News Digest 22.08.2025 — 29.08.2025
Regulators
Roszdravnadzor has approved a new procedure for maintaining a register of clinical trials of medical devices
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) has approved a new procedure for maintaining a register of permits to conduct clinical trials of medical devices.
Order No. 4484 "On approval of the Procedure for maintaining a register of issued permits to conduct clinical trials of a medical device" was published on August 22 and will be valid until December 31, 2026. According to the updated regulations, the register will be maintained in electronic format and will contain a complete list of data on issued permits to conduct clinical trials. The database will include:
- date and number of permit;
- name of medical device;
- type of product in accordance with the nomenclature classification;
- class of potential risk of use;
- information about the manufacturer and authorized representative;
- place of production;
- information about the trials themselves, including the clinics where they are conducted, and the current status of the clinical trials.
Information must be entered into the register on the day of the decision to issue a permit to conduct a clinical trial and within three working days after receiving notification of the start of a clinical trial.
Manufacturers or authorized representatives will be able to send information about the start of trials online - through their personal account on the public services portal.
Changes have been prepared to the rules for marking for the purchase of medical devices
The Ministry of Industry and Trade is going to amend the rules for marking certain types of medical devices with identification means (approved by RF Government Resolution No. 894 dated 31.05.2023). The draft resolution is undergoing public discussion until September 11.
The authors of the document propose to clarify the concept of "withdrawal from circulation". According to the draft, withdrawal from circulation will be the sale to legal entities (including purchases for state needs), if the purpose is not related to subsequent resale. Exceptions will be cases of purchasing goods for medical activities and the provision of social medical services (including for state needs).
According to the draft, the Rules will not apply to goods under transactions with state secrets during transportation, as well as to goods purchased under special procurement procedures under 44-FZ "On the contract system in the field of procurement of goods, works, services to meet state and municipal needs" and 223-FZ "On the procurement of goods, works, services by certain types of legal entities".
Deliveries under state (municipal) contracts (agreements) are added to the list of transactions for which information is transferred to the state information system for monitoring the circulation of goods subject to mandatory labeling with identification means (GIS MT). If approved, the document will come into force on September 1, 2026.
The resolution does not apply to purchases, notifications of which were posted in the GIS EIS before the document came into force, as well as to contracts concluded before this date. Mandatory labeling for medical devices, antiseptics, dietary supplements and wheelchairs was introduced in 2023.
The Ministry of Industry and Trade proposed integrating the EIS and the GIS MT in terms of exchanging data on the labeling of medical devices
The Ministry of Industry and Trade of Russia has prepared a draft government resolution with amendments to the current Rules for the Labeling of Medical Devices.
The adjustments will allow automatic transfer of data on medical devices supplied under government contracts: if the purchase is posted in the unified information system (UIS) or the contract is concluded with a single supplier, then market participants will need to transfer information to the goods monitoring system (GIS MT) "Honest Sign" through integration with the UIS.
The department indicates that the innovations will allow institutions to verify bona fide suppliers, as well as identify potential violations.
Mandatory labeling of medical devices is gradually introduced from 2023, the operator of the system is "Operator-CRPT". Monitoring is designed to prevent illegal production and circulation of medical devices.
Market news
The Ministry of Labor clarified the terms of use of technical rehabilitation equipment for people with disabilities with permanent IPRA
The Ministry of Labor of the Russian Federation approved an order establishing the terms of use of technical rehabilitation equipment (TSR), prostheses and prosthetic and orthopedic products.
The document replaced a similar regulation in force since 2021.
The changes were necessary to "synchronize the nomenclature" used by medical and social expertise (MSE) specialists when assigning TSR to people with disabilities under individual rehabilitation and habilitation programs for people with disabilities (IPRA).
After the adoption of the thematic document, Order No. 107n of the Ministry of Labor of the Russian Federation dated March 5, 2021 "On approval of the terms of use of technical rehabilitation equipment, prostheses and prosthetic and orthopedic products" became invalid.
