Update on Swissmedic FSCA Report and PRRC Change

Changes to Swissmedic FSCA Report V2.3

Swissmedic has recently updated the Foreign Serious Incident Report (FSCA) template to version 2.3. We have reviewed the changes between V2.2 and V2.3 and here are the updates:

• • Section 1 – Administrative Information: An additional field has been added to record the ‘expected date of the next report’.
  • Section 1 – FSCA Basis: Extra fields have been added repeating the manufacturer reference number and Swissmedic reference number.
  • Section 7 – Description of the FSCA: A minor change has been made to the list of countries the medical device has been distributed to. CH and LI have been moved from the main list and placed on the first line alone.
  • Submit the FSCA: GDPR regulations now apply. The tick box to confirm completeness and correctness of the data has an addition of ‘’and that the FSN to be published complies with data protection regulations’.

You can find the updated FSCA template, titled “MU680_21_019e_FO Field Safety Corrective Action (FSCA) Report,” on the Swissmedic website here. Go to the “Field Safety Corrective Action (FSCA) section,” scroll down, and select the PDF form displayed below.

Please review the updated FSCA template and make necessary updates to ensure compliance. 

Change in PRRC 

We would also like to inform our customers about a change in the Person Responsible for Regulatory Compliance (PRRC). Daniëlle Sleegers will now be the new PRRC for our company for Europe and Switzerland. Please update your records accordingly.

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Next Steps for Customers

Please update your records with the new FSCA V2.3 and the new PRRC, Danieëlle Sleegers.

For any questions or clarifications regarding these updates, please contact our support team.

Thank you for your attention to these important updates. We remain committed to providing you with the most up-to-date and compliant information.

Learn how MedEnvoy can assist you:

• • Swiss Authorized Representative
  • Swiss Regulatory Importer
  • Consulting Services
  • CE Marking Compliance Consulting