EC only

These clinical studies only require a positive opinion from the EC, recognised by the Act of 07/05/2004. Approval of the FAMHP is not necessary. The file needs to be submitted directly to the EC.

The following types of studies should be submitted according to this pathway:

➔ PMCF-research without extra burdensome or invasive procedures ( Act on experiments on human beings - the EC has 28 days to deliver an opinion)

other clinical study with CE-marked tool that is used for the intended purpose (BRD clinical study - the EC has 45 days to deliver an opinion)

Compile the file


The following are mandatory for a valid application:


If relevant for your study, the following components are also submitted:

Last edit: 13 January 2023