natgillin/translations-raw huggingface dataset:
information on the registration of persons responsible for placing devices on the market in accordance with Article 10a;
informacije o registraciji oseb, odgovornih za dajanje pripomočkov na trg v skladu s členom 10a;
information to users sent out by the manufacturer, authorised representative or distributor in relation to a measure in accordance with Article 8;
informacije, ki jih uporabnikom posreduje proizvajalec, pooblaščeni zastopnik ali distributer v zvezi z ukrepom v skladu s členom 8;
information contained in certificates issued, modified, supplemented, suspended or withdrawn.
informacije v izdanih, spremenjenih, dopolnjenih, začasno preklicanih ali umaknjenih potrdilih.
The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the determination of the conditions under which information other than that referred to in paragraph 2, and in particular concerning any obligation for manufacturers to prepare and make available a summary of the information and data related to the device, may be made publicly available shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).’;
Ukrepi za spreminjanje nebistvenih določb te direktive, med drugim z njenim dopolnjevanjem, v zvezi z določitvijo pogojev, pod katerimi so lahko javnosti dostopne druge informacije, in zlasti tistih o obveznostih proizvajalcev, da pripravijo in dajo na voljo povzetek informacij in podatkov o pripomočku, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 6(4).“;
Member States shall take appropriate measures to ensure that the competent authorities of the Member States cooperate with each other and with the Commission and transmit to each other the information necessary to enable this Directive to be applied uniformly.
Države članice sprejmejo ustrezne ukrepe za zagotovitev, da pristojni organi držav članic sodelujejo med seboj in s Komisijo ter si izmenjujejo potrebne informacije za enotno uporabo te direktive.
The Commission shall provide for the organisation of an exchange of experience between the competent authorities responsible for market surveillance in order to coordinate the uniform application of this Directive.
Za uskladitev enotne uporabe te direktive Komisija zagotovi izmenjavo izkušenj med pristojnimi organi, odgovornimi za nadzor trga.
Without prejudice to the provisions of this Directive, cooperation may be part of initiatives developed at an international level.’;
Brez poseganja v določbe te direktive je lahko sodelovanje del pobud, nastalih na mednarodni ravni.“;
Annexes 1 to 7 shall be amended in accordance with Annex I to this Directive.
priloge 1 do 7 se spremenijo v skladu s Prilogo I k tej direktivi.
Directive 93/42/EEC is hereby amended as follows:
Direktiva 93/42/EGS se spremeni, kakor sledi:
in point (a) the introductory phrase shall be replaced by the following:
v točki (a) se uvodni stavek nadomesti z:
‘“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:’;
„‚medicinski pripomoček‘ pomeni vsak instrument, aparaturo, napravo, programsko opremo, material ali drug predmet, ki se uporablja samostojno ali v kombinaciji, vključno s programsko opremo, ki jo je proizvajalec predvidel izrecno za uporabo za diagnostiko in/ali v terapevtske namene in je potrebna za njegovo pravilno uporabo, ki ga je proizvajalec predvidel za uporabo na ljudeh z namenom:“;
in the third paragraph of point (d) the words ‘are not’ shall be replaced by the words ‘shall not be’;
sprememba v tretjem odstavku točke 2 ne zadeva slovenske različice;
clinical investigation(s) of the device concerned; or
klinične(-ih) preiskave(-) zadevnega pripomočka, ali
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
klinične(-ih) preiskave(-) ali druge raziskave podobnih pripomočkov, objavljene v znanstveni literaturi, za katere je mogoče dokazati enakovrednost z zadevnim pripomočkom, ali
published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated;
objavljenih in/ali neobjavljenih poročil o drugih kliničnih izkušnjah z zadevnim pripomočkom ali podobnim pripomočkom, za katerega je mogoče dokazati enakovrednost z zadevnim pripomočkom;
“device subcategory” means a set of devices having common areas of intended use or common technology;
‚podkategorija pripomočkov‘ pomeni sklop pripomočkov, ki imajo skupno področje predvidene uporabe ali skupno tehnologijo;
“generic device group” means a set of devices having the same or similar intended uses or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;
‚skupina generičnih pripomočkov‘ pomeni sklop pripomočkov, ki imajo enako ali podobno predvideno uporabo ali skupno tehnologijo, kar jim omogoča, da so razvrščeni generično, ne da bi to odražalo posebne lastnosti;
“single use device” means a device intended to be used once only for a single patient.’;
‚pripomoček za enkratno uporabo‘ pomeni pripomoček, ki je namenjen zato, da se ga uporabi enkrat le za enega bolnika.“;
Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 2001/83/EC, that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.
Če je pripomoček namenjen aplikaciji zdravila v smislu člena 1 Direktive 2001/83/ES, ta pripomoček ureja ta direktiva, brez poseganja v določbe Direktive 2001/83/ES glede zdravil.
If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 2001/83/EC.
Če se ta pripomoček da na trg tako, da pripomoček in zdravilo tvorita en sam enoten izdelek, ki je namenjen izključno uporabi v dani kombinaciji in ki ni namenjen za ponovno uporabo, ta enotni izdelek ureja Direktiva 2001/83/ES.
The relevant essential requirements of Annex I to this Directive shall apply as far as safety and performance-related device features are concerned.
Ustrezne bistvene zahteve Priloge I k tej direktivi se uporabljajo, če zadevajo z varnostjo in zmogljivostjo povezane lastnosti pripomočka.
in paragraph 4:
v odstavku 4:
the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;
sklicevanje „65/65/EGS“ se nadomesti s sklicevanjem „2001/83/ES“;
the words ‘that device must’ shall be replaced by the words ‘that device shall’;
besede „se mora ta pripomoček oceniti“ se nadomestijo z besedami „je ta pripomoček ocenjen“;
in paragraph 4a:
v odstavku 4a:
the reference ‘89/381/EEC’ shall be replaced by the reference ‘2001/83/EC’;
sklicevanje „89/381/EGS“ se nadomesti s sklicevanjem „2001/83/ES“;
paragraph 5 shall be amended as follows:
odstavek 5 se spremeni:
point (c) shall be replaced by the following:
točka (c) se nadomesti z:
In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;’;
Pri odločanju, ali izdelek ureja navedena direktiva ali ta direktiva, je treba upoštevati zlasti glavni način delovanja zadevnega izdelka.“;
point (f) shall be replaced by the following:
točka (f) se nadomesti z:
transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a.’;
presaditvene organe ali tkiva ali celice človeškega izvora ali za izdelke, ki vsebujejo tkiva ali celice človeškega izvora ali so iz njih pridobljeni, razen za pripomočke iz odstavka 4a.“;
paragraph 6 shall be replaced by the following:
odstavek 6 se nadomesti z:
Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in Council Directive 89/686/EEC and this Directive, the relevant basic health and safety requirements of Directive 89/686/EEC shall also be fulfilled.
Če je bil namen proizvajalca, da se pripomoček uporabi v skladu z določbami o osebni zaščitni opremi iz Direktive Sveta 89/686/EGS in te direktive, morajo biti izpolnjene tudi ustrezne osnovne zahteve za zdravje in varnost iz Direktive 89/686/EGS.
paragraphs 7 and 8 shall be replaced by the following:
odstavka 7 in 8 se nadomestita z:
This Directive is a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC of the European Parliament and of the Council.
Ta direktiva je posebna direktiva v smislu člena 1(4) Direktive 2004/108/ES Evropskega parlamenta in Sveta.
This Directive shall not affect the application of 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, nor of 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.
Ta direktiva ne vpliva na uporabo Direktive Sveta 96/29/Euratom z dne 13. maja 1996 o določitvi temeljnih varnostnih standardov za varstvo zdravja delavcev in prebivalstva med nevarnostmi zaradi ionizirajočega sevanja niti Direktive Sveta 97/43/Euratom z dne 30. junija 1997 o varstvu zdravja posameznikov pred nevarnostjo ionizirajočega sevanja zaradi izpostavljenosti sevanju v zdravstvu.
in Article 3 the following paragraph shall be added:
v členu 3 se doda naslednji odstavek:
‘Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to this Directive.3. the second indent of Article 4(2) shall be replaced by the following:
„Če obstaja ustrezna stopnja nevarnosti, pripomočki, ki so tudi stroji v smislu člena 2(a) Direktive 2006/42/ES Evropskega parlamenta in Sveta z dne 17. maja 2006 o strojih, ustrezajo osnovnim zdravstvenim in varnostnim zahtevam iz Priloge 1 k navedeni direktivi v obsegu, v katerem so tiste zdravstvene in varnostne zahteve bolj specifične kot osnovne zahteve iz Priloge I k tej direktivi.3. druga alinea člena 4(2) se nadomesti z:
custom-made devices being placed on the market and put into service if they meet the conditions laid down in Article 11 in combination with Annex VIII; Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified by name, an acronym or a numerical code.’;
dajanja na trg ali v uporabo uporabniku prilagojenih pripomočkov, če izpolnjujejo pogoje iz člena 11 v kombinaciji s Prilogo VIII; pripomočke v razredih IIa, IIb in III spremlja izjava iz Priloge VIII, ki je dana na razpolago posameznemu bolniku, identificiranemu z imenom, akronimom ali numerično kodo.“;
in Article 6(1) the reference ‘83/189/EEC’ shall be replaced by the reference ‘98/34/EC
v odstavku 6(1) se sklicevanje „83/189/EGS“ nadomesti s sklicevanjem „98/34/ES.
