natgillin/translations-raw huggingface dataset:
A Member State concerned shall refuse to authorise a performance study if it disagrees with the conclusion of the coordinating Member State as regards any of the grounds referred to in the second subparagraph of paragraph 8, or if it finds, on duly justified grounds, that the aspects addressed in Sections 1.13, 4.2, 4.3 and 4.4 of Chapter I of Annex XIV are not complied with, or where an ethics committee has issued a negative opinion in relation to that performance study which is valid in accordance with national law for that entire Member State.
Vsaka zadevna država članica prek elektronskega sistema iz člena 69 sponzorja uradno obvesti o tem, ali je študija učinkovitosti odobrena, pogojno odobrena ali pa je njena odobritev zavrnjena.
That Member State shall provide for an appeal procedure in respect of such refusal.
Z eno samo odločitvijo v petih dneh od posredovanja ga v skladu s točko (d) odstavka 4 tega člena uradno obvesti država članica koordinatorka končnega ocenjevalnega poročila.
Each Member State concerned shall notify the sponsor through the electronic system referred to in Article 69 as to whether the performance study is authorised, whether it is authorised subject to conditions, or whether authorisation has been refused.
Če je odobritev študije učinkovitosti odvisna od pogojev, so ti pogoji lahko zgolj takšni, da zaradi svoje narave ne morejo biti izpolnjeni ob odobritvi.
Notification shall be done by way of one single decision within five days of the transmission, pursuant to point (d) of paragraph 4 of this Article, by the coordinating Member State of the final assessment report.
Zadevne države članice so o vseh znatnih spremembah, navedenih v členu 71, uradno obveščene prek elektronskega sistema iz člena 69.
Where an authorisation of a performance study is subject to conditions, those conditions may only be such that, by their nature, they cannot be fulfilled at the time of that authorisation.
Vsakršno ocenjevanje o tem, ali obstajajo razlogi za nestrinjanje iz drugega pododstavka odstavka 8 tega člena, se izvede pod vodstvom države članice koordinatorke, razen če gre za bistvene spremembe v zvezi z oddelki 1.13, 4.2, 4.3 in 4.4 poglavja I Priloge XIV in točke (c) oddelka 2.3.2 dela A Priloge XIII, ki jih vsaka zadevna država članica oceni sama.
Any substantial modifications as referred to in Article 71 shall be notified to the Member States concerned by means of the electronic system referred to in Article 69.
Komisija državi članici koordinatorki zagotovi administrativno podporo pri izvajanju njenih nalog v skladu s tem poglavjem.
The Commission shall provide administrative support to the coordinating Member State in the accomplishment of its tasks under this Chapter.
Pregled postopka usklajenega ocenjevanja
The procedure set out in this Article shall, until 27 May 2029, be applied only by those of the Member States in which the performance studies are to be conducted which have agreed to apply it.
Komisija do 27. maja 2028 Evropskemu parlamentu in Svetu predloži poročilo o izkušnjah, pridobljenih z uporabo člena 74, ter, če je to potrebno, predlaga pregled člena 74(14) in točke (g) člena 113(3).
After 27 May 2029, all Member States shall be required to apply that procedure.
Člen 76
Article 75
Evidentiranje neželenih dogodkov, ki se zgodijo med izvajanjem študij učinkovitosti, in poročanje o njih
Review of the coordinated assessment procedure
Sponzor v celoti evidentira:
By 27 May 2028, the Commission shall submit to the European Parliament and to the Council a report on the experience gained from the application of Article 74 and, if necessary, propose a review of Article 74(14) and point (g) of Article 113(3).
vse neželene dogodke, ki so v skladu z načrtom študije učinkovitosti opredeljeni kot ključni za oceno rezultatov te študije učinkovitosti;
Article 76
vse resne neželene dogodke;
Recording and reporting of adverse events that occur during performance studies
vseh pomanjkljivostih pripomočka, ki bi lahko povzročile resen neželeni dogodek v primeru, da ne bi bili sprejeti ustrezni ukrepi, ne bi prišlo do posredovanja ali bi bile okoliščine manj ugodne;
The sponsor shall fully record all of the following:
vse nove ugotovitve v zvezi z vsakim dogodkom iz točk (a) do (c).
