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    Legal manufacturer applicability

    This message was posted by a user wishing to remain anonymous A manufacturer of medical devices is contemplating to sell the intellectual property and commercialization rights of a medical device to another company. However, the original developer will ...

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    Product Transfer during acquisition

    This message was posted by a user wishing to remain anonymous A manufacturing company is being acquired through a process where the old company (OLD-comp) will no longer exist while a new one (NEW-comp) is created to continue doing the same manufacturing ...

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    SiMD UDI for EU

    This message was posted by a user wishing to remain anonymous Hi all, Does anyone know what the labeling requirement for a class I SiMD in EU? Would we need a separate software UDI to be applied in the software if a UDI is on the computer itself. ...

  • T here’s limited regulatory guidance on gene therapies for many drug manufacturer s and how i t can be a struggle to develop successful strategies for CMC. At this upcoming RAPS workshop , @Janmeet Anant will ...

  • The Commission has harmonized the next group of standards for the purpose of Europe's MDR and IVDR Article 8 harmonized standard provisions. For the MDR, these are harmonized standard entries No. 18 through 25 and they relate to medical gloves, biological ...

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