natgillin/translations-raw huggingface dataset:
Where justified in view of well-established technologies, similar to those used in the exempted devices listed in point (b) of paragraph 6 of this Article, being used in other devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the list of exempted devices referred to in the second subparagraph of Article 52(4) and in point (b) of paragraph 6 of this Article, by adding other types of implantable or class III devices to that list or removing devices therefrom.
Klinične raziskave so zasnovane in se izvajajo tako, da so pravice, varnost, dostojanstvo in dobro počutje udeležencev v klinični raziskavi zagotovljene in prevladajo nad vsemi drugimi interesi ter da so pridobljeni klinični podatki znanstveno veljavni, zanesljivi in ponovljivi.
In the case of the products without an intended medical purpose listed in Annex XVI, the requirement to demonstrate a clinical benefit in accordance with this Chapter and Annexes XIV and XV shall be understood as a requirement to demonstrate the performance of the device.
Klinične raziskave so predmet znanstvenega in etičnega pregleda.
Clinical evaluations of those products shall be based on relevant data concerning safety, including data from post-market surveillance, PMCF, and, where applicable, specific clinical investigation.
Etični pregled opravi odbor za etiko v skladu z nacionalnim pravom.
Clinical investigations shall be performed for those products unless reliance on existing clinical data from an analogous medical device is duly justified.
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 klinične raziskave.
Without prejudice to paragraph 4, where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception shall be given based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer.
Pri etičnem pregledu sodeluje vsaj en nestrokovnjak.
In such a case, the manufacturer shall duly substantiate in the technical documentation referred to in Annex II why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, to be adequate.
Klinična raziskava iz odstavka 1 se lahko izvaja samo, če so izpolnjeni vsi naslednji pogoji:
The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer's PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84.
zanjo je v skladu s to uredbo potrebna odobritev s strani države članice ali držav članic, v katerih bo izvajana, razen če ni navedeno drugače;
For class III devices and implantable devices, the PMCF evaluation report and, if indicated, the summary of safety and clinical performance referred to in Article 32 shall be updated at least annually with such data.
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 clinical evaluation, its results and the clinical evidence derived from it shall be documented in a clinical evaluation report as referred to in Section 4 of Annex XIV, which, except for custom-made devices, shall be part of the technical documentation referred to in Annex II relating to the device concerned.
sponzor ali njegov zakoniti zastopnik ali kontaktna oseba po odstavku 2 ima sedež v Uniji;
Where necessary to ensure the uniform application of Annex XIV, 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.
ranljive populacije in udeleženci so ustrezno zaščiteni v skladu s členi 64 do 68;
Article 62
pričakovane koristi za udeležence ali javno zdravje upravičujejo predvidena tveganja in neprijetnosti, pri čemer se stalno spremlja upoštevanje tega pogoja;
General requirements regarding clinical investigations conducted to demonstrate conformity of devices
udeleženec ali njegov zakonito imenovani zastopnik, če udeleženec ni sposoben dati privolitve po seznanitvi, je dal privolitev po seznanitvi v skladu s členom 63;
Clinical investigations shall be designed, authorised, conducted, recorded and reported in accordance with the provisions of this Article and of Articles 63 to 80, the acts adopted pursuant to Article 81, and Annex XV, where carried out as part of the clinical evaluation for conformity assessment purposes, for one or more of the following purposes:
udeleženec ali njegov zakonito imenovani zastopnik, če udeleženec ni sposoben dati privolitve po seznanitvi, je prejel kontaktne podatke ustanove, pri kateri je po potrebi mogoče dobiti dodatne informacije;
to establish and verify that, under normal conditions of use, a device is designed, manufactured and packaged in such a way that it is suitable for one or more of the specific purposes listed in point (1) of Article 2, and achieves the performance intended as specified by its manufacturer;
pravice udeleženca do telesne in duševne celovitosti, zasebnosti in varstva njegovih osebnih podatkov v skladu z Direktivo 95/46/ES so zaščitene;
to establish and verify the clinical benefits of a device as specified by its manufacturer;
klinična raziskava 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 klinične raziskave in pod stalnim nadzorom;
to establish and verify the clinical safety of the device and to determine any undesirable side-effects, under normal conditions of use of the device, and assess whether they constitute acceptable risks when weighed against the benefits to be achieved by the device.
za zdravstveno oskrbo udeležencev je odgovoren ustrezno kvalificiran zdravnik ali, kadar je to ustrezno, kvalificiran zobozdravnik ali katera koli druga oseba, ki sme v skladu z nacionalnim pravom ustrezno obravnavati paciente pod pogoji klinične raziskave;
Where the sponsor of a clinical investigation 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.
na udeleženca ali, kjer je to ustrezno, njegovega zakonito imenovanega zastopnika se ne vrši noben neupravičen pritisk – niti finančni – za udeležbo v klinični raziskavi;
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.
zadevni pripomoček ali pripomočki, ki so predmet raziskave, so skladni z veljavnimi splošnimi zahtevami glede varnosti in učinkovitosti iz Priloge I, razen kar zadeva vidike, zajete v klinični raziskavi, v zvezi s katerimi pa so bili sprejeti vsi previdnostni ukrepi za zaščito zdravja in varnosti udeležencev.
Any communication with that legal representative shall be deemed to be a communication with the sponsor.
To po potrebi vključuje testiranje tehnične in biološke varnosti in predklinično oceno ter določbe na področju varnosti pri delu in preprečevanja nesreč, ob upoštevanju najnovejšega tehničnega razvoja;
Member States may choose not to apply the first subparagraph to clinical investigations 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 clinical investigation who shall be the addressee for all communications with the sponsor provided for in this Regulation.
zahteve iz Priloge XV so izpolnjene.
Clinical investigations shall be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in a clinical investigation are protected and prevail over all other interests and the clinical data generated are scientifically valid, reliable and robust.
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 klinične raziskave, tako da prekliče svojo privolitev po seznanitvi.
Clinical investigations shall be subject to scientific and ethical review.
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.
The ethical review shall be performed by an ethics committee in accordance with national law.
Raziskovalec je oseba, ki opravlja poklic, ki je v zadevni državi članici priznan kot primeren za vlogo raziskovalca, ker ima zahtevano strokovno znanje in izkušnje z obravnavo pacientov.
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 clinical investigation.
Drugo osebje, vključeno v izvajanje klinične raziskave, je po izobrazbi, usposobljenosti ali izkušnjah na ustreznem medicinskem področju in v zvezi z metodologijo kliničnega raziskovanja ustrezno kvalificirano za izvajanje nalog.
At least one lay person shall participate in the ethical review.
Prostori, v katerih se bo klinična raziskava izvajala, morajo biti primerni za to raziskavo in podobni prostorom, v katerih naj bi se pripomoček uporabljal.
A clinical investigation as referred to in paragraph 1 may be conducted only where all of the following conditions are met:
Člen 63
the clinical investigation is the subject of an authorisation by the Member State(s) in which the clinical investigation is to be conducted, in accordance with this Regulation, unless otherwise stated;
Privolitev po seznanitvi
an ethics committee, set up in accordance with national law, has not issued a negative opinion in relation to the clinical investigation, which is valid for that entire Member State under its national law;
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 ni sposoben dati privolitve po seznanitvi, potem ko je bil ustrezno obveščen v skladu z odstavkom 2.
the sponsor, or its legal representative or a contact person pursuant to paragraph 2, is established in the Union;
Kadar udeleženec ne more pisati, se lahko privolitev da na drugačen način v prisotnosti vsaj ene nepristranske priče, kar se dokumentira.
vulnerable populations and subjects are appropriately protected in accordance with Articles 64 to 68;
V tem primeru izjavo s privolitvijo po seznanitvi podpiše in datira priča.
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 njegov zakonito imenovani zastopnik, kadar udeleženec ni sposoben dati privolitve po seznanitvi, prejme izvod izjave ali drugačen zapis o privolitvi po seznanitvi.
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 63;
Privolitev po seznanitvi se dokumentira.
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;
Udeležencu ali njegovemu zakonito imenovanemu zastopniku se zagotovi dovolj časa, da razmisli o svoji odločitvi glede sodelovanja v klinični raziskavi.
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;
Informacije, ki se udeležencu ali njegovemu zakonito imenovanemu zastopniku, kadar udeleženec ni sposoben dati privolitve po seznanitvi, dajo z namenom pridobitve njegove privolitve po seznanitvi:
the clinical investigation 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 clinical investigation plan and constantly monitored;
udeležencu ali njegovemu zakonito imenovanemu zastopniku omogočijo, da razume:
the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner or any other person entitled by national law to provide the relevant patient care under clinical investigation conditions;
naravo, cilje, koristi, posledice, tveganja in neprijetnosti kliničnih raziskav;
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 clinical investigation;
udeleženčeve pravice in zagotovila za njegovo zaščito, zlasti njegovo pravico, da zavrne sodelovanje in da se brez vsakršnih škodljivih posledic in brez obrazložitve kadar koli umakne iz klinične raziskave;
the investigational device(s) in question conform(s) to the applicable general safety and performance requirements set out in Annex I apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects.
pogoje, pod katerimi se bodo klinične raziskave izvajale, vključno s predvidenim trajanjem udeleženčevega sodelovanja v klinični raziskavi, ter
This includes, where appropriate, technical and biological safety testing and pre-clinical evaluation, as well as provisions in the field of occupational safety and accident prevention, taking into consideration the state of the art;
morebitna alternativna zdravljenja, vključno z ukrepi za nadaljnje spremljanje, če udeleženec ne sodeluje več v klinični raziskavi;
the requirements of Annex XV are fulfilled.
so izčrpne, kratke, jasne, ustrezne in razumljive udeležencu ali njegovemu zakonito imenovanemu zastopniku;
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 clinical investigation at any time by revoking his or her informed consent.
se zagotovijo v predhodnem razgovoru s članom raziskovalne skupine, ki je ustrezno usposobljen v skladu z nacionalnim pravom;
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.
vključujejo informacije o veljavnem odškodninskem sistemu iz člena 69 in
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.
vključujejo enotno identifikacijsko številko klinične raziskave, navedeno v členu 70(1), ki je edinstvena za celotno Unijo, ter informacije o razpoložljivosti rezultatov klinične raziskave v skladu z odstavkom 6 tega člena.
Other personnel involved in conducting a clinical investigation shall be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks.
Informacije iz odstavka 2 se pripravijo v pisni obliki in so na voljo udeležencu ali njegovemu zakonito imenovanemu zastopniku, kadar udeleženec ni sposoben dati privolitve po seznanitvi.
The facilities where the clinical investigation is to be conducted shall be suitable for the clinical investigation and shall be similar to the facilities where the device is intended to be used.
Med razgovorom iz točke (c) odstavka 2 se posebna pozornost nameni potrebam posebnih skupin pacientov in posameznih udeležencev po informacijah ter metodam za dajanje informacij.
Article 63
Med razgovorom iz točke (c) odstavka 2 se preveri, ali je udeleženec informacije razumel.
Informed consent
Udeleženec je seznanjen, da bosta ne glede na izid klinične raziskave poročilo o kliničnih raziskavah in povzetek, pripravljen na predvidenemu uporabniku razumljiv način, na podlagi člena 77(5) na voljo v elektronskem sistemu za klinične raziskave iz člena 73, in če je mogoče, je o tem obveščen, čim se to zgodi.
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.
Ta uredba ne posega v nacionalno pravo, ki zahteva, da mladoletnik, ki je sposoben oblikovati lastno mnenje in oceniti prejete informacije, poleg privolitve po seznanitvi, ki jo da njegov zakonito imenovani zastopnik, še sam pristane, da se bo udeležil klinične raziskave.
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.
Člen 64
In that case, the witness shall sign and date the informed consent document.
Klinične raziskave na udeležencih, ki niso sposobni odločati o sebi
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.
