natgillin/translations-raw huggingface dataset:
The sponsor shall include the documentation referred to in Section 2 of Part A of Annex XIII and in Annex XIV.
Kadar je treba izvesti študijo učinkovitosti za dodatno oceno pripomočka, ki že ima oznako CE v skladu s členom 18(1), in sicer zunaj okvira njegovega predvidenega namena, se uporabljajo členi 58 do 77.
Points (b) to (l) and (p) of Article 58(5), and Articles 71, 72 and 73 Article 76(5) and the relevant provisions of Annexes XIII and XIV shall apply to PMPF studies.
Člen 71
Where a performance study 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 18(1), Articles 58 to 77 shall apply.
Bistvene spremembe študij učinkovitosti
Article 71
Če namerava sponzor v študijo učinkovitosti vključiti spremembe, ki utegnejo znatno vplivati na varnost, zdravje ali pravice udeležencev ali na ponovljivost ali zanesljivost podatkov, pridobljenih s študijo, v enem tednu prek elektronskega sistema iz člena 69 uradno obvesti državo članico oziroma države članice, v katerih se študija učinkovitosti izvaja ali se bo izvajala, o razlogih za te spremembe in njihovi vsebini.
Substantial modifications to performance studies
Sponzor v uradno obvestilo vključi posodobljeno različico ustrezne dokumentacije iz Priloge XIV.
If a sponsor intends to introduce modifications to a performance study 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 data generated by the study, it shall notify, within one week, by means of the electronic system referred to in Article 69, the Member State(s) in which the performance study is being or is to be conducted of the reasons for and the nature of those modifications.
Spremembe ustrezne dokumentacije so jasno prepoznavne.
The sponsor shall include an updated version of the relevant documentation referred to in Annex XIV as part of the notification.
Država članica vsakršno bistveno spremembo študije učinkovitosti oceni v skladu s postopkom, določenim v členu 67.
Changes to the relevant documentation shall be clearly identifiable.
Sponzor sprememb iz odstavka 1 ne sme vnesti prej kot v 38 dneh po uradnem obvestilu iz odstavka 1, razen če:
The Member State shall assess any substantial modification to the performance study in accordance with the procedure laid down in Article 67.
ga je država članica, v kateri se študija učinkovitosti izvaja ali se bo izvajala, uradno obvestila, da spremembe iz razlogov, navedenih v členu 67(4), ali zaradi pomislekov glede javnega zdravja, varnosti ali zdravja udeleženca in uporabnika ali javnega reda zavrača ali
The sponsor may implement the modifications referred to in paragraph 1 at the earliest 38 days after the notification referred to in paragraph 1, unless:
je odbor za etiko v navedeni državi članici v zvezi z vsebinskimi spremembami študije učinkovitosti dal negativno mnenje, ki je veljavno za celotno to državo članico v skladu z njenim nacionalnim pravom.
the Member State in which the performance study is being or is to be conducted has notified the sponsor of its refusal based on the grounds referred to in Article 67(4) or on considerations of public health, of subject and user safety or health, or of public policy; or
Zadevna država članica oziroma zadevne države članice lahko rok iz odstavka 3 podaljšajo za dodatnih sedem dni zaradi posvetovanja s strokovnjaki.
an ethics committee in that Member State has issued a negative opinion in relation to the substantial modification to the performance study, which, in accordance with national law, is valid for that entire Member State.
Člen 72
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.
Korektivni ukrepi, ki jih morajo sprejeti države članice, in izmenjava informacij o študijah učinkovitosti med državami članicami
Article 72
Kadar država članica, v kateri se študija učinkovitosti izvaja ali se bo izvajala, utemeljeno meni, da zahteve iz te uredbe niso več izpolnjene, lahko na svojem ozemlju sprejme katerega koli od naslednjih ukrepov:
Corrective measures to be taken by Member States and information exchange between Member States on performance studies
prekliče odobritev za študijo učinkovitosti;
Where a Member State in which a performance study 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:
prekine ali ustavi študijo učinkovitosti;
revoke the authorisation for the performance study;
od sponzorja zahteva, da spremeni katerega od vidikov študije učinkovitosti.
suspend or terminate the performance study;
Preden zadevna država članica sprejme kateri koli ukrep iz odstavka 1, prosi za mnenje sponzorja ali raziskovalca oziroma oba, razen kadar je potrebno takojšnje ukrepanje.
require the sponsor to modify any aspect of the performance study.
