FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: 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 procedures referred to in Article 6 (1), - the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorized representative established within the Community.
Slovenian: Kadar je odločitev, navedena v odstavku 1, pripisana pomanjkljivostim v standardih, Komisija po posvetu z zadevnimi stranmi v dveh mesecih predloži zadevo odboru iz člena 6(1), če država članica, ki je sprejela odločitev, namerava to obdržati, in začne postopek, naveden v členu 6(1), so ukrepi neupravičeni, o tem nemudoma obvesti državo članico, ki je dala pobudo, in proizvajalca ali njegovega pooblaščenega zastopnika s sedežem v Skupnosti.
English: follow the procedure relating to the EC declaration of conformity set out in Annex 2; or
French: suivre la procédure relative à la déclaration CE de conformité visée à l'annexe II
Spanish: seguir el procedimiento relativo a la declaración CE de conformidad a que se refiere el Anexo 2, ó
Italian: svolgere la procedura relativa alla dichiarazione di conformità CE di cui all'allegato 2, oppure
Dutch: de in bijlage 2 omschreven procedure inzake de EG-verklaring van overeenstemming volgen
Slovenian: slediti postopku v zvezi z izjavo ES o skladnosti, določenemu v Prilogi 2; ali
Bulgarian: като следва процедурата, свързана с декларацията за съответствие на ЕО, определена в приложение 2;
Latvian: jāievēro procedūra, kas paredz apliecināt ierīču atbilsmi EK standartiem, kura izklāstīta 2. pielikumā; vai
Maltese: jimxi mal-proċedura marbuta mad-dikjarazzjoni KE ta’ konformità msemmija f’Anness 2;
English: the procedure relating to EC verification set out in Annex 4, or
Italian: la procedura relativa alla verifica CE di cui all'allegato 4, oppure
Slovenian: postopek v zvezi z ES overjanjem, določen v Prilogi 4; ali
English: O'MALLEY
French: J O'MALLEY
Italian: O'MALLEY
Slovenian: O'MALLEY
Maltese: O’malley
English: risks connected with ionizing radiation from radioactive substances included in the device, in compliance with the protection requirements laid down in Directive 80/836/Euratom , as amended by Directives 84/467/Euratom and 84/466/Euratom ,
Slovenian: nevarnosti, povezane z ionizacijskim sevanjem radioaktivnih snovi, ki jih vsebuje pripomoček v skladu z varnostnimi zahtevami, določenimi v Direktivi 80/836/Euratom1, kakor je bila spremenjena z Direktivama 84/467/Euratom in 84/466/Euratom,
English: mutual compatibility between the materials used and biological tissues,
Slovenian: medsebojni združljivosti uporabljenih materialov in bioloških tkiv,
English: cells and body fluids,
Slovenian: celic in telesnih tekočin,
English: account being taken of the anticipated use of the device,
Slovenian: pri čemer se upošteva načrtovana uporaba pripomočka,
English: Where a device incorporates, as an integral part, a substance which, when used separately, is likely to be considered to be a medicinal product as defined in Article 1 of Directive 65/65/EEC, and whose action in combination with the device may result in its bioavailability, the safety, quality and usefulness of the substance, account being taken of the purpose of the device, must be verified by analogy with the appropriate methods specified in Directive 75/318/EEC, as last amended by Directive 89/341/EEC.
Slovenian: Kadar je kot bistven sestavni del v pripomoček vključena snov, ki bi lahko, če se uporablja ločeno, veljala za zdravilo, kakor je določeno v členu 1 Direktive 65/65/EGS, in katere delovanje v kombinaciji s pripomočkom lahko povzroči njeno biološko uporabnost, je treba varnost, kakovost in uporabnost snovi ob upoštevanju namembnosti pripomočka overiti po analogiji z ustreznimi metodami, določenimi v Direktivi 75/318/EGS1, kakor je bila nazadnje spremenjena z Direktivo 89/341/EGS.
English: On the sales packaging: - the name and address of the manufacturer, - a description of the device, - the purpose of the device, - the relevant characteristics for its use, - if the device is intended for clinical investigations, the words: 'exclusively for clinical investigations', - if the device is custom-made, the words: 'custom-made device', - a declaration that the implantable device is in a sterile condition, - the month and year of manufacture, - an indication of the time limit for implanting a device safely,- the conditions for transporting and storing the device.
Slovenian: Na prodajni embalaži: ime in naslov proizvajalca, opis pripomočka, namen pripomočka, ustrezne značilnosti njegove uporabe, če je pripomoček namenjen kliničnim preiskavam, navedba "izključno za klinične preiskave", če je pripomoček prilagojen pacientu, navedba "uporabniku prilagojen pripomoček", izjava, da je pripomoček za vsaditev sterilen, mesec in leto izdelave, navedba roka za varno vsaditev pripomočka, pogoji prevoza in skladiščenja pripomočka.
English: ANNEX 2 EC DECLARATION OF CONFORMITY
Slovenian: PRILOGA 2 IZJAVA ES O SKLADNOSTI
Maltese: ANNESS 2 DIKJARAZZJONI KE TA’ KONFORMITÀ
English: (Complete quality assurance system) 1.
Slovenian: (Sistem za zagotavljanje celovite kakovosti)
English: This proof must include the results of the appropriate tests carried out by the manufacturer or carried out under his responsibility, - a statement as to whether or not the device incorporates, as an integral part, a substance as referred to in section 10 of Annex 1, whose action in combination with the device may result in its bioavailability, together with data on the relevant trials conducted, - the clinical data referred to in Annex 7, - the draft instruction leaflet.
Slovenian: To dokazilo mora vsebovati rezultate ustreznih preskušanj, ki jih opravi proizvajalec ali ki so opravljena na njegovo odgovornost, izjavo, ali pripomoček kot bistveni sestavni del vključuje snov, kakor je navedeno v oddelku 10 Priloge 1, katere delovanje v kombinaciji s pripomočkom lahko povzroči biološko razpoložljivost, ter podatke o ustreznih opravljenih preskusih, klinične podatke, navedene v Prilogi 7, osnutek prospekta z navodili.
English: EC TYPE-EXAMINATION 1.
Slovak: TYPOVÁ SKÚŠKA ES
Slovenian: ES TIPSKI PRESKUS
English: The applicant shall make a 'type' available to the notified body. The notified body may request other samples as necessary.
Slovenian: Vlagatelj da tip na razpolago priglašenemu organu, ki lahko po potrebi zahteva druge vzorce.
English: design drawings,
Slovenian: projektne risbe,
English: methods of manufacture envisaged, in particular as regards sterilization,
Slovenian: metode predvidene proizvodnje, zlasti kar zadeva sterilizacijo,
English: and diagrams of parts, sub-assemblies, circuits, etc.,
Slovenian: in diagramov delov, sestavnih delov, vezij itd.,
English: The undertaking shall include an obligation for the manufacturer to notify the competent authorities of the following events immediately on learning of them: i(i) any deterioration in the characteristics or performances, and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or a deterioration in his state of health;
Slovenian: zagotovilo vključuje izdelovalčevo obveznost, da obvesti pristojne organe o naslednjih zapletih, takoj ko jih opazi: (i) o poslabšanju značilnosti in učinkovitosti pripomočka kakor tudi o kakršnikoli nepravilnosti v prospektu z navodili, ki lahko povzročijo ali so povzročile pacientovo smrt ali poslabšanje njegovega zdravstvenega stanja;
English: a level of quality corresponding to a probibility of acceptance of 95 %, with a non-conformity percentage of between 0,29 and 1 %, - a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity percentage of between 3 and 7 %.
Slovenian: raven kakovosti, ki ustreza 95-odstotni verjetnosti sprejetja, pri čemer je odstotek neskladnosti med 0,29 in 1 %, meja kakovosti, ki ustreza 5-odstotni verjetnosti sprejetja, pri čemer je odstotek neskladnosti med 3 in 7 %.
English: the organizational structures, the responsibilities of the managerial staff and their organizational authority where manufacture of the products is concerned, - the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of the design and of the products, including control of products which do not conform;
Slovenian: organizacijskih struktur, obveznosti vodstvenih delavcev in njihovih organizacijskih pooblastil, kar zadeva kakovost projektiranja in izdelave izdelka, metod spremljanja učinkovitega delovanja sistema kakovosti in zlasti njegove zmožnosti, da doseže zaželeno kakovost projektiranja in izdelkov, vključno z nadzorom izdelkov, ki niso skladni;
English: a list of the standards laid down in Article 5, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements of the Directive where the standards in Article 5 have not been applied, - the results of the design calculations, checks and technical tests carried out, etc.
Slovenian: seznam standardov, omenjenih v členu 5, ki se uporabljajo v celoti ali delno, in opis rešitev, sprejetih, da bi se izpolnile bistvene zahteve te direktive, kadar se ne uporabljajo standardi, omenjeni v členu 5, rezultate projektnih izračunov, pregledov in tehničnih preskusov, ki so opravljeni, itd.
English: Clinical investigations shall be performed according to an appropriate state of the art plan of investigation defined in such a way as to confirm or refute the manufacturer's claims for the device; the investigations shall include an adequate number of observations to guarantee the scientific validity of the conclusions.
