FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: control of conception, 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;
Estonian: viljastumise kontrollimiseks, ja mis ei avalda oma peamist ettenähtud toimet farmakoloogilisel, keemilisel, immunoloogilisel või ainevahetuslikul teel, kuid mille toimele nimetatud viiside kasutamine võib kaasa aidata;
English: The Committee shall deliver its opinion according to the urgency of the matter, if necessary by taking a vote. The opinion shall be recorded in the minutes;
Estonian: Komitee esitab oma arvamuse vastavalt küsimuse olulisusele ja kiireloomulisusele, viies vajadusel läbi hääletuse.
English: incorrect application of those standards; (c)
Bulgarian: неправилно прилагане на тези стандарти;
Estonian: nimetatud standardite ebaõigest rakendamisest;
English: regarding which the manufacturer has failed to fulfil his obligations under the relevant EC declaration of conformity, the notified body shall take appropriate measures and forthwith inform the competent Member State thereof.
Estonian: mille osas tootja ei ole täitnud EÜ vastavusdeklaratsiooniga võetud kohustusi, võtab teavitatud asutus asjakohased meetmed ning teavitab sellest pädevat liikmesriiki.
English: ESSENTIAL REQUIREMENTS
Dutch: ESSENTIËLE EISEN
Slovak: ZÁKLADNÉ POŽIADAVKY
Polish: ZASADNICZE WYMOGI
Hungarian: ALAPVETŐ KÖVETELMÉNYEK
Slovenian: BISTVENE ZAHTEVE
Bulgarian: ОСНОВНИ ИЗИСКВАНИЯ
Estonian: PÕHINÕUDED
Latvian: PAMATPRASĪBAS
Lithuanian: ESMINIAI REIKALAVIMAI
Maltese: ĦTIĠIJIET ESSENZJALI
English: The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in I 'General requirements', with particular attention being paid to:
Estonian: Seade peab olema kavandatud ja toodetud nii, et ta saavutaks käesoleva lisa I osas pealkirja "Üldnõuded" all osutatud omadused ja toimivustaseme, kusjuures erilist tähelepanu tuleks pöörata:
English: examine and evaluate the documentation, verify that the type has been manufactured in accordance with that documentation, it shall also record the items which have been designed in accordance with the applicable provisions of the standards referred to in Article 5, as well as the items for which the design is not based on the relevant provisions of the said standards;
Estonian: uurib ja hindab dokumente ning teeb kindlaks, kas tüüp on valmistatud taotlusele lisatud dokumentide kohaselt, samuti registreerib artiklis 5 osutatud standardite vastavate sätete kohaselt kavandatud esemed ja esemed, mis ei ole kavandatud eespool nimetatud standardite vastavate sätete kohaselt;
English: The manufacturer shall apply the quality system approved for the manufacture and shall conduct the final inspection of the products concerned as specified in 3, he shall be subject to the surveillance referred to in section 4.
Estonian: Tootja peab tootmisel rakendama kinnitatud kvaliteedisüsteemi ja läbi viima asjakohaste toodete lõppkontrolli nagu see on kindlaks määratud jaos 6 ning tema suhtes kehtib jaos 4 sätestatud järelevalve.
English: The notified body shall evaluate the proposed modifications and shall verify whether the quality system so modified would meet the requirements referred to in 3.2, it shall notify the manufacturer of its decision.
Estonian: Teavitatud asutus hindab muutmisettepanekuid ja kontrollib, kas muudetud kvaliteedisüsteem vastab punktis 3.2 viidatud nõuetele ning teavitab seejärel tootjat otsusest.
English: The manufacturer or his authorized representative established within the Community shall draw up for custom-made devices or for devices intended for clinical investigations the statement comprising the elements stipulated in section
French: Le fabricant ou son mandataire établi dans la Communauté dresse, pour les dispositifs sur mesure ou les dispositifs destinés à des investigations cliniques, la déclaration comprenant les éléments spécifiés au point
Estonian: Tellimus- või uuringumeditsiiniseadmete korral peab tootja või tema ühenduses asuv volitatud esindaja koostama jaos 2 ettenähtud teavet sisaldava deklaratsiooni.
