natgillin/translations-raw huggingface dataset:
Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3.
V istem obdobju 28 dni distributer ali uvoznik pristojnemu organu predloži certifikat, ki ga izda priglašeni organ, imenovan za vrsto pripomočkov, ki so predmet dejavnosti iz točk (a) in (b) odstavka 2, s katerim potrjuje, da je sistem vodenja kakovosti, vzpostavljen s strani distributerja ali uvoznika, skladen z zahtevami iz odstavka 3.
The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled.
V izjavi EU o skladnosti je navedeno, da so zahteve iz te uredbe izpolnjene.
The manufacturer shall continuously update the EU declaration of conformity.
Proizvajalec redno posodablja izjavo EU o skladnosti.
The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.
Izjava EU o skladnosti vsebuje vsaj informacije iz Priloge IV in se prevede v uradni jezik Unije ali jezike, ki jih zahteva država članica oziroma države članice, v katerih je pripomoček dostopen.
Where, concerning aspects not covered by this Regulation, devices are subject to other Union legislation which also requires an EU declaration of conformity by the manufacturer that fulfilment of the requirements of that legislation has been demonstrated, a single EU declaration of conformity shall be drawn up in respect of all Union acts applicable to the device.
Kadar so pripomočki v zvezi z vidiki, ki jih ta uredba ne zajema, predmet druge zakonodaje Unije, na podlagi katere je prav tako potrebna izjava EU o skladnosti proizvajalca za dokazovanje izpolnjevanja zahtev iz navedene zakonodaje, se pripravi enotna izjava EU o skladnosti, ki upošteva vse akte Unije, ki se uporabljajo za pripomoček.
The declaration shall contain all the information required for identification of the Union legislation to which the declaration relates.
Ta izjava vsebuje vse informacije, ki so potrebne za identifikacijo zakonodaje Unije, na katero se izjava nanaša.
By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all other Union legislation applicable to the device.
S pripravo izjave EU o skladnosti proizvajalec prevzame odgovornost za skladnost z zahtevami iz te uredbe in vso drugo zakonodajo Unije, ki se uporablja za pripomočke.
The Commission is empowered to adopt delegated acts in accordance with Article 108 amending the minimum content of the EU declaration of conformity set out in Annex IV in the light of technical progress.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 108, s katerimi zaradi tehničnega napredka spremeni ali dopolni osnovno vsebino izjave EU o skladnosti, določene v Prilogi IV.
CE marking of conformity
Oznaka skladnosti CE
Devices, other than devices for performance studies, considered to be in conformity with the requirements of this Regulation shall bear the CE marking of conformity, as presented in Annex V.
Pripomočki, razen pripomočkov za študije učinkovitosti, za katere se šteje, da so skladni z zahtevami te uredbe, so opremljeni z oznako skladnosti CE, kot je predstavljena v Prilogi V.
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Za oznako CE veljajo splošna načela, določena v členu 30 Uredbe (ES) št. 765/2008.
The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging.
Oznaka CE se vidno, čitljivo in neizbrisno namesti na pripomoček ali njegovo sterilno pakiranje.
Where such affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the packaging.
Če takšna namestitev ni mogoča ali ni upravičena zaradi narave pripomočka, se oznaka CE namesti na embalažo.
The CE marking shall also appear in any instructions for use and on any sales packaging.
Oznaka CE je navedena tudi v vseh navodilih za uporabo in na vsaki prodajni embalaži.
The CE marking shall be affixed before the device is placed on the market.
Oznaka CE je nameščena, preden je pripomoček dan na trg.
Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 48.
Oznaki CE po potrebi sledi identifikacijska številka priglašenega organa, odgovornega za postopke ugotavljanja skladnosti, določene v členu 48.
The identification number shall also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking.
Identifikacijska številka je navedena tudi v promocijskem gradivu, v katerem je navedeno, da pripomoček izpolnjuje zahteve za oznako CE.
Where devices are subject to other Union legislation which also provides for the affixing of the CE marking, the CE marking shall indicate that the devices also fulfil the requirements of that other legislation.
Če pripomočke ureja druga zakonodaja Unije, ki prav tako predvideva pritrditev oznake CE, ta kaže, da pripomočki izpolnjujejo tudi zahteve te druge zakonodaje.
Devices for special purposes
Pripomočki za posebne namene
Member States shall not create obstacles to devices for performance study being supplied for that purpose to laboratories or other institutions, if they meet the conditions laid down in Articles 57 to 76, and in the implementing acts adopted pursuant to Article 77.
Države članice ne ovirajo pripomočkov za študijo učinkovitosti, ki so za ta namen dobavljeni laboratorijem ali drugim ustanovam, če izpolnjujejo pogoje iz členov 57 do 76 in iz izvedbenih aktov, sprejetih na podlagi člena 77.
The devices referred to in paragraph 1 shall not bear the CE marking, with the exception of the devices referred to in Article 70.
Pripomočki iz odstavka 1, razen pripomočkov iz člena 70, nimajo oznake CE.
At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create obstacles to the showing of devices which do not comply with this Regulation, provided that a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with this Regulation.
Države članice na obrtnih sejmih, razstavah, demonstracijah ali podobnih prireditvah ne ovirajo prikazovanja pripomočkov, ki niso skladni s to uredbo, če viden znak jasno navaja, da so taki pripomočki namenjeni samo za prikaz ali predstavitev in ne morejo biti dostopni, dokler niso skladni s to uredbo.
Parts and components
Deli in komponente
Any natural or legal person who makes available on the market an item specifically intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, shall ensure that the item does not adversely affect the safety and performance of the device.
Vsaka fizična ali pravna oseba, ki omogoči dostopnost predmeta na trgu, posebej namenjenega za nadomestitev enakega ali podobnega sestavnega dela ali komponente pripomočka, ki je okvarjen ali izrabljen, z namenom ohranjanja ali ponovne vzpostavitve delovanja pripomočka, ne da bi spremenila njegovo učinkovitost ali varnostne značilnosti ali njegov predvideni namen, zagotovi, da predmet ne slabi varnosti in učinkovitosti pripomočka.
Supporting evidence shall be kept available for the competent authorities of the Member States.
Ustrezna dokazila so na voljo pristojnim organom držav članic.
An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Regulation.
Predmet, ki je posebej namenjen nadomestitvi dela ali komponente pripomočka in ki bistveno spremeni učinkovitost ali varnostne značilnosti ali predvideni namen pripomočka, se šteje za pripomoček in ustreza zahtevam iz te uredbe.
Except where otherwise provided for in this Regulation, Member States shall not refuse, prohibit or restrict the making available on the market or putting into service within their territory of devices which comply with the requirements of this Regulation.
Če v tej uredbi ni določeno drugače, države članice ne smejo zavrniti, prepovedati ali omejiti omogočanja dostopnosti pripomočkov, ki so skladni z zahtevami te uredbe, na trgu ali dajanja takšnih pripomočkov v uporabo na svojem ozemlju.
IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES
IDENTIFIKACIJA IN SLEDLJIVOST PRIPOMOČKOV, REGISTRACIJA PRIPOMOČKOV IN GOSPODARSKIH SUBJEKTOV, POVZETEK O VARNOSTI IN KLINIČNI UČINKOVITOSTI, EVROPSKA PODATKOVNA ZBIRKA ZA MEDICINSKE PRIPOMOČKE
Identification within the supply chain
Identifikacija v dobavni verigi
Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.
Distributerji in uvozniki sodelujejo s proizvajalci ali pooblaščenimi predstavniki, da bi dosegli ustrezno raven sledljivosti pripomočkov.
Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(7):
Gospodarski subjekti lahko v obdobju iz člena 10(7) pristojnim organom identificirajo:
any economic operator to whom they have directly supplied a device;
vsakega gospodarskega subjekta, ki so mu neposredno dobavili pripomoček;
any economic operator who has directly supplied them with a device;
vsakega gospodarskega subjekta, ki jim je neposredno dobavil pripomoček;
any health institution or healthcare professional to which they have directly supplied a device.
vsako zdravstveno ustanovo ali zdravstvenega delavca, ki so mu neposredno dobavili pripomoček.
