FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant national standards adopted pursuant to the harmonized standards the references of which have been publishes in the Official Journal of the European Communities; Member States shall publish the references of such national standards.
Maltese: L-Istati Membri għandhom jippresumu l-konformità mal-ħtiġiet essenzjali msemmija fl-Artikolu 3 għal dak il-mezz li jikkonforma ma' l-istandards nazzjonali rilevanti adottati b'mod konformi ma' l-istandards armonizzati li r-referenzi tagħhom ġew ippubblikati fil-Ġurnal Uffiċjali tal-Komunità Ewrupea, l-Istati Membri għandhom jippubblikaw ir-referenzi ta' dawn l-istandards nazzjonali.
English: the procedure relating to the EC verification set out in Annex IV; (b) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance);
Maltese: il-proċedura dwar il-verifikazzjoni tal-KE stabbilita fl-Anness IV; a) il-proċedura dwar id-dikjarazzjoni tal-konformità tal-KE stabbilita fl-Anness V (assigurazzjoni tal-kwalità tal-prodott);
English: in Article 9 the following paragraphs are added: '5.
Maltese: fl-Artikolu 9 is-subparagrafi li ġejjin huma miżjudin:
English: the organization of the business and in particular: - 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 product, including control of products which fail to conform;
Maltese: l-organizzazzjoni tan-negozju u b'mod partikolari:
English: whereas Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market; Whereas in cases where the conformity of the devices can be assessed under the responsibility of the manufacturer the competent authorities must be able, particularly in emergencies, to contact a person responsible for placing the device on the market and established in the Community, whether the manufacturer or another person established in the Community and designated by the manufacturer for the purpose;
Polish: w przypadkach, gdzie zgodność wyrobów można ocenić w ramach odpowiedzialności wytwórcy, właściwe organy muszą być zdolne, szczególnie w sytuacjach zagrożenia do nawiązania kontaktu z osobą odpowiedzialną za wprowadzenie danego wyrobu do obrotu i mającą siedzibę we Wspólnocie, czy też z wytwórcą lub inną osobą mającą siedzibę we Wspólnocie i wyznaczoną przez wytwórcę do tych celów;
English: The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee of the manner in which its opinion has been taken into account.
Spanish: La Comisión tendrá lo más en cuenta posible el dictamen emitido por el Comité e informará al Comité de la manera en que ha tenido en cuenta dicho dictamen.
Polish: Komisja bierze pod uwagę opinię Komitetu w jak najszerszym zakresie, oraz informuje Komitet o zakresie, w jakim jego opinia została uwzględniona.
English: and
Spanish: y, que
Polish: oraz
English: the changes referred to in Section 3.4, - the documentation referred to in Section 4.2, and - the decisions and reports from the notified body as referred to in Sections 3.3, 4.3, 4.4, 5.3 and 5.4.
Polish: decyzje i sprawozdania jednostki notyfikowanej, określone w sekcjach 3.3, 4.3, 4.4, 5.3 i 5.4.
English: ANNEX III EC TYPE-EXAMINATION 1.
Polish: dokumentację opisaną w sekcji 3, konieczną do oceny zgodności reprezentatywnej próbki przedmiotowej produkcji, zwanej dalej "typem", z wymogami niniejszej dyrektywy.
English: EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative sample of the production covered fulfils the relevant provisions of this Directive. 2. The application includes:
Polish: Wnioskodawca musi udostępnić "typ" jednostce notyfikowanej.
English: the documentation described in Section 3 needed to assess the conformity of the representative sample of the production in question, hereinafter referred to as the 'type', with the requirements of this Directive. The applicant must make a 'type' available to the notified body. The notified body may request other samples as necessary, - a written declaration that no application has been lodged with any other notified body for the same type.
Polish: pisemne oświadczenie, że żaden wniosek nie został przedłożony innej jednostce notyfikowanej dla tego samego typu.
English: the decisions and reports from the notified body as referred to in Sections 4.3 and 4.4, - where appropriate, the type-examination certificate referred to in Annex III.
Polish: gdzie stosowne, certyfikat badania typu określony w załączniku III.
