Regulations

Information on reimbursement for individual methods and diagnoses

SÚKL Statement on Clinical Trials

When do I need to submit a notification/study to SÚKL?

Every planned prospective randomized placebo-controlled clinical study involving a neurostimulation medical device (e.g., tDCS, rTMS) must be approved in advance by SÚKL.

You must submit an application to SÚKL if:

• You are testing a new medical device or using a medical device outside its intended purpose (e.g., tDCS outside an approved indication)

• You are conducting a clinical investigation of a medical device or an "other clinical trial" under the MDR
• The study includes a placebo
• The patient is exposed to any burden beyond standard diagnostic or therapeutic procedures — e.g., additional examinations (EEG, MRI, blood sampling) for the purpose of biomarker measurement
• You are using an unregistered (non-CE-marked) device
• You are evaluating the safety or effectiveness of the device in a systematic way in patients

You do NOT need to apply to SÚKL if:

• You are using a registered, CE-marked device within its approved indication and the study does not assess its safety or effectiveness (e.g., routine clinical use within standard care)

• The study is non-interventional (e.g., you only collect data about patients receiving rTMS as part of their treatment)

• You do not expose the patient to any additional burden (examination) beyond standard clinical practice. According to SÚKL: even performing an EEG or taking blood samples, if these are not part of routine care, already qualifies the study as an "other clinical trial."

Notification of Intent to Conduct an "Other Clinical Trial" with a Medical Device