Submission of authorisation applications and notifications

The following items can be sent by email to clinicaltrials.devices@swissmedic.ch:

Tabular listings of reportable serious adverse events and device deficiencies according to European reporting formats.
Communications with no documents attached, e.g. for extension of deadlines, coordination needs, various questions.

In all other cases, you must follow the eGov submission procedures. In order for your submission to be handled correctly, standardised forms and a standardised folder structure are necessary and must always be used. Electronic submissions consist of three steps:

(1) Prepare the standardised form and download the standardised folder structure
To prepare a submission, choose and fill in the correct form and download the standardised folder structure.

(2) Generate an eDok
Copy the form, an accompanying letter if needed and every document into the correct folder. Your files should be in pdf or Excel format. Zip the whole structure (the standardised folders with all your files). This is called an “eDok”. One eDok includes one entire submission. In rare cases of errors due to size overload, you can split the submission (two eDoks for one submission).

(3) Submit the eDok
Send eDoks for clinical trials of devices to Swissmedic via the Swissmedic Portal eMessage (www.swissmedic.ch/emessage-en). Swissmedic also runs a second portal, eSubmission, which cannot be used for devices.

In order to create an eGovernment account, you need an email-address and a mobile phone. Immediately after the registration step, you can submit to Swissmedic. A two-way identification procedure will be carried out for safety reasons each time you access the portal, with a code that is sent to your mobile phone. For a submission, answer the questions on the screen, select your eDok, select the “Upload” button and confirm. You will receive two automatic communications. The first one shows whether the 'submit' step was successful ('delivery confirmation'). Shortly afterwards, a second communication will show whether your files passed the technical validation ('acceptance of delivery' or 'denial of acceptance'). Confirmations and error messages will be stored in eMessage for you. Always check the messages you receive.

You should not store files in the portal. Instead, download correspondence of Swissmedic and store your submissions and the correspondence in the trial master file, so all authorised persons can access them during the clinical trial and the mandatory archiving period.

Further information is provided in the information sheet OS000_00_005e_MB

Screencast – Submission of authorisation applications and notifications relating to clinical trials with medical devices

www.swissmedic.ch/emessage-en

If you are unable to register or to submit, you can contact

esubmission@swissmedic.ch

for help.

Trouble shooting: The error message 'denial of acceptance' mostly occurs when the eDok format is not respected.

Troubleshooting for PDF forms

Subject	Requirement
eDok structure	eDoks must be structured as follows: eDok folder structure (PNG, 56 kB, 21.06.2022) eDok electronic folder structure (ZIP, 27 kB, 26.05.2022) Do not delete or rename folders in the structure.
File formats	In your eDok, include pdf and Excel files only (xlsx, xls, ods). Files from digital sources are preferred. When scanning documents you must use the OCR standard in order for the texts to be machine-readable.
File size	To ensure an effective review, the maximum file size should not exceed 200MB per PDF file. Larger files must be split.
File names	The maximum recommended length is 60 characters with the file extension. File names can include 'A' to 'Z', 'a' to 'z', '0' to '9', '.', '-', and '_'. You may not use blank space at the beginning or end of a file name the following characters: « * : < > ? / \ \| ~ # % & " { }.
No message from Swissmedic	If you do not see the messages from Swissmedic, you can adapt the filter option in eMessage to see unread messages only (default setting), or all messages. Please be aware that you will only see messages and other correspondence made under your ID, not correspondence concerning the same clinical trial sent to other users that have used a different ID.