English: The manufacturer may authorize the evaluation, by audit where necessary, of the effectiveness of these measures.
French: Le fabricant peut autoriser l'évaluation, le cas échéant par un audit, de l'efficacité de ces mesures.
German: Der Hersteller kann eine Bewertung der Wirksamkeit dieser Maßnahmen, falls erforderlich durch eine förmliche Produktüberprüfung (Produktaudit), veranlassen.
Spanish: El fabricante podrá autorizar la evaluación, en su caso mediante una auditoría, de la eficacia de dichas medidas.
Dutch: De fabrikant kan beoordeling van de doeltreffendheid van deze maatregelen toestaan, in voorkomend geval door middel van een audit.
Slovak: Výrobca môže povoliť vyhodnotenie účinnosti týchto opatrení, v prípade potreby v rámci auditu.
Polish: Wytwórca może zlecić sprawdzenie skuteczności tych środków, jeżeli trzeba przez sprawdzenie produktu.
Hungarian: A gyártó engedélyezheti az intézkedések hatékonyságának, szükség esetén audit útján történő értékelését.
Bulgarian: Производителят може да разреши извършването на оценка за ефективността на тези мерки, при необходимост чрез одит.
Estonian: Tootja võib lubada nende meetmete hindamist või vajaduse korral nende tõhususe kontrolli.
Latvian: Izgatavotājs var dot tiesības izvērtēt šo pasākumu efektivitāti, vajadzības gadījumā – ar revīziju.
Lithuanian: Gamintojas gali įgalioti įvertinti šių priemonių veiksmingumą, jei reikia, atliekant auditą.
Maltese: Il-manifattur jista’ jawtorizza l-evalwazzjoni, permezz ta’ audit fejn meħtieġ, ta’ kemm huma effettivi dawn il-miżuri.
English: or the results of all clinical investigations made, including those carried out in accordance with section 2.
Estonian: või 1.1.2. kõikide tehtud kliiniliste uuringute, sh vastavalt jaole 2 tehtud uuringute tulemustel.
English: Ethical consideration Clinical investigations shall be made in accordance with the Declaration of Helsinki approved by the 18th World Medical Assembly in Helsinki, Finland, in 1964, and amended by the 29th World Medical Assembly in Tokyo, Japan, in 1975 and the 35th World Medical Assembly in Venice, Italy, in 1983.
Estonian: Eetiline kaalutlus Kliinilised uuringud tuleb teha vastavalt Helsingi deklaratsioonile, mis võeti vastu 18. ülemaailmsel meditsiiniassambleel Helsingis 1964. aastal ja mida muudeti 29. ülemaailmsel meditsiiniassambleel Jaapanis Tokios 1975. aastal ja 35. ülemaailmsel meditsiiniassambleel Itaalias Veneetsias 1983. aastal.
English: MINIMUM CRITERIA TO BE MET WHEN DESIGNATING INSPECTION BODIES TO BE NOTIFIED
Polish: MINIMALNE KRYTERIA NOTYFIKACJI JEDNOSTEK
Hungarian: A KIJELÖLT SZERVEZETEK KIVÁLASZTÁSÁNÁL FIGYELEMBE VEENDŐ MINIMUMFELTÉTELEK
Slovenian: MINIMALNA MERILA, KI JIH JE TREBA IZPOLNJEVATI PRI IMENOVANJU NADZORNIH ORGANOV ZA PRIGLAŠENE
Bulgarian: МИНИМАЛНИ КРИТЕРИИ ЗА ОПРЕДЕЛЯНЕ НА ИНСПЕКЦИОННИТЕ ОРГАНИ, КОИТО СЕ НОТИФИЦИРАТ
Estonian: TEAVITATUD ASUTUSTE MÄÄRAMISE MIINIMUMNÕUDED
Latvian: KRITĒRIJI, KAS OBLIGĀTI JĀIEVĒRO, IZRAUGOTIES PILNVAROTĀS UZRAUDZĪBAS IESTĀDES
Lithuanian: MINIMALŪS KRITERIJAI, KURIŲ BŪTINA LAIKYTIS, SKIRIANT NOTIFIKUOTĄSIAS ĮSTAIGAS
Maltese: KRITERJI MINIMI LI GĦANDHOM JINTLAĦQU META JIĠU NNOMINATI L-KORPI LI JISPEZZJONAW LI GĦANDHOM IKUNU NOTIFIKATI
English: The impartiality of inspection staff must be guaranteed. Their remuneration must not depend on the number of controls carried out, nor on the results of such controls.
