natgillin/translations-raw huggingface dataset:
data relating to registration of manufacturers and authorised representatives and devices in accordance with Article 14 excluding data related to custom-made devices;’;
podatke v zvezi z registracijo proizvajalcev, pooblaščenih zastopnikov in pripomočkov v skladu s členom 14 razen podatkov v zvezi z uporabniku prilagojenimi pripomočki;“;
data relating to clinical investigations referred to in Article 15;’;
podatke v zvezi s kliničnimi preiskavami iz člena 15;“;
The measures necessary for the implementation of paragraphs 1 and 2 of this Article, in particular paragraph 1(d), shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’
Ukrepi, potrebni za izvajanje odstavkov 1 in 2 tega člena, zlasti odstavka 1(d), se sprejmejo v skladu z regulativnim postopkom iz člena 7(2).“;
The provisions of this Article shall be implemented no later than 5 September 2012.
Določbe tega člena se izvedejo najpozneje do 5. septembra 2012.
The Commission shall, no later than 11 October 2012, evaluate the operational functioning and the added value of the databank.
Komisija najpozneje do 11. oktobra 2012 oceni operativno delovanje in dodano vrednost baze podatkov.
On the basis of this evaluation, the Commission shall, if appropriate, present proposals to the European Parliament and the Council or present draft measures in accordance with paragraph 3.’;
Na osnovi te ocene po potrebi predstavi predloge Evropskemu parlamentu in Svetu ali osnutke ukrepov v skladu z odstavkom 3.“;
Article 14b shall be replaced by the following:
člen 14b se nadomesti z:
‘Article 14b
„Člen 14b
Particular health monitoring measures
Posebni ukrepi za spremljanje zdravstvenega stanja
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protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take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, da se spoštujejo zahteve javnega zdravja, take izdelke umakniti s trga ali dajanje takih izdelkov na trg ali njihovo dajanje v uporabo prepovedati ali omejiti ali zanje uvesti posebne zahteve, lahko sprejme vse potrebne in upravičene prehodne ukrepe.
The Member State shall then inform the Commission and all other Member States, giving the reasons for its decision.
Država članica potem obvesti Komisijo in vse druge države članice ter navede razloge za svojo odločitev.
paragraphs 1, 2 and 3 shall be replaced by the following:
odstavki 1, 2 in 3 se nadomestijo z:
In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII.
V primeru pripomočkov, namenjenih kliničnim preiskavam, sledi proizvajalec ali pooblaščeni zastopnik s sedežem v Skupnosti postopku iz Priloge VIII, in pristojne organe držav članic, v katerih naj bi preiskave izvedli, o tem obvesti z izjavo iz oddelka 2.2 Priloge VIII.
In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.
Pri pripomočkih, ki spadajo v razred III, ter pripomočkih za vsaditev in invazivnih pripomočkih za dolgotrajno uporabo, ki spadajo v razred IIa ali IIb, lahko proizvajalec začne ustrezno klinično preiskavo ob koncu obdobja 60 dni po priglasitvi, razen če ga pristojni organ v tem času obvesti o nasprotni odločitvi, utemeljeni s preudarki javnega zdravja ali javnega reda.
Member States may however authorise manufacturers to commence the relevant clinical investigations before the expiry of the period of 60 days, insofar as the relevant ethics committee has issued a favourable opinion on the programme of investigation 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.
In the case of devices other than those referred to in paragraph 2, Member States may authorise manufacturers to commence clinical investigations immediately after the date of notification, provided that the ethics committee concerned has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan.’;
V primeru pripomočkov, razen pri tistih iz odstavka 2, lahko države članice pooblastijo proizvajalce, da začnejo izvajati klinične preiskave takoj po datumu priglasitve, če zadevni etični odbor izda ugodno mnenje o zadevnem programu preiskav, vključno s pregledom načrta kliničnih preiskav.“;
paragraphs 5, 6 and 7 shall be replaced by the following:
odstavki 5, 6 in 7 se nadomestijo z:
The clinical investigations must be conducted in accordance with the provisions of Annex X.
Klinične preiskave je treba izvesti v skladu z določbami iz Priloge X.
The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the provisions on clinical investigation in Annex X shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).
Potrebni ukrepi v zvezi z določbami o kliničnih preiskavah iz Priloge X, ki so namenjeni spreminjanju nebistvenih določb te direktive, med drugim z njeno dopolnitvijo, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 7(3).
