natgillin/translations-raw huggingface dataset:
It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.
Uporablja se za upravljanje strukture, odgovornosti, postopkov, procesov in sredstev za upravljanje, zahtevanih za uveljavitev načel in ukrepov, ki so potrebni za zagotovitev skladnosti z določbami te uredbe.
The quality management system shall address at least the following aspects:
Sistem vodenja kakovosti vključuje vsaj naslednje vidike:
a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;
strategijo za skladnost z zakonodajo, tudi skladnost s postopki za ugotavljanje skladnosti in postopki za upravljanje sprememb pripomočkov, zajetih v sistem;
identification of applicable general safety and performance requirements and exploration of options to address those requirements;
ugotavljanje veljavnih splošnih zahtev glede varnosti in učinkovitosti ter preučitev možnosti za obravnavanje teh zahtev;
responsibility of the management;
odgovornost uprave;
resource management, including selection and control of suppliers and sub-contractors;
upravljanje z viri, vključno z izbiro ter nadzorom dobaviteljev in podizvajalcev;
risk management as set out in Section 3 of Annex I;
obvladovanje tveganja, kot je določeno v oddelku 3 Priloge I;
performance evaluation, in accordance with Article 56 and Annex XIII, including PMPF;
oceno učinkovitosti v skladu s členom 56 in Prilogo XII, vključno s kliničnim spremljanjem po dajanju na trg;
product realisation, including planning, design, development, production and service provision;
izdelovanje izdelka, vključno z načrtovanjem, zasnovo, razvojem, izdelavo in zagotavljanjem storitev;
verification of the UDI assignments made in accordance with Article 24(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 26;
preverjanje dodeljevanja UDI v skladu s členom 24(3) vsem ustreznim pripomočkom, in zagotavljanje usklajenosti in veljavnosti informacij, posredovanih v skladu s členom 26;
setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 78;
pripravo, izvajanje in vzdrževanje sistema za nadzor po dajanju na trg v skladu s členom 78;
handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;
komuniciranje s pristojnimi organi, priglašenimi organi, drugimi gospodarskimi subjekti, strankami in/ali drugimi deležniki;
processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;
postopke pri poročanju o resnih zapletih in varnostnih korektivnih ukrepih v okviru vigilance;
management of corrective and preventive actions and verification of their effectiveness;
izvajanje korektivnih in preventivnih ukrepov ter preverjanje njihove učinkovitosti;
processes for monitoring and measurement of output, data analysis and product improvement.
postopke za spremljanje in merjenje proizvodnje, analizo podatkov in izboljšavo izdelkov.
Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 78.
Proizvajalci pripomočkov izvajajo in posodabljajo sistem za nadzor po dajanju na trg v skladu s členom 78.
Manufacturers shall ensure that the device is accompanied by the information set out in Section 20 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient.
Proizvajalci zagotovijo, da je pripomoček opremljen z informacijami, določenimi v oddelku 20 Priloge I, v uradnem jeziku ali jezikih Unije, ki jih določi država članica, v kateri je pripomoček dostopen uporabniku ali pacientu.
The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.
Podatki na oznaki so neizbrisni, čitljivi in jasno razumljivi predvidenemu uporabniku ali pacientu.
The information supplied in accordance with Section 20 of Annex I with devices for self-testing or near-patient testing shall be easily understandable and provided in the official Union language(s) determined by the Member State in which the device is made available to the user or patient.
Informacije, ki se priložijo v skladu z oddelkom 20 Priloge I s pripomočki za samotestiranje ali testiranje ob pacientu, so zlahka razumljive in navedene v uradnem jeziku ali jezikih Unije, ki jih določi država članica, v kateri je pripomoček dostopen uporabniku ali pacientu.
Manufacturers that consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate.
Proizvajalci, ki menijo ali utemeljeno domnevajo, da pripomoček, ki so ga dali na trg ali v uporabo, ni v skladu s to uredbo, nemudoma sprejmejo potrebne korektivne ukrepe, da zagotovijo skladnost pripomočka ali pa ga po potrebi umaknejo ali odpokličejo.
They shall inform the distributors of the device in question and, where applicable, the authorised representative and importers accordingly.
