natgillin/translations-raw huggingface dataset:
Verification by examination and testing of every product
oblikovanje načrta preskušanja, v katerem so opredeljeni vsi pomembni in kritični parametri, ki jih mora priglašeni organ preskusiti ali pa je za njihov preskus odgovoren;
have documented procedures, sufficient expertise and facilities for the verification by examination and testing of every product in accordance with Part B of Annex XI;
dokumentiranje svoje utemeljitve za izbiro teh parametrov;
establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility in order to:
izvedbo ustreznih pregledov in preskusov, da se preveri, ali rešitve, ki jih je sprejel proizvajalec, izpolnjujejo splošne zahteve glede varnosti in učinkovitosti iz Priloge I. Takšni pregledi in preskusi vključujejo vse preskuse, s katerimi se preveri, ali je proizvajalec dejansko uporabil ustrezne standarde, za uporabo katerih se je odločil;
verify, for class IIb devices, the conformity of the device with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to those devices,
dogovor z vložnikom o tem, kje bodo izvedeni potrebni preskusi, če jih ne izvede neposredno priglašeni organ, in
confirm, for class IIa devices, the conformity with the technical documentation referred to in Annexes II and III and with the requirements of this Regulation which apply to those devices;
prevzem polne odgovornosti za rezultate preskusa.
document its rationale for the selection of the parameters referred to in point (b);
Poročila o preskusih, ki jih predloži proizvajalec, se upoštevajo le, če so jih izdali pristojni organi za ugotavljanje skladnosti, ki so neodvisni od proizvajalca.
have documented procedures to carry out the appropriate assessments and tests in order to verify the conformity of the device with the requirements of this Regulation by examining and testing every product as specified in Section 15 of Annex XI;
Preverjanje s pregledom in preskusom vsakega izdelka
have documented procedures providing for the reaching of an agreement with the applicant concerning when and where necessary tests that are not to be carried out by the notified body itself are to be performed; and
ima vzpostavljene dokumentirane postopke, dovolj strokovnega znanja in zmogljivosti za preverjanje s pregledovanjem in preskušanjem vsakega izdelka v skladu z delom B Priloge XI;
assume full responsibility for test results in accordance with documented procedures; test reports submitted by the manufacturer shall only be taken into account if they have been issued by conformity assessment bodies which are competent and independent of the manufacturer.
oblikuje načrt preskušanja, v katerem opredeli vse pomembne in kritične parametre, ki jih mora priglašeni organ preskusiti ali pa je za njihov preskus odgovoren, da:
Pre-clinical evaluation assessment
za pripomočke razreda IIb preveri skladnost pripomočka s tipom, opisanim v certifikatu o EU-pregledu tipa, in z zahtevami iz te uredbe, ki veljajo za te pripomočke,
The notified body shall have documented procedures in place for the review of the manufacturer's procedures and documentation relating to the evaluation of pre-clinical aspects.
za pripomočke razreda IIa potrdi skladnost s tehnično dokumentacijo iz prilog II in III ter z zahtevami iz te uredbe, ki veljajo za te pripomočke;
The notified body shall examine, validate and verify that the manufacturer's procedures and documentation adequately address:
dokumentira svojo utemeljitev za izbiro parametrov iz točke (b);
the planning, conduct, assessment, reporting and, where appropriate, updating of the pre-clinical evaluation, in particular of
ima vzpostavljene dokumentirane postopke za izvedbo ustreznih ocenjevanj in preskusov, tako da s pregledom in preskusom vsakega izdelka, kakor je določeno v oddelku 15 Priloge XI, preverijo skladnost pripomočka z zahtevami iz te uredbe;
the scientific pre-clinical literature search, and
ima vzpostavljene dokumentirane postopke, ki omogočajo dosego dogovora z vložnikom o tem, kdaj in kje se opravijo potrebni preskusi, ki jih ne izvede priglašeni organ sam, in
the pre-clinical testing, for example laboratory testing, simulated use testing, computer modelling, the use of animal models,
prevzame polno odgovornost za rezultate preskusov v skladu z dokumentiranimi postopki; poročila o preskusih, ki jih predloži proizvajalec, se upoštevajo le, če so jih izdali pristojni organi za ugotavljanje skladnosti, ki so neodvisni od proizvajalca.
the nature and duration of body contact and the specific associated biological risks,
Vrednotenje predklinične ocene
the interface with the risk management process, and
Priglašeni organ ima vzpostavljene dokumentirane postopke za pregled proizvajalčevih postopkov in dokumentacije v zvezi z ocenjevanjem predkliničnih vidikov.
the appraisal and analysis of the available pre-clinical data and its relevance with regard to demonstrating conformity with the relevant requirements in Annex I.
