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Emergo by UL - We Specialize in Global Medical Device …

    https://www.emergobyul.com/
    We Specialize in Global Medical Device and IVD Compliance and Innovation Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and …

Europe CE Marking Regulatory Process for Medical Devices

    https://www.emergobyul.com/resources/europe-ce-marking-regulatory-process-medical-devices
    Determine which EU Medical Device Directive applies to your device: …

Placing Medical Devices on the Swiss Market After the EU MDR …

    https://www.emergobyul.com/news/placing-medical-devices-swiss-market-after-eu-mdr-date-application
    With the EU Medical Devices Regulation (MDR)'s Date of Application happening and no Mutual Recognition Agreement in place, Switzerland is a third country …

European Union Medical Device Classification - Emergo

    https://www.emergobyul.com/services/medical-device-classification-europe

    B COUNCIL DIRECTIVE 93/42/EEC of 14 June …

      https://www.emergogroup.com/sites/default/files/file/europe-consolidated-mdd-93-42-eec.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; whereas if, …

    IVD Medical Device Clinical Performance …

      https://www.emergobyul.com/resources/ivd-medical-device-clinical-performance-evaluation-studies
      Requirements for CP evaluation studies under the current European In Vitro Diagnostic Medical Devices Directive (IVDD) as well as under the new IVDR The ISO 20916 …

    EU Medical Device Vigilance Reporting in Europe - Emergo

      https://www.emergobyul.com/services/medical-device-vigilance-and-incident-reporting-europe
      What is medical device vigilance and adverse event reporting? The vigilance requirements in the Medical Device Regulation (MDR) No. 2017/745 (for medical devices or active …

    Key medical device and IVD topics discussed during the 2023 …

      https://www.emergobyul.com/news/report-7th-european-association-authorised-representatives-annual-conference
      The IVD sector faces possibly even bigger challenges than the medical device sector. Most self-certified IVDs under the In Vitro Medical Devices Directive …

    Medical Device Directive vs Medical Device Regulation

      https://studycorgi.com/medical-device-directive-vs-medical-device-regulation/
      The Directive applies to medical devices if the above objectives cannot be achieved using chemical, pharmacological, and metabolic means (“Medical Devices …



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