Slovenian: Klinična preskušanja se opravljajo v skladu z ustreznim najsodobnejšim načrtom preiskave, ki je določen tako, da se potrdijo ali zavrnejo izdelovalčeve zahteve po pripomočku; preiskave vključujejo ustrezno število opazovanj, da se zagotovi znanstvena veljavnost ugotovitev.
English: failure to meet the essential requirements referred to in Article 3, where the device does not meet in full or in part the standards referred to in Article 5; (b)
Bulgarian: неизпълнение на основните изисквания, посочени в член 3, когато изделието не отговаря напълно или частично на стандартите, посочени в член 5;
Latvian: neatbilstība 3. pantā minētajām pamatprasībām, ja ierīce pilnībā vai daļēji neatbilst standartiem, kas minēti 5. pantā;
English: the procedure relating to EC verification set out in Annex 4, or (ii)
Latvian: procedūra attiecībā uz EK verificēšanu, kas izklāstīta 4. pielikumā, vai
English: adequate information regarding the medicinal products which the device in question is designed to administer. Confirmation that the device satisfies the requirements in respect of characteristics and performances, as referred to in I. 'General requirements', in normal conditions of use, and the evaluation of the side effects or undesirable effects must be based on clinical data established in accordance with Annex 7.
Latvian: pietiekamai informācijai par zālēm, ko paredzēts dot ar attiecīgo ierīci. 16. Apliecinājumam, ka ierīce, parastos apstākļos lietota, parametru un funkciju ziņā atbilst prasībām, kas minētas I iedaļā "Vispārējas prasības", un, ka vērtējot tās blakusiedarbības vai nevēlamu iedarbību, jāpamatojas uz klīniskiem datiem, kas iegūti saskaņā ar 7. pielikumu.
English: Adequacy of the clinical data presented, as referred to in section 4.2 of Annex 2, and in section 3 of Annex 3, shall be based, account being taken as appropriate of the relevant harmonized standards, on either: a collation of currently available relevant scientific literature covering the intended use of the device and the techniques therefor, as well as, if appropriate, a written report making a critical assessment of this collation; or
Latvian: To, cik precīzi ir sniegtie medicīnas dati, kas, kā minēts 2. pielikuma 4. daļas 2. punktā un 3. pielikuma 3. daļā, nosaka, vajadzības gadījumos ņemot vērā attiecīgos saskaņotos standartus, kas attiecas vai nu uz: konkrētā brīdī pieejamo attiecīgo zinātnisko literatūru, kas attiecas uz ierīces paredzamo lietojumu un tās izmantojuma paņēmieniem, kā arī vajadzības gadījumā ar rakstisku ziņojumu, kas to rūpīgi izvērtē, vai arī,
English: and which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but which may be assisted in its function by such means; (b)
Maltese: u li ma jilħaqx l-azzjoni prinċipali intenzjonata tiegħu permezz ta’ mezzi farmkoloġiċi, kimiċi, immunoliġiċi jew metaboliċi, iżda li jistgħu jgħinuh jaħdem permezz ta’ dawk il-mezzi;
English: 'active medical device' means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity; (c)
Maltese: ‘mezz attiv mediku’ jfisser kull mezz mediku li biex jaħdem għandu bżonn sors ta’ enerġija elettrika jew sors ieħor ta’ enerġija barra minn dak iġġenerat direttament mill-ġisem tal-bniedem jew mill-gravità;
English: 'custom-made device' means any active implantable medical device specifically made in accordance with a medical specialist's written prescription which gives, under his responsibility, specific design characteristics and is intended to be used only for an individual named patient; (e)
Maltese: ‘mezz magħmul apposta għall-individwu’ ifisser kull mezz mediku attiv li jiddaħħal f’xi parti tal-ġisem li hu speċifikament magħmul skond preskrizzjoni miktuba tal-ispeċjalista mediku li jagħti, taħt ir-responsabbiltà tiegħu, karatteristiċi ta’ disinn speċifiku u li huma maħsuba biex jintużaw għal pazjent individwali msemmi b’ismu;
English: i(i) the procedure relating to EC verification set out in Annex 4, or (ii)
Bulgarian: процедурата, свързана с проверката на ЕО, определена в приложение 4, или
Maltese: il-proċedura marbuta mat-tip ta’ eżami KE msemmi f’Anness 4, jew
English: The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in I.
Slovak: Prostriedky sa musia navrhnúť a vyrábať takým spôsobom, aby sa zabezpečili charakteristické vlastnosti a výkon uvedené v I.
Maltese: Il-mezzi għandhom ikunu ddisinjati u mmanifatturati b’tali mod biex jiggarantixxu l-karatteristiċi u l-ħidmiet imsemmija f’I.
English: 'General requirements', with particular attention being paid to:
Slovak: "Všeobecné požiadavky", pričom treba venovať osobitnú pozornosť:
Maltese: ‘Ħtiġijiet ġenerali’, u attenzjoni speċjali għandha tingħata lil:
English: Confirmation that the device satisfies the requirements in respect of characteristics and performances, as referred to in I.
Slovak: Potvrdenie dodržania požiadaviek týkajúcich sa charakteristických vlastností a výkonu pomôcky za normálnych podmienok použitia uvedených v I.
Bulgarian: Потвърждението, че изделието отговаря на изискванията по отношение на характеристиките и изпълнението, посочени в част I
Maltese: Konferma li l-mezz jilħaq il-ħtiġijiet marbuta mal-karatteristiċi u ħidmiet, kif imsemmija f’I.
English: 'General requirements', in normal conditions of use, and the evaluation of the side effects or undesirable effects must be based on clinical data established in accordance with Annex 7. (*)
Maltese: ‘Ħtiġijiet ġenerali’, f’kondizzjonijiet normali tal-użu, u l-evalwazzjoni tal-effetti ta’ wara jew effetti mhux mixtieqa għandhom ikunu bażati fuq informazzjoni klinika stabbilita skond Anness 7.
English: Whereas rules governing active implantable medical devices can be confined to those provisions needed to satisfy the OJ No C 149, 18.6.1990.
Slovak: keďže predpisy týkajúce sa aktívnych implantovateľných zdravotníckych pomôcok sa môžu obmedziť len na nevyhnutné ustanovenia, ktoré sú potrebné na splnenie základných požiadaviek;
Bulgarian: като има предвид, че правилата, управляващи активните имплантируеми медицински изделия, могат да бъдат ограничени до тези разпоредби, които са необходими, за да бъдат удовлетворени основните изисквания;
English: essential requirements; whereas, because they are essential, these requirements must replace corresponding national provisions;
Slovak: keďže tieto požiadavky, pretože sú zásadné, musia nahradiť zodpovedajúce vnútroštátne právne predpisy;
Bulgarian: като има предвид, че, тъй като са основни, тези изисквания трябва да заменят съответните национални разпоредби;
English: Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (6),
Slovak: Ak je aktívna implantovateľná pomôcka určená na podanie látky definovanej ako liečivo podľa smernice Rady 65/65/EHS z 26. januára 1965 o aproximácii ustanovení zákonov, iných právnych predpisov a správnych opatrení, týkajúcich sa liekov [6],
English: as last amended by Directive 87/21/EEC (7), that substance shall be subject to the system of marketing authorization provided for in that Directive.
Slovak: ktorá bola naposledy zmenená a doplnená smernicou 87/21/EHS [7], táto látka podlieha povoľovaciemu konaniu na jej uvedenie na trh stanovenej v spomenutej smernici.
English: follow the procedure relating to the EC declaration of conformity set out in Annex 2; or (b) follow the procedure relating to EC type-examination set out in Annex 3, coupled with:
Slovak: postupovať podľa postupu vzťahujúceho sa na vyhlásenie ES o zhode podľa prílohy II alebo b) postupovať podľa postupu vzťahujúceho sa na typovú skúšku ES uvedenú v prílohe III v kombinácii:
English: I. GENERAL REQUIREMENTS
Slovak: I. VŠEOBECNÉ POŽIADAVKY
Bulgarian: I. ОБЩИ ИЗИСКВАНИЯ
English: The devices must achieve the performances intended by the manufacturer,
Slovak: Prostriedky musia dosiahnuť výkon, ktorý uvádza výrobca;
English: viz. be designed and manufactured in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a) as specified by him.
Slovak: majú sa navrhnúť a vyrábať takým spôsobom, aby plnili funkciu alebo funkcie podľa článku 1 ods. 2 písm. a), ako ich špecifikoval výrobca.
English: 'custom-made device', - a declaration that the implantable device is in a sterile condition,
Slovak: vyhlásenie o tom, že implantovateľná pomôcka je v sterilnom stave,
English: 'General requirements', in normal conditions of use, and the evaluation of the side effects or undesirable effects must be based on clinical data established in accordance with Annex 7.
Slovak: Všeobecné požiadavky a hodnotenie vedľajších nežiaducich účinkov sa musí zakladať na klinických údajoch získaných v zhode s prílohou VII.
Bulgarian: "Общи изисквания" при нормални условия на работа, както и оценката на страничните ефекти или нежеланите ефекти трябва да бъдат основани на клинични данни, установени в съответствие с приложение 7.
English: data allowing the devices in question to be identified, - an investigation plan giving in particular the purpose, scope and number of the devices concerned,
Slovak: údaje umožňujúce určiť totožnosť danej pomôcky, - plán skúšania obsahujúci najmä cieľ, rozsah a počet príslušných pomôcok,
English: the manufacturer's quality objectives; (b)
Bulgarian: целите по качеството на производителя;