To mnenje se predloži v sedmih dneh.
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.
Kadar država članica sprejme ukrep iz odstavka 1 tega člena ali zavrne študijo učinkovitosti ali pa jo sponzor uradno obvesti o predčasni ustavitvi študije učinkovitosti iz varnostnih razlogov, navedena država članica prek elektronskega sistema iz člena 69 vsem državam članicam in Komisiji sporoči ustrezno odločitev in razloge zanjo.
That opinion shall be delivered within seven days.
Če sponzor vlogo umakne pred odločitvijo države članice, je ta informacija na voljo vsem drugim državam članicam in Komisiji prek elektronskega sistema iz člena 69.
Where a Member State has taken a measure referred to in paragraph 1 of this Article, or has refused a performance study, or has been notified by the sponsor of the early termination of a performance study 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 69.
Člen 73
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 69 to all Member States and the Commission.
Informacije, ki jih predloži sponzor ob zaključku študije učinkovitosti ali v primeru njene začasne ali predčasne ustavitve
Article 73
Če sponzor začasno ali predčasno ustavi študijo učinkovitosti, v 15 dneh prek elektronskega sistema iz člena 69 o začasni ali predčasni ustavitvi obvesti države članice, v katerih je do te začasne ali predčasne ustavitve prišlo.
Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination
Če sponzor študijo učinkovitosti začasno ali predčasno ustavi iz varnostnih razlogov, v 24 urah o tem obvesti vse države članice, v katerih se izvaja ta študija učinkovitosti.
If the sponsor has temporarily halted a performance study or has terminated a performance study early, it shall inform within 15 days the Member States in which that performance study has been temporarily halted or terminated early, through the electronic system referred to in Article 69, of the temporary halt or early termination.
Šteje se, da zaključek študije učinkovitosti sovpada z zadnjim obiskom zadnjega udeleženca, razen če je v načrtu študije učinkovitosti določen zaključek ob drugem času.
In the event that the sponsor has temporarily halted or terminated early the performance study on safety grounds, it shall inform all Member States in which that performance study is being conducted thereof within 24 hours.
Sponzor vsako državo članico, v kateri se je izvajala študija učinkovitosti, uradno obvesti, da se je ta v njej zaključila.
The end of a performance study shall be deemed to coincide with the last visit of the last subject unless another point in time for such end is set out in the performance study plan.
To stori v 15 dneh po njenem zaključku.
The sponsor shall notify each Member State in which that performance study was being conducted of the end of that performance study in that Member State.
Če študija 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.
That notification shall be made within 15 days of the end of the performance study in relation to that Member State.
To stori v 15 dneh po njenem zaključku.
If a study is conducted in more than one Member State, the sponsor shall notify all Member States in which that performance study was conducted of the end of the performance study in all Member States.
Ne glede na izid študije učinkovitosti 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 2.3.3 dela A Priloge XIII.
That notification shall be made within 15 days of that end of the performance study.
Poročilu o študiji učinkovitosti se priloži povzetek, ki je napisan tako, da je lahko razumljiv predvidenemu uporabniku.
Irrespective of the outcome of the performance study, within one year of the end of the performance study or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a performance study was conducted a performance study report as referred to in Section 2.3.3. of Part A of Annex XIII.
Sponzor poročilo in povzetek predloži prek elektronskega sistema iz člena 69.
The performance study report shall be accompanied by a summary presented in terms that are easily understandable to the intended user.
Če iz znanstvenih razlogov poročila o študiji učinkovitosti ni mogoče predložiti v enem letu po zaključku študije, se predloži takoj, ko je na voljo.
Both the report and summary shall be submitted by the sponsor by means of the electronic system referred to in Article 69.
