natgillin/translations-raw huggingface dataset:
‘NANDO’; see http://ec.europa.eu/enterprise/newapproach/nando
„NANDO“; glej http://ec.europa.eu/enterprise/newapproach/nando.
Interpretation of the criteria set out in Annex 8 to Directive 90/385/EEC and in Annex XI to Directive 93/42/EEC
Razlaga meril iz Priloge 8 k Direktivi 90/385/EGS in Priloge XI k Direktivi 93/42/EGS
Sections 1 and 5 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:
Oddelka 1 in 5 Priloge 8 k Direktivi 90/385/EGS in Priloge XI k Direktivi 93/42/EGS se razlagata tako, da vključujeta naslednje elemente:
The conformity assessment body shall be a third-party body that is independent of the manufacturer of the product in relation to which it performs conformity assessment activities.
Organ za ugotavljanje skladnosti je organ tretje strani, ki je neodvisen od proizvajalca proizvoda, v zvezi s katerim opravlja dejavnosti ugotavljanja skladnosti.
The conformity assessment body shall also be independent of any other economic operator having an interest in the product as well as of any competitor of the manufacturer.
Organ za ugotavljanje skladnosti je neodvisen tudi od katerega koli drugega gospodarskega subjekta, ki je zainteresiran za proizvod, in od katerega koli konkurenta proizvajalca.
That conformity assessment body shall be organised and operated so as to safeguard the independence, objectivity and impartiality of its activities.
Navedeni organ za ugotavljanje skladnosti s svojo organizacijo in delovanjem zagotavlja neodvisnost, objektivnost in nepristranskost pri izvajanju svojih dejavnosti.
The conformity assessment body shall have procedures in place that effectively ensure identification, investigation and resolution of any case in which a conflict of interests may arise, including involvement of its staff in consultancy services in the field of medical devices prior to taking up employment with the body.
Organ za ugotavljanje skladnosti ima vzpostavljene postopke za učinkovito zagotavljanje identifikacije, preiskovanja in odločanja v vsakem primeru, v katerem lahko pride do navzkrižja interesov, vključno s sodelovanjem njegovega osebja pri svetovalnih storitvah na področju medicinskih pripomočkov pred zaposlitvijo pri organu.
That conformity assessment body, its top management and the personnel responsible for carrying out the conformity assessment tasks shall not:
Navedeni organ za ugotavljanje skladnosti, njegovo najvišje vodstvo in osebje, pristojno za izvajanje nalog ugotavljanja skladnosti:
engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified;
ne sodelujejo pri nobenih dejavnostih, ki bi lahko bile v nasprotju z njihovo neodvisno presojo ali integriteto v zvezi z dejavnostmi ugotavljanja skladnosti, za katere so priglašeni;
offer or provide any service which may jeopardise the confidence in their independence, impartiality or objectivity.
ne nudijo ali izvajajo nobenih storitev, ki bi lahko ogrozile zaupanje v njihovo neodvisnost, nepristranskost ali objektivnost.
In particular, they shall not offer or provide or have offered or provided, during the last three years, consultancy services to the manufacturer, his authorised representative, a supplier or a commercial competitor as regards Union requirements for the design, construction, marketing or maintenance of the products or processes under assessment.
Zlasti ne ponujajo ali izvajajo oziroma niso v zadnjih treh letih ponujali ali izvajali svetovalnih storitev za proizvajalca, njegovega pooblaščenega predstavnika, dobavitelja ali tržnega konkurenta v zvezi z zahtevami Unije glede načrtovanja, konstrukcije, trženja ali vzdrževanja proizvodov ali postopkov, ki se ocenjujejo.
This does not preclude conformity assessment activities for manufacturers and economic operators mentioned above or general training activities relating to medical device regulations or related standards that are not client specific.
To ne izključuje dejavnosti ugotavljanja skladnosti za proizvajalce in gospodarske subjekte, navedene zgoraj, ali splošnega usposabljanja, ki se nanaša na predpise o medicinskih pripomočkih ali povezane standarde, ki se ne osredotočajo na potrebe stranke.
The conformity assessment body’s top level management and its assessment personnel shall be impartial.
Najvišje vodstvo organa za ugotavljanje skladnosti in njegovo osebje za ugotavljanje skladnosti je nepristransko.
The remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number or the results of assessments carried out.
Plačilo za najvišje vodstvo in osebje organa za ugotavljanje skladnosti ni odvisno od števila ali rezultatov opravljenih ocenjevanj skladnosti.
When a conformity assessment body is owned by a public entity or institution, the Member State shall ensure and document the independence of the conformity assessment body and the absence of any conflict of interests between, on the one hand, the designating authority and/or competent authority and, on the other hand, the conformity assessment body.
Če je organ za ugotavljanje skladnosti v lasti javne osebe ali ustanove, država članica zagotovi in dokumentira neodvisnost organa za ugotavljanje skladnosti in odsotnost vsakega navzkrižja interesov med organom za imenovanje in/ali pristojnim organom na eni strani in organom za ugotavljanje skladnosti na drugi strani.
The conformity assessment body shall ensure and document that the activities of its subsidiaries or subcontractors, or of any associated body, do not affect its independence, impartiality or objectivity in its conformity assessment activities.
Organ za ugotavljanje skladnosti zagotavlja in dokumentira, da dejavnosti njegovih pomožnih organov ali podizvajalcev ali katerega koli povezanega organa ne vplivajo na njegovo neodvisnost, nepristranskost ali objektivnost njegovih dejavnosti ugotavljanja skladnosti.
The requirements of points 1.1 to 1.6 do not preclude exchanges of technical information and regulatory guidance between a body and a manufacturer seeking their conformity assessment.
Zahteve iz točk 1.1 do 1.6 ne izključujejo izmenjave tehničnih informacij in regulativnih navodil med organom in proizvajalcem, ki zahteva ugotavljanje skladnosti.
The second paragraph of Section 2 of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:
Drugi odstavek oddelka 2 Priloge XI k Direktivi 93/42/EGS se razlaga tako, da vključuje naslednje elemente:
Subcontracting shall be limited to specific tasks.
Podizvajanje je omejeno na posebne naloge.
The subcontracting of the auditing of quality management systems or of products related reviews in its entirety is not allowed.
Sklepanje pogodb s podizvajalci za revizijo sistemov upravljanja kakovosti ali preglede v zvezi s proizvodi kot celote ni dovoljeno.
The conformity assessment body shall in particular keep internal the review of the qualification and the monitoring of the performance of the external experts, the experts’ assignment to specific conformity assessment activities, and the final review and decision-making functions.
Organ za ugotavljanje skladnosti ne odda v podizvajanje zlasti pregleda kvalifikacij in spremljanja uspešnosti zunanjih strokovnjakov, dodeljevanja strokovnjakov posebnim dejavnostim glede ugotavljanja skladnosti in končnega pregleda ter funkcij odločanja.
Where a conformity assessment body subcontracts specific tasks or consults external experts related to the conformity assessment, it shall have a policy describing the conditions under which subcontracting or the consultation of external experts may take place.
Kadar organ za ugotavljanje skladnosti odda posebne naloge v podizvajanje ali se v zvezi z ugotavljanjem skladnosti posvetuje z zunanjimi strokovnjaki, ima vzpostavljeno politiko, ki določa pogoje, pod katerimi lahko poteka oddajanje del podizvajalcem ali posvetovanje z zunanjimi strokovnjaki.
Any subcontracting or consultation of external experts shall be properly documented and be subject to a written agreement covering, among others, confidentiality and conflict of interests.
Vsako podizvajanje ali posvetovanje z zunanjimi strokovnjaki je ustrezno dokumentirano in je predmet pisnega sporazuma, ki med drugim zajema zaupnost in navzkrižje interesov.
The conformity assessment body shall establish procedures for assessing and monitoring the competence of all subcontractors and external experts used.
Organ za ugotavljanje skladnosti vzpostavi postopke za ocenjevanje in spremljanje kompetenc vseh podizvajalcev in zunanjih strokovnjakov.
Sections 3 and 4 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:
Oddelka 3 in 4 Priloge 8 k Direktivi 90/385/EGS in Priloge XI k Direktivi 93/42/EGS se razlagata tako, da vključujeta naslednje elemente:
At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been or wishes to be notified, a conformity assessment body shall have within its organisation the following elements:
Organ za ugotavljanje skladnosti ima vedno in za vsak postopek ugotavljanja skladnosti ter za vsako vrsto ali kategorijo proizvodov, za katere je ali želi biti priglašen, v svoji organizaciji naslednje elemente:
the necessary administrative, technical, clinical and scientific personnel with technical and scientific knowledge and sufficient and appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks, including the assessment of clinical data;
zaposleno potrebno upravno, tehnično, klinično in znanstveno osebje s tehničnim in znanstvenim znanjem ter zadostnimi in ustreznimi izkušnjami v zvezi z medicinskimi pripomočki in ustreznimi tehnologijami za opravljanje nalog ugotavljanja skladnosti, vključno z ugotavljanjem skladnosti kliničnih podatkov;
a documented process for the conduct of the conformity assessment procedures for which it is designated [1] taking into account their respective specificities, including legally required consultations, in respect of the different categories of devices covered by the scope of notification, ensuring transparency and the ability of reproduction of those procedures.
dokumentiran proces za izvajanje postopkov ugotavljanja skladnosti, za katere je imenovan [1], ob upoštevanju njihovih posebnosti, vključno s pravno zahtevanimi posvetovanji, glede na različne kategorije pripomočkov, ki so zajete v področje uporabe priglasitve, da se zagotovita preglednost in zmožnost reprodukcije navedenih postopkov.
The conformity assessment body shall have the necessary personnel and shall possess or have access to all equipment and facilities needed to perform properly the technical and administrative tasks entailed in the conformity assessment activities in relation to which it has been notified.
Organ za ugotavljanje skladnosti ima zaposleno potrebno osebje, v lasti oz. dostop pa ima tudi do vse opreme in objektov, potrebnih za pravilno opravljanje tehničnih in upravnih nalog, povezanih z dejavnostmi ugotavljanja skladnosti, za katere je priglašen.
The conformity assessment body shall have at its disposal the financial resources required to conduct its conformity assessment activities and related business operations.
Organ za ugotavljanje skladnosti ima na voljo finančna sredstva, potrebna za izvajanje dejavnosti ugotavljanja skladnosti in z njimi povezanih poslovnih dejavnosti.
It shall document and provide evidence of its financial capacity and its sustainable economic viability, taking into account specific circumstances during an initial start-up phase.
Dokumentira in predloži dokaze o svoji finančni učinkovitosti in trajnostni ekonomski sposobnosti, ob upoštevanju posebnih okoliščin v začetni zagonski fazi.
The conformity assessment body shall have a quality management system in place and operating.
Organ za ugotavljanje skladnosti ima vzpostavljen in delujoč sistem upravljanja kakovosti.
The experience and knowledge of the personnel responsible for carrying out conformity assessment activities shall be interpreted as including the following:
Izkušnje in znanje osebja, pristojnega za izvajanje dejavnosti ugotavljanja skladnosti, se razlagajo tako, da vključujejo naslednje:
sound scientific, technical and vocational training, in particular in the relevant fields of medicine, pharmacy, engineering or other relevant sciences, covering all the conformity assessment activities in relation to which the body has been notified or wishes to be notified;
dobro znanstveno, tehnično in poklicno usposabljanje, zlasti na zadevnih področjih medicine, farmacije, inženirstva ali drugih zadevnih znanosti, ki zajemajo vse dejavnosti ugotavljanja skladnosti, v zvezi s katerimi je organ bil ali želi biti priglašen;
substantial relevant experience covering all the conformity assessment activities in relation to which the body has been notified or wishes to be notified;
znatne ustrezne izkušnje, ki zajemajo vse dejavnosti ugotavljanja skladnosti, v zvezi s katerimi je organ bil ali želi biti priglašen;
satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;
zadovoljivo znanje o zahtevah glede ugotavljanja skladnosti, ki jih izvaja, in ustrezna pooblastila zanje;
appropriate knowledge and understanding of the relevant provisions of the medical devices legislation and of the applicable harmonised standards;
primerno znanje in razumevanje ustreznih določb zakonodaje o medicinskih pripomočkih in veljavnih harmoniziranih standardov;
the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
sposobnost priprave certifikatov, evidenc in poročil, ki dokazujejo, da je bilo ugotavljanje skladnosti izvedeno.
The conformity assessment body shall establish and document qualification criteria and procedures for selection and authorisation of persons involved in conformity assessment activities (knowledge, experience and other competence required) and the required training (initial and ongoing training).
Organ za ugotavljanje skladnosti vzpostavi in dokumentira merila glede kvalifikacij ter postopke za izbor in pooblaščanje oseb, vključenih v dejavnosti ugotavljanja skladnosti (znanje, izkušnje in druge potrebne kompetence), ter potrebno usposabljanje (začetno in tekoče usposabljanje).
The qualification criteria shall address the various functions within the conformity assessment process (e.g. auditing, product evaluation/testing, design dossier/file review, decision-making) as well as the devices, technologies and areas (e.g. biocompatibility, sterilisation, tissues and cells of animal origin, clinical evaluation) covered by the scope of designation.
