natgillin/translations-raw huggingface dataset:
See Section 10 of Annex 1, Section 4.3 of Annex 2 and Section 5 of Annex 3 to Directive 90/385/EEC, Section 7.4 of Annex I, Section 4.3 of Annex II and Section 5 of Annex III to Directive 93/42/EEC and Regulation (EU) No 722/2012.
Glej oddelek 10 Priloge 1, oddelek 4.3 Priloge 2 in oddelek 5 Priloge 3 k Direktivi 90/385/EGS, oddelek 7.4 Priloge I, oddelek 4.3 Priloge II in oddelek 5 Priloge III k Direktivi 93/42/EGS ter Uredbo (EU) št. 722/2012.
See Section 1.4 of Annex 7 to Directive 90/385/EEC and Section 1.1c of Annex X to Directive 93/42/EEC.
Glej oddelek 1.4. Priloge 7 k Direktivi 90/385/EGS in oddelek 1.1c Priloge X k Direktivi 93/42/EGS.
See Annex 7 to Directive 90/385/EEC and Annex X to Directive 93/42/EEC.
Glej Prilogo 7 k Direktivi 90/385/EGS in Prilogo X k Direktivi 93/42/EGS.
To be regarded as complete, a technical documentation should cover with appropriate depth the items listed in the document of the Global Harmonization Task Force ‘Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)’ as well as additional items required by the European legislation or, for in vitro diagnostic medical devices, ‘Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices’ as well as additional items required by the European legislation, see for these documents http://www.imdrf.org/ghtf/ghtf-archives-sg1.asp
Da bi bilo tehnično dokumentacijo mogoče šteti za popolno, bi morale biti v njej dovolj podrobno opisane postavke, ki jih je delovna skupina za svetovno usklajevanje (Global Harmonization Task Force) navedla v dokumentu „Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)“ ter morebitne dodatne postavke, zahtevane v skladu z evropsko zakonodajo, ali, za in vitro diagnostične medicinske pripomočke, v dokumentu „Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices“ ter morebitne dodatne postavke, zahtevane v skladu z evropsko zakonodajo; za oba dokumenta glej http://www.imdrf.org/ghtf/ghtf-archives-sg1.asp.
Quality system assessment
Ocena sistema kakovosti
In the case of full quality assurance system, the verification should ascertain that the application of the quality system assures the conformity of the devices [1] with the legal requirements set out in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC.
V primeru sistema za celovito zagotavljanje kakovosti bi bilo treba s preverjanjem potrditi, da uporaba sistema kakovosti zagotavlja skladnost pripomočkov [1] z zakonskimi zahtevami, določenimi v Direktivi 90/385/EGS, Direktivi 93/42/EGS in Direktivi 98/79/ES.
In the case of production or product quality assurance, the verification should ascertain that the application of the quality system ensures the conformity of the devices with the device type [2].
V primeru zagotavljanja kakovosti proizvodnje ali izdelka bi bilo treba s preverjanjem potrditi, da uporaba sistema kakovosti zagotavlja skladnost pripomočkov s tipom pripomočka [2].
The quality system assessment should include audits on the premises of the manufacturer and, if this is also necessary to ensure efficient control, on those of its critical subcontractors or of its crucial suppliers.
Ocena sistema kakovosti bi morala vključevati revizije v prostorih proizvajalca in, če je za zagotovitev učinkovitega nadzora potrebno tudi to, v prostorih njegovih ključnih podizvajalcev ali ključnih dobaviteljev.
Notified bodies should establish a risk-based approach to identify such subcontractors and suppliers and should clearly document this decision process.
Priglašeni organi bi morali vzpostaviti na tveganjih temelječ pristop za opredelitev takih podizvajalcev in dobaviteljev ter ta postopek odločanja jasno dokumentirati.
Notified bodies should identify which products the manufacturer regards as covered by its application, whether these products fall under Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC and whether there have been changes to these products or to the quality system since the last audit or since the application.
Priglašeni organi bi morali ugotoviti, za katere izdelke proizvajalec šteje, da so zajeti v njegovo vlogo, ali ti izdelki spadajo v okvir Direktive 90/385/EGS, Direktive 93/42/EGS in Direktive 98/79/ES ter ali so bili od zadnje revizije ali predložitve vloge izdelki ali sistem kakovosti spremenjeni.
Furthermore, notified bodies should identify the post-market information available to them or to the manufacturer, which might need to be taken into account when planning and executing the audit.
Poleg tega bi morali priglašeni organi opredeliti poprodajne informacije, ki so jim na voljo ali s katerimi razpolaga proizvajalec ter ki bi jih lahko bilo treba upoštevati pri načrtovanju in opravljanju revizije.
For medical devices of Class IIa or IIb, the notified bodies should review the technical documentation on the basis of representative samples with a frequency and depth following established best practices, taking account of the device’s class, risk and novelty.
Za medicinske pripomočke razredov IIa ali IIb bi morali priglašeni organi tehnično dokumentacijo pregledovati na podlagi reprezentativnih vzorcev tako pogosto in temeljito, kot je predvideno z določenimi najboljšimi praksami, ob upoštevanju razreda, tveganja in novosti pripomočka.
Samples chosen and reviews conducted should be clearly documented and justified.
Izbrani vzorci in opravljeni pregledi bi morali biti jasno dokumentirani in utemeljeni.
Over the period of certification of the specific quality system (i.e. for a maximum of five years) the sampling plan should be sufficient to ensure that every device category covered by the certificate has been sampled.
V obdobju certificiranja posameznega sistema kakovosti (tj. za največ pet let) bi moral načrt vzorčenja zadostovati za zagotavljanje, da je bil pregledan vzorec iz vsake kategorije pripomočkov, ki jih zajema certifikat.
Where doubts arise as to the conformity of a device, including its documentation, notified bodies should carry out or ask for relevant tests of the device.
Če se pojavijo dvomi glede skladnosti pripomočka, vključno z njegovo dokumentacijo, bi morali priglašeni organi opraviti ustrezne preizkuse pripomočka oziroma zaprositi zanje.
Where any non-conformity of a device is detected, they should investigate whether elements of the quality system or incorrect application thereof caused the non-conformity.
Kadar se odkrije neskladnost pripomočka, bi morali preiskati, ali je ta neskladnost posledica elementov sistema kakovosti ali njegove nepravilne uporabe.
Where a test has been carried out, notified bodies should provide the manufacturer with a test report and with an audit report which highlights in particular the link between quality system deficiencies and detected non-conformities of devices.
Kadar se opravi preizkus, bi morali priglašeni organi proizvajalcu zagotoviti poročilo o preizkusu in revizijsko poročilo, v katerem je izpostavljena zlasti povezava med pomanjkljivostmi sistema kakovosti in odkritimi neskladnostmi pripomočkov.
Notified bodies should verify whether the quality objectives and the quality manual or procedures developed by the manufacturer are appropriate to ensure the conformity of the devices falling under the application of the manufacturer.
Priglašeni organi bi morali preveriti, ali so cilji kakovosti in priročnik z navodili glede kakovosti ali postopki, ki jih je zasnoval proizvajalec, primerni za zagotavljanje skladnosti pripomočkov, zajetih v proizvajalčevi vlogi.
Notified bodies should verify whether the manufacturer’s business organisation is appropriate for ensuring the conformity of the quality system and of the medical devices.
Priglašeni organi bi morali preveriti, ali je organizacija proizvajalčevega podjetja primerna za zagotavljanje skladnosti sistema kakovosti in medicinskih pripomočkov.
In particular, the following aspects should be examined: the organisational structure, the qualification of managerial staff and their organisational authority, the qualification and the training of other staff, the internal auditing, the infrastructure, and the monitoring of the quality system in operation, including with regard to involved third parties such as suppliers or subcontractors.