The Commission shall be assisted by the Committee set up by Article 6(2) of Directive 90/385/EEC, hereinafter referred to as “the Committee”.
Komisiji pomaga odbor, ustanovljen s členom 6(2) Direktive 90/385/EGS, 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.“;
In Article 8 paragraph 2 shall be replaced by the following:
v členu 8 se odstavek 2 nadomesti z:
The Commission shall enter into consultation with the Parties concerned as soon as possible.
Komisija čim prej začne posvetovanja z zadevnimi stranmi.
Where, after such consultation, the Commission finds that:
Če po teh posvetovanjih Komisija ugotovi, da:
the measures are justified:
so ukrepi upravičeni:
it shall immediately so inform the Member State which took the measures and the other Member States. Where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the Parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the advisory procedure referred to in Article 6(2);
nemudoma o tem obvesti državo članico, ki je ukrep sprejela, in druge države članice; če je odločitev iz odstavka 1 sprejeta zaradi pomanjkljivosti standardov, Komisija zadevo po posvetovanju z zadevnimi stranmi v roku dveh mesecev predloži odboru iz člena 6(1), če država članica, ki je sprejela odločitev, namerava pri tej odločitvi vztrajati, in začne svetovalni postopek iz člena 6(2);
when necessary in the interests of public health, appropriate measures designed to amend non-essential elements of this Directive relating to withdrawal from the market of devices referred to in paragraph 1 or to prohibition or restriction of their placement on the market or being put into service or to introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).
če je to potrebno zaradi varovanja javnega zdravja, se v skladu z regulativnim postopkom s pregledom iz člena 7(3) sprejmejo ustrezni ukrepi za spreminjanje nebistvenih določb te direktive v zvezi z umikom pripomočkov iz odstavka 1 iz trga ali prepovedjo oziroma omejitvijo dajanja na trg ali v uporabo, ali uvedbo posebnih zahtev za dajanje teh pripomočkov na trg.
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 7(4);
Zaradi nujnih razlogov lahko Komisija uporabi nujni postopek iz člena 7(4);
the measures are unjustified, it shall immediately so inform the Member State which took the measures and the manufacturer or his authorised representative.’;
so ukrepi neupravičeni, nemudoma o tem obvesti državo članico, ki je ukrep sprejela, in proizvajalca ali njegovega pooblaščenega zastopnika.“;
In Article 9 paragraph 3 shall be replaced by the following:
v členu 9 se odstavek 3 nadomesti z:
Where a Member State considers that the classification rules set out in Annex IX require adaptation in the light of technical progress and any information which becomes available under the information system provided for in Article 10, it may submit a duly substantiated request to the Commission and ask it to take the necessary measures for adaptation of classification rules.
Če država članica meni, da je treba klasifikacijska pravila iz Priloge IX prilagoditi glede na tehnični napredek in vse informacije, dostopne v okviru informacijskega sistema iz člena 10, lahko predloži Komisiji ustrezno utemeljeno prošnjo in jo zaprosi za ustrezne ukrepe za prilagoditev klasifikacijskih pravil.
The measures designed to amend non-essential elements of this Directive relating to adaptation of classification rules shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;
Ukrepi, ki so namenjeni spreminjanju nebistvenih določb te direktive v zvezi s prilagoditvijo klasifikacijskih pravil, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 7(3).“;
in paragraph 2, the words ‘established in the Community’ shall be deleted;
v odstavku 2 se črtajo besede „s sedežem v Skupnosti“;
After carrying out an assessment, if possible together with the manufacturer or his authorised representative, Member States shall, without prejudice to Article 8, 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 8 nemudoma obvestijo Komisijo in druge države članice o uvedenih ali načrtovanih ukrepih za zmanjšanje zapletov iz odstavka 1, vključno z informacijami o teh zapletih.“;
Any appropriate measures to adopt procedures to implement this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;
Vsak ustrezen ukrep za sprejetje postopkov za izvajanje tega člena se sprejme v skladu z regulativnim postopkom iz člena 7(2).“;
in paragraphs 8 and 9 the words ‘established in the Community’ shall be deleted;
v odstavkih 8 in 9 se črtajo besede „s sedežem v Skupnosti“;
in paragraph 11, the words ‘Annexes II and III’ shall be replaced by the words ‘Annexes II, III, V and VI’ and the words ‘for further periods of five years’ shall be replaced by the words ‘for further periods of a maximum length of five years’;
v odstavku 11 se besede „Prilogama II in III“ nadomestijo z besedami „prilogami II, III, V in VI“, besede „za nadaljnjih pet let“ pa se nadomestijo z besedami „za nadaljnja obdobja, vendar največ za pet let“;
The measures designed to amend non-essential elements of this Directive, 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 I Section 13.1 may be set out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).’;
Ukrepi za spreminjanje nebistvenih določb te direktive z njenimi dopolnitvami v zvezi s sredstvi, s katerimi se, glede na tehnični napredek in ob upoštevanju predvidenih uporabnikov zadevnih pripomočkov, določijo informacije iz oddelka 13.1 Priloge I, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 7(3).“;
the title shall be replaced by ‘Particular procedure for systems and procedure packs and procedure for sterilisation’;
naslov se nadomesti s „Poseben postopek za sisteme in pakete ter postopek za sterilizacijo“;
Any natural or legal person who sterilises, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility until the sterile package is opened or damaged.
