natgillin/translations-raw huggingface dataset:
identifying previously unknown risks or limits to performance and contra-indications,
drugi ustrezni razpoložljivi klinični podatki glede varnosti, znanstvene veljavnosti, klinične učinkovitosti, kliničnih koristi za paciente, značilnosti zasnove in predvidenega namena podobnih pripomočkov, vključno s podrobnostmi o njihovih podobnostih in razlikah v primerjavi z zadevnim pripomočkom;
identifying and analysing emergent risks on the basis of factual evidence,
povzetek analize razmerja med koristmi in tveganji ter obvladovanja tveganja, vključno z informacijami o znanih ali predvidljivih tveganjih in opozorilih;
ensuring the continued acceptability of the clinical evidence and of the benefit-risk ratio referred to in Sections 1 and 8 of Chapter I of Annex I, and
v primeru pripomočkov, ki vsebujejo tkiva, celice in snovi človeškega, živalskega ali mikrobnega izvora, podrobne informacije o tkivih, celicah in snoveh ter o skladnosti z ustreznimi splošnimi zahtevami glede varnosti in učinkovitosti ter posebnimi ukrepi za obvladovanje tveganja v zvezi s temi tkivi, celicami in snovmi;
identifying possible systematic misuse.
podroben seznam o doslednem ali delnem izpolnjevanju zadevnih splošnih zahtev glede varnosti in učinkovitosti iz Priloge I, vključno s koristmi in tveganji standardi in skupnimi specifikacijami, ki se uporabljajo, ter opis rešitev za izpolnjevanje zadevnih splošnih zahtev glede varnosti in učinkovitosti, če ti standardi in skupne specifikacije niso bili izpolnjeni ali so bili le delno izpolnjeni ali pa ne obstajajo;
The PMPF plan shall include at least:
podroben opis kliničnih postopkov in diagnostičnih preskusov, uporabljenih med študijo učinkovitosti, in zlasti informacije o morebitnih odstopanjih od običajne klinične prakse.
the general methods and procedures of the PMPF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of performance or scientific data;
Načrt študije učinkovitosti, kot je naveden v oddelkih 2 in 3 Priloge XIII.
the specific methods and procedures of PMPF to be applied, such as ring trials and other quality assurance activities, epidemiological studies, evaluation of suitable patient or disease registers, genetic databanks or post-market clinical performance studies;
Druge informacije
a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);
Podpisana izjava fizične ali pravne osebe, odgovorne za izdelavo pripomočka za ocenjevanje učinkovitosti, s katero izjavlja, da zadevni pripomoček izpolnjuje splošne zahteve glede varnosti in učinkovitosti iz Priloge I, razen vidikov, zajetih v študiji učinkovitosti, in da so bili v zvezi s temi vidiki sprejeti vsi previdnostni ukrepi za zaščito zdravja in varnosti udeleženca.
a reference to the relevant parts of the performance evaluation report referred to in Section 1.3 of this Annex and to the risk management referred to in Section 3 of Annex I;
Kadar je to ustrezno v skladu z nacionalnim pravom, izvod mnenja ali mnenj zadevnega odbora ali odborov za etiko.
the specific objectives to be addressed by the PMPF;
Če v skladu z nacionalnim pravom ob predložitvi vloge ni treba predložiti mnenja ali mnenj odbora ali odborov za etiko, se kopija tega mnenja ali mnenj predloži takoj, ko je na voljo.
an evaluation of the performance data relating to equivalent or similar devices, and the current state of the art;
Dokazilo o zavarovanju ali odškodnini za udeležence v primeru poškodbe v skladu s členom 65 in ustreznim nacionalnim pravom.
reference to any relevant CS, harmonised standards when used by the manufacturer, and relevant guidance on PMPF, and;
Dokumenti, ki se uporabljajo za pridobitev privolitve po seznanitvi, vključno s pacientovim informativnim listom in obrazcem za privolitev po seznanitvi.
a detailed and adequately justified time schedule for PMPF activities, such as analysis of PMPF data and reporting, to be undertaken by the manufacturer.
