News Digest 14.02.2025 — 21.02.2025
Regulators
The EEC Board recommended amending GOSTs for medical devices
The Board of the Eurasian Economic Commission (EEC) published recommendation No. 2 "On amendments to the list of standards, the application of which on a voluntary basis fully or partially ensures compliance of medical devices with the General Requirements for the Safety and Efficiency of Medical Devices, the requirements for their labeling and operational documentation for them."
In Section I (the main list of standards), it is proposed to amend positions 79, 83 and 139. These standards concern:
- clinical studies of medical devices (GOST R ISO 14155-2022);
- symbols used for labeling medical devices (GOST R ISO 15223-1-2023);
- design of medical devices taking into account ease of use (GOST R IEC 62366-1-2023).
In Section II (additional list of standards), it is proposed to amend positions 32 and 42. These standards also concern the labeling and design of medical devices.
EAEU members are recommended to apply the document from March 19 (30 working days after its official publication).
At the end of 2024, the EEC Board adopted Methodological Recommendations on the content and structure of registration dossier documents for a medical device and the examination of its safety, quality and effectiveness for registration. Three orders were also adopted to amend the composition of the Advisory Committee on Medical Devices and the composition of working groups on medical devices within the EAEU.
Market news
Adviser to the Governor of the Oryol Region was left in custody on suspicion of theft during the supply of medical equipment
The Sovetsky District Court of Oryol extended the arrest of the governor's adviser Sergei Lezhnev until March 24, 2025. He has been in pretrial detention since May 2024. Lezhnev was detained on charges of embezzling 76.5 million rubles during the repair of road infrastructure. Later, new episodes appeared in the criminal case: the investigation believes that Lezhnev was also involved in the theft of 100 million rubles during the supply of medical equipment to the regional clinical hospital, as well as in fraudulent reporting on his business trips with humanitarian aid to the LPR.
Lezhnev denies guilt and insists on his innocence. The court rejected his motions to transfer him to house arrest. An attempt to present a contract with the Ministry of Defense for service was also unsuccessful - Lezhnev was unable to provide evidence of the contract.
Source: https://www.kommersant.ru/doc/7516760
A polyclinic will be built in Golitsyno near Moscow for 1.6 billion rubles
The Competition Policy Committee of the Moscow Region has announced a tender for the construction of a polyclinic for 300 visits per shift in Golitsyno, Odintsovo Urban District. The contractor must conduct engineering surveys, prepare design and working documentation, erect the facility and equip it with equipment. The starting price of the contract is 1.58 billion rubles. The deadline for accepting applications from contractors is scheduled for March 4, 2025.
Other
By 2026, a laboratory for medical cybernetics will appear at NSU
Novosibirsk State University (NSU) has signed a cooperation agreement with Russian companies Papillon (developer and manufacturer of functional medical beds) and SafeVision (developer and manufacturer of a system for supporting medical decision-making). The partnership should result in the opening of a laboratory in 2025-2026 at the Institute of Medicine and Medical Technologies of NSU. The laboratory will be integrated into the educational process in the specialty "medical cybernetics", training in which will begin in September 2025.
The main goal of the laboratory is to create a scientific base where students and teachers will be able to conduct research. In addition, students are planned to be involved in production activities in partner companies during the completion of their diploma theses. This project will consolidate the efforts of the university and organizations in the development of new treatment methods and the use of partner products.
At the moment, several working groups have been created from 2nd and 3rd year students of the NSU Institute of Intelligent Robotics, who are working on creating algorithms for the SafeVision software and hardware complex. This complex is used for contactless monitoring of the patient's condition, analysis of risk factors, such as apnea.
NSU received a license for the specialist program in medical cybernetics in mid-December 2024. At the same time, it was reported that the pilot recruitment was designed for 20 students. The training will be conducted for six years.
Newly registered medical devices
We publish a list of new medical devices registered from 02.14.2025 to 02.21.2025
Link to the list: [see table in the attachment]
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