Temporary halt, termination and restart – according to IVDR

Submit the notification

Submit the notification via the same e-service as for application/notification/substantial modification of a clinical investigation/performance study. Refer to the CIV-ID and the Swedish MPA reference number of the performance study.

It is also possible to submit notifications by email or on DVD/CD or USB by regular mail.

More information is available in section Technical prerequisites on page Application and notification – according to IVDR.

Restart 

An approval from the Swedish MPA is required to restart the performance study if the temporary halt was due to safety reasons.

In the notification for restart, a justification to why the study can be restarted shall be included together with any updated documents.

Timelines for termination and report 

If a performance study conducted in Sweden is temporarily halted or terminated early due to safety reasons, the Swedish MPA shall be informed within 24 hours. If temporarily halted or terminated early for other reasons, the MPA shall be informed within 15 calendar days.

When a performance study is terminated according to plan, the Swedish MPA shall be informed within 15 calendar days after the end of study in Sweden.
The Swedish MPA shall also be notified within 15 calendar days of the end of the study globally.

More information on when a final report needs to be submitted to the Swedish MPA after the end of the study is found on the web page “Final study report – according to IVDR”.