V tem primeru načrt študije klinične učinkovitosti iz oddelka 2.3.2 dela A Priloge XIII natančno določa, kdaj bodo predloženi rezultati študije učinkovitosti skupaj z utemeljitvijo.
Where, for scientific reasons, it is not possible to submit the performance study report within one year of the end of the study, it shall be submitted as soon as it is available.
Komisija izda smernice glede vsebine in strukture povzetka poročila o študiji učinkovitosti.
In such case, the clinical performance study plan referred to in Section 2.3.2. of Part A of Annex XIII shall specify when the results of the performance study are going to be available, together with a justification.
Poleg tega lahko izda tudi smernice za oblikovanje in izmenjavo neobdelanih podatkov za primere, v katerih se sponzor odloči za prostovoljno izmenjavo neobdelanih podatkov.
The Commission shall issue guidelines regarding the content and structure of the summary of the performance study report.
Te smernice lahko izhajajo iz obstoječih smernic za izmenjavo neobdelanih podatkov na področju študij učinkovitosti in jih, kjer je to mogoče, prilagodijo.
In addition, the Commission may issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis.
Povzetek in poročilo o študiji učinkovitosti iz odstavka 5 tega člena postaneta prek elektronskega sistema iz člena 69 javno dostopna najpozneje takrat, ko je pripomoček registriran v skladu s členom 26 in preden je dan na trg.
Those guidelines may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of performance studies.
V primeru predčasne ali začasne ustavitve postaneta povzetek in poročilo javno dostopna takoj po predložitvi.
The summary and the performance study report referred to in paragraph 5 of this Article shall become publicly accessible through the electronic system referred to in Article 69, at the latest when the device is registered in accordance with Article 26 and before it is placed on the market.
Povzetek in poročilo o študiji učinkovitosti 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 26.
In cases of early termination or temporary halt, the summary and the report shall become publicly accessible immediately after submission.
Člen 74
If the device is not registered in accordance with Article 26 within one year of the summary and the performance study report having been entered into the electronic system pursuant to paragraph 5 of this Article, they shall become publicly accessible at that point in time.
Postopek usklajenega ocenjevanja za študije učinkovitosti
Article 74
Sponzor študije učinkovitosti, ki se bo izvajala v več kot eni državi članici, lahko prek elektronskega sistema iz člena 69 za namene člena 66 predloži enotno vlogo, ki se ob prejemu elektronsko posreduje vsem državam članicam, v katerih bo ta študija potekala.
Coordinated assessment procedure for performance studies
Sponzor v enotni vlogi iz odstavka 1 predlaga, da ima ena od držav članic, v katerih bo potekala študija učinkovitosti, vlogo države članice koordinatorke.
By means of the electronic system referred to in Article 69, the sponsor of a performance study to be conducted in more than one Member State may submit, for the purpose of Article 66, a single application that, upon receipt, is transmitted electronically to all Member States in which the performance study is to be conducted.
Države članice, v katerih bo potekala študija učinkovitosti, se v šestih dneh po predložitvi vloge dogovorijo, katera od njih bo prevzela to vlogo.
The sponsor shall propose in the single application referred to in paragraph 1 that one of the Member States in which the performance study is to be conducted acts as coordinating Member State.
Če se ne morejo dogovoriti, vlogo prevzame država članica, ki jo predlaga sponzor.
The Member States in which the performance study is to be conducted shall, within six days of submission of the application, agree on one of them taking the role of the coordinating Member State.
Zadevne države članice pod vodstvom države članice koordinatorke iz odstavka 2 usklajujejo ocenjevanje vloge, zlasti dokumentacije iz poglavja I Priloge XIV.
If they do not agree on a coordinating Member State, the coordinating Member State proposed by the sponsor shall assume that role.
Koliko je dokumentacija iz oddelkov 1.13, 4.2, 4.3 in 4.4 poglavja I Priloge XIV ter točke (c) oddelka 2.3.2 dela A Priloge XIII popolna, pa oceni vsaka zadevna država članica ločeno v skladu s členom 66(1) do (5).
Under the direction of the coordinating Member State referred to in paragraph 2, the Member States concerned shall coordinate their assessment of the application, in particular of the documentation referred to in Chapter I of Annex XIV.