Priglašeni organ pregleda, potrdi in preveri, ali proizvajalčevi postopki in dokumentacija ustrezno obravnavajo:
The notified body's assessment of pre-clinical evaluation procedures and documentation shall address the results of literature searches and all validation, verification and testing performed and conclusions drawn, and shall typically include considering the use of alternative materials and substances and take account of the packaging, stability, including shelf life, of the finished device.
načrtovanje, izvajanje, ocenjevanje, poročanje in, kjer je ustrezno, posodobitev predklinične ocene, zlasti
Where no new testing has been undertaken by a manufacturer or where there are deviations from procedures, the notified body in question shall critically examine the justification presented by the manufacturer.
znanstvenega predkliničnega preučevanja literature in
Clinical evaluation assessment
predkliničnega preskušanja, na primer laboratorijskega preskušanja, simuliranih preskusov uporabnosti, računalniškega modeliranja, uporabe živalskih modelov,
The notified body shall have documented procedures in place relating to the assessment of a manufacturer's procedures and documentation relating to clinical evaluation both for initial conformity assessment and on an ongoing basis.
naravo in trajanje telesnega stika in posebna s tem povezana biološka tveganja,
The notified body shall examine, validate and verify that manufacturers' procedures and documentation adequately address:
povezave s postopkom obvladovanja tveganj ter
the planning, conduct, assessment, reporting and updating of the clinical evaluation as referred to in Annex XIV,
oceno in analizo razpoložljivih predkliničnih podatkov ter njihovega pomena za dokazovanje skladnosti z ustreznimi zahtevami iz Priloge I.
post-market surveillance and PMCF,
Priglašeni organ pri vrednotenju postopkov predkliničnega ocenjevanja in dokumentacije obravnava rezultate preučevanja literature in vsa opravljena potrjevanja, preverjanja in preskušanja ter iz tega izpeljane ugotovitve, vanj pa običajno vključi tudi obravnavo možnosti uporabe alternativnih materialov in snovi ter upošteva embalažo in stabilnost, vključno z rokom uporabnosti, končnega pripomočka.
the interface with the risk management process,
Če proizvajalec ni opravil nobenega novega preskušanja ali če so bila ugotovljena odstopanja od postopkov, zadevni priglašeni organ kritično preuči utemeljitev, ki jo je predložil proizvajalec.
the appraisal and analysis of the available data and its relevance with regard to demonstrating conformity with the relevant requirements in Annex I, and
Vrednotenje klinične ocene
the conclusions drawn with regard to the clinical evidence and drawing up of the clinical evaluation report.
Priglašeni organ ima vzpostavljene dokumentirane postopke za vrednotenje proizvajalčevih postopkov in dokumentacije v zvezi s klinično oceno, tako za začetno kot za redno ugotavljanje skladnosti.
These procedures referred to in the first paragraph shall take into consideration available CS, guidance and best practice documents.
Priglašeni organ pregleda, potrdi in preveri, ali postopki in dokumentacija proizvajalcev ustrezno obravnavajo:
The notified body's assessment of clinical evaluations as referred to in Annex XIV shall cover:
načrtovanje, izvajanje, ocenjevanje, poročanje in posodabljanje klinične ocene iz Priloge XIV,
the intended use specified by the manufacturer and claims for the device defined by it,
nadzor po dajanju na trg in klinično spremljanje po dajanju na trg,
the planning of the clinical evaluation,
povezavo s postopkom obvladovanja tveganja,
the methodology for the literature search,
oceno in analizo razpoložljivih podatkov ter njihovega pomena v zvezi z dokazovanjem skladnosti z ustreznimi zahtevami iz Priloge I in
relevant documentation from the literature search,
ugotovitve na podlagi kliničnih dokazov in oblikovanje poročila o klinični oceni.
the clinical investigation,
Pri postopkih iz prvega odstavka se upoštevajo razpoložljive skupne specifikacije, smernice in dokumenti o najboljših praksah.
validity of equivalence claimed in relation to other devices, the demonstration of equivalence, the suitability and conclusions data from equivalent and similar devices,
Vrednotenje kliničnih ocen iz Priloge XIV, ki jih opravi priglašeni organ, zajema:
the clinical evaluation report, and
predvideno uporabo, kot jo opredeli proizvajalec, in njegove trditve glede pripomočka,
justifications in relation to non-performance of clinical investigations or PMCF.
