natgillin/translations-raw huggingface dataset:
the name of the manufacturer and address of its registered place of business and any additional manufacturing site covered by the quality management system, and, if the manufacturer's application is lodged by its authorised representative the name of the authorised representative and the address of the authorised representative's registered place of business,
Odobritev vsake bistvene spremembe sistema vodenja kakovosti ali obsega vanj zajetih pripomočkov je v obliki dopolnila k certifikatu EU o sistemu vodenja kakovosti.
all relevant information on the device or group of devices covered by the quality management system,
Ocena nadzora za pripomočke razreda C in razreda D
a written declaration that no application has been lodged with any other notified body for the same device-related quality management system, or information about any previous application for the same device-related quality management system,
Namen nadzora je zagotoviti, da proizvajalec ustrezno izpolnjuje obveznosti, ki jih nalaga odobreni sistem vodenja kakovosti.
a draft of an EU declaration of conformity in accordance with Article 17 and Annex IV for the device model covered by the conformity assessment procedure,
Proizvajalec pooblasti priglašeni organ za izvedbo vseh potrebnih presoj, vključno s presojami na kraju samem, in mu predloži vse ustrezne informacije, zlasti:
the documentation on the manufacturer's quality management system,
dokumentacijo o svojem sistemu vodenja kakovosti;
a documented description of the procedures in place to fulfil the obligations arising from by the quality management system and required under this Regulation and of the undertaking by the manufacturer in question to apply those procedures,
dokumentacijo o vseh ugotovitvah in zaključkih, pridobljenih z uporabo načrta nadzora po dajanju na trg, vključno z načrtom spremljanja učinkovitosti po dajanju na trg, za reprezentativen vzorec pripomočkov, in z uporabo določb o vigilanci iz členov 82 do 87;
a description of the procedures in place to ensure that the quality management system remains adequate and effective, and the undertaking by the manufacturer to apply those procedures,
podatke, določene v tistem delu sistema vodenja kakovosti, ki se nanaša na zasnovo, kot so rezultati analiz, izračuni, preskusi in sprejete rešitve v zvezi z upravljanjem tveganj iz oddelka 4 Priloge I;
the documentation on the manufacturer's post-market surveillance system, and, where applicable, on the PMPF plan, and the procedures put in place to ensure compliance with the obligations resulting from the provisions on vigilance set out in Articles 82 to 87,
podatke, določene v tistem delu sistema vodenja kakovosti, ki se nanaša na izdelavo, kot so poročila o kontroli kakovosti in podatki o preskusih, kalibracijski podatki ter evidenc o kvalifikacijah zadevnega osebja.
a description of the procedures in place to keep up to date the post-market surveillance system and, where applicable, the PMPF plan, and the procedures ensuring compliance with the obligations resulting from the provisions on vigilance set out in Articles 82 to 87, as well as the undertaking by the manufacturer to apply those procedures,
Priglašeni organi redno, vsaj enkrat vsakih 12 mesecev, opravijo ustrezne presoje in ocenjevanja za zagotovitev, da zadevni proizvajalec uporablja odobreni sistem vodenja kakovosti in načrt nadzora po dajanju na trg.
documentation on the performance evaluation plan, and
Te presoje in ocenjevanja vključujejo presoje v prostorih proizvajalca ter, kjer je ustrezno, proizvajalčevih dobaviteljev in/ali podizvajalcev.
a description of the procedures in place to keep up to date the performance evaluation plan, taking into account the state of the art.
Priglašeni organ v času takih presoj na kraju samem po potrebi izvede ali zaprosi za izvedbo preskusov, da preveri, ali sistem vodenja kakovosti pravilno deluje.
Implementation of the quality management system shall ensure compliance with this Regulation.
Proizvajalcu predloži poročilo o nadzorni presoji in, če je bil opravljen preskus, poročilo o preskusu.
All the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be documented in a systematic and orderly manner in the form of a quality manual and written policies and procedures, such as quality programmes, quality plans and quality records.
Priglašeni organ vsaj enkrat vsakih pet let izvede naključne nenapovedane presoje na kraju samem pri proizvajalcu ter, kjer je ustrezno, pri proizvajalčevih dobaviteljih in/ali podizvajalcih, ki se lahko združijo z redno oceno nadzora iz oddelka 3.3. ali se izvedejo dodatno k tej oceni nadzora.
