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.
strategijo za skladnost z zakonodajo, tudi skladnost s postopki za ugotavljanje skladnosti in postopki za upravljanje sprememb pripomočkov, zajetih v sistem;
The quality management system shall address at least the following aspects:
ugotavljanje veljavnih splošnih zahtev glede varnosti in učinkovitosti ter preučitev možnosti za obravnavanje teh zahtev;
a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;
odgovornost uprave;
identification of applicable general safety and performance requirements and exploration of options to address those requirements;
upravljanje virov, vključno z izbiro ter nadzorom dobaviteljev in podizvajalcev;
responsibility of the management;
obvladovanje tveganja, kot je določeno v oddelku 3 Priloge I;
resource management, including selection and control of suppliers and sub-contractors;
klinično oceno v skladu s členom 61 in Prilogo XIV, vključno s kliničnim spremljanjem po dajanju na trg;
risk management as set out in in Section 3 of Annex I;
izdelovanje izdelka, vključno z načrtovanjem, zasnovo, razvojem, izdelavo in zagotavljanjem storitev;
clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;
preverjanje dodeljevanja UDI v skladu s členom 27(3) vsem ustreznim pripomočkom in zagotavljanje usklajenosti in veljavnosti informacij, posredovanih v skladu s členom 29;
product realisation, including planning, design, development, production and service provision;
pripravo, izvajanje in vzdrževanje sistema nadzora po dajanju na trg v skladu s členom 83;
verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29;
komuniciranje s pristojnimi organi, priglašenimi organi, drugimi gospodarskimi subjekti, strankami in/ali drugimi deležniki;
setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;
postopke pri poročanju o resnih zapletih in varnostnih korektivnih ukrepih v okviru vigilance;
handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;
upravljanje korektivnih in preventivnih ukrepov ter preverjanje njihove učinkovitosti;
processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;
postopke za spremljanje in merjenje proizvodnje, analizo podatkov in izboljšavo izdelkov.
management of corrective and preventive actions and verification of their effectiveness;
Proizvajalci pripomočkov izvajajo in posodabljajo sistem nadzora po dajanju na trg v skladu s členom 83.
processes for monitoring and measurement of output, data analysis and product improvement.
Proizvajalci zagotovijo, da je pripomoček opremljen z informacijami, določenimi v oddelku 23 Priloge I v uradnem jeziku ali uradnih jezikih Unije, ki jih določi država članica, v kateri je pripomoček dostopen uporabniku ali pacientu.
Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 83.
Podatki na oznaki so neizbrisni, čitljivi in jasno razumljivi predvidenemu uporabniku ali pacientu.
Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 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, ki menijo ali utemeljeno domnevajo, da pripomoček, ki so ga dali na trg ali v uporabo, ni skladen s to uredbo, nemudoma sprejmejo potrebne korektivne ukrepe, da zagotovijo skladnost pripomočka ali pa ga po potrebi umaknejo ali odpokličejo.
The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.
O tem ustrezno obvestijo distributerje zadevnega pripomočka ter po potrebi pooblaščenega predstavnika in uvoznike.
Manufacturers who 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.
Če pripomoček pomeni resno tveganje, proizvajalci o tem 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 56, zlasti o neskladnosti in sprejetih korektivnih ukrepih.
They shall inform the distributors of the device in question and, where applicable, the authorised representative and importers accordingly.
Proizvajalci imajo sistem za beleženje zapletov ter poročanje o njih in varnostnih korektivnih ukrepih, opisan v členih 87 in 88.
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 56, in particular, of the non-compliance and of any corrective action taken.
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.
Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88.
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, 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 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.
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.
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.
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.
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, in sicer brez poseganja v predpise o varstvu podatkov in, razen če prevlada javni interes za razkritje, brez poseganja v zaščito pravic intelektualne lastnine.
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.
Pristojnemu organu obveznosti iz tretjega pododstavka ni treba izpolniti, če se razkritje informacij in dokumentacije iz prvega pododstavka običajno obravnava v okviru sodnega postopka.
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.
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 30(1).
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.
Fizične ali pravne osebe lahko v skladu z veljavnim pravom Unije in nacionalnim pravom zahtevajo nadomestilo za škodo, ki jo je povzročil okvarjen pripomoček.
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 30(1).
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.
Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law.
Člen 11
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.
Pooblaščeni predstavnik
Article 11
Če proizvajalec pripomočka nima sedeža v državi članici, je mogoče pripomoček dati na trg Unije le, če proizvajalec imenuje enega samega pooblaščenega predstavnika.
Authorised representative
Imenovanje pomeni pooblastilo za pooblaščenega predstavnika, veljavno je samo, če ga pisno sprejme pooblaščeni predstavnik, in učinkuje vsaj, kar zadeva vse pripomočke iste generične skupine pripomočkov.
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.
Pooblaščeni predstavnik izvaja naloge, določene v pooblastilu, ki ga sklene s proizvajalcem.
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.
Pooblaščeni predstavnik pristojnemu organu na zahtevo predloži kopijo pooblastila.
The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer.
Pooblastilo od pooblaščenega predstavnika zahteva, proizvajalec pa mu omogoča, da opravlja vsaj naslednje naloge v zvezi s pripomočki, za katere je bil pooblaščen:
The authorised representative shall provide a copy of the mandate to the competent authority, upon request.
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;
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:
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 56, pristojnim organom na voljo za obdobje iz člena 10(8);
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;
izpolnjuje obveznosti registracije iz člena 31 ter preverja proizvajalčevo izpolnjevanje obveznosti registracije iz členov 27 in 29;
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 56, at the disposal of competent authorities for the period referred to in Article 10(8);
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;
comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;
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;
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;
sodeluje s pristojnimi organi glede morebitnih preventivnih ali korektivnih ukrepov, sprejetih za odpravo ali – če to ni mogoče – zmanjšanje tveganj, povezanih s pripomočki;
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;
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;
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;
odpove pooblastilo, če proizvajalec ravna v nasprotju s svojimi obveznostmi iz te uredbe.
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;
Pooblastilo iz odstavka 3 tega člena ne pomeni prenosa obveznosti proizvajalca iz člena 10(1), (2), (3), (4), (6), (7), (9), (10), (11) in (12).
terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
Če proizvajalec nima sedeža v eni od držav članic 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.
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), (6), (7), (9), (10), (11) and (12).
Pooblaščeni predstavnik, ki pooblastilo odpove iz razloga iz točke (h) odstavka 3, o prenehanju pooblastila in vzrokih zanj nemudoma obvesti pristojni organ države članice, v kateri ima sedež, in, kadar je ustrezno, priglašeni organ, ki je bil vključen v ugotavljanje skladnosti pripomočka.
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.
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.
An authorised representative who terminates its mandate on the ground 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.
Člen 12
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.
Zamenjava pooblaščenega predstavnika
Article 12
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.
Change of authorised representative
Ta sporazum vključuje vsaj:
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.
datum prenehanja pooblastila odhajajočemu pooblaščenemu predstavniku in datum začetka pooblastila novemu pooblaščenemu predstavniku;
That agreement shall address at least the following aspects:
datum, do katerega je odhajajoči pooblaščeni predstavnik lahko naveden v informacijah, ki jih predloži proizvajalec, vključno s promocijskim gradivom;
the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;
prenos dokumentov, vključno z vidiki zaupnosti in lastninskimi pravicami;
the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material;
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.
the transfer of documents, including confidentiality aspects and property rights;
Člen 13
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.
Splošne obveznosti uvoznikov
Article 13
Uvozniki dajejo na trg Unije le pripomočke, ki so skladni s to uredbo.
General obligations of importers
Preden lahko uvozniki dajo pripomoček na trg, preverijo, da je:
Importers shall place on the Union market only devices that are in conformity with this Regulation.
pripomoček je opremljen z oznako CE, pripravljena pa je tudi izjava EU o skladnosti pripomočka;
In order to place a device on the market, importers shall verify that:
proizvajalec znan in je imenoval pooblaščenega predstavnika v skladu s členom 11;
the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
pripomoček označen v skladu s to uredbo in so mu priložena potrebna navodila za uporabo;
a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;
proizvajalec v skladu s členom 27 določil UDI, kjer je to ustrezno.
the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
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 applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
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.
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.
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.
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.
Zagotovijo, da dodatne oznake ne prekrivajo nobene informacije na oznaki proizvajalca.
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 preverijo, da je pripomoček registriran v elektronskem sistemu v skladu s členom 29.
They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
Registracijo dopolnijo s svojimi podatki v skladu s členom 31.
Importers shall verify that the device is registered in the electronic system in accordance with Article 29.
Uvozniki zagotovijo, da v času, ko so odgovorni za pripomoček, pogoji skladiščenja ali prevoza ne ogrožajo njegove skladnosti s splošnimi zahtevami glede varnosti in učinkovitosti, določenimi v Prilogi I, in da so izpolnjeni morebitni pogoji, ki jih je določil proizvajalec.
Importers shall add their details to the registration in accordance with Article 31.
Uvozniki vodijo register pritožb, neskladnih, odpoklicanih in umaknjenih pripomočkov ter proizvajalcu, pooblaščenemu predstavniku in distributerjem sporočijo vse informacije, ki jih ti zahtevajo, da bi lahko preiskali pritožbe.
Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available.
Uvozniki, ki menijo ali utemeljeno domnevajo, da pripomoček, ki so ga dali na trg, ni v skladu s to uredbo, o tem nemudoma obvestijo proizvajalca in njegovega pooblaščenega predstavnika.