Medical devices nomenclature
Nomenklatura o medicinskih pripomočkih
To facilitate the functioning of the European database on medical devices (Eudamed) as referred to in Article 33 of Regulation (EU) 2017/745, the Commission shall ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature.
Komisija za lažje delovanje Evropske podatkovne zbirke za medicinske pripomočke (v nadaljnjem besedilu: Eudamed) iz člena 33 Uredbe (EU) 2017/745 zagotovi, da je mednarodno priznana nomenklatura o medicinskih pripomočkih brezplačno na voljo proizvajalcem in drugim fizičnim ali pravnim osebam, ki jo morajo uporabljati v skladu s to uredbo.
The Commission shall also endeavour to ensure that that nomenclature is available to other stakeholders free of charge, where reasonably practicable.
Komisija si prav tako prizadeva zagotoviti, da je nomenklatura brezplačno na voljo drugim deležnikom, kadar je to upravičeno in izvedljivo.
Unique Device Identification system
Sistem edinstvene identifikacije pripomočka
The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than devices for performance studies, and shall consist of the following:
Sistem edinstvene identifikacije pripomočka (v nadaljnjem besedilu: sistem UDI – Unique Device Identification system)), opisan v delu C Priloge VI, omogoča identifikacijo in olajša sledljivost pripomočkov, razen pripomočkov za študije učinkovitosti, sestavljajo pa ga:
production of a UDI that comprises the following:
izdelava UDI, ki zajema:
a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Annex VI;
identifikator pripomočka UDI (v nadaljnjem besedilu: UDI-DI – UDI device identifier), ki je specifičen za proizvajalca, in pripomoček, ki omogoča dostop do informacij iz dela B Priloge VI;
a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI;
identifikator proizvodnje UDI (v nadaljnjem besedilu: UDI-PI – UDI production identifier), ki določa enoto proizvodnje pripomočka in po potrebi pakirane pripomočke, kot je določeno v delu C Priloge VI;
placing of the UDI on the label of the device or on its packaging;
navedba UDI na oznaki pripomočka ali na njegovi embalaži;
storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 respectively;
hramba UDI s strani gospodarskih subjektov, zdravstvenih ustanov in zdravstvenih delavcev v skladu s pogoji iz odstavkov 8 oziroma 9;
establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with Article 28 of Regulation (EU) 2017/745.
vzpostavitev elektronskega sistema za edinstveno identifikacijo pripomočka (v nadaljnjem besedilu: podatkovna zbirka UDI) v skladu s členom 28 Uredbe (EU) 2017/745.
The Commission shall, by means of implementing acts, designate one or several entities to operate a system for assignment of UDIs pursuant to this Regulation (‘issuing entity’).
Komisija z izvedbenimi akti imenuje enega ali več subjektov, ki upravljajo sistem za dodeljevanje UDI v skladu s to uredbo (v nadaljnjem besedilu: subjekt izdajatelj).
That entity or those entities shall satisfy all of the following criteria:
Ta subjekt ali ti subjekti izpolnjujejo vsa naslednja merila:
the entity is an organisation with legal personality;
subjekt je pravna oseba;
its system for the assignment of UDIs is adequate to identify a device throughout its distribution and use in accordance with the requirements of this Regulation;
njegov sistem za dodeljevanje UDI je primeren za identifikacijo pripomočka v celotnem procesu njegove distribucije in uporabe v skladu z zahtevami te uredbe;
its system for the assignment of UDIs conforms to the relevant international standards;
njegov sistem za dodeljevanje UDI je v skladu z ustreznimi mednarodnimi standardi;
the entity gives access to its system for the assignment of UDIs to all interested users in accordance with a set of predetermined and transparent terms and conditions;
subjekt omogoča dostop do sistema za dodelitev UDI vsem zainteresiranim uporabnikom na podlagi vnaprej določenih in preglednih pogojev;
the entity undertakes to do the following:
subjekt se obveže, da bo:
operate its system for the assignment of UDIs for at least 10 years after its designation;
upravljal sistem za dodelitev UDI vsaj deset let po njegovem imenovanju;
make available to the Commission and to the Member States, upon request, information concerning its system for the assignment of UDIs;
Komisiji in državam članicam na njihovo zahtevo dal na voljo informacije o sistemu za dodeljevanje UDI;
remain in compliance with the criteria for designation and the terms of designation.
ohranjal skladnost z merili in pogoji iz imenovanja.