Pregledati bi morali zlasti naslednje vidike: organizacijsko strukturo, usposobljenost vodstvenega osebja in njegova organizacijska pooblastila, usposobljenost in usposabljanje drugega osebja, notranje revizije, infrastrukturo ter spremljanje sistema kakovosti med delovanjem, tudi v zvezi z udeleženimi tretjimi osebami, kot so dobavitelji oziroma podizvajalci.
Notified bodies should verify the existence of an unequivocal product identification system.
Priglašeni organi bi morali preveriti obstoj nedvoumnega sistema identifikacije izdelkov.
This system should ensure that the notified body’s certificates, the manufacturer’s declarations of conformity and the manufacturer’s technical documentations can, in conjunction with that system, unequivocally be attributed to certain devices and not to others.
Ta sistem bi moral zagotavljati, da je mogoče certifikate priglašenih organov ter proizvajalčeve izjave o skladnosti in tehnične dokumentacije v povezavi z navedenim sistemom nedvoumno pripisati določenim pripomočkom, ne pa tudi drugim.
Notified bodies should verify the manufacturer’s procedures with regard to the product documentation.
Priglašeni organi bi morali preveriti proizvajalčeve postopke v zvezi z dokumentacijo izdelkov.
The procedures relating to the product documentation should ensure that all products intended to be placed on the market or put into service are covered by the necessary certificates issued or to be issued by the notified body.
Ti postopki bi morali zagotavljati, da imajo ali bodo imeli vsi izdelki, namenjeni dajanju na trg ali v uporabo, potrebne certifikate, ki jih je ali jih bo izdal priglašeni organ.
The procedures with regard to the product documentation should also ensure that all products intended to be placed on the market or put into service, regardless of their trade name, are covered by the declarations of conformity of the manufacturer and that these are contained in and are compatible with the technical documentation.
Postopki v zvezi z dokumentacijo izdelkov bi morala zagotavljati tudi, da so vsi izdelki, namenjeni dajanju na trg ali v uporabo, ne glede na njihovo tržno ime, zajeti v proizvajalčevih izjavah o skladnosti ter da so te vključene v tehnično dokumentacijo in so skladne z njo.
Notified bodies should verify the correct execution of these procedures by sampling the product documentation of individual devices.
Priglašeni organi bi morali preveriti pravilno izvajanje teh postopkov z vzorčenjem dokumentacije posameznih pripomočkov.
Notified bodies should verify that the manufacturer’s procedures aiming at the fulfilment of procedural legal requirements, in particular with regard to determining the appropriate class and conformity assessment procedure, are up-to-date, complete, consistent and correct.
Priglašeni organi bi morali preveriti, ali so proizvajalčevi postopki, namenjeni izpolnjevanju postopkovnih zakonskih zahtev, zlasti v zvezi z določanjem ustreznega razreda in postopka ocenjevanja skladnosti, ažurni, popolni, dosledni in pravilni.
These procedures should take account of the necessity to provide data in order to allow the notified bodies to respect their consultation obligations for certain devices referred to in Section 1 of Annex I.
V teh postopkih bi bilo treba upoštevati potrebo po zagotavljanju podatkov, da se priglašenim organom omogoči izpolnjevanje njihovih obveznosti glede posvetovanja za nekatere pripomočke, navedenih v oddelku 1 Priloge I.
Notified bodies should verify that the manufacturer’s procedures aiming at the fulfilment of device related legal requirements, are up-to-date, complete, consistent and correct.
Priglašeni organi bi morali preveriti, ali so proizvajalčevi postopki, namenjeni izpolnjevanju s pripomočki povezanih zakonskih zahtev, ažurni, popolni, dosledni in pravilni.
They should verify that the procedures on the risk management are in conformity with the legal requirements contained in Part I (general requirements) of Annex 1 to Directive 90/385/EEC, in Part I of Annex I to Directive 93/42/EEC and in Part A of Annex I to Directive 98/79/EC and that the procedures cover among others the aspects listed in Section 4 of Annex I to this Recommendation.
Preveriti bi morali, ali so postopki glede obvladovanja tveganj v skladu z zakonskimi zahtevami iz dela I (Splošne zahteve) Priloge 1 k Direktivi 90/385/EGS, dela I Priloge I k Direktivi 93/42/EGS in dela A Priloge I k Direktivi 98/79/ES ter ali ti postopki med drugim vključujejo vidike, navedene v oddelku 4 Priloge I k temu priporočilu.
They should verify the correct execution of these procedures by sampling the product documentation of individual devices.
Preveriti bi morali pravilno izvajanje teh postopkov z vzorčenjem dokumentacije posameznih pripomočkov.
In case of manufacturers of medical devices other than in vitro diagnostic devices, notified bodies should verify that the manufacturer’s procedures on clinical evaluations and on the post-market clinical follow-up are complete and correct and that these are correctly implemented.
V primeru proizvajalcev medicinskih pripomočkov, ki niso in vitro diagnostični pripomočki, bi morali priglašeni organi preveriti, ali so proizvajalčevi postopki glede kliničnih vrednotenj in poprodajnega kliničnega spremljanja popolna in pravilna ter ali se navedena vrednotenja in spremljanje pravilno izvajajo.
To that end, they should examine clinical evaluations and the post-market clinical follow-up for some of the device types covered by the application, applying the principles described in Section 5 of Annex I to this Recommendation.
V ta namen bi morali pregledati klinična vrednotenja in poprodajno klinično spremljanje za nekatere od tipov pripomočkov, zajetih v vlogi, z uporabo načel iz oddelka 5 Priloge I k temu priporočilu.
In case of manufacturers of in vitro diagnostic medical devices, notified bodies should verify the manufacturer’s working procedures on performance evaluations, on the identification of certified reference materials or reference measurement procedures to allow for metrological traceability.
V primeru proizvajalcev in vitro diagnostičnih medicinskih pripomočkov bi morali priglašeni organi preveriti proizvajalčeve delovne postopke o vrednotenjih delovanja, identifikaciji certificiranih referenčnih materialov ali referenčnih meritvenih postopkih, da se omogoči meroslovna sledljivost.
Notified bodies should verify that the procedures regarding the design and product development, including any change control procedures, are appropriate to ensure the compliance of the devices.
Priglašeni organi bi morali preveriti, ali so postopki glede načrtovanja in razvoja izdelkov, vključno z vsemi postopki za nadzor nad spremembami, primerni za zagotavljanje skladnosti pripomočkov.
Notified bodies should verify that the manufacturer controls the manufacturing environment and processes so as to ensure the conformity of the devices with the legal requirements.
Priglašeni organi bi morali preveriti, ali proizvajalec za zagotavljanje skladnosti pripomočkov z zakonskimi zahtevami nadzira proizvodno okolje in proizvodne postopke.
Notified bodies should pay special attention to critical processes such as design control, establishment of material specifications, purchasing and control of incoming material or components, assembling, software validation, sterilisation, batch-release, packaging, and product quality control, regardless of whether they are subcontracted or not.
Posebno pozornost bi morali nameniti ključnim postopkom, kot so nadzor nad načrtovanjem, priprava specifikacij materialov, nakup zunanjih materialov in sestavnih delov ter nadzor nad njimi, sestavljanje, validacija ustreznosti programske opreme, sterilizacija, izdaja serij, pakiranje ter nadzor nad kakovostjo izdelkov, ne glede na to, ali jih izvajajo podizvajalci ali ne.
Notified bodies should verify the manufacturer’s system ensuring traceability of materials and components, from the entry into the manufacturer’s, suppliers’ or subcontractors’ premises to the delivery of the final product.
Priglašeni organi bi morali preveriti proizvajalčev sistem za zagotavljanje sledljivosti materialov in sestavnih delov od njihovega vstopa v proizvajalčeve, dobaviteljeve ali podizvajalčeve prostore do dobave končnega izdelka.
In particular where risks might be caused by the exchange of raw materials, notified bodies should check the coherence between the quantity of produced or purchased crucial raw material or components approved for the design and the quantity of finished products.
Zlasti kadar so mogoča tveganja zaradi izmenjave surovin, bi morali priglašeni organi preveriti ujemanje med količino proizvedenih ali kupljenih ključnih surovin ali sestavnih delov, odobrenih za načrt, in količino končnih izdelkov.
Notified bodies should verify that experience gained in the post-production phase, in particular user complaints and vigilance data, is systematically collected and evaluated for the devices covered by the application of the manufacturer and that the necessary improvement of the devices or of their production has been initiated.
Priglašeni organi bi morali preveriti, ali se izkušnje, pridobljene v fazi po proizvodnji, zlasti pritožbe uporabnikov in podatki o vigilanci, sistematično zbirajo in ocenjujejo za pripomočke, zajete v proizvajalčevi vlogi, ter ali so se začele potrebne izboljšave pripomočkov ali njihove proizvodnje.
They should in particular verify that the manufacturer has in place distributor, user or patient related business processes which are suitable for providing information indicating the need for reviewing the design of the device, its manufacturing or the quality system.
Preveriti bi morali zlasti, ali ima proizvajalec vzpostavljene poslovne postopke v povezavi z distributerji, uporabniki ali bolniki, primerne za zagotavljanje informacij, ki nakazujejo potrebo po pregledu načrta pripomočka, njegove proizvodnje ali sistema kakovosti.
Notified bodies should verify that the documentation and records with regard to the quality system and its changes, the procedure of management review, and the respective documentation control are up-to-date, consistent, complete, correct and properly structured.
Priglašeni organi bi morali preveriti, ali so dokumentacija in evidence v zvezi s sistemom kakovosti in njegovimi spremembami, postopkom vodstvenega pregleda ter zadevnim nadzorom nad dokumentacijo ažurne, dosledne, popolne, pravilne in ustrezno sestavljene.
At each annual surveillance audit, the notified bodies should verify that the manufacturer correctly applies the approved quality management system and the post-market surveillance plan.
Pri vsaki letni nadzorni reviziji bi morali priglašeni organi preveriti, ali proizvajalec pravilno uporablja odobreni sistem za upravljanje kakovosti in načrt za poprodajni nadzor.
General advice in case of outsourcing of the production via subcontractors or suppliers
Splošni nasveti v primeru proizvodnje, oddane v zunanje izvajanje, prek podizvajalcev ali dobaviteljev
Critical subcontractors or crucial suppliers may be suppliers of suppliers or even suppliers further down the supply chain.
Ključni podizvajalci ali ključni dobavitelji so lahko dobavitelji dobaviteljev ali celo dobavitelji na bolj oddaljenih stopnjah dobavne verige.
Notified bodies should refrain from signing arrangements with manufacturers unless they receive access to all critical subcontractors and crucial suppliers and thus to all sites where the devices or its crucial components are produced, regardless of the length of the contractual chain between the manufacturer and the subcontractor or supplier.
Priglašeni organi ne bi smeli podpisovati dogovorov s proizvajalci, če jim ni odobren dostop do vseh ključnih podizvajalcev in ključnih dobaviteljev ter torej do vseh lokacij, na katerih se proizvajajo pripomočki ali njihovi ključni sestavni deli, ne glede na dolžino pogodbene verige med proizvajalcem in podizvajalcem ali dobaviteljem.
