natgillin/translations-raw huggingface dataset:
the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation.
Kadar sistem ali paket vsebuje pripomočke, ki nimajo oznake CE, kadar izbrana kombinacija pripomočkov ni združljiva z njihovim prvotno predvidenim namenom ali kadar sterilizacija ni bila opravljena v skladu s proizvajalčevimi navodili, se sistem ali paket obravnava kot pripomoček sam po sebi in je kot tak predmet postopka ugotavljanja skladnosti v skladu s členom 52.
Any natural or legal person who sterilises systems or procedure packs referred to in paragraph 1 for the purpose of placing them on the market shall, at their choice, apply one of the procedures set out in Annex IX or the procedure set out in Part A of Annex XI.
Fizična ali pravna oseba prevzame obveznosti proizvajalcev.
The application of those procedures and the involvement of the notified body shall be limited to the aspects of the procedure relating to ensuring sterility until the sterile packaging is opened or damaged.
Sistemi ali paketi iz odstavka 1 tega člena nimajo dodatne oznake CE, vendar so opremljeni z imenom, registriranim trgovskim imenom ali registrirano blagovno znamko osebe iz odstavkov 1 in 3 tega člena ter naslovom, na katerem je ta oseba dosegljiva, tako da je mogoče ugotoviti naslov njene dejanske lokacije.
The natural or legal person shall draw up a statement declaring that sterilisation has been carried out in accordance with the manufacturer's instructions.
Sistemom ali paketom morajo biti priložene informacije iz oddelka 23 Priloge I. Po tem, ko je bil sistem ali paket sestavljen, je izjava iz odstavka 2 tega člena na voljo pristojnim organom za obdobje, ki se uporablja v skladu s členom 10(8) za pripomočke, ki so bili kombinirani.
Where the system or procedure pack incorporates devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manufacturer's instructions, the system or procedure pack shall be treated as a device in its own right and shall be subject to the relevant conformity assessment procedure pursuant to Article 52.
Če se ta obdobja razlikujejo, se uporabi daljše.
The natural or legal person shall assume the obligations incumbent on manufacturers.
Člen 23
The systems or procedure packs referred to in paragraph 1 of this Article shall not themselves bear an additional CE marking but they shall bear the name, registered trade name or registered trade mark of the person referred to in paragraphs 1 and 3 of this Article as well as the address at which that person can be contacted, so that the person's location can be established.
Deli in komponente
Systems or procedure packs shall be accompanied by the information referred to in Section 23 of Annex I. The statement referred to in paragraph 2 of this Article shall be kept at the disposal of the competent authorities, after the system or procedure pack has been put together, for the period that is applicable under Article 10(8) to the devices that have been combined.
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.
Where those periods differ, the longest period shall apply.
Ustrezna dokazila so na voljo pristojnim organom držav članic.
Article 23
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.
Parts and components
Člen 24
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.
Prosti pretok
Supporting evidence shall be kept available for the competent authorities of the Member States.
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.
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.
POGLAVJE III
Article 24
IDENTIFIKACIJA IN SLEDLJIVOST PRIPOMOČKOV, REGISTRACIJA PRIPOMOČKOV IN GOSPODARSKIH SUBJEKTOV, POVZETEK O VARNOSTI IN KLINIČNI UČINKOVITOSTI, EVROPSKA PODATKOVNA ZBIRKA ZA MEDICINSKE PRIPOMOČKE
Free movement
Člen 25
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.
Identifikacija v dobavni verigi
CHAPTER III
Distributerji in uvozniki sodelujejo s proizvajalci ali pooblaščenimi predstavniki, da bi dosegli ustrezno raven sledljivosti pripomočkov.
IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES
Gospodarski subjekti lahko v obdobju iz člena 10(8) pristojnim organom identificirajo:
Article 25
vsakega gospodarskega subjekta, ki so mu neposredno dobavili pripomoček;
Identification within the supply chain
vsakega gospodarskega subjekta, ki jim je neposredno dobavil pripomoček;
Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.
vsako zdravstveno ustanovo ali zdravstvenega delavca, ki so mu neposredno dobavili pripomoček.
Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(8):
Člen 26
any economic operator to whom they have directly supplied a device;
Nomenklatura o medicinskih pripomočkih
any economic operator who has directly supplied them with a device;
Komisija za lažje delovanje Evropske podatkovne zbirke za medicinske pripomočke (v nadaljnjem besedilu: Eudamed) iz člena 33 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.
any health institution or healthcare professional to which they have directly supplied a device.
Komisija si prav tako prizadeva zagotoviti, da je nomenklatura brezplačno na voljo drugim deležnikom, kadar je to upravičeno in izvedljivo.
Article 26
Člen 27
Medical devices nomenclature
Sistem edinstvene identifikacije pripomočka
To facilitate the functioning of the European database on medical devices (‘Eudamed’) as referred to in Article 33, 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.
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, izdelanih za posameznega uporabnika, in pripomočkov, ki so predmet raziskave, sestavljajo pa ga:
The Commission shall also endeavour to ensure that that nomenclature is available to other stakeholders free of charge, where reasonably practicable.
izdelava UDI, ki zajema:
Article 27
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;
Unique Device Identification system
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;
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 custom-made and investigational devices, and shall consist of the following:
navedba UDI na oznaki pripomočka ali na njegovi embalaži;
production of a UDI that comprises the following:
hramba UDI s strani gospodarskih subjektov, zdravstvenih ustanov in zdravstvenih delavcev v skladu s pogoji iz odstavkov 8 oziroma 9 tega člena;
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;
vzpostavitev elektronskega sistema za edinstveno identifikacijo pripomočka (v nadaljnjem besedilu: podatkovna zbirka UDI ) v skladu s členom 28.
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;
Komisija z izvedbenimi akti imenuje enega ali več subjektov, ki upravljajo sistem za dodeljevanje UDI v skladu s to uredbo (subjekt izdajatelj).
placing of the UDI on the label of the device or on its packaging;
Ta subjekt ali ti subjekti izpolnjujejo vsa naslednja merila:
storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 of this Article respectively;
subjekti so pravne osebe;
establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with Article 28.
njihov sistem za dodeljevanje UDI je ustrezen za identifikacijo pripomočka v celotnem procesu njegove distribucije in uporabe v skladu z zahtevami te uredbe;
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’).
njihov sistem za dodeljevanje UDI je v skladu z ustreznimi mednarodnimi standardi;
That entity or those entities shall satisfy all of the following criteria:
omogočajo dostop do sistema za dodelitev UDI vsem zainteresiranim uporabnikom na podlagi vnaprej določenih in preglednih pogojev;
the entity is an organisation with legal personality;
se obvežejo, da bodo:
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;
sistem za dodelitev UDI upravljali vsaj deset let po tem, ko so bili imenovani;
its system for the assignment of UDIs conforms to the relevant international standards;
Komisiji in državam članicam na njihovo zahtevo dali na voljo informacije o sistemu za dodeljevanje UDI;
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;
ohranjali skladnost z merili in pogoji iz imenovanja.
the entity undertakes to do the following:
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 in zdravstvene ustanove.
operate its system for the assignment of UDIs for at least 10 years after its designation;
Proizvajalec pripomočku, ki ni pripomoček, izdelan za posameznega uporabnika, preden ga da na trg, in, če je to ustrezno, vsem višjim stopnjam pakiranja določi UDI, ustvarjeno v skladu s pravili subjekta izdajatelja, ki ga imenuje Komisija v skladu z odstavkom 2.
make available to the Commission and to the Member States, upon request, information concerning its system for the assignment of UDIs;
Preden se pripomoček, ki ni pripomoček, izdelan za posameznega uporabnika, ali pripomoček, ki je predmet raziskave, da na trg, proizvajalec zagotovi, da so informacije iz dela B Priloge VI v zvezi z zadevnim pripomočkom pravilno predložene in prenesene v podatkovno zbirko UDI iz člena 28.
remain in compliance with the criteria for designation and the terms of designation.
Zapisi UDI se navedejo na oznaki pripomočka in vseh višjih stopnjah pakiranja.
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 and health institutions.
Višje stopnje pakiranja ne vključujejo vsebnikov za prevoz.
Before placing a device, other than a custom-made device, 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.
UDI se uporablja za poročanje o resnih zapletih in varnostnih korektivnih ukrepih v skladu s členom 87.
Before a device, other than a custom-made or investigational device, is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in question are correctly submitted and transferred to the UDI database referred to in Article 28.
Osnovni UDI-DI kot je opredeljen v delu C Priloge VI, se navede v izjavi EU o skladnosti iz člena 19.
UDI carriers shall be placed on the label of the device and on all higher levels of packaging.
Proizvajalec kot del tehnične dokumentacije iz Priloge II hrani posodobljeni seznam vseh UDI, ki jih je dodelil.
Higher levels of packaging shall not be understood to include shipping containers.
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:
The UDI shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 87.
pripomočke za vsaditev razreda III;
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 19.
pripomočke, kategorije ali skupine pripomočkov, določene z ukrepom iz točke (a) odstavka 11.
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.
Zdravstvene ustanove shranijo in hranijo, po možnosti v elektronski obliki, UDI za pripomočke, ki so jih dobavile ali so jim bili dobavljeni, če ti pripomočki spadajo med pripomočke za vsaditev razreda III.
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:
Za pripomočke, ki niso pripomočki za vsaditev razreda III, države članice zdravstvene ustanove spodbujajo ter od njih lahko zahtevajo, da shranijo in hranijo, po možnosti v elektronski obliki, UDI za pripomočke, ki so jim bili dobavljeni.
class III implantable devices;
Države članice zdravstvene delavce spodbujajo ter od njih lahko zahtevajo, da shranijo in hranijo, po možnosti v elektronski obliki, UDI za pripomočke, ki so jim bili dobavljeni.
the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 11.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 115, s katerimi:
Health institutions 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 class III implantable devices.
spreminja seznam informacij iz dela B Priloge VI zaradi tehničnega napredka ter
For devices other than class III implantable devices, 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.
spreminja Prilogo VI glede na mednarodni razvoj in tehnični napredek na področju edinstvene identifikacije pripomočka.
Member States shall encourage, and may require, healthcare professionals to store and keep preferably by electronic means, the UDI of the devices with which they have been supplied with.
Komisija lahko z izvedbenimi akti določi podrobne ureditve in postopkovne vidike za sistem UDI z namenom zagotavljanja njegove harmonizirane uporabe glede naslednjega:
The Commission is empowered to adopt delegated acts in accordance with Article 115:
določitev pripomočkov, kategorij ali skupin pripomočkov, za katere velja obveznost iz odstavka 8, ali
amending the list of information set out in Part B of Annex VI in the light of technical progress; and
določitev podatkov, ki jih je treba vključiti v UDI-PI za posamezne pripomočke ali skupine pripomočkov.
amending Annex VI in the light of international developments and technical progress in the field of Unique Device Identification.
Izvedbeni akti iz prvega pododstavka se sprejmejo v skladu s postopkom pregleda iz člena 114(3).
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:
Pri sprejetju ukrepov iz odstavka 11 Komisija upošteva vse od naslednjega:
determining the devices, categories or groups of devices to which the obligation laid down in paragraph 8 is to apply;
zaupnost in varstvo podatkov iz členov 109 oziroma 110;
specifying the data to be included in the UDI-PI of specific devices or device groups;
pristop, ki temelji na tveganju;
The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 114(3).
stroškovno učinkovitost ukrepov;
When adopting the measures referred to in paragraph 11, the Commission shall take into account all of the following:
zbliževanje s sistemi UDI, nastalimi na mednarodni ravni;
confidentiality and data protection as referred to in Articles 109 and 110 respectively;
potrebo po izogibanju podvajanja v sistemu UDI;
the risk-based approach;
potrebe zdravstvenih sistemov držav članic in, kjer je to mogoče, kompatibilnost z drugimi sistemi za identifikacijo medicinskih pripomočkov, ki jih uporabljajo deležniki.
the cost-effectiveness of the measures;
Člen 28
the convergence of UDI systems developed at international level;
Podatkovna zbirka UDI
the need to avoid duplications in the UDI system;
Komisija po posvetovanju s Koordinacijsko skupino za medicinske pripomočke vzpostavi in upravlja podatkovno zbirko UDI za potrjevanje, zbiranje in obdelovanje informacij iz dela B Priloge VI ter za dostop javnosti do njih.
the needs of the healthcare systems of the Member States, and where possible, compatibility with other medical device identification systems that are used by stakeholders.
Komisija pri zasnovi podatkovne zbirke UDI upošteva splošna načela iz oddelka 5 dela C Priloge VI.
Article 28
Podatkovna zbirka UDI je zasnovana zlasti tako, da ne vsebuje UDI-PI in zaupnih poslovnih informacij o izdelku.
UDI database
Osnovni elementi podatkov, ki jih je treba posredovati podatkovni zbirki UDI, iz dela B Priloge VI so javnosti dostopni brezplačno.
The Commission, after consulting the MDCG shall set up and manage a UDI database to validate, collate, process and make available to the public the information mentioned in Part B of Annex VI.
Tehnična zasnova podatkovne zbirke UDI zagotavlja maksimalno dostopnost informacij, shranjenih v njej, vključno z večuporabniškim dostopom ter avtomatičnim nalaganjem in prenosom teh informacij.
When designing the UDI database, the Commission shall take into account the general principles set out in Section 5 of Part C of Annex VI.
Komisija proizvajalcem in drugim uporabnikom podatkovne zbirke UDI zagotovi tehnično in administrativno podporo.
The UDI database shall be designed in particular such that no UDI-PIs and no commercially confidential product information can be included therein.
Člen 29
The core data elements to be provided to the UDI database, referred to in Part B of Annex VI, shall be accessible to the public free of charge.
Registracija pripomočkov
The technical design of the UDI database shall ensure maximum accessibility to information stored therein, including multi-user access and automatic uploads and downloads of that information.
Proizvajalec pripomočku, ki ni pripomoček, izdelan za posameznega uporabnika, preden ga da na trg, v skladu s pravili subjekta izdajatelja iz člena 27(2) dodeli osnovni UDI-DI, kot je opredeljen v delu C Priloge VI, in ga vnese v podatkovno zbirko UDI skupaj z drugimi osnovnimi elementi podatkov iz dela B Priloge VI v zvezi s tem pripomočkom.
The Commission shall provide for technical and administrative support to manufacturers and other users of the UDI database.
Pristojna fizična ali pravna oseba sistemu ali paketu iz člena 22(1) in (3), ki ni pripomoček, izdelan za posameznega uporabnika, preden ga da na trg, v skladu s pravili subjekta izdajatelja dodeli osnovni UDI-DI in ga posreduje v podatkovno zbirko UDI skupaj z drugimi osnovnimi elementi podatkov iz dela B Priloge VI v zvezi s tem sistemom ali paketom.
Article 29
Za pripomočke, ki so predmet ugotavljanja skladnosti iz člena 52(3) ter iz drugega in tretjega pododstavka člena 52(4), se osnovni UDI-DI iz odstavka 1 tega člena dodeli, preden proizvajalec vloži vlogo pri priglašenem organu za to ugotavljanje.
Registration of devices
Za pripomočke iz prvega pododstavka priglašeni organ na certifikatu, izdanem v skladu s točko (a) oddelka 4 poglavja I Priloge XII, navede sklic na osnovni UDI-DI in v Eudamedu potrdi, da so informacije iz oddelka 2.2 dela A Priloge IV pravilne.
Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 27(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.
Proizvajalec po izdaji ustreznega certifikata in pred dajanjem pripomočka na trg osnovni UDI-DI posreduje v podatkovno zbirko UDI skupaj z drugimi osnovnimi elementi podatkov iz dela B Priloge VI v zvezi s tem pripomočkom.
Before placing on the market a system or procedure pack pursuant to Article 22(1) and (3), that is not a custom-made device, the natural or legal person responsible shall assign to the system or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI 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 system or procedure pack.
Člen 30
After the issuing of the relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.
Podrobnosti o informacijah, ki jih v ta elektronski sistem posredujejo gospodarski subjekti, so določene v oddelku 1 dela A Priloge VI.
Before placing a device on the market, other than a custom-made device, the manufacturer shall enter or if, already provided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2 thereof, and shall thereafter keep the information updated.
Države članice lahko ohranijo ali uvedejo nacionalne določbe o registraciji distributerjev pripomočkov, ki so dostopni na njihovem ozemlju.