New IVD Guidelines: Performance Studies

On May 16, 2024, new guidelines for performance studies involving in vitro diagnostic medical devices (IVDs) were announced by the European Commission.

These guidelines, detailed in the European guidance document MDCG 2024-4, require sponsors to report certain serious adverse events and device deficiencies using Excel tables. It is important to note that this guidance, along with the accompanying Summary Reporting Form (MDCG 2024-4 Appendix), is also applicable for reporting in Switzerland.

Key Points for IVD Reporting Serious Adverse Events Include:

• • The template of the Summary Reporting Form in the appendix should be used for all Performance Studies from 26 May 2022.
  • The form contains filters to facilitate the use of preferred terminology in the reporting. The table gives an overview of the reportable events based on the Performance Study and will be updated and transmitted to the participating national competent authority’s each time a new event or a new finding bas been reported.
  • Sponsors who generate the excel report file by automated processes may implement other technical features in their systems for excel file generation to ensure the preferred terms listed in metadata are used.

Further details on reporting obligations can be found in the Swissmedic information sheet BW600_00_016e_MB.

______________________________________________

If you need help in understanding the new IVD guidelines for performance studies or have questions about how these updates will affect your medical device, contact us so our consultants can assist you.

Learn how MedEnvoy can assist you:

• • Swiss Authorized Representative – MedEnvoy
  • Consulting Services