natgillin/translations-raw huggingface dataset:
The notified body shall have sufficient internal competence to critically evaluate assessments conducted by external expertise.
ustrezno poznavanje zakonodaje o pripomočkih ter zadevnih harmoniziranih standardov, skupnih specifikacij in smernic;
Tasks which a notified body is precluded from subcontracting are set out in Section 4.1.
ustrezno znanje s področja sistemov vodenja kakovosti ter povezanih standardov in smernic za pripomočke;
Personnel involved in the management of the operation of a notified body's conformity assessment activities for devices shall have appropriate knowledge to set up and operate a system for the selection of assessment and verification staff, for verification of their competence, for authorisation and allocation of their tasks, for organisation of their initial and ongoing training, and for their assignment of their duties and monitoring of those staff, in order to ensure that personnel who carry out and perform assessment and verification operations are competent to fulfil the tasks required of them.
ustrezno znanje in izkušnje s področja postopkov ugotavljanja skladnosti iz prilog od IX do XI, zlasti za vidike tistih postopkov, za katere je odgovorno, in ustrezna pooblastila za izvajanje navedenih presoj;
The notified body shall identify at least one individual within its top-level management as having overall responsibility for all conformity assessment activities in relation to devices.
usposabljanje na področju metod presoje, ki mu omogoča, da izpodbija sisteme vodenja kakovosti;
The notified body shall ensure that personnel involved in conformity assessment activities maintain their qualification and expertise by implementing a system for exchange of experience and a continuous training and education programme.
Osebje s splošno pristojnostjo za končne preglede in odločanje glede certificiranja so uslužbenci samega priglašenega organa in niso zunanji strokovnjaki ali podizvajalci.
The notified body shall clearly document the extent and limits of duties and responsibilities and the level of authorisation of to the personnel, including any subcontractors and external experts involved in conformity assessment activities and inform those personnel accordingly.
To osebje ima kot skupina dokazano znanje in številne izkušnje z vseh naslednjih področij:
Qualification criteria in relation to personnel
zakonodaja o pripomočkih in ustrezne smernice;
The notified body shall establish and document qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities, including as regards knowledge, experience and other competence required, and the required initial and ongoing training.
ugotavljanje skladnosti pripomočkov, ki ga ureja ta uredba;
The qualification criteria shall address the various functions within the conformity assessment process, such as auditing, product evaluation or testing, technical documentation review, decision-making, and batch release, as well as the devices, technologies and areas, such as biocompatibility, sterilisation, self and near patient-testing, companion diagnostics and performance evaluation, covered by the scope of designation.
vrste kvalifikacij, izkušnje in strokovno znanje, ki so pomembni za ugotavljanje skladnosti pripomočkov;
The qualification criteria referred to in Section 3.2.1 shall refer to the scope of the notified body's designation in accordance with the scope description used by the Member State for the notification referred to in Article 38(3), providing a sufficient level of detail for the required qualification within the subdivisions of the scope description.
širok spekter znanja o tehnologijah pripomočkov, vključno z zadostnimi izkušnjami z ugotavljanjem skladnosti pripomočkov, ki se pregledujejo za certificiranje, industrijo pripomočkov ter zasnovo in izdelavo pripomočkov;
Specific qualification criteria shall be defined at least for the assessment of:
sistem priglašenega organa za vodenje kakovosti, s tem povezani postopki in potrebne kvalifikacije za vpleteno osebje;
biological safety,
znanje za pripravo evidenc in poročil, ki dokazujejo, da so bile dejavnosti ugotavljanja skladnosti ustrezno izvedene.
performance evaluation,
Dokumentacija o kvalifikacijah, usposabljanju in pooblaščanju osebja
devices for self and near patient testing,
Priglašeni organ ima vzpostavljen postopek za popolno dokumentiranje kvalifikacij vsakega člana osebja, ki je vključen v dejavnosti ugotavljanja skladnosti in izpolnjevanje meril glede kvalifikacij iz oddelka 3.2.
companion diagnostics,
Kadar v izjemnih okoliščinah izpolnjevanja meril glede kvalifikacij iz oddelka 3.2. ni mogoče v celoti dokazati, priglašeni organ organu, pristojnemu za priglašene organe, utemelji pooblastitev teh članov osebja za izvajanje posebnih dejavnosti ugotavljanja skladnosti.
functional safety,
Priglašeni organ za vse svoje osebje iz oddelkov 3.2.3. do 3.2.7. vzpostavi in posodablja:
software,
matriko s podrobnostmi o dovoljenjih in odgovornostih osebja v zvezi z dejavnostmi ugotavljanja skladnosti; in
packaging, and
evidence, ki dokazujejo zahtevano znanje in izkušnje za dejavnosti ugotavljanja skladnosti, za katere je osebje pooblaščeno.
the different types of sterilisation processes.
Evidence vsebujejo utemeljitev za določitev obsega odgovornosti za vse člane osebja za izvajanje ugotavljanja skladnosti in evidence o izvedenih dejavnostih ugotavljanja skladnosti vsakega člana posebej.
The personnel responsible for establishing qualification criteria and for authorising other personnel to perform specific conformity assessment activities shall be employed by the notified body itself and shall not be external experts or subcontracted.
Podizvajalci in zunanji strokovnjaki
They shall have proven knowledge and experience in all of the following:
Priglašeni organi lahko brez poseganja v oddelek 3.2. za izvajanje določenih jasno opredeljenih delov dejavnosti ugotavljanja skladnosti sklenejo pogodbe s podizvajalci.
Union devices legislation and relevant guidance documents;
Sklepanje pogodb s podizvajalci za presojo sistemov vodenja kakovosti ali preglede v zvezi z izdelki kot celote ni dovoljeno, vendar lahko dele teh dejavnosti izvedejo podizvajalci ter zunanji presojevalci in strokovnjaki, ki delujejo v imenu priglašenega organa.
the conformity assessment procedures provided for in this Regulation;
Zadevni priglašeni organ je še naprej v celoti odgovoren za predložitev ustreznega dokazila o usposobljenosti podizvajalcev in strokovnjakov za izpolnjevanje njihovih specifičnih nalog, za sprejemanje odločitev na podlagi ocenjevanja podizvajalca ter za delo, ki ga opravljajo podizvajalci in strokovnjaki v njegovem imenu.
a broad base of knowledge of device technologies and the design and manufacture of devices;
Naslednjih dejavnosti priglašeni organi ne smejo oddati v podizvajanje:
the notified body's quality management system, related procedures and the required qualification criteria;
pregled kvalifikacij in spremljanje dela zunanjih strokovnjakov;
training relevant to personnel involved in conformity assessment activities in relation to devices;
dejavnosti presoje in certificiranja, če se zadevne podizvajalske pogodbe sklepajo z organizacijami za presojo ali organizacijami za certificiranje;
adequate experience in conformity assessments under this Regulation or previously applicable law within a notified body.
dodeljevanje dela zunanjim strokovnjakom za posebne dejavnosti ugotavljanja skladnosti;
The notified body shall have permanent availability of personnel with relevant clinical expertise and where possible such personnel shall be employed by the notified body itself.
končni pregled in funkcije na ravni odločanja.
Such personnel shall be integrated throughout the notified body's assessment and decision-making process in order to:
Kadar priglašeni organ za določene dejavnosti ugotavljanja skladnosti sklene podizvajalsko pogodbo z organizacijo ali posameznikom, ima vzpostavljeno politiko, ki določa pogoje, pod katerimi lahko poteka oddajanje del podizvajalcem, in zagotovi, da:
identify when specialist input is required for the assessment of the performance evaluation conducted by the manufacturer and identify appropriately qualified experts;
podizvajalec izpolnjuje ustrezne zahteve iz te priloge;
appropriately train external clinical experts in the relevant requirements of this Regulation, CS, guidance and harmonised standards and ensure that the external clinical experts are fully aware of the context and implications of their assessment and the advice they provide;
podizvajalci in zunanji strokovnjaki nadalje ne oddajajo del organizacijam ali osebju;
be able to review and scientifically challenge the clinical data contained within the performance evaluation, and any associated performance study, and appropriately guide external clinical experts in the assessment of the performance evaluation presented by the manufacturer;
je bila fizična ali pravna oseba, ki je oddala vlogo za ugotavljanje skladnosti, obveščena o zahtevah iz prve in druge alineje.
be able to scientifically evaluate and, if necessary, challenge the performance evaluation presented, and the results of the external clinical experts' assessment of the manufacturer's performance evaluation;
Vsako podizvajanje ali posvetovanje z zunanjim osebjem se ustrezno dokumentira, ne vključuje posrednikov in je predmet pisnega sporazuma, ki med drugim zajema zaupnost in nasprotja interesov.
be able to ascertain the comparability and consistency of the assessments of performance evaluation conducted by clinical experts;
Zadevni priglašeni organ prevzame polno odgovornost za naloge, ki jih opravijo podizvajalci.
be able to make an assessment of the manufacturer's performance evaluation and a clinical judgement of the opinion provided by any external expert and make a recommendation to the notified body's decision maker; and
Kadar podizvajalci ali zunanji strokovnjaki sodelujejo pri ugotavljanju skladnosti, zlasti glede novih pripomočkov ali tehnologij, ima zadevni priglašeni organ ustrezne notranje pristojnosti na vsakem področju v zvezi z izdelkom, za katerega je imenovan, ki so ustrezne za namene vodenja splošnega ugotavljanja skladnosti, preverjanja ustreznosti in veljavnosti strokovnih mnenj ter sprejemanja odločitev o certificiranju.
be able to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
Spremljanje kompetenc, usposabljanje in izmenjava izkušenj
The personnel responsible for carrying out product-related reviews, (product reviewers), such as technical documentation reviews or type examination, including aspects such as performance evaluation, biological safety, sterilisation and software validation, shall have all the following proven qualifications:
Priglašeni organ vzpostavi postopke za začetno oceno in stalno spremljanje kompetenc, dejavnosti ugotavljanja skladnosti in dela celotnega notranjega in zunanjega osebja in podizvajalcev, vključenih v dejavnosti ugotavljanja skladnosti.
successful completion of a university or a technical college degree or an equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences;
Priglašeni organi redno pregledujejo kompetence svojega osebja, opredeljujejo potrebe po usposabljanju in pripravljajo načrt usposabljanja, da se ohranja zahtevana raven kvalifikacij in znanja posameznih članov osebja.
four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing or use of devices or technology to be assessed or related to the scientific aspects to be assessed;
Pri tem pregledu se preveri vsaj, ali (je) osebje:
knowledge of device legislation, including the general safety and performance requirements set out in Annex I;
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.;
appropriate knowledge and experience of relevant harmonised standards, CS and guidance documents;
sodeluje pri notranji izmenjavi izkušenj ter v programu stalnega usposabljanja in izobraževanja iz oddelka 3.1.2.
appropriate knowledge and experience of risk management and related device standards and guidance documents;
ZAHTEVE GLEDE POSTOPKA
appropriate knowledge and experience of performance evaluation;
Priglašeni organ za izvajanje vsake dejavnosti ugotavljanja skladnosti, za katero je imenovani, 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.
appropriate knowledge of the devices which they are assessing;
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.
appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those assessments;
Navedbe priglašenega organa in dejavnosti pred oddajo vloge
the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
Priglašeni organ:
The personnel responsible for carrying out audits of the manufacturer's quality management system (site auditors) shall have all of the following proven qualifications:
objavi javno dostopen opis postopka za oddajo vloge, po katerem lahko proizvajalci od njega pridobijo certifikacijo.
successful completion of a university or a technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences;
V tem opisu je določeno, kateri jeziki so sprejemljivi za predložitev dokumentacije in s tem povezano korespondenco;
four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the area of quality management;
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;
appropriate knowledge of devices legislation as well as related harmonised standards, CS and guidance documents;
ima dokumentirane postopke v zvezi z oglaševanjem svojih storitev ugotavljanja skladnosti.
appropriate knowledge of quality management systems and related l devices standards and guidance documents;
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;
appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those audits;
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;
training in auditing techniques enabling them to challenge quality management systems;
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 personnel with overall responsibility for final reviews and decision-making on certification shall be employed by the notified body itself and shall not be external experts or be subcontracted.
Pregled vloge in pogodbene zahteve
Those personnel, as a group, shall have proven knowledge and comprehensive experience of all of the following:
Priglašeni organi 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 IX do XI.
devices legislation and relevant guidance documents;
Pogodba med priglašenim organom in proizvajalcem ima obliko pisnega dogovora, ki ga podpišeta obe strani.
device conformity assessments relevant to this Regulation;
Hrani jo priglašeni organ.
the types of qualifications, experience and expertise relevant to device conformity assessment;
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.
a broad base of knowledge of device technologies, including sufficient experience of the conformity assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices;
Priglašeni organ ima vzpostavljene dokumentirane postopke za pregled vlog, ki se nanašajo na:
the notified body's quality system, related procedures and the required qualifications for personnel involved;
popolnost navedenih vlog v zvezi z zahtevami zadevnega postopka ugotavljanja skladnosti iz ustrezne priloge, na podlagi katere se zaproša za odobritev,
the ability to draw up records and reports demonstrating that the conformity assessment activities have been appropriately carried out.
preverjanje opredelitve izdelkov, na katere se vloge nanašajo, kot pripomočkov in njihovih razvrstitev,
Documentation of qualification, training and authorisation of personnel
ali se postopki ugotavljanja skladnosti, ki jih izbere vložnik, uporabljajo za zadevni pripomoček v skladu s to uredbo,
The notified body shall have a procedure in place to fully document the qualification of each member of personnel involved in conformity assessment activities and the satisfaction of the qualification criteria referred to in Section 3.2.
zmožnost priglašenega organa za ocenjevanje vloge na podlagi njegovega imenovanja ter
Where, in exceptional circumstances, the fulfilment of the qualification criteria set out in Section 3.2 cannot be fully demonstrated, the notified body shall justify to the authority responsible for notified bodies the authorisation of those members of personnel to carry out specific conformity assessment activities.
razpoložljivost zadostnih in ustreznih sredstev.
For all of its personnel referred to in Sections 3.2.3 to 3.2.7, the notified body shall establish and maintain up to date:
Rezultati vsakega pregleda vloge se dokumentirajo.
a matrix detailing the authorisations and responsibilities of the personnel in respect of conformity assessment activities;
O zavrnitvah ali umikih vlog se uradno obvesti elektronski sistem iz člena 52, te informacije pa so na voljo tudi drugim priglašenim organom.
records attesting to the required knowledge and experience for the conformity assessment activity for which they are authorised.
Dodeljevanje sredstev
The records shall contain a rationale for defining the scope of the responsibilities for each of the assessment personnel and records of the conformity assessment activities carried out by each of them.
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.
Subcontractors and external experts
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.
Notified bodies may, without prejudice to Section 3.2, subcontract certain clearly defined component parts of a conformity assessment activity.
Dodelitev nalog, ki jih je treba izvesti kot del ugotavljanja skladnosti, in naknadne spremembe te dodelitve se dokumentirajo.
The subcontracting of the auditing of quality management systems or of product-related reviews as a whole shall not be permitted, nevertheless parts of those activities may be conducted by subcontractors and external auditors and experts working on behalf of the notified body.
Dejavnosti ugotavljanja skladnosti
The notified body in question shall retain full responsibility for being able to produce appropriate evidence of the competence of subcontractors and experts to fulfil their specific tasks, for making a decision based on a subcontractor's assessment and for the work conducted by subcontractors and experts on its behalf.
Priglašeni organ in njegovo osebje izvajajo dejavnosti ugotavljanja skladnosti z najvišjo stopnjo profesionalne integritete ter potrebnimi tehničnimi in znanstvenimi kompetencami na posameznih področjih.
The following activities may not be subcontracted by notified bodies:
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 ter zlasti naslednje zahteve:
review of the qualifications and monitoring of the performance of external experts;
ustrezno načrtovanje izvedbe vsakega posameznega projekta,
auditing and certification activities where the subcontracting in question is to auditing or certification organisations;
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,
allocation of work to external experts for specific conformity assessment activities;
obrazložitev razlogov za določitev časovne omejitve za dokončanje dejavnosti ugotavljanja skladnosti,
final review and decision-making functions.
ocena tehnične dokumentacije proizvajalca in rešitev, sprejetih za izpolnitev zahtev iz Priloge I,
Where a notified body subcontracts certain conformity assessment activities either to an organisation or an individual, it shall have a policy describing the conditions under which subcontracting may take place, and shall ensure that:
preverjanje proizvajalčevih postopkov in dokumentacije v zvezi z oceno učinkovitosti;
the subcontractor meets the relevant requirements of this Annex;
obravnava povezave med postopkom obvladovanja tveganj proizvajalca ter njegovo oceno in analizo ocene učinkovitosti ter vrednotenje njihovega pomena za dokazovanje skladnosti z ustreznimi zahtevami iz Priloge I,
subcontractors and external experts do not further subcontract work to organisations or personnel;
izvedba „posebnih postopkov“ iz oddelka 5 Priloge IX,
the natural or legal person that applied for conformity assessment has been informed of the requirements referred to in the first and second indent.
v primeru pripomočkov razreda B ali C ocena tehnične dokumentacije pripomočkov, izbranih na reprezentativni podlagi,
Any subcontracting or consultation of external personnel shall be properly documented, shall not involve any intermediaries, and shall be subject to a written agreement covering, among other things, confidentiality and conflicts of interest.
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,