natgillin/translations-raw huggingface dataset:
a description of the procedures in place to keep up to date the clinical evaluation plan, taking into account the state of the art.
dokumentacijo o sistemu vodenja kakovosti proizvajalca;
Implementation of the quality management system shall ensure compliance with this Regulation.
dokumentiran opis postopkov, vzpostavljenih za izpolnjevanje obveznosti, ki izhajajo iz sistema vodenja kakovosti in te uredbe, ter zavezo zadevnega proizvajalca k uporabi teh postopkov;
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.
opis vzpostavljenih postopkov za zagotavljanje ohranjanja ustreznosti in učinkovitosti sistema vodenja kakovosti ter zavezo proizvajalca k uporabi teh postopkov;
Moreover, the documentation to be submitted for the assessment of the quality management system shall include an adequate description of, in particular:
dokumentacijo o proizvajalčevem sistemu nadzora po dajanju na trg in, kjer je ustrezno, o načrtu kliničnega spremljanja po dajanju na trg in vzpostavljenih postopkih za zagotovitev izpolnjevanja obveznosti, ki izhajajo iz določb o vigilanci iz členov 87 do 92;
the manufacturer's quality objectives;
opis vzpostavljenih postopkov za posodabljanje sistema nadzora po dajanju na trg in, kjer je ustrezno, načrta kliničnega spremljanja po dajanju na trg ter postopkov za zagotovitev izpolnjevanja obveznosti, ki izhajajo iz določb o vigilanci iz členov 87 do 92, ter zavezo proizvajalca k uporabi teh postopkov;
the organisation of the business and in particular:
dokumentacijo o načrtu klinične ocene ter
the organisational structures with the assignment of staff responsibilities in relation to critical procedures, the responsibilities of the managerial staff and their organisational authority,
opis vzpostavljenih postopkov za posodabljanje načrta klinične ocene, v katerih je upoštevano zadnje stanje tehničnega razvoja.
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,
Izvajanje sistema vodenja kakovosti je tako, da je zagotovljena skladnost s to uredbo.
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, and
Vsi elementi, zahteve in določbe, ki jih sprejme proizvajalec za svoj sistem vodenja kakovosti, so sistematično in urejeno dokumentirani v priročniku kakovosti ter zapisanih politikah in postopkih, kot so programi kakovosti, načrti kakovosti in evidenca kakovosti.
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;
Poleg tega dokumentacija, ki jo je treba predložiti za oceno sistema vodenja kakovosti, vključuje zlasti ustrezen opis:
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.
ciljev proizvajalca glede kakovosti;
Those procedures and techniques shall specifically cover:
organizacije poslovanja in še posebej:
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,
organizacijskih struktur z opisom, kdo od zaposlenih je odgovoren za kritične postopke, ter opisom pristojnosti vodstvenega osebja in njegovih organizacijskih pooblastil;
identification of applicable general safety and performance requirements and solutions to fulfil those requirements, taking applicable CS and, where opted for, harmonised standards or other adequate solutions into account,
metod spremljanja, ali je delovanje sistema vodenja kakovosti učinkovito, in zlasti tega, ali se s tem sistemom dosega želena kakovost zasnove in pripomočka, vključno z nadzorom pripomočkov, ki ne dosegajo skladnosti;
risk management as referred to in Section 3 of Annex I,
kadar zasnovo, izdelavo in/ali končno preverjanje ter preskus pripomočkov ali delov teh postopkov izvaja druga stran, opis metod spremljanja učinkovitega delovanja sistema vodenja kakovosti ter zlasti vrste in obsega nadzora nad drugo stranjo; in
the clinical evaluation, pursuant to Article 61 and Annex XIV, including post-market clinical follow-up,
kadar proizvajalec nima registriranega kraja poslovanja v državi članici, osnutek pooblastila za imenovanje pooblaščenega predstavnika in pismo pooblaščenega predstavnika o nameri za sprejem mandata;
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,
postopkov in tehnik za spremljanje, preverjanje, potrjevanje in nadzor zasnove pripomočkov in ustrezne dokumentacije ter podatkov in evidenc, pridobljenih iz navedenih postopkov in tehnik.
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,
Ti postopki in tehnike še zlasti zajemajo:
the device identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture, and
strategijo za skladnost z zakonodajo, vključno s postopki za ugotavljanje ustreznih zakonskih zahtev, kvalifikacijo, razvrščanje, obravnavanje enakovrednosti ter izbiro postopkov ugotavljanja skladnosti in skladnost z njimi;
management of design or quality management system changes; and
identifikacijo veljavnih splošnih zahtev glede varnosti in učinkovitosti in rešitev za izpolnitev teh zahtev, ob upoštevanju veljavnih skupnih specifikacij in harmoniziranih standardov, če so bili uporabljeni, ali drugih ustreznih rešitev;
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
obvladovanje tveganja iz oddelka 3 Priloge I;
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.
klinično oceno v skladu s členom 61 in Prilogo XIV, vključno s kliničnim spremljanjem po dajanju na trg;
In addition, the manufacturer shall grant the notified body access to the technical documentation referred to in Annexes II and III.
rešitve za izpolnjevanje posebnih veljavnih zahtev glede zasnove in zgradbe, vključno z ustrezno predklinično oceno, zlasti zahtev iz poglavja II Priloge I;
Audit
rešitve za izpolnjevanje posebnih veljavnih zahtev glede informacij, ki jih je treba priložiti pripomočku, zlasti zahtev iz poglavja III Priloge I;
The notified body shall audit the quality management system to determine whether it meets the requirements referred to in Section 2.2.
postopke identifikacije pripomočka, ki se oblikujejo in posodabljajo na podlagi risb, specifikacij ali drugih relevantnih dokumentov v vsaki fazi proizvodnje, ter
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.
upravljanje sprememb zasnove ali sistema vodenja kakovosti in
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 substantiates not doing so.
tehnik preverjanja in zagotavljanja kakovosti v proizvodni fazi ter zlasti procesov in postopkov, ki se uporabljajo, predvsem za sterilizacijo, in relevantnih dokumentov, ter
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.
ustreznih preskusov in preskušanj, ki se opravijo pred in med proizvodnjo ter po njej, njihove pogostosti in opreme za preskuse, ki se uporabi; omogočena je ustrezna sledljivost kalibracije opreme za preskuse.
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.
Poleg tega proizvajalci priglašenemu organu odobrijo dostop do tehnične dokumentacije iz prilog II in III.
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.
Presoja
Moreover, in the case of class IIa and class IIb devices, the quality management system assessment shall be accompanied by the assessment of technical documentation for devices selected on a representative basis in accordance with Sections 4.4 to 4.8.
Priglašeni organ izvede presojo sistema vodenja kakovosti, da ugotovi, ali izpolnjuje zahteve iz oddelka 2.2.
In choosing representative samples, the notified body shall take into account the published guidance developed by the MDCG pursuant to Article 105 and in particular the novelty of the technology, similarities in design, technology, manufacturing and sterilisation methods, the intended purpose and the results of any previous relevant assessments such as with regard to physical, chemical, biological or clinical properties, that have been carried out in accordance with this Regulation.
Če proizvajalec uporablja harmonizirane standarde ali skupne specifikacije, ki se nanašajo na sistem vodenja kakovosti, oceni skladnost s temi standardi ali skupnimi specifikacijami.
The notified body in question shall document its rationale for the samples taken.
Priglašeni organ domneva, da je sistem vodenja kakovosti, ki izpolnjuje ustrezne harmonizirane standarde ali skupne specifikacije, skladen z zahtevami iz navedenih standardov ali skupnih specifikacij, razen če ustrezno utemelji, da temu ni tako.
If the quality management system conforms to the relevant provisions of this Regulation, the notified body shall issue an EU quality management system certificate.
V skupini priglašenega organa za presojo ima vsaj en član že izkušnje z ocenjevanjem zadevne tehnologije v skladu z oddelki 4.3. do 4.5.
The notified body shall notify the manufacturer of its decision to issue the certificate.
Priloge VII.
The decision shall contain the conclusions of the audit and a reasoned report.
Kadar ni mogoče takoj razbrati, ali član že ima te izkušnje, oziroma kadar take izkušnje niso potrebne, priglašeni organ predloži dokumentirano utemeljitev za sestavo te skupine.
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.
Ocenjevalni postopek vključuje presojo v prostorih proizvajalca ter, kjer je ustrezno, v prostorih proizvajalčevih dobaviteljev in/ali podizvajalcev, da se preverijo postopki izdelave in drugi ustrezni postopki.
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.
Poleg tega se za pripomočke razredov IIa in IIb, izbrane na reprezentativni osnovi v skladu z oddelki 4.4 do 4.8, skupaj z oceno sistema vodenja kakovosti opravi tudi ocena tehnične dokumentacije.
It shall notify the manufacturer of its decision which shall contain the conclusions of the assessment, and where applicable, conclusions of additional audits.
Priglašeni organ pri izbiri reprezentativnih vzorcev upošteva objavljene smernice, ki jih je pripravila Koordinacijska skupina za medicinske pripomočke v skladu s členom 105, ter zlasti tehnološke novosti, podobnosti v zasnovi, tehnologijo, metode izdelave in sterilizacije, predviden namen in rezultate vseh prejšnjih relevantnih ocen, na primer fizikalnih, kemijskih, bioloških ali kliničnih lastnosti, ki so bile opravljene v skladu s to uredbo.
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.
Zadevni priglašeni organ dokumentira svojo utemeljitev za odvzete vzorce.
Surveillance assessment applicable to class IIa, class IIb and class III devices
Če je sistem vodenja kakovosti skladen z zadevnimi določbami te uredbe, priglašeni organ izda certifikat EU o sistemu vodenja kakovosti.
The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations arising from the approved quality management system.
Priglašeni organ proizvajalca uradno obvesti o svoji odločitvi, da izda certifikat.
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:
Odločitev vsebuje zaključke presoje in obrazloženo poročilo.
the documentation on its quality management system,
Zadevni proizvajalec priglašeni organ, ki je odobril sistem vodenja kakovosti, obvesti o vseh načrtovanih bistvenih spremembah sistema vodenja kakovosti ali obsega vanj zajetih pripomočkov.
documentation on any findings and conclusions resulting from the application of the post-market surveillance plan, including the PMCF plan, for a representative sample of devices, and of the provisions on vigilance set out in Articles 87 to 92,
Priglašeni organ oceni predlagane spremembe, presodi, ali so potrebne dodatne presoje, in preveri, ali sistem vodenja kakovosti po teh spremembah še naprej izpolnjuje zahteve iz oddelka 2.2.
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, and
Proizvajalca uradno obvesti o svoji odločitvi, v katero vključi zaključke ocene in, kjer je ustrezno, zaključke dodatnih presoj.
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.
Odobritev vsake bistvene spremembe sistema vodenja kakovosti ali obsega vanj zajetih pripomočkov je v obliki dopolnila k certifikatu EU o sistemu vodenja kakovosti.
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.
Ocena nadzora, ki se uporablja za pripomočke razredov IIa, IIb in III
Those audits and assessments shall include audits on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors.
Namen nadzora je zagotoviti, da proizvajalec ustrezno izpolnjuje obveznosti, ki jih nalaga odobreni sistem vodenja kakovosti.
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 pooblasti priglašeni organ za izvedbo vseh potrebnih presoj, vključno s presojami na kraju samem, in mu predloži vse ustrezne informacije, zlasti:
It shall provide the manufacturer with a surveillance audit report and, if a test has been carried out, with a test report.
dokumentacijo o svojem sistemu vodenja kakovosti;
The notified body shall randomly perform at least once every five years unannounced audits on the site of the manufacturer and, where appropriate, 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.
dokumentacijo o vseh ugotovitvah in zaključkih, pridobljenih z uporabo načrta nadzora po dajanju na trg, vključno z načrtom kliničnega spremljanja po dajanju na trg, za reprezentativen vzorec pripomočkov, in z uporabo določb o vigilanci iz členov 87 do 92;
The notified body shall establish a plan for such unannounced on-site audits but shall not disclose it to the manufacturer.
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, in
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, with the exception of the devices referred to in the second subparagraph of Article 52(8).
podatke, določene v tistem delu sistema vodenja kakovosti, ki se nanaša na izdelavo, kot so poročila o kontrole kakovosti in podatki o preskusih, kalibracijski podatki ter evidence o kvalifikacijah zadevnega osebja.
Prior to unannounced on-site audits, the notified body shall specify the relevant sampling criteria and testing procedure.
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.
Instead of, or in addition to, sampling referred to in the second paragraph, the notified body shall take samples of devices from the market to verify that the manufactured device is in conformity with the technical documentation, with the exception of the devices referred to in the second subparagraph of Article 52(8).
Te presoje in ocenjevanje vključujejo presoje v prostorih proizvajalca ter, kjer je ustrezno, proizvajalčevih dobaviteljev in/ali podizvajalcev.
Prior to the sampling, the notified body in question shall specify the relevant sampling criteria and testing procedure.
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.
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.
Proizvajalcu predloži poročilo o nadzorni presoji in, če je bil opravljen preskus, poročilo o preskusu.
In the case of class IIa and class IIb devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 for the device or devices concerned on the basis of further representative samples chosen in accordance with the rationale documented by the notified body in accordance with the second paragraph of Section 2.3.
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.
In the case of class III devices, the surveillance assessment shall also include a test of the approved parts and/or materials that are essential for the integrity of the device, including, where appropriate, a check that the quantities of produced or purchased parts and/or materials correspond to the quantities of finished devices.
Priglašeni organ pripravi načrt za takšne nenapovedane presoje na kraju samem, vendar ga ne razkrije proizvajalcu.
The notified body shall ensure that the composition of the assessment team is such that there is sufficient experience with the evaluation of the devices, systems and processes concerned, continuous objectivity and neutrality; this shall include a rotation of the members of the assessment team at appropriate intervals.
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, razen v primeru pripomočkov iz drugega pododstavka člena 52(8).
As a general rule, a lead auditor shall neither lead nor attend audits for more than three consecutive years in respect of the same manufacturer.
Priglašeni organ pred nenapovedanimi presojami na kraju samem določi relevantna merila vzorčenja in preskusni postopek.
If the notified body finds a divergence between the sample taken from the devices produced or from the market and the specifications laid down in the technical documentation or the approved design, it shall suspend or withdraw the relevant certificate or impose restrictions on it.
Priglašeni organ namesto ali poleg vzorčenja iz drugega odstavka odvzame vzorce pripomočkov s trga, da preveri, ali je izdelan pripomoček skladen s tehnično dokumentacijo, razen v primeru pripomočkov iz drugega pododstavka člena 52(8).
ASSESSMENT OF THE TECHNICAL DOCUMENTATION
Zadevni priglašeni organ pred vzorčenjem določi relevantna merila vzorčenja in preskusni postopek.
Assessment of the technical documentation applicable to class III devices and to the class IIb devices referred to in the second subparagraph of Article 52(4)
Priglašeni organ zadevnemu proizvajalcu predloži poročilo o presoji na kraju samem, ki po potrebi vključuje rezultate preskusa vzorca.
In addition to the obligations laid down in Section 2, the manufacturer shall lodge with the notified body an application for assessment of the technical documentation relating to the device which it plans to place on the market or put into service and which is covered by the quality management system referred to in Section 2.
Ocena nadzora v primeru pripomočkov razredov IIa in IIb 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 z drugim odstavkom oddelka 2.3.
The application shall describe the design, manufacture and performance of the device in question.
Ocena nadzora v primeru pripomočkov razreda III vključuje tudi preskus odobrenih delov in/ali materialov, ki so bistveni za celovitost pripomočka, in po potrebi tudi preverjanje skladnosti med številom proizvedenih ali kupljenih delov in/ali materialov ter številom končnih pripomočkov.
It shall include the technical documentation as referred to in Annexes II and III.
Priglašeni organ poskrbi, 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.
The notified body shall examine the application by using staff, employed by it, with proven knowledge and experience regarding the technology concerned and its clinical application.
Glavni presojevalec praviloma ne vodi presoj niti ne sodeluje pri presojah istega proizvajalca več kot tri zaporedna leta.
The notified body may require the application to be completed by having further tests carried out or requesting further evidence to be provided to allow assessment of conformity with the relevant requirements of the Regulation.
Če priglašeni organ ugotovi odstopanje med vzorcem, odvzetim izmed proizvedenih pripomočkov, ali vzorcem, vzetim s trga, in specifikacijami iz tehnične dokumentacije ali odobrene zasnove, začasno ali trajno prekliče zadevni certifikat ali uvede omejitve zanj.