načrtovanje klinične ocene,
In relation to clinical data from clinical investigations included within the clinical evaluation, the notified body in question shall ensure that the conclusions drawn by the manufacturer are valid in the light of the approved clinical investigation plan.
metodologijo preučevanja literature,
The notified body shall ensure that the clinical evaluation adequately addresses the relevant safety and performance requirements provided for in Annex I, that it is appropriately aligned with the risk management requirements, that it is conducted in accordance with Annex XIV and that it is appropriately reflected in the information provided relating to the device.
zadevno dokumentacijo na podlagi preučevanja literature,
Specific Procedures
klinično raziskavo,
The notified body shall have documented procedures, sufficient expertise and facilities for the procedures referred to in Sections 5 and 6 of Annex IX, Section 6 of Annex X and Section 16 of Annex XI, for which they are designated.
veljavnost navedene enakovrednosti glede na druge pripomočke, dokaz enakovrednosti, podatke o ustreznosti in ugotovitvah za enakovredne in podobne pripomočke,
In the case of devices manufactured utilising tissues or cells of animal origin or their derivatives, such as from TSE susceptible species, as referred to in Regulation (EU) No 722/2012, the notified body shall have documented procedures in place that fulfil the requirements laid down in that Regulation, including for the preparation of a summary evaluation report for the relevant competent authority.
poročilo o klinični oceni in
Reporting
utemeljitve za neizvajanje kliničnih raziskav ali kliničnega spremljanja po dajanju na trg.
ensure that all steps of the conformity assessment are documented so that the conclusions of the assessment are clear and demonstrate compliance with the requirements of this Regulation and can represent objective evidence of such compliance to persons that are not themselves involved in the assessment, for example personnel in designating authorities,
Kar zadeva klinične podatke iz kliničnih raziskav, vključene v klinično oceno, zadevni priglašeni organ zagotovi, da so ugotovitve, do katerih je prišel proizvajalec, veljavne ob upoštevanju odobrenega načrta klinične raziskave.
ensure that records that are sufficient to provide a discernible audit trail are available for quality management system audits,
Priglašeni organ zagotovi, da klinična ocena ustrezno izpolnjuje zadevne zahteve glede varnosti in učinkovitosti iz Priloge I, da je ustrezno usklajena z zahtevami v zvezi z obvladovanjem tveganj, da je izvedena v skladu s Prilogo XIV in da se ustrezno odraža v informacijah, predloženih v zvezi s pripomočkom.
clearly document the conclusions of its assessment of clinical evaluation in a clinical evaluation assessment report, and
Posebni postopki
for each specific project, provide a detailed report which shall be based on a standard format containing a minimum set of elements determined by the MDCG.
Priglašeni organ ima vzpostavljene dokumentirane postopke, dovolj strokovnega znanja in zmogljivosti za postopke iz oddelkov 5 in 6 Priloge IX, oddelka 6 Priloge X in oddelka 16 Priloge XI, za katere je imenovan.
The report of the notified body shall:
V primeru pripomočkov, izdelanih z uporabo tkiv ali celic živalskega izvora ali njihovih derivatov, kot so vrste živali, dovzetne za transmisivno spongiformno encefalopatijo, kot je določeno v Uredbi (EU) št. 722/2012, ima priglašeni organ vzpostavljene dokumentirane postopke, ki izpolnjujejo zahteve iz navedene uredbe, vključno s pripravo zbirnega ocenjevalnega poročila za zadevni pristojni organ.
clearly document the outcome of its assessment and draw clear conclusions from the verification of the manufacturer's conformity with the requirements of this Regulation,
Poročanje
make a recommendation for a final review and for a final decision to be taken by the notified body; this recommendation shall be signed off by the member of personnel responsible in the notified body, and
poskrbi, da so dokumentirane vse faze ugotavljanja skladnosti, tako da so ugotovitve, ki iz tega izhajajo, jasne in dokazujejo skladnost z zahtevami iz te uredbe ter so lahko nepristranski dokaz o tej skladnosti za osebe, ki same niso neposredno vključene v ugotavljanje skladnosti, na primer osebje organov za imenovanje,
be provided to the manufacturer in question.
zagotovi, da so za presoje sistema vodenja kakovosti na voljo evidence, ki zadostujejo za zagotovitev jasne sledi za presojo,
Final review
ugotovitve svojega vrednotenja kliničnih ocen jasno dokumentira v poročilu o vrednotenju klinične ocene in
The notified body shall prior to making a final decision:
za vsak posamezni projekt predloži podrobno poročilo, pripravljeno na podlagi standardnega obrazca, ki vsebuje minimalni nabor elementov, ki jih določi Koordinacijska skupina za medicinske pripomočke.
ensure that the personnel assigned for the final review and decision-making on specific projects are appropriately authorised and are different from the personnel who have conducted the assessments,
Poročilo priglašenega organa:
verify that the report or reports and supporting documentation needed for decision making, including concerning resolution of non-conformities noted during assessment, are complete and sufficient with respect to the scope of the application, and
vsebuje jasno dokumentirane rezultate njegovega ugotavljanja skladnosti in jasne ugotovitve v zvezi s preverjanjem, ali proizvajalec izpolnjuje zahteve iz te uredbe,
verify whether there are any unresolved non-conformities preventing issuance of a certificate.
vsebuje priporočilo za končni pregled in za končno odločitev priglašenega organa; to priporočilo potrdi odgovorni član osebja v priglašenem organu, in
Decisions and Certifications
se predloži zadevnemu proizvajalcu.
The notified body shall have documented procedures for decision-making including as regards the allocation of responsibilities for the issuance, suspension, restriction and withdrawal of certificates.
Končni pregled
Those procedures shall include the notification requirements laid down in Chapter V of this Regulation.
Priglašeni organ pred sprejetjem končne odločitve:
The procedures shall allow the notified body in question to:
zagotovi, da ima osebje, imenovano za pregled in odločanje o posebnih projektih, ustrezno pristojnost in se razlikuje od osebja, ki je izvedlo ugotavljanje skladnosti,
decide, based on the assessment documentation and additional information available, whether the requirements of this Regulation are fulfilled,
preveri, da so poročilo ali poročila in pripadajoča dokumentacija, potrebna za odločanje, vključno v zvezi z odpravo neskladnosti, ki so bile ugotovljene med ugotavljanjem skladnosti, popolna in zadostna glede na področje uporabe, ter
decide, based on the results of its assessment of the clinical evaluation and risk management, whether the post-market surveillance plan, including the PMCF plan, is adequate,
preveri, ali ni kakršnih koli nerešenih neskladnosti, ki preprečujejo izdajo certifikata.
decide on specific milestones for further review by the notified body of the up to date clinical evaluation,
Sklepi in certificiranja
decide whether specific conditions or provisions need to be defined for the certification,
Priglašeni organ ima dokumentirane postopke za odločanje, vključno v zvezi z dodelitvijo odgovornosti za izdajo, začasni preklic, omejitev in preklic certifikatov.
decide, based on the novelty, risk classification, clinical evaluation and conclusions from the risk analysis of the device, on a period of certification not exceeding five years,
Ti postopki vključujejo zahteve glede uradnega obveščanja iz poglavja V te uredbe.
clearly document decision making and approval steps including approval by signature of the members of personnel responsible,
Postopki zadevnemu priglašenemu organu omogočajo, da:
clearly document responsibilities and mechanisms for communication of decisions, in particular, where the final signatory of a certificate differs from the decision maker or decision makers or does not fulfil the requirements laid down in Section 3.2.7,
na podlagi ocene dokumentacije in dodatnih informacij, ki so na voljo, odloči, ali so zahteve iz te uredbe izpolnjene,
issue a certificate or certificates in accordance with the minimum requirements laid down in Annex XII for a period of validity not exceeding five years and shall indicate whether there are specific conditions or limitations associated with the certification,
na podlagi rezultatov svojega vrednotenja klinične ocene in obvladovanja tveganj odloči, ali je načrt nadzora po dajanju na trg, vključno z načrtom kliničnega spremljanja po dajanju na trg, ustrezen,
issue a certificate or certificates for the applicant alone and shall not issue certificates covering multiple entities, and
odloči o posebnih mejnikih za nadaljnji pregled posodobljene klinične ocene, ki ga izvede priglašeni organ,
ensure that the manufacturer is notified of the outcome of the assessment and the resultant decision and that they are entered into the electronic system referred to in Article 57.
odloči, ali je treba opredeliti posebne pogoje ali določbe za certificiranje,
Changes and modifications
na podlagi novosti, razvrstitve v razred tveganja, klinične ocene in zaključkov analize tveganja pripomočka odloči o obdobju certificiranja, ki ne presega pet let,
The notified body shall have documented procedures and contractual arrangements with manufacturers in place relating to the manufacturers' information obligations and the assessment of changes to:
jasno dokumentira odločanje in odobritvene postopke, med drugim odobritev s podpisom odgovornih članov osebja,
the approved quality management system or systems or to the product-range covered,
jasno dokumentira odgovornosti in mehanizme za sporočanje odločitev, zlasti kadar se zadnji podpisnik certifikata razlikuje od subjekta ali subjektov, ki sprejemajo odločitve, ali ne izpolnjuje zahtev iz oddelka 3.2.7.,
the approved design of a device,
izda certifikat ali certifikate v skladu z minimalnimi zahtevami iz Priloge XIII, z obdobjem veljavnosti, ki ne presega pet let, in navede, ali obstajajo posebni pogoji ali omejitve, povezane s certificiranjem,
the intended use of or claims made for the device,
izda certifikat ali certifikate le za vlagatelja, ne izda pa certifikatov za več subjektov, in
the approved type of a device, and
zagotovi, da se rezultat ugotavljanja skladnosti in posledična odločitev sporočita proizvajalcu ter se vneseta v elektronski sistem iz člena 57.
any substance incorporated in or utilised for the manufacturing of a device and being subject to the specific procedures in accordance with Section 4.5.6.
Spremembe in dopolnitve
The procedures and contractual arrangements referred to in the first paragraph shall include measures for checking the significance of the changes referred to in the first paragraph.
Priglašeni organ ima vzpostavljene dokumentirane postopke in pogodbene ureditve s proizvajalci v zvezi z obveznostmi obveščanja proizvajalcev in oceno sprememb:
In accordance with its documented procedures, the notified body in question shall:
odobrenega sistema ali sistemov vodenja kakovosti ali vključenih izdelkov,
ensure that manufacturers submit for prior approval plans for changes as referred to in the first paragraph and relevant information relating to such changes,
odobrene zasnove pripomočka,
assess the changes proposed and verify whether, after these changes, the quality management system, or the design of a device or type of a device, still meets the requirements of this Regulation, and
predvidene uporabe pripomočka ali navedb v zvezi z njim,
notify the manufacturer of its decision and provide a report or as applicable a supplementary report, which shall contain the justified conclusions of its assessment.
homologiranega tipa pripomočka in
Surveillance activities and post-certification monitoring
vsake snovi, ki se vključi ali uporabi za izdelavo pripomočka in za katero veljajo posebni postopki v skladu z oddelkom 4.5.6.
The notified body shall have documented procedures:
Postopki in pogodbene ureditve iz prvega odstavka vključujejo ukrepe za preverjanje pomena sprememb iz prvega odstavka.
defining how and when surveillance activities of manufacturers are to be conducted.
Zadevni priglašeni organ v skladu s svojimi dokumentiranimi postopki:
Those procedures shall include arrangements for unannounced on-site audits of manufacturers and, where applicable, subcontractors and suppliers carrying out product tests and the monitoring of compliance with any conditions binding manufacturers and associated with certification decisions, such as updates to clinical data at defined intervals,
zagotovi, da proizvajalci predložijo v predhodno odobritev načrte za spremembe iz prvega odstavka in ustrezne informacije v zvezi s takšnimi spremembami,
for screening relevant sources of scientific and clinical data and post-market information relating to the scope of their designation.
oceni predlagane spremembe in preveri, ali so po teh spremembah sistem vodenja kakovosti ali zasnova pripomočka ali tip pripomočka še vedno izpolnjuje zahteve iz te uredbe, in
Such information shall be taken into account in the planning and conduct of surveillance activities, and
proizvajalca uradno obvesti o svoji odločitvi in zagotovi poročilo ali po potrebi dopolnilno poročilo, ki vsebuje utemeljene zaključke njegovega ugotavljanja.
to review vigilance data to which they have access under Article 92(2) in order to estimate its impact, if any, on the validity of existing certificates.
Dejavnosti nadzora in spremljanje po certificiranju
The results of the evaluation and any decisions taken shall be thoroughly documented.
Priglašeni organ ima dokumentirane postopke:
The notified body in question shall, upon receipt of information about vigilance cases from a manufacturer or competent authorities, decide which of the following options to apply:
v katerih je opredeljeno, kako in kdaj se izvajajo dejavnosti nadzora nad proizvajalci.
not to take action on the basis that the vigilance case is clearly not related to the certification granted,
Ti postopki zajemajo ureditve za nenapovedane presoje na kraju samem pri proizvajalcih ter, kadar je to ustrezno, podizvajalcih in dobaviteljih, ki opravljajo preskušanje izdelkov in spremljanje izpolnjevanja kakršnih koli pogojev, ki zavezujejo proizvajalce in so povezani z odločitvami o certificiranju, kot je posodabljanje kliničnih podatkov v določenih časovnih presledkih,