any adverse event of a type identified in the performance study plan as being critical to the evaluation of the results of that performance study;
Sponzor vsem državam članicam, v katerih poteka študija učinkovitosti, prek elektronskega sistema iz člena 69 nemudoma poroča o naslednjem:
any serious adverse event;
vseh resnih neželenih dogodkih, ki so vzročno povezani s pripomočkom, primerjalnim pripomočkom ali postopkom študije ali kadar je taka vzročna povezava razumno mogoča;
any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
vseh novih ugotovitvah v zvezi z vsakim dogodkom iz točk (a) in (b).
any new findings in relation to any event referred to in points (a) to (c).
Pri roku za poročanje se upošteva resnost dogodka.
The sponsor shall report without delay to all Member States in which a performance study is being conducted all of the following by means of the electronic system referred to in Article 69:
Po potrebi lahko sponzor zaradi zagotavljanja pravočasnega poročanja najprej predloži začetno poročilo, ki je nepopolno, pozneje pa še popolno poročilo.
any serious adverse event that has a causal relationship with the device, the comparator or the study procedure or where such causal relationship is reasonably possible;
Sponzor na podlagi zahteve katere koli države članice, v kateri poteka študija učinkovitosti, zagotovi vse informacije iz odstavka 1.
any new findings in relation to any event referred to in points (a) and (b).
Sponzor zadevnim državam članicam, v katerih poteka študija učinkovitosti, prek elektronskega sistema iz člena 69 poroča tudi o vseh dogodkih iz odstavka 2 tega člena, ki se zgodijo v tretjih državah, v katerih študija učinkovitosti poteka po enakem načrtu študije klinične učinkovitosti, kot je tisti, ki se uporablja za študijo učinkovitosti, ki jo ureja ta uredba.
The period for reporting shall take account of the severity of the event.
Sponzor v primeru študije učinkovitosti, za katero je uporabil enotno vlogo iz člena 74, o vseh primerih iz odstavka 2 tega člena poroča prek elektronskega sistema iz člena 69.
Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.
To poročilo se po prejemu v elektronski obliki pošlje vsem državam članicam, v katerih poteka študija učinkovitosti.
Upon request by any Member State in which the performance study is being conducted, the sponsor shall provide all information referred to in paragraph 1.
Države članice pod vodstvom države članice koordinatorke iz člena 74(2) uskladijo svoje ocenjevanje resnih neželenih dogodkov in pomanjkljivosti pripomočkov, da določijo, ali je treba študijo učinkovitosti spremeniti, prekiniti ali ustaviti, ali pa je treba preklicati odobritev za to študijo učinkovitosti.
The sponsor shall also report to the Member States in which the performance study is being conducted any event referred to in paragraph 2 of this Article that occurred in third countries in which a performance study is performed under the same clinical performance study plan as the one applying to a performance study covered by this Regulation by means of the electronic system referred to in Article 69.
Ta odstavek ne vpliva na pravice drugih držav članic, da izvajajo lastne ocene in sprejemajo ukrepe v skladu s to uredbo, da bi varovale javno zdravje in varnost pacientov.
In the case of a performance study for which the sponsor has used the single application referred to in Article 74, the sponsor shall report any event as referred to in paragraph 2 of this Article by means of the electronic system referred to in Article 69.
Država članica koordinatorka in Komisija sta obveščeni o rezultatu vsake take ocene in sprejetju vseh takih ukrepov.
Upon receipt, this report shall be transmitted electronically to all Member States in which the performance study is being conducted.
V primeru študij spremljanja učinkovitosti po dajanju na trg iz člena 70(1) se namesto tega člena uporabljajo določbe o vigilanci iz členov 82 do 85 in iz izvedbenih aktov, sprejetih na podlagi člena 86.
Under the direction of the coordinating Member State referred to in Article 74(2), the Member States shall coordinate their assessment of serious adverse events and device deficiencies to determine whether to modify, suspend or terminate the performance study or whether to revoke the authorisation for that performance study.
Brez poseganja v odstavek 5 se ta člen uporablja, če obstaja vzročna povezava med resnim neželenim dogodkom in prej izvedeno študijo učinkovitosti.
