natgillin/translations-raw huggingface dataset:
For the purposes of this Directive, reference to harmonised standards also includes the monographs of the European Pharmacopoeia notably on interaction between medicinal products and materials used in devices containing such medicinal products, the references of which have been published in the Official Journal of the European Union.’;
Za namene te direktive sklicevanje na usklajene standarde vključuje tudi monografije Evropske farmakopeje, zlasti o medsebojnem učinkovanju zdravil in materialov, uporabljenih v pripomočkih, ki vsebujejo takšna zdravila, sklicevanja na katere so bila objavljena v Uradnem listu Evropske unije.“;
Article 6 shall be amended as follows:
člen 6 se spremeni:
in paragraph 1 the reference ‘83/189/EEC’ shall be replaced by the reference
v odstavku 1 se sklicevanje „83/189/EGS“ nadomesti s sklicevanjem „98/34/ES
‘98/34/EC(b) paragraph 2 shall be replaced by the following:
odstavek 2 se nadomesti z:
The Commission shall be assisted by a standing committee (hereinafter referred to as the Committee).
Komisiji pomaga stalni odbor (v nadaljevanju ‚odbor‘).
Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;
Pri sklicevanju na ta odstavek se uporabljata člen 5a(1), (2), (4) in (6) ter člen 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.“;
Article 8 shall be replaced by the following:
člen 8 se nadomesti z:
Member States shall take the necessary steps to ensure that information brought to their knowledge regarding the incidents mentioned below involving a device is recorded and evaluated in a centralised manner:
Države članice sprejmejo potrebne ukrepe za zagotovitev, da se informacije, o katerih so obveščene, glede spodaj navedenih zapletov v zvezi s pripomočkom zapišejo in ovrednotijo centralizirano:
any malfunction of or deterioration in the characteristics and performances of a device, as well as any inadequacy in the labelling or in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;
vsaka okvara ali poslabšanje lastnosti in učinkovitosti pripomočka kakor tudi nepravilnosti na oznaki ali v navodilih za uporabo, ki lahko povzročijo ali so povzročile pacientovo ali uporabnikovo smrt ali resno poslabšanje njegovega zdravstvenega stanja;
any technical or medical reason in relation to the characteristics or performances of a device for the reasons referred to in point (a), leading to systematic recall of devices of the same type by the manufacturer.
vsak tehničen ali medicinski razlog, povezan z lastnostmi ali delovanjem pripomočka zaradi razlogov iz pododstavka (a), ki povzroči sistematičen odpoklic pripomočkov istega tipa s strani proizvajalca.
Where a Member State requires medical practitioners or the medical institutions to inform the competent authorities of any incidents referred to in paragraph 1, it shall take the necessary steps to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incident.
Kjer država članica od zdravnikov ali zdravstvenih ustanov zahteva, naj pristojne organe obveščajo o vseh zapletih iz odstavka 1, mora sprejeti ustrezne ukrepe, da zagotovi, da sta tudi proizvajalec zadevnega pripomočka ali njegov pooblaščeni zastopnik obveščena o teh zapletih.
After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 7, immediately inform the Commission and the other Member States of measures that have been taken or are contemplated to minimise the recurrence of the incidents referred to in paragraph 1, including information on the underlying incidents.
Po izvedeni oceni, po možnosti skupaj s proizvajalcem ali njegovim pooblaščenim zastopnikom, države članice brez poseganja v člen 7 nemudoma obvestijo Komisijo in druge države članice o uvedenih ali načrtovanih ukrepih za zmanjšanje zapletov iz odstavka 1, vključno z informacijami o teh zapletih.
The measures necessary for the implementation of this Article shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;
Ukrepi, potrebni za izvajanje tega člena, se sprejmejo v skladu z regulativnim postopkom iz člena 6(3).“;
Decisions taken by the notified bodies in accordance with Annexes 2, 3 and 5 shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both Parties, for further periods of a maximum length of five years.’;
Odločitve, ki jih sprejmejo priglašeni organi v skladu s prilogami 2, 3 in 5 veljajo največ pet let in jih je mogoče na podlagi vloge podaljšati za največ pet let, če je vloga vložena v roku, določenem v pogodbi, ki jo podpišeta obe strani.“;
The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex 1 Section 15 may be set out shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;
Ukrepi, oblikovani za spremembo nebistvenih določb te direktive, med drugim z njeno dopolnitvijo, v zvezi z načinom, s katerimi se lahko, v luči tehničnega napredka in ob upoštevanju predvidenih uporabnikov pripomočka, določijo informacije iz Priloge 1 oddelka 15, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 6(4).“;
Article 9a shall be replaced by the following:
člen 9a se nadomesti z:
A Member State shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:
Država članica v naslednjih primerih poda Komisiji utemeljeno zahtevo in od nje zahteva, da sprejme potrebne ukrepe:
that Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9,
država članica meni, da je treba ugotoviti skladnost pripomočka ali družine pripomočkov, z odstopanjem od določb iz člena 9, z uporabo zgolj enega od danih postopkov, izbranega izmed postopkov iz člena 9;
that Member State considers that a decision is required as to whether a particular product or product group falls within the definition of Article 1(2)(a), (c), (d) or (e).
država članica meni, da je potrebna odločitev, ali izdelek ali skupina izdelkov spada pod opredelitev iz člena 1(2)(a), (c), (d) ali (e).