Moreover, the documentation to be submitted for the assessment of the quality management system shall include an adequate description of, in particular:
Priglašeni organ pripravi načrt za takšne nenapovedane presoje na kraju samem, vendar ga ne razkrije proizvajalcu.
the manufacturer's quality objectives;
Priglašeni organ med takšnimi nenapovedanimi presojami na kraju samem preskusi ustrezen vzorec proizvedenih pripomočkov ali ustrezen vzorec iz postopka izdelave, da ugotovi, ali je izdelani pripomoček v skladu s tehnično dokumentacijo.
the organisation of the business and in particular:
Priglašeni organ pred nenapovedanimi presojami na kraju samem določi relevantna merila vzorčenja in preskusni postopek.
the organisational structures with the assignment of staff responsibilities in relation to critical procedures, the responsibilities of the managerial staff and their organisational authority,
Priglašeni organi namesto ali poleg vzorčenja iz drugega odstavka odvzamejo vzorce pripomočkov s trga, da preverijo, ali je izdelan pripomoček skladen s tehnično dokumentacijo.
the methods of monitoring whether the operation of the quality management system is efficient and in particular the ability of that system to achieve the desired design and device quality, including control of devices which fail to conform,
Zadevni priglašeni organ pred vzorčenjem določi relevantna merila vzorčenja in preskusni postopek.
where the design, manufacture, and/or final verification and testing of the devices, or parts of any of those processes, is carried out by another party, the methods of monitoring the efficient operation of the quality management system and in particular the type and extent of control applied to the other party,
Priglašeni organ zadevnemu proizvajalcu predloži poročilo o presoji na kraju samem, ki po potrebi vključuje rezultate preskusa vzorca.
where the manufacturer does not have a registered place of business in a Member State, the draft mandate for the designation of an authorised representative and a letter of intention from the authorised representative to accept the mandate;
Ocena nadzora v primeru pripomočkov razreda C vključuje tudi oceno tehnične dokumentacije iz oddelkov 4.4 do 4.8 za zadevni pripomoček ali zadevne pripomočke na podlagi nadaljnjih reprezentativnih vzorcev, izbranih v skladu z utemeljitvijo priglašenega organa v skladu s tretjim odstavkom oddelka 2.3.
the procedures and techniques for monitoring, verifying, validating and controlling the design of the devices, and the corresponding documentation as well as the data and records arising from those procedures and techniques.
Priglašeni organi poskrbijo, da ima ocenjevalna ekipa dovolj članov z izkušnjami z ocenjevanjem zadevnih pripomočkov, sistemov in postopkov ter da je ta ekipa vedno objektivna in nevtralna; to se med drugim doseže z rotacijo članov ocenjevalne skupine v ustreznih časovnih presledkih.
Those procedures and techniques shall specifically cover:
Glavni presojevalec praviloma ne vodi presoj niti ne sodeluje pri presojah istega proizvajalca več kot tri zaporedna leta.
the strategy for regulatory compliance, including processes for identification of relevant legal requirements, qualification, classification, handling of equivalence, choice of, and compliance with, conformity assessment procedures,
Če priglašeni organ ugotovi odstopanje med vzorcem, odvzetim iz proizvodnje, ali vzorcem, vzetim s trga, in specifikacijami iz tehnične dokumentacije ali odobrene zasnove, začasno ali trajno prekliče zadevni certifikat ali uvede omejitve zanj.
identification of applicable general safety and performance requirements and solutions to fulfil those requirements, taking applicable CS into account and, where opted for, harmonised standards,
OCENJEVANJE TEHNIČNE DOKUMENTACIJE
risk management as referred to in Section 3 of Annex I,
Ocenjevanje tehnične dokumentacije pripomočkov razreda B, C in D ter preverjanje serije, ki se uporablja za pripomočke razreda
the performance evaluation, pursuant to Article 56 and Annex XIII, including PMPF,
Proizvajalec pripomočkov poleg izpolnjevanja obveznosti iz oddelka 2 pri priglašenem organu vloži vlogo za oceno tehnične dokumentacije pripomočka, ki ga namerava dati na trg ali v uporabo in za katerega se uporablja sistem vodenja kakovosti iz oddelka 2.
solutions for fulfilling the applicable specific requirements regarding design and construction, including appropriate pre-clinical evaluation, in particular the requirements of Chapter II of Annex I,
V vlogi so opisani zasnova, izdelava in učinkovitost zadevnega pripomočka.
solutions for fulfilling the applicable specific requirements regarding the information to be supplied with the device, in particular the requirements of Chapter III of Annex I,
Vloga vključuje tehnično dokumentacijo iz prilog II in III.