This paragraph shall not affect the rights of the other Member States to perform their own evaluation and to adopt measures in accordance with this Regulation in order to ensure the protection of public health and patient safety.
Člen 77
The coordinating Member State and the Commission shall be kept informed of the outcome of any such evaluation and the adoption of any such measures.
Izvedbeni akti
In the case of PMPF studies referred to in Article 70(1), the provisions on vigilance laid down in Articles 82 to 85 and in the implementing acts adopted pursuant to Article 86 shall apply instead of this Article.
Komisija lahko z izvedbenimi akti določi podrobne ureditve in postopkovne vidike, potrebne za izvajanje tega poglavja, v zvezi s:
Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the serious adverse event and the preceding performance study has been established.
harmoniziranimi elektronskimi obrazci za vlogo za študije učinkovitosti in njihovo oceno, kakor je navedeno v členih 66 in 74, ob upoštevanju posebnih kategorij ali skupin pripomočkov;
Article 77
delovanjem elektronskega sistema iz člena 69;
Implementing acts
harmoniziranimi elektronskimi obrazci za priglasitev spremljanja učinkovitosti po dajanju na trg iz člena 70(1) ter bistvenih sprememb iz člena 71;
The Commission may, by means of implementing acts, establish the detailed arrangements and procedural aspects necessary for the implementation of this Chapter, as regards the following:
izmenjavo informacij med državami članicami iz člena 72;
harmonised electronic forms for the application for performance studies and their assessment as referred to in Articles 66 and 74, taking into account specific categories or groups of devices;
harmoniziranimi elektronskimi obrazci za poročanje o resnih neželenih dogodkih in pomanjkljivostih pripomočkov iz člena 76;
the functioning of the electronic system referred to in Article 69;
roki za poročanje o resnih neželenih dogodkih in pomanjkljivostih pripomočkov, ob upoštevanju resnosti dogodka, o katerem se poroča, iz člena 76;
harmonised electronic forms for the notification of PMPF studies as referred to in Article 70(1), and of substantial modifications as referred to in Article 71;
enotno uporabo zahtev, kar zadeva klinične dokaze/podatke, ki so potrebni za dokazovanje skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti iz Priloge I.
the exchange of information between Member States as referred to in Article 72;
Izvedbeni akti iz prvega odstavka se sprejmejo v skladu s postopkom pregleda iz člena 107(3).
harmonised electronic forms for the reporting of serious adverse events and device deficiencies as referred to in Article 76;
POGLAVJE VII
the timelines for the reporting of serious adverse events and device deficiencies, taking into account the severity of the event to be reported as referred to in Article 76;
NADZOR PO DAJANJU NA TRG, VIGILANCA IN NADZOR TRGA
uniform application of the requirements regarding the clinical evidence/data needed to demonstrate compliance with the general safety and performance requirements set out in Annex I.
Nadzor po dajanju na trg
The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Člen 78
CHAPTER VII
Proizvajalčev sistem nadzora po dajanju na trg
POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
Proizvajalci za vsak pripomoček sorazmerno z razredom tveganja in ustrezno vrsti pripomočka načrtujejo, vzpostavijo, dokumentirajo, izvajajo, vzdržujejo in posodabljajo sistem nadzora po dajanju na trg.
Post-market surveillance
Takšen sistem je sestavni del proizvajalčevega sistema vodenja kakovosti iz člena 10(8).
Article 78
Sistem nadzora po dajanju na trg je primeren za dejavno in sistematično zbiranje, evidentiranje in analizo ustreznih podatkov o kakovosti, učinkovitosti in varnosti pripomočka skozi njegovo celotno življenjsko dobo, za to, da se pride do potrebnih ugotovitev, ter za določanje, izvajanje in spremljanje vseh morebitnih preventivnih in korektivnih ukrepov.
Post-market surveillance system of the manufacturer
Podatki, zbrani prek proizvajalčevega sistema nadzora po dajanju na trg, se uporabljajo zlasti:
For each device manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device.
za posodobitev določitve koristi in tveganja ter za izboljšanje obvladovanja tveganja iz poglavja I Priloge I;
That system shall be an integral part of the manufacturer's quality management system referred to in Article 10(8).
za posodobitev informacij o zasnovi in izdelavi, navodil za uporabo in označevanja;
The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions.
za posodobitev ocene učinkovitosti;
Data gathered by the manufacturer's post-market surveillance system shall in particular be used:
za posodobitev povzetka o varnosti in učinkovitosti iz člena 29;
to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;
za ugotavljanje potreb po preventivnih, korektivnih ali varnostnih korektivnih ukrepih;
to update the design and manufacturing information, the instructions for use and the labelling;
za ugotavljanje možnosti, kako je mogoče izboljšati uporabnost, učinkovitost in varnost pripomočka;
to update the performance evaluation;
da bi se po potrebi pripomoglo k nadzoru drugih pripomočkov po dajanju na trg; in
to update the summary of safety and performance referred to in Article 29;
za odkrivanje trendov v skladu s členom 83 in poročanje o njih.
for the identification of needs for preventive, corrective or field safety corrective action;
Tehnična dokumentacija se ustrezno posodablja.
for the identification of options to improve the usability, performance and safety of the device;
Če se med nadzorom po dajanju na trg ugotovi, da so potrebni preventivni ali korektivni ukrepi oziroma oboji, proizvajalec izvede ustrezne ukrepe ter obvesti zadevne pristojne organe in, kjer je to ustrezno, priglašeni organ.
when relevant, to contribute to the post-market surveillance of other devices; and
Če se odkrije resni zaplet ali se izvede varnostni korektivni ukrep, se o tem poroča v skladu s členom 82.
to detect and report trends in accordance with Article 83.
Člen 79
The technical documentation shall be updated accordingly.
Načrt nadzora po dajanju na trg
If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body.
Sistem nadzora po dajanju na trg iz člena 78 temelji na načrtu nadzora po dajanju na trg, zahteve za ta načrt pa so določene v oddelku 1 Priloge III.
Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 82.
Načrt nadzora po dajanju na trg je del tehnične dokumentacije, določene v Prilogi II.
Article 79
Člen 80
Post-market surveillance plan
Poročilo o nadzoru po dajanju na trg
The post-market surveillance system referred to in Article 78 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1 of Annex III.
Proizvajalci pripomočkov razreda A in B pripravijo poročilo o nadzoru po dajanju na trg, v katerem so povzeti rezultati in ugotovitve analiz podatkov, zbranih v okviru tega nadzora na podlagi načrta tega nadzora iz člena 79, ter utemeljitve in opisi vseh sprejetih preventivnih in korektivnih ukrepov.
The post-market surveillance plan shall be part of the technical documentation specified in Annex II.
Poročilo se po potrebi posodablja in je na zahtevo na voljo priglašenemu organu in pristojnemu organu.
Post-market surveillance report
Redno posodobljeno poročilo o varnosti
Manufacturers of class A and B devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken.
Proizvajalci pripomočkov razreda C in D pripravijo za vsak pripomoček in po potrebi za vsako kategorijo ali skupino pripomočkov redno posodobljeno poročilo o varnosti, v katerem so povzeti rezultati in ugotovitve analiz podatkov, zbranih v okviru tega nadzora na podlagi načrta tega nadzora iz člena 79, ter utemeljitve in opisi vseh sprejetih preventivnih in korektivnih ukrepov.
The report shall be updated when necessary and made available to the notified body and the competent authority upon request.
To poročilo skozi celotno življenjsko dobo pripomočka zajema:
Article 81
ugotovitve, ki se uporabijo pri določitvi koristi in tveganja;
Periodic safety update report
glavne ugotovitve spremljanja učinkovitosti po dajanju na trg ter
Manufacturers of class C and class D devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken.
obseg prodaje pripomočka in oceno števila in drugih značilnosti prebivalstva, ki uporablja pripomoček, in pogostost uporabe pripomočka, kjer je to mogoče.
Throughout the lifetime of the device concerned, that PSUR shall set out:
Proizvajalci pripomočkov razreda C in D poročilo posodabljajo vsaj enkrat letno.
the conclusions of the benefit-risk determination;
Vključijo ga v tehnično dokumentacijo, določeno v prilogah II in III.
the main findings of the PMPF; and
Proizvajalci pripomočkov razreda D prek elektronskega sistema iz člena 87 predložijo poročilo priglašenemu organu, vključenemu v ugotavljanje skladnosti takšnih pripomočkov v skladu s členom 48.
the volume of sales of the device and an estimate of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.
