natgillin/translations-raw huggingface dataset:
The notified body in question shall take full responsibility for the tasks performed by subcontractors.
kar zadeva vzorčenje pripomočkov za preverjanje, ali je izdelan pripomoček v skladu s tehnično dokumentacijo, se s temi zahtevami določijo zadevna merila za vzorčenje in postopek preskušanja pred vzorčenjem,
Where subcontractors or external experts are used in the context of a conformity assessment, in particular regarding novel devices or technologies, the notified body in question shall have adequate internal competence in each product area for which it is designated that is adequate for the purpose of leading the overall conformity assessment, verifying the appropriateness and validity of expert opinions and making decisions on certification.
ocena in preverjanje, ali proizvajalec izpolnjuje zahteve iz ustreznih prilog.
Monitoring of competences, training and exchange of experience
Priglašeni organ, kadar je to ustrezno, upošteva razpoložljive skupne specifikacije, smernice in dokumente o najboljših praksah ter harmonizirane standarde, tudi če proizvajalec ne navaja skladnosti.
The notified body shall establish procedures for the initial evaluation and on-going monitoring of the competence, conformity assessment activities and performance of all internal and external personnel and subcontractors, involved in conformity assessment activities.
Presoja sistema vodenja kakovosti
Notified bodies shall review at regular intervals, the competence of their personnel, identify training needs and draw up a training plan to maintain the required level of qualification and knowledge of individual personnel.
Kot del ocenjevanja sistema vodenja kakovosti priglašeni organ pred presojo in v skladu s svojimi dokumentiranimi postopki:
That review shall as a minimum, verify that personnel:
oceni dokumentacijo, ki je bila predložena v skladu z zadevno prilogo o ugotavljanju skladnosti, in oblikuje program presoje, ki jasno opredeljuje število in zaporedje dejavnosti, potrebnih za prikaz popolne pokritosti proizvajalčevega sistema vodenja kakovosti ter za opredelitev, ali sistem izpolnjuje zahteve iz te uredbe,
are aware of the Union and national law in force on devices, relevant harmonised standards, CS, guidance documents and the results of the coordination activities referred to in Section 1.6;
opredeli povezave in dodelitev pristojnosti med različnimi proizvodnimi lokacijami ter določi zadevne dobavitelje in/ali podizvajalce proizvajalca in preuči, ali je pri katerem od teh dobaviteljev in/ali podizvajalcev treba opraviti posebno presojo,
take part in the internal exchange of experience and the continuous training and education programme referred to in Section 3.1.2.
za vsako presojo iz programa presoje jasno določi cilje, merila in obseg presoje ter oblikuje načrt presoje, v katerem se ustrezno upoštevajo posebne zahteve za vpletene pripomočke, tehnologije in postopke,
PROCESS REQUIREMENTS
za pripomočke razreda B in razreda C oblikuje in posodablja načrt vzorčenja za oceno tehnične dokumentacije iz prilog II in III, v katerega so vključeni različni pripomočki, navedeni v proizvajalčevi vlogi.
The notified body shall have in place documented processes and sufficiently detailed procedures for the conduct of each conformity assessment activity for which it is designated, comprising the individual steps from pre-application activities up to decision making and surveillance and taking into account, when necessary, the respective specificities of the devices.
S tem načrtom se zagotovi, da se vsi pripomočki, ki jih zajema certifikat, vzorčijo v obdobju veljavnosti certifikata,
The requirements laid down in Sections 4.3, 4.4, 4.7 and 4.8 shall be fulfilled as part of the internal activities of notified bodies and shall not be subcontracted.
izbere in imenuje ustrezno usposobljeno in pooblaščeno osebje za opravljanje posameznih presoj.
Notified body quotations and pre-application activities
Posamezne vloge, odgovornosti in pooblastila članov skupine se jasno opredelijo in dokumentirajo.
