natgillin/translations-raw huggingface dataset:
Notified body quotations and pre-application activities
seznanjeno z veljavnim pravom Unije in nacionalnim pravom v zvezi s pripomočki, zadevnimi harmoniziranimi standardi, skupnimi specifikacijami, smernicami in rezultati usklajevalnih dejavnosti iz oddelka 1.6. in
The notified body shall:
sodeluje pri notranji izmenjavi izkušenj ter v programu stalnega usposabljanja in izobraževanja iz oddelka 3.1.2.
publish a publicly available description of the application procedure by which manufacturers can obtain certification from it.
ZAHTEVE GLEDE POSTOPKA
That description shall include which languages are acceptable for submission of documentation and for any related correspondence;
Priglašeni organ za izvajanje vsake dejavnosti ugotavljanja skladnosti, za katero je imenovan, vzpostavi dokumentirane in dovolj podrobne postopke, ki zajemajo posamezne korake od dejavnosti pred oddajo vloge do odločanja in nadzora ter v katerih se po potrebi upoštevajo zadevne posebnosti pripomočkov.
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;
Zahteve iz oddelkov 4.3., 4.4., 4.7. in 4.8. se izpolnijo kot del notranjih dejavnosti priglašenih organov in se ne smejo oddati v podizvajanje.
have documented procedures in relation to advertising of their conformity assessment services.
Navedbe priglašenega organa in dejavnosti pred oddajo vloge
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;
Priglašeni organ:
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; and
objavi javno dostopen opis postopka za oddajo vloge, po katerem lahko proizvajalci od njega pridobijo certifikacijo.
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.
V tem opisu je določeno, kateri jeziki so sprejemljivi za predložitev dokumentacije in s tem povezano korespondenco;
Application review and contract
ima dokumentirane postopke in dokumentirane podrobnosti v zvezi s pristojbinami, ki se zaračunajo za določene dejavnosti ugotavljanja skladnosti, ter drugimi finančnimi pogoji v zvezi z dejavnostmi ugotavljanja skladnosti priglašenih organov za pripomočke;
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.
ima dokumentirane postopke v zvezi z oglaševanjem svojih storitev ugotavljanja skladnosti.
The contract between a notified body and a manufacturer shall take the form of a written agreement signed by both parties.
S temi postopki se zagotovi, da oglaševalske ali promocijske dejavnosti nikakor ne pomenijo oziroma ne morejo privesti do sklepa, da bo ugotavljanje skladnosti priglašenega organa proizvajalcem omogočilo zgodnejši dostop do trga ali da bo hitrejše, enostavnejše in manj strogo kot pri drugih priglašenih organih;
It shall be kept by the notified body.
ima dokumentirane postopke za pregled informacij pred oddajo vloge, vključno s predhodnim preverjanjem, ali je izdelek zajet v to uredbo, in njegovo razvrstitvijo, preden se proizvajalcu sporočijo navedbe v povezavi z določenim ugotavljanjem skladnosti, in
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.
zagotovi, da se vse pogodbe, ki se nanašajo na dejavnosti ugotavljanja skladnosti, zajete s to uredbo, sklenejo neposredno med proizvajalcem in priglašenim organom in ne s katero koli drugo organizacijo.
The notified body shall have documented procedures to review applications, addressing:
Pregled vloge in pogodbene zahteve
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 organ zahteva uradno vlogo, ki jo podpiše proizvajalec ali pooblaščeni predstavnik, v kateri so vse informacije in izjave proizvajalca, zahtevane v skladu z zadevnim ugotavljanjem skladnosti iz prilog od IX do XI.
the verification of the qualification of products covered by those applications as devices and their respective classifications,
Pogodba med priglašenim organom in proizvajalcem ima obliko pisnega dogovora, ki ga podpišeta obe strani.
whether the conformity assessment procedures chosen by the applicant are applicable to the device in question under this Regulation,
Hrani jo priglašeni organ.
the ability of the notified body to assess the application based on its designation, and
V pogodbi morajo biti jasno opredeljeni pogoji in obveznosti, kar priglašenemu organu omogoča, da deluje v skladu s to uredbo, vključno z obveznostjo proizvajalca, da priglašeni organ obvesti o poročilih o vigilanci, in pravico, da priglašeni organ začasno prekliče, omeji ali prekliče izdane certifikate ter izpolni svoje obveznosti obveščanja.
the availability of sufficient and appropriate resources.
Priglašeni organ ima vzpostavljene dokumentirane postopke za pregled vlog, ki se nanašajo na:
The outcome of each review of an application shall be documented.
popolnost navedenih vlog v zvezi z zahtevami zadevnega postopka ugotavljanja skladnosti iz ustrezne priloge, na podlagi katere se zaproša za odobritev,
Refusals or withdrawals of applications shall be notified to the electronic system referred to in Article 57 and shall be accessible to other notified bodies.
preverjanje opredelitve izdelkov, na katere se vloge nanašajo, kot pripomočkov in njihovih razvrstitev,
Allocation of resources
ali se postopki ugotavljanja skladnosti, ki jih izbere vložnik, uporabljajo za zadevni pripomoček v skladu s to uredbo,
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.
zmožnost priglašenega organa za ocenjevanje vloge na podlagi njegovega imenovanja ter
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.
razpoložljivost zadostnih in ustreznih sredstev.