Vsaka fizična ali pravna oseba, ki z namenom dajanja na trg sterilizira sisteme ali pakete iz odstavka 2, ali druge medicinske pripomočke z oznako CE, ki so jih proizvajalci predvideli za sterilizacijo pred uporabo, pri svoji izbiri ravna po enem od postopkov iz prilog II ali V. Uporaba zgoraj navedenih prilog in posredovanje priglašenega organa sta omejena na vidike postopka za zagotavljanje sterilnosti do odprtja oziroma poškodbe sterilne ovojnine.
The person shall draw up a declaration stating that sterilisation has been carried out in accordance with the manufacturer's instructions.’;
Oseba ob tem poda izjavo, da je bila sterilizacija opravljena v skladu s proizvajalčevimi navodili.“;
in paragraph 4, the third sentence shall be replaced by the following:
v odstavku 4 se tretji stavek nadomesti z:
‘The declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the competent authorities for a period of five years.’;
„Izjave iz odstavkov 2 in 3 se hranijo na voljo pristojnim organom za obdobje petih let.“;
The following Article shall be inserted:
doda se naslednji člen:
Reprocessing of medical devices
Predelava medicinskih pripomočkov
The Commission shall, no later than 5 September 2010, submit a report to the European Parliament and to the Council on the issue of the reprocessing of medical devices in the Community.
Komisija najpozneje do 5. septembra 2010 predloži poročilo Evropskemu parlamentu in Svetu o predelavi medicinskih pripomočkov v Skupnosti.
In the light of the findings of this report, the Commission shall submit to the European Parliament and to the Council any additional proposal it may deem appropriate in order to ensure a high level of health protection.’
Komisija glede na ugotovitve poročila predloži Evropskemu parlamentu in Svetu dodatne predloge, ki so po njenem mnenju potrebni za zagotovitev visoke ravni varovanja zdravja.“;
Decisions with regard to classification and derogation clause
Odločitve glede klasifikacije in klavzula o odstopanju
that Member State considers that the application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices;
če država članica meni, da uveljavljanje klasifikacijskih pravil iz Priloge IX zahteva odločitev o klasifikaciji danega pripomočka ali kategorije pripomočkov;
that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class;
če država članica meni, da bi moral biti dan pripomoček ali družina pripomočkov razvrščen v drug razred, z odstopanjem od določb Priloge IX;
that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;
če država članica meni, da je treba dognati skladnost pripomočka ali družine pripomočkov, z odstopanjem od člena 11, z uporabo zgolj enega od danih postopkov, izbranega izmed postopkov v členu 11;
that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e).
če država članica meni, da je potrebna odločitev o tem, ali nek izdelek ali skupina izdelkov spada pod opredelitev iz člena 1(2)(a) do(e).
The measures referred to in the first subparagraph of this paragraph shall, as appropriate, be adopted in accordance with the procedure referred to in Article 7(2).
Ukrepi iz prvega pododstavka tega odstavka se sprejmejo v skladu s postopkom iz člena 7(2).
in the second subparagraph of paragraph 1, the words ‘Classes IIb and III’ shall be replaced by the words ‘Classes IIa, IIb and III’;
v drugem pododstavku odstavka 1 se besede „razreda IIb in III“ nadomestijo z besedami „razredov IIa, IIb in III“;
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 the details referred to in paragraph 1.’;
Za pripomočke iz prvega pododstavka odstavka 1 obvesti pooblaščeni zastopnik pristojni organ v državi članici, v kateri ima registrirano poslovno enoto, o 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.“;
Article 14a shall be amended as follows:
člen 14a se spremeni:
the second subparagraph of paragraph 1 shall be amended as follows:
drugi pododstavek odstavka 1 se spremeni: