Medical DeviceAfter 5 years of drafting, the new European Medical Devices Regulations and In Vitro Diagnostics Devices Regulations were both adopted and came into force in 2017. Manufacturers now face increased challenges to ensure compliance before 2020 for medical devices, and 2022 for in vitro diagnostic devices, in order to affix the CE Mark to their products going forward.

Is your organization ready for the transition? Have you take the initial steps in preparation?

This brochure from IQVIA outlines the key elements to both the Medial Device and IVD Regulations, and addresses how your organization can navigate the complexities of the transition by partnering with IQVIA experts who can provide support for:

  • Strategic planning
  • Technical documentation updates
  • Clinical evaluations report preparation
  • Interim in-house staffing

Download this brochure to learn more. »

 

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