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, o svojih ukrepih in o razlogih zanje obvesti zadevne države članice.
The manufacturer or his authorised representative shall keep the report referred to in Section 2.3.7 of Annex X at the disposal of the competent authorities.’;
Proizvajalec ali njegov pooblaščeni zastopnik hranita poročilo, navedeno v točki 2.3.7 Priloge X, da je na voljo pristojnim organom.“;
Article 16 shall be amended as follows:
člen 16 se spremeni:
the following subparagraph shall be added to paragraph 2:
v odstavku 2 se doda naslednji pododstavek:
‘When appropriate in the light of technical progress, the detailed measures necessary to ensure a consistent application of the criteria set out in Annex XI for the designation of bodies by the Member States shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;
„Glede na tehnični napredek se po potrebi in v skladu z regulativnim postopkom iz člena 7(2) sprejmejo natančni ukrepi, potrebni za zagotavljanje dosledne uporabe kriterijev iz Priloge XI, ki veljajo pri imenovanju organov s strani držav članic.“;
in paragraph 4, the words ‘established in the Community’ shall be deleted;
v odstavku 4 se črtajo besede „s sedežem v Skupnosti“;
The notified body shall also make available, on request, all additional relevant information.’;
Priglašeni organ na zahtevo da na voljo tudi vse dodatne ustrezne informacije.“;
in Article 18 point (a) shall be replaced by the following:
v členu 18 se točka (a) nadomesti z:
where a Member State establishes that the CE marking has been affixed unduly or is missing in violation of the Directive, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;’;
če država članica ugotovi, da oznaka CE ni ustrezno pritrjena ali oznake CE ni, kar je v nasprotju s to direktivo, je izvajalec ali njegov pooblaščeni zastopnik dolžan kršitev odpraviti pod pogoji, ki jih predpiše država članica;“;
in Article 19(2), the words ‘established in the Community’ shall be deleted;
v odstavku 19(2) se črtajo besede „s sedežem v Skupnosti“;
Article 20 shall be replaced by the following:
člen 20 se nadomesti z:
This does not affect the obligation 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 razširjenjem opozoril, niti na obveznost zadevnih oseb, da zagotovijo podatke v skladu s kazenskim pravom.
information on the registration of persons responsible for placing devices on the market in accordance with Article 14;
informacije o registraciji oseb, odgovornih za dajanje pripomočkov na trg v skladu s členom 14;
information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure according to Article 10(3);
informacije o določenem ukrepu v skladu s členom 10(3), ki jih uporabnikom posreduje proizvajalec, pooblaščeni zastopnik ali distributer;
The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to determination of the conditions under which other information may be made publicly available, and in particular for Class IIb and Class III devices to any obligation for manufacturers to prepare and make available a summary of the information and data related to the device, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;
V skladu z regulativnim postopkom s pregledom iz člena 7(3) se sprejmejo ukrepi za spreminjanje nebistvenih določb te direktive, med drugim z njenimi dopolnitvami, v zvezi z določitvijo pogojev, pod katerimi so lahko javnosti dostopne druge informacije, in obveznost, zlasti za pripomočke iz razreda IIb in razreda III, da proizvajalci pripravijo in dajo na voljo povzetek informacij in podatkov v zvezi s pripomočkom.“;
Annexes I to X shall be amended in accordance with Annex II to this Directive.
priloge I do X se spremenijo v skladu s Prilogo II k tej direktivi.
In Article 1(2) of Directive 98/8/EC the following point shall be added:
Členu 1(2) Direktive 98/8/ES se doda naslednja točka:
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.
Direktiva 98/79/ES Evropskega parlamenta in Sveta z dne 27. oktobra 1998 o in vitro diagnostičnih medicinskih pripomočkih.
Member States shall adopt and publish by 21 December 2008 the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo, do 21. decembra 2008.
They shall forthwith communicate to the Commission the text of those measures.
Besedilo teh ukrepov nemudoma sporočijo Komisiji.
They shall apply those measures from 21 March 2010.
Te določbe začnejo uporabljati 21. marca 2010.
OJ C 195, 18.8.2006, p. 14.
UL C 195, 18.8.2006, str. 14.
Opinion of the European Parliament of 29 March 2007 (not yet published in the Official Journal) and Council Decision of 23 July 2007.
Mnenje Evropskega parlamenta z dne 29. marca 2007 (še ni objavljeno v Uradnem listu) in Sklep Sveta z dne 23. julija 2007.