The notified body shall
Priglašeni organ na podlagi oblikovanega programa presoje v skladu s svojimi dokumentiranimi postopki izvaja naslednje naloge:
publish a publicly available description of the application procedure by which manufacturers can obtain certification from it.
izvede presojo proizvajalčevega sistema vodenja kakovosti zaradi preverjanja, da sistem vodenja kakovosti zagotavlja, da so zajeti pripomočki v skladu z ustreznimi določbami te uredbe, ki se uporabljajo za pripomočke na vsaki stopnji, od zasnove do končne kontrole kakovosti in stalnega nadzora, in ugotovitev, ali so zahteve iz te uredbe izpolnjene,
That description shall include which languages are acceptable for submission of documentation and for any related correspondence;
na podlagi ustrezne tehnične dokumentacije in da bi ugotovili, ali proizvajalec izpolnjuje zahteve iz zadevne priloge o ugotavljanju skladnosti, pregled in presoja proizvajalčevih postopkov in podsistemov, zlasti za:
have documented procedures relating to, and documented details about, fees charged for specific conformity assessment activities and any other financial conditions relating to notified bodies' assessment activities for devices;,
zasnovo in razvoj,
have documented procedures in relation to advertising of its conformity assessment services.
kontrole izdelave in postopka,
Those procedures shall ensure that advertising or promotional activities in no way imply or are capable of leading to an inference that their conformity assessment will offer manufacturers earlier market access or be quicker, easier or less stringent than that of other notified bodies;
dokumentacijo o izdelku,
have documented procedures requiring the review of pre-application information including the preliminary verification that the product is covered by this Regulation and its classification prior to issuing any quotation to the manufacturer relating to a specific conformity assessment;
kontrole nakupa, vključno s preverjanjem kupljenih pripomočkov,
ensure that all contracts relating to the conformity assessment activities covered by this Regulation are concluded directly between the manufacturer and the notified body and not with any other organisation.
ter pregled in presoja zahtev in določb, ki jih je sprejel proizvajalec, vključno s tistimi v zvezi z izpolnjevanjem splošnih zahtev glede varnosti in učinkovitosti iz Priloge I.
Application review and contract
dokumentacija se vzorči, tako da odraža tveganja, povezana s predvideno uporabo pripomočka, kompleksnost proizvodnih tehnologij, obseg in razrede proizvedenih pripomočkov ter vse razpoložljive informacije o nadzoru po dajanju na trg,
The notified body shall require a formal application signed by a manufacturer or an authorised representative containing all of the information and the manufacturer's declarations required by the relevant conformity assessment as referred to in Annexes IX to XI.
če še ni zajet v program presoje, presoja nadzora postopkov v prostorih proizvajalčevih dobaviteljev, če je na skladnost končnih pripomočkov bistveno vplivala dejavnost dobaviteljev in zlasti če proizvajalec ne more dokazati zadostne kontrole nad svojimi dobavitelji,
The contract between a notified body and a manufacturer shall take the form of a written agreement signed by both parties.
ocene tehnične dokumentacije na podlagi njegovega načrta vzorčenja ter ob upoštevanju oddelka 4.5.4. za oceno učinkovitosti,
It shall be kept by the notified body.
priglašeni organ zagotovi, da se ugotovitve presoje ustrezno in dosledno razvrstijo v skladu z zahtevami iz te uredbe in ustreznimi standardi ali z dokumenti o najboljših praksah, ki jih je pripravila ali sprejela Koordinacijska skupina za medicinske pripomočke.
This contract shall have clear terms and conditions and contain obligations that enable the notified body to act as required under this Regulation, including an obligation on the manufacturer to inform the notified body of vigilance reports, the right of the notified body to suspend, restrict or withdraw certificates issued and the duty of the notified body to fulfil its information obligations.
Preverjanje izdelka
the completeness of those applications with respect to the requirements of the relevant conformity assessment procedure, as referred to in the corresponding Annex, under which approval has been sought,
Priglašeni organi imajo za ocenjevanje tehnične dokumentacije, opravljeno v skladu s poglavjem II Priloge IX, dovolj strokovnega znanja, zmogljivosti in dokumentirane postopke za:
the verification of the qualification of products covered by those applications as devices and their respective classifications,
dodelitev ustrezno usposobljenega in pooblaščenega osebja za obravnavo posameznih vidikov, kot so uporaba pripomočka, biokompatibilnost, ocena učinkovitosti, obvladovanje tveganj in sterilizacija,
whether the conformity assessment procedures chosen by the applicant are applicable to the device in question under this Regulation,
ocenjevanje skladnosti zasnove s to uredbo ob upoštevanju oddelkov 4.5.4. in 4.5.5.
the ability of the notified body to assess the application based on its designation, and
To ocenjevanje vključuje pregled izvajanja in rezultatov prihodnjih, tekočih in končnih pregledov s strani proizvajalcev.
the availability of sufficient and appropriate resources.