Where measures are deemed necessary pursuant to the first subparagraph of this paragraph they shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).
Kadar se oceni, da so v skladu s prvim pododstavkom tega odstavka ukrepi nujni, se ti sprejmejo v skladu z regulativnim postopkom iz člena 6(3).
The Commission shall inform the Member States of the measures taken.’;
Komisija obvesti države članice o sprejetih ukrepih.“;
Article 10 shall be amended as follows:
člen 10 se spremeni:
in paragraph 1, the word ‘his’ shall be replaced by the word ‘the’.
v odstavku 1 se črta beseda „njegov“;
the second subparagraph of paragraph 2 shall be replaced by the following:
drugi pododstavek odstavka 2 se nadomesti z:
‘Member States may, however, authorise manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the ethics committee concerned has issued a favourable opinion with respect to the investigation programme in question including its review of the clinical investigation plan.’;
„Države članice lahko vseeno pooblastijo proizvajalce, da začnejo izvajati ustrezne klinične preiskave pred iztekom obdobja 60 dni, če pristojni etični odbor izda pozitivno mnenje o zadevnem programu preiskav, vključno s pregledom načrta kliničnih preiskav.“;
The Member States shall, if necessary, take the appropriate steps to ensure public health and public policy.
Države članice sprejmejo potrebne ukrepe za zaščito javnega zdravja in reda.
Where a clinical investigation is refused or halted by a Member State, that Member State shall communicate its decision and the grounds therefor to all Member States and the Commission.
Kadar država članica zavrne ali zaustavi klinično preiskavo, o svoji odločitvi in o razlogih zanjo obvesti vse države članice in Komisijo.
Where a Member State has called for a significant modification or temporary interruption of a clinical investigation, that Member State shall inform the Member States concerned about its actions and the grounds for the actions taken.’;
Kadar država članica zahteva znatne spremembe ali začasno prekinitev klinične preiskave, mora ta država članica o svojih ukrepih in o razlogih za izvedene ukrepe obvestiti zadevne države članice.“;
The manufacturer or his authorised representative shall notify the competent authorities of the Member States concerned of the end of the clinical investigation, with a justification in case of early termination.
Proizvajalec ali njegov pooblaščeni zastopnik obvestita pristojne organe zadevnih držav članic o zaključku klinične preiskave, skupaj z obrazložitvijo v primeru predčasne prekinitve.
In the case of early termination of the clinical investigation on safety grounds this notification shall be communicated to all Member States and the Commission.
V primeru predčasne prekinitve klinične preiskave zaradi varnostnih razlogov je obvestilo o tem poslano vsem državam članicam in Komisiji.
The manufacturer or his authorised representative shall keep the report referred to in point 2.3.7 of Annex 7 at the disposal of the competent authorities.
Proizvajalec ali njegov pooblaščeni zastopnik da poročilo iz točke 2.3.7 Priloge 7 na razpolago pristojnim organom.
Clinical investigations shall be conducted in accordance with the provisions of Annex 7.
Klinična preiskava se izvaja v skladu z določbami Priloge 7.
The measures designed to amend non-essential elements of this Directive relating to the provisions on clinical investigation in Annex 7 shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;
Ukrepi, namenjeni spremembam nebistvenih določb te direktive v zvezi z določbami o klinični preiskavi iz Priloge 7, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 6(4).“;
Any manufacturer who, under his own name, places devices on the market in accordance with the procedure referred to in Article 9(2) shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned.
Vsak proizvajalec, ki daje pripomočke na trg pod lastnim imenom, v skladu s postopkom iz člena 9(2), obvesti pristojne organe v državi članici, v kateri ima registrirano poslovno enoto, o naslovu registrirane poslovne enote in opisu zadevnih pripomočkov.
Member States may request to be informed of all data allowing for the devices to be identified together with the label and the instructions for use when the devices are put into service within their territory.
Ko so pripomočki dani v uporabo znotraj njihovega ozemlja, lahko države članice zahtevajo vse podatke za identifikacijo pripomočkov, skupaj z oznako in navodili za uporabo.
Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union.
Če proizvajalec, ki daje pripomoček na trg pod lastnim imenom, v državi članici nima registrirane poslovne enote, imenuje enega pooblaščenega zastopnika v Evropski uniji.