Če udeleženec, ki ni sposoben odločati o sebi, v času, ko je bil še sposoben odločati o sebi, privolitve po seznanitvi ni dal ali je ni zavrnil, se lahko klinična raziskava izvede samo, če so poleg pogojev iz člena 62(4) izpolnjeni vsi naslednji pogoji:
The informed consent shall be documented.
pridobljena je bila privolitev po seznanitvi, ki jo je dal zakonito imenovani zastopnik;
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 clinical investigation.
udeleženec, ki ni sposoben odločati o sebi, je informacije iz člena 63(2) prejel na način, ki je glede na njegove sposobnosti razumevanja primeren;
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:
udeleženec, ki ni sposoben odločati o sebi, lahko pa oblikuje lastno mnenje in oceni informacije iz člena 63(2), želi zavrniti sodelovanje v klinični raziskavi ali se iz nje kadar koli umakniti, raziskovalec pa to njegovo izrecno željo spoštuje;
enable the subject or his or her legally designated representative to understand:
udeleženec ali njegov zakonito imenovani zastopnik ni deležen nobene spodbude ali finančne podpore, razen nadomestila za stroške in izgubljene prihodke, ki so neposredna posledica sodelovanja v klinični raziskavi;
the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigations;
klinična raziskava je v zvezi s podatki o udeležencu, ki ni sposoben odločati o sebi, ključnega pomena, podatkov primerljive veljavnosti pa ni mogoče pridobiti v okviru kliničnih raziskav na osebah, ki so sposobne dati privolitev po seznanitvi, ali z drugimi raziskovalnimi metodami;
the subject's rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate in and the right to withdraw from the clinical investigation at any time without any resulting detriment and without having to provide any justification;
klinična raziskava se neposredno nanaša na zdravstveno stanje udeleženca;
the conditions under which the clinical investigations is to be conducted, including the expected duration of the subject's participation in the clinical investigation; and
na podlagi znanstvenih dokazov se upravičeno pričakuje, da bo udeležencu, ki ni sposoben odločati o sebi, udeležba v klinični raziskavi prinesla neposredno korist, ki bo odtehtala z udeležbo povezana tveganja in bremena.
the possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical investigation is discontinued;
Udeleženec v čim večji meri sodeluje pri postopku privolitve po seznanitvi.
be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her legally designated representative;
Člen 65
be provided in a prior interview with a member of the investigating team who is appropriately qualified under national law;
Klinične raziskave na mladoletnih osebah
include information about the applicable damage compensation system referred to in Article 69; and
Klinična raziskava na mladoletni osebi se lahko izvaja le, kadar so poleg pogojev iz člena 62(4) izpolnjeni vsi naslednji pogoji:
include the Union-wide unique single identification number of the clinical investigation referred to in Article 70(1) and information about the availability of the clinical investigation results in accordance with paragraph 6 of this Article.
mladoletna oseba je od raziskovalcev ali članov raziskovalne skupine, ki so usposobljeni za delo z otroki ali imajo izkušnje na tem področju, informacije iz člena 63(2) dobila tako, kot je ustrezno za njeno starost in duševno zrelost;
The information referred to in paragraph 2 shall be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative.
mladoletna oseba, ki je sposobna oblikovati lastno mnenje in oceniti informacije iz člena 63(2), želi zavrniti sodelovanje v klinični raziskavi ali se iz nje kadar koli umakniti, raziskovalec pa to njeno izrecno željo spoštuje;
In the interview referred to in point (c) of paragraph 2, special attention shall be paid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information.
udeleženec ali njegov zakonito imenovani zastopnik ni deležen nobene spodbude ali finančne podpore, razen nadomestila za stroške in izgubljene prihodke, ki so neposredna posledica sodelovanja v klinični raziskavi;
In the interview referred to in point (c) of paragraph 2, it shall be verified that the subject has understood the information.
namen klinične raziskave je raziskati načine zdravljenja zdravstvenega stanja, ki se pojavlja samo pri mladoletnih osebah, ali pa je v zvezi z mladoletnimi osebami klinična raziskava nepogrešljiva za potrditev podatkov, pridobljenih v okviru kliničnih raziskav na osebah, ki so sposobne dati privolitev po seznanitvi, ali z drugimi raziskovalnimi metodami;
The subject shall be informed that a clinical investigation report and a summary presented in terms understandable to the intended user will be made available pursuant to Article 77(5) in the electronic system on clinical investigations referred to in Article 73 irrespective of the outcome of the clinical investigation, and shall be informed, to the extent possible, when they have become available.
klinična raziskava se neposredno nanaša na zdravstveno stanje zadevne mladoletne osebe ali je take narave, da jo je mogoče izvajati samo na mladoletnih osebah;