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.
Rezultati vsakega pregleda vloge se dokumentirajo.
Conformity assessment activities
O zavrnitvah ali umikih vlog se uradno obvesti elektronski sistem iz člena 57, te informacije pa so na voljo tudi drugim priglašenim organom.
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.
Dodeljevanje sredstev
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 all of the following requirements:
Priglašeni organ ima vzpostavljene dokumentirane postopke za zagotovitev, da vse dejavnosti ugotavljanja skladnosti izvaja ustrezno pooblaščeno in usposobljeno osebje, ki ima dovolj izkušenj z ocenjevanjem pripomočkov, sistemov in postopkov ter s tem povezane dokumentacije, ki so predmet ugotavljanja skladnosti.
appropriately plan the conduct of each individual project,
Priglašeni organ za vsako vlogo določi potrebna sredstva in imenuje eno osebo, ki je odgovorna za zagotovitev, da se ta vloga oceni v skladu z ustreznimi postopki in da se pri vsaki od nalog v okviru ugotavljanja skladnosti uporabijo ustrezna sredstva, vključno z osebjem.
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,
Dodelitev nalog, ki jih je treba izvesti kot del ugotavljanja skladnosti, in naknadne spremembe te dodelitve se dokumentirajo.
specify the rationale for fixing time limits for completion of conformity assessment activities,
Dejavnosti ugotavljanja skladnosti
assess the manufacturer's technical documentation and the solutions adopted to meet the requirements laid down in Annex I,
Priglašeni organ in njegovo osebje izvajajo dejavnosti ugotavljanja skladnosti z najvišjo stopnjo profesionalne integritete ter potrebnimi tehničnimi in znanstvenimi kompetencami na posameznih področjih.
review the manufacturer's procedures and documentation relating to the evaluation of pre-clinical aspects,
Priglašeni organ ima strokovno znanje, zmogljivosti in dokumentirane postopke, ki zadostujejo za učinkovito izvajanje dejavnosti ugotavljanja skladnosti, za katere je zadevni priglašeni organ imenovan, pri čemer se upoštevajo ustrezne zahteve iz prilog IX do XI in zlasti vse naslednje zahteve:
review the manufacturer's procedures and documentation relating to clinical evaluation,
ustrezno načrtovanje izvedbe vsakega posameznega projekta,
address the interface between the manufacturer's risk management process and its appraisal and analysis of the pre-clinical and clinical evaluation and to evaluate their relevance for the demonstration of conformity with the relevant requirements in Annex I,
zagotovitev, da so ocenjevalne skupine sestavljene tako, da obstaja dovolj izkušenj v zvezi z zadevno tehnologijo ter da obstaja stalna objektivnost in neodvisnost, ter zagotovitev rotacije članov ocenjevalne skupine v ustreznih časovnih presledkih,
carry out the specific procedures referred to in Sections 5.2 to 5.4 of Annex IX,
obrazložitev razlogov za določitev časovne omejitve za dokončanje dejavnosti ugotavljanja skladnosti,
in the case of class IIa or class IIb devices, assess the technical documentation of devices selected on a representative basis,
ocena tehnične dokumentacije proizvajalca in rešitev, sprejetih za izpolnitev zahtev iz Priloge I,
plan and periodically carry out appropriate surveillance audits and assessments, carry out or request certain tests to verify the proper functioning of the quality management system and to perform unannounced on site audits,
preverjanje proizvajalčevih postopkov in dokumentacije v zvezi z oceno predkliničnih vidikov,
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,
preverjanje proizvajalčevih postopkov in dokumentacije v zvezi s klinično oceno,
evaluate and verify a manufacturer's compliance with relevant Annexes.
obravnava povezave med postopkom obvladovanja tveganj proizvajalca ter njegovo oceno in analizo predklinične in klinične ocene ter vrednotenje njihovega pomena za dokazovanje skladnosti z ustreznimi zahtevami iz Priloge I,
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.
izvedba posebnih postopkov iz oddelkov 5.2. do 5.4.
Quality management system auditing
Priloge IX,
As part of the assessment of the quality management system, a notified body shall prior to an audit and in accordance with its documented procedures:
v primeru pripomočkov razreda IIa ali razreda IIb ocena tehnične dokumentacije pripomočkov, izbranih na reprezentativni podlagi,
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,
načrtovanje in redno izvajanje ustreznih nadzornih presoj in ocenjevanj, izvajanje ali zahteva nekaterih preskusov, da se preveri pravilno delovanje sistema vodenja kakovosti in se izvedejo nenapovedane presoje na kraju samem,
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,
kar zadeva vzorčenje pripomočkov, preverjanje, ali je izdelan pripomoček skladen s tehnično dokumentacijo; s temi zahtevami se določijo zadevna merila za vzorčenje in postopek preskušanja pred vzorčenjem,
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,
ocena in preverjanje, ali proizvajalec izpolnjuje zahteve iz ustreznih prilog.
draw up and keep up to date, for class IIa and class IIb 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.