Estonian: Kontrollijate erapooletus peab olema tagatud. Nende palk ei tohi sõltuda teostatud kontrollide hulgast ega nende tulemustest.
English: the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States;
Dutch: dat de maatregel gerechtvaardigd is, deelt zij dit onverwijld mede aan de lidstaat die de maatregel heeft getroffen, en tevens aan de overige lidstaten.
Bulgarian: мерките са оправдани, тя незабавно информира държавата-членка, която е предприела инициативата, и останалите държави-членки;
Lithuanian: priemonės yra pagrįstos, ji nedelsdama apie tai praneša valstybei narei, kuri ėmėsi iniciatyvos, bei kitoms valstybėms narėms;
Maltese: il-miżuri huma ġustifikati, hi għandu tgħarraf minnufih lill-Istat Membru li ħa l-inizjattiva u lill-Istati Membri l-oħra;
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),
Dutch: Wanneer het in lid 1 bedoelde besluit het gevolg is van een leemte in de normen, legt de Commissie, indien de lidstaat die de maatregel heeft getroffen voornemens is deze te handhaven, deze aangelegenheid na overleg met de betrokken partijen binnen twee maanden voor aan het in artikel 6, lid 1, bedoelde Comité, en leidt zij de in artikel 6, lid 1, bedoelde procedure in;
Hungarian: amennyiben az (1) bekezdésben említett döntés a szabványok hiányosságának tulajdonítható, a Bizottság az ügyet az érintett felekkel való egyeztetés után két hónapon belül a 6. cikk (1) bekezdésében említett bizottság elé terjeszti, ha az a tagállam, amelyik a döntést meghozta, azt továbbra is fenn kívánja tartani és kezdeményezi a 6. cikk (1) bekezdésében említett eljárásokat,
Bulgarian: когато решението, посочено в член 1, се основава на недостатък в стандартите, Комисията, след консултации със засегнатите страни, отнася въпроса към Комитета в рамките на два месеца, ако държавата-членка, която е взела решението, възнамерява да го поддържа, и инициира процедурата, посочена в член 6, параграф 1,
Lithuanian: jeigu 1 dalyje nurodytas sprendimas buvo priimtas dėl standartų netikslumų ir jeigu šį sprendimą priėmusi valstybė narė ketina jį įgyvendinti, Komisija, pasitarusi su atitinkamomis šalimis, per du mėnesius pateikia klausimą 6 straipsnio 1 dalyje nurodytam komitetui ir inicijuoja 6 straipsnio 1 dalyje nurodytą procedūrą,
Maltese: fejn id-deċiżjoni msemmija fil-paragrafu 1 hi kkaġunata minn difetti fl-istandards, il-Kummissjoni, wara li tikkonsulta mal-partijiet ikkonċernati, għandu tressaq il-każ quddiem il-Kumitat imsemmi f’Artikolu 6(1) fi żmien xahrejn jekk l-Istat Membru li ħa d-deċiżjoni jkun beħsiebu jżommha u għandu jibda l-proċeduri msemmija f’Artikolu 6(1),
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,
Dutch: de gevaren verbonden aan ioniserende straling afkomstig van radioactieve stoffen die deel uitmaken van de voorziening, met inachtneming van de beschermingsvoorschriften in de zin van Richtlijn 80/836/Euratom, als gewijzigd bij Richtlijn 84/467/Euratom, alsmede in de zin van Richtlijn 84/466/Euratom;
English: (;) OJ No L 246, 17.9.1980, p. 1.
