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MDR vs. MDD: 13 Key Changes - The FDA Group

    https://www.thefdagroup.com/blog/mdr-vs-mdd-13-key-changes
    Europe's new Medical Devices Regulation (MDR) will bring significant regulatory changes that may impact multiple business units within your organization. The date of application (DoA) of the EU Medical Devices Regulation (EU MDR) has been …

Revision of the medical device regulatory framework

    https://www.bsigroup.com/en-AE/medical-devices/our-services/MDR-Revision/
    The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three …

Medical Devices Directive 93/42/EEC is due …

    https://www.cti-cem.com/blog/medical-devices-directive-93-42-eec/
    The Directive excludes any products which come within the scope of one of the other two medical device …

Directives - Public Health

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

    The revision of the EU Medical Devices …

      https://www.medtecheurope.org/resource-library/the-revision-of-the-eu-medical-devices-directives/
      The revision of the EU Medical Devices Directives The European medical device industry is a …

    MEDDEV 2.7/1 revision 4, Clinical evaluation: a …

      https://www.medical-device-regulation.eu/wp-content/uploads/2019/05/2_7_1_rev4_en.pdf
      The medical device legislation in Europe is currently being significantly revised. A new Regulation of the European Parliament and of the Council on medical devices will be …

    What’s changed compared to the MDD – The European …

      https://eumdr.com/whats-changed/
      On 26 May 2021 the EUMDR entered into application and the MDD was repealed. The new EU Medical Device Regulation (EU MDR) is not radically different from the current …

    Medical device directives revision: variations in national laws

      https://medtech.pharmaintelligence.informa.com/MT096434/Medical-device-directives-revision-variations-in-national-laws
      The revision of the EU medical device directives and variations in national laws How successful have the EU member states been in implementing the revision of …

    Medical Device Directives

      https://www.abhi.org.uk/what-we-do/regulation/medical-device-legislation/medical-device-directives/
      Medical Device Directives Medical Devices have been regulated by three European Union Directives since the early 1990’s. They cover: Active implantable medical …

    Medical Devices Directive - Wikipedia

      https://en.wikipedia.org/wiki/Medical_Devices_Directive
      The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws …



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