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Medical devices | European Medicines Agency

    https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
    The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national …

New Regulations - Public Health

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

    Medical Devices - New regulations - Public Health

      https://health.ec.europa.eu/medical-devices-new-regulations_en
      An official website of the European Union Public Health Home Medical Devices - New regulations Medical Devices - New regulations Overview The EU has …

    Medical Device Regulation comes into application | European …

      https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application
      Medical Device Regulation comes into application. Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021. The …

    EUR-Lex - 32017R0745 - EN - EUR-Lex - Europa

      https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
      To recognise the important role of standardisation in the field of medical devices, compliance with harmonised standards as defined in Regulation (EU) No 1025/2012 of the European …

    The European Union Medical Device Regulation – Regulation (EU…

      https://eumdr.com/
      The European Commission published IMPLEMENTING DECISION (EU) 2019/939, designating four entities to assign Unique Device Identifiers (UDIs) to medical devices for the European market. The European Medicines Agency (EMA) published a draft guideline and commenced consultations on the implementation of EU MDR Article 117 related to drug …

    EUR-Lex - 02017R0745-20200424 - EN - EUR-Lex - Europa

      https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20200424
      Without prejudice to Article 2(2) of Directive 2001/83/EC, upon a duly substantiated request of a Member State, the Commission shall, after consulting the …

    Medical Devices - New regulations - Latest updates

      https://health.ec.europa.eu/medical-devices-new-regulations/latest-updates_en
      European Medical Device Nomenclature (EMDN) - Questions and Answers News announcement 26 May 2021 Stronger rules on medical devices News …

    Regulation (EU) 2017/745 - Wikipedia

      https://en.wikipedia.org/wiki/Regulation_(EU)_2017/745
      Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC …

    Guidance - MDCG endorsed documents and other guidance

      https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
      European Medical Device Nomenclature (EMDN) Implant cards In-house devices Authorised Representatives, Importers, Distributors In Vitro Diagnostic medical devices …



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