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Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    The medical device may be co-packaged with, obtained separately from or integral to the medicinal product. EMA issued a final guideline on quality documentation for medicinal products that include a medical device in July 2021. This clarifies expectations …

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
      B COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) Amended by: Official Journal No page date M1 …

    Directives - Public Health

      https://health.ec.europa.eu/medical-devices-sector/directives_en

      What Is the EU Medical Devices Directive? | Assent

        https://www.assent.com/resources/knowledge-article/what-is-the-eu-medical-devices-directive/
        The European Union (EU) Medical Devices Directive (MDD) was introduced in 1994 to regulate medical devices sold in the EU. The MDD is based on the principles of the “New …

      MEDICAL DEVICES Guidance document …

        https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native
        The manufacturer should first decide if the product concerned is a medical device as defined in Directive 93/42/EEC or an accessory to such a medical device, if it is not excluded …

      Guide to Medical Device Directive Compliance …

        https://instrktiv.com/en/medical-device-directive/
        Medical Device Directive (93/42/EEC) - Certification Guide. 28/5/2019 Ferry Vermeulen Law & Legislation. 1. What is the Medical Devices Directive. The Medical Devices Directive …

      EU Medical Device Directives - 6 Key Elements to Ensure …

        https://www.complianceonline.com/resources/eu-medical-device-directives-key-elements.html
        At present, the EU's regulatory framework for medical devices includes the following directives: Council Directive 90/385/EEC on active implantable medical devices …

      Medical Device Directive (MDD)

        https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf
        Slide 1 of 37 Robert Packard, Consultant www.MedicalDeviceAcademy.com [email protected] Medical Device Directive (MDD) 93/42/EEC as modified by …

      Medical Devices Directive (MDD) …

        https://www.presentationeze.com/presentations/medical-device-validation/medical-devices-directive-mdd-9342eec-explained/
        In the Medical Device Directive M.D.D. 93/42/EEC there are defined articles and annex’s which detail the requirements for compliance within the European Union and European Economic …



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