natgillin/translations-raw huggingface dataset:
For the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI on the certificate issued in accordance with point (a) of Section 4 of Annex XII and confirm in Eudamed that the information referred to in Section 2.2 of Part A of Annex VI is correct.
Za pripomočke iz prvega pododstavka priglašeni organ na certifikatu, izdanem v skladu s točko (a) oddelka 4 Priloge XII, navede sklic na osnovni UDI-DI in v Eudamedu potrdi, da so informacije iz oddelka 2.2 dela A Priloge IV pravilne.
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.
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 a device on the market, 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 thereafter shall keep the information updated.
Proizvajalec pred dajanjem pripomočka na trg v Eudamed vnese oziroma, če so že vnešene, preveri informacije iz oddelka 2 dela A Priloge VI, razen oddelka 2.2 navedene priloge, in jih potem redno posodablja.
Electronic system for registration of economic operators
Elektronski sistem za registracijo gospodarskih subjektov
The Commission, after consulting the MDCG, shall set up and manage an electronic system to create the single registration number referred to in Article 28(2) and to collate and process information that is necessary and proportionate to identify the manufacturer and, where applicable, the authorised representative and the importer.
Komisija po posvetovanju s Koordinacijsko skupino za medicinske pripomočke vzpostavi in upravlja elektronski sistem za določitev enotne registrske številke iz člena 28(2) in za zbiranje in obdelavo informacij, ki so potrebne in sorazmerne za identifikacijo proizvajalca ter po potrebi pooblaščenega predstavnika in uvoznika.
The details regarding the information to be provided to that electronic system by the economic operators are laid down in Section 1 of Part A of Annex VI.
Podrobnosti o informacijah, ki jih v ta elektronski sistem posredujejo gospodarski subjekti, so določene v oddelku 1 dela A Priloge VI.
Member States may maintain or introduce national provisions on registration of distributors of devices which have been made available on their territory.
Države članice lahko ohranijo ali uvedejo nacionalne določbe o registraciji distributerjev pripomočkov, ki so dostopni na njihovem ozemlju.
Within two weeks of placing a device on the market, importers shall verify that the manufacturer or authorised representative has provided to the electronic system the information referred to in paragraph 1.
Uvozniki v dveh tednih po dajanju pripomočka na trg preverijo, ali je proizvajalec ali pooblaščeni predstavnik v elektronski sistem posredoval informacije iz odstavka 1.
Where applicable, importers shall inform the relevant authorised representative or manufacturer if the information referred to in paragraph 1 is not included or is incorrect.
Uvozniki po potrebi obvestijo ustreznega pooblaščenega predstavnika ali proizvajalca, da informacije iz odstavka 1 niso bile vnesene ali da so napačne.
Importers shall add their details to the relevant entry/entries.
Uvozniki zadevne vnose dopolnijo s svojimi podatki.
Registration of manufacturers, authorised representatives and importers
Registracija proizvajalcev, pooblaščenih predstavnikov in uvoznikov
Before placing a device on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article.
Preden se pripomoček da na trg, se proizvajalci, pooblaščeni predstavniki in uvozniki registrirajo tako, da vnesejo v elektronski sistem iz člena 30 informacije iz oddelka 1 dela A Priloge VI, če še niso registrirani v skladu s tem členom.
In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to Article 48, the information referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the notified body.
Kadar mora v postopku ugotavljanja skladnosti v skladu s členom 48 sodelovati priglašeni organ, se informacije iz oddelka 1 dela A Priloge VI v ta elektronski sistem posredujejo pred vložitvijo vloge pri priglašenem organu.
After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 27 and issue it to the manufacturer, the authorised representative or the importer.
Pristojni organ po potrditvi podatkov, vnesenih v skladu z odstavkom 1, iz elektronskega sistema iz člena 27 pridobi enotno registrsko številko in jo izda proizvajalcu, pooblaščenemu predstavniku ali uvozniku.
The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 26.
