CAAmendment object

Authorisation mandatory for

Any changes to the conditions of the clinical investigation/ clinical investigation plan

Responsible for submission of SA


Timeline for approval of SA (max nr days)

In case that the CA does not provide its decision within the specified timeline, the changes shall be considered approved thereby.

Applicable national legal framework/ Reference

Section 15 of Act No 268/2014 on Medical Devices

Additional Information

The proposed changes in the clinical investigation dossier and a written approval of the proposed changes by the ethics committee shall be submitted to the CA.