Če so za ugotavljanje skladnosti z zahtevami iz te uredbe potrebni nadaljnji preskusi ali drugi dokazi, zadevni priglašeni organ opravi ustrezne fizikalne ali laboratorijske preskuse v zvezi s pripomočkom ali od proizvajalca zahteva izvedbo takih preskusov.
The outcome of each review of an application shall be documented.
Pregledi tipa
Refusals or withdrawals of applications shall be notified to the electronic system referred to in Article 52 and shall be accessible to other notified bodies.
Priglašeni organ ima vzpostavljene dokumentirane postopke, dovolj strokovnega znanja in zmogljivosti za pregled tipa pripomočkov v skladu s Prilogo X, vključno z zmogljivostjo za:
Allocation of resources
pregled in oceno tehnične dokumentacije, ob upoštevanju oddelkov 4.5.4. in 4.5.5., ter preverjanje, ali je bil tip izdelan v skladu s to dokumentacijo;
The notified body shall have documented procedures to ensure that all conformity assessment activities are conducted by appropriately authorised and qualified personnel who are sufficiently experienced in the evaluation of the devices, systems and processes and related documentation that are subject to conformity assessment.
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;
For each application, the notified body shall determine the resources needed and identify one individual responsible for ensuring that the assessment of that application is conducted in accordance with the relevant procedures and for ensuring that the appropriate resources including personnel are utilised for each of the tasks of the assessment.
dokumentiranje svoje utemeljitve za izbiro teh parametrov;
The allocation of tasks required to be carried out as part of the conformity assessment and any changes subsequently made to this allocation shall be documented.
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;
Conformity assessment activities
dogovor z vložnikom o tem, kje bodo izvedeni potrebni preskusi, če jih ne izvede neposredno priglašeni organ;
The notified body and its personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical and scientific competence in the specific fields.
prevzem polne odgovornosti za rezultate preskusa.
The notified body shall have expertise, facilities and documented procedures that are sufficient to effectively conduct the conformity assessment activities for which the notified body in question is designated, taking account of the relevant requirements set out in Annexes IX to XI and in particular the following requirements:
Poročila o preskusih, ki jih predloži proizvajalec, se upoštevajo le, če so jih izdali pristojni organi za ugotavljanje skladnosti, ki so neodvisni od proizvajalca.
to appropriately plan the conduct of each individual project,
Preverjanje s pregledovanjem in preskušanjem vsake serije izdelka
to ensure that the composition of the assessment teams is such that there is sufficient experience in relation to the technology concerned, and that there is continuous objectivity and independence, and to provide for rotation of the members of the assessment team at appropriate intervals,
Priglašeni organ:
to specify the rationale for fixing time limits for completion of conformity assessment activities,
ima vzpostavljene dokumentirane postopke, dovolj strokovnega znanja in zmogljivosti za preverjanje s pregledovanjem in preskušanjem vsake serije izdelka v skladu s prilogama IX in XI;
to assess the manufacturer's technical documentation and the solutions adopted to meet the requirements laid down in Annex I,
oblikuje načrt preskušanja, v katerem opredelijo vse pomembne in kritične parametre, ki jih mora priglašeni organ preskusiti ali pa je za njihov preskus odgovoren, da:
to review the manufacturer's procedures and documentation relating to performance evaluation,
za pripomočke razreda C preveri skladnost pripomočka s tipom, opisanim v certifikatu o EU-pregledu tipa, in z zahtevami iz te uredbe, ki veljajo za te pripomočke,
to address the interface between the manufacturer's risk management process and its appraisal and analysis of the performance evaluation and to evaluate their relevance for the demonstration of conformity with the relevant requirements in Annex I,
za pripomočke razreda B potrdi skladnost s tehnično dokumentacijo iz prilog II in III ter z zahtevami iz te uredbe, ki veljajo za te pripomočke,
to carry out the ‘specific procedures’ referred to in Section 5 of Annex IX,
dokumentira svojo utemeljitev za izbiro parametrov iz točke (b);
in the case of class B or C devices, to assess the technical documentation of devices selected on a representative basis,
imajo vzpostavljene dokumentirane postopke za izvedbo ustreznih ocenjevanj in preskusov, tako da s pregledom in preskusom vsake serije izdelka, kakor je določeno v oddelku 5 Priloge XI, preverijo skladnost pripomočka z zahtevami iz te uredbe;
to plan and periodically carry out appropriate surveillance audits and assessments, to carry out or request certain tests to verify the proper functioning of the quality management system and to perform unannounced on site audits,
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;
relating to the sampling of devices verify that the manufactured device is in conformity with the technical documentation; such requirements shall define the relevant sampling criteria and testing procedure prior to sampling,
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.
to evaluate and verify a manufacturer's compliance with relevant Annexes.
Vrednotenje ocene učinkovitosti
The notified body shall, where relevant, take into consideration available CS, guidance and best practice documents and harmonised standards, even if the manufacturer does not claim to be in compliance.
Priglašeni organi pri vrednotenju postopkov in dokumentacije obravnavajo rezultate preučevanja literature in vsa opravljena potrjevanja, preverjanja in preskušanja ter iz tega izpeljane ugotovitve, vanj pa običajno vključijo tudi obravnavo možnosti uporabe alternativnih materialov in snovi ter upoštevajo embalažo in stabilnost, vključno z rokom uporabnosti, končnega pripomočka.
Quality management system auditing
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.
As part of the assessment of the quality management system a, a notified body shall prior to an audit and in accordance with its documented procedures:
Priglašeni organ ima vzpostavljene dokumentirane postopke za vrednotenje proizvajalčevih postopkov in dokumentacije v zvezi z oceno učinkovitosti, tako za začetno kot za redno ugotavljanje skladnosti.
assess the documentation submitted in accordance with the relevant conformity assessment Annex, and draw up an audit programme which clearly identifies the number and sequence of activities required to demonstrate complete coverage of a manufacturer's quality management system and to determine whether it meets the requirements of this Regulation,
Priglašeni organ pregleda, potrdi in preveri, ali proizvajalčevi postopki in dokumentacija ustrezno obravnavajo:
identify links between and allocation of responsibilities among, the various manufacturing sites, and identify relevant suppliers and/or subcontractors of the manufacturer, and consider the need to specifically audit any of those suppliers or subcontractors or both,
načrtovanje, izvajanje, ocenjevanje, poročanje in posodabljanje ocene učinkovitosti iz Priloge XIII,
clearly define, for each audit identified in the audit programme, the objectives, criteria and scope of the audit, and draw up an audit plan that adequately addresses and takes account of the specific requirements for the devices, technologies and processes involved,
nadzor po dajanju na trg in spremljanje učinkovitosti po dajanju na trg;
draw up and keep up to date, for class B and class C devices, a sampling plan for the assessment of technical documentation as referred to in Annexes II and III covering the range of such devices covered by the manufacturer's application.
povezavo s postopkom obvladovanja tveganj,
That plan shall ensure that all devices covered by the certificate are sampled over the period of validity of the certificate,
oceno in analizo razpoložljivih podatkov ter njihovega pomena za dokazovanje skladnosti z ustreznimi zahtevami iz Priloge I,
select and assign appropriately qualified and authorised personnel for conducting the individual audits.
ugotovitve na podlagi kliničnih dokazov in oblikovanje poročila o oceni učinkovitosti.
The respective roles, responsibilities and authorities of the team members shall be clearly defined and documented.
Pri postopkih iz drugega odstavka se upoštevajo razpoložljive skupne specifikacije, smernice in dokumenti o najboljših praksah.
Based on the audit programme it has drawn up, the notified body shall, in accordance with its documented procedures:
Vrednotenje ocen učinkovitosti iz Priloge XIII, ki jih opravi priglašeni organ, zajema:
audit the manufacturer's quality management system in order to verify that the quality management system ensures that the devices covered conform to the relevant provisions of this Regulation which apply to devices at every stage, from design through final quality control to ongoing surveillance, and shall determine whether the requirements of this Regulation are met,
predvideno uporabo, kot jo opredeli proizvajalec, in njegove trditve glede pripomočka,
based on relevant technical documentation, and in order to determine whether the manufacturer meets the requirements referred to in the relevant conformity assessment Annex, review and audit the manufacturer's processes and subsystems,– in particular for:
načrtovanje ocene učinkovitosti;
design and development,
metodologijo preučevanja literature,
production and process controls,
zadevno dokumentacijo na podlagi preučevanja literature;
product documentation,
študije učinkovitosti;
purchasing controls including verification of purchased devices,
veljavnost navedene enakovrednosti glede na druge pripomočke, dokaz enakovrednosti, podatke o ustreznosti in ugotovitvah za enakovredne in podobne pripomočke,
corrective and preventive actions including for post-market surveillance, and PMPF,
poročilo o oceni učinkovitosti,
and review and audit requirements and provisions adopted by the manufacturer, including those in relation to fulfilling the general safety and performance requirements set out in Annex I,
utemeljitve za neizvajanje študij učinkovitosti ali spremljanja učinkovitosti po dajanju na trg.
the documentation shall be sampled in such as a manner as to reflect the risks associated with the intended use of the device, the complexity of the manufacturing technologies, the range and classes of devices produced and any available post-market surveillance information,
Kar zadeva podatke iz študij učinkovitosti, vključene v oceno učinkovitosti, zadevni priglašeni organ zagotovi, da so ugotovitve, do katerih je prišel proizvajalec, veljavne ob upoštevanju odobrenega načrta študije učinkovitosti.
if not already covered by the audit programme, audit the control of processes on the premises of the manufacturer's suppliers, when the conformity of finished devices is significantly influenced by the activity of suppliers and, in particular when the manufacturer cannot demonstrate sufficient control over its suppliers,
Priglašeni organ zagotovi, da ocena učinkovitosti ustrezno izpolnjuje zadevne zahteve glede varnosti in učinkovitosti iz Priloge I, da je ustrezno usklajena z zahtevami v zvezi z obvladovanjem tveganj in da je izvedena v skladu s Prilogo XIII ter da se ustrezno odraža v informacijah, predloženih v zvezi s pripomočkom.
conduct assessments of the technical documentation based on its sampling plan and taking account of Section 4.5.4. for performance evaluation,
Posebni postopki
the notified body shall ensure that audit findings are appropriately and consistently classified in accordance with the requirements of this Regulation and with relevant standards, or with best practice documents developed or adopted by the MDCG.
Priglašeni organ ima vzpostavljene dokumentirane postopke, dovolj strokovnega znanja in zmogljivosti za postopke iz oddelka 5 Priloge IX, za katere je imenovan.
Product verification
V primeru dopolnilne diagnostike ima priglašeni organ vzpostavljene dokumentirane postopke, katerih cilj je izpolnitev zahtev iz te uredbe v zvezi s posvetovanjem z Evropsko agencijo za zdravila ali pristojnim organom za zdravila pri vrednotenju takšnih tipov pripomočkov.
Assessment of the technical documentation
Poročanje
For assessment of the technical documentation conducted in accordance with Chapter II of Annex IX, notified bodies shall have sufficient expertise, facilities and documented procedures for:
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,
the allocation of appropriately qualified and authorised personnel for the examination of individual aspects, such as use of the device, biocompatibility, performance evaluation, risk management and sterilisation, and
zagotovi, da so za presoje sistema vodenja kakovosti na voljo evidence, ki zadostujejo za zagotovitev jasne sledi za presojo,
the assessment of conformity of the design with this Regulation, and taking account of Sections 4.5.4. and 4.5.5.
ugotovitve svojega vrednotenja ocen učinkovitosti jasno dokumentira v poročilu o vrednotenju ocene učinkovitosti;
This assessment shall include the examination of the implementation by manufacturers of incoming, in-process and final checks and the results thereof.
za vsak posamezni projekt predložijo podrobno poročilo, pripravljeno na podlagi standardnega obrazca, ki vsebuje minimalni nabor elementov, ki jih določi Koordinacijska skupina za medicinske pripomočke.