New Technical Regulations: is the market ready to adapt?

18/ 11/ 2025

The European Business Association has joined the public discussion of the draft new Technical Regulations for medical devices and in vitro diagnostic medical devices, published on the website of the Ministry of Health on 1 October 2025. The Association appreciates that the Ministry has taken previous proposals from the business community into account. However, the updated drafts still contain provisions of concern - in particular, the short transition periods, which create risks for the entire market. The draft regulations envisage discontinuing the circulation of products under the “old rules” after 31 December 2031. At first glance, this appears to be a sufficient transition period. However, when assessing the actual prerequisites for the system’s launch, if these draft Technical Regulations are adopted, the real time available to businesses turns out to be significantly shorter. Association experts analysed the experience of the European Union and manufacturers’ operational processes and emphasize that the key factor is the moment when the state actually ensures the possibility to operate under the new rules. This concerns two basic prerequisites: the designation of conformity assessment bodies (CABs) and the launch of the necessary IT systems (registration of economic operators, SRN, UDI-DI coding, etc.). According to the action plan included in the draft regulations, the IT infrastructure is expected to be ready in December 2029. Since the data from these systems is essential for manufacturers, only from that moment will they be able to submit applications, finalize the preparation of technical files in accordance with the new requirements, and begin conformity assessment procedures. Until then, carrying out such procedures is physically impossible. Under these conditions, the real “transition window” will be roughly two years — from the moment the state systems are launched to the expiry of the current regulations. Given the procedures manufacturers must undergo, this timeframe is insufficient. There are several key reasons for this: First, the transition to a fundamentally new regulatory model for medical devices and in vitro diagnostic devices. The new regulations significantly increase requirements for evidence, technical documentation, and conformity assessment procedures. According to the Factsheet for healthcare professionals and health institutions published on the EMA website, about 80% of in vitro diagnostic devices that previously did not require the involvement of notified bodies will now require their participation — both during quality and risk management assessment and certification. For medical devices overall, the scope of verification of technical documentation, clinical evidence, and post-market surveillance is expanding. As a result, a significant portion of products that previously did not require CAB involvement will now be subject to mandatory participation. Second, the limited capacity of CABs. Implementing the new Technical Regulations requires a large volume of procedures, including manufacturer audits, technical documentation review, and mass re-issuance of existing certificates. The experience of the European Union shows that the limited number of notified bodies became the main “bottleneck” in transitioning to MDR and IVDR. Ukraine will inevitably face the same challenge: simultaneous submissions from manufacturers combined with a limited number of designated bodies create a risk of long queues for audits and documentation reviews. Experts from the Association predict that this could lead to delays in issuing certificates and, consequently, to potential shortages of certain device categories even when products fully comply with the new requirements. Third, the manufacturer’s operational cycle. From the moment a certificate is issued to the actual supply of products to the market, it usually takes between 6 and 18 months. This is an objective necessity, as manufacturers must update labelling to include UDI, prepare packaging, procure materials, and complete production and logistics processes. For high-technology devices, this period may be even longer. Shortening this period is unrealistic, as it is determined by the physical production cycle. Representatives of the Association emphasize that the risks of shortages and disruptions in the supply of medical devices stem not from the introduction of new rules as such, but from the attempt to implement a large-scale reform within extremely tight deadlines that do not align with European experience or manufacturers’ operational realities. Such an approach could create additional risks for patients, particularly regarding continuity of treatment and availability of the full range of necessary medical devices. The European Union underwent a similar transition over roughly eleven years, introducing restrictions in stages and applying differentiated transition periods depending on risk class. This approach helped avoid supply disruptions and ensured a smooth system transition. Business experts stress the importance of considering this experience when implementing new Technical Regulations in Ukraine, as well as the need for regular updates to public progress roadmaps. Such a model minimizes risks and creates a foundation for a harmonious transition to European standards. For this reason, the European Business Association urges the Ministry of Health to review the transition deadlines and introduce a phased model differentiated by risk classes to avoid disruptions in the supply of medical devices. It is also important to ensure the timely designation of conformity assessment bodies, the launch of IT systems, and the regular updating of the roadmap for transparent communication with the market.

