CASubmissionFormat object

Email
Regular mail
Data carrier (CD-rom/DVD)
Via Eudralink (EMA)

Yes

The standard application form to be used: “Application form for the authorisation of clinical investigations of medical devices”
Available on CA website in section: Medicines & medical devices / Medical devices / Clinical investigations / Application

A comprehensive guidance on application format and required documentation (“Guidance on application for the authorisation for clinical investigation of medical devices”) is available on the CA website in section:
Medicines & medical devices / Medical devices / Clinical investigations / Application

ad Format options: :
One copy of all required documents with relevant signatures should be submitted via:
(1) CD-ROM (Preferred I): a signed cover in paper form and as a PDF file on the CD-ROM)
(3) Via Eudralink (Preferred II):
- documentation sent to med-udstyr@dkma.dk without a password
- register as Eudralink user via https://eudralink.ema.europa.eu/
(3) Regular mail
(4) Email: For submission of supplementary information (NB! Limited data size)