O tem ustrezno obvestijo distributerje zadevnega pripomočka ter po potrebi pooblaščenega predstavnika in uvoznike.
Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities of the Member States in which they made the device available and, where applicable, the notified body that issued a certificate for the device in accordance with Article 51, in particular, of the non-compliance and of any corrective action taken.
Če pripomoček pomeni resno tveganje, proizvajalci o tem prav tako nemudoma obvestijo pristojne organe držav članic, v katerih so omogočili dostopnost pripomočka, in po potrebi priglašeni organ, ki je izdal certifikat za pripomoček v skladu s členom 51, zlasti o neskladnosti in sprejetih korektivnih ukrepih.
Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 82 and 83.
Proizvajalci imajo sistem za beleženje zapletov ter poročanje o njih in varnostnih korektivnih ukrepih, opisan v členih 82 in 83.
Manufacturers shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language determined by the Member State concerned.
Proizvajalci pristojnemu organu na njegovo zahtevo posredujejo vse informacije in dokumentacijo, ki so potrebne, da dokažejo skladnost pripomočka, v enem od uradnih jezikov Unije, ki ga določi zadevna država članica.
The competent authority of the Member State in which the manufacturer has its registered place of business may require that the manufacturer provide samples of the device free of charge or, where that is impracticable, grant access to the device.
Pristojni organ države članice, v kateri ima proizvajalec registrirani kraj poslovanja, lahko od proizvajalca zahteva, naj mu predloži brezplačne vzorce pripomočka ali, kadar to ni izvedljivo, omogoči dostop do pripomočka.
Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market or put into service.
Proizvajalci s pristojnim organom na njegovo zahtevo sodelujejo pri katerem koli korektivnem ukrepu, katerega cilj je odpraviti ali – če to ni mogoče – zmanjšati tveganje zaradi pripomočka, ki so ga dali na trg ali v uporabo.
If the manufacturer fails to cooperate or the information and documentation provided is incomplete or incorrect, the competent authority may, in order to ensure the protection of public health and patient safety, take all appropriate measures to prohibit or restrict the device's being made available on its national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete and correct information.
Če proizvajalec ne sodeluje ali če so predložene informacije in dokumentacija nepopolne ali napačne, lahko pristojni organ za zagotovitev varovanja javnega zdravja in varnosti pacientov sprejme vse ustrezne ukrepe za prepoved ali omejitev dostopnosti pripomočka na nacionalnem trgu ali za umik pripomočka z navedenega trga ali njegov odpoklic, dokler proizvajalec ne začne sodelovati ali ne predloži popolnih in natančnih informacij.
If a competent authority considers or has reason to believe that a device has caused damage, it shall, upon request, facilitate the provision of the information and documentation referred to in the first subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's successor in title, the patient's or user's health insurance company or other third parties affected by the damage caused to the patient or user, without prejudice to data protection rules and, unless there is an overriding public interest in disclosure, without prejudice to the protection of intellectual property rights.
Če pristojni organ meni ali utemeljeno domneva, da je pripomoček povzročil škodo, na zahtevo olajša zagotavljanje informacij in dokumentacije iz prvega pododstavka potencialno poškodovanemu pacientu ali uporabniku in po potrebi pravnemu nasledniku pacienta ali uporabnika, zdravstveni zavarovalnici pacienta ali uporabnika ali drugim tretjim osebam, na katere vpliva škoda, storjena pacientu ali uporabniku, brez poseganja v predpise o varstvu podatkov in, razen če prevlada javni interes za razkritje, brez poseganja v zaščito pravic intelektualne lastnine.
The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt with in the context of legal proceedings.
Pristojnemu organu obveznosti iz tretjega pododstavka ni treba izpolniti, če se razkritje informacij in dokumentacije iz prvega pododstavka običajno obravnava v okviru sodnega postopka.
Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 27(1).
Kadar pripomočke za proizvajalce zasnuje ali izdela druga pravna ali fizična oseba, se informacije o identiteti te osebe predložijo skupaj z informacijami, ki se predložijo v skladu s členom 27(1).
Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law.
Fizične ali pravne osebe lahko v skladu z veljavno zakonodajo Unije in nacionalno zakonodajo zahtevajo nadomestilo za škodo, ki jo je povzročil okvarjen pripomoček.
Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.
Proizvajalci sorazmerno z razredom tveganja, vrsto pripomočka in velikostjo podjetja uvedejo ukrepe, s katerimi zagotovijo zadostno finančno kritje za svojo morebitno odgovornost po Direktivi 85/374/EGS, brez poseganja v strožje zaščitne ukrepe po nacionalnem pravu.
Authorised representative
Pooblaščeni predstavnik
Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
Če proizvajalec pripomočka nima sedeža v državi članici, je mogoče pripomoček dati na trg Unije le, če proizvajalec imenuje enega samega pooblaščenega predstavnika.
The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.
Imenovanje pomeni pooblastilo za pooblaščenega predstavnika, veljavno je samo, če ga pisno sprejme pooblaščeni predstavnik, in velja vsaj za vse pripomočke iste generične skupine pripomočkov.
The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer.
Pooblaščeni predstavnik izvaja naloge, določene v pooblastilu, ki ga sklene s proizvajalcem.
The authorised representative shall provide a copy of the mandate to the competent authority, upon request.
Pooblaščeni predstavnik pristojnemu organu na zahtevo predloži kopijo pooblastila.
The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:
Pooblastilo od pooblaščenega predstavnika zahteva, proizvajalec pa mu omogoča, da opravlja vsaj naslednje naloge v zvezi s pripomočki, za katere je bil pooblaščen:
verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
preveri, ali sta bili izjava EU o skladnosti in tehnična dokumentacija pripravljeni, kjer je potrebno pa tudi, ali je proizvajalec opravil ustrezen postopek ugotavljanja skladnosti;
keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51, at the disposal of competent authorities for the period referred to in Article 10(7);
zagotovi, da so izvod tehnične dokumentacije, izjave EU o skladnosti in, kjer je potrebno, izvod ustreznega certifikata, vključno z vsemi spremembami in dopolnili, izdanimi v skladu s členom 51, pristojnim organom na voljo za obdobje iz člena 10(7);
comply with the registration obligations laid down in Article 28 and verify that the manufacturer has complied with the registration obligations laid down in Article 26;
izpolnjuje obveznosti glede registracije iz člena 28 in preverja, ali proizvajalec izpolnjuje obveznosti glede registracije iz člena 26;
in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
pristojnemu organu na njegovo zahtevo predloži vse informacije in dokumentacijo, ki so potrebne, da se dokaže skladnost pripomočka, v enem od uradnih jezikov Unije, ki ga določi zadevna država članica;
forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;
proizvajalcu posreduje morebitne zahteve pristojnega organa države članice, v kateri ima pooblaščeni predstavnik registrirani kraj poslovanja, za vzorce ali za dostop do pripomočka in preveri, da je pristojni organ prejel vzorce ali dobil dostop do pripomočka;
cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
sodeluje s pristojnimi organi glede morebitnih preventivnih ali korektivnih ukrepov, sprejetih za odpravo ali – če to ni mogoče – zmanjšanje tveganj, povezanih s pripomočki;
immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
proizvajalca takoj obvesti o pritožbah in poročilih zdravstvenih delavcev, pacientov in uporabnikov o sumih na zaplete v zvezi s pripomočkom, za katerega je bil pooblaščen;
terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
odpove pooblastilo, če proizvajalec ravna v nasprotju s svojimi obveznostmi iz te uredbe.
The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (11).
Pooblastilo iz odstavka 3 tega člena ne pomeni prenosa obveznosti proizvajalca iz člena 10(1), (2), (3), (4), (5), (6), (8), (9), (10) in (11).
Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.
Če proizvajalec nima sedeža v nobeni državi članici in ni izpolnil obveznosti iz člena 10, je pooblaščeni predstavnik brez poseganja v odstavek 4 tega člena za okvarjene pripomočke pravno odgovoren na isti podlagi kot proizvajalec in solidarno z njim.
An authorised representative who terminates its mandate on the grounds referred to in point (h) of paragraph 3 shall immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor.
