Medical device - clinical investigation

Medical device – e-service for notification of clinical investigation

Instructions

Here you can upload and submit your notification form and attachments.

E-mail address
Enter the e-mail address where you want the confirmation of receipt to be sent to.

Attach files
Notification form The notification form must be submitted in two different formats.
1. Electronically completed form in the file format docx.
2. The completed form signed and scanned as a pdf file.
Attachments You can attach files in the following formats: pdf, doc, docx, xls, xlsx, tif, gif, txt, zip and jpeg. All files must be fully searchable.
For further instructions regarding attachments, please see the MPA website for clinical investigations of medical devices.
Review that the e-mail address and selected attachments are correct before submitting.
Confirm this by clicking the checkbox at the bottom.
Then send the notification and attachments via the button "Submit".

Correction instructions

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E-mail address

Attach file

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Indicated information in the notification form will be submitted to the Eudamed database. All submitted documents will be archived electronically in the MPA case management system.

Verify information

I have checked that the e-mail address is correct and that all mandatory documents are attached.

Medical Products Agency
P.O. Box 26, SE-751 03 Uppsala, Sweden
phone: +46 18 174600, fax: +46 18 548566

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Version: 1.0.3