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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 States relating to active implantable medical devices, Council Directive …

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)

    https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf
    Class I devices, that are non- sterile and non-measuring, do not require a Notified Body (NB). All other products require NB involvement. Annex IX of the MDD defines the …

Medical Devices Directive - Wikipedia

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

    ANNEX X Medical Device Directive - CLINICAL EVALUATION

      https://lexparency.org/eu/31993L0042/ANX_X/
      All the appropriate features, including those involving the safety and performances of the device, and its effect on patients must be examined. M5 All serious adverse events must …

    Medical Device Directive 93/42/EWG (MDD) …

      https://www.johner-institute.com/articles/regulatory-affairs/medical-device-directive/
      The medical device directive was introduced in 1993 and appended in 2007 by 2007/47/EC. For more than 25 year it served as the most important regulatory document in …

    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; …

    MDD vs MDR - Understanding the difference | Kobridge

      https://kobridgeconsulting.com/mdd-vs-mdr/
      The Medical Devices Directive (MDD) is an older regulatory requirement that was established in 1994. It applied to all devices sold on the European market, which means …

    Guide to Medical Device Directive Compliance …

      https://instrktiv.com/en/medical-device-directive/
      The Medical Devices Directive (MDD) is a European CE-Directive that is replaced by the Regulation (EU) 2017/745 . Medical Devices Directive (MDD) has a wide scope and its …

    MDD 2007 47 EC : PresentationEZE

      https://www.presentationeze.com/blog/changes-implemented-mdd-2007-47-ec/
      Directive 2007/47/EEC was published in the Official Journal of the EU in 2007, compliance became mandatory from 21st March 2010. The amendments impacted the following …



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