Priglašeni organ pregleda poročilo in v ta elektronski sistem doda svojo oceno s podrobnostmi morebitnih sprejetih ukrepov.
Manufacturers of class C and D devices shall update the PSUR at least annually.
Takšna poročila in ocene priglašenega organa so prek tega elektronskega sistema dostopni pristojnim organom.
That PSUR shall be part of the technical documentation as specified in Annexes II and III.
Proizvajalci za pripomočke razreda C dostop do redno posodobljenih poročil o varnosti omogočijo priglašenemu organu, ki je vključen v ugotavljanje skladnosti, na njihovo zahtevo pa tudi pristojnim organom.
Manufacturers of class D devices shall submit PSUR by means of the electronic system referred to in Article 87 to the notified body involved in the conformity assessment of such devices in accordance with Article 48.
Vigilanca
The notified body shall review the report and add its evaluation to that electronic system with details of any action taken.
Člen 82
Such PSUR and the evaluation by the notified body shall be made available to competent authorities through that electronic system.
Poročanje o resnih zapletih in varnostni korektivni ukrepi
For class C devices, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
Proizvajalci pripomočkov, ki so dostopni na trgu Unije, razen pripomočkov za študijo učinkovitosti, poročajo ustreznim pristojnim organom v skladu s členi 87(5) in (7) o:
Vigilance
vsakem resnem zapletu, povezanem s pripomočki, ki so dostopni na trgu Unije, razen o pričakovanih napačnih rezultatih, ki so jasno dokumentirani in količinsko opredeljeni v informacijah o izdelku in v tehnični dokumentaciji, zanje pa velja poročanje o trendu v skladu s členom 83;
Article 82
vseh varnostnih korektivnih ukrepih v zvezi s pripomočki, dostopnimi na trgu Unije, tudi o vseh varnostnih korektivnih ukrepih, sprejetih v tretji državi, v zvezi s pripomočkom, ki je prav tako pravno dostopen na trgu Unije, če razlog za varnostni korektivni ukrep ni omejen na pripomoček, ki je dostopen v tretji državi
Reporting of serious incidents and field safety corrective actions
Poročila iz prvega pododstavka se predložijo prek elektronskega sistema iz člena 87.
Manufacturers of devices, made available on the Union market, other than devices for performance study, shall report, to the relevant competent authorities, in accordance with Articles 87(5) and (7), the following:
Pri roku za poročanje iz odstavka 1 se praviloma upošteva resnost zapleta.
any serious incident involving devices made available on the Union market, except expected erroneous results which are clearly documented and quantified in the product information and in the technical documentation and are subject to trend reporting pursuant to Article 83;
Proizvajalci poročajo o vsakem resnem zapletu iz točke (a), takoj ko ugotovijo vzročno povezavo med tem zapletom in svojim pripomočkom ali da je vzročna povezava razumno mogoča, nikakor pa ne pozneje kot 15 dni po tem, ko so seznanjeni z zapletom.
any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country.
Ne glede na odstavek 3 se v primeru resne grožnje za javno zdravje poročilo iz odstavka 1 predloži takoj, najpozneje pa v dveh dneh po tem, ko je proizvajalec seznanjen s to grožnjo.
The reports referred to in the first subparagraph shall be submitted through the electronic system referred to in Article 87.
Ne glede na odstavek 3 se v primeru smrti ali nepričakovanega resnega poslabšanja zdravstvenega stanja osebe poročilo predloži takoj, ko proizvajalec ugotovi ali posumi, da obstaja vzročna povezava med pripomočkom in resnim zapletom, najpozneje pa v desetih dneh po tem, ko je proizvajalec seznanjen z resnim zapletom.
As a general rule, the period for the reporting referred to in paragraph 1 shall take account of the severity of the serious incident.
Po potrebi lahko proizvajalec za pravočasno poročanje predloži začetno poročilo, ki je nepopolno, pozneje pa še popolno poročilo.