EC only

These clinical studies only require a positive opinion from the EC. Approval of the FAMHP is not necessary. The file needs to be submitted directly to EC after validation by the CTC.

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

➔ PMCF-research without extra burdensome or invasive procedures (Study falls under the Law of 7 May 2004 - EC has 28 days to deliver an opinion)

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

Compile the file

Mandatory

The following are mandatory for a valid application:

Optional

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

Submit the file

Pay the study 

The contributions are legally laid down according to the Royal Decree of 15 July 2004.  Indexed amounts are applicable from 01/01/2023.

Provide the following data to EC Research on submission of a commercial study:

  • Invoicing address (preferably an address in Belgium)
  • Name of contact
  • PO number (Purchase Order), if applicable
  • VAT number

You will receive an invoice from the Financial department of UZ Leuven (with payment reference).

Payment is only possible upon receipt of an invoice of the Financial department.

Last edit: 18 April 2024