Notified bodies should note that manufacturers:
Priglašeni organi bi morali paziti, da proizvajalci:
have to fulfil their obligations themselves regardless of any partial or total outsourcing of the production via subcontractors or suppliers;
sami izpolnjujejo svoje obveznosti, ne glede na kakršno koli delno ali popolno oddajo proizvodnje v zunanje izvajanje prek podizvajalcev ali dobaviteljev;
do not fulfil their obligation to have at their disposal the full technical documentation and/or of a quality system by referring to the technical documentation of a subcontractor or supplier and/or to their quality system;
svoje obveznosti glede zagotavljanja razpoložljivosti celotne tehnične dokumentacije in/ali sistema kakovosti ne izpolnjujejo s sklicevanjem na tehnično dokumentacijo podizvajalca ali dobavitelja in/ali njun sistem kakovosti;
should integrate the quality system of critical subcontractors and of crucial suppliers with their quality system;
sisteme kakovosti ključnih podizvajalcev in ključnih dobaviteljev vključijo v svoj sistem kakovosti;
need to control the quality of services provided and of components supplied and the quality of production thereof regardless of the length of the contractual chain between the manufacturer and the subcontractor or supplier.
nadzirajo kakovost opravljenih storitev in dobavljenih sestavnih delov ter kakovost njihove proizvodnje ne glede na dolžino pogodbene verige med proizvajalcem in podizvajalcem ali dobaviteljem.
See first sentence of Section 3.2 of Annex 2 to Directive 90/385/EEC, first sentence of Section 3.2 of Annex II to Directive 93/42/EEC and first sentence of Section 3.2 of Annex IV to Directive 98/79/EC.
Glej prvi stavek točke 3.2 Priloge 2 k Direktivi 90/385/EGS, prvi stavek točke 3.2 Priloge II k Direktivi 93/42/EGS in prvi stavek točke 3.2 Priloge IV k Direktivi 98/79/ES.
See first sentence of Section 3.2 of Annex 5 to Directive 90/385/EEC, first sentence of Section 3.2 of Annex V and first sentence of Section 3.2 of Annex VI to Directive 93/42/EEC and first sentence of Section 3.2 of Annex VII to Directive 98/79/EC.
Glej prvi stavek točke 3.2 Priloge 5 k Direktivi 90/385/EGS, prvi stavek točke 3.2 Priloge V in prvi stavek točke 3.2 Priloge VI k Direktivi 93/42/EGS ter prvi stavek točke 3.2 Priloge VII k Direktivi 98/79/ES.
Unannounced audits
Nenapovedane revizije
Notified bodies should carry out unannounced audits at least once every third year.
Priglašeni organi bi morali najmanj enkrat vsako tretje leto opravljati nenapovedane revizije.
Notified bodies should increase the frequency of unannounced audits if the devices bear a high risk, if the devices of the type in question are frequently non-compliant or if specific information provides reasons to suspect non-conformities of the devices or of their manufacturer.
Če je tveganje pripomočkov visoko, če so pripomočki zadevnega tipa pogosto neskladni ali če je mogoče na podlagi posebnih informacij sklepati o neskladnosti pripomočkov oziroma njihovega proizvajalca, pa bi morali priglašeni organi povečati pogostnost nenapovedanih revizij.
The timing of the unannounced audits should be unpredictable.
Čas nenapovedanih revizij bi moral biti nepredvidljiv.
As a general principle an unannounced audit should not take less than one day and should be executed by at least two auditors.
Praviloma bi morala nenapovedana revizija trajati vsaj en dan, opraviti pa bi jo morala najmanj dva revizorja.
Notified bodies may, instead of or in addition to visiting the manufacturer, visit one of the premises of the manufacturer’s critical subcontractors or crucial suppliers if this is likely to ensure more efficient control.
Priglašeni organi lahko namesto ali poleg obiska pri proizvajalcu obiščejo katere izmed prostorov proizvajalčevih ključnih podizvajalcev ali ključnih dobaviteljev, če bi to lahko zagotovilo učinkovitejši nadzor.