natgillin/translations-raw huggingface dataset:
Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2).
Ti izvedbeni akti se sprejmejo v skladu s svetovalnim postopkom iz člena 107(2).
CLINICAL EVIDENCE, PERFORMANCE EVALUATION AND PERFORMANCE STUDIES
KLINIČNI DOKAZ, OCENA UČINKOVITOSTI IN ŠTUDIJE UČINKOVITOSTI
Performance evaluation and clinical evidence
Ocena učinkovitosti in klinični dokaz
Confirmation of conformity with relevant general safety and performance requirements set out in Annex I, in particular those concerning the performance characteristics referred to in Chapter I and Section 9 of Annex I, under the normal conditions of the intended use of the device, and the evaluation of the interference(s) and cross-reaction(s) and of the acceptability of the benefit-risk ratio referred to in Sections 1 and 8 of Annex I, shall be based on scientific validity, analytical and clinical performance data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III.
Potrditev skladnosti z ustreznimi splošnimi zahtevami glede varnosti in učinkovitosti iz Priloge I, zlasti zahtevami v zvezi z učinkovitostjo iz poglavja I in oddelka 9 Priloge I, pri običajnih pogojih predvidene uporabe pripomočka ter ocenjevanje interferenc, navzkrižnih reakcij in sprejemljivosti razmerja med koristjo in tveganjem iz oddelkov 1 in 8 Priloge I temeljita na podatkih o znanstveni veljavnosti ter analitični in klinični učinkovitosti, ki omogočajo zadosten klinični dokaz, po potrebi pa tudi na ustreznih podatkih iz Priloge III.
The manufacturer shall specify and justify the level of the clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements.
Proizvajalec podrobno opiše in utemelji stopnjo kliničnega dokaza, potrebno za dokazovanje skladnosti z ustreznimi splošnimi zahtevami glede varnosti in učinkovitosti.
That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose.
Ta stopnja kliničnega dokaza mora biti primerna glede na lastnosti pripomočka in njegov predvideni namen.
To that end, manufacturers shall plan, conduct and document a performance evaluation in accordance with this Article and with Part A of Annex XIII.
Proizvajalci v ta namen načrtujejo, izvedejo in dokumentirajo oceno učinkovitosti v skladu s tem členom in delom A Priloge XIII.
The clinical evidence shall support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan.
Klinični dokazi podpirajo predvideni namen pripomočka, kot ga navaja proizvajalec, in temeljijo na stalnem procesu ocene učinkovitosti, ki poteka skladno z načrtom ocene učinkovitosti.
A performance evaluation shall follow a defined and methodologically sound procedure for the demonstration of the following, in accordance with this Article and with Part A of Annex XIII:
Ocena učinkovitosti poteka po natančno določenem in metodološko zanesljivem postopku, s katerim se v skladu s tem členom in delom A Priloge XIII dokaže naslednje:
scientific validity;
znanstvena veljavnost;
analytical performance;
analitska učinkovitost;
clinical performance.
klinična učinkovitost.
The data and conclusions drawn from the assessment of those elements shall constitute the clinical evidence for the device.
Podatki in ugotovitve, pridobljeni iz ocene teh elementov, so klinični dokaz za pripomoček.
The clinical evidence shall be such as to scientifically demonstrate, by reference to the state of the art in medicine, that the intended clinical benefit(s) will be achieved and that the device is safe.
Klinični dokaz ob opiranju na zadnje stanje tehničnega razvoja v medicini znanstveno dokazuje, da bodo predvidene klinične koristi dosežene in da je pripomoček varen.
The clinical evidence derived from the performance evaluation shall provide scientifically valid assurance, that the relevant general safety and performance requirements set out in Annex I, are fulfilled, under normal conditions of use.
Klinični dokaz, pridobljen iz ocene učinkovitosti, je znanstveno veljavno zagotovilo, da so ustrezne splošne zahteve glede varnosti in učinkovitosti, določene v Prilogi I, pri običajnih pogojih uporabe izpolnjene.
Clinical performance studies in accordance with Section 2 of Part A of Annex XIII shall be carried out unless it is duly justified to rely on other sources of clinical performance data.
Študije klinične učinkovitosti v skladu z oddelkom 2 dela A Priloge XIII se opravijo, razen če obstajajo ustrezno utemeljeni razlogi, da se je mogoče zanesti na druge vire podatkov klinične učinkovitosti.
The scientific validity data, the analytical performance data and the clinical performance data, their assessment and the clinical evidence derived therefrom, shall be documented in the performance evaluation report referred to in Section 1.3.2 of Part A of Annex XIII.
Podatki o znanstveni veljavnosti, analitski učinkovitosti in klinični učinkovitosti, njihova ocena ter klinični dokazi, ki izhajajo iz njih, se dokumentirajo v poročilu o oceni učinkovitosti iz oddelka 1.3.2 dela A Priloge XIII.
The performance evaluation report shall be part of the technical documentation, referred to in Annex II, relating to the device concerned.
Poročilo o oceni učinkovitosti je del tehnične dokumentacije iz Priloge II v zvezi z zadevnim pripomočkom.
The performance evaluation and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from implementation of the manufacturer's PMPF plan in accordance with Part B of Annex XIII and the post-market surveillance plan referred to in Article 79.
Ocena učinkovitosti in njena dokumentacija se v celotni življenjski dobi zadevnega pripomočka posodabljata s podatki, pridobljenimi z izvajanjem proizvajalčevega načrta spremljanja učinkovitosti po dajanju na trg v skladu z delom B Priloge XIII in načrta nadzora po dajanju na trg iz člena 79.
The performance evaluation report for class C and D devices shall be updated when necessary, but at least annually, with the data referred to in the first subparagraph.
Poročilo o oceni učinkovitosti za pripomočke razreda C in D se posodobi, kadar je to potrebno, vendar vsaj enkrat na leto s podatki iz prvega pododstavka.
The summary of safety and performance referred to in Article 29(1) shall be updated as soon as possible, where necessary.
Povzetek o varnosti in učinkovitosti iz člena 29(1) se posodobi čim prej, kadar je to potrebno.
Where necessary to ensure the uniform application of Annex XIII, the Commission may, having due regard to technical and scientific progress, adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application.
Komisija lahko ob ustreznem upoštevanju tehničnega napredka in znanstvenih dognanj sprejme izvedbene akte, če je to potrebno za rešitev vprašanj različne razlage in praktične uporabe ter za zagotovitev enotne uporabe Priloge XIII.
General requirements regarding performance studies
Splošne zahteve glede študij učinkovitosti
The manufacturer shall ensure that a device for performance study complies with the general safety and performance requirements set out in Annex I apart from the aspects covered by the performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the patient, user and other persons.
Proizvajalec zagotovi, da pripomoček za študije učinkovitosti izpolnjuje splošne zahteve glede varnosti in učinkovitosti iz Priloge I, razen vidikov, ki jih zajema študija učinkovitosti, in da so v zvezi z navedenimi vidiki sprejeti vsi previdnostni ukrepi za zaščito zdravja in varnosti pacienta, uporabnika in drugih oseb.
Where appropriate, performance studies shall be performed in circumstances similar to the normal conditions of use of the device.
Kadar je to ustrezno, se študije učinkovitosti izvedejo v okoliščinah, ki so podobne običajnim okoliščinam uporabe pripomočka.
Performance studies shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in such performance studies are protected and prevail over all other interests and the data generated are scientifically valid, reliable and robust.
Študije učinkovitosti se načrtujejo in izvedejo ob zaščiti pravic, varnosti, dostojanstva in dobrega počutja udeležencev v takšni študiji učinkovitosti, kar prevlada nad vsemi drugimi interesi, ter tako, da so pridobljeni podatki znanstveno veljavni, zanesljivi in ponovljivi.
Performance studies, including performance studies that use left-over samples, shall be conducted in accordance with applicable law on data protection.
Študije učinkovitosti, vključno s študijami, pri katerih se uporabljajo ostanki vzorcev, se izvajajo v skladu z veljavnim pravom o varstvu podatkov.
Additional requirements for certain performance studies
Dodatne zahteve za nekatere študije učinkovitosti
Any performance study:
Vse študije učinkovitosti:
in which surgically invasive sample-taking is done only for the purpose of the performance study;
pri katerih je invazivno odvzemanje vzorcev opravljeno le za namen študije učinkovitosti;
that is an interventional clinical performance study as defined in point (46) of Article 2; or
ki so intervencijske študije klinične učinkovitosti, kot so opredeljene v točki (46) člena 2 ali
where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies,
kadar izvedba študije vključuje dodatne invazivne postopke ali druga tveganja za udeležence v študijah,
shall, in addition to meeting the requirements set out in Article 57 and Annex XIII, be designed, authorised, conducted, recorded and reported in accordance with this Article and Articles 59 to 77 and Annex XIV.
so poleg tega, da izpolnjujejo zahteve iz člena 57 in Priloge XIII, zasnovane, odobrene, izvedene, evidentirane in se o njih poroča v skladu s tem členom in členi 59 do 77 in Prilogo XIV.
Performance studies involving companion diagnostics shall be subject to the same requirements as the performance studies listed in paragraph 1.
Za študije učinkovitosti, ki vključujejo dopolnilno diagnostiko, veljajo iste zahteve kot za študije učinkovitosti, navedene v odstavku 1.
Such studies shall however be notified to the competent authority.
Etični pregled opravi odbor za etiko v skladu z nacionalnim pravom.
Performance studies shall be subject to scientific and ethical review.
Države članice zagotovijo, da so postopki odbora za etiko v zvezi s pregledom skladni s postopki, določenimi v tej uredbi za oceno vloge za odobritev študije učinkovitosti.
The ethical review shall be performed by an ethics committee in accordance with national law.
Pri etičnem pregledu sodeluje vsaj en nestrokovnjak.
Member States shall ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Regulation for the assessment of the application for authorisation of a performance study.
Če sponzor študije učinkovitosti nima sedeža v Uniji, ta sponzor zagotovi, da ima sedež v Uniji fizična ali pravna oseba kot njegov zakoniti zastopnik.
At least one lay person shall participate in the ethical review.
Ta zakoniti zastopnik je odgovoren, da sponzor izpolnjuje svoje obveznosti iz te uredbe, poleg tega pa je kontaktna oseba za vso komunikacijo s sponzorjem, ki jo določa ta uredba.
Where the sponsor of a performance study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative.
Vsa komunikacija s tem zakonitim zastopnikom se šteje za komunikacijo s sponzorjem.
Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation.
Države članice lahko sklenejo, da prvega pododstavka ne bodo uporabljale pri študijah učinkovitosti, ki se izvajajo samo na njihovem ozemlju ali na njihovem ozemlju in ozemlju tretjih držav, če zagotovijo, da sponzor na njihovem ozemlju določi vsaj kontaktno osebo za navedene študije učinkovitosti, ki bo naslovnik za vso komunikacijo s sponzorjem, določeno v tej uredbi.
Any communication with that legal representative shall be deemed to be a communication with the sponsor.
Študija učinkovitosti iz odstavka 1 se lahko izvede samo, če so izpolnjeni vsi naslednji pogoji:
Member States may choose not to apply the first subparagraph to performance studies to be conducted solely on their territory, or on their territory and the territory of a third country, provided that they ensure that the sponsor establishes at least a contact person on their territory in respect of that performance study who shall be the addressee for all communications with the sponsor provided for in this Regulation.
zanjo je v skladu s to uredbo potrebno dovoljenje države članice ali držav članic, v katerih bo izvajana, razen če ni navedeno drugače;
A performance study as referred to in paragraph 1 may be conducted only where all of the following conditions are met:
odbor za etiko, ustanovljen v skladu z nacionalnim pravom, v zvezi z njo ni izdal negativnega mnenja, ki bi bilo veljavno za celotno navedeno državo članico v skladu z njenim nacionalnim pravom;
the performance study is the subject of an authorisation by the Member State(s) in which the performance study is to be conducted, in accordance with this Regulation, unless otherwise stated;
sponzor ali njegov zakoniti zastopnik ali kontaktna oseba v skladu z odstavkom 4 ima sedež v Uniji;
an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the performance study, which is valid for that entire Member State under its national law;
ranljive populacije in udeleženci so ustrezno zaščiteni v skladu s členi 59 do 64;
the sponsor or its legal representative or a contact person pursuant to paragraph 4 is established in the Union;
pričakovane koristi za udeleženca ali javno zdravje upravičujejo predvidena tveganja in neprijetnosti, upoštevanje tega pogoja pa se stalno spremlja;
vulnerable populations and subjects are appropriately protected in accordance with Articles 59 to 64;
udeleženec ali, če udeleženec ni sposoben dati privolitve po seznanitvi, njegov zakonito imenovani zastopnik je dal privolitev po seznanitvi v skladu s členom 59;
the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored;
udeleženec ali, če udeleženec ni sposoben dati privolitve po seznanitvi, njegov zakonito imenovani zastopnik je prejel kontaktne podatke ustanove, kadar je po potrebi mogoče dobiti dodatne informacije;
the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent, in accordance with Article 59;
pravice udeleženca do telesne in duševne celovitosti, zasebnosti in varstva njegovih osebnih podatkov v skladu z Direktivo 95/46/ES so zaščitene;
the subject or, where the subject is not able to give informed consent, his or her legally designated representative, has been provided with the contact details of an entity where further information can be received in case of need;
študija učinkovitosti je zasnovana tako, da povzroča čim manj bolečine, nelagodja, strahu in drugih predvidljivih tveganj za udeleženca in sta tako prag tveganja kot stopnja nelagodja natančno opredeljena v načrtu študije učinkovitosti in pod stalnim nadzorom;
the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with Directive 95/46/EC are safeguarded;
za zdravstveno oskrbo udeležencev je odgovoren ustrezno kvalificiran zdravnik ali, kadar je to ustrezno, druga oseba, ki sme v skladu z nacionalnim pravom ustrezno obravnavati paciente pod pogoji študije učinkovitosti;
the performance study has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the performance study plan and constantly monitored;
na udeleženca ali, kadar je to ustrezno, njegovega zakonito imenovanega zastopnika se za udeležbo v študiji učinkovitosti ne izvaja noben neupravičen niti finančni pritisk;
the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, any other person entitled by national law to provide the relevant patient care under performance study conditions;
kadar je to ustrezno, je bilo opravljeno testiranje biološke varnosti, ki odraža najnovejša znanstvena dognanja, ali kateri koli drug preskus, ki velja za nujnega glede na predvideni namen pripomočka;
no undue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on his or her legally designated representatives, to participate in the performance study;
v primeru študij klinične učinkovitosti je bila dokazana analitska učinkovitost ob upoštevanju zadnjega stanja tehničnega razvoja;
where appropriate, biological safety testing reflecting the latest scientific knowledge or any other test deemed necessary in the light of the device's intended purpose has been conducted;
v primeru intervencijskih študij klinične učinkovitosti sta bila dokazana analitska učinkovitost in znanstvena veljavnost ob upoštevanju zadnjega stanja tehničnega razvoja.
in the case of clinical performance studies, the analytical performance has been demonstrated, taking into consideration the state of the art;
Če znanstvena veljavnost dopolnilne diagnostike ni dokazana, se navede znanstvena utemeljitev za uporabo biološkega označevalca;
in the case of interventional clinical performance studies, the analytical performance and scientific validity has been demonstrated, taking into consideration the state of the art.
tehnična varnost pripomočka z vidika njegove uporabe je bila dokazana ob upoštevanju zadnjega stanja tehničnega razvoja in določb na področju varnosti pri delu in preprečevanja nesreč;
Where, for companion diagnostics, the scientific validity is not established, the scientific rationale for the use of the biomarker shall be provided;
izpolnjene so zahteve iz Priloge XIV.
the technical safety of the device with regard to its use has been proven, taking into consideration the state of the art as well as provisions in the field of occupational safety and accident prevention;
Vsak udeleženec ali njegov zakonito imenovani zastopnik, kadar udeleženec ni sposoben dati privolitve po seznanitvi, se lahko brez vsakršne škode in brez obrazložitve kadar koli umakne iz študije učinkovitosti, tako da prekliče svojo privolitev po seznanitvi.
the requirements of Annex XIV are fulfilled.
Brez poseganja v Direktivo 95/46/ES preklic privolitve po seznanitvi ne vpliva na dejavnosti, ki so bile že izvedene, in na uporabo podatkov, ki so bili pridobljeni na podlagi privolitve po seznanitvi pred njenim preklicem.
Any subject, or, where the subject is not able to give informed consent, his or her legally designated representative, may, without any resulting detriment and without having to provide any justification, withdraw from the performance study at any time by revoking his or her informed consent.
Raziskovalec je oseba, ki opravlja poklic, ki je v zadevni državi članici priznan kot ustrezen za vlogo raziskovalca, ker ima zahtevano strokovno znanje in izkušnje z obravnavo pacientov ali s področja laboratorijske medicine.
Without prejudice to Directive 95/46/EC, the withdrawal of the informed consent shall not affect the activities already carried out and the use of data obtained based on informed consent before its withdrawal.
Drugo osebje, ki je vključeno v izvajanje študije učinkovitosti, je po izobrazbi, usposobljenosti ali izkušnjah na ustreznem medicinskem področju ali iz metodologije kliničnega raziskovanja ustrezno kvalificirano za izvajanje nalog.
The investigator shall be a person exercising a profession which is recognised in the Member State concerned, as qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care or laboratory medicine.
Po potrebi morajo biti prostori, v katerih se bo študija učinkovitosti, ki vključuje udeležence, izvajala, ustrezni za to študijo in podobni prostorom, v katerih naj bi se pripomoček uporabljal.
Other personnel involved in conducting a performance study shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks.
Člen 59
Where appropriate, the facilities where the performance study involving subjects is to be conducted shall be suitable for the performance study and shall be similar to the facilities where the device is intended to be used.
Privolitev po seznanitvi
Article 59
Privolitev po seznanitvi napiše, datira in podpiše oseba, ki je opravila predhodni razgovor iz točke (c) odstavka 2, in udeleženec ali njegov zakonito imenovani zastopnik, kadar udeleženec ne more podati privolitve po seznanitvi, potem ko je bil ustrezno obveščen v skladu z odstavkom 2.
Informed consent
Kadar udeleženec ne more pisati, se lahko privolitev poda na drugačen način v prisotnosti vsaj ene nepristranske priče, kar se dokumentira.
Informed consent shall be written, dated and signed by the person performing the interview referred to in point (c) of paragraph 2, and by the subject or, where the subject is not able to give informed consent, his or her legally designated representative after having been duly informed in accordance with paragraph 2.
V tem primeru izjavo s privolitvijo po seznanitvi podpiše in datira priča.
Where the subject is unable to write, consent may be given and recorded through appropriate alternative means in the presence of at least one impartial witness.
Udeleženec ali njegov zakonito imenovani zastopnik, kadar udeleženec ne more dati privolitve po seznanitvi, prejme izvod izjave ali drugačen zapis o privolitvi po seznanitvi.
In that case, the witness shall sign and date the informed consent document.
Privolitev po seznanitvi se dokumentira.
The subject or, where the subject is not able to give informed consent, his or her legally designated representative shall be provided with a copy of the document or the record, as appropriate, by which informed consent has been given.
Udeležencu ali njegovem zakonito imenovanem zastopniku se zagotovi dovolj časa za razmislek o svoji odločitvi glede sodelovanja v študiji učinkovitosti.
The informed consent shall be documented.
Informacije, ki se dajo udeležencu ali, kadar udeleženec ne more podati privolitve po seznanitvi, njegovemu zakonito imenovanemu zastopniku z namenom pridobitve privolitve po seznanitvi:
Adequate time shall be given for the subject or his or her legally designated representative to consider his or her decision to participate in the performance study.
udeležencu ali njegovemu zakonito imenovanemu zastopniku omogočijo, da razume:
Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent shall:
naravo, cilje, koristi, posledice, tveganja in neprijetnosti študij učinkovitosti;
enable the subject or his or her legally designated representative to understand:
udeleženčeve pravice in zagotovila za njegovo zaščito, zlasti pa njegovo pravico, da zavrne sodelovanje in da brez vsakršnih škodljivih posledic in brez obrazložitve kadar koli umakne iz študije učinkovitosti;
the nature, objectives, benefits, implications, risks and inconveniences of the performance study;
pogoje, pod katerimi se študije učinkovitosti izvajajo, vključno s predvidenim trajanjem udeleženčevega sodelovanja v študiji učinkovitosti, in