When designating issuing entities, the Commission shall endeavour to ensure that UDI carriers, as defined in Part C of Annex VI, are universally readable regardless of the system used by the issuing entity, with a view to minimising financial and administrative burdens for economic operators, health institutions and healthcare professionals.
Komisija si pri imenovanju subjektov izdajateljev prizadeva zagotoviti, da so zapisi UDI, kot so opredeljeni v delu C Priloge VI, splošno čitljivi, ne glede na sistem, ki ga uporablja subjekt izdajatelj, da bi se čim bolj zmanjšala finančna in upravna bremena za gospodarske subjekte, zdravstvene ustanove in zdravstvene delavce.
Before placing a device, other than a device for performance study, on the market, the manufacturer shall assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2.
Proizvajalec pred dajanjem pripomočka na trg, razen pripomočka za študijo učinkovitosti, pripomočku in, če je to ustrezno, vsem višjim stopnjam pakiranja določi edinstveno identifikacijo pripomočka, ustvarjeno v skladu s pravili subjekta izdajatelja, ki ga imenuje Komisija v skladu z odstavkom 2.
Before a device, other than a device for performance study, is placed on the market the manufacturer must ensure that the information referred to in Part B of Annex V of the device in question are correctly submitted and transferred to the UDI database referred to in Article 25.
Proizvajalec pred dajanjem pripomočka na trg, razen pripomočka za študijo učinkovitosti, zagotovi, da so informacije iz dela B Priloge V zvezi z zadevnim pripomočkom pravilno predložene in prenesene v podatkovno zbirko UDI iz člena 25.
UDI carriers shall be placed on the label of the device and on all higher levels of packaging.
Zapisi UDI se navedejo na oznaki pripomočka in vseh višjih stopnjah pakiranja.
Higher levels of packaging shall not be understood to include shipping containers.
Višje stopnje pakiranja ne vključujejo vsebnikov za prevoz.
The UDI shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 82.
UDI se uporablja za poročanje o resnih zapletih in varnostnih korektivnih ukrepih v skladu s členom 82.
The Basic UDI-DI, as defined in Part C of Annex VI of the device shall appear on the EU declaration of conformity referred to in Article 17.
Osnovni UDI-DI, kot je opredeljen v delu C Priloge VI, se navede v izjavi EU o skladnosti iz člena 17.
As part of the technical documentation referred to in Annex II, the manufacturer shall keep up-to-date a list of all UDIs that it has assigned.
Proizvajalec kot del tehnične dokumentacije iz Priloge II hrani posodobljeni seznam vseh UDI, ki jih je dodelil.
Economic operators shall store and keep, preferably by electronic means, the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 11.
Gospodarski subjekti shranijo in hranijo, po možnosti v elektronski obliki, UDI za pripomočke, ki so jih dobavili ali so jim bili dobavljeni, če ti pripomočki spadajo med pripomočke, kategorije ali skupine pripomočkov, določene z ukrepom iz točke (a) odstavka 11.
Member States shall encourage, and may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied.
Države članice spodbujajo zdravstvene ustanove ter lahko od njih zahtevajo, da shranijo in hranijo, po možnosti v elektronski obliki, UDI za pripomočke, ki so jim bili dobavljeni.
Member States shall encourage, and may require, health care professionals to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied with.
Države članice spodbujajo zdravstvene delavce ter lahko od njih zahtevajo, da shranijo in hranijo, po možnosti v elektronski obliki, UDI za pripomočke, ki so jim bili dobavljeni.
