natgillin/translations-raw huggingface dataset:
If further tests or other evidence is required for the assessment of conformity with the requirements of this Regulation, the notified body in question shall carry out adequate physical or laboratory tests in relation to the device or request the manufacturer to carry out such tests.
Poročilo priglašenega organa:
Type-examinations
vsebuje jasno dokumentirane rezultate njegovega ugotavljanja skladnosti in jasne ugotovitve v zvezi s preverjanjem, ali proizvajalec izpolnjuje zahteve iz te uredbe,
The notified body shall have documented procedures, sufficient expertise and facilities for the type-examination of devices in accordance with Annex X including the capacity to:
vsebuje priporočilo za končni pregled in za končno odločitev priglašenega organa; to priporočilo potrdi odgovorni član osebja v priglašenem organu,
examine and assess the technical documentation, taking account of Sections 4.5.4. and 4.5.5, and verify that the type has been manufactured in conformity with that documentation;
se predloži zadevnemu proizvajalcu.
establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility;
Končni pregled
document its rationale for the selection of those parameters;
Priglašeni organ pred sprejetjem končne odločitve:
carry out the appropriate examinations and tests in order to verify that the solutions adopted by the manufacturer meet the general safety and performance requirements set out in Annex I. Such examinations and tests shall include all tests necessary to verify that the manufacturer has in fact applied the relevant standards it has opted to use;
zagotovi, da ima osebje, imenovano za končni pregled in odločanje o posebnih projektih, ustrezno pristojnost in se razlikuje od osebja, ki je izvedlo ugotavljanje skladnosti,
agree with the applicant as to where the necessary tests will be performed if they are not to be carried out directly by the notified body;
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
assume full responsibility for test results.
preveri, ali ni kakršnih koli nerešenih neskladnosti, ki preprečujejo izdajo certifikata.
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.
Sklepi in certificiranja
Verification by examination and testing of every product batch
Priglašeni organ ima dokumentirane postopke za odločanje, vključno v zvezi z dodelitvijo odgovornosti za izdajo, začasni preklic, omejitev in preklic certifikatov.
The notified body shall:
Ti postopki vključujejo zahteve glede uradnega obveščanja iz poglavja V te uredbe.
have documented procedures, sufficient expertise and facilities for the verification by examination and testing of every product batch in accordance with Annexes IX and XI;
Postopki zadevnemu priglašenemu organu omogočajo, da:
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:
na podlagi ocene dokumentacije in dodatnih informacij, ki so na voljo, odloči, ali so zahteve iz te uredbe izpolnjene,
verify, for class C 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,
na podlagi rezultatov svojega vrednotenja ocene učinkovitosti in obvladovanja tveganj odloči, ali je načrt nadzora po dajanju na trg, vključno z načrtom spremljanja učinkovitosti po dajanju na trg, ustrezen,
confirm, for class B 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,
odloči o posebnih mejnikih za nadaljnji pregled posodobljene ocene učinkovitosti, ki ga izvede priglašeni organ,
document its rationale for the selection of the parameters referred to in point (b);
odloči, ali je treba opredeliti posebne pogoje ali določbe za certificiranje,
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 batch as specified in Section 5 of Annex XI;
na podlagi novosti, razvrstitve v razred tveganja, ocene učinkovitosti in zaključkov analize tveganja pripomočka odloči o obdobju certificiranja, ki ne presega pet let,
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;
jasno dokumentira odločanje in odobritvene postopke, med drugim odobritev s podpisom odgovornih članov osebja,
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.
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.,
Performance evaluation assessment
izda certifikat ali certifikate v skladu z minimalnimi zahtevami iz Priloge XII, z obdobjem veljavnosti, ki ne presega pet let, in navede, ali obstajajo posebni pogoji ali omejitve, povezane s certificiranjem,
The assessment by notified bodies of 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.
izda certifikat ali certifikate le za vlagatelja, ne izda pa certifikatov za več subjektov,
Where no new testing has been undertaken by a manufacturer or where there have been deviations from procedures, the notified body in question shall critically examine the justification presented by the manufacturer.
zagotovi, da se rezultat ugotavljanja skladnosti in posledična odločitev sporočita proizvajalcu ter se vneseta v elektronski sistem iz člena 52.
The notified body shall have documented procedures in place relating to the assessment of a manufacturer's procedures and documentation relating to performance evaluation both for initial conformity assessment and on an ongoing basis.
