Information for applicants regarding email created for contact, information and documents submission about clinical investigation and performance studies
As of 19.01.2026 applications/notifications and accompanying documentation for conducting clinical investigations with medical devices and performance studies with in vitro diagnostic medical devices on the territory of the Republic of Bulgaria, as well as for substantial modifications in the studies can also be submitted electronically to the following email address: This email address is being protected from spambots. You need JavaScript enabled to view it..
The customary way for submitting of applications/notifications and accompanying documentation for conducting clinical investigations with medical devices and performance studies with in vitro diagnostic medical devices on the territory of the Republic of Bulgaria, as well as for substantial modifications in the studies, remains in force - on paper and/or electronic carrier in chancery of BDA , in person or by courier (mail) by a sponsor’s investigation authorized representative on the following address: Bulgaria, Sofia 1303, 8 Damyan Gruev str., BULGARIAN DRUG AGENCY.
It should be noted that applications/notifications, cover letters, declarations and power of attorney/assignment letters should be signed with a qualified electronic signature when submitted electronically.
We remind you that parallel submission of documentation for assessment by Ethics Committee for Clinical Trials in Bulgaria is also necessary for conducting clinical investigations with medical devices and performance studies with in vitro diagnostic medical devices on the territory of the Republic of Bulgaria, as well as for substantial modifications in the studies. Submission has to be performed on paper and/or electronic carrier in chancery of BDA, in person or by courier (mail) by a sponsor’s investigation authorized representative on the address: Bulgaria, Sofia 1303, 8 Damyan Gruev str., BULGARIAN DRUG AGENCY, Ethics Committee for Clinical Trials, as well as by еmail: This email address is being protected from spambots. You need JavaScript enabled to view it. (applications/notifications, cover letters, declarations and power of attorney/assignment letters should be signed with a qualified electronic signature when submitted electronically). Approval by the Ethics committee is required before issuance of BDA authorization for clinical investigation according to art. 70, para 7, letter b) of Regulation (ЕU) 2017/745 and performance studies according to art. 66, para 7, letter b) of Regulation (ЕU) 2017/746, as well as before the start of studies according to art. 70, para 7, letter a) and art. 74, para 1 of Regulation (ЕU) 2017/745 and before the start of performance studies according to art. 58, para 2, second statement, art. 66, para 7, letter a) and art. 70, para 1 of Regulation (ЕU) 2017/746.
The above manner is applicable for submission of Clinical Investigation Summary Safety Report Form (MDCG 2020-10/2) and Performance Study Summary Safety Report Form (MDCG 2024-4, Appendix).
Cinical investigations under Medical Device Regulation (Regulation (EU) 2017/745)
Clinical investigation – application form under Medical Device Regulation.
MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form
