Billev Pharma East Ltd participated as an exhibitor at the MedTech Summit 2025, which took place from 16 to 20 June at the Mercure MOA Hotel in Berlin. Recognized as one of Europe’s premier conferences for professionals in the medical devices and in vitro diagnostics sectors, this year’s summit placed particular emphasis on the implementation and further development of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Participation as an exhibitor at the MedTech Summit 2025 provided a valuable opportunity for our company to further strengthen its position as a trusted regulatory consultancy for medical device and IVD manufacturers navigating an increasingly complex and dynamic regulatory landscape. Our exhibition booth served as a platform to increase visibility and engage in meaningful conversations with industry experts and stakeholders from Europe, the USA, the UK, and beyond.

Discussions centered on strategic regulatory support under MDR and IVDR, implementation and maintenance of quality management systems (QMS), development of the medical device technical file, vigilance and post-market surveillance, as well as customized compliance solutions for both legacy and innovative products.

In addition to exhibiting, our team actively participated in a wide range of expert-led presentations and panel discussions, gaining valuable insights into upcoming regulatory developments, best practices, and evolving trends shaping the future of the industry. The knowledge and connections acquired at the summit will directly contribute to the continued growth of our services and our ability to deliver even greater value to our clients.

One of the key sessions at the summit addressed the EUDAMED gradual rollout planning, focusing on the current status of the database, official release timelines, and mandatory use dates for each module. It was emphasized that the mandatory use of the Actor, UDI/Devices, and NB Certificates modules will begin from Q4 2026, once the entire system is declared fully functional. The Market Surveillance (MSU) module and the Vigilance module will also become mandatory six months after that official declaration. Speakers highlighted the importance of early preparation and noted that onboarding activities are already ongoing for the modules that have been declared functional. The session also touched on the Swiss equivalent system, Swissdamed, which is being developed to align with EUDAMED requirements, ensuring that manufacturers placing products on the Swiss market have a compatible and nationally governed system for registration and traceability.

Particular attention at the MedTech Summit 2025 was given to the specific challenges faced by small and medium-sized enterprises (SMEs), especially in the implementation of compliant quality management systems in line with ISO 13485. As experienced ISO 13485 consultants, we bring firsthand knowledge and proven expertise in establishing and maintaining robust quality systems. This positions us ideally to support SMEs in developing QMS frameworks that are both regulatory-compliant and tailored to their operational needs.

A key theme was the increasing scrutiny by Notified Bodies, especially regarding the content and structure of technical documentation. Sessions highlighted the need for comprehensive, well-structured files fully aligned with MDR and IVDR, covering all aspects from design to post-market surveillance—as if the reviewers were holding the device in their hands.

Another interesting and important session focused on the EU Artificial Intelligence (AI) Act, which sets out a risk-based framework for the development and use of AI systems, including in the medical device sector. The presentation provided an overview of the AI Act’s classification of AI systems by risk level—ranging from minimal to unacceptable—and its requirements for high-risk systems, such as transparency, human oversight, and conformity assessment.

Our team also took part in practical workshops where they analyzed a sample case study, identifying how it would be classified under the AI Act, and discussing its potential advantages and shortcomings in terms of compliance and real-world application.

The MedTech Summit 2025 represented a significant milestone in business development and brand positioning for Billev Pharma East Ltd. The event provided access to essential regulatory insights, enhanced brand visibility, facilitated meaningful engagement with clients, and established a solid foundation for future collaborations. With these strengthened capabilities and strategic connections, the company is well equipped to support clients in effectively navigating the complexities of the MDR and IVDR frameworks.

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