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Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on …

New Regulations - Public Health

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

    Medical Device Regulation comes into application

      https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
      The MDR replaces the existing Directives for medical devices (93/42/EEC and 90/385/EEC). The Regulation on in vitro diagnostic medical devices, which also …

    Medical Devices | FDA - U.S. Food and Drug Administration

      https://www.fda.gov/Medical-Devices
      CDRH 2022 Annual Report. Accomplishments for 2022, including the Pandemic Response, MDUFA V, Device Innovation, over-the-counter (OTC) hearing aid final rule, and device …

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

      https://www.thefdagroup.com/blog/mdr-vs-mdd-13-key-changes
      The new regulation is four times longer, and contains five more annexes than its predecessor, the Medical Device Directive (MDD).; The word "safety" appears 290 …

    New EU MDR Regulations and Revamp of the Medical …

      https://www.medtechintelligence.com/feature_article/new-eu-mdr-regulations-revamp-medical-device-directive/
      The new Europe (EU) Medical Device Regulations (MDR) published by the European Commission on May 5, 2017 revamped major portions of the EU Medical Device Directive (MDD), raising compliance …

    Medical Devices - New regulations - Public Health

      https://health.ec.europa.eu/medical-devices-new-regulations_en
      Medical Devices - New regulations; Medical Devices - New regulations. Overview. The EU has revised the legal framework of 3 directives to reflect progress …

    MDR Guidance | Medical Device Regulatory Guide

      https://www.mdr.guide/mdr
      The new European Medical Device Regulation (MDR), originally set to become a requirement in May 2020, will drastically change the field for companies selling devices …

    Medical Device Directive (MDD)

      https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf
      Medical Device Directive (MDD) 93/42/EEC as modified by 2007/47/EC. Slide 2 of 37 Robert Packard, Consultant www.MedicalDeviceAcademy.com [email protected] • …

    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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