Fees for performance studies

Fee

According to the Ordinance (2021:988) on fees for medical devices, applicants conducting a performance study must pay an application or notification fee.

The Swedish Ethics Review Authority's fee is included in the fees listed below and which are paid to the Swedish Medical Products Agency (Swedish MPA).

Applications following the coordinated assessment procedure within EU – multinational performance studies

This application option will be available only once EUDAMED is fully functional.

* Of which 5 000 SEK pertains to the Swedish Ethics Review Authority’s handling.
** Of which 2 000 SEK pertains to the Swedish Ethics Review Authority’s handling.

Please note

• A document with invoice details must be included in the submission of application/notification.
• The Swedish MPA will send an invoice to the applicant.
• The invoice must be paid even if an application for a reduction of fee has been submitted.
• If a reduction of fee is granted, a refund of all or parts of the fee will be made.
• In case of resubmission of application/notification, the fee must be paid again.

Invoice documentation

Reduction of fee

The Swedish MPA may grant a reduction of fee if there are exceptional reasons. If the applicant would like to apply for a reduction of the fee, the grounds for why such reduction would be justified, should be clearly stated in the cover letter when submitting the application/notification for the performance study.

The Swedish MPA will not give any notice in advance regarding whether the fee may be reduced or not since all studies will be assessed on a case-by-case basis. The applicant should be aware that the assessment of the performance study is initiated regardless of whether the reduction of the fee is granted or not and presuppose that the entire fee should be paid when the application/notification has been submitted. This applies both for initial application/notification and resubmissions.

Related information