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.
That plan shall ensure that all devices covered by the certificate are sampled over the period of validity of the certificate, and
Presoja sistema vodenja kakovosti
select and assign appropriately qualified and authorised personnel for conducting the individual audits.
Kot del ocenjevanja sistema vodenja kakovosti priglašeni organ pred presojo in v skladu s svojimi dokumentiranimi postopki:
The respective roles, responsibilities and authorities of the team members shall be clearly defined and documented.
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,
Based on the audit programme it has drawn up, the notified body shall, in accordance with its documented procedures:
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,
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,
za vsako presojo iz programa presoje jasno določi cilje, merila in obseg ter oblikuje načrt presoje, v katerem se ustrezno upoštevajo posebne zahteve za vpletene pripomočke, tehnologije in postopke,
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:
za pripomočke razreda IIa in razreda IIb oblikuje in posodablja načrt vzorčenja za oceno tehnične dokumentacije iz prilog II in III, v katerega so vključeni različni pripomočki, navedeni v proizvajalčevi vlogi.
design and development,
S tem načrtom se zagotovi, da se vsi pripomočki, na katere se certifikat nanaša, vzorčijo v obdobju veljavnosti certifikata, in
production and process controls,
izbere in imenuje ustrezno usposobljeno in pooblaščeno osebje za opravljanje posameznih presoj.
product documentation,
Posamezne vloge, odgovornosti in pooblastila članov skupine se jasno opredelijo in dokumentirajo.
purchasing controls including verification of purchased devices,
Priglašeni organ na podlagi oblikovanega programa presoje v skladu s svojimi dokumentiranimi postopki izvaja naslednje naloge:
corrective and preventive actions, including for post-market surveillance, and
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 ugotovi, ali so zahteve iz te uredbe izpolnjene,
PMCF,
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:
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.
zasnovo in razvoj,
The documentation shall be sampled in such 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,
kontrole izdelave in postopka,
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,
dokumentacijo o izdelku,
conduct assessments of the technical documentation based on its sampling plan and taking account of Sections 4.5.4. and 4.5.5. for pre-clinical and clinical evaluations, and
kontrole nakupa, vključno s preverjanjem kupljenih pripomočkov,
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.
korektivne in preventivne ukrepe, vključno z nadzorom po dajanju na trg, in
Product verification
klinično spremljanje po dajanju na trg
Assessment of the technical documentation
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.
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:
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 allocation of appropriately qualified and authorised personnel for the examination of individual aspects such as use of the device, biocompatibility, clinical evaluation, risk management, and sterilisation, and
če še ni zajeta 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 assessment of conformity of the design with this Regulation, and for taking account of Sections 4.5.4. to 4.5.6.
ocene tehnične dokumentacije na podlagi njegovega načrta vzorčenja ter ob upoštevanju oddelkov 4.5.4. in 4.5.5. za predklinične in klinične ocene ter
That assessment shall include examination of the implementation by manufacturers of incoming, in-process and final checks and the results thereof.
priglašeni organ zagotovi, da se ugotovitve presoje ustrezno in dosledno razvrstijo v skladu z zahtevami iz te uredbe in ustreznimi standardi ali dokumenti o najboljših praksah, ki jih je pripravila ali sprejela Koordinacijska skupina za medicinske pripomočke.
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.
Preverjanje proizvoda
Type-examinations
Ocenjevanje tehnične dokumentacije
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:
Priglašeni organi imajo za ocenjevanje tehnične dokumentacije, opravljeno v skladu s poglavjem II Priloge IX, dovolj strokovnega znanja, zmogljivosti in dokumentirane postopke za:
examine and assess the technical documentation taking account of Sections 4.5.4. to 4.5.6., and verify that the type has been manufactured in conformity with that documentation;
dodelitev ustrezno usposobljenega in pooblaščenega osebja za obravnavo posameznih vidikov, kot so uporaba pripomočka, biokompatibilnost, klinična ocena, obvladovanje tveganj in sterilizacija, ter
establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility;
ocenjevanje skladnosti zasnove s to uredbo ob upoštevanju oddelkov od 4.5.4. do 4.5.6.
document its rationale for the selection of those parameters;
To ocenjevanje vključuje pregled izvajanja in rezultatov prihodnjih, tekočih in končnih pregledov s strani proizvajalcev.
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;
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.
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; and
Pregledi tipa
assume full responsibility for test results.
Priglašeni organ ima vzpostavljene dokumentirane postopke, dovolj strokovnega znanja in zmogljivosti za pregled tipa pripomočkov v skladu s Prilogo X, vključno z zmogljivostjo za:
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.
pregled in oceno tehnične dokumentacije, ob upoštevanju oddelkov 4.5.4. do 4.5.6., ter preverjanje, ali je bil tip izdelan v skladu s to dokumentacijo;