the device identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture, and
V primeru pripomočkov za samotestiranje ali testiranje ob pacientu vloga vključuje tudi vidike iz točke (b) oddelka 5.1.
management of design or quality management system changes;
Pregled vloge opravlja pri priglašenem organu zaposleno osebje z dokazanim znanjem in izkušnjami pri ocenjevanju zadevne tehnologije in pripomočkov ter ocenjevanju kliničnih dokazov.
the verification and quality assurance techniques at the manufacturing stage and in particular the processes and procedures which are to be used, particularly as regards sterilisation, and the relevant documents, and
Priglašeni organ lahko zahteva, da se vloga dopolni z nadaljnjimi preskusi ali predložijo dodatni dokazi, da se omogoči ugotavljanje skladnosti z zadevnimi zahtevami iz te uredbe.
the appropriate tests and trials which are to be carried out before, during and after manufacture, the frequency with which they are to take place, and the test equipment to be used; it shall be possible to trace back adequately the calibration of that test equipment.
Priglašeni organ opravi ustrezne fizikalne ali laboratorijske preskuse v zvezi s pripomočkom ali proizvajalcu naroči, da take preskuse opravi.
In addition, the manufacturer shall grant the notified body access to the technical documentation referred to in Annexes II and III.
Priglašeni organ pregleda klinične dokaze, ki jih predloži proizvajalec v poročilu o oceni učinkovitosti, in s tem povezano izvedeno oceno učinkovitosti.
Audit
Priglašeni organ ima za namene tega pregleda zaposlenih dovolj pregledovalcev pripomočkov z zadostnim kliničnim strokovnim znanjem, sodeluje pa lahko tudi z zunanjimi kliničnimi strokovnjaki z neposrednimi in aktualnimi izkušnjami s klinično uporabo zadevnega pripomočka.
The notified body shall audit the quality management system to determine whether it meets the requirements referred to in Section 2.2.
Kadar klinični dokazi delno ali v celoti temeljijo na podatkih o pripomočkih, ki naj bi bili enakovredni pripomočku, ki se ocenjuje, priglašeni organ oceni primernost uporabe teh podatkov, pri čemer upošteva dejavnike, kot so nove indikacije in inovacije.
Where the manufacturer uses a harmonised standard or CS related to a quality management system, the notified body shall assess conformity with those standards or CS.
Priglašeni organ jasno dokumentira svoje zaključke o domnevni enakovrednosti ter o relevantnosti in primernosti podatkov za dokazovanje skladnosti;
The notified body shall assume that a quality management system which satisfies the relevant harmonised standards or CS conforms to the requirements covered by those standards or CS, unless it duly substantiate not doing so.
Priglašeni organ preuči ustreznost kliničnih dokazov in ocene učinkovitosti ter preveri proizvajalčeve ugotovitve glede skladnosti z ustreznimi splošnimi zahtevami glede varnosti in učinkovitosti.
The audit team of the notified body shall include at least one member with past experience of assessments of the technology concerned in accordance with Sections 4.3. to 4.5. of Annex VII.
Pri tem preuči tudi ustreznost določitve razmerja med koristmi in tveganji, upravljanje tveganja, navodila za uporabo, usposabljanje uporabnikov in načrt proizvajalca za nadzor po dajanju na trg, preveri pa tudi, ali je potreben predlagani načrt spremljanja učinkovitosti po dajanju na trg, in primernost takšnega načrta, kjer je ustrezno.
In circumstances where such experience is not immediately obvious or applicable, the notified body shall provide a documented rationale for the composition of that team.
Priglašeni organ na podlagi svoje ocene kliničnih dokazov preuči oceno učinkovitosti in določitev razmerja med koristmi in tveganji, pa tudi, ali je treba določiti specifične mejnike, da bo lahko pregledal posodobitve kliničnih dokazov, temelječih na podatkih iz nadzora po dajanju na trg in spremljanja učinkovitosti po dajanju na trg.
The assessment procedure shall include an audit on the manufacturer's premises and, if appropriate, on the premises of the manufacturer's suppliers and/or subcontractors to verify the manufacturing and other relevant processes.
Priglašeni organ v poročilu o vrednotenju ocene učinkovitosti jasno dokumentira rezultat svojega ocenjevanja.
Moreover, in the case of class C devices, the quality management system assessment shall be accompanied by the assessment of the technical documentation for devices selected on a representative basis in accordance with provisions in Sections 4.4 to 4.8.
Priglašeni organ pred izdajo certifikata EU o oceni tehnične dokumentacije od referenčnega laboratorija EU, kadar je ta imenovan v skladu s členom 100, zahteva, da preveri učinkovitost, kot jo navaja proizvajalec, in skladnost pripomočka s skupnimi specifikacijami, kadar so na voljo, ali z drugimi rešitvami, ki jih izbere proizvajalec za zagotovitev vsaj enakovredne ravni varnosti in učinkovitosti.
In choosing representative samples the notified body shall take into account the published guidance developed by the MDCG pursuant to Article 99 and in particular, the novelty of the technology, the potential impact on the patient and standard medical practice, similarities in design, technology, manufacturing and, where applicable, sterilisation methods, the intended purpose and the results of any previous relevant assessments that have been carried out in accordance with this Regulation.
Preverjanje vključuje laboratorijske preskuse v referenčnem laboratoriju EU iz člena 48(5).
The notified body in question shall document its rationale for the samples taken.
V primerih iz člena 48(6) te uredbe se priglašeni organ posvetuje tudi z ustreznimi strokovnjaki iz člena 106 Uredbe (EU) 2017/745, pri čemer uporablja postopek iz člena 48(6) te uredbe o poročilu proizvajalca o oceni učinkovitosti.
If the quality management system conforms to the relevant provisions of this Regulation, the notified body shall issue an EU quality management system certificate.
Referenčni laboratorij EU znanstveno mnenje predloži v 60 dneh.
The notified body shall notify the manufacturer of tits decision to issue the certificate.
Znanstveno mnenje referenčnega laboratorija EU in, kjer ustrezno, mnenja strokovnjakov, s katerimi so bila opravljena posvetovanja v skladu s postopkom iz člena 48(6), ter morebitne spremembe teh mnenj se vključijo v dokumentacijo pripomočka, ki jo pripravi priglašeni organ.
The decision shall contain the conclusions of the audit and a reasoned report.
Priglašeni organ pri sprejemanju odločitve ustrezno upošteva stališča, izražena v znanstvenem mnenju referenčnega laboratorija EU, ter, kjer je ustrezno, stališča, ki so jih izrazili strokovnjaki, s katerimi so bila opravljena posvetovanja v skladu s členom 48(6).
The manufacturer in question shall inform the notified body which approved the quality management system of any plan for substantial changes to the quality management system, or the device-range covered.
Priglašeni organ certifikata ne izda, če je to znanstveno mnenje referenčnega laboratorija EU negativno.
The notified body shall assess the changes proposed, determine the need for additional audits and verify whether, after those changes, the quality management system still meets the requirements referred to in Section 2.2.
Priglašeni organ proizvajalcu predloži poročilo o oceni tehnične dokumentacije, vključno s poročilom o vrednotenju ocene učinkovitosti.
It shall notify the manufacturer of its decision which shall contain the conclusions of the assessment, and where applicable, conclusions of additional audits.
Če je pripomoček skladen z ustreznimi določbami iz te uredbe, priglašeni organ izda certifikat EU o oceni tehnične dokumentacije.
The approval of any substantial change to the quality management system or the device-range covered shall take the form of a supplement to the EU quality management system certificate.
Certifikat vključuje zaključke ocene tehnične dokumentacije, pogoje veljavnosti certifikata, podatke, potrebne za identifikacijo odobrenega pripomočka, in, kjer je ustrezno, opis predvidenega namena pripomočka.
Surveillance assessment applicable to class C and class D devices
Kadar bi spremembe odobrenega pripomočka lahko vplivale na varnost in učinkovitost pripomočka ali pogoje, predpisane za uporabo pripomočka, mora te spremembe nadalje odobriti priglašeni organ, ki je izdal certifikat EU o oceni tehnične dokumentacije.
The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality management system.
Kadar proizvajalec namerava vključiti katere koli od zgoraj navedenih sprememb, o tem obvesti priglašeni organ, ki je izdal certifikat EU o oceni tehnične dokumentacije.
The manufacturer shall give authorisation to the notified body to carry out all the necessary audits, including on-site audits, and supply it with all relevant information, in particular:
Priglašeni organ oceni načrtovane spremembe in odloči, ali je zaradi njih potrebno novo ugotavljanje skladnosti v skladu s členom 48 ali pa bi zadostovala dopolnitev certifikata EU o oceni tehnične dokumentacije.
the documentation on its quality management system,
V primeru slednjega priglašeni organ oceni spremembe, uradno obvesti proizvajalca o svoji odločitvi in mu, če so spremembe odobrene, predloži dopolnilo certifikata EU o oceni tehnične dokumentacije.
the documentation on any findings and conclusions resulting from the application of the post-market surveillance plan, including the PMPF plan, for a representative sample of devices, and of the provisions on vigilance set out in Articles 82 to 87,
Kadar bi te spremembe lahko vplivale na skladnost s skupnimi specifikacijami ali drugimi rešitvami, ki jih izbere proizvajalec in ki so bile odobrene s certifikatom EU o oceni tehnične dokumentacije, se priglašeni organ posvetuje z referenčnim laboratorijem EU, ki je bil vključen v začetno posvetovanje, da se potrdi ohranjanje skladnosti s skupnimi specifikacijami ali drugimi rešitvami, ki jih izbere proizvajalec za zagotovitev vsaj enakovredne ravni varnosti in učinkovitosti.
the data stipulated in the part of the quality management system relating to design, such as the results of analyses, calculations, tests and the solutions adopted regarding the risk-management as referred to in Section 4 of Annex I,
Proizvajalec za preverjanje skladnosti izdelanih pripomočkov razreda D preskusi vsako izdelano serijo pripomočkov.
the data stipulated in the part of the quality management system relating to manufacture, such as quality control reports and test data, calibration data, and records on the qualifications of the personnel concerned.
Po opravljenih kontrolah in preskusih priglašenemu organu nemudoma pošlje zadevna poročila o teh preskusih.
Notified bodies shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer in question applies the approved quality management system and the post-market surveillance plan.
Poleg tega proizvajalec vzorce izdelanih serij pripomočkov da na voljo priglašenemu organu v skladu s predhodno dogovorjenimi pogoji in podrobnimi pravili, vključno s pogojem, da priglašeni organ ali proizvajalec vzorce izdelanih serij pripomočkov pošilja referenčnemu laboratoriju EU, kadar je bil ta imenovan v skladu s členom 100, ki opravi ustrezne preskuse.
Those audits and assessments shall include audits on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors.
Referenčni laboratorij EU svoje ugotovitve sporoči priglašenemu organu.
At the time of such on-site audits, the notified body shall, where necessary, carry out or ask for tests in order to check that the quality management system is working properly.
Proizvajalec lahko da pripomočke na trg, razen če mu priglašeni organ v dogovorjenem času, toda najpozneje v 30 dneh od prejema vzorcev, sporoči drugačno odločitev, vključno z vsakim morebitnim pogojevanjem veljavnosti izdanih certifikatov.
It shall provide the manufacturer with a surveillance audit report and, if a test has been carried out, with a test report.
Ocenjevanje tehnične dokumentacije posebnih vrst pripomočkov
The notified body shall randomly perform at least once every five years unannounced audits on the site of the manufacturer and, where appropriate, the site of the manufacturer's suppliers and/or subcontractors, which may be combined with the periodic surveillance assessment referred to in Section 3.3 or be performed in addition to that surveillance assessment.
Ocenjevanje tehnične dokumentacije za pripomočke razreda B, C in D za samotestiranje in za testiranje ob pacientu
The notified body shall establish a plan for such unannounced on-site audits but shall not disclose it to the manufacturer.
Proizvajalec pripomočkov razreda B, C in D za samotestiranje in za testiranje ob pacientu pri priglašenem organu vloži vlogo za ocenjevanje tehnične dokumentacije.
Within the context of such unannounced on-site audits, the notified body shall test an adequate sample of the devices produced or an adequate sample from the manufacturing process to verify that the manufactured device is in conformity with the technical documentation.
Vloga omogoči razumevanje zasnove pripomočka, lastnosti in učinkovitosti ter oceno skladnosti z zahtevami iz te uredbe, povezanimi z zasnovo.
Prior to unannounced on-site audits, the notified body shall specify the relevant sampling criteria and testing procedure.
Vloga vsebuje:
Instead of, or in addition to, sampling referred to in the second paragraph, notified bodies shall take samples of devices from the market to verify that the manufactured device is in conformity with the technical documentation.
poročila o preskusih, vključno z rezultati študij, opravljenih s predvidenimi uporabniki;
Prior to the sampling, the notified body in question shall specify the relevant sampling criteria and testing procedure.
kjer je izvedljivo, primerek pripomočka; po potrebi se pripomoček vrne po opravljenem ocenjevanju tehnične dokumentacije;
The notified body shall provide the manufacturer in question with an on-site audit report which shall include, if applicable, the result of the sample test.
podatke, ki kažejo primernost pripomočka glede na njegov predvideni namen za samotestiranje ali testiranje ob pacientu;