For devices referred to in the first subparagraph of paragraph 1 the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of all details as referred to in paragraph 1.
Za pripomočke iz prvega pododstavka odstavka 1 pooblaščeni zastopnik obvesti pristojni organ v državi članici, v kateri ima registrirano poslovno enoto, o vseh podrobnostih iz odstavka 1.
The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.
Države članice na zahtevo obvestijo druge države članice in Komisijo o podatkih iz prvega pododstavka odstavka 1, ki jih posreduje proizvajalec ali pooblaščeni zastopnik.
Regulatory data in accordance with this Directive shall be stored in a European databank accessible to the competent authorities to enable them to carry out their tasks relating to this Directive on a well-informed basis.
Regulatorni podatki v skladu s to direktivo se shranijo v Evropski banki podatkov, ki je dostopna pristojnim organom, kar jim omogoča dobro obveščenost pri opravljanju nalog v zvezi s to direktivo.
The databank shall contain the following:
Banka podatkov vsebuje:
data relating to certificates issued, modified, supplemented, suspended, withdrawn or refused according to the procedures as laid down in Annexes 2 to 5;
podatke v zvezi z izdanimi, spremenjenimi, dopolnjenimi, začasno preklicanimi, umaknjenimi ali zavrnjenimi potrdili v skladu s postopki iz prilog 2 do 5;
data obtained in accordance with the vigilance procedure as defined in Article 8;
podatke, pridobljene v skladu z vigilančnim postopkom, opredeljenim v členu 8;
data relating to clinical investigations referred to in Article 10.
podatke v zvezi s kliničnimi preiskavami iz člena 10.
Data shall be forwarded in a standardised format.
Podatki se posredujejo v standardizirani obliki.
The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(c), shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).
Ukrepi, potrebni za izvajanje odstavkov 1 in 2 tega člena in zlasti odstavka 1(c), se sprejmejo v skladu z regulativnim postopkom iz člena 6(3).
Where a Member State considers in relation to a given product or group of products that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures.
Če država članica v zvezi z danim izdelkom ali skupino izdelkov meni, da bi bilo treba za zagotovitev varovanja zdravja in varnosti in/ali za zagotovitev spoštovanja zahtev javnega zdravja, take izdelke umakniti s trga ali dajanje takih izdelkov na trg in začetek njihove uporabe prepovedati, omejiti ali zanje uvesti posebne zahteve, lahko sprejme vse potrebne in upravičene prehodne ukrepe.
The Member State shall then inform the Commission and all the other Member States of the transitional measures, giving the reasons for its decision.
Država članica nato obvesti Komisijo in vse druge države članice o prehodnih ukrepih ter navede razloge za svojo odločitev.
The Commission shall, whenever possible, consult the interested Parties and the Member States.
Komisija se, kadar je mogoče, posvetuje z zainteresiranimi stranmi in državami članicami.
The Commission shall adopt its opinion, indicating whether the national measures are justified or not.
Komisija sprejme mnenje o tem, ali so nacionalni ukrepi upravičeni ali ne.
The Commission shall inform all the Member States and the consulted interested Parties.
Komisija obvesti vse države članice in zainteresirane strani, s katerimi se je posvetovala.
When appropriate, the necessary measures designed to amend non-essential elements of this Directive, by supplementing it, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements therefor, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).
Po potrebi se v skladu z regulativnim postopkom s pregledom iz člena 6(4) sprejmejo ustrezni ukrepi za spreminjanje nebistvenih določb te direktive z njenimi dopolnitvami v zvezi z umikom določenih izdelkov ali skupin izdelkov s trga, prepovedjo njihovega dajanja na trg in začetka njihove uporabe ali omejevanjem oziroma uvedbo posebnih zahtev zanje.
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 6(5).’;
Zaradi nujnih razlogov lahko Komisija uporabi nujni postopek iz člena 6(5).“;
Article 11 shall be amended as follows:
člen 11 se spremeni:
in paragraph 2, the following subparagraph shall be added: ‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex 8 to this Directive for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).’;
v odstavku 2 se doda naslednji pododstavek: „Glede na tehnični napredek se po potrebi in v skladu z regulativnim postopkom iz člena 6(3) sprejmejo natančni ukrepi, potrebni za zagotavljanje dosledne uporabe meril iz Priloge 8 k tej direktivi za imenovanje organov s strani držav članic.“;
in paragraph 4, the words ‘agent established in the Community’ shall be replaced by the words ‘authorised representative’;
v odstavku 4 se besede „zastopnik s sedežem v Skupnosti“ nadomestijo z besedami „pooblaščeni zastopnik“;
The notified body shall inform its competent authority about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of this Directive about certificates suspended, withdrawn or refused and, on request, about certificates issued.
