natgillin/translations-raw huggingface dataset:
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;
Komisija podnosi Europskom parlamentu i Vijeću izvješće o iskustvu stečenom primjenom članka 74. stavka 14. i, prema potrebi, predlaže preispitivanje članka 113. stavka 3. točke (g).
the functioning of the electronic system referred to in Article 69;
Članak 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;
Evidentiranje i izvješćivanje o nepoželjnim događajima tijekom studija učinkovitosti
the exchange of information between Member States as referred to in Article 72;
Naručitelj vodi potpunu evidenciju o sljedećem:
harmonised electronic forms for the reporting of serious adverse events and device deficiencies as referred to in Article 76;
svakom nepoželjnom događaju koji je u planu kliničkog ispitivanja identificiran kao kritičan za procjenu rezultata te studije učinkovitosti
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;
svakom ozbiljnom nepoželjnom događaju;
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.
svim manjkavostima proizvoda koje su mogle dovesti do ozbiljnog nepoželjnog događaja da nije poduzeta odgovarajuća mjera, da nije poduzeta intervencija ili u slučaju da su okolnosti bile nepovoljnije;
The implementing acts referred to in the first paragraph shall be adopted in accordance with the examination procedure referred to in Article 107(3).
svim novim saznanjima povezanima s bilo kojim događajem iz točaka od (a) do (c).
CHAPTER VII
Naručitelj putem elektroničkog sustava iz članka 69. bez odgode izvješćuje sve države članice u kojima se provodi studija učinkovitosti o svim sljedećim elementima:
POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE
svakom ozbiljnom nepoželjnom događaju koji je uzročno povezan s proizvodom, komparatorom ili postupkom studije ili u slučaju kada je takva uzročna povezanost razumno moguća;
Post-market surveillance
svim novim saznanjima povezanima s bilo kojim događajem iz točaka (a) i (b).
Article 78
Pri određivanju roka za podnošenje izvješća uzima se u obzir ozbiljnost događaja.
Post-market surveillance system of the manufacturer
Kada je iz razloga pravodobnog izvješćivanja potrebno, naručitelj može podnijeti inicijalno nepotpuno izvješće nakon kojega će slijediti potpuno izvješće.
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.
Naručitelj na zahtjev bilo koje države članice u kojoj se provodi studija učinkovitosti pruža sve informacije iz stavka 1.
That system shall be an integral part of the manufacturer's quality management system referred to in Article 10(8).
Naručitelj ujedno putem elektroničkog sustava iz članka 69. izvješćuje države članice u kojima se provodi studija učinkovitosti o svakom događaju iz stavka 2. ovog članka koji se dogodio u trećim zemljama u kojima se provodi studija učinkovitosti u okviru istog plana studije kliničke učinkovitosti kao što je onaj koji se primjenjuje na studiju učinkovitosti obuhvaćenu ovom Uredbom.
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.
U slučaju studije učinkovitosti za koju je podnio jedinstveni zahtjev iz članka 74., naručitelj izvješćuje o svakom događaju kako je navedeno u stavku 2. ovog članka putem elektroničkog sustava iz članka 69.
Data gathered by the manufacturer's post-market surveillance system shall in particular be used:
Nakon primitka to izvješće elektroničkim putem prenosi se svim državama članicama u kojima se provodi studija učinkovitosti.
to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;
Pod vodstvom koordinirajuće države članice iz članka 74. stavka 2., države članice koordiniraju svoje ocjenjivanje ozbiljnih nepoželjnih događaja i nedostataka proizvoda kako bi se utvrdilo je li potrebno izmijeniti, suspendirati ili završiti studiju učinkovitosti ili opozvati odobrenje za tu studiju učinkovitosti.
to update the design and manufacturing information, the instructions for use and the labelling;
Ovaj stavak ne utječe na prava drugih država članica da provedu vlastitu procjenu te donose mjere u skladu s ovom Uredbom radi osiguranja zaštite javnog zdravlja i sigurnosti pacijenata.
to update the performance evaluation;
Koordinirajuća država članica i Komisija redovito se obavješćuju o rezultatu svake takve procjene te o donošenju svake takve mjere.
to update the summary of safety and performance referred to in Article 29;
U slučaju studija posttržišnog praćenja učinkovitosti iz članka 70. stavka 1., umjesto ovog članka primjenjuju se odredbe o vigilanciji utvrđene u člancima od 82. do 85. i u provedbenim aktima donesenima u skladu s člankom 86.
for the identification of needs for preventive, corrective or field safety corrective action;
Neovisno o stavku 5. ovaj se članak ipak primjenjuje kada se utvrdi uzročna veza između ozbiljnog nepoželjnog događaja i studije učinkovitosti koja mu je prethodila.
for the identification of options to improve the usability, performance and safety of the device;
Članak 77.
when relevant, to contribute to the post-market surveillance of other devices; and
Provedbeni akti
to detect and report trends in accordance with Article 83.
Komisija može provedbenim aktima utvrditi podrobne aranžmane i postupovne aspekte nužne za provedbu ovog poglavlja u pogledu sljedećeg:
The technical documentation shall be updated accordingly.
usklađenih elektroničkih obrazaca zahtjeva za studije učinkovitosti i njihovo ocjenjivanje kako je navedeno u člancima 66. i 74., pri čemu se uzimaju u obzir posebne kategorije ili skupine proizvoda;
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.
funkcioniranja elektroničkog sustava iz članka 69.;
Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 82.
usklađenih elektroničkih obrazaca obavijesti o studijama posttržišnog praćenja učinkovitosti kako je navedeno u članku 70. stavku 1. te o znatnim izmjenama iz članka 71.;
Article 79
razmjene informacija među državama članicama kako je navedeno u članku 72.;
Post-market surveillance plan
usklađenih elektroničkih obrazaca za prijavljivanje ozbiljnih nepoželjnih događaja i manjkavosti proizvoda iz članka 76.;
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.
rokova za prijavu ozbiljnih nepoželjnih događaja i nedostataka proizvoda, pri čemu se uzima u obzir ozbiljnost događaja koji se prijavljuje kako je navedeno u članku 76.;
The post-market surveillance plan shall be part of the technical documentation specified in Annex II.
jedinstvene primjene zahtjeva u vezi s kliničkim dokazima/podacima potrebnima za dokazivanje usklađenosti s općim zahtjevima sigurnosti i učinkovitosti navedenima u Prilogu I.
Article 80
Provedbeni akti navedeni u prvom stavku donose se u skladu s postupkom ispitivanja iz članka 107. stavka 3.
Post-market surveillance report
POGLAVLJE VII.
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.
POSTTRŽIŠNI NADZOR, VIGILANCIJA I NADZOR TRŽIŠTA
The report shall be updated when necessary and made available to the notified body and the competent authority upon request.
Posttržišni nadzor
Article 81
Članak 78.
Periodic safety update report
Sustav posttržišnog nadzora proizvođača
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.
Proizvođači za svaki proizvod razmjerno klasi rizika i prilagođeno vrsti proizvoda planiraju, uspostavljaju, dokumentiraju, provode, održavaju i ažuriraju sustav posttržišnog nadzora.
Throughout the lifetime of the device concerned, that PSUR shall set out:
Taj sustav sastavni je dio proizvođačeva sustava upravljanja kvalitetom iz članka 10. stavka 8.
the conclusions of the benefit-risk determination;
Sustav posttržišnog nadzora prikladan je za aktivno i sustavno prikupljanje, evidentiranje i analizu relevantnih podataka o kakvoći, učinkovitosti i sigurnosti proizvoda tijekom čitavog njegova životnog vijeka, za donošenje potrebnih zaključaka te kako bi se utvrdile, provele i pratile sve preventivne i korektivne radnje.
the main findings of the PMPF; and
Podaci koji su prikupljeni sustavom posttržišnog nadzora proizvođača osobito se upotrebljavaju za:
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.
ažuriranje utvrđivanja odnosa koristi i rizika te poboljšanje upravljanja rizicima iz poglavlja I. Priloga I.;
Manufacturers of class C and D devices shall update the PSUR at least annually.
ažuriranje informacija o projektiranju i proizvodnji, uputa za uporabu i označivanja;
That PSUR shall be part of the technical documentation as specified in Annexes II and III.
ažuriranje procjene učinkovitosti;
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.
ažuriranje sažetka o sigurnosti i učinkovitosti iz članka 29.;
The notified body shall review the report and add its evaluation to that electronic system with details of any action taken.
utvrđivanje potreba za preventivnim, korektivnim ili sigurnosnim korektivnim radnjama;
Such PSUR and the evaluation by the notified body shall be made available to competent authorities through that electronic system.
utvrđivanje opcija za poboljšanje upotrebljivosti, sigurnosti i učinkovitosti proizvoda;
For class C devices, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
prema potrebi, davanje doprinosa posttržišnom nadzoru drugih proizvoda; i
Vigilance
otkrivanje razvojnih kretanja i izvješćivanje o njima u skladu s člankom 83.
Article 82
Tehnička dokumentacija ažurira se na odgovarajući način.
Reporting of serious incidents and field safety corrective actions
Ako se u okviru posttržišnog nadzora prepozna potreba za preventivnim i/ili korektivnim radnjama, proizvođač provodi odgovarajuće mjere i obavješćuje dotična nadležna tijela i, ako je primjenjivo, prijavljeno tijelo.
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:
Kada se utvrdi ozbiljan štetni događaj ili se provede sigurnosna korektivna radnja, to se prijavljuje u skladu s člankom 82.
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;
Članak 79.
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.
Plan posttržišnog nadzora
The reports referred to in the first subparagraph shall be submitted through the electronic system referred to in Article 87.
Sustav posttržišnog nadzora iz članka 78. temelji se na planu posttržišnog nadzora čiji su zahtjevi utvrđeni u odjeljku 1.
As a general rule, the period for the reporting referred to in paragraph 1 shall take account of the severity of the serious incident.
Priloga II.
Manufacturers shall report any serious incident as referred to in point (a) immediately after they have established a causal relationship between that incident and their device or that such causal relationship is reasonably possible, and not later than 15 days after they become aware of the incident.
Plan posttržišnog nadzora dio je tehničke dokumentacije iz Priloga II.
Notwithstanding paragraph 3, in the event of a serious public health threat the report referred to in paragraph 1 shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat.
Članak 80.
Notwithstanding paragraph 3, in the event of death or an unanticipated serious deterioration in a person's state of health the report shall be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident.
Izvješće o posttržišnom nadzoru
Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is incomplete followed up by a complete report.
Proizvođači proizvodâ klase A i B sastavljaju izvješće o posttržišnom nadzoru, u kojem sažimaju rezultate i zaključke analiza podataka prikupljenih posttržišnim nadzorom kao rezultat plana posttržišnog nadzora iz članka 79., zajedno s objašnjenjem i opisom svih preventivnih i korektivnih radnji koje su poduzete.
If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about whether the incident is reportable, it shall nevertheless submit a report within the timeframe required in accordance with paragraphs 2 to 5.
Izvješće se prema potrebi ažurira i na zahtjev stavlja na raspolaganje prijavljenom tijelu i nadležnom tijelu.
Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in point (b) of paragraph 1, in advance of the field safety corrective action being undertaken.
Članak 81.
For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a field safety corrective action implemented or where the incidents are common and well documented, the manufacturer may provide periodic summary reports instead of individual serious incident reports, on condition that the coordinating competent authority referred to in Article 84(9), in consultation with the competent authorities referred to in points (a) and (b) of Article 87(8), has agreed with the manufacturer on the format, content and frequency of the periodic summary reporting.
Periodično izvješće o neškodljivosti
Where a single competent authority is referred to in points (a) and (b) of Article 87(8), the manufacturer may provide periodic summary reports following agreement with that competent authority.
Proizvođači proizvodâ klase A i B pripremaju periodično izvješće o neškodljivosti za svaki proizvod i, prema potrebi, za svaku kategoriju ili skupinu proizvoda u kojem sažimaju rezultate i zaključke analiza podataka prikupljenih posttržišnim nadzorom kao rezultat plana posttržišnog nadzora iz članka 79., zajedno s objašnjenjem i opisom svih poduzetih preventivnih i korektivnih radnji.
The Member States shall take appropriate measures such as organising targeted information campaigns, to encourage and enable healthcare professionals, users and patients to report to the competent authorities suspected serious incidents referred to in point (a) of paragraph 1.
Tijekom životnog vijeka dotičnog proizvoda u periodičnom izvješću o neškodljivosti navode se:
The competent authorities shall record centrally at national level reports they receive from healthcare professionals, users and patients.
zaključci koje utvrđivanja odnosa koristi i rizika;
Where a competent authority of a Member State obtains such reports on suspected serious incidents referred to in point (a) of paragraph 1 from healthcare professionals, users or patients, it shall take the necessary steps to ensure that the manufacturer of the device concerned is informed of the suspected serious incident without delay.
glavni nalazi posttržišnog praćenja učinkovitosti te
Where the manufacturer of the device concerned considers that the incident is a serious incident, it shall provide a report in accordance with paragraphs 1 to 5 of this Article on that serious incident to the competent authority of the Member State in which that serious incident occurred and shall take the appropriate follow-up action in accordance with Article 84.
obujam prodaje proizvoda i procjena brojnosti i drugih značajki populacije koja upotrebljavaju proizvod te, ako je izvedivo, učestalost uporabe proizvoda.
Where the manufacturer of the device concerned considers that the incident is not a serious incident or is to be treated as an increase in expected erroneous results, which will be covered by trend reporting in accordance with to Article 83, it shall provide an explanatory statement.
Proizvođači proizvodâ klase C i D najmanje jednom godišnje ažuriraju izvješće o neškodljivosti.
If the competent authority does not agree with the conclusion of the explanatory statement, it may require the manufacturer to provide a report in accordance with paragraphs 1 to 5 of this Article and require it to ensure that appropriate follow-up action is taken in accordance with Article 84.
To periodično izvješće o neškodljivosti dio je tehničke dokumentacije kako je određeno u prilozima II. i III.
Article 83
Proizvođači proizvodâ klase D podnose periodično izvješće o neškodljivosti putem elektroničkog sustava iz članka 87. prijavljenom tijelu koje je uključeno u ocjenjivanje sukladnosti takvih proizvoda u skladu s člankom 48.
Trend reporting
Prijavljeno tijelo preispituje izvješće i dodaje svoju procjenu u taj elektronički sustav s detaljima o svim poduzetim mjerama.
Manufacturers shall report by means of the electronic system referred to in Article 87 any statistically significant increase in the frequency or severity of incidents that are not serious incidents that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons or of any significant increase in expected erroneous results established in comparison to the stated performance of the device as referred to in points (a) and (b) of Section 9.1 of Annex I and specified in the technical documentation and product information.
Takvo periodično izvješće o neškodljivosti i procjena prijavljenog tijela dostupni su nadležnim tijelima putem tog elektroničkog sustava.
The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology used for determining any statistically significant increase in the frequency or severity of such events or change in performance, as well as the observation period, in the post-market surveillance plan referred to in Article 79.
U pogledu proizvoda klase C proizvođači periodična izvješća o neškodljivosti stavljaju na raspolaganje prijavljenom tijelu koje je uključeno u ocjenjivanje sukladnosti te, na zahtjev, nadležnim tijelima.
The competent authorities may conduct their own assessments on the trend reports referred to in paragraph 1 and require the manufacturer to adopt appropriate measures in accordance with this Regulation in order to ensure the protection of public health and patient safety.
Vigilancija
Each competent authority shall inform the Commission, the other competent authorities and the notified body that issued the certificate, of the results of such assessment and of the adoption of such measures.
Članak 82.
Article 84
Izvješćivanje o ozbiljnim štetnim događajima i sigurnosnim korektivnim radnjama
Analysis of serious incidents and field safety corrective actions
Proizvođači proizvoda koji su stavljeni na raspolaganje na tržištu Unije, osim proizvoda za studiju učinkovitosti, izvješćuju relevantna nadležna tijela, u skladu s člankom 87. stavcima 5. i 7.o sljedećemu:
Following the reporting of a serious incident pursuant to Article 82(1), the manufacturer shall, without delay, perform the necessary investigations in relation to the serious incident and the devices concerned.
svakom ozbiljnom štetnom događaju koji se tiče proizvoda stavljenih na raspolaganje na tržištu Unije, uz iznimku očekivanih pogrešnih rezultata koji su jasno dokumentirani i kvantificirani u okviru informacija o proizvodu i u tehničkoj dokumentaciji te za koje se u skladu s člankom 83. podnosi izvješće o razvojnim kretanjima;
This shall include risk assessment of the incident and field safety corrective action taking into account the criteria as referred to in paragraph 3 of this Article as appropriate.
svakoj sigurnosnoj korektivnoj radnji u vezi s proizvodima stavljenima na raspolaganje na tržištu Unije, uključujući svaku sigurnosnu korektivnu radnju poduzetu u trećoj zemlji u odnosu na proizvod koji je također zakonito stavljen na raspolaganje na tržištu Unije ako razlog za sigurnosnu korektivnu radnju nije ograničen na proizvod koji je stavljen na raspolaganje u trećoj zemlji.
The manufacturer shall co-operate with the competent authorities and where relevant with the notified body concerned during the investigations referred to in the first subparagraph and shall not perform any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.
Izvješća iz prvog podstavka podnose se putem putem elektroničkog sustava iz članka 87.
Member States shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory, or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 82 is evaluated centrally at national level by their competent authority, if possible together with the manufacturer, and, where relevant, the notified body concerned.
Kao opće pravilo, pri određivanju roka za izvješćivanje iz stavka 1. uzima se u obzir ozbiljnost ozbiljnog štetnog događaja.