The Commission is empowered to adopt delegated acts in accordance with Article 108:
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 108 za:
amending the list of information set out in Part B of Annex VI in the light of technical progress; and
spreminjanje seznama informacij iz dela B Priloge VI glede na tehnični napredek ter
amending Annex VI in the light of international developments and technical progress in the field of Unique Device Identification.
spreminjanje Priloge VI glede na mednarodni razvoj in tehnični napredek na področju edinstvene identifikacije pripomočka.
The Commission may, by means of implementing acts, specify the detailed arrangements and the procedural aspects for the UDI system with a view to ensuring its harmonised application in relation to any of the following:
Komisija lahko z izvedbenimi akti določi podrobne ureditve in postopkovne vidike za sistem UDI z namenom zagotavljanja njegove harmonizirane uporabe glede naslednjega:
determining the devices, categories or groups of devices to which the obligation laid down in paragraph 8 is to apply;
določitev pripomočkov, kategorij ali skupin pripomočkov, za katere velja obveznost iz odstavka 8;
specifying the data to be included in the UDI-PI of specific devices or device groups.
določitev podatkov, ki jih je treba vključiti v UDI-PI za posamezne pripomočke ali skupine pripomočkov.
The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Izvedbeni akti iz prvega pododstavka se sprejmejo v skladu s postopkom pregleda iz člena 107(3).
When adopting the measures referred to in paragraph 11, the Commission shall take into account all of the following:
Pri sprejetju ukrepov iz odstavka 11 Komisija upošteva vse od naslednjega:
confidentiality and data protection as referred to in Articles 102 and 103 respectively;
zaupnost in varstvo podatkov iz členov 102 oziroma 103;
the risk-based approach;
pristop, ki temelji na tveganju;
the cost-effectiveness of the measures;
stroškovno učinkovitost ukrepov;
the convergence of UDI systems developed at international level;
zbliževanje s sistemi UDI, nastalimi na mednarodni ravni;
the need to avoid duplications in the UDI system;
potrebo po izogibanju podvajanja v sistemu UDI;
the needs of the health care systems of the Member States, and where possible, compatibility with other medical device identification systems that are used by stakeholders.
potrebe zdravstvenih sistemov držav članic in, kjer je to mogoče, kompatibilnost z drugimi sistemi za identifikacijo medicinskih pripomočkov, ki jih uporabljajo deležniki.
UDI database
Podatkovna zbirka UDI
The Commission, after consulting the MDCG, shall set up and manage a UDI database in accordance with the conditions and detailed arrangements provided for in Article 28 of Regulation (EU) 2017/745.
Komisija po posvetovanju s Koordinacijsko skupino za medicinske pripomočke vzpostavi in upravlja podatkovno zbirko UDI v skladu s pogoji in podrobnimi ureditvami iz člena 28 Uredbe (EU) 2017/745.
Registration of devices
Registracija pripomočkov
Before placing a device on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 24(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.
Preden se pripomoček da na trg, proizvajalec v skladu s pravili subjekta izdajatelja iz člena 24(2) pripomočku dodeli osnovni UDI-DI, kot je opredeljen v delu C Priloge VI, in ga posreduje v podatkovno zbirko UDI skupaj z drugimi osnovnimi elementi podatkov iz dela B Priloge VI v zvezi s tem pripomočkom.
For devices that are the subject of a conformity assessment as referred to in Article 48(3) and (4), the second subparagraph of Article 48(7), Article 48(8) and the second subparagraph of Article 48(9), the assignment of a Basic UDI-DI referred to in paragraph 1 of this Article shall be done before the manufacturer applies to a notified body for that assessment.
Za pripomočke, ki so predmet ugotavljanja skladnosti iz člena 48(3) in (4), drugega pododstavka člena 48(7), člena 48(8) in drugega pododstavka člena 48(9), se osnovni UDI-DI iz odstavka 1 tega člena dodeli, preden proizvajalec vloži vlogo pri priglašenem organu za to ugotavljanje.