Fee for clinical investigation of medical device
- Published: December 16, 2019
- Last updated: March 7, 2022
An application or a notification of a clinical investigation of medical devices in Sweden incurs a fee.
Application and notification fee
According to the Ordinance (2021:988) on fees for medical devices, applicants conducting the clinical investigation 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).
| Type of application/notification | Fee |
| Application – for clinical investigation of devices in class III and invasive devices in class IIa and IIb | 60 000 SEK* |
| Application – for clinical investigation of devices in class I and non-invasive devices in class IIa and IIb | 25 000 SEK* |
| Notification – of a clinical investigation to further investigate a CE marked device within its intended purpose | 16 000 SEK* |
| Notifications of substantial modifications of previously authorised clinical investigations | 13 000 SEK** |
Applications following the coordinated assessment procedure within EU – multinational clinical investigations
This application option will be available only once EUDAMED is fully functional.
| Type of application | Fee |
| When Sweden is the coordinating member state | 65 000 SEK* |
| When Sweden is the member state concerned | 60 000 SEK* |
* 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. This part of the fee is not charged for notifications where no coordinated handling is applicable.
Please note
- A document with invoice details must be attached to the submission of application or 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 the entire or parts of the fee will be made.
- In case of resubmission, the application or notification fee must be paid again.
Invoice documentation for clinical trials
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 clinical investigation notification/application.
No advance notices regarding whether the fee may be reduced or not will be given by the Swedish MPA, the investigations will be assessed on a case by case basis. The applicant should be aware that the assessment of the clinical investigation is initiated regardless of whether the reduction of fee is granted or not and presuppose that the entire fee should be paid when the notification/application has been submitted. This applies both for initial notifications and resubmissions.