Medical device – e-service for notification of clinical investigation

Instructions

This e-service can be used to upload and submit notification forms and attachments.

Attach files
In sections 10 and 11 in the notification form you can find a list of the files that will need to be attached to your submission. You can either upload the entire submission as a zip file or as separate documents. When you submit an initial notification/resubmission, please upload the attachments according to the following structure:

1. Notification form – Electronically completed form in the file format docx
2. Notification form – The completed form signed and scanned as a pdf file
3. Clinical Investigational Plan
4. Patient information
5. Insurance
6. Product documentation (Investigators Brochure, Declaration of conformity etc)
7. Investigators and sites
8. Other documents

If there are several documents in a category, name them 3a+Document name, 3b + Document name etc and/or make a folder

For amendment submissions it is not mandatory to enclose a notification form, however, it should be done if the form has been updated. If the amendment includes plenty of documents, the same folder structure as above may be used. Otherwise separate documents can be attached.

Files can be attached 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:
https://lakemedelsverket.se/english/product/Medical-devices/Clinical-Investigations/Notification-of-Clinical-Investigations/..
There you can also find the document “Guidance for use of notification form”.

Review that the e-mail address and selected attachments are correct before submitting.
Then send the notification and attachments via the button "Submit".

Correction instructions

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Thank you!

Attach file

Typ av dokument
Tillåtna filändelser
Tillåtet antal
 
*Attached documents
pdf, doc, docx, xls, xlsx, tif, gif, txt, zip, jpeg
minst: 1
maximalt: 20

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.

Version: 1.0.0