bistvene spremembe kliničnih raziskav
to be used as an entry point for the submission of all applications or notifications for clinical investigations referred to in Articles 70, 74, 75 and 78 and for all other submission of data, or processing of data in this context;
Če namerava sponzor v klinično raziskavo vključiti spremembe, ki utegnejo znatno vplivati na varnost, zdravje ali pravice udeležencev ali na ponovljivost ali zanesljivost kliničnih podatkov, pridobljenih z raziskavo, v enem tednu prek elektronskega sistema iz člena 73 uradno obvesti državo članico ali države članice, v katerih se klinična raziskava izvaja ali se bo izvajala, o razlogih za te spremembe in njihovi naravi.
for the exchange of information relating to clinical investigations in accordance with this Regulation between the Member States and between them and the Commission including the exchange of information referred to in Articles 70 and 76;
Sponzor v uradno obvestilo vključi posodobljeno različico ustrezne dokumentacije iz poglavja II Priloge XV.
for information to be provided by the sponsor in accordance with Article 77, including the clinical investigation report and its summary as required in paragraph 5 of that Article;
Spremembe ustrezne dokumentacije so jasno prepoznavne.
for reporting on serious adverse events and device deficiencies and related updates referred to in Article 80.
Država članica vsakršno bistveno spremembo klinične raziskave oceni v skladu s postopkom, določenim v členu 71.
When setting up the electronic system referred 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 [37] as concerns combined clinical investigations of devices with a clinical trial under that Regulation.
Sponzor sprememb iz odstavka 1 ne sme vnesti prej kot v 38 dneh po uradnem obvestilu iz navedenega odstavka, razen če:
The information referred to in point (c) of paragraph 1 shall only be accessible to the Member States and the Commission.
ga je država članica, v kateri se klinična raziskava izvaja ali se bo izvajala, uradno obvestila, da spremembe iz razlogov, navedenih v členu 71(4), ali zaradi pomislekov glede javnega zdravja, varnosti ali zdravja udeleženca in uporabnika ter javnega reda zavrača, ali
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:
je odbor za etiko v navedeni državi članici v zvezi z vsebinskimi spremembami klinične raziskave dal negativno mnenje, ki je veljavno za celotno to državo članico v skladu z njenim nacionalnim pravom.
protection of personal data in accordance with Regulation (EC) No 45/2001;
Zadevna država članica ali zadevne države članice lahko rok iz odstavka 3 podaljšajo za dodatnih sedem dni zaradi posvetovanja s strokovnjaki.
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;
Člen 76
effective supervision of the conduct of the clinical investigation by the Member State(s) concerned.
Korektivni ukrepi, ki jih morajo sprejeti države članice, in izmenjava informacij med državami članicami
No personal data of subjects shall be publicly available.
Kadar država članica, v kateri se klinična raziskava izvaja ali se bo izvajala, utemeljeno meni, da zahteve iz te uredbe niso izpolnjene, lahko na svojem ozemlju sprejme vsaj katerega koli od naslednjih ukrepov:
The user interface of the electronic system referred to in paragraph 1 shall be available in all official languages of the Union.
prekliče odobritev za klinično raziskavo;
Article 74
prekine ali ustavi klinično raziskavo;
Clinical investigations regarding devices bearing the CE marking
od sponzorja zahteva, da spremeni katerega od vidikov klinične raziskave.
Where a clinical investigation 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 20(1), (‘PMCF investigation’), and where the investigation 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 73.
Preden zadevna država članica sprejme kateri koli ukrep iz odstavka 1, prosi za mnenje sponzorja ali raziskovalca ali pa oba, razen kadar je potrebno takojšnje ukrepanje.
The sponsor shall include the documentation referred to in Chapter II of Annex XV as part of the notification.
To mnenje se predloži v sedmih dneh.
Points (b) to (k) and (m) of Article 62(4), Article 75, Article 76, Article 77, Article 80(5) and the relevant provisions of Annex XV shall apply to PMCF investigations.
Kadar država članica sprejme ukrep iz odstavka 1 tega člena ali zavrne klinično raziskavo ali pa jo sponzor uradno obvesti o predčasni ustavitvi klinične raziskave iz varnostnih razlogov, prek elektronskega sistema iz člena 73 vsem državam članicam in Komisiji sporoči odločitev v zvezi s tem in razloge zanjo.
Where a clinical investigation is to be conducted to assess, outside the scope of its intended purpose, a device which already bears the CE marking in accordance with Article 20(1), Articles 62 to 81 shall apply.
Če sponzor vlogo umakne, preden država članica sprejme odločitev, je ta informacija prek elektronskega sistema iz člena 73 na voljo vsem drugim državam članicam in Komisiji.
Article 75
Člen 77
Substantial modifications to clinical investigations
Informacije, ki jih sponzor predloži ob zaključku klinične raziskave ali v primeru njene začasne ali predčasne ustavitve
If a sponsor intends to introduce modifications to a clinical investigation that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation, it shall notify, within one week, by means of the electronic system referred to in Article 73 the Member State(s) in which the clinical investigation is being or is to be conducted of the reasons for and the nature of those modifications.
