Clinical Trials
Clinical trials of medical devices are carried out based on the following:
1. Authorization for conducting or certificate of registration of a clinical trial (CT) issued by the Agency and
2. Positive opinion given by the Ethics Committee of Serbia (ECS)
in accordance with the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and the regulations adopted for its implementation.
The request for authorization or certificate of registration of a clinical trial and the request for the opinion of the Ethics Committee of Serbia are submitted through the Agency concurrently..
II. Types of requests submitted to the Agency regarding CT of medical devices:
A) Request for authorization of a clinical trial of a medical device
(issuance of a license for authorization of a clinical trial of a medical device)
Prior to the start of a clinical trial, the sponsor submits to the Agency a request with the documentation for the authorization of a clinical trial of a medical device for the following medical devices:
• class IIa which are for long-term use or invasive;
• class IIb;
• class III;
• active implantable medical devices (AIMD).
*An EOS application is submitted concurrently
B) Registration of a clinical trial of a medical device
(issuance of certificate of receipt of registration)
The sponsor reports to the Agency the implementation of:
1) post-marketing non-interventional clinical trial of a medical device;
2) clinical trial of Class I medical devices;
3) clinical trial of class IIa medical devices that are not
intended for long-term use or are invasive;
4) Performance evaluation studies of in vitro diagnostic medical devices;
*An EOS application is submitted concurrently
C) Non-commercial clinical trial of a medical device (academic clinical trial of a medical device)
The instructions from item No. A) and B) shall apply, depending on the type of application submitted to the Agency.
*An EOS application is submitted concurrently