Proizvajalec enotno registrsko številko uporabi pri vložitvi vloge za ugotavljanje skladnosti pri priglašenem organu in za dostop do Eudameda zaradi izpolnitve svojih obveznosti na podlagi člena 26.
Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 27.
Gospodarski subjekt posodobi podatke v elektronskem sistemu iz člena 27 v enem tednu po vsaki spremembi informacij iz odstavka 1 tega člena.
Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data.
Gospodarski subjekt potrdi natančnost podatkov najpozneje eno leto po predložitvi informacij v skladu z odstavkom 1 in zatem vsako drugo leto.
In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation.
Če tega ne stori v šestih mesecih po roku, lahko katera koli država članica sprejme ustrezne korektivne ukrepe na svojem ozemlju, dokler ta gospodarski subjekt ne izpolni te obveznosti.
Without prejudice to the economic operator's responsibility for the data, the competent authority shall verify the confirmed data referred to in Section 1 of Part A of Annex VI.
Brez poseganja v odgovornost gospodarskega subjekta, kar zadeva podatke, pristojni organ preveri potrjene podatke iz oddelka 1 dela A Priloge VI.
The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 27 shall be accessible to the public.
Podatki, vneseni v skladu z odstavkom 1 tega člena v elektronski sistem iz člena 27, so dostopni javnosti.
The competent authority may use the data to charge the manufacturer, the authorised representative or the importer a fee pursuant to Article 104.
Pristojni organ lahko podatke uporabi za zaračunavanje pristojbine proizvajalcu, pooblaščenemu predstavniku ali uvozniku v skladu s členom 104.
Summary of safety and performance
Povzetek o varnosti in učinkovitosti
For class C and D devices, other than devices for performance studies, the manufacturer shall draw up a summary of safety and performance.
Proizvajalec za pripomočke razreda C in D, razen za pripomočke za študije učinkovitosti, pripravi povzetek o varnosti in učinkovitosti.
The summary of safety and performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed.
Povzetek o varnosti in učinkovitosti je sestavljen tako, da je razumljiv predvidenemu uporabniku in po potrebi pacientu ter je na voljo javnosti prek Eudameda.
The draft of the summary of safety and performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 48 and shall be validated by that body.
Osnutek povzetka o varnosti in učinkovitosti je del dokumentacije, ki jo je treba predložiti priglašenemu organu, vključenemu v ugotavljanje skladnosti v skladu s členom 48, in ga navedeni organ potrdi.
After its validation, the notified body shall upload the summary to Eudamed.
Po potrditvi priglašeni organ povzetek naloži v Eudamed.
The manufacturer shall mention on the label or instructions for use where the summary is available.
Proizvajalec na oznaki ali v navodilih za uporabo navede, kje je na voljo povzetek.
The summary of safety and performance shall include at least the following aspects:
Povzetek o varnosti in učinkovitosti vključuje vsaj naslednje vidike:
the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;
identifikacijo pripomočka in proizvajalca, vključno z osnovnim UDI-DI in enotno registrsko številko, če je bila že dodeljena;
the intended purpose of the device and any indications, contra-indications and target populations;
predvideni namen pripomočka ter vse indikacije, kontraindikacije in ciljne populacije;
a description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device;
opis pripomočka, vključno z navajanjem prejšnjih generacij ali različic, če te obstajajo, in opis razlik, po potrebi pa tudi opis kakršnih koli dodatkov, drugih pripomočkov in izdelkov, ki so namenjeni uporabi v kombinaciji s pripomočkom;
reference to any harmonised standards and CS applied;
sklic na kakršne koli uporabljene harmonizirane standarde in skupne specifikacije;
the summary of the performance evaluation as referred to in Annex XIII, and relevant information on the PMPF;
povzetek o oceni učinkovitosti iz Priloge XIII in ustrezne informacije o spremljanju učinkovitosti po dajanju na trg;
the metrological traceability of assigned values;
meroslovno sledljivost pripisanih vrednosti;
suggested profile and training for users;
predlagani profil in usposabljanje uporabnikov;
information on any residual risks and any undesirable effects, warnings and precautions.
informacije o morebitnih preostalih tveganjih in neželenih učinkih, opozorila in previdnostni ukrepi.