French: (;) JO no L 246 du 17.9.1980, p. 1.
German: (;) ABl. Nr. L 246 vom 17.9.1980, S. 1.
Spanish: (;) DO no L 246 de 17.9.1980, p. 1.
Dutch: (;) PB nr. L 246 van 17.9.1980, blz. 1.
English: ($) OJ No L 265, 5.10.1984, p. 4.
French: ($) JO no L 265 du 5.10.1984, p. 4.
German: ($) ABl. Nr. L 265 vom 5.10.1984, S. 4.
Spanish: ($) DO no L 265 de 5.10.1984, p. 4.
Dutch: ($) PB nr. L 265 van 5.10.1984, blz. 4.
English: (=) OJ No L 265, 5.10.1984, p. 1.
French: (=) JO no L 265 du 5.10.1984, p. 1.
German: (=) ABl. Nr. L 265 vom 5.10.1984, S. 1.
Spanish: (=) DO no L 265 de 5.10.1984, p. 1.
Dutch: (=) PB nr. L 265 van 5.10.1984, blz. 1.
English: if the device is intended for clinical investigations, the words: 'exclusively for clinical investigations',
French: s'il s'agit d'un dispositif destiné à des investigations cliniques, la mention «exclusivement pour des investigations cliniques»,
German: bei einem für klinische Prüfungen bestimmten Gerät der Hinweis "ausschließlich für klinische Prüfungen";
Spanish: si se trata de un producto destinado a la investigación clínica, la mención «exclusivamente para investigación clínica»;
Italian: qualora si tratti di un dispositivo destinato a indagini cliniche, l'indicazione «esclusivamente per indagini cliniche»;
Dutch: in geval van een voor klinisch onderzoek bestemd hulpmiddel, de vermelding "uitsluitend voor klinisch onderzoek'';
Czech: u prostředku určeného ke klinickým zkouškám nápis "Výhradně pro klinické zkoušky",
Slovak: ak ide o pomôcku určenú na klinické skúšanie, označenie "výlučne na klinické skúšanie",
Polish: napis: "wyłącznie do badań klinicznych", jeśli wyrób jest przeznaczony do badań klinicznych,
Hungarian: ha az eszközt klinikai vizsgálatokra tervezték, a következő szöveget: "kizárólag klinikai vizsgálatokhoz",
Slovenian: če je pripomoček namenjen kliničnim preiskavam, navedba "izključno za klinične preiskave",
Bulgarian: ако изделието е предназначено за клинични изпитвания, думите "изключително за клинични изпитвания";
Estonian: kui seade on mõeldud kliinilisteks uuringuteks, siis sõnad: "ainult kliinilisteks uuringuteks",
Latvian: ja ierīce ir domāta klīniskiem pētījumiem, vārdiem: "tikai klīniskiem pētījumiem",
English: (;) OJ No L 147, 9.6.1975, p. 1.
French: (;) JO no L 147 du 9.6.1975, p. 1.
German: (¹) ABl. Nr. L 147 vom 9.6.1975, S. 1.
Spanish: (;) DO no L 147 de 9.6.1975, p. 1.
Dutch: (;) PB nr. L 147 van 9.6.1975, blz. 1.
English: ($) OJ No L 142, 25.5.1989, p. 11.
French: ($) JO no L 142 du 25.5.1989, p. 11.
German: (²) ABl. Nr. L 142 vom 25.5.1989, S. 11.
Spanish: ($) DO no L 142 de 25.5.1989, p. 11.
Dutch: ($) PB nr. L 142 van 25.5.1989, blz. 11.
English: if the device is custom-made, the words: 'custom-made device',
French: s'il s'agit d'un dispositif sur mesure, la mention «dispositif sur mesure»,
German: bei einer Sonderanfertigung der Hinweis "Sonderanfertigung";
Spanish: si se trata de un producto a medida, la mención «producto a medida»;
Italian: qualora si tratti di un dispositivo su misura, l'indicazione «dispositivo su misura»;
Dutch: in geval van een naar maat gemaakt hulpmiddel, de vermelding "hulpmiddel naar maat'';
Czech: u prostředku na zakázku nápis "Prostředek na zakázku",
Polish: napis: "wyrób medyczny wykonany na zamówienie", jeśli został wykonany na zamówienie,
Hungarian: ha az eszközt rendelésre készítették, a következő szöveg: "rendelésre készült eszköz",
Estonian: tellimusmeditsiiniseadme korral sõna: "tellimusmeditsiiniseade",
Latvian: ja ierīce izgatavota pēc pasūtījuma, vārdiem "izgatavots pēc pasūtījuma",
English: ANNEX 2 EC DECLARATION OF CONFORMITY (Complete quality assurance system)
French: ANNEXE II DÉCLARATION «CE» DE CONFORMITÉ (Système complet d'assurance de qualité)
Dutch: BIJLAGE 2 EG-VERKLARING VAN OVEREENSTEMMING (Volledig kwaliteitssysteem)
English: ANNEX 3 EC TYPE-EXAMINATION 1.
German: Die benannte Stelle teilt den anderen benannten Stellen die einschlägigen Informationen über die erteilten, versagten und zurückgezogenen Genehmigungen von Qualitätssicherungssystemen mit.ANHANG 3
Spanish: ANEXO 3 EXAMEN DE MODELO CE 1.
Dutch: BIJLAGE 3 EG-TYPEONDERZOEK
English: ANNEX 4 EC VERIFICATION 1.
Spanish: ANEXO 4 VERIFICACIÓN CE 1.
Dutch: BIJLAGE 4 EG-KEURING
Slovenian: PRILOGA 4 OVERJANJE ES
English: ANNEX 5 EC DECLARATION OF CONFORMITY TO TYPE (Assurance of production quality) 1.
Spanish: ANEXO 5 DECLARACIÓN CE DE CONFORMIDAD CON EL MODELO (Garantía de la calidad de la producción) 1.
Dutch: BIJLAGE 5 EG-VERKLARING VAN OVEREENSTEMMING MET HET TYPE (Kwaliteitsgarantie van de productie)
Slovenian: PRILOGA 5 IZJAVA ES O SKLADNOSTI S TIPOM (Zagotavljanje kakovosti proizvodnje)
English: ANNEX 6 STATEMENT CONCERNING DEVICES INTENDED FOR SPECIAL PURPOSES
French: ANNEXE VI DÉCLARATION RELATIVE AUX DISPOSITIFS À DESTINATIONS PARTICULIÈRES
Dutch: BIJLAGE 6 VERKLARING BETREFFENDE HULPMIDDELEN VOOR BIJZONDER GEBRUIK
Bulgarian: ПРИЛОЖЕНИЕ 6 ДЕКЛАРАЦИЯ ОТНОСНО ИЗДЕЛИЯТА, ПРЕДНАЗНАЧЕНИ ЗА СПЕЦИАЛНИ ЦЕЛИ
Maltese: ANNESS 6 STQARRIJA DWAR IL-MEZZI MAĦSUBA GĦAL GĦANIJIET SPEĊJALI
English: ANNEX 7CLINICAL EVALUATION
French: ANNEXE VII ÉVALUATION CLINIQUE
Dutch: BIJLAGE 7 KLINISCHE EVALUATIE
Maltese: ANNESS 7 EVALWAZZJONI KLINIKA
English: All appropriate features, including those involving the safety and performances of the device, and its effects on the patients, shall be examined. All adverse events shall be fully recorded.
Dutch: Alle relevante eigenschappen, met inbegrip van die welke betrekking hebben op de veiligheid, de prestaties van het hulpmiddel en de uitwerking op de patiënt moeten worden onderzocht.
English: ANNEX 8 MINIMUM CRITERIA TO BE MET WHEN DESIGNATING INSPECTION BODIES TO BE NOTIFIED
French: ANNEXE VIII CRITÈRES MINIMAUX DEVANT ÊTRE RÉUNIS POUR LA DÉSIGNATION DES ORGANISMES À NOTIFIER
German: EINZUHALTENDE MINDESTKRITERIEN FÜR DIE BEAUFTRAGUNG DER ZU BENENNENDEN STELLEN
Dutch: BIJLAGE 8 MINIMUMCRITERIA VOOR DE AANWIJZING VAN DE AAN TE MELDEN INSTANTIES
English: ANNEX 9 CE MARK OF CONFORMITY
French: ANNEXE IX MARQUE CE DE CONFORMITÉ
Spanish: ANEXO 9 MARCA DE CONFORMIDAD CE
Dutch: BIJLAGE 9 EG-MERKTEKEN VAN OVEREENSTEMMING
English: Having regard to the proposal from the Commission ,
Spanish: Vista la propuesta de la Comisión,
English: Whereas rules governing active implantable medical devices can be confined to those provisions needed to satisfy the
German: Die Regelungen über aktive implantierbare medizinische Geräte können auf die Bestimmungen beschränkt werden,ABl.
Spanish: Considerando que las regulaciones sobre productos sanitarios implantables activos se pueden limitar a las disposiciones
English: essential requirements;
German: die zur Erfuellung der grundlegenden Anforderungen notwendig sind.
Spanish: necesarias para cumplir los requisitos esenciales;
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 , as last amended by Directive 87/21/EEC, that substance shall be subject to
Spanish: Cuando el producto sanitario implantable activo esté destinado a administrar una sustancia definida como medicamento con arreglo a la Directiva 65/65/CEE del Consejo, de 26 de enero de 1965, relativa a la aproximación de las disposiciones legales, reglamentarias y administrativas, sobre especialidades farmacéuticas, modificada en último lugar por la Directiva 87/21/CEE, dicha sustancia estará
English: This Directive constitutes a specific Directive within the meaning of Article 2 (2) of Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to electromagnetic compatibility.
Spanish: La presente Directiva constituye una Directiva específica con arreglo al apartado 2 del artículo 2 de la Directiva 89/336/CEE del Consejo, de 3 de mayo de 1989, sobre la aproximación de las legislaciones de los Estados miembros relativas a la compatibilidad electromagnética.
English: O'MALLEY(1) OJ No C 14, 18.1.1989, p. 4.
German: O'MALLEY
Spanish: O'MALLEY(1) DO no C 14 de 18.1.1989, p. 4.
English: ANNEX 1 ESSENTIAL REQUIREMENTS I. GENERAL REQUIREMENTS
French: ANNEXE I EXIGENCES ESSENTIELLES I. EXIGENCES GÉNÉRALES
German: GRUNDLEGENDE ANFORDERUNGEN I. ALLGEMEINE ANFORDERUNGEN
Spanish: ANEXO 1 REQUISITOS ESENCIALES I. REQUISITOS GENERALES
English: Devices must bear a code by which they and their manufacturer can be unequivocably identified (particularly with regard to the type of device and year of manufacture); it must be possible to read this code, if necessary, without the need for a surgical operation.
Spanish: Los productos deberán llevar un código que permita la identificación inequívoca del producto (en particular, el tipo de producto y el año de fabricación) y del fabricante y dicho código deberá ser detectable, en su caso, sin necesidad de recurrir a una intervención quirúrgica.
English: ANNEX 6 STATEMENT CONCERNING DEVICES INTENDED FOR SPECIAL PURPOSES 1.
Spanish: ANEXO 6 DECLARACIÓN RELATIVA A LOS PRODUCTOS DE USOS ESPECIALES 1.
Slovenian: PRILOGA 6 IZJAVA V ZVEZI S PRIPOMOČKI ZA POSEBNE NAMENE
English: ANNEX 7CLINICAL EVALUATION 1.
Spanish: ANEXO 7 EVALUACIÓN CLÍNICA 1.