Priglašeni organ obvesti svoj pristojni organ o vseh izdanih, spremenjenih, dopolnjenih, začasno preklicanih, umaknjenih ali zavrnjenih potrdilih ter druge priglašene organe iz te direktive o začasno preklicanih, umaknjenih ali zavrnjenih potrdilih in, na zahtevo, o izdanih potrdilih.
The notified body shall also make available, on request, all additional relevant information.
Priglašeni organ da na zahtevo na voljo tudi vse dodatne ustrezne informacije.
Where a notified body finds that pertinent requirements of this Directive have not been met or are no longer met by the manufacturer or that a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.
Če priglašeni organ ugotovi, da ustrezne zahteve iz te direktive niso bile izpolnjene ali da jih proizvajalec ne izpolnjuje več ali da potrdilo ne bi smelo biti izdano, ob upoštevanju načela sorazmernosti začasno prekliče ali umakne izdano potrdilo ali ga omeji, razen če proizvajalec z izvajanjem ustreznih korektivnih ukrepov zagotovi skladnost s temi zahtevami.
In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform its competent authority thereof.
V primeru začasnega preklica ali umika potrdila ali katere koli njegove omejitve ali če je potrebno posredovanje pristojnega organa, priglašeni organ o tem obvesti pristojni organ.
The Member State shall inform the other Member States and the Commission.
Države članice obvestijo druge države članice in Komisijo.
The notified body shall, on request, supply all relevant information and documents, including budgetary documents, required to enable the Member State to verify compliance with the criteria laid down in Annex 8.’;
Priglašeni organ na zahtevo predloži vse ustrezne informacije in dokumente, vključno s proračunskimi dokumenti, ki so potrebni, da država članica preveri skladnost z merili iz Priloge 8.“;
Without prejudice to Article 7
Brez poseganja v člen 7:
where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of this Directive, the manufacturer or his authorised representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State;
kadar država članica ugotovi, da oznaka CE ni bila ustrezno pritrjena ali da oznake CE ni, kar je v nasprotju s to direktivo, je proizvajalec ali njegov pooblaščeni zastopnik s sedežem v Skupnosti, zavezan prenehati s kršitvijo pod pogoji, ki jih določi država članica;
where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.
kadar se neskladnost nadaljuje, mora država članica sprejeti vse ustrezne ukrepe za omejitev ali prepoved dajanja zadevnega pripomočka na trg ali za zagotovitev njegove odstranitve s trga v skladu s postopki, določenimi v členu 7.
Those provisions shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.’;
Te določbe se uporabljajo tudi v primeru, ko je oznaka CE pritrjena v skladu s postopki iz te direktive, vendar neustrezno na izdelkih, ki niso predmet te direktive.“;
Article 14 shall be amended as follows:
člen 14 se spremeni:
the first paragraph shall be replaced by the following:
prvi odstavek se nadomesti z naslednjim:
‘Any decision taken pursuant to this Directive
„Vsaka odločitev, sprejeta v skladu s to direktivo:
to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations;
ki zavrne ali omeji dajanje pripomočka na trg in/ali začetek uporabe pripomočka ali opravljanje kliničnih preiskav;
to withdraw devices from the market
ki zahteva umik pripomočkov s trga,
shall state the exact grounds on which it is based.
je natančno obrazložena.
Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.’;
Tako odločitev je treba nemudoma sporočiti zadevni stranki, ki mora biti obenem obveščena tudi o pravnih sredstvih, ki so ji na voljo v skladu z zakonodajo, veljavno v zadevni državi članici, in o predpisanih rokih za vložitev pravnih sredstev.“;
in the second paragraph the words ‘established in the Community’ shall be deleted;
v drugem odstavku se črtajo besede „s sedežem v Skupnosti“;
Article 15 shall be replaced by the following:
člen 15 se nadomesti z:
Without prejudice to the existing national provisions and practices on medical confidentiality, Member States shall ensure that all the Parties involved in the application of this Directive are bound to observe confidentiality with regard to all information obtained in carrying out their tasks.
Brez poseganja v veljavne nacionalne predpise in prakso zdravniške zaupnosti države članice zagotovijo, da so vse strani, ki uporabljajo to direktivo, zavezane k spoštovanju zaupnosti vseh podatkov, pridobljenih pri izvajanju svojih nalog.
This does not affect the obligations of Member States and notified bodies with regard to mutual information and the dissemination of warnings, nor the obligations of the persons concerned to provide information under criminal law.
To ne vpliva na obveznosti držav članic in priglašenih organov v zvezi z vzajemnim obveščanjem in širjenjem opozoril, niti na obveznost vpletenih oseb, da zagotovijo podatke v skladu s kazenskim pravom.
The following information shall not be treated as confidential:
Naslednje informacije se ne štejejo za zaupne: