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EUDAMED

This page shows the latest EUDAMED news and features for those working in and with pharma, biotech and healthcare.

Medical devices probe uncovers need for “drastic regulatory changes”

Medical devices probe uncovers need for “drastic regulatory changes”

The EU is currently reviewing shared public information on a system called Eudamed, but despite this, the European Commission told ICIJ that injury and malfunction reports were “likely to remain confidential

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  • Changes to look out for in Medical Devices Regulations Changes to look out for in Medical Devices Regulations

    Enhancing transparency and vigilance. Under the New Regulations, each device will be required to have a unique device identifier (UDI) which will then be logged on the European database (EUDAMED).

  • Tightening medical device safety Tightening medical device safety

    After validation, the notified body must upload the summary report to the EUDAMED database. ... Other innovations include increased transparency and information sharing, the creation of an EU portal and the upgrading of the EUDAMED database.

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