Pooblaščeni predstavnik, ki svoje pooblastilo odpove iz razlogov iz točke (h) odstavka 3, o prenehanju pooblastila in razlogih zanj nemudoma obvesti pristojni organ države članice, v kateri ima sedež, in, kadar je to ustrezno, priglašeni organ, ki je bil vključen v ugotavljanje skladnosti pripomočka.
Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business.
V tej uredbi se vsako sklicevanje na pristojni organ države članice, v kateri ima proizvajalec registrirani kraj poslovanja, razume kot sklicevanje na pristojni organ države članice, v kateri ima registrirani kraj poslovanja pooblaščeni predstavnik, ki ga določi proizvajalec iz odstavka 1.
Change of authorised representative
Zamenjava pooblaščenega predstavnika
The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative.
Podrobne ureditve za zamenjavo pooblaščenega predstavnika so jasno določene v sporazumu med proizvajalcem ter, kadar je to izvedljivo, odhajajočim pooblaščenim predstavnikom in novim pooblaščenim predstavnikom.
That agreement shall address at least the following aspects:
Ta sporazum vključuje vsaj:
the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;
datum prenehanja pooblastila odhajajočemu pooblaščenemu predstavniku in datum začetka pooblastila novemu pooblaščenemu predstavniku;
the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;
datum, do katerega je odhajajoči pooblaščeni predstavnik lahko naveden v informacijah, ki jih predloži proizvajalec, vključno s promocijskim gradivom;
the transfer of documents, including confidentiality aspects and property rights;
prenos dokumentov, vključno z vidiki zaupnosti in pravicami intelektualne lastnine;
the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised representative.
obveznost odhajajočega pooblaščenega predstavnika po prenehanju pooblastila, da proizvajalcu ali novemu pooblaščenemu predstavniku posreduje vse pritožbe ali poročila zdravstvenih delavcev, pacientov ali uporabnikov o sumih na zaplete v zvezi s pripomočkom, za katerega je bil imenovan kot pooblaščeni predstavnik.
General obligations of importers
Splošne obveznosti uvoznikov
Importers shall place on the Union market only devices that are in conformity with this Regulation.
Uvozniki dajejo na trg Unije le pripomočke, ki so skladni s to uredbo.
In order to place a device on the market, importers shall verify that:
Preden lahko uvozniki dajo pripomoček na trg, preverijo, da je:
the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
pripomoček opremljen z oznako CE ter da je pripravljena izjava EU o skladnosti pripomočka;
a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;
proizvajalec znan in je imenoval pooblaščenega predstavnika v skladu s členom 11;
the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
pripomoček označen v skladu s to uredbo in so mu priložena potrebna navodila za uporabo;
where applicable, a UDI has been assigned by the manufacturer in accordance with Article 24.
proizvajalec v skladu s členom 24 določil UDI, kjer je to ustrezno.
Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative.
Če uvoznik meni ali utemeljeno domneva, da pripomoček ni skladen z zahtevami iz te uredbe, ga ne sme dati na trg, dokler ni skladen z zahtevami, ter o tem obvesti proizvajalca in pooblaščenega predstavnika proizvajalca.
Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.
Če uvoznik meni ali utemeljeno domneva, da pripomoček pomeni resno tveganje ali da je ponarejen, o tem obvesti tudi pristojni organ države članice, v kateri ima uvoznik sedež.
Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established.
Uvozniki na pripomočku, njegovi embalaži ali spremnem dokumentu navedejo svoje ime, registrirano trgovsko ime ali registrirano blagovno znamko, svoj registrirani kraj poslovanja in naslov, na katerem so dosegljivi, tako da je mogoče ugotoviti naslov njihove dejanske lokacije.
They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
Zagotovijo, da dodatne oznake ne prekrivajo nobene informacije na oznaki proizvajalca.
Importers shall verify that the device is registered in the electronic system in accordance with Article 26.
Uvozniki preverijo, da je pripomoček registriran v elektronskem sistemu v skladu s členom 26.
Importers shall add their details to the registration in accordance with Article 28.
Registracijo dopolnijo s svojimi podatki v skladu s členom 28.