Directive as last amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council (OJ L 378, 27.12.2006, p. 1).
1901/2006 Evropskega parlamenta in Sveta (UL L 378, 27.12.2006, str. 1).
OJ C 20, 24.1.2004, p. 1.
UL C 20, 24.1.2004, str. 1.
OJ C 68 E, 18.3.2004, p. 85.
UL C 68 E, 18.3.2004, str. 85.
Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma (OJ L 313, 13.12.2000, p. 22).
Direktiva 2000/70/ES Evropskega parlamenta in Sveta z dne 16. novembra 2000 o spremembi Direktive Sveta 93/42/EGS glede medicinskih pripomočkov, ki vsebujejo stabilne derivate človeške krvi ali človeške plazme (UL L 313, 13.12.2000, str. 22).
Directive as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1)’
Direktiva, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1901/2006 (UL L 378, 27.12.2006, str. 1).“;
Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility (OJ L 390, 31.12.2004, p. 24).’;
Direktiva 2004/108/ES Evropskega parlamenta in Sveta z dne 15. decembra 2004 o približevanju zakonodaj držav članic v zvezi z elektromagnetno združljivostjo (UL L 390, 31.12.2004, str. 24).“;
OJ L 157, 9.6.2006, p. 24.’;
UL L 157, 9.6.2006, str. 24.“;
Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37).
Direktiva 98/34/ES Evropskega parlamenta in Sveta z dne 22. junija 1998 o določitvi postopka za zbiranje informacij na področju tehničnih standardov in tehničnih predpisov o storitvah informacijske družbe (UL L 204, 21.7.1998, str. 37).
Directive as last amended by the 2003 Act of Accession.’;
Direktiva, kakor je bila nazadnje spremenjena z Aktom o pristopu iz leta 2003.“;
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zdravilih za uporabo v humani medicini (UL L 311, 28.11.2001, str. 67).
Directive as last amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).’;
Direktiva, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1901/2006 (UL L 378, 27.12.2006, str. 1).“;
Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ L 399, 30.12.1989, p. 18).
Direktiva Sveta 89/686/EGS z dne 21. decembra 1989 o približevanju zakonodaj držav članic v zvezi z osebno zaščitno opremo (UL L 399, 30.12.1989, str. 18).
Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).’
Direktiva kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1882/2003 Evropskega parlamenta in Sveta (UL L 284, 31.10.2003, str. 1).“;
Directive 2004/108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility (OJ L 390, 31.12.2004, p. 24).
Direktiva 2004/108/ES Evropskega parlamenta in Sveta z dne 15. decembra 2004 o približevanju zakonodaj držav članic v zvezi z elektromagnetno združljivostjo (UL L 390, 31.12.2004, str. 24).
OJ L 180, 9.7.1997, p. 22.’
UL L 180, 9.7.1997, str. 22.“;
OJ L 157, 9.6.2006, p. 24.’
UL L 157, 9.6.2006, str. 24.“;
Directive as last amended by the 2003 Act of Accession.’
Direktiva, kakor je bila nazadnje spremenjena z Aktom o pristopu iz leta 2003.“;
Directive as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).’
Direktiva, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1882/2003 (UL L 284, 31.10.2003, str. 1).“
Annexes 1 to 7 to Directive 90/385/EEC shall be amended as follows:
Priloge 1 do 7 k Direktivi 90/385/EGS se spremenijo:
Annex 1 shall be amended as follows:
Priloga 1 se spremeni:
Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex 7.’;
Dokazovanje skladnosti z bistvenimi zahtevami mora vključevati klinično vrednotenje v skladu s Prilogo 7.“;
in Section 8, the fifth indent shall be replaced by the following:
v oddelku 8 se peta alinea nadomesti z:
risks connected with ionising radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation and Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionising radiation in relation to medical exposure.
nevarnosti, povezane z ionizacijskim sevanjem radioaktivnih snovi, ki jih vsebuje pripomoček v skladu z varnostnimi zahtevami, določenimi v Direktivi Sveta 96/29/Euratom z dne 13. maja 1996 o določitvi temeljnih varnostnih standardov za varstvo zdravja delavcev in prebivalstva pred nevarnostmi zaradi ionizirajočega sevanja in Direktive Sveta 97/43/Euratom z dne 30. junija 1997 o varstvu zdravja posameznikov pred nevarnostjo ionizirajočega sevanja zaradi izpostavljenosti sevanju v zdravstvu.
in Section 9, seventh indent, the following phrase shall be added:
v sedmi alinei oddelka 9 se doda naslednje besedilo:
‘For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.’;
„Za pripomočke, ki vsebujejo programsko opremo ali ki so sami po sebi medicinska programska oprema, mora biti programska oprema potrjena v skladu s tehničnim razvojem, ob upoštevanju načel razvojnega življenjskega cikla, obvladovanja tveganja, validacije in verifikacije.“;
Section 10 shall be replaced by the following:
oddelek 10 se nadomesti z naslednjim:
Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.