Spremembe in dopolnitve
The notified body shall examine, validate and verify that the manufacturer's procedures and documentation adequately address:
Priglašeni organ ima vzpostavljene dokumentirane postopke in pogodbene ureditve s proizvajalci v zvezi z obveznostmi obveščanja proizvajalcev in oceno sprememb:
the planning, conduct, assessment, reporting and updating of the performance evaluation as referred to in Annex XIII,
odobrenega sistema ali sistemov vodenja kakovosti ali vključenih izdelkov,
post-market surveillance and post-market performance follow up,
odobrene zasnove pripomočka,
the interface with the risk management process,
homologiranega tipa pripomočka,
the appraisal and analysis of the available data and its relevance with regard to demonstrating conformity with the relevant requirements in Annex I,
vsake snovi, ki se vključi ali uporabi za izdelavo pripomočka in za katero veljajo posebni postopki v skladu z oddelkom 4.5.5.
the conclusions drawn with regard to the clinical evidence and drawing up of the performance evaluation report.
Postopki in pogodbene ureditve iz prvega odstavka vključujejo ukrepe za preverjanje pomena sprememb iz prvega odstavka.
The procedures referred to in the second paragraph shall take into consideration available CS, guidance and best practice documents.
Zadevni priglašeni organ v skladu s svojimi dokumentiranimi postopki:
The notified body's assessment of performance evaluations as referred to in Annex XIII shall cover:
zagotovi, da proizvajalci predložijo v predhodno odobritev načrte za spremembe iz prvega odstavka in ustrezne informacije v zvezi s takšnimi spremembami,
the intended use specified by the manufacturer and claims for the device defined by it,
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,
the planning of the performance evaluation,
proizvajalca uradno obvesti o svoji odločitvi in zagotovi poročilo ali po potrebi dopolnilno poročilo, ki vsebuje utemeljene zaključke njegovega ugotavljanja.
the methodology for the literature search,
Dejavnosti nadzora in spremljanje po certificiranju
relevant documentation from the literature search,
Priglašeni organ ima dokumentirane postopke:
the performance studies,
v katerih je opredeljeno, kako in kdaj se izvajajo dejavnosti nadzora nad proizvajalci.
validity of equivalence claimed in relation to other devices, the demonstration of equivalence, the suitability and conclusions data from equivalent and similar devices,
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,
the performance evaluation report,
za pregled ustreznih virov znanstvenih in kliničnih podatkov ter informacij po dajanju na trg v zvezi s področjem, za katerega so imenovani.
justifications in relation to non-performance of performance studies or PMPF.
Te informacije je treba upoštevati pri načrtovanju in izvajanju dejavnosti nadzora,
In relation to data from performance studies included within the performance evaluation, the notified body in question shall ensure that the conclusions drawn by the manufacturer are valid in the light of the approved performance study plan.
za pregled podatkov o vigilanci, do katerih imajo dostop v skladu s členom 87, da se oceni njihov morebiten vpliv na veljavnost obstoječih certifikatov.
The notified body shall ensure that the performance evaluation adequately addresses the relevant safety and performance requirements provided for in Annex I, that it is appropriately aligned with the risk management requirements and that it is conducted in accordance with Annex XIII and that it is appropriately reflected in the information provided relating to the device.
Rezultati ocene in vse sprejete odločitve se natančno dokumentirajo.
Specific Procedures
Potem ko zadevni priglašeni organ od proizvajalca ali pristojnih organov prejme informacije o primerih vigilance, odloči o tem, katera od naslednjih možnostih se uporabi:
The notified body shall have documented procedures, sufficient expertise and facilities for the procedures referred to in Section 5 of Annex IX, for which they are designated.
ukrepanje ni potrebno na podlagi tega, da primer vigilance očitno ni povezan z izdanim certifikatom,
In the case of companion diagnostics, the notified body shall have documented procedures in place that aim to fulfil the requirements of this Regulation in relation to consultation of the EMA or a medicinal products competent authority during its assessment of such types of device.
preučijo se dejavnosti proizvajalca in pristojnih organov ter rezultati raziskave proizvajalca, da bi se določilo, ali je izdani certifikat ogrožen oziroma ali so bili sprejeti ustrezni korektivni ukrepi,
Reporting
izvedejo se izredni nadzorni ukrepi, kot so pregledi dokumentacije, na kratek rok napovedane presoje ali nenapovedane presoje in preskušanje izdelkov, kadar je verjetno, da je izdani certifikat ogrožen,
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,
poveča se pogostost nadzornih presoj,
ensure that records that are sufficient to provide a discernible audit trail are available for quality management system audits,
ob naslednji presoji pri proizvajalcu se pregledajo posebni izdelki ali postopki ali
clearly document the conclusions of its assessment of performance evaluation in a performance evaluation assessment report,
sprejme se kateri koli drug ustrezen ukrep.
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.
V zvezi z nadzornimi presojami pri proizvajalcih ima priglašeni organ vzpostavljene dokumentirane postopke, na podlagi katerih se:
The report of the notified body shall:
najmanj enkrat letno izvedejo nadzorne presoje pri proizvajalcu, ki se načrtujejo in izvajajo v skladu z ustreznimi zahtevami iz oddelka 4.5.,
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,
poskrbi za ustrezno oceno dokumentacije proizvajalca v zvezi z določbami o vigilanci, nadzorom po dajanju na trg in spremljanjem učinkovitosti po dajanju na trg ter njihovo uporabo,
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,
vzorčijo in preskušajo pripomočki in tehnična dokumentacija med presojami, v skladu z vnaprej določenimi merili vzorčenja in postopki preskušanja, s čimer se zagotovi, da proizvajalec stalno uporablja odobreni sistem vodenja kakovosti,
be provided to the manufacturer in question.
zagotovi, da proizvajalec izpolnjuje obveznosti glede dokumentacije in informacij, določene v zadevnih prilogah, in da pri svojih postopkih upošteva najboljše prakse na področju izvajanja sistemov vodenja kakovosti,
Final review
zagotovi, da proizvajalec odobritev sistema vodenja kakovosti ali pripomočka ne uporablja na zavajajoč način,
The notified body shall prior to making a final decision:
pridobi zadostne informacije za ugotovitev, ali je sistem vodenja kakovosti še naprej v skladu z zahtevami te uredbe;
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,
v primeru odkritja neskladnosti od proizvajalca zahtevajo popravki, korektivni ukrepi in, kjer je to ustrezno, preventivni ukrepi ter
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
po potrebi uvedejo posebne omejitve za zadevni certifikat oziroma se certifikat začasno ali trajno prekliče.
verify whether there are any unresolved non-conformities preventing issuance of a certificate.
Če je to del pogojev za certificiranje, priglašeni organ:
Decisions and certifications
izvede poglobljen pregled ocene učinkovitosti, ki jo je proizvajalec nazadnje posodobil na podlagi svojega nadzora po dajanju na trg, svojega spremljanja učinkovitosti po dajanju na trg in klinične literature v zvezi z zdravljenjem stanja s pripomočkom ali klinične literature v zvezi s podobnimi pripomočki,
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.
jasno dokumentira rezultat poglobljenega pregleda in proizvajalcu sporoči morebitne posebne pomisleke ali mu naloži morebitne posebne pogoje,
Those procedures shall include the notification requirements laid down in Chapter V of this Regulation.
zagotovi, da se ocena učinkovitosti, ki je bila nazadnje posodobljena, ustrezno upošteva v navodilih za uporabo in, kjer je to ustrezno, v povzetku o varnosti in učinkovitosti.
The procedures shall allow the notified body in question to:
Ponovno certificiranje
decide, based on the assessment documentation and additional information available whether the requirements of this Regulation are fulfilled,
Priglašeni organ ima vzpostavljene dokumentirane postopke za preglede ponovnega certificiranja in podaljšanje veljavnosti certifikatov.
decide, based on the results of its assessment of the performance evaluation and risk management whether the post-market surveillance plan, including the PMPF plan, is adequate,
Ponovno certificiranje odobrenih sistemov za vodenje kakovosti ali certifikatov EU o oceni tehnične dokumentacije ali certifikatov o EU-pregledu tipa se opravi najmanj vsakih pet let.
decide on specific milestones for further review by the notified body of the up to date performance evaluation,
Priglašeni organ ima vzpostavljene dokumentirane postopke za podaljšanje veljavnosti certifikatov EU o oceni tehnične dokumentacije in certifikatov o EU-pregledu tipa, s temi postopki pa se od zadevnega proizvajalca zahteva, da predloži povzetek sprememb in znanstvenih ugotovitev o pripomočku, vključno z:
decide whether specific conditions or provisions need to be defined for the certification,
vsemi spremembami prvotno odobrenega pripomočka, vključno s spremembami, ki še niso bile priglašene,
decide, based on the novelty, risk classification, performance evaluation and conclusions from the risk analysis of the device, on a period of certification not exceeding five years,
izkušnjami, pridobljenimi z nadzorom po dajanju na trg,
clearly document decision making and approval steps including approval by signature of the members of personnel responsible,
izkušnjami z upravljanjem tveganja,
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.,
izkušnjami s posodabljanjem dokazovanja skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti iz Priloge I,
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,
izkušnjami s pregledi ocene učinkovitosti, vključno z rezultati vseh študij učinkovitosti in spremljanja učinkovitosti po dajanju na trg;
issue a certificate or certificates for the applicant alone and shall not issue certificates covering multiple entities,
spremembami zahtev, sestavnih delov pripomočka ali znanstvenega ali regulativnega okolja,
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 52.
spremembami veljavnih ali novih harmoniziranih standardov, skupnih specifikacij ali enakovrednih dokumentov ter
Changes and modifications
spremembami medicinskega, znanstvenega in tehničnega znanja, kot so:
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:
nove terapije,
the approved quality management system or systems or to the product-range covered,
spremembe preskusnih metod,
the approved design of a device,
nove znanstvene ugotovitve v zvezi z materiali in sestavinami, vključno z ugotovitvami o njihovi biokompatibilnosti,
the approved type of a device,
izkušnje, pridobljene s študijami o primerljivih pripomočkih,
any substance incorporated in or utilised for the manufacturing of a device and being subject to the specific procedures in accordance with Section 4.5.5.
podatki iz podatkovnih bank in registrov,
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.
izkušnje, pridobljene s študijami učinkovitosti s primerljivimi pripomočki.
In accordance with its documented procedures, the notified body in question shall:
Priglašeni organ ima vzpostavljene dokumentirane postopke za ocenjevanje informacij iz drugega odstavka in posebno pozornost nameni kliničnim podatkom, pridobljenim z nadzorom po dajanju na trg in z dejavnostmi spremljanja učinkovitosti po dajanju na trg, ki so bile izvedene od prejšnjega certificiranja ali ponovnega certificiranja, vključno z ustreznimi posodobitvami poročil proizvajalcev o oceni učinkovitosti.
ensure that manufacturers submit for prior approval plans for changes as referred to in the first paragraph and relevant information relating to such changes,
Zadevni priglašeni organ za odločitev o ponovnem certificiranju uporabi enake metode in načela kot za prvotno odločitev o certificiranju.
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,
Če je potrebno, se za ponovno certificiranje pripravijo ločeni obrazci, ob upoštevanju uporabljenih ukrepov za certificiranje, kot sta vloga in pregled vloge.
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.
PRILOGA VIII
Surveillance activities and post-certification monitoring
PRAVILA ZA RAZVRŠČANJE
The notified body shall have documented procedures:
IZVEDBENA PRAVILA
defining how and when surveillance activities of manufacturers are to be conducted.
Pravila za razvrščanje se uporabljajo glede na predviden namen pripomočkov.
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,
Če je zadevni pripomoček namenjen uporabi v kombinaciji z drugim pripomočkom, se pravila za razvrščanje uporabljajo ločeno za vsak pripomoček.
for screening relevant sources of scientific and clinical data and post-market information relating to the scope of their designation.
Dodatki za in vitro diagnostične medicinske pripomočke se razvrščajo ločeno od pripomočka, s katerim se uporabljajo.
Such information shall be taken into account in the planning and conduct of surveillance activities,
Programska oprema, ki poganja pripomoček ali vpliva na uporabo pripomočka, spada v isti razred kot pripomoček.
to review vigilance data to which they have access under to Article 87 in order to estimate its impact, if any, on the validity of existing certificates.
Če je programska oprema neodvisna od katerega koli drugega pripomočka, se razvrsti ločeno.
The results of the evaluation and any decisions taken shall be thoroughly documented.
Umerjevalci, predvideni za uporabo s pripomočkom, se razvrstijo v isti razred kot pripomoček.
The notified body in question shall, upon receipt of information about vigilance cases from a manufacturer or competent authorities, decide on which of the following options to apply:
Kontrolni materiali s kvantitativnimi ali kvalitativnimi pripisanimi vrednostmi, predvideni za določen analit ali več analitov, se razvrstijo v isti razred kot pripomoček.
not to take action on the basis that the vigilance case is clearly not related to the certification granted,
Proizvajalec upošteva vsa pravila za razvrščanje in izvedbena pravila za določitev pravilne razvrstitve za pripomoček.