Duty to notify during the ongoing investigation

The Sponsor must report to the MPA:

  • all serious (assured or suspected) adverse events, known as SAE (see MEDDEV 2.7/3)
  • substantial changes to the investigation plan
  • changes regarding the coordinating investigator or principal investigator
  • changes regarding participating investigation sites
  • interruptions for reasons of safety in the investigation with an explanation
  • restart of interrupted investigation with a justification
  • if the investigation was terminated prematurely with a justification
  • when the clinical investigation was completed

All serious adverse events must be fully recorded and immediately reported to all the competent authorities in the Member States where the clinical investigation is being conducted. The sponsor and the principal investigator must notify each other on an ongoing basis in accordance with SS-EN ISO 14155:2011 and the applicable investigation plan.

All reports of serious adverse events (SAE/SADE) for medical devices should be submitted to the MPA in electronic format by using the online e-service (see link to the right).

  • In the e-service drop down menu for Recipient, please choose the “SAE Report Clinical Investigation of Medical Device”option
  • Add your name and e-mail address in the mandatory fields
  • Attach the file with the report
  • Please indicate both the MPA reference number and CIV ID of the clinical investigation in the message field.

The notification of amendments made to the investigation plan and the participating investigator(s) must be dated and signed by the sponsor and the relevant principal /coordinating investigator.

Use online e-service (see Notification of clinical investigations) to also electronically submit notifications of amendments. When using the e-service it is required that the notification form is resubmitted, specify in a cover letter if the form is updated to a new version.

 
 

Reporting SAE/SADE

 

Related information

   
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information