V zvezi z dokumentacijo, ki ni tista iz drugega pododstavka odstavka 3, država članica koordinatorka:
However, the completeness of the documentation referred to in Sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV and point (c) of Section 2.3.2. of Part A of Annex XIII shall be assessed separately by each Member State concerned in accordance with Article 66(1) to (5).
v šestih dneh od prejema enotne vloge sponzorja uradno obvesti, da je država članica koordinatorka ona (v nadaljnjem besedilu: datum uradnega obvestila);
With regard to documentation other than that referred to in the second subparagraph of paragraph 3, the coordinating Member State shall:
za potrditev vloge upošteva vse pomisleke, ki jih zadevne države članice predložijo v sedmih dneh od datuma uradnega obvestila;
within six days of receipt of the single application, notify the sponsor that it is the coordinating Member State (‘notification date’);
v desetih dneh od datuma uradnega obvestila oceni, ali študija učinkovitosti spada v področje uporabe te uredbe in ali je vloga popolna, ter o tem uradno obvesti sponzorja.
for the purpose of the validation of the application, take into account any considerations submitted within seven days of the notification date by any Member State concerned;
Za državo članico koordinatorko se v zvezi s to oceno uporablja člen 66(1) do (5);
within 10 days of the notification date, assess whether the performance study falls within the scope of this Regulation and whether the application is complete and shall notify the sponsor accordingly.
rezultate svoje ocene strne v osnutku ocenjevalnega poročila, ki se v 26 dneh po datumu potrditve pošlje zadevnim državam članicam.
Article 66(1) and (3) to (5) shall apply to the coordinating Member State in relation to that assessment;
Druge zadevne države članice do 38. dne po datumu potrditve svoje pripombe in predloge glede osnutka ocenjevalnega poročila in osnovne vloge pošljejo državi članici koordinatorki, ki jih ustrezno upošteva pri dokončnem oblikovanju končnega ocenjevalnega poročila, ki mora biti v 45 dneh po datumu potrditve poslano sponzorju in drugim zadevnim državam članicam.
establish the results of its assessment in a draft assessment report to be transmitted within 26 days of the validation date to the Member States concerned.
Končno ocenjevalno poročilo upoštevajo vse zadevne države članice, ko odločajo o vlogi sponzorja v skladu s členom 66(7).
By day 38 after the validation date, the other Member States concerned shall transmit their comments and proposals on the draft assessment report and the underlying application to the coordinating Member State which shall take due account of those comments and proposals in its finalisation of the final assessment report, to be transmitted within 45 days of the validation date to the sponsor and the other Member States concerned.
Kar zadeva ocenjevanje dokumentacije iz drugega pododstavka odstavka 3, lahko vsaka zadevna država članica od sponzorja enkrat samkrat zahteva dodatne informacije.
The final assessment report shall be taken into account by all Member States concerned when deciding on the sponsor's application in accordance with Article 66(7).
Sponzor zahtevane dodatne informacije predloži v roku, ki ga določi zadevna država članica in ki ni daljši od 12 dni od prejema zahteve.
As regards the assessment of the documentation referred to in the second subparagraph of paragraph 3, each Member State concerned may request, on a single occasion, additional information from the sponsor.
Tek zadnjega roka iz točke (d) odstavka 4 se prekine od datuma zahtevka do prejetja dodatnih informacij.
The sponsor shall submit the requested additional information within the period set by the Member State concerned, which shall not exceed 12 days from the receipt of the request.
Za pripomočke razreda C in D lahko država članica koordinatorka roke iz odstavka 4 podaljša za dodatnih 50 dni zaradi posvetovanja s strokovnjaki.
The expiry of the last deadline pursuant to point (d) of paragraph 4 shall be suspended from the date of the request until such time as the additional information has been received.
Komisija lahko z izvedbenimi akti podrobneje določi postopke in časovne okvire za usklajena ocenjevanja, ki jih zadevne države članice upoštevajo pri odločanju o vlogi sponzorja.
For class C and D devices, the coordinating Member State may also extend the periods referred to in paragraph 4 by a further 50 days, for the purpose of consulting with experts.
