natgillin/translations-raw huggingface dataset:
Article 30
Uvozniki v dveh tednih po tem, ko so pripomoček, ki ni pripomoček, izdelan za posameznega uporabnika, dali na trg, preverijo, ali je proizvajalec ali pooblaščeni predstavnik v elektronski sistem posredoval informacije iz odstavka 1.
Electronic system for registration of economic operators
Kjer je to ustrezno, uvozniki ustreznega pooblaščenega predstavnika ali proizvajalca obvestijo, da informacije iz odstavka 1 niso bile vnesene ali da so napačne.
The Commission, after consulting the MDCG, shall set up and manage an electronic system to create the single registration number referred to in Article 31(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.
Uvozniki zadevne vnose dopolnijo s svojimi podatki.
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.
Člen 31
Member States may maintain or introduce national provisions on registration of distributors of devices which have been made available on their territory.
Registracija proizvajalcev, pooblaščenih predstavnikov in uvoznikov
Within two weeks of placing a device, other than a custom-made 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.
Proizvajalci, pooblaščeni predstavniki in uvozniki, preden dajo pripomoček, ki ni pripomoček, izdelan za posameznega uporabnika, na trg, v elektronski sistem iz člena 30 vnesejo informacije iz oddelka 1 dela A Priloge VI, zato da se registrirajo, če v skladu s tem členom tega še niso storili.
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.
Kadar mora v postopku ugotavljanja skladnosti v skladu s členom 52 sodelovati priglašeni organ, se informacije iz oddelka 1 dela A Priloge VI v ta elektronski sistem sporočijo pred vložitvijo vloge pri priglašenem organu.
Importers shall add their details to the relevant entry/entries.
Pristojni organ po preveritvi podatkov, vnesenih v skladu z odstavkom 1, iz elektronskega sistema iz člena 30 pridobi enotno registrsko številko in jo dodeli proizvajalcu, pooblaščenemu predstavniku ali uvozniku.
Article 31
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 29.
Registration of manufacturers, authorised representatives and importers
Gospodarski subjekt posodobi podatke v elektronskem sistemu iz člena 30 v enem tednu po vsaki spremembi informacij iz odstavka 1 tega člena.
Before placing a device, other than a custom-made 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.
Gospodarski subjekt potrdi natančnost podatkov najpozneje eno leto po predložitvi informacij v skladu z odstavkom 1 in zatem vsako drugo leto.
In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to Article 52, 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.
Če tega ne stori še nadaljnjih šest mesecev, lahko katera koli država članica sprejme ustrezne korektivne ukrepe na svojem ozemlju, dokler ta gospodarski subjekt ne izpolni te obveznosti.
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 30 and issue it to the manufacturer, the authorised representative or the importer.
Brez poseganja v odgovornost gospodarskega subjekta, kar zadeva podatke, pristojni organ preveri potrjene podatke iz oddelka 1 dela A Priloge VI.
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 29.
Podatki, vneseni v skladu z odstavkom 1 tega člena v elektronski sistem iz člena 30, so dostopni javnosti.
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 30.
Pristojni organ lahko podatke uporabi za zaračunavanje pristojbine proizvajalcu, pooblaščenemu predstavniku ali uvozniku v skladu s členom 111.
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.
Člen 32
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.
Povzetek o varnosti in klinični učinkovitosti
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.
Proizvajalec za pripomočke za vsaditev in pripomočke razreda III, razen pripomočkov, izdelanih za posameznega uporabnika, in pripomočkov, ki so predmet raziskave, pripravi povzetek o varnosti in klinični učinkovitosti.
The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 30 shall be accessible to the public.
Ta povzetek je sestavljen tako, da je razumljiv predvidenemu uporabniku in po potrebi pacientu ter na voljo javnosti prek Eudameda.
The competent authority may use the data to charge the manufacturer, the authorised representative or the importer a fee pursuant to Article 111.
Osnutek povzetka je del dokumentacije, ki jo je treba predložiti priglašenemu organu, vključenemu v ugotavljanje skladnosti v skladu s členom 52, in ga navedeni organ potrdi.
Article 32
Po potrditvi priglašeni organ povzetek naloži v Eudamed.
Summary of safety and clinical performance
Proizvajalec na oznaki ali v navodilih za uporabo navede, kje je na voljo povzetek.
For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance.
