natgillin/translations-raw huggingface dataset:
Such documentation shall include information about ownership and the legal or natural persons exercising control over the notified body.
Finančne zahteve
If the notified body is a legal entity that is part of a larger organisation, the activities of that organisation as well as its organisational structure and governance, and the relationship with the notified body shall be clearly documented.
Priglašeni organ ima na razpolago finančna sredstva, potrebna za izvajanje dejavnosti ugotavljanja skladnosti v okviru njegovega področja, za katero je imenovan, in z njimi povezanih poslovnih dejavnosti.
In such cases, the requirements of Section 1.2 are applicable to both the notified body and the organisation to which it belongs.
Dokumentira in predloži dokaze o svoji finančni zmogljivosti in dolgoročni ekonomski sposobnosti, ob upoštevanju, kjer je to ustrezno, posebnih okoliščin v začetni zagonski fazi.
If a notified body wholly or partly owns legal entities established in a Member State or in a third country or is owned by another legal entity, the activities and responsibilities of those entities, as well as their legal and operational relationships with the notified body, shall be clearly defined and documented.
Sodelovanje pri usklajevalnih dejavnostih
Personnel of those entities performing conformity assessment activities under this Regulation shall be subject to the applicable requirements of this Regulation.
Priglašeni organ sodeluje pri ustreznih dejavnostih standardizacije in dejavnostih koordinacijske skupine priglašenega organa iz člena 49 Uredbe (EU) 2017/745 ali zagotovi, da je njegovo osebje za ugotavljanje skladnosti o tem obveščeno, ter prav tako zagotovi, da je njegovo osebje za ugotavljanje skladnosti in odločanje obveščeno o vseh zadevnih zakonodajnih dokumentih, smernicah in dokumentih o najboljših praksah, ki so bili sprejeti v okviru te uredbe.
The organisational structure, allocation of responsibilities, reporting lines and operation of the notified body shall be such that they ensure that there is confidence in the performance by the notified body and in the results of the conformity assessment activities it conducts.
Priglašeni organ upošteva smernice in dokumente o najboljših praksah.
The notified body shall clearly document its organisational structure and the functions, responsibilities and authority of its top-level management and of other personnel who may have an influence upon the performance by the notified body upon the results of its conformity assessment activities.
ZAHTEVE GLEDE VODENJA KAKOVOSTI
The notified body shall identify the persons in top-level management that have overall authority and responsibility for each of the following:
Priglašeni organ vzpostavi, dokumentira, izvaja, vzdržuje in upravlja sistem vodenja kakovosti, ustrezen naravi, področju in obsegu njegovih dejavnosti ugotavljanja skladnosti ter je zmožen podpirati in dokazovati dosledno izpolnjevanje zahtev iz te uredbe.
provision of adequate resources for conformity assessment activities;
Sistem vodenja kakovosti priglašenega organa obravnava vsaj naslednje:
development of procedures and policies for the operation of the notified body;
strukturo in dokumentacijo sistema upravljanja, vključno s politikami in cilji za njegove dejavnosti;
supervision of implementation of the procedures, policies and quality management systems of the notified body;
politike za dodelitev dejavnosti in odgovornosti osebju;
supervision of the notified body's finances;
ocenjevanje in postopek odločanja v skladu z nalogami, odgovornostmi in vlogo osebja in najvišjega vodstva priglašenega organa;
activities and decisions taken by the notified body, including contractual agreements;
načrtovanje, izvajanje, ocenjevanje in po potrebi prilagajanje njegovih postopkov ugotavljanja skladnosti;
delegation of authority to personnel and/or committees, where necessary, for the performance of defined activities;
kontrola dokumentov;
interaction with the authority responsible for notified bodies and the obligations regarding communications with other competent authorities, the Commission and other notified bodies.
kontrola evidenc;
Independence and impartiality
vodstveni pregledi;
The notified body shall be a third-party body that is independent of the manufacturer of the device in relation to which it performs conformity assessment activities.
notranje presoje;
The notified body shall also be independent of any other economic operator having an interest in the device as well as of any competitors of the manufacturer.
korektivne in preventivne ukrepe;
This does not preclude the notified body from carrying out conformity assessment activities for competing manufacturers.
pritožbe;
The notified body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities.
nadaljnje usposabljanje.
