Questions and Answers

Clinical Investigations

 

Question: Is it necessary to notify a clinical investigation carried out using medical devices, the conformity of which has been assessed (which are entitled to bear the CE marking), if these medical devices are used within the intended use to SÚKL?

Answer: In this case, the clinical investigation is not to be notified to SÚKL.

 

Question: What is the fee for clinical investigation notification in the Czech Republic?

Answer: No fee is charged for a notification of clinical investigation of a medical device.

 

Question: What are the specific requirements for reporting SAE as compared with MEDDEV 2.7/3?

Answer: The investigator is required to report promptly the occurrence of serious adverse events and the measures that have been taken to the sponsor or, as the case may be, the sponsor’s assistant, the relevant ethics committee and SÚKL. The sponsor has an obligation to report any serious adverse events to SÚKL without any delay after their occurrence. Other requirements of MEDDEV 2.7/3 remain applicable.

 

Question: Is a sponsor required to send in periodical reports on the course and safety of a clinical investigation that is under way?

Answer: At present, a sponsor is not required to send periodical reports to SÚKL on the course and safety of a clinical investigation that is under way. However, this information is important for checks on the implementation of a clinical investigation.

 

Question: Is it necessary to wait for an opinion statement from SÚKL on substantial amendments to the documentation of a clinical investigation?

Answer: If a substantial amendment is made in the documentation of a clinical investigation, it must be approved by the relevant ethics committee. The documentation, with highlighted changes, is sent, along with the approval statement from the ethics committee to SÚKL for its information. SÚKL does not comment on the changes in the documentation. An opinion statement from SÚKL is only sent at a written request.

 

Question: What information needs to be sent to SÚKL during a clinical investigation?

Answer: A sponsor has an obligation to report all serious adverse events (SAE) to SÚKL, to give notice of changes in the documentation of the clinical investigation, to give notice of the termination or interruption of the clinical investigation, including the reasons, if it is a case of interruption or early termination. The investigator is required to notify SÚKL of the occurrence of an SAE and of the measures that have been taken.