Opis ureditev za usklajenost z veljavnimi pravili o varstvu in zaupnosti osebnih podatkov, zlasti opis:
The manufacturer shall analyse the findings of the PMPF and document the results in a PMPF evaluation report that shall update the performance evaluation report and be part of the technical documentation.
organizacijskih in tehničnih ureditev, ki bodo uvedene za preprečevanje nepooblaščenega dostopa do obdelanih informacij in osebnih podatkov, njihovega razkritja, razširjanja, spreminjanja ali izgube;
The conclusions of the PMPF evaluation report shall be taken into account for the performance evaluation referred to in Article 56 and Part A of this Annex and in the risk management referred to in Section 3 of Annex I. If, through the PMPF, the need for preventive and/or corrective measures has been identified, the manufacturer shall implement them.
ukrepov, ki bodo uvedeni za zagotavljanje zaupnosti evidenc in osebnih podatkov udeležencev;
If PMPF is not deemed appropriate for a specific device then a justification shall be provided and documented within the performance evaluation report.
ukrepov, ki bodo uvedeni v primeru kršitve varnosti podatkov za ublažitev morebitnih neželenih učinkov.
ANNEX XIV
Vse podrobnosti o razpoložljivi tehnični dokumentaciji, na primer podrobna dokumentacija o analizi/obvladovanju tveganja ali posebna poročila o preskusih, se na zahtevo predložijo pristojnemu organu, ki pregleduje vlogo.
INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND CERTAIN OTHER PERFORMANCE STUDIES
DRUGE OBVEZNOSTI SPONZORJA
DOCUMENTATION REGARDING THE APPLICATION FOR INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND OTHER PERFORMANCE STUDIES INVOLVING RISKS FOR THE SUBJECTS OF THE STUDIES
Sponzor se zaveže, da bo za pristojne nacionalne organe hranil vsako potrebno dokumentacijo, ki služi kot dokaz za dokumentacijo iz poglavja I te priloge.
For devices intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects of the studies, the sponsor shall draw up and submit the application in accordance with Article 58 accompanied by the following documents:
Če sponzor ni fizična ali pravna oseba, odgovorna za izdelavo pripomočka za študijo učinkovitosti, lahko to obveznost v imenu sponzorja izpolni oseba, odgovorna za izdelavo pripomočka za študijo učinkovitosti.
Application form
Sponzor določi, da mu raziskovalec ali raziskovalci pravočasno poročajo o vseh resnih neželenih dogodkih ali vseh drugih dogodkih iz člena 76(2).
The application form shall be duly filled in, containing the following information:
Dokumentacija iz te priloge se hrani za obdobje vsaj deset let po zaključku študije klinične učinkovitosti zadevnega pripomočka ali, v primeru da je pripomoček dan na trg pozneje, vsaj deset let po tem, ko je bil na trg dan zadnji pripomoček.
name, address and contact details of the sponsor and, if applicable, name, address and contact details of its contact person or legal representative in accordance with Article 58(4) established in the Union;
Vsaka država članica zagotovi, da je dokumentacija iz te priloge na voljo pristojnim organom za obdobje iz prvega pododstavka, če sponzor ali njegova kontaktna oseba, ki ima sedež na njenem ozemlju, prijavi stečaj ali preneha opravljati svojo poslovno dejavnost pred koncem tega obdobja.
if different from those in Section 1.1, name, address and contact details of the manufacturer of the device intended for performance evaluation and, if applicable, of its authorised representative;
Sponzor imenuje nadzornika, ki je neodvisen od mesta raziskave, da se zagotovi izvedba študije klinične učinkovitosti v skladu z načrtom študije klinične učinkovitosti, načeli dobre klinične prakse in to uredbo.
title of the performance study;
Sponzor dokonča nadaljnje spremljanje udeležencev raziskave.
single identification number in accordance with Article 66(1);
PRILOGA XIV
status of the performance study, such as. the first submission, resubmission, significant amendment;
KORELACIJSKA TABELA
details and/ or reference to the performance study plan, such as including details of the design phase of the performance study;
Direktiva 98/79/ES
if the application is a resubmission with regard to a device for which an application has been already submitted, the date or dates and reference number or numbers of the earlier application or in the case of significant amendment, reference to the original application.
Ta uredba
The sponsor shall identify all of the changes from the previous application together with a rationale for those changes, in particular, whether any changes have been made to address conclusions of previous competent authority or ethics committee reviews;
Člen 1(1)
if the application is submitted in parallel with an application for a clinical trial in accordance with Regulation (EU) No 536/2014, reference to the official registration number of the clinical trial;
Člen 1(2)
identification of the Member States and third countries in which the clinical performance study is to be conducted as part of a multicentre or multinational study at the time of application;
Člen 1(3)
brief description of the device for performance study, its classification and other information necessary for the identification of the device and device type;
Člen 2, točki (54) in (55)
summary of the performance study plan;
Člen 1(4)
if applicable, information regarding a comparator device, its classification and other information necessary for the identification of the comparator device;
Člen 1(5)
evidence from the sponsor that the clinical investigator and the investigational site are capable of conducting the clinical performance study in accordance with the performance study plan;
Člen 5(4) in (5)
details of the anticipated start date and duration of the performance study;
Člen 1(6)
details to identify the notified body, if already involved at the stage of application for the performance study;
Člen 1(9)
confirmation that the sponsor is aware that the competent authority may contact the ethics committee that is assessing or has assessed the application;
Člen 1(7)
the statement referred to in Section 4.1.
Člen 5(1)
Investigator's brochure
Člen 5(2)
The investigator's brochure (IB) shall contain the information on the device for performance study that is relevant for the study and available at the time of application.
Člen 4(1)
Any updates to the IB or other relevant information that is newly available shall be brought to the attention of the investigators in a timely manner.
Člen 4(2)
The IB shall be clearly identified and contain in particular the following information:
Člen 19(1) in (2)
Identification and description of the device, including information on the intended purpose, the risk classification and applicable classification rule pursuant to Annex VIII, design and manufacturing of the device and reference to previous and similar generations of the device.
Člen 4(3)
Manufacturer's instructions for installation, maintenance, maintaining hygiene standards and for use, including storage and handling requirements, as well as, to the extent that such information is available, information to be placed the label, and instructions for use to be provided with the device when placed on the market.
Člen 19(3)
In addition, information relating to any relevant training required.
Člen 4(4)
Analytical performance.
Člen 10(10)
Existing clinical data, in particular:
Člen 4(5)
from relevant peer-reviewed scientific literature and available consensus expert opinions or positions from relevant professional associations relating to the safety, performance, clinical benefits to patients, design characteristics, scientific validity, clinical performance and intended purpose of the device and/or of equivalent or similar devices;
Člen 18(6)
other relevant clinical data available relating to the safety, scientific validity, clinical performance, clinical benefits to patients, design characteristics and intended purpose of similar devices, including details of their similarities and differences with the device in question.
Člen 8(1)
Summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks and warnings.
Člen 5(3)
In the case of devices that include tissues, cells and substances of human, animal or microbial origins detailed information on the tissues, cells and substances, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to those tissues, cells and substances.
Člena 89 in 92
A list detailing the fulfilment of the relevant general safety and performance requirements set out in Annex I, including the standards and CS applied, in full or in part, as well as a description of the solutions for fulfilling the relevant general safety and performance requirements, in so far as those standards and CS have not or have only been partly fulfilled or are lacking.
Člen 9(1), prvi pododstavek)
A detailed description of the clinical procedures and diagnostic tests used in the course of the performance study and in particular information on any deviation from normal clinical practice.
Člen 48(10), prvi pododstavek
Performance study plan as referred to in Sections 2 and 3 of Annex XIII.
Člen 9(1), drugi pododstavek
Other information
Člen 48(3), drugi pododstavek, člen 48(7), drugi pododstavek in člen 48(9), drugi pododstavek
A signed statement by the natural or legal person responsible for the manufacture of the device for performance study that the device in question conforms to the general safety and performance requirements laid down in Annex I apart from the aspects covered by the clinical performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.
Člen 9(2)
Where applicable according to national law, a copy of the opinion or opinions of the ethics committee or committees concerned.
Člen 48(3) do (6)
Where under national law the opinion or opinions of the ethics committee or committees is not required at the time of the submission of the application, a copy of the opinion or opinions shall be submitted as soon as available.
Člen 9(3)
Proof of insurance cover or indemnification of subjects in case of injury, pursuant to Article 65 and the corresponding national law.
Člen 48(3) do 9
Documents to be used to obtain informed consent, including the patient information sheet and the informed consent document.
Člen 9(4)
Description of the arrangements to comply with the applicable rules on the protection and confidentiality of personal data, in particular:
Člen 5(6)
organisational and technical arrangements that will be implemented to avoid unauthorised access, disclosure, dissemination, alteration or loss of information and personal data processed;
Člen 9(5)
a description of measures that will be implemented to ensure confidentiality of records and personal data of subjects;
Člen 9(6)
a description of measures that will be implemented in case of a data security breach in order to mitigate the possible adverse effects.
Člen 11(3) in (4)
Full details of the available technical documentation, for example detailed risk analysis/management documentation or specific test reports shall be submitted to the competent authority reviewing an application upon request.
Člen 9(7)
OTHER OBLIGATIONS OF THE SPONSOR
Člen 10(7)
The sponsor shall undertake to keep available for the competent national authorities any documentation necessary to provide evidence for the documentation referred to in Chapter I of this Annex.
Člen 9(8)
If the sponsor is not the natural or legal person responsible for the manufacture of the device intended for performance study, that obligation may be fulfilled by that person on behalf of the sponsor.
Člen 49(1)
The sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as referred to in Article 76(2) are reported by the investigator or investigators to the sponsor in a timely manner.
Člen 9(9)
The documentation mentioned in this Annex shall be kept for a period of time of at least 10 years after the clinical performance study with the device in question has ended, or, in the event that the device is subsequently placed on the market, for at least 10 years after the last device has been placed on the market.
Člen 49(4)
Each Member State shall require that the documentation referred to in this Annex is kept at the disposal of the competent authorities for the period indicated in the first subparagraph in case the sponsor, or his contact person, established within its territory, goes bankrupt or ceases its activity prior to the end of this period.
Člen 9(10)
The sponsor shall appoint a monitor that is independent of the investigation site to ensure that the clinical performance study is conducted in accordance with the Clinical Performance Study Plan, the principles of good clinical practice and this Regulation.
Člen 51(2)
The sponsor shall complete the follow-up of investigation subjects.
Člen 9(11)
ANNEX XV
Člen 48(12)
CORRELATION TABLE
Člen 9(12)
Directive 98/79/EC
Člen 54(1)
This Regulation
Člen 9(13)
Article 1(1)
Člen 48(2)
