natgillin/translations-raw huggingface dataset:
The qualification criteria referred to in Section 3.2.1 shall refer to the scope of a notified body's designation in accordance with the scope description used by the Member State for the notification referred to in Article 42(3), providing a sufficient level of detail for the required qualification within the subdivisions of the scope description.
Priglašeni organ zagotovi, da osebje, vključeno v dejavnosti ugotavljanja skladnosti, ohrani svoje kvalifikacije in strokovno znanje, ter v ta namen uvede sistem za izmenjavo izkušenj in program stalnega usposabljanja in izobraževanja.
Specific qualification criteria shall be defined at least for the assessment of:
Priglašeni organ jasno dokumentira obseg in omejitve dolžnosti in pristojnosti ter raven pooblastil osebja, vključno z morebitnimi podizvajalci in zunanjimi strokovnjaki, vključenimi v dejavnosti ugotavljanja skladnosti, ter zadevno osebje ustrezno obvesti o tem.
the pre-clinical evaluation,
Merila glede kvalifikacij osebja
clinical evaluation,
Priglašeni organ vzpostavi in dokumentira merila glede kvalifikacij ter postopke za izbiro in odobritev oseb, vključenih v dejavnosti ugotavljanja skladnosti, vključno v zvezi z znanjem, izkušnjami in drugimi potrebnimi kompetencami, ter potrebno začetno in tekoče usposabljanje.
tissues and cells of human and animal origin,
Merila glede kvalifikacij se nanašajo na različne funkcije v postopku ugotavljanja skladnosti, kot so presoje, ocenjevanje ali preskusi izdelkov, pregled tehnične dokumentacije in odločanje, pa tudi na pripomočke, tehnologije in področja, kot so biokompatibilnost, sterilizacija, tkiva in celice človeškega in živalskega izvora ter klinično ocenjevanje, za katera je priglašeni organ imenovan.
functional safety,
Merila glede kvalifikacij iz oddelka 3.2.1. se nanašajo na področje uporabe imenovanja priglašenega organa v skladu z opisom področja uporabe, ki ga države članice uporabljajo za priglasitev iz člena 42(3), pri čemer je v podrazdelkih opisa področja uporabe zagotovljenih dovolj podrobnosti za zahtevane kvalifikacije.
software,
Posebna merila glede kvalifikacij se določijo vsaj za vrednotenje:
packaging,
predklinične ocene,
devices that incorporate as an integral part a medicinal product,
klinične ocene,
devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body and
tkiv in celic človeškega in živalskega izvora,
the different types of sterilisation processes.
funkcionalne varnosti,
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.
programske opreme,
They shall have proven knowledge and experience in all of the following:
embalaže,
Union devices legislation and relevant guidance documents;
pripomočkov, ki kot sestavni del vsebujejo zdravilo,
the conformity assessment procedures provided for in this Regulation;
pripomočkov, ki so sestavljeni iz snovi ali kombinacij snovi, ki jih človeško telo absorbira ali se lokalno razpršijo po človeškem telesu, in
a broad base of knowledge of device technologies and the design and manufacture of devices;
različnih vrst postopkov sterilizacije.
the notified body's quality management system, related procedures and the required qualification criteria;
Osebje, pristojno za določanje meril glede kvalifikacij in pooblastitev drugega osebja za opravljanje posebnih dejavnosti ugotavljanja skladnosti, so uslužbenci samega priglašenega organa ter niso zunanji strokovnjaki ali podizvajalci.
training relevant to personnel involved in conformity assessment activities in relation to devices;
Ima dokazano znanje in izkušnje z vseh naslednjih področij:
adequate experience in conformity assessments under this Regulation or previously applicable law within a notified body.
zakonodaja Unije o pripomočkih in ustrezne smernice;
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.
postopki ugotavljanja skladnosti, določeni v tej uredbi;
Such personnel shall be integrated throughout the notified body's assessment and decision-making process in order to:
širok spekter znanja o tehnologijah pripomočkov ter zasnovi in izdelavi pripomočkov;
identify when specialist input is required for the assessment of the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts;
sistem priglašenega organa za vodenje kakovosti, s tem povezani postopki in merila glede potrebnih kvalifikacij;
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;
usposabljanje osebja, ki je vključeno v dejavnosti ugotavljanja skladnosti v zvezi s pripomočki;
be able to review and scientifically challenge the clinical data contained within the clinical evaluation, and any associated clinical investigations, and appropriately guide external clinical experts in the assessment of the clinical evaluation presented by the manufacturer;
ustrezne izkušnje v priglašenem organu na področju ugotavljanja skladnosti v skladu s to uredbo ali prej veljavnim pravom.
be able to scientifically evaluate and, if necessary, challenge the clinical evaluation presented, and the results of the external clinical experts' assessment of the manufacturer's clinical evaluation;
Priglašeni organ ima stalno na voljo osebje z ustreznim kliničnim strokovnim znanjem, ki ga po možnosti zaposluje priglašeni organ sam.
be able to ascertain the comparability and consistency of the assessments of clinical evaluations conducted by clinical experts;
Takšno osebje je vključeno v celotni postopek ocenjevanja in odločanja priglašenega organa, da je mogoče:
be able to make an assessment of the manufacturer's clinical 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
ugotoviti, kdaj je potrebno strokovno mnenje za vrednotenje klinične ocene, ki jo izvede proizvajalec, in opredeliti ustrezno usposobljene strokovnjake;
be able to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
ustrezno usposobiti zunanje klinične strokovnjake v zvezi z ustreznimi zahtevami iz te uredbe, skupnimi specifikacijami, smernicami in harmoniziranimi standardi, ter zagotoviti, da se zunanji klinični strokovnjaki v celoti zavedajo konteksta in posledic njihovega ugotavljanja skladnosti in danih nasvetov;
The personnel responsible for carrying out product-related reviews (product reviewers), such as technical documentation reviews or type examination, including aspects such as clinical evaluation, biological safety, sterilisation and software validation, shall have all of the following proven qualifications:
pregledati in znanstveno izpodbijati klinične podatke iz klinične ocene in morebitnih z njo povezanih kliničnih raziskav ter ustrezno usmerjati zunanje klinične strokovnjake pri vrednotenju klinične ocene, ki jo predstavi proizvajalec;
successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, pharmacy, engineering or other relevant sciences;
znanstveno oceniti in po potrebi izpodbijati predstavljeno klinično oceno in rezultate preučitve klinične ocene proizvajalca s strani zunanjih kliničnih strokovnjakov;
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 the device or technology to be assessed or related to the scientific aspects to be assessed;
ugotoviti primerljivost in doslednost ocenjevanj kliničnih ocen, ki jih izvajajo klinični strokovnjaki;
knowledge of device legislation, including the general safety and performance requirements set out in Annex I;
oceniti klinično oceno proizvajalca in klinično presojo mnenja zunanjega strokovnjaka ter predložiti priporočilo nosilcu odločanja priglašenega organa ter
appropriate knowledge and experience of relevant harmonised standards, CS and guidance documents;
pripraviti evidence in poročila, ki dokazujejo, da so bile zadevne dejavnosti ugotavljanja skladnosti ustrezno izvedene.
appropriate knowledge and experience of risk management and related device standards and guidance documents;
Osebje, pristojno za izvajanje pregledov v zvezi z izdelki (pregledovalci izdelka), kot so pregledi tehnične dokumentacije ali pregled tipa, vključno z vidiki, kot so klinično ocenjevanje, biološka varnost, sterilizacija in potrjevanje programske opreme, ima vse naslednje dokazane kvalifikacije:
appropriate knowledge and experience of clinical evaluation;
univerzitetna izobrazba ali višja strokovna šola ali enakovredna kvalifikacija na ustreznem študijskem področju, npr. medicina, farmacija, inženirstvo ali druge ustrezne znanosti;
appropriate knowledge of the devices which they are assessing;
štiri leta poklicnih izkušenj na področju zdravstvenih izdelkov ali povezanih dejavnosti, kot so izdelava, presoje ali raziskave, od tega dve leti iz snovanja, izdelave, preskušanja ali uporabe pripomočkov ali tehnologije, katerih skladnost je treba ugotoviti ali ki so povezani z znanstvenimi vidiki, katerih skladnost je treba ugotoviti;
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;
poznavanje zakonodaje o pripomočkih, vključno s splošnimi zahtevami glede varnosti in učinkovitosti iz Priloge I;
the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
ustrezno znanje in izkušnje s področja zadevnih harmoniziranih standardov, skupnih specifikacij in smernic;
The personnel responsible for carrying out audits of the manufacturer's quality management system (site auditors) shall have all of the following proven qualifications:
ustrezno znanje in izkušnje s področja obvladovanja tveganj ter povezanih standardov in smernic za pripomočke;
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;
ustrezno znanje in izkušnje iz kliničnega ocenjevanja;
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;
ustrezno poznavanje pripomočkov, ki jih ocenjujejo;
appropriate knowledge of devices legislation as well as related harmonised standards, CS and guidance documents;
ustrezno znanje in izkušnje s področja postopkov ugotavljanja skladnosti iz prilog IX do XI, zlasti za vidike tistih postopkov, za katere je odgovorno, in ustrezna pooblastila za izvajanje tega ugotavljanja skladnosti;
appropriate knowledge of quality management systems and related standards and guidance documents;
znanje za pripravo evidenc in poročil, ki dokazujejo, da so bile zadevne dejavnosti ugotavljanja skladnosti ustrezno izvedene.
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;
Osebje, pristojno za izvajanje presoj proizvajalčevega sistema vodenja kakovosti (presojevalci na kraju samem), ima vse naslednje dokazane kvalifikacije:
training in auditing techniques enabling them to challenge quality management systems;
univerzitetna izobrazba ali višja strokovna šola ali enakovredna kvalifikacija na ustreznem študijskem področju, kot so medicina, farmacija, inženirstvo ali druge ustrezne znanosti;
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.
štiri leta poklicnih izkušenj na področju zdravstvenih izdelkov ali povezanih dejavnosti, kot so izdelava, presoje ali raziskave, od tega dve leti na področju vodenja kakovosti;
Those personnel shall, as a group, have proven knowledge and comprehensive experience of all of the following:
ustrezno poznavanje zakonodaje o pripomočkih ter zadevnih harmoniziranih standardov, skupnih specifikacij in smernic;
devices legislation and relevant guidance documents;
ustrezno znanje s področja sistemov vodenja kakovosti ter zadevnih standardov in smernic;
the device conformity assessments relevant to this Regulation;
ustrezno znanje in izkušnje s področja postopkov ugotavljanja skladnosti iz prilog IX do XI, zlasti za vidike tistih postopkov, za katere je odgovorno, in ustrezna pooblastila za izvajanje navedenih presoj;
the types of qualifications, experience and expertise relevant to device conformity assessment;
usposabljanje na področju metod presoje, ki mu omogoča, da izpodbija sisteme vodenja kakovosti;
a broad base of knowledge of device technologies, including sufficient experience of conformity assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices;
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's quality management system, related procedures and the required qualifications for personnel involved;
To osebje ima kot skupina dokazano znanje in številne izkušnje z vseh naslednjih področij:
the ability to draw up records and reports demonstrating that the conformity assessment activities have been appropriately carried out.
zakonodaja o pripomočkih in ustrezne smernice;
Documentation of qualification, training and authorisation of personnel
ugotavljanje skladnosti pripomočkov, ki ga ureja ta uredba;
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.
vrste kvalifikacij, izkušnje in strokovno znanje, ki so pomembni za ugotavljanje skladnosti pripomočkov;
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.
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;
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:
sistem priglašenega organa za vodenje kakovosti, s tem povezani postopki in potrebne kvalifikacije za vpleteno osebje;
a matrix detailing the authorisations and responsibilities of the personnel in respect of conformity assessment activities; and
znanje za pripravo evidenc in poročil, ki dokazujejo, da so bile dejavnosti ugotavljanja skladnosti ustrezno izvedene.
records attesting to the required knowledge and experience for the conformity assessment activity for which they are authorised.
Dokumentacija o kvalifikacijah, usposabljanju in pooblaščanju osebja
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 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.
Subcontractors and external experts
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.
Notified bodies may, without prejudice to Section 3.2, subcontract certain clearly defined component parts of a conformity assessment activity.
Priglašeni organ za vse svoje osebje iz oddelkov 3.2.3. do 3.2.7. vzpostavi in posodablja:
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.
matriko s podrobnostmi o dovoljenjih in odgovornostih osebja v zvezi z dejavnostmi ugotavljanja skladnosti in
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.
evidence, ki dokazujejo zahtevano znanje in izkušnje za dejavnosti ugotavljanja skladnosti, za katere je osebje pooblaščeno.
The following activities may not be subcontracted by notified bodies:
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.
review of the qualifications and monitoring of the performance of external experts;
Podizvajalci in zunanji strokovnjaki
auditing and certification activities where the subcontracting in question is to auditing or certification organisations;
Priglašeni organi lahko brez poseganja v oddelek 3.2. za izvajanje določenih jasno opredeljenih delov dejavnosti ugotavljanja skladnosti sklenejo pogodbe s podizvajalci.
allocation of work to external experts for specific conformity assessment activities; and
Sklepanje pogodb s podizvajalci za presojo sistemov upravljanja 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.
final review and decision making functions.
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.
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:
Naslednjih dejavnosti priglašeni organi ne smejo oddati v podizvajanje:
the subcontractor meets the relevant requirements of this Annex;
pregled kvalifikacij in spremljanje dela zunanjih strokovnjakov;
subcontractors and external experts do not further subcontract work to organisations or personnel; and
dejavnosti presoje in certificiranja, če se zadevne podizvajalske pogodbe sklepajo z organizacijami za presojo ali organizacijami za certificiranje;
the natural or legal person that applied for conformity assessment has been informed of the requirements referred to in the first and second indent.
dodeljevanje dela zunanjim strokovnjakom za posebne dejavnosti ugotavljanja skladnosti in
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.
končni pregled in funkcije na ravni odločanja.
The notified body in question shall take full responsibility for the tasks performed by subcontractors.
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:
Where subcontractors or external experts are used in the context of a conformity assessment, in particular regarding novel, invasive and implantable devices or technologies, the notified body in question shall have 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.
podizvajalec izpolnjuje ustrezne zahteve iz te priloge;
Monitoring of competences, training and exchange of experience
podizvajalci in zunanji strokovnjaki nadalje ne oddajajo del organizacijam ali osebju in
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.
je bila fizična ali pravna oseba, ki je oddala vlogo za ugotavljanje skladnosti, obveščena o zahtevah iz prve in druge alineje.
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.
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.
That review shall at a minimum, verify that personnel:
Zadevni priglašeni organ prevzame polno odgovornost za naloge, ki jih opravijo podizvajalci.
are aware of 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; and
Kadar podizvajalci ali zunanji strokovnjaki sodelujejo pri ugotavljanju skladnosti, zlasti glede novih in invazivnih pripomočkov ali tehnologij ter pripomočkov ali tehnologij za vsaditev, ima zadevni priglašeni organ 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.
take part in the internal exchange of experience and the continuous training and education programme referred to in Section 3.1.2.
Spremljanje kompetenc, usposabljanje in izmenjava izkušenj
PROCESS REQUIREMENTS
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.
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.
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.
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.
Pri tem pregledu se preveri vsaj, ali (je) osebje: