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Medical Devices – USA/Europe Regulatory News – Dec. 2023

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FDA reissued a guidance on how to request a review of its decision not to issue certain export certificates to device manufacturers. It updates details on what information the agency will provide to companies that have had a request for a Certificate to Foreign Government (CFG) denied, and the process to contest the denial.

  • Design and manufacturing changes to address component unavailability due to supply chain disruptions
  • Manufacturing changes to allow the establishment to maintain operations and to accommodate social distancing in appropriate situations based on local conditions
  • Changes in manufacturing facility or establishment
  • Changes to packaging procedures

If you received your new MDEL before April 1, 2024, you will also need to submit an ALR package before this date. You must also pay the applicable fees when you do so. This is in accordance with section 46.1(1) of the regulations.

  • Regular exchange of information between market surveillance authorities;
  • Cooperation related to the implementation of market surveillance measures;
  • Cooperation of inspectors;
  • Joint inspections targeting manufacturers and other economic operators in order to harmonize inspection activities at the Union level.

The institute draws attention to the published updated versions of information and recommended guidelines for advertising medical devices and in vitro diagnostic medical devices, which are also available at https://www.sukl.cz/sukl/obecne-pokyny-a-formulare. The information and recommendations are updated due to the changes made by the amendments in the legislation concerning medical devices and in vitro diagnostic medical devices.

https://www.hpra.ie/docs/default-source/default-document-library/public-consultation-on-human-medicines-and-medical-device-fees-2024.pdf?sfvrsn=2