Article 1(2)
Člen 10(1) in (2), člen 10(3), drugi stavek in člen 10(4)
Article 1(3)
Členi 26(3), 27 in 28
points (54) and (55) of Article 2
Člen 10(3), prvi stavek
Article 1(4)
Člen 11(1)
Article 1(5)
Člena 82(1) in 84(2)
Article 5(4) and (5)
Člen 11(2)
Article 1(6)
Člen 82(10) in člen 82(11), prvi pododstavek
Article 1(9)
Člen 11(3)
Article 1(7)
Člen 84(7)
Article 5(1)
Člen 11(4)
Article 5(2)
Člen 11(5)
Article 4(1)
Člen 14(1)(a)
Article 4(2)
Člen 14(1)(b)
Article 19(1) and (2)
Člen 47(3) in (6)
Article 4(3)
Člen 14(2)
Article 19(3)
Člen 14(3)
Article 4(4)
Člen 15(1)
Article 10(10)
Člen 38 in člen 39
Article 4(5)
Člen 15(2)
Article 18(6)
Člen 15(3)
Article 8(1)
Člen 40(2) in (4)
Article 5(3)
Člen 15(4)
Articles 89 and 92
Člen 15(5)
Article 9(1) first subparagraph
Člen 51(5)
Article 48(10) first subparagraph
Člen 15(6)
Article 9(1) second subparagraph
Člen 51(4)
Article 48(3) second subparagraph, Article 48(7) second subparagraph and Article 48(9) second subparagraph
Člen 15(7)
Article 9(2)
Člen 34(2) in člen 40(2)
Article 48(3) to (6)
Členi 89 do 92
Article 9(3)
Brez poseganja v obveznosti na podlagi drugih postopkov iz odstavkov 3 in 4, za pripomočke, za katere je v skladu s členom 100 imenovan eden ali več referenčnih laboratorijev EU, priglašeni organ, ki opravlja ugotavljanje skladnosti, zahteva, da eden od referenčnih laboratorijev EU preveri učinkovitost, ki jo navaja proizvajalec, in skladnost pripomočka z veljavnimi skupnimi specifikacijami, in sicer z laboratorijskim testiranjem ali na drug način, ki ga izbere proizvajalec, da se zagotovi vsaj enakovredna raven varnosti in učinkovitosti, kot je določeno v oddelku 4.9 Priloge IX in v točki (j) oddelka 3 Priloge X.
Article 48(3) to (9)
Pri laboratorijskih testih, ki jih opravi referenčni laboratorij EU, se z uporabo najboljših razpoložljivih referenčnih materialov posebna pozornost nameni analitični in diagnostični občutljivosti.
Article 9(4)
To se ne uporablja za študije učinkovitosti, ki vključujejo dopolnilno diagnostiko, pri katerih se uporabljajo le ostanki vzorcev.
Article 5(6)
Take študije se pa priglasijo pristojnemu organu.
Article 9(5)
Postopek, določen v tem členu, se do 27. maja 2029 uporablja le za tiste države članice, v katerih se bodo ocene učinkovitosti izvajale, ki so se strinjale z njegovo uporabo.
Article 9(6)
Po 27. maju 2029 se uporaba tega postopka zahteva od vseh držav članic.
Article 11(3) and (4)
Pooblastilo za sprejemanje delegiranih aktov iz členov 10(4), 17(4), 24(10), 51(6) in 66(8) se prenese na Komisijo za obdobje petih let od 25. maja 2017.
Article 9(7)
Komisija pripravi poročilo o prenosu pooblastila najpozneje devet mesecev pred koncem petletnega obdobja.
Article 10(7)
Z odstopanjem od Direktive 98/79/ES so lahko organi za ugotavljanje skladnosti, ki izpolnjujejo zahteve iz te uredbe, imenovani in priglašeni pred 26. majem 2022.
Article 9(8)
Priglašeni organi, ki so imenovani in priglašeni v skladu s to uredbo, lahko izvajajo postopke ugotavljanja skladnosti, ki so določeni v tej uredbi, in izdajajo spričevala v skladu s to uredbo pred 26. majem 2022.
Article 9(9)
Vendar se od tega datuma do 26. maja 2022 obveznosti priglašenih organov na podlagi členov 31 do 46 uporabljajo le za tiste organe, ki predložijo vlogo za imenovanje v skladu s členom 34;
Article 49(4)
Kadar je učinkovitost pripomočkov odvisna od uporabe umerjevalcev in/ali kontrolnih materialov, se meroslovna sledljivost vrednosti, pripisanih umerjevalcem in/ali kontrolnim materialom, zagotovi z ustreznimi referenčnimi meritvenimi postopki in/ali ustreznimi referenčnimi materiali višjega meroslovnega reda.
Article 9(10)
Kadar je to mogoče, se meroslovna sledljivost vrednosti, pripisanih umerjevalcem in kontrolnim materialom, zagotovi za potrjene referenčne materiale ali referenčne merilne postopke.
Article 51(2)
če je to ustrezno, so informacije, ki jih navede proizvajalec v obliki mednarodno priznanih simbolov, pri čemer se upoštevajo predvideni uporabniki.
Article 9(11)
Vsak uporabljen simbol ali identifikacijska barva je v skladu s harmoniziranimi standardi ali skupnimi specifikacijami.
Article 48(12)
če navodila za uporabo niso zagotovljena v papirnati obliki skladno s točko (f) oddelka 20.1., navedba o dostopnosti (ali razpoložljivosti) teh navodil, kadar je to ustrezno, pa tudi naslov spletnega mesta, kjer so na voljo;
Article 9(12)
kadar je to ustrezno, morebitna posebna navodila za delovanje;
Article 54(1)
Če je to izvedljivo in ustrezno, so informacije navedene na pripomočku samem in/ali, če je to ustrezno, na prodajni embalaži;
Article 11(1)
Informacije na embalaži, ki ohranja sterilno stanje pripomočka („sterilna embalaža“)
Articles 82(1) and 84(2)
Na sterilni embalaži se navedejo naslednji podatki:
Article 11(2)
navedba, na podlagi katere je mogoče sterilno embalažo kot tako tudi prepoznati,
Article 82(10) and Article 82(11) first subparagraph
izjava, da je pripomoček v sterilnem stanju,
Article 11(3)
metoda sterilizacije,
Article 84(7)
ime in naslov proizvajalca,
Article 11(4)
opis pripomočka,
Article 11(5)
mesec in leto izdelave,
Article 14(1)(a)
nedvoumna navedba roka, do katerega je pripomoček varen za uporabo in izraženega vsaj kot leto in mesec, po potrebi pa tudi dan, v tem vrstnem redu,
Article 14(1)(b)
navodilo, naj se preverijo navodila za uporabo v primeru, ko je sterilna embalaža poškodovana ali po nesreči odprta pred uporabo.
Article 47(3) and (6)
Informacije v navodilih za uporabo
Article 14(2)
podrobnosti, na podlagi katerih lahko uporabnik identificira edino zadevni pripomoček;
Article 14(3)
predvideni namen pripomočka:
Article 15(1)
kaj se odkriva in/ali meri;
Article 38 and Article 39
nagnjenostjo k bolezenskemu stanju ali bolezni;
Article 15(2)
določitvijo varnosti in združljivosti z morebitnimi prejemniki;
Article 15(3)
predvidevanjem odzivanja ali reakcij na zdravljenje;
Article 40(2) and (4)
opredelitvijo ali spremljanjem terapevtskih ukrepov;
Article 15(4)
po potrebi testno populacijo in
Article 15(5)
predvideni uporabnik, kot je to ustrezno (npr. uporaba za samotestiranje, uporaba ob pacientu in strokovna uporaba v laboratoriju, uporaba s strani zdravstvenih delavcev);
Article 51(5)
načelo testa;
Article 15(6)
opis umerjevalcev in kontrol ter vse omejitve pri njihovi uporabi (npr. ustrezni samo za namenski instrument);
Article 51(4)
opis reagentov in vse omejitve pri njihovi uporabi (npr. ustreznost samo za namenski instrument) ter sestavo reagenčnega izdelka po naravi in količini ali koncentraciji aktivne(-ih) sestavine(-in) reagenta(-ov) ali kompleta ter izjavo, kadar je to ustrezno, da pripomoček vsebuje druge sestavine, ki bi lahko vplivale na meritev;
Article 15(7)
seznam priloženih materialov in seznam posebnih materialov, ki se zahtevajo, vendar niso priloženi;
Article 34(2) and Article 40(2)
za pripomočke, predvidene za uporabo v kombinaciji, nameščene ali povezane z drugimi pripomočki in/ali opremo za splošno uporabo:
Articles 89 to 92
stabilnost pri uporabi, ki lahko vključuje pogoje skladiščenja in rok uporabnosti po prvem odprtju prvotne posode, skupaj s pogoji skladiščenja in stabilnostjo delovnih raztopin, kadar je to ustrezno;