The notified body shall document and implement a structure and procedures for safeguarding impartiality and for promoting and applying the principles of impartiality throughout its organisation, personnel and assessment activities.
Če se dokumenti uporabljajo v različnih jezikih, priglašeni organ zagotovi in preveri, da je njihova vsebina enaka.
Such procedures shall provide for the identification, investigation and resolution of any case in which a conflict of interest may arise including involvement in consultancy services in the field of devices prior to taking up employment with the notified body.
Najvišje vodstvo priglašenega organa zagotovi, da celotna organizacija priglašenega organa, vključno z odvisnimi družbami in podizvajalci, ki so udeleženi pri dejavnostih ugotavljanja skladnosti v skladu s to uredbo, v celoti razume, izvaja in vzdržuje sistem vodenja kakovosti.
The investigation, outcome and its resolution shall be documented.
Priglašeni organ od celotnega osebja zahteva, da se s podpisom ali na enakovreden način formalno zaveže k spoštovanju postopkov, ki jih določi priglašeni organ.
The notified body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not:
Pri tem so vključeni vidiki zaupnosti in neodvisnosti od gospodarskih in drugih interesov ter trenutna ali predhodna povezava s strankami.
be the designer, manufacturer, supplier, installer, purchaser, owner or maintainer of devices which they assess, nor the authorised representative of any of those parties.
Osebje mora izpolniti pisne izjave, ki potrjujejo njegovo spoštovanje načel zaupnosti, neodvisnosti in nepristranskosti.
Such restriction shall not preclude the purchase and use of assessed devices that are necessary for the operations of the notified body and the conduct of the conformity assessment, or the use of such devices for personal purposes;
ZAHTEVE GLEDE VIROV
be involved in the design, manufacture or construction, marketing, installation and use, or maintenance of the devices for which they are designated, nor represent the parties engaged in those activities;
Splošno
engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are designated;
Priglašeni organi so sposobni izvajati vse naloge, ki jim pripadajo v skladu s to uredbo, z najvišjo stopnjo profesionalne integritete in potrebnimi kompetencami na določenem področju, ne glede na to, ali navedene naloge izvaja priglašeni organ sam ali se izvajajo v njegovem imenu in pod njegovo odgovornostjo.
offer or provide any service which may jeopardise the confidence in their independence, impartiality or objectivity.
Priglašeni organi imajo zlasti zaposleno potrebno osebje, v posesti oziroma dostop pa imajo tudi do vse opreme, objektov in zmogljivosti, potrebnih za pravilno izvajanje tehničnih, znanstvenih in upravnih nalog, povezanih z dejavnostmi ugotavljanja skladnosti, za katere so imenovani.
In particular, they shall not offer or provide consultancy services to the manufacturer, its authorised representative, a supplier or a commercial competitor as regards the design, construction, marketing or maintenance of the devices or processes under assessment; and
Pri takšni zahtevi se predpostavlja, da ima priglašeni organ vedno in za vsak postopek ugotavljanja skladnosti ter za vsako vrsto pripomočkov, za katere je imenovan, stalno na voljo zadostno število administrativnega, tehničnega in znanstvenega osebja, ki ima dovolj izkušenj in znanja v zvezi z zadevnimi pripomočki in ustrezno tehnologijo.
be linked to any organisation which itself provides consultancy services as referred to in the point (d).
Takšnega osebja je dovolj, da lahko zadevni priglašeni organ opravlja naloge ugotavljanja skladnosti, vključno z ocenjevanjem medicinske funkcionalnosti, ocenami učinkovitosti ter učinkovitostjo in varnostjo pripomočkov, za katere je bil imenovan, ob upoštevanju zahtev iz te uredbe in zlasti tistih iz Priloge I.
Such restriction shall not preclude general training activities that are not client specific and that relate to regulation of devices s or to related standards.