Če sponzor začasno ali predčasno ustavi klinično raziskavo, v 15 dneh prek elektronskega sistema iz člena 73 o začasni ali predčasni ustavitvi obvesti državo članico, v kateri je do te začasne ali predčasne ustavitve prišlo, in navede utemeljitev.
The sponsor shall include an updated version of the relevant documentation referred to in Chapter II of Annex XV as part of the notification.
Če sponzor klinično raziskavo začasno ali predčasno ustavi prekine iz varnostnih razlogov, v 24 urah o tem obvesti vse države članice, v katerih se ta raziskava izvaja.
Changes to the relevant documentation shall be clearly identifiable.
Šteje se, da zaključek klinične raziskave sovpada z zadnjim obiskom zadnjega udeleženca, razen če je v načrtu klinične raziskave določeno, da se ta zaključi ob drugem času.
The Member State shall assess any substantial modification to the clinical investigation in accordance with the procedure laid down in Article 71.
Sponzor vsako državo članico, v kateri se je izvajala klinična raziskava, uradno obvesti, da se je ta v njej zaključila.
The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days after the notification referred to in that paragraph, unless:
To stori v 15 dneh po tem, ko se je ta raziskava v tej državi članici zaključila.
the Member State in which the clinical investigation is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 71(4) or on considerations of public health, subject and user safety or health, of public policy, or
Če raziskava poteka v več kot eni državi članici, sponzor vse države članice, v katerih se je ta izvajala, uradno obvesti, da se je ta v vseh državah članicah zaključila.
an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the clinical investigation, which, in accordance with national law, is valid for that entire Member State.
To stori v 15 dneh po tem zaključku.
The Member State(s) concerned may extend the period referred to in paragraph 3 by a further seven days, for the purpose of consulting with experts.
Ne glede na izid klinične raziskave sponzor v enem letu po njenem zaključku ali v treh mesecih po njeni predčasni ali začasni ustavitvi državam članicam, v katerih se je izvajala, predloži poročilo o njej, navedeno v oddelku 2.8 poglavja I in oddelku 7 poglavja III Priloge XV.
Article 76
Poročilu o klinični raziskavi priloži povzetek, ki je napisan tako, da je lahko razumljiv predvidenemu uporabniku.
Corrective measures to be taken by Member States and information exchange between Member States
Sponzor poročilo in povzetek predloži prek elektronskega sistema iz člena 73.
Where a Member State in which a clinical investigation is being or is to be conducted has grounds for considering that the requirements set out in this Regulation are not met, it may take at least any of the following measures on its territory:
Če iz znanstvenih razlogov poročila o klinični raziskavi ni mogoče predložiti v enem letu po njenem zaključku, se predloži takoj, ko je mogoče.
revoke the authorisation for the clinical investigation;
V takšnem primeru je v načrtu klinične raziskave iz oddelka 3 poglavja II Priloge XV natančno določeno, kdaj bodo rezultati te raziskave skupaj z utemeljitvijo na voljo.
suspend or terminate the clinical investigation;
Komisija izda smernice glede vsebine in strukture povzetka poročila o klinični raziskavi.
require the sponsor to modify any aspect of the clinical investigation.
Poleg tega lahko izda tudi smernice za oblikovanje in izmenjavo neobdelanih podatkov za primere, v katerih se sponzor odloči za prostovoljno izmenjavo neobdelanih podatkov.
Before the Member State concerned takes any of the measures referred to in paragraph 1 it shall, except where immediate action is required, ask the sponsor or the investigator or both for their opinion.
Te smernice lahko izhajajo iz obstoječih smernic za izmenjavo neobdelanih podatkov na področju kliničnih raziskav in jih, kjer je to mogoče, prilagodijo.
That opinion shall be delivered within seven days.
Povzetek in poročilo o klinični raziskavi iz odstavka 5 tega člena postaneta prek elektronskega sistema iz člena 73 javno dostopna najpozneje takrat, ko je pripomoček registriran v skladu s členom 29 in preden je dan na trg.
Where a Member State has taken a measure referred to in paragraph 1 of this Article or has refused a clinical investigation, or has been notified by the sponsor of the early termination of a clinical investigation on safety grounds, that Member State shall communicate the corresponding decision and the grounds therefor to all Member States and the Commission by means of the electronic system referred to in Article 73.
V primeru predčasne ali začasne ustavitve postaneta povzetek in poročilo javno dostopna takoj po predložitvi.
Where an application is withdrawn by the sponsor prior to a decision by a Member State, that information shall be made available through the electronic system referred to in Article 73 to all Member States and the Commission.
Povzetek in poročilo postaneta eno leto po tem, ko sta bila vnesena v elektronski sistem iz odstavka 5 tega člena, javno dostopna, četudi pripomoček še vedno ni registriran v skladu s členom 29.
Article 77
Člen 78