The draft regulations envisage discontinuing the circulation of products under the “old rules” after 31 December 2031. At first glance, this appears to be a sufficient transition period. However, when assessing the actual prerequisites for the system’s launch, if these draft Technical Regulations are adopted, the real time available to businesses turns out to be significantly shorter.

Association experts analysed the experience of the European Union and manufacturers’ operational processes and emphasize that the key factor is the moment when the state actually ensures the possibility to operate under the new rules. This concerns two basic prerequisites: the designation of conformity assessment bodies (CABs) and the launch of the necessary IT systems (registration of economic operators, SRN, UDI-DI coding, etc.).

According to the action plan included in the draft regulations, the IT infrastructure is expected to be ready in December 2029. Since the data from these systems is essential for manufacturers, only from that moment will they be able to submit applications, finalize the preparation of technical files in accordance with the new requirements, and begin conformity assessment procedures. Until then, carrying out such procedures is physically impossible.

Under these conditions, the real “transition window” will be roughly two years — from the moment the state systems are launched to the expiry of the current regulations. Given the procedures manufacturers must undergo, this timeframe is insufficient. There are several key reasons for this:

First, the transition to a fundamentally new regulatory model for medical devices and in vitro diagnostic devices. The new regulations significantly increase requirements for evidence, technical documentation, and conformity assessment procedures. According to the Factsheet for healthcare professionals and health institutions published on the EMA website, about 80% of in vitro diagnostic devices that previously did not require the involvement of notified bodies will now require their participation — both during quality and risk management assessment and certification. For medical devices overall, the scope of verification of technical documentation, clinical evidence, and post-market surveillance is expanding. As a result, a significant portion of products that previously did not require CAB involvement will now be subject to mandatory participation.

Second, the limited capacity of CABs. Implementing the new Technical Regulations requires a large volume of procedures, including manufacturer audits, technical documentation review, and mass re-issuance of existing certificates. The experience of the European Union shows that the limited number of notified bodies became the main “bottleneck” in transitioning to MDR and IVDR. Ukraine will inevitably face the same challenge: simultaneous submissions from manufacturers combined with a limited number of designated bodies create a risk of long queues for audits and documentation reviews. Experts from the Association predict that this could lead to delays in issuing certificates and, consequently, to potential shortages of certain device categories even when products fully comply with the new requirements.

Third, the manufacturer’s operational cycle. From the moment a certificate is issued to the actual supply of products to the market, it usually takes between 6 and 18 months. This is an objective necessity, as manufacturers must update labelling to include UDI, prepare packaging, procure materials, and complete production and logistics processes. For high-technology devices, this period may be even longer. Shortening this period is unrealistic, as it is determined by the physical production cycle.

Representatives of the Association emphasize that the risks of shortages and disruptions in the supply of medical devices stem not from the introduction of new rules as such, but from the attempt to implement a large-scale reform within extremely tight deadlines that do not align with European experience or manufacturers’ operational realities. Such an approach could create additional risks for patients, particularly regarding continuity of treatment and availability of the full range of necessary medical devices.

The European Union underwent a similar transition over roughly eleven years, introducing restrictions in stages and applying differentiated transition periods depending on risk class. This approach helped avoid supply disruptions and ensured a smooth system transition. Business experts stress the importance of considering this experience when implementing new Technical Regulations in Ukraine, as well as the need for regular updates to public progress roadmaps. Such a model minimizes risks and creates a foundation for a harmonious transition to European standards.

For this reason, the European Business Association urges the Ministry of Health to review the transition deadlines and introduce a phased model differentiated by risk classes to avoid disruptions in the supply of medical devices. It is also important to ensure the timely designation of conformity assessment bodies, the launch of IT systems, and the regular updating of the roadmap for transparent communication with the market.