Priglašeni organ ima takšne skupne pristojnosti, da lahko oceni vrste pripomočkov, za katere je imenovan.
Involvement in consultancy services in the field of devices prior to taking up employment with a notified body shall be fully documented at the time of employment, and potential conflicts of interests shall be monitored and resolved in accordance with this Annex.
Ima zadostne notranje pristojnosti za kritično oceno ocenjevanja, ki ga izvajajo zunanji strokovnjaki.
Personnel who were formerly employed by a specific client, or provided consultancy services in the field of devices to that specific client prior to taking up employment with a notified body, shall not be assigned for conformity assessment activities for that specific client or companies belonging to the same group for a period of three years.
Naloge, v zvezi s katerimi priglašeni organ ne more skleniti podizvajalske pogodbe, so navedene v oddelku 4.1.
The impartiality of notified bodies, of their top-level management and of the assessment personnel shall be guaranteed.
Osebje priglašenega organa, vključeno v vodenje njegovih dejavnosti ugotavljanja skladnosti za pripomočke, ima ustrezno znanje za vzpostavitev in upravljanje sistema za izbiro osebja za ocenjevanje in preverjanje, preverjanje njihovih kompetenc, izdajanje dovoljenj za njihove naloge in razporeditev teh nalog, organizacijo njihovega začetnega in nadaljnjega usposabljanja ter dodeljevanje njihovih nalog in spremljanje tega osebja, s čimer se zagotovi, da je osebje, ki izvaja in opravlja ocenjevanja in preverjanja, usposobljeno za opravljanje zahtevanih nalog.
The level of the remuneration of the top-level management and assessment personnel of a notified body and subcontractors involved in assessment activities shall not depend on the results of the assessments.
Priglašeni organ med svojim najvišjim vodstvom določi vsaj eno osebo, ki je v celoti odgovorna za vse dejavnosti ugotavljanja skladnosti pripomočkov.
Notified bodies shall make publicly available the declarations of interest of their top-level management.
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.
If a notified body is owned by a public entity or institution, independence and absence of any conflict of interests shall be ensured and documented between, on the one hand, the authority responsible for notified bodies and/or the competent authority and, on the other hand, the notified body.
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 notified body shall ensure and document that the activities of its subsidiaries or subcontractors or of any associated body, including the activities of its owners do not affect its independence, impartiality or the objectivity of its conformity assessment activities.
Merila glede kvalifikacij osebja
The notified body shall operate in accordance with a set of consistent, fair and reasonable terms and conditions, taking into account the interests of small and medium-sized enterprises as defined in Recommendation 2003/361/EC in relation to fees.
Priglašeni organ vzpostavi in dokumentirajo 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.
The requirements laid down in this Section shall in no way preclude exchanges of technical information and regulatory guidance between a notified body and a manufacturer applying for conformity assessment.
Merila glede kvalifikacij se nanašajo na različne funkcije v postopku ugotavljanja skladnosti, kot so presoje, ocenjevanje ali preskusi izdelkov, pregled tehnične dokumentacije,odločanje in sprostitev serij, pa tudi na pripomočke, tehnologije in področja, kot so biokompatibilnost, sterilizacija, samotestiranje in testiranje ob pacientu, dopolnilna diagnostika in ocena učinkovitosti, za katera so priglašeni organi imenovani.
The notified body shall have documented procedures in place ensuring that its personnel, committees, subsidiaries, subcontractors, and any associated body or personnel of external bodies respect the confidentiality of the information which comes into its possession during the performance of the conformity assessment activities, except when disclosure is required by law.
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 38(3), pri čemer je v podrazdelkih opisa področja uporabe zagotovljenih dovolj podrobnosti za zahtevane kvalifikacije.
The personnel of a notified body shall observe professional secrecy in carrying out their tasks under this Regulation or any provision of national law giving effect to it, except in relation to the authorities responsible for notified bodies, competent authorities for devices in the Member States or the Commission.
Posebna merila glede kvalifikacij se določijo vsaj za ocenjevanje:
Proprietary rights shall be protected.
biološke varnosti,
The notified body shall have documented procedures in place in respect of the requirement of this Section.
ocene učinkovitosti,
Liability
pripomočkov za samotestiranje in testiranje ob pacientu,
The notified body shall take out appropriate liability insurance for its conformity assessment activities, unless liability is assumed by the Member State in question in accordance with national law or that Member State is directly responsible for their conformity assessment.
dopolnilne diagnostike,
The scope and overall financial value of the liability insurance shall correspond to the level and geographic scope of activities of the notified body and be commensurate with the risk profile of the devices certified by the notified body.
funkcionalne varnosti,
The liability insurance shall cover cases where the notified body may be obliged to withdraw, restrict or suspend certificates.
programske opreme,
Financial requirements
pakiranja ter
The notified body shall have at its disposal the financial resources required to conduct its conformity assessment activities within its scope of designation and related business operations.
različnih vrst postopkov sterilizacije.
It shall document and provide evidence of its financial capacity and its long-term economic viability, taking into account, where relevant, any specific circumstances during an initial start-up phase.
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.
Participation in coordination activities
Ima dokazano znanje in izkušnje z vseh naslednjih področij:
The notified body shall participate in, or ensure that its assessment personnel is informed of any relevant standardisation activities and in the activities of the notified body coordination group referred to in Article 49 of Regulation (EU) 2017/745 and that its assessment and decision-making personnel are informed of all relevant legislation, guidance and best practice documents adopted in the framework of this Regulation.
zakonodaja Unije o pripomočkih in ustrezne smernice;
The notified body shall take into consideration guidance and best practice documents.
postopki ugotavljanja skladnosti, določeni v tej uredbi;
QUALITY MANAGEMENT REQUIREMENTS
širok spekter znanja o tehnologijah pripomočkov ter zasnovi in izdelavi pripomočkov;
The notified body shall establish, document, implement, maintain and operate a quality management system that is appropriate to the nature, area and scale of its conformity assessment activities and is capable of supporting and demonstrating the consistent fulfilment of the requirements of this Regulation.
sistem priglašenega organa za vodenje kakovosti, s tem povezani postopki in merila glede potrebnih kvalifikacij;
The quality management system of the notified body shall address at least the following:
usposabljanje osebja, ki je vključeno v dejavnosti ugotavljanja skladnosti v zvezi s pripomočki;
management system structure and documentation, including policies and objectives for its activities;
ustrezne izkušnje v priglašenem organu na področju ugotavljanja skladnosti v skladu s to uredbo ali prej veljavnim pravom.
policies for assignment of activities and responsibilities to personnel;
Priglašeni organ ima stalno na voljo osebje z ustreznim kliničnim strokovnim znanjem, ki ga po možnosti zaposluje priglašeni organ sam.
assessment and decision-making processes in accordance with the tasks, responsibilities and role of the notified body's personnel and top-level management;
Takšno osebje je vključeno v celotni postopek ocenjevanja in odločanja priglašenega organa, da je mogoče:
the planning, conduct, evaluation and, if necessary, adaptation of its conformity assessment procedures;
ugotoviti, kdaj je potrebno strokovno mnenje za vrednotenje ocene učinkovitosti, ki jo izvede proizvajalec, in opredeliti ustrezno usposobljene strokovnjake;
control of documents;
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;
control of records;
pregledati in znanstveno izpodbijati klinične podatke iz ocene učinkovitosti in morebitnih z njo povezanih študij učinkovitosti ter ustrezno usmerjati zunanje klinične strokovnjake pri vrednotenju ocene učinkovitosti, ki jo predstavi proizvajalec;
management reviews;
znanstveno oceniti in po potrebi izpodbijati predstavljeno oceno učinkovitosti in rezultate vrednotenja ocene učinkovitosti proizvajalca s strani zunanjih kliničnih strokovnjakov;
internal audits;
ugotoviti primerljivost in doslednost vrednotenja ocen učinkovitosti, ki ga izvajajo klinični strokovnjaki;
corrective and preventive actions;
oceniti oceno učinkovitosti proizvajalca in klinično presojo mnenja zunanjega strokovnjaka ter predložiti priporočilo nosilcu odločanja priglašenega organa; in
complaints and appeals;
pripraviti evidence in poročila, ki dokazujejo, da so bile zadevne dejavnosti ugotavljanja skladnosti ustrezno izvedene.
continuous training.
Osebje, pristojno za izvajanje pregledov v zvezi z izdelki (pregledovalci izdelka), kot so pregledi tehnične dokumentacije ali pregled tipa, vključno z vidiki, kot so ocena učinkovitosti, biološka varnost, sterilizacija in potrjevanje programske opreme, ima vse naslednje dokazane kvalifikacije:
Where documents are used in various languages, the notified body shall ensure and control that they have the same content.
univerzitetna izobrazba ali višja strokovna šola ali enakovredna kvalifikacija na ustreznem študijskem področju, npr. medicina, farmacija, inženirstvo ali druge ustrezne znanosti;
The top-level management of the notified body shall ensure that the quality management system is fully understood, implemented and maintained throughout the notified body organisation including subsidiaries and subcontractors involved in conformity assessment activities pursuant to this Regulation.
štiri leta poklicnih izkušenj na področju zdravstvenih izdelkov ali povezanih dejavnosti, kot so izdelava, presoje ali raziskave, od tega dve leti iz zasnove, izdelave, preskušanja ali uporabe pripomočkov ali tehnologije, katerih skladnost je treba ugotoviti ali ki so povezani z znanstvenimi vidiki, katerih skladnost je treba ugotoviti;
The notified body shall require all personnel to formally commit themselves by a signature or equivalent to comply with the procedures defined by the notified body.
poznavanje zakonodaje o pripomočkih, vključno s splošnimi zahtevami glede varnosti in učinkovitosti iz Priloge I;
That commitment shall cover aspects relating to confidentiality and to independence from commercial and other interests, and any existing or prior association with clients.
ustrezno znanje in izkušnje s področja zadevnih harmoniziranih standardov, skupnih specifikacij in smernic;
The personnel shall be required to complete written statements indicating their compliance with confidentiality, independence and impartiality principles.
ustrezno znanje in izkušnje s področja obvladovanja tveganj ter povezanih standardov in smernic za pripomočke;
RESOURCE REQUIREMENTS
ustrezno znanje in izkušnje v zvezi z oceno učinkovitosti;
General
ustrezno poznavanje pripomočkov, ki jih ocenjujejo;
Notified bodies shall be capable of carrying out all the tasks falling to them under this Regulation with the highest degree of professional integrity and the requisite competence in the specific field, whether those tasks are carried out by the notified body itself or on its behalf and under its responsibility.
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;
In particular, notified bodies shall have the necessary personnel and possess or have access to all equipment, facilities and competence needed to perform properly the technical, scientific and administrative tasks entailed in the conformity assessment activities in relation to which they have been designated.
znanje za pripravo evidenc in poročil, ki dokazujejo, da so bile zadevne dejavnosti ugotavljanja skladnosti ustrezno izvedene.
Such requirement presupposes at all times and for each conformity assessment procedure and each type of devices in relation to which they have been designated, that the notified body has permanent availability of sufficient administrative, technical and scientific personnel who possess experience and knowledge relating to the relevant devices and the corresponding technologies.
Osebje, pristojno za izvajanje presoj proizvajalčevega sistema vodenja kakovosti (presojevalci na kraju samem), ima vse naslednje dokazane kvalifikacije:
Such personnel shall be in sufficient numbers to ensure that the notified body in question can perform the conformity assessment tasks, including the assessment of the medical functionality, performance evaluations and the performance and safety of devices, for which it has been designated, having regard to the requirements of this Regulation, in particular those set out in Annex I.
univerzitetna izobrazba ali višja strokovna šola ali enakovredna kvalifikacija na ustreznem študijskem področju, kot so medicina, farmacija, inženirstvo ali druge ustrezne znanosti;
A notified body's cumulative competences shall be such as to enable it to assess the types of devices for which it is designated.
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;