Povzetek o varnosti in klinični učinkovitosti vključuje vsaj naslednje vidike:
The summary of safety and clinical 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.
identifikacijo pripomočka in proizvajalca, vključno z osnovnim UDI-DI in enotno registrsko številko, če je bila že dodeljena;
The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52 and shall be validated by that body.
predvideni namen pripomočka ter vse indikacije, kontraindikacije in ciljne populacije;
After its validation, the notified body shall upload the summary to Eudamed.
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;
The manufacturer shall mention on the label or instructions for use where the summary is available.
morebitne druge diagnostične ali terapevtske možnosti;
The summary of safety and clinical performance shall include at least the following aspects:
sklic na kakršne koli uporabljene harmonizirane standarde in skupne specifikacije;
the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN;
zbirno poročilo o klinični oceni iz Priloge XIV in ustrezne informacije o kliničnem spremljanju po dajanju na trg;
the intended purpose of the device and any indications, contraindications and target populations;
predlagani profil in usposabljanje uporabnikov;
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;
informacije o morebitnih preostalih tveganjih in neželenih učinkih, opozorila in previdnostne ukrepe.
possible diagnostic or therapeutic alternatives;
Komisija lahko z izvedbenimi akti določi obliko in predstavitev podatkovnih elementov, ki morajo biti vključeni v povzetek o varnosti in klinični učinkovitosti.
reference to any harmonised standards and CS applied;
Navedeni izvedbeni akti se sprejmejo v skladu s svetovalnim postopkom iz člena 114(2).
the summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up;
Člen 33
suggested profile and training for users;
Evropska podatkovna zbirka za medicinske pripomočke
information on any residual risks and any undesirable effects, warnings and precautions.
Komisija po posvetovanju s Koordinacijsko skupino za medicinske pripomočke vzpostavi, vzdržuje in upravlja Evropsko podatkovno zbirko za medicinske pripomočke (Eudamed), da omogoča:
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 clinical performance.
da so javnosti zagotovljene ustrezne informacije o pripomočkih, danih na trg, ustreznih certifikatih, ki jih izdajo priglašeni organi, in ustreznih gospodarskih subjektih;
Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 114(2).
edinstveno identifikacijo pripomočkov na notranjem trgu in njihovo lažjo sledljivost;
Article 33
da so javnosti zagotovljene ustrezne informacije o kliničnih raziskavah, sponzorjem kliničnih raziskav pa, da izpolnjujejo obveznosti na podlagi členov 62 do 80, člena 82 in vseh aktov, sprejetih v skladu s členom 81;
European database on medical devices
proizvajalcem, da izpolnjujejo obveznosti obveščanja iz členov 87 do 90 ali iz vseh aktov, sprejetih v skladu s členom 91;
The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on medical devices (‘Eudamed’) for the following purposes:
pristojnim organom držav članic in Komisije, da so dobro obveščeni pri opravljanju nalog v zvezi s to uredbo, ter da se izboljša sodelovanje med njimi.
to enable the public to be adequately informed about devices placed on the market, the corresponding certificates issued by notified bodies and about the relevant economic operators;
Eudamed vključuje naslednje elektronske sisteme:
to enable unique identification of devices within the internal market and to facilitate their traceability;
elektronski sistem za registracijo pripomočkov iz člena 29(4);
to enable the public to be adequately informed about clinical investigations and to enable sponsors of clinical investigations to comply with obligations under Articles 62 to 80, Article 82, and any acts adopted pursuant to Article 81;
podatkovno zbirko UDI iz člena 28;
to enable manufacturers to comply with the information obligations laid down in Articles 87 to 90 or in any acts adopted pursuant to Article 91;
elektronski sistem za registracijo gospodarskih subjektov iz člena 30;
to enable the competent authorities of the Member States and the Commission to carry out their tasks relating to this Regulation on a well-informed basis and to enhance the cooperation between them.
elektronski sistem za priglašene organe in certifikate iz člena 57;
Eudamed shall include the following electronic systems:
elektronski sistem za klinične raziskave iz člena 73;
the electronic system for registration of devices referred to in Article 29(4);
elektronski sistem za vigilanco in nadzor po dajanju na trg iz člena 92;
the UDI-database referred to in Article 28;
elektronski sistem za nadzor trga iz člena 100.
the electronic system on registration of economic operators referred to in Article 30;
Komisija pri oblikovanju Eudameda ustrezno upošteva skladnost z nacionalnimi podatkovnimi zbirkami in spletnimi vmesniki, da se omogoči uvoz in izvoz podatkov.
the electronic system on notified bodies and on certificates referred to in Article 57;
Podatke v Eudamed vnesejo države članice, priglašeni organi, gospodarski subjekti in sponzorji, kot je opredeljeno v določbah o elektronskih sistemih iz odstavka 2.
the electronic system on clinical investigations referred to in Article 73;
Komisija uporabnikom Eudameda zagotovi tehnično in administrativno podporo.
the electronic system on vigilance and post-market surveillance referred to in Article 92;
Vse informacije, zbrane in obdelane v Eudamedu, so dostopne državam članicam in Komisiji.
the electronic system on market surveillance referred to in Article 100.
Informacije so dostopne priglašenim organom, gospodarskim subjektom, sponzorjem in javnosti v obsegu, opredeljenem v določbah o elektronskih sistemih iz odstavka 2.
When designing Eudamed the Commission shall give due consideration to compatibility with national databases and national web-interfaces to allow for import and export of data.
Komisija zagotovi, da so javno dostopni deli Eudameda predstavljeni v uporabnikom prijaznem formatu in da je iskanje po njih enostavno.
The data shall be entered into Eudamed by the Member States, notified bodies, economic operators and sponsors as specified in the provisions on the electronic systems referred to in paragraph 2.
Eudamed vsebuje osebne podatke le, kolikor je to potrebno za elektronske sisteme iz odstavka 2 tega člena za zbiranje in obdelavo informacij v skladu s to uredbo.
The Commission shall provide for technical and administrative support to users of Eudamed.
Osebni podatki so v obliki, ki dopušča identifikacijo posameznikov, na katere se podatki nanašajo, shranjeni največ za obdobja iz člena 10(8).
All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission.
Komisija in države članice zagotovijo, da lahko posamezniki, na katere se nanašajo osebni podatki, učinkovito uveljavljajo svoje pravice do informacij, dostopa, popravka in ugovora v skladu z Uredbo (ES) št. 45/2001 oziroma Direktivo 95/46/ES.
The information shall be accessible to notified bodies, economic operators, sponsors and the public to the extent specified in the provisions on the electronic systems referred to in paragraph 2.
Zagotovijo tudi, da lahko posamezniki, na katere se nanašajo osebni podatki, učinkovito uveljavljajo pravico dostopa do podatkov, ki se nanašajo nanje, in pravico do popravka ali izbrisa netočnih ali nepopolnih podatkov.
The Commission shall ensure that public parts of Eudamed are presented in a user-friendly and easily-searchable format.
Komisija in države članice v okviru svojih pristojnosti zagotovijo, da se netočni in nezakonito obdelani podatki izbrišejo v skladu z veljavno zakonodajo.
Eudamed shall contain personal data only insofar as necessary for the electronic systems referred to in paragraph 2 of this Article to collate and process information in accordance with this Regulation.
Ti podatki se popravijo in izbrišejo čim prej, vendar najpozneje v 60 dneh od take zahteve posameznika, na katerega se nanašajo osebni podatki.
Personal data shall be kept in a form which permits identification of data subjects for periods no longer than those referred to in Article 10(8).
Komisija z izvedbenimi akti določi podrobne ureditve, potrebne za vzpostavitev in vzdrževanje Eudameda.
The Commission and the Member States shall ensure that data subjects may effectively exercise their rights to information, of access, to rectification and to object in accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively.
Komisija pri sprejemanju teh izvedbenih aktov v čim večji meri zagotovi, da se sistem razvije tako, da ni treba dvakrat vnesti istih informacij v isti modul ali različne module sistema.
They shall also ensure that data subjects may effectively exercise the right of access to data relating to them, and the right to have inaccurate or incomplete data corrected and erased.
Komisija se glede svojih obveznosti v skladu s tem členom in v njem navedene obdelave osebnih podatkov šteje za upravljavca Eudameda in njegovih elektronskih sistemov.
Within their respective responsibilities, the Commission and the Member States shall ensure that inaccurate and unlawfully processed data are deleted, in accordance with the applicable legislation.
Člen 34
Corrections and deletions shall be carried out as soon as possible, but no later than 60 days after a request is made by a data subject.