Če pripomoček, kot sestavni del, vsebuje snov, ki lahko velja za zdravilo iz člena 1 Direktive 2001/83/ES, če se uporablja ločeno, in ki ima ob tem pripomočku na telo verjetno dopolnilni učinek, je treba kakovost, varnost in uporabnost snovi preveriti po analogiji z metodami iz Priloge I k Direktivi 2001/83/ES.
For the substances referred to in the first paragraph, the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device, seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA) acting particularly through its committee in accordance with Regulation (EC) No 726/2004 on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device.
Za snovi iz prvega odstavka zahteva priglašeni organ, potem ko preveri uporabnost snovi kot dela medicinskega pripomočka in ob upoštevanju predvidenega namena pripomočka, od enega izmed pristojnih organov, ki jih je imenovala država članica, ali od EMEA, ki deluje zlasti prek svojega odbora v skladu z Uredbo (ES) št. 726/2004, znanstveno mnenje o kakovosti in varnosti snovi, vključno z mnenjem o razmerju med klinično koristjo in tveganjem vključitve te snovi v pripomoček.
When issuing its opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.
Ob izdaji mnenja pristojni organ ali EMEA upošteva postopek izdelave in podatke, povezane z uporabnostjo vključitve snovi v pripomoček, kot to določa priglašeni organ.
Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, having verified the usefulness of the substance as part of the device and taking account of the intended purpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on the quality and safety of the substance, including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device.
Če pripomoček kot sestavni del, vsebuje derivat človeške krvi, zahteva priglašeni organ, potem ko preveri uporabnost snovi kot dela pripomočka in ob upoštevanju predvidenega namena pripomočka, od EMEA, ki deluje zlasti prek svojega odbora, znanstveno mnenje o kakovosti in varnosti snovi, vključno z mnenjem o razmerju med klinično koristjo in tveganjem vključitve derivata človeške krvi v pripomoček.
When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.
Ob izdaji mnenja upošteva EMEA postopek izdelave in podatke, povezane z uporabnostjo vključitve snovi v pripomoček, kot to določa priglašeni organ.
Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes and shall consult the relevant medicines competent authority (i.e. the one involved in the initial consultation), in order to confirm that the quality and safety of the ancillary substance are maintained.
Kadar se pomožna snov, vključena v pripomoček, zlasti v zvezi s postopkom izdelave, spremeni, je priglašeni organ obveščen o spremembi in se posvetuje z ustreznim pristojnim organom za zdravila (tj. tisti, ki sodeluje pri začetnem posvetovanju), zato da se potrdi ohranjanje kakovosti in varnosti pomožne snovi.
The competent authority shall take into account the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the device.
Pristojni organ upošteva podatke o uporabnosti vključitve snovi v pripomoček, kot to določa priglašeni organ, in tako zagotovi, da spremembe nimajo negativnega vpliva na vzpostavljeno razmerje med koristjo in tveganjem dodajanja snovi v pripomoček.
When the relevant medicines competent authority (i.e. the one involved in the initial consultation) has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice, whether this information has an impact on the established benefit/risk profile of the addition of the substance to the device or not.
Kadar je ustrezni pristojni organ za zdravila (tj. tisti, ki sodeluje pri začetnem posvetovanju) prejel podatke o pomožni snovi, ki bi lahko vplivala na vzpostavljeno razmerje med koristjo in tveganjem dodajanja snovi v pripomoček, priglašenemu organu svetuje, ali imajo ti podatki vpliv na vzpostavljeno razmerje med koristjo in tveganjem dodajanja snovi pripomočku.
The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure.
Priglašeni organ posodobljeno znanstveno mnenje upošteva pri ponovni preučitvi svoje ocene postopka ocenjevanja skladnosti.
Section 14.2 shall be amended as follows:
oddelek 14.2 se spremeni:
the first indent shall be replaced by the following:
prva alinea se nadomesti z: