Declaration to SÚKL – affidavit

It is no longer required; instead of this annex, it is necessary to answer two questions directly in the project proposal, namely whether "The project proposal corresponds to the clinical evaluation of medicines according to the provisions of Act No. 378/2007 Coll., on Medicinal Products" and whether "The project proposal corresponds to the clinical trial of medical devices according to Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices' (the bidder is responsible for the correctness of the answers).

If the answer is in the affirmative, you must provide the original, a certified copy or an electronic conversion of the document:

The decision on the authorisation of the clinical evaluation for the Czech Republic within the meaning of the Medicinal Products Act and the same documentation that was approved in this decision (or a valid Authorisation of a reported clinical evaluation according to Directive 2001/20/EC including the opinion of the Ethics Committees and the same documentation) in case the proposal corresponds to the clinical evaluation of the medicinal product;

In the case of a project proposal that corresponds to the conduct of a clinical trial of a medical device with a CE marking that will be used in a clinical trial outside its intended use and/or in the case of a project proposal that corresponds to the conduct of a clinical trial of a medical device without a CE marking, the applicant shall attach the Decision on Authorisation of the CP within the meaning of the Medical Devices and MDR Act (if such a clinical trial requires a Decision on Authorisation) or the Confirmation of Acceptance of the submitted notification (if the clinical trial requires a notification of the intention to conduct a clinical trial) within the meaning of the Act on Medical Devices and MDR Act. Medical Devices and MDR.