News Digest 01.08.2025 — 08.08.2025
Regulators
The Ministry of Health has lowered the risk class for alcohol wipes
The Ministry of Health has approved Order No. 364n dated 24.06.2025, which amends the nomenclature classification of medical devices by class depending on the potential risk of their use (approved by Order of the Ministry of Health of Russia No. 4n dated 06.06.2012).
Subparagraph 4.13 of paragraph 4 of the document, which is being amended, states that medical devices, the components of which include a substance that is a drug or other biologically active agent and affects the human body in addition to the effect of the medical device, belong to class 3.
According to the new order, exceptions to this paragraph will be antiseptic wipes for treating the hands of medical personnel, as well as for treating surgical and injection fields. These products are classified as class 2a.
Source: https://pharmvestnik.ru/content/news/Minzdrav-ponizil-klass-riska-dlya-spirtovyh-salfetok.html
Market news
A manufacturer of medical devices has succeeded in overturning a decision to certify a measurement method in court
The Moscow Arbitration Court has considered a claim by the manufacturer of Elta blood glucose meters to the All-Russian Research Institute of Optical and Physical Measurements (VNIIOFI) and satisfied the claim to overturn the institution's decision to certify the measurement method. Lawyers from the K&P. Group law firm, who represented the applicant in court, emphasized that his victory in the dispute was a precedent - previously, market operators had failed to challenge the decision to certify methods that, in particular, are used to test goods.
Other
Chinese scientists will work on the creation of a space hospital
The corresponding agreement was signed by the Shenzhen University of Advanced Technology and the Shanghai Microsatellite Engineering Center. The parties agreed to combine their efforts in the field of medical technology, pharmaceuticals, aerospace development and instrumentation in order to expand the capabilities for monitoring health and life support in space.
It is planned to conduct applied research, including testing specialized equipment, developing new diagnostic and treatment methods, as well as creating drugs for use in space. In addition, the creation of the hospital provides for the development of scenarios for medical support of promising areas - such as space tourism and long-term interplanetary missions.
In Europe, mobile health apps are equated with medical devices
European developers of mobile health apps are sad: in the new version of the EU regulatory principles for medical devices, mobile health apps are classified as software with a high risk class corresponding to medical devices.
As Mobihealthnews writes, EU regulators claim that any software that provides therapy or diagnostics can be classified as high risk class IIb or III, or if it is “intended to prevent disease.”
Higher requirements are also imposed on applications compatible with electronic medical records in EU healthcare organizations. Local regulators have stated that they will have to comply not only with the Medical Devices Regulation and the In Vitro Diagnostics Regulation, but also with the upcoming European Health Data Regulation.
In fact, any app that includes a course with recommendations for improving the health of the body can now be equated to a medical device. Accordingly, in order to enter the market, the software will have to undergo clinical trials and comply with other bureaucratic procedures.
How will this affect the market? It will certainly lead to a reduction in the number of healthy lifestyle and medical software developers targeting European app stores. One of the advantages of the regulation is that developers will assess the risks before creating another app that “reduces stress”: there will be more responsibility for using such software.
Source: https://t.me/medicalksu/5838
New registered medical devices
We publish a list of new medical devices registered from 08.01.2025 to 08.08.2025
Link to the list: [see table in the attachment]
News