The nomenclature of technical rehabilitation equipment establishing the terms of use was brought into line with the list of rehabilitation equipment defined by departmental order No. 687n of December 10, 2024 "On approval of the list of medical and social indications, medical contraindications for providing disabled people with technical rehabilitation equipment, technical solutions, including special, design features and parameters of technical rehabilitation equipment used to eliminate or compensate as fully as possible for persistent limitations in the life of disabled people." The Ministry of Labor issued this document in March 2025. The updated list retains certain items on technical rehabilitation equipment that are no longer assigned at present, and disabled people with permanent IPRA have the right to receive them.
Other
AI-powered medical devices in the US are recalled twice as often in the first year as regular medical devices
Specialists in the US have analyzed the use of medical devices with artificial intelligence (AI) approved by the Food and Drug Administration (FDA).
Of the 950 devices approved for use under the simplified 510(k) procedure, 60 had to be recalled. In total, 182 recalls were recorded for them, with 43% of them occurring in the first year after entering the market, which is twice as high as the rate for other medical devices.
The results of the study were published in the journal JAMA Health Forum.
During the analysis, experts divided the devices by the status of clinical validation: without testing, with retrospective verification on already collected data, or with prospective trials on patients. The status of the company was taken into account separately - private or public.
The authors of the study classified the reasons for the recalls as diagnostic and measurement errors, loss or delay in functionality, physical and biochemical risks. This approach allowed us to evaluate not only the devices themselves, but also the conditions for their launch on the market.
The authors of the study noted that the current FDA procedure does not always identify vulnerabilities in AI devices at an early stage. As a solution to the problem, they propose making clinical trials mandatory or issuing temporary permits that remain valid only if safety and effectiveness are confirmed.
Meanwhile, in Russia, they are also discussing the regulation of the use of AI in various industries: in August 2025, the Ministry of Digital Development, together with the Alliance in the field of AI, prepared a draft concept for the development of technology regulation until 2030, and in March of the same year, the Ministry of Health approved the Code of Ethics for the Use of AI in Healthcare. The document is designed to increase the confidence of doctors and patients in new solutions and ensure their safe implementation in medicine.
Verily is winding down medical device development to invest in AI
The developer Verily (part of the Alphabet holding, which manages Google Inc. and all its divisions) is closing its medical equipment program and cutting staff. The decision, according to CEO Stephen Gillett, is related to the company's reorientation to solutions in the field of artificial intelligence and the development of infrastructure for working with data.
Verily noted that over the years of its existence, it has accumulated significant experience in the field of medical technologies, but "moving forward requires difficult decisions." The closure of the direction was part of a broader Alphabet strategy to concentrate resources on AI and optimize costs.
Among the main developments of Verily are the Dexcom G7 continuous glucose monitoring system, the Verily Numetric Retinal Service non-mydriatic fundus camera, and the Verily Study Watch smart watch for collecting data during clinical trials.
Source: https://t.me/vademecum_live/18889
Chest compression devices have shown effectiveness in space
Scientists from the University of Nancy, together with colleagues from the University of Lorraine, the University of Paris, and the National Center for Space Research, evaluated the performance of various methods and devices for cardiopulmonary resuscitation in microgravity. The results of the study were published on the ESC portal.
The analysis showed that manual chest compression methods, including the handstand method, the reverse bear hug, and the Evetts Russomano method, did not provide the necessary compression depth for effective resuscitation.
The authors analyzed test data from three types of automatic devices and several manual methods of cardiopulmonary resuscitation in microgravity conditions. The main results were the depth of chest compression and its compliance with international standards.
The authors concluded that automatic chest compression devices can be useful in resuscitation in space. At the same time, their use can be widely used on Earth - in situations where medical care is limited, for example, on submarines or Arctic bases.
New registered medical devices
We publish a list of new medical devices registered from 08.15.2025 to 08.29.2025
Link to the list: [see table in the attachment]
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