CASubmissionFee object

Fees for trial submission mandatory

Yes

Fees

Notification fee for a clinical investigation on MD:
SEK 22.000.- (~ € 2.200.-)

Academic research without economic support from external commercial sponsor may be waived.

Waiver for academic (non-commercial) studies possible

Upon request

Official guidance on required fees

Fees are provided on the MPA website in section > Medical devices >Clinical Investigations > Notification Fee

Applicable national legal framework/ Reference

Medical Devices Ordinance SFS 1993:876 (sv)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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