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EUR-Lex - 32007L0047 - EN - EUR-Lex - Europa

    https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32007L0047
    Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member …

Directive 2007/47/EC of the European Parliament and of …

    https://www.legislation.gov.uk/eudr/2007/47/contents
    Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member …

Medical Device Directive (MDD), Directive 2007/47/EC - Lexparency

    https://lexparency.org/eu/32007L0047/
    Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member …

Medical Devices Directive - Wikipedia

    https://en.wikipedia.org/wiki/Medical_Devices_Directive

    B COUNCIL DIRECTIVE 93/42/EEC of 14 June …

      https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
      medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive 65/65/EEC; …

    IMPLEMENTATION OF DIRECTIVE 2007/47/EC …

      https://ec.europa.eu/docsroom/documents/10264/attachments/1/translations/en/renditions/pdf
      Directive 2007/47/EC introduced several changes or clarifications which Notified Bodies have to respect when they carry out conformity assessment activities. For example, they …

    ANNEX II — EC DECLARATION OF CONFORMITY - Lexparency

      https://lexparency.org/eu/31993L0042/ANX_II/
      M5 In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regards the aspects referred to in that section, consult one of the …

    Medical Device Directive (MDD)

      https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf
      EN ISO 13485:2012 is a harmonized standard 100% of MDD requirements are NOTcovered by the ISO 13485. Annex ZB… MDD-Specific Procedures Post-market …

    GUIDELINES ON MEDICAL DEVICES - European …

      https://ec.europa.eu/docsroom/documents/10334/attachments/1/translations/en/renditions/pdf
      91 amended by Directive 2007/47/EC of the European Parliament and of the Council of 92 5 September 2007. 93 94 Council Directive 90/385/EEC of 20 June 1990 on the …

    Directive 2007/47/EC of the European Parliament and of …

      https://www.legislation.gov.uk/eudr/2007/47/introduction
      Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member …



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