Adoption of Serbian standard for testing medical devices for human subjects

The ISS NTC KS Z076, Medical devices, after intensive work on translation and harmonization of content, has put up for public enquiry the third edition of the standard SRPS EN ISO 14155:2021, Clinical investigation of medical devices for human subjects - Good clinical practice, Serbian language version (identical to ISO 14155:2020).

During the public enquiry stage, all interested parties can access the draft standard via link: https://iss.rs/sr_Cyrl/project-translation/feedback/29, after opening an account on the ISS website. Public enquiry at the national level can influence the improvement of the quality of the translation of the standard, so we invite you to enter your comments and suggestions by filling in the table below the draft access field. Your comments will be considered by NTC KS Z076 before adopting the definitive text of the standard.

The purpose of SRPS EN ISO 14155:2021 is to help manufacturers comply with the requirements of good clinical practice in the design, conduct and reporting of clinical trials. This standard is widely applied in the industry and has been revised to comply with regulatory changes and amendments to other relevant standards. It also contains a wealth of additional details and information designed to help protect clinical trial participants and medical device users to achieve good results. The standard is supplemented with sections that introduce risk management throughout the clinical trial process (from planning to review of results).

SRPS EN ISO 14155:2021 protects the rights, safety and well-being of trial participants and includes requirements for appropriate methodology that ensures the scientific credibility of clinical data. Defines the responsibilities of sponsors and researchers and explains the role of ethics committees, regulatory authorities, safety boards and other involved parties.

The publication of this standard in Serbian language is expected in the beginning of 2023.