The Commission may, by means of implementing acts, set out the form and the presentation of the data elements to be included in the summary of safety and performance.
Komisija lahko z izvedbenimi akti določi obliko in predstavitev podatkovnih elementov, ki morajo biti vključeni v povzetek o varnosti in učinkovitosti.
Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 107(2).
Ti izvedbeni akti se sprejmejo v skladu s svetovalnim postopkom iz člena 107(2).
European database on medical devices
Evropska podatkovna zbirka za medicinske pripomočke
The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (‘Eudamed’) in accordance with the conditions and detailed arrangements established by Articles 33 and 34 of Regulation (EU) 2017/745.
Komisija po posvetovanju s Koordinacijsko skupino za medicinske pripomočke vzpostavi, vzdržuje in upravlja evropsko podatkovno zbirko za medicinske pripomočke (Eudamed) v skladu s pogoji in podrobnimi ureditvami, določenimi v členih 33 in 34 Uredbe (EU) 2017/745.
Eudamed shall include the following electronic systems:
Eudamed vključuje naslednje elektronske sisteme:
the electronic system for registration of devices referred to in Article 26;
elektronski sistem za registracijo pripomočkov iz člena 26;
the UDI database referred to in Article 25;
podatkovno zbirko UDI iz člena 25;
the electronic system on registration of economic operators referred to in Article 27;
elektronski sistem za registracijo gospodarskih subjektov iz člena 27;
the electronic system on notified bodies and on certificates referred to in Article 52;
elektronski sistem za priglašene organe in certifikate iz člena 52;
the electronic system on performance studies referred to in Article 69,
elektronski sistem za študije učinkovitosti iz člena 69;
the electronic system on vigilance and post-market surveillance referred to in Article 87;
elektronski sistem za vigilanco in nadzor po dajanju na trg iz člena 87;
the electronic system on market surveillance referred to in Article 95.
elektronski sistem za nadzor trga iz člena 95.
Authorities responsible for notified bodies
Organi, pristojni za priglašene organe
Any Member State that intends to designate a conformity assessment body as a notified body, or has designated a notified body, to carry out conformity assessment activities under this Regulation shall appoint an authority (the ‘authority responsible for notified bodies’), which may consist of separate constituent entities under national law and shall be responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, including subcontractors and subsidiaries of those bodies.
Država članica, ki namerava imenovati organ za ugotavljanje skladnosti kot priglašeni organ ali je imenovala priglašeni organ za izvajanje dejavnosti ugotavljanja skladnosti v skladu s to uredbo, imenuje organ (v nadaljnjem besedilu: organ, pristojen za priglašene organe), ki ga v skladu z nacionalnim pravom lahko tvorijo ločeni sestavni subjekti in je pristojen za vzpostavitev in izvajanje potrebnih postopkov za ocenjevanje, imenovanje in priglasitev organov za ugotavljanje skladnosti ter za spremljanje priglašenih organov, vključno s podizvajalci in odvisnimi družbami navedenih organov.
The authority responsible for notified bodies shall be established, organised and operated so as to safeguard the objectivity and impartiality of its activities and to avoid any conflicts of interests with conformity assessment bodies.
Organ, pristojen za priglašene organe, je ustanovljen, organiziran in voden tako, da ščiti objektivnost in nepristranskost svojih dejavnosti ter preprečuje nasprotje interesov z organi za ugotavljanje skladnosti.
The authority responsible for notified bodies shall be organised in a manner such that each decision relating to designation or notification is taken by personnel different from those who carried out the assessment.
Organ, pristojen za priglašene organe, je organiziran tako, da vsako odločitev v zvezi z imenovanjem ali priglasitvijo sprejme drugo osebje od tistega, ki je izvedlo ocenjevanje.
The authority responsible for notified bodies shall not perform any activities that notified bodies perform on a commercial or competitive basis.
Organ, pristojen za priglašene organe, ne izvaja nobenih dejavnosti, ki jih priglašeni organi izvajajo na komercialni ali konkurenčni osnovi.
The authority responsible for notified bodies shall safeguard the confidential aspects of the information it obtains.
Organ, pristojen za priglašene organe, zagotovi zaupnost informacij, ki jih pridobi.
However, it shall exchange information on notified bodies with other Member States, the Commission and, when required, with other regulatory authorities.
Vendar informacije o priglašenih organih izmenjuje z drugimi državami članicami, Komisijo in po potrebi z drugimi regulativnimi organi.
The authority responsible for notified bodies shall have a sufficient number of competent personnel permanently available for the proper performance of its tasks.
Organ, pristojen za priglašene organe, razpolaga z zadostnim številom usposobljenega osebja, ki je stalno na voljo za ustrezno izvajanje svojih nalog.
Where the authority responsible for notified bodies is a different authority from the national competent authority for in vitro diagnostic medical devices, it shall ensure that the national authority responsible for in vitro diagnostic medical devices is consulted on relevant matters.
Če organ, pristojen za priglašene organe, ni tudi pristojni nacionalni organ za in vitro diagnostične medicinske pripomočke, poskrbi za posvetovanje z nacionalnim organom, pristojnim za in vitro diagnostične medicinske pripomočke, o ustreznih zadevah.
Member States shall make publicly available general information on their measures governing the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, and on changes which have a significant impact on such tasks.
Države članice javno objavijo splošne informacije o svojih ukrepih, ki urejajo ocenjevanje, imenovanje in priglasitev organov za ugotavljanje skladnosti ter za spremljanje priglašenih organov, ter o spremembah, ki pomembno vplivajo na takšne naloge.
The authority responsible for notified bodies shall participate in peer-review activities provided for in Article 44.
Organ, pristojen za priglašene organe, sodeluje pri dejavnostih medsebojnega strokovnega pregleda iz člena 44.
Notified bodies shall fulfil the tasks for which they are designated in accordance with this Regulation.
Priglašeni organi izvajajo naloge, za katere so imenovani v skladu s to uredbo.
They shall satisfy the organisational and general requirements and the quality management, resource and process requirements that are necessary to fulfil those tasks.
Izpolnjujejo organizacijske in splošne zahteve ter zahteve glede vodenja kakovosti, virov in postopkov, ki so potrebni za izpolnjevanje teh nalog.
In particular, notified bodies shall comply with Annex VII.
Zlasti pa se ravnajo v skladu s Prilogo VII.
In order to meet the requirements referred to in the first subparagraph, notified bodies shall have permanent availability of sufficient administrative, technical and scientific personnel in accordance with Section 3.1.1 of Annex VII, and personnel with relevant clinical expertise in accordance with Section 3.2.4 of Annex VII, where possible employed by the notified body itself.
Da bi izpolnili zahteve iz prvega pododstavka, morajo imeti priglašeni organi stalno na voljo zadostno število upravnega, tehničnega in znanstvenega osebja v skladu z oddelkom 3.1.1 Priloge VII ter osebje z ustreznim kliničnim strokovnim znanjem v skladu z oddelkom 3.2.4 Priloge VII, ki ga po možnosti zaposluje priglašeni organ sam.
The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall be employed by the notified body itself and shall not be external experts or subcontractors.
Osebje iz oddelkov 3.2.3 in 3.2.7 Priloge VII zaposluje priglašeni organ sam in ne smejo biti zunanji strokovnjaki ali podizvajalci.
Notified bodies shall make available and submit upon request all relevant documentation, including the manufacturer's documentation, to the authority responsible for notified bodies to allow it to conduct its assessment, designation, notification, monitoring and surveillance activities and to facilitate the assessment outlined in this Chapter.
Da se organu, pristojnemu za priglašene organe, omogoči izvajanje dejavnosti ocenjevanja, imenovanja, priglasitve ter spremljanja in nadzora ter da se olajša ocenjevanje, opisano v tem poglavju, mu priglašeni organi omogočijo dostop do vse zadevne dokumentacije, vključno z dokumentacijo proizvajalca, ter mu jo na zahtevo predložijo.
In order to ensure the uniform application of the requirements set out in Annex VII, the Commission may adopt implementing acts, to the extent necessary to resolve issues of divergent interpretation and of practical application.
Da se zagotovi enotna uporaba zahtev, določenih v Prilogi VII, lahko Komisija sprejme izvedbene akte, če je to potrebno za rešitev vprašanj različne razlage in praktične uporabe.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 107(3).
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 107(3).
Subsidiaries and subcontracting
Odvisne družbe in oddaja naročil podizvajalcem
Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the applicable requirements set out in Annex VII and shall inform the authority responsible for notified bodies accordingly.
Kadar priglašeni organ naročilo za posebne naloge, povezane z ugotavljanjem skladnosti, odda podizvajalcu ali za posebne naloge, povezane z ugotavljanjem skladnosti, uporabi odvisno družbo, preveri, ali podizvajalec oziroma odvisna družba izpolnjuje veljavne zahteve, določene v Prilogi VII, in o tem ustrezno obvesti organ, pristojen za priglašene organe.
Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontractors or subsidiaries.
Priglašeni organi prevzamejo polno odgovornost za naloge, ki jih v njihovem imenu opravijo podizvajalci ali odvisne družbe.
Notified bodies shall make publicly available a list of their subsidiaries.
Priglašeni organi omogočijo javni dostop do seznama svojih odvisnih družb.
Conformity assessment activities may be subcontracted or carried out by a subsidiary provided that the legal or natural person that applied for conformity assessment has been informed accordingly.
Naročilo za izvedbo dejavnosti ugotavljanja skladnosti se lahko odda podizvajalcu ali jih lahko opravi odvisna družba pod pogojem, da je bila pravna ali fizična oseba, ki je oddala vlogo za ugotavljanje skladnosti, o tem ustrezno obveščena.
Notified bodies shall keep at the disposal of the authority responsible for notified bodies all relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.
Priglašeni organi dajo organu, pristojnemu za priglašene organe, na voljo vse zadevne dokumente v zvezi s preverjanjem kvalifikacij podizvajalca ali odvisne družbe ter delom, ki sta ga navedena izvedla v skladu s to uredbo.
Application by conformity assessment bodies for designation
Vloga organov za ugotavljanje skladnosti za imenovanje
Conformity assessment bodies shall submit an application for designation to the authority responsible for notified bodies.
Organi za ugotavljanje skladnosti vložijo vlogo za imenovanje pri organu, pristojnem za priglašene organe.
The application shall specify the conformity assessment activities as defined in this Regulation, and the types of devices for which the body is applying to be designated, and shall be supported by documentation demonstrating compliance with Annex VII.
V vlogi se opredelijo dejavnosti ugotavljanja skladnosti, kot so opredeljene v tej uredbi, in vrste pripomočkov, za katere organ zaprosi za imenovanje, priložena pa ji je dokumentacija, ki dokazuje skladnost z vsemi zahtevami iz Priloge VII.
In respect of the organisational and general requirements and the quality management requirements set out in Sections 1 and 2 of Annex VII, a valid accreditation certificate and the corresponding evaluation report delivered by a national accreditation body in accordance with Regulation (EC) No 765/2008 may be submitted and shall be taken into consideration during the assessment described in Article 35.
Pri dokazovanju skladnosti z organizacijskimi in splošnimi zahtevami ter zahtevami glede vodenja kakovosti, določenimi v oddelkih 1 in 2 Priloge VII, se lahko predložita veljaven certifikat o akreditaciji in ustrezno poročilo o oceni, ki ga izda nacionalni akreditacijski organ v skladu z Uredbo (ES) št. 765/2008 ter se upoštevata pri ocenjevanju iz člena 35.