V takšnih izvedbenih aktih so lahko določeni tudi postopki in časovni okviri za usklajeno ocenjevanje v primeru bistvenih sprememb v skladu z odstavkom 12 tega člena, v primeru poročanja o neželenih dogodkih v skladu s členom 76(4) in v primeru študij učinkovitosti, ki vključujejo dopolnilno diagnostiko, če so zdravila vključena v vzporedno usklajeno oceno kliničnega preskušanja v skladu z Uredbo (EU) št. 536/2014.
The Commission may, by means of implementing acts, further specify the procedures and timescales for coordinated assessments to be taken into account by Member States concerned when deciding on the sponsor's application.
Kadar država članica koordinatorka v zvezi s področjem usklajenega ocenjevanja ugotovi, da je izvedba študije učinkovitosti sprejemljiva ali pogojno sprejemljiva, se ta ugotovitev šteje za ugotovitev vseh zadevnih držav članic.
Such implementing acts may also set out the procedures and timescales for coordinated assessment in the case of substantial modifications pursuant to paragraph 12 of this Article and in the case of reporting of adverse events pursuant to Article 76(4) and in the case of performance studies involving companion diagnostics, where the medicinal products are under a concurrent coordinated assessment of a clinical trial under Regulation (EU) No 536/2014.
Ne glede na prvi pododstavek lahko zadevna država članica nestrinjanje z ugotovitvijo države članice koordinatorke v zvezi s področjem usklajenega ocenjevanja izrazi:
Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the conduct of the performance study is acceptable or acceptable subject to compliance with specific conditions, that conclusion shall be deemed to be the conclusion of all Member State(s) concerned.
kadar meni, da bi bilo zdravljenje udeleženca zaradi udeležbe v študiji učinkovitosti slabše kot pri običajni klinični praksi v tej zadevni državi članici;
Notwithstanding the first subparagraph, a Member State concerned may only disagree with the conclusion of the coordinating Member State concerning the area of coordinated assessment on the following grounds:
zaradi kršitev nacionalnega prava ali
when it considers that participation in the performance study would lead to a subject receiving treatment inferior to that received in normal clinical practice in that Member State concerned;
zaradi pomislekov glede varnosti udeleženca ter zanesljivosti in ponovljivosti podatkov, predloženih na podlagi točke (d) odstavka 4.
infringement of national law; or
Kadar se ena od zadevnih držav članic na podlagi drugega pododstavka tega odstavka z ugotovitvijo ne strinja, o tem prek elektronskega sistema iz člena 69 obvesti Komisijo, vse ostale zadevne države članice in sponzorja ter priloži podrobno utemeljitev.
considerations as regards subject safety and data reliability and robustness submitted under point (d) of paragraph 4.
Kadar država članica koordinatorka v zvezi s področjem usklajenega ocenjevanja ugotovi, da študija učinkovitosti ni sprejemljiva, se ta ugotovitev šteje kot ugotovitev vseh zadevnih držav članic.
Where one of the Member States concerned disagrees with the conclusion on the basis of the second subparagraph of this paragraph, it shall communicate its disagreement, together with a detailed justification, through the electronic system referred to in Article 69 to the Commission, to all other Member States concerned, and to the sponsor.
Zadevna država članica odobritev študije učinkovitosti zavrne, če se ne strinja z ugotovitvami države članice koordinatorke glede katerega koli od razlogov, navedenih v drugem pododstavku odstavka 8, ali če na podlagi ustrezno utemeljenih razlogov meni, da niso upoštevani vidiki iz oddelkov 1.13, 4.2, 4.3 in 4.4 poglavja I Priloge XIV, ali če je odbor za etiko v zvezi z navedeno študijo učinkovitosti dal negativno mnenje, ki je veljavno za celotno zadevno državo članico v skladu z njenim nacionalnim pravom.
Where the conclusion of the coordinating Member State concerning the area of coordinated assessment is that the performance study is not acceptable, that conclusion shall be deemed to be the conclusion of all Member States concerned.
Ta država članica omogoči postopek pritožbe na takšno zavrnitev.