Funkcionalnost Eudameda
The Commission shall, by means of implementing acts, lay down the detailed arrangements necessary for the setting up and maintenance of Eudamed.
Komisija v sodelovanju s Koordinacijsko skupino za medicinske pripomočke pripravi funkcijske specifikacije za Eudamed.
When adopting those implementing acts, the Commission shall ensure that, as far as possible, the system is developed in such a way as to avoid having to enter the same information twice within the same module or in different modules of the system.
Ko Komisija preveri, da Eudamed polno deluje in da izpolnjuje funkcijske specifikacije, pripravljene v skladu z odstavkom 1, o tem na podlagi neodvisnega poročila o presoji obvesti Koordinacijsko skupino za medicinske pripomočke.
In relation to its responsibilities under this Article and the processing of personal data involved therein, the Commission shall be considered to be the controller of Eudamed and its electronic systems.
Ko Komisija po posvetovanju s Koordinacijsko skupino za medicinske pripomočke ugotovi, da so pogoji iz odstavka 2 izpolnjeni, v Uradnem listu Evropske unije objavi obvestilo o tem.
Article 34
POGLAVJE IV
The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed.
Člen 35
The Commission shall draw up a plan for the implementation of those specifications by 26 May 2018.
Organi, pristojni za priglašene organe
That plan shall seek to ensure that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in paragraph 3 of this Article by 25 March 2020 and that all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation (EU) 2017/746 are met.
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 Commission shall, on the basis of an independent audit report, inform the MDCG when it has verified that Eudamed has achieved full functionality and Eudamed meets the functional specifications drawn up pursuant to paragraph 1.
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 Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European Union.
Organ, pristojen za priglašene organe, je organiziran tako, da vsako odločitev v zvezi z imenovanjem ali priglasitvijo sprejme drugo osebje kot tisto, ki je izvedlo ocenjevanje.
CHAPTER IV
Organ, pristojen za priglašene organe, ne izvaja nobenih dejavnosti, ki jih priglašeni organi izvajajo na komercialni ali konkurenčni osnovi.
NOTIFIED BODIES
Organ, pristojen za priglašene organe, zagotovi zaupnost informacij, ki jih pridobi.
Article 35
Vendar informacije o priglašenih organih izmenjuje z drugimi državami članicami, Komisijo in po potrebi z drugimi regulativnimi organi.
Authorities responsible for notified bodies
Organ, pristojen za priglašene organe, razpolaga z zadostnim številom usposobljenega osebja, ki je stalno na voljo za ustrezno izvajanje svojih nalog.
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 (‘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.
Če organ, pristojen za priglašene organe, ni pristojni nacionalni organ za medicinske pripomočke, poskrbi, da se o ustreznih zadevah organizirajo posvetovanja z nacionalnim organom, pristojnim za medicinske pripomočke.
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.
Države članice javno objavijo splošne informacije o svojih predpisih, 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 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, sodeluje pri dejavnostih medsebojnega strokovnega pregleda iz člena 48.
The authority responsible for notified bodies shall not perform any activities that notified bodies perform on a commercial or competitive basis.
Člen 36
The authority responsible for notified bodies shall safeguard the confidential aspects of the information it obtains.
Zahteve v zvezi s priglašenimi organi
However, it shall exchange information on notified bodies with other Member States, the Commission and, when required, with other regulatory authorities.
Priglašeni organi izvajajo naloge, za katere so imenovani v skladu s to uredbo.
The authority responsible for notified bodies shall have a sufficient number of competent personnel permanently available for the proper performance of its tasks.
Izpolnjujejo organizacijske in splošne zahteve ter zahteve glede vodenja kakovosti, virov in postopkov, ki so potrebni za izpolnjevanje teh nalog.
Where the authority responsible for notified bodies is a different authority from the national competent authority for medical devices, it shall ensure that the national authority responsible for medical devices is consulted on relevant matters.
Zlasti pa se priglašeni organi ravnajo v skladu s Prilogo VII.
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.
Da bi priglašeni organi izpolnili zahteve iz prvega pododstavka, morajo imeti stalno na voljo zadostno število upravnega, tehničnega in znanstvenega osebja v skladu z oddelkom 3.1.1.
The authority responsible for notified bodies shall participate in the peer-review activities provided for in Article 48.
Priloge VII ter osebje z ustreznim kliničnim strokovnim znanjem v skladu z oddelkom 3.2.4.