English: The manufacturer must ensure application of the quality system approved for the final inspection and testing of the product, as specified in Section 3 and must be subject to the surveillance referred to in Section 4. In addition, for products placed on the market in sterile condition, and only for those aspects of the manufacturing process designed to secure and maintain sterility, the manufacturer must apply the provisions of Annex V, Sections 3 and 4.
Polish: Ponadto, w odniesieniu do wyrobów wprowadzanych do obrotu w warunkach sterylnych, i tylko w odniesieniu do tych aspektów procesu produkcyjnego, które są przeznaczone do zapewnienia i utrzymywania sterylności, wytwórca stosuje przepisy załącznika V sekcja 3 i 4.
English: the documentation referred to in the seventh indent of Section 3.1, - the changes referred to in Section 3.4,
Polish: zmiany określone w sekcji 3.4,
English: A NNEX X
Polish: ZAŁĄCZNIK X
English: C LINICAL EVALUATION
Polish: OCENA KLINICZNA
English: Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the 41st World Medical Assembly in Hong Kong in 1989. It is mandatory that all measures relating to the protection of human subjects are carried out in the spirit of the Helsinki Declaration.
Polish: Badania kliniczne należy przeprowadzać zgodnie z Deklaracją Helsińską przyjętą przez osiemnaste Światowe Zgromadzenie Medyczne w Helsinkach, w Finlandii w 1964 r., ostatnio zmienioną przez czterdzieste pierwsze Światowe Zgromadzenie Medyczne w Hongkongu w 1989 r. Obowiązkowe jest, by wszelkie środki odnoszące się do ochrony zdrowia ludzkiego wykonywane były w duchu Deklaracji Helsińskiej.
English: whereas for the same reasons Directive 90/385/EEC must be amended to insert the general provisions laid down in this Directive; Whereas the electromagnetic compatibility aspects form an integral part of the safety of medical devices;
Slovak: keďže z rovnakých dôvodov smernica Rady 90/385/EHS sa musí zmeniť a doplniť včlenením všeobecných ustanovení z tejto smernice;
English: Article 10. Article 10
Slovak: Článok 10
English: The applicant must make a 'type' available to the notified body. The notified body may request other samples as necessary,
French: Le demandeur met un type à la disposition de l'organisme notifié, qui peut demander d'autres exemplaires en tant que de besoin,
Slovak: Žiadateľ dáva typ k dispozícii notifikovanému orgánu, ktorý môže požadovať podľa potreby ďalšie vzorky,
English: the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 11, by applying solely one of the given procedures chosen from among those referred to in Article 11, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures.
Slovenian: mora biti ugotovljena skladnost pripomočka ali družine pripomočkov z odstopanjem od določb člena 11 z uporabo enega samega postopka, izbranega izmed navedenih postopkov v členu 11, predloži ustrezno utemeljeno prošnjo Komisiji in jo zaprosi za potrebne ukrepe.
Romanian: conformitatea unui dispozitiv sau a unei familii de dispozitive trebuie prevăzută, prin derogare de la articolul 11, prin aplicarea numai a uneia dintre procedurile date, aleasă dintre cele menționate la articolul 11, statul membru respectiv înaintează Comisiei o cerere justificată, prin care îi cere să ia măsurile necesare.
English: The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation referred to in the first paragraph of this Section. The manufacturer must authorize the assessment, or audit where necessary, of the effectiveness of these measures.
Slovenian: Proizvajalec mora ukreniti vse potrebno za zagotovitev, da so v proizvodnem postopku izdelani izdelki, ki so v skladu z dokumentacijo iz odstavka 1 tega oddelka. Proizvajalec mora dovoliti ocenjevanje ali po potrebi preverjanje učinkovitosti teh ukrepov.
English: Particular attention must be paid to: - the choice of materials used, particularly as regards toxicity and, where appropriate, flammability,
Spanish: la elección de los materiales utilizados, especialmente en lo que respecta a la toxicidad y, en su caso, la inflamabilidad;
English: The decision is notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.
Spanish: Se notificará al fabricante la decisión y en ella figurarán las conclusiones de la inspección y una evaluación motivada.
English: The application must describe the design, manufacture and performances of the product in question. It must include the documents needed to assess whether the product conforms to the requirements of this Directive, as referred to in Section 3.2 (c).
Spanish: La solicitud describirá el diseño, la fabricación y las prestaciones del producto sanitario de que se trate e incluirá los documentos necesarios, contemplados en la letra c) del punto 3.2, que permitan juzgar su conformidad con los requisitos de la presente Directiva.
English: At the time of such visits, the notified body may, where necessary, carry out or ask for tests in order to check that the quality system is working properly. It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report.
Spanish: Con ocasión de tales visitas, el organismo notificado podrá efectuar o hacer que se efectuén ensayos para verificar el buen funcionamiento del sistema de calidad, cuando lo considere necesario, y entregará al fabricante un informe de inspección y, si se hubiera efectuado algún ensayo, un informe de ensayo.
English: After the abovementioned information has been received the decision is notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.
Spanish: La decisión será notificada al fabricante previa recepción de la información antes citada y se expondrán en ella las conclusiones de la inspección y una evaluación justificada.
English: The decision must be notified to the manufacturer. It must contain the conclusions of the inspection and a reasoned assessment.
Spanish: Se comunicará la decisión al fabricante y en la misma figurarán las conclusiones del control y una evaluación motivada.
Bulgarian: Решението трябва да бъде оповестено след окончателната инспекция и да съдържа заключенията от инспекцията и една аргументирана оценка.
English: After receiving the abovementioned information it must notify the manufacturer of its decision. This decision must contain the conclusions of the inspection and a reasoned assessment.
Spanish: La decisión será notificada al fabricante previa recepción de la información antes citada y se expondrán en ella las conclusiones del control y una evaluación motivada.
English: The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. It must include in particular:
Spanish: La documentación técnica deberá hacer posible la evaluación de la conformidad del producto con los requisitos de la presente Directiva e incluirá, en particular:
English: All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in Class IIa, unless this is done in a manner: - that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are in Class IIb.
Spanish: Todos los productos activos destinados a administrar medicamentos, líquidos corporales u otras sustancias al organismo, o a extraerlos del mismo, se incluirán en la clase IIa, a no ser que ello se efectúe de forma potencialmente peligrosa, teniendo en cuenta la naturaleza de las sustancias, la parte del cuerpo de que se trate y el modo de aplicación, en cuyo caso se incluirán en la clase IIb.
Swedish: Alla aktiva produkter som är avsedda att administrera eller avlägsna läkemedel, kroppsvätskor eller andra ämnen till eller från kroppen tillhör klass IIa, om det inte görs på ett sätt som är potentiellt skadligt med tanke på de aktuella ämnenas egenskaper, den kroppsdel och det användningssätt det är fråga om, då de tillhör klass IIb.
Slovak: Všetky aktívne pomôcky určené na podávanie liečiv, biologických kvapalín alebo iných látok do tela a/alebo na ich odňatie z tela sa zaraďujú do triedy IIa, s výnimkou, ak táto operácia je potenciálne nebezpečná so zreteľom na charakter podávaných látok, príslušnú časť tela a spôsob podania, v tomto prípade sa zaraďujú do triedy IIb.
Estonian: Kõik aktiivsed meditsiiniseadmed, mis on ette nähtud ravimite, kehavedelike või muude ainete manustamiseks ja/või kehast eemaldamiseks, kuuluvad IIa klassi, kui see ei toimu potentsiaalselt ohtlikul viisil, võttes arvesse nimetatud ainete laadi, asjaomast kehaosa ja manustamise viisi, mispuhul nad kuuluvad IIb klassi.
English: It is mandatory that all measures relating to the protection of human subjects are carried out in the spirit of the Helsinki Declaration. This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results.
Spanish: Es imperativo que se aplique el espíritu de la Declaración de Helsinki a todas las disposiciones relativas a la protección de la persona humana, y esto en cada una de las etapas de las investigaciones clínicas, desde la primera reflexión sobre la necesidad y la justificación del estudio hasta la publicación de los resultados.
English: They may not be directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. This in no way precludes the possibility of exchanges of technical information between the manufacturer and the body.
Spanish: No podrán intervenir, ni directamente ni como representantes, en el diseño, construcción, comercialización o mantenimiento de estos productos, Esto no excluye la posibilidad de que se intercambie información técnica entre el fabricante y el organismo.
English: CE MARKING OF CONFORMITY The CE conformity marking shall consist of the initials 'CE' taking the following form:
Spanish: MARCHAMO CE DE CONFORMIDAD El marchamo CE de conformidad consistirá en las iniciales «CE» presentadas en la siguiente forma:
English: This Directive shall ap ply to medical devices and their accessories.
Latvian: Šī direktīva attiecas uz medicīnas ierīcēm un to palīgierīcēm.
Lithuanian: Ši direktyva taikoma medicinos prietaisams ir jų priedams.
English: The clinical investigations must be conducted in accordance with the provisions of Annex X.
French: Les investigations cliniques doivent être conduites conformément aux dispositions de l'annexe X.
Romanian: Investigațiile clinice sunt desfășurate în conformitate cu dispozițiile din anexa X.
Bulgarian: Клиничните изпитвания трябва да бъдат проведени съгласно разпоредбите на приложение Х.
Latvian: Klīniski pētījumi jāveic saskaņā ar X pielikuma noteikumiem.
Lithuanian: Klinikiniai tyrimai privalo būti atliekami pagal X priedo nuostatas.
English: to withdraw devices from the market, shall state the exact grounds on which it is based.
Latvian: izņemt ierīces no apgrozības ir skaidri jāpamato.
English: This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;'
French: Cela ne s'applique pas à la personne qui, sans être fabricant aux termes du premier alinéa, assemble ou adapte conformément à leur destination des dispositifs déjà mis sur le marché, pour un patient individuel;»
Dutch: Zij zijn niet van toepassing voor de persoon, die zonder fabrikant te zijn in de zin van de eerste alinea, hulpmiddelen die reeds in de handel zijn voor een individuele patiënt assembleert of aanpast overeenkomstig hun bestemming.";
Romanian: Acest paragraf nu se adresează persoanei care, fără a fi un producător în temeiul primului paragraf, asamblează sau adaptează dispozitive deja introduse pe piață, în conformitate cu scopul propus lor, pentru un anumit pacient;”;
Bulgarian: Тази алинея не се прилага за лице, което докато не произвежда по смисъла на първа алинея, монтира или адаптира продуктите, които вече са на пазара, за специално предназначение за индивидуален пациент.
Latvian: Šī daļa neattiecas uz personām, kas nav ražotāji pirmās daļas nozīmē, tomēr komplektē vai pielāgo tirgū jau laistās ierīces, lai konkrēti slimnieki varētu tās lietot paredzētajā nolūkā;".
Lithuanian: Ši pastraipa netaikoma asmeniui, kuris, nebūdamas gamintoju pagal pirmosios pastraipos apibrėžimą, surenka ar pritaiko jau esančius rinkoje prietaisus, kad šie galėtų būti panaudoti pagal paskirtį individualiam pacientui;"
English: the following A rticle 9a is inserted after Article 9:
Latvian: Pēc 9. panta iekļauj šādu 9.a pantu:
Lithuanian: Po 9 straipsnio įrašomas toks 9a straipsnis:
English: These measures shall be adopted in accordance with the procedure referred to in Article 7 (2) of Directive 93/42/EEC.
Latvian: Šos pasākumus paredz saskaņā ar Direktīvas 93/42/EEK 7. panta 2. punktā minēto procedūru.
English: REQUIREMENTS REGARDING DES IGN AND CONSTRUCTION
Latvian: PRASĪBAS ATTIECĪBĀ UZ PROJEKTĒŠANU UN KONSTRUKCIJU
Lithuanian: PROJEKTAVIMO IR KONSTRAVIMO REIKALAVIMAI
English: (Full quality assurance system)
Romanian: (Sistem complet de asigurarea calității)
Latvian: (Pilnīgas kvalitātes nodrošinājuma sistēma)
English: the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of design and of product, including control of products which fail to con form;
Latvian: metodes, ar kādām pārrauga kvalitātes nodrošinājuma sistēmas darbības efektivitāti, un jo īpaši tās spēju panākt vajadzīgo projektēšanas un ražojuma kvalitāti, ietverot neatbilstīgo ražojumu kontroli;
Lithuanian: kokybės sistemos stebėjimo metodai, ypač leidžiantys užtikrinti norimą gaminių projektavimo ir gamybos kokybę, apimant ir neatitinkančius gaminius,
English: A pplication to devices in Classes IIa and IIb
Latvian: Piemērošana attiecībā uz IIa un IIb klases ierīcēm
Lithuanian: Taikymas IIa ir IIb klasių prietaisams
English: (Production quality assurance)
Romanian: (Asigurarea calității producției)
Latvian: (Ražošanas kvalitātes nodrošināšana)
English: (Product quality assurance)
Romanian: (Asigurarea calității produsului)
Latvian: (Ražojuma kvalitātes apstiprinājums)
English: the descriptions and explanations necessary to understand the abovementioned drawings and di agrams and the operations of the product,
Latvian: apraksti un paskaidrojumi, kas vajadzīgi, lai izprastu minētos rasējumus, shēmas un ražojuma darbību,
Lithuanian: aprašymas ir paaiškinimai, kad galima būtų suprasti minėtus brėžinius, diagramas ir gaminio veikimą,
English: CLASSIFICATION CRITERIA I. DEFINITIONS
Latvian: KLASIFIKĀCIJAS KRITĒRIJI I. DEFINĪCIJAS
English: Bo dy orifice
Latvian: Ķermeņa atvere
Lithuanian: K ū n o a n g o s
English: Devices shall be divided into Classes I, IIa, IIb and III. Classification shall be carried out in accordance with Annex IX.
Dutch: De hulpmiddelen worden onderverdeeld in klasse I, klasse IIa, klasse IIb en klasse III. De classificatie gebeurt overeenkomstig de regels voor de classificatie van bijlage IX.
Bulgarian: Продуктите се разделят в класове І, ІІ а, ІІ б и ІІІ. класификацията се прилага в съответствие с приложение ІХ.
English: Where a 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, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. These measures shall be adopted in accordance with the procedure referred to in Article 7 (2) of Directive 93/42/EEC (*).
Dutch: Wanneer een lidstaat van mening is dat de overeenstemming van een hulpmiddel of een groep van hulpmiddelen, in afwijking van artikel 9, door de uitsluitende toepassing van een van de in artikel 9 bedoelde procedures moet worden vastgesteld, dient deze lidstaat bij de Commissie een met redenen omkleed verzoek in om de noodzakelijke maatregelen te treffen. deze maatregelen worden vastgesteld volgens de procedure van artikel 7, lid 2, van Richtlijn 93/42/EEG (*).
English: or (b) follow the procedure relating to the EC type-examination set out in Annex III, coupled with:
Lithuanian: arba laikosi EB tipo tyrimo tvarkos, kuri aprašyta III priede, taip pat:
English: and (b) he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers;
Lithuanian: kad jis įpakavo sistemą ar procedūrų rinkinį ir pateikė reikalingą informaciją vartotojams, įtraukdamas ir atitinkamą gamintojo instrukciją;
English: and (c) the whole activity is subjected to appropriate methods of internal control and inspection.
Lithuanian: kad visa ši veikla patikrinta atitinkamais vidinės kontrolės ir inspektavimo metodais.
English: All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class IIb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat,
Lithuanian: Visi neinvaziniai prietaisai, skirti kraujo ar kitų organizmo skysčių arba kitų į organizmą numatomų leisti skysčių, biologinės ir cheminės sudėties pakeitimui, priskiriami IIb klasei, išskyrus tuos atvejus, jei gydymą sudaro filtravimas, centrifugavimas arba dujų, šilumos apykaita.
English: in which case they are in Class IIa.
Lithuanian: Tuomet jie priklauso IIa klasei.