Merila glede kvalifikacij se nanašajo na različne funkcije v postopku ugotavljanja skladnosti (npr. revizije, ocenjevanje/testiranje proizvodov, pregled projektnega dosjeja/dokumentacije, odločanje) ter na pripomočke, tehnologije in področja (npr. biokompatibilnost, sterilizacija, živalska tkiva in celice, klinično ocenjevanje), za katera je organ imenovan.
The conformity assessment body shall have procedures in place to ensure that its subsidiaries operate on the basis of the same operating procedures and with the same stringency as its headquarters.
Organ za ugotavljanje skladnosti ima uvedene postopke za zagotovitev, da njegovi pomožni organi delujejo na podlagi istih delovnih postopkov in z enako strogostjo kot njihov sedež.
Where subcontractors or external experts are used in the context of the conformity assessment, in particular regarding novel, invasive and implantable medical devices or technologies, the conformity assessment body shall have adequate internal competence in each product area for which it is designated to direct the conformity assessment, to verify the appropriateness and validity of expert opinions and make the decision on the certification.
Kadar podizvajalci ali zunanji strokovnjaki sodelujejo pri ugotavljanju skladnosti, zlasti glede novih in invazivnih pripomočkov ali tehnologij ter pripomočkov ali tehnologij za vsaditev, ima organ za ugotavljanje skladnosti ustrezne kompetence na vsakem področju v zvezi s proizvodom, za katerega je določen za vodenje ugotavljanja skladnosti, da preveri ustreznost in veljavnost strokovnih mnenj in sprejme odločitev o certificiranju.
The internal competence requested shall cover technological, clinical and auditing aspects.
V okviru notranjih zahtevanih kompetenc so zajeti tehnološki, klinični in revizijski vidiki.
Sections 6 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:
Oddelek 6 Priloge 8 k Direktivi 90/385/EGS in Priloge XI k Direktivi 93/42/EGS se razlaga tako, da vključuje naslednje elemente:
The conformity assessment body shall take out appropriate liability insurance corresponding to the conformity assessment activities for which it is notified, including the possible suspension, restriction or withdrawal of certificates, and the geographic scope of its activities, unless liability is assumed by the State under domestic legislation or the Member State itself carries out the inspections directly.
Organ za ugotavljanje skladnosti sklene ustrezno zavarovanje odgovornosti, ki ustreza dejavnostim ugotavljanja skladnosti, za katere je priglašen, vključno z možnostjo začasnega odvzema, omejitve ali odvzema certifikatov, in geografskemu obsegu njegovih dejavnosti, razen če ni v skladu z nacionalno zakonodajo odgovorna država ali če država članica sama neposredno izvede inšpekcijske preglede.
Sections 7 of Annex 8 to Directive 90/385/EEC and of Annex XI to Directive 93/42/EEC shall be interpreted as including the following elements:
Oddelek 7 Priloge 8 k Direktivi 90/385/EGS in Priloge XI k Direktivi 93/42/EGS se razlaga tako, da vključuje naslednje elemente:
The conformity assessment body shall ensure that confidentiality of the information which comes into its possession during the performance of the conformity assessment activities is observed by its personnel, committees, subsidiaries, subcontractors or any associated body, except when disclosure is required by law.
Organ za ugotavljanje skladnosti zagotovi, da njegovo osebje, odbori, pomožni organi, podizvajalci ali kateri koli povezan organ spoštujejo zaupnost informacij, pridobljenih med opravljanjem dejavnosti ugotavljanja skladnosti, razen kadar njihovo razkritje zahteva zakon.
To this end, it shall have documented procedures in place.
V ta namen ima organ za ugotavljanje skladnosti vzpostavljene dokumentirane postopke.
The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks, except in relation to the designating authorities and the competent authorities or the Commission.
Osebje organa za ugotavljanje skladnosti je zavezano k poklicni molčečnosti glede vseh informacij, pridobljenih pri opravljanju nalog, razen v zvezi z organi za imenovanje in pristojnimi organi ali Komisijo.
Proprietary rights shall be protected.
Lastniške pravice so zaščitene.
To this end, the conformity assessment body shall have documented procedures in place.
V ta namen ima organ za ugotavljanje skladnosti vzpostavljene dokumentirane postopke.
See Annex II Item 41.
Glej Prilogo II, točka 41.
Application form to be submitted when applying for designation as notified body
Obrazec, ki se predloži ob predložitvi vloge za imenovanje za priglašeni organ
Designating authority: …
Organ za imenovanje: …
Name of the applying conformity assessment body: …
Ime organa za ugotavljanje skladnosti, ki je predložil vlogo: …
Previous name (if applicable): …
Prejšnje ime (če obstaja): …
EU Notified Body number (if applicable): …
EU številka priglašenega organa (če obstaja): …
Legal form of the conformity assessment body: …
Pravna oblika organa za ugotavljanje skladnosti: …
Company registration number: …
Matična številka podjetja: …
At company register: …
V registru podjetij: …
The following documents shall be added.
Dodati je treba naslednje dokumente.
In case of extension or renewal, only new or modified documents shall be submitted.
V primeru podaljšanja ali obnovitve imenovanja se predložijo le novi ali spremenjeni dokumenti.
Item/issue
Postavka/zadeva
Corresponding Annex I section
Ustrezen oddelek Priloge I
Attachment number + Reference
Številka priloge
(Section/page)
+ sklic (oddelek/stran)
ORGANISATIONAL AND GENERAL REQUIREMENTS
ORGANIZACIJSKE IN SPLOŠNE ZAHTEVE
Legal status and organisational structure
Pravni status in organizacijska struktura
Company statutes
Statuti podjetja
Extract of company registration or enrolment act (Company register)
Izvleček iz registracije podjetja ali vpisa (register podjetij)
Documentation on the activities of the organisation to which the conformity assessment body belongs (if any) and its relationship with the conformity assessment body
Dokumentacija o dejavnostih organizacije, ki ji pripada organ za ugotavljanje skladnosti (če obstaja) in njuno razmerje
Documentation on entities the conformity assessment body owns (if any), either within the Member State or outside, and the relationship with those entities
Dokumentacija o subjektih, ki jih ima organ za ugotavljanje skladnosti (če obstajajo), v državi članici ali zunaj nje, in razmerje s temi subjekti
Description of legal ownership and the legal or natural persons exercising control of the conformity assessment body
Opis pravnega lastništva in pravnih ali fizičnih oseb, ki nadzorujejo organ za ugotavljanje skladnosti
Description of organisational structure and the operational management of the conformity assessment body
Opis organizacijske strukture in operativnega vodstva organa za ugotavljanje skladnosti
Descriptions of functions, responsibilities and authorities of top-level management
Opisi funkcij, pristojnosti ter pooblastil najvišjega vodstva
List of all staff who have an influence in the conformity assessment activities
Seznam vseh zaposlenih, ki vplivajo na dejavnosti ugotavljanja skladnosti
Documentation on other services provided by the conformity assessment body (if any) (e.g. consultancy relevant to devices, training etc.)
Dokumentacija o drugih storitvah, ki jih zagotavlja organ za ugotavljanje skladnosti (če obstajajo) (npr. svetovanje v zvezi s pripomočki, usposabljanje itd.)
Documentation on accreditation(s) relevant to this application
Dokumentacija o akreditacijah, pomembnih za to predloženo vlogo
Documentation on structures, policies and procedures to safeguard and promote the principles of impartiality throughout the organisation, personnel and assessment activities, including ethical rules or codes of conduct
Dokumentacija o strukturah, politikah in postopkih za varovanje in spodbujanje načela nepristranskosti v celotni organizaciji, pri dejavnostih osebja in ocenjevanja, vključno z etičnimi pravili ali kodeksi ravnanja
Description of how the conformity assessment body ensures that the activities of subsidiaries, subcontractors and external experts do not affect its independence, impartiality or objectivity
Opis načina, na katerega organ za ugotavljanje skladnosti zagotovi, da dejavnosti pomožnih organov, podizvajalcev in zunanjih strokovnjakov ne vplivajo na njegovo neodvisnost, nepristranskost ali objektivnost
Documentation on the impartiality of the top-level management and personnel involved in conformity assessment activities, including their remuneration and bonuses
Dokumentacija o nepristranskosti najvišjega vodstva in osebja, ki sodeluje pri dejavnostih ugotavljanja skladnosti, vključno z njihovimi plačami in bonusi
Documentation on conflict of interest and resolution of potential conflict procedure/form
Dokumentacija o navzkrižju interesov in odločitvi v okviru morebitnega postopka in/ali vrste spora
Description of independence of the conformity assessment body from the designating authority and from the competent authority, in particular when this body is a public entity/institution
Opis neodvisnosti organa za ugotavljanje skladnosti s strani organa za imenovanje in pristojnega organa, zlasti če je ta organ javno podjetje/ustanova