Bulgarian: ПРИЛОЖЕНИЕ 7 КЛИНИЧНА ОЦЕНКА
English: ANNEX 8 MINIMUM CRITERIA TO BE MET WHEN DESIGNATING INSPECTION BODIES TO BE NOTIFIED 1.
Spanish: ANEXO 8 CRITERIOS MÍNIMOS QUE DEBERÁN REUNIRSE PARA LA DESIGNACIÓN DE LOS ORGANISMOS NOTIFICADOS 1.
English: This Directive shall apply to active implantable medical devices. 2. For the purposes of this Directive, the following definitions shall apply:
German: Diese Richtlinie gilt für aktive implantierbare medizinische Geräte.(2) Für diese Richtlinie gelten folgende Begriffsbestimmungen:
English: 'intended purpose' means the use for which the medical device is intended and for which it is suited according
German: Zweckbestimmung:
English: to the data supplied by the manufacturer in the instructions;
German: die Verwendung, für die das medizinische Gerät nach den Angaben des Herstellers in der Gebrauchsanweisung bestimmt und geeignet ist.
English: follow the procedure relating to the EC declaration of conformity set out in Annex 2; or (b)
German: das Verfahren der EG-Konformitätserklärung gemäß Anhang 2 einhalten
English: The notified body shall periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report. In addition, the notified body may make unannounced visits to the manufacturer, and shall supply him with an inspection report.
German: Die benannte Stelle führt regelmäßig die erforderlichen Inspektionen und Bewertungen durch, um sich davon zu überzeugen, daß der Hersteller das genehmigte Qualitätssicherungssystem anwendet, und übermittelt dem Hersteller einen Bewertungsbericht.
English: EC VERIFICATION 1.
German: EG-ÜBERPRÜFUNG
Slovak: OVEROVANIE ZHODY ES
English: ANNEX 5 EC DECLARATION OF CONFORMITY TO TYPE
German: ANHANG 5 EG-ERKLÄRUNG ZUR ÜBEREINSTIMMUNG MIT DEM BAUMUSTER
Bulgarian: ПРИЛОЖЕНИЕ 5 ДЕКЛАРАЦИЯ НА ЕО ЗА СЪОТВЕТСТВИЕ НА ТИПА
English: (Assurance of production quality) 1.
German: (Qualitätssicherung der Produktion)
English: STATEMENT CONCERNING DEVICES INTENDED FOR SPECIAL PURPOSES 1.
German: ERKLÄRUNG ZU GERÄTEN FÜR BESONDERE ZWECKE
Slovak: VYHLÁSENIE VZŤAHUJÚCE SA NA PROSTRIEDKY NA OSOBITNÝ ÚČEL URČENIA
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), as last amended by Directive 87/21/EEC (7), that substance shall be subject to
French: Lorsqu'un dispositif médical implantable actif est destiné à administrer une substance définie comme médicament au sens de la directive 65/65/CEE du Conseil, du 26 janvier 1965, concernant le rapprochement des dispositions législatives, réglementaires et administratives relatives aux spécialités pharmaceutiques (6), modifiée en dernier lieu par la directive 87/21/CEE (7), cette substance est soumise au
English: OJ No C 14, 18.1.1989, p. 4.
French: JO no C 14 du 18.1.1989, p. 4.
English: ANNEX 5 EC DECLARATION OF CONFORMITY TO TYPE (Assurance of production quality)
French: ANNEXE V DÉCLARATION CE DE CONFORMITÉ AU TYPE (Assurance de la qualité de la production)
Maltese: ANNESS 5 DIKJARAZZJONI KE TA’ KONFORMITÀ MAT-TIP (Garanzija tal-kwalità tal-produzzjoni)
English: i(i) the procedure relating to EC verification set out in Annex 4,
Slovak: buď s postupom vzťahujúcim sa na overovanie zhody ES podľa prílohy IV;
Polish: procedurą dotyczącą sprawdzenia wyrobu podaną w załączniku IV;
Lithuanian: procedūros, susijusios su 4 priede nurodyta EB patikra;