News Digest 27.09.2024 — 04.10.2024
Regulators
The EEC adopted recommendations on the classification of medical devices for in vitro diagnostics according to the degree of risk
The EAEU countries are recommended to apply Methodological Recommendations on the classification of medical devices for in vitro diagnostics according to the degree of risk. The document is aimed at forming common approaches to classification within the framework of the Eurasian Economic Union (EAEU), increasing mutual recognition of the results of the examination.
The Board of the Eurasian Economic Commission (EEC) has adopted Methodological Recommendations on the classification of medical devices for in vitro diagnostics, depending on the potential risk of use in order to register them within the framework of the Eurasian Economic Union. The corresponding decision was made at the meeting of the EEC Council on 09/23/2024.
We are talking about performing a wide range of laboratory tests, including hematological, general clinical, genetic, immunological, microbiological, hemostasis research, biochemical blood analysis for infections and others. They are necessary to better understand diseases and choose the most effective ways to treat them.
The recommendations contain explanations and examples to the Rules for Classifying Medical Devices depending on the potential risk of use, approved by the Board of the Commission in 2015, and are aimed at forming unified approaches in the EAEU countries to classify medical devices for in vitro diagnostics in accordance with these rules. This will increase the level of mutual recognition of the results of the examination of such products.
In January, the EEC Council amended the Rules for Conducting Clinical and Clinical Laboratory Tests for the Registration of Medical Devices, which came into force at the end of July. The document revised the requirements for conducting clinical trials. The EEC Council also prescribed the parameters for conducting research for medical devices for in vitro diagnostics and based on IT solutions using artificial intelligence.
In addition, the registration rules were supplemented with a clause on the justification for conducting clinical trials in cases where the safety and effectiveness of medical products cannot be confirmed in any other way. The document does not affect products that are in the process of registration.
WHO has developed guidelines for medical organizations to conduct CI
The World Health Organization (WHO) has published the "Guidance for best practices for clinical Trials". The purpose of the document, the WHO notes, is to improve the quality of CI conducted in different countries, increase their accessibility, as well as the diversity of CI participants. In addition, the guidelines are aimed at reducing the disparity of CI between low- and high-income countries, and introducing CI into the regular practice of medical organizations, regardless of their financial condition.
According to the text of the guidelines, clinical trials can be considered reliable, informative, ethical and effective if they correspond to five key aspects. Thus, it is necessary that CI provides scientifically based answers to the questions posed, respects the rights of participants, interaction is based on the principles of cooperation and transparency, CI management is rational, and CI itself is feasible in the existing context.
The guidelines indicate that it is necessary to strive to reduce uncertainty and bias. For example, the questions left at the end of the study should not be so significant as to interfere with further important decision-making. In order to eliminate bias on the part of researchers, it is required that randomization be carried out without prior notification of the condition of volunteers. Thus, any differences in the participants' health indicators will be due to random selection.
New grounds for unscheduled inspections by Rospotrebnadzor have come into force
Starting from September 23, 2024, amendments to the Decree of the Government of the Russian Federation No. 336 dated March 10, 2022 "On the specifics of the organization and implementation of State control, municipal control" came into force. In accordance with the changes, Rospotrebnadzor may conduct sudden inspections without notifying controlled persons when identifying indicators of risk of violation of requirements for products that are subject to labeling by means of identification. In particular, such products include medical devices.
In addition, unscheduled inspections will now be carried out against organizations operating in the field of medical products circulation if such organizations have not notified the relevant authorities about the start of their activities.
Market news
ORTHO-Market invests 1 billion rubles in the launch of the production of components for prostheses in Krasnodar
The governor of the Krasnodar Territory, Veniamin Kondratiev, said that the implementation of two import-substituting projects in the field of medicine continues in the region. ORTHO-Market and April companies have built two factories for the production of medical devices for rehabilitation and prosthetics. They should be launched in 2025, each investor will invest 1 billion rubles.
The regional authorities and representatives of the companies agreed on the establishment of production facilities in the village of Smolenskaya in the Seversky district at the St. Petersburg Economic Forum in June 2024.
The ORTHO-Market company has placed production on an area of 1.3 thousand square meters, where they intend to produce components for prostheses. The implementation of the investment project will require 1 billion rubles. 70 jobs will be created at the plant, the planned capacity is 10 thousand products annually.
Other
Russia has developed a test system for the selection of targeted therapy for breast cancer
Scientists from Sechenov University and the OncoAtlas Center for Molecular Oncology have developed a high-tech genetic test of a new generation for patients with breast cancer. The first domestic test system makes it possible to identify mutations in genes that provoke the development of a hereditary disease, and at the same time determine sensitivity to targeted drugs to prescribe the most effective treatment, the press service of the university reported.
The new test system will be used by oncologists and specialists from clinical laboratories performing molecular genetic research. Its use will help improve the quality of medical care for patients by personalizing treatment.
In Russia, testing for genetic mutations is currently carried out in patients only by blood analysis. The new test system allows you to identify them in a tumor sample, and not only hereditary, but also acquired. In addition, it can be used to assess the sensitivity of the tumor to targeted drugs, as well as to monitor the effectiveness of treatment.
New registered medical devices
We publish a list of new medical devices registered from 27.09.2024 to 04.10.2024
Link to the list: [see table in the attachment]
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