<\/p>\n
Member companies of the Medical Devices Subcommittee of the Health Care Committee of the European Business Association have repeatedly raised concerns regarding the operation of the Register of Persons Responsible for Placing Medical Devices on the Market. As a result of business appeals and discussions with the State Service of Ukraine on Medicines and Drugs Control (SMDC), the Ministry of Health of Ukraine, and the system administrators, the Association\u2019s Subcommittee has received official clarifications on a number of problematic issues, as well as approaches to their possible resolution.<\/p>\n
This dialogue was prompted by the challenges companies face when submitting and updating information in the Register. These are not isolated inconveniences, but systemic factors that directly affect the speed and predictability of processes. These include the return of submissions due to additional requirements lacking clear regulatory justification, technical failures, risks of data loss, limited functionality for handling extensive lists of medical devices, as well as difficulties with searching for and identifying records.<\/p>\n
One of the most sensitive issues remains the additional requirements imposed<\/strong> when submitting or updating data<\/strong>. In particular, companies have reported cases where submissions were returned due to the absence of a letter from a conformity assessment body confirming the device classification, even though MoH Order No. 122 does not explicitly provide for such a requirement. At the same time, obstacles have arisen even during technical updates (for example, due to a change of the legal manufacturer without changes to the device itself). During the discussions, the SMDC clarified that the key requirement is confirmation of the device classification rather than the form of the document. However, the lack of a clear and unified approach creates risks of unpredictability in the review of submissions for market participants.<\/p>\n A separate set of issues concerned the technical stability of the Register and the risks of data loss<\/strong>. Companies reported cases where, during data entry, the system displayed messages such as \u201cSomething went wrong\u201d, froze, or effectively forced users to restart the process. During the working discussions, it was clarified that the user session is limited to 30 minutes, after which unsaved data may be lost. While this may be a standard feature for the technical team, such logic is not obvious to users. This once again underscores the importance of systematic communication between business, the regulator, and technical administrators. For its part, the Ministry of Health reported that some technical improvements have already been tested and are planned for implementation in the next version of the Register. In addition, the system\u2019s technical team acknowledged the importance of the issues raised by the Association and confirmed its readiness to continue working on removing the barriers that currently hinder efficient use of the Register.<\/p>\n Member companies of the Association also highlighted usability issues that directly affect data quality and operational efficiency<\/strong>. For companies with large product portfolios, critical features include item numbering, horizontal scrolling, the ability to copy entries, data import from files, as well as safeguards against accidental submission without the possibility of further editing. Currently, a significant portion of these improvements remains in the backlog and requires dedicated technical solutions and resources, making the timeline for their implementation uncertain.<\/p>\n Another important area concerns data quality and search logic<\/strong> within the Register. Companies reported duplicate records, difficulties in identifying manufacturers with identical names, as well as incorrect search results by product name or number. As part of the dialogue with government representatives, it became clear that solutions are already being prepared for some of these issues, in particular through integration with the Unified State Register of Legal Entities, Individual Entrepreneurs and Public Organisations. This update is expected to improve identification quality and reduce duplication.<\/p>\n The European Business Association expresses its gratitude to the public authorities for their openness to a substantive dialogue and for taking the business perspective into account. The business community looks forward to the timely implementation of updates to the Register and the acceleration of technical changes to improve users\u2019 day-to-day experience. We also emphasise the importance of ensuring transparent and consistent application of requirements, without broad interpretation or the introduction of additional conditions not provided for\u00a0by the current regulatory framework.<\/p>\n <\/p>","protected":false},"excerpt":{"rendered":" Member companies of the Medical Devices Subcommittee of the Health Care Committee of the European Business Association have repeatedly raised concerns regarding the operation of the Register of Persons Responsible for Placing Medical Devices on the Market. As a result of business appeals and discussions with the State Service of Ukraine on Medicines and Drugs […]<\/p>\n","protected":false},"author":33544,"featured_media":730762,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n