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15 - 18 June 2026 |JW Marriott Hotel Berlin, Berlin, Germany, Attend In-Person or 100% Digitally

Where the MedTech Community Accelerates Regulatory Excellence

Expert guidance from regulators and industry to streamline compliance, stay deadline-ready, and advance patient safety through rigorous science

European Regulatory Affairs • Clinical Evaluations • SaMD & AI • Post Market Surveillance • Global Markets • Biocompatibility

Your Path to MDR and IVDR Success: Overcome Today’s Challenges, Meet Tomorrow’s Deadlines, and Future-Proof Your Strategy

Gain insights to master the upcoming important revisions and stay prepared for deadlines. Achieve regulatory excellence and position your organisation as a leader in compliance and innovation.

Build meaningful connections with a community of top regulators and industry leaders. Participate in dynamic workshops and interactive roundtables, and take the first step in shaping your medical device regulation journey today.

MedTech Summit 2026 agenda at a glance which includes the agenda topics over 4 conference days. Day 1 (15 June) - Welcome Keynote Plenary, European Regulatory Affairs, SaMD & AI and SME Survival Guide Workshop. Day 2 (16 June) - European Regulatory Affairs, SaMD & AI, Biocompatibility Workshop and Patient Access & Reimbursement Workshop. Day 3 (17 June) - Clinical Evaluations & PMS, Global Markets, Biocompatibility and Future Regulatory Leaders Linkup. Day 4 (18 June) - Clinical Evaluations & PMS, Global Markets and Biocompatibility. The event will livestream 1 track per day from Berlin (Keynote Plenary, European Regulatory Affairs and Clinical Evaluations & PMS). All other tracks will be recorded and available for ondemand post-event (subject to speaker approval). You'll have access to the sessions on the days you're registered to attend.

From Regulation to Innovation: What’s on the 2026 Agenda?

Stay ahead of the curve with expert insights designed to tackle today’s MedTech challenges and prepare for tomorrow’s opportunities. Gain the knowledge you need to innovate, comply, and lead in a rapidly evolving regulatory landscape.

European Regulatory Affairs

Overcome Bottlenecks, Stay Transition-Ready
Navigate the complexities of Europe’s evolving regulatory frameworks, tackle certification delays caused by limited Notified Body availability, and confidently integrate cutting-edge technologies like AI. Ensure your organisation is prepared to meet deadlines and transition requirements without compromising innovation.


Software as a Medical Device & AI

Innovation Meets Regulation: Avoid Costly Delays
Dive into the intersection of AI, digital health, and medical devices. Gain critical insights into the EU’s AI Act and Asia's stance to stay ahead of regulatory changes. Avoid compliance pitfalls and costly delays in this rapidly advancing field while positioning your organisation as a leader in digital health innovation.

Biocompatibility

Ensure Safety, Avoid Compliance Risks
Explore the latest updates to ISO 10993-1 and master biocompatibility testing methods to ensure device safety and compliance. Avoid regulatory setbacks by gaining practical knowledge to streamline biological evaluations and meet global standards.

Global Markets

Expand Confidently Across Borders
Immerse yourself in the latest global regulatory updates and gain a comprehensive understanding of international requirements from the USA, Japan, China, LATAM, the UK, ASEAN, and GCC. Learn how to navigate global reliance efforts and ensure your products meet the demands of diverse markets without delays or compliance risks.

Clinical Evaluations & PMS

Streamline Processes, Stay Aligned
Optimise your clinical evaluation processes and align with current European and global post-market surveillance requirements. Avoid gaps in compliance and ensure your organisation is prepared to meet evolving expectations for safety and performance.

Workshop: SME Survival Guide

Actionable Strategies for SMEs
Gain practical insights and strategies tailored to SMEs navigating the rapidly evolving medical device regulatory sector. Learn how to overcome resource constraints, meet compliance requirements, and thrive in a competitive landscape.

Workshop: Biocompatibility

Hands-On Training for Compliance Excellence
Master biological evaluation and safety assessment for medical devices through interactive, hands-on training. Learn practical techniques to ensure compliance with ISO standards and maintain device safety, avoiding costly regulatory setbacks.

*NEW* Workshop: Patient Access & Reimbursement

Bridge Compliance and Market Success
Delve into the critical intersection of regulatory compliance and market access. Gain actionable insights to navigate patient access and reimbursement challenges, ensuring your medical devices achieve commercial success while meeting stringent regulatory requirements.

Who You'll Connect with at MedTech Summit

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Competent Authority & Notified Body Speakers

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Leading MedTech Industry Stakeholders

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Medical Device, Software, and Combination Product Companies Represented

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Countries Represented

Your Roadmap to Regulatory Excellence

Connect with regulatory, quality, clinical, and biocompatibility professionals, along with notified bodies, consultants, and future leaders, all shaping the future of MedTech. Explore tailored tracks like EU MDR, SaMD & AI, and Clinical & PMS, and gain expert insights, build connections, and overcome challenges with personalised programming. Ready to advance your career? Discover your path to success at MedTech Summit 2026.

A virtual attendee watching live sessions on a laptop.

Stay Ahead in Medical Devices Regulation. Anywhere, Anytime.

Unlock the MedTech Summit with the Digital Experience Pass. Access cutting-edge regulatory updates, expert insights, and vital networking opportunities—all in a fully digital format. Watch live-streamed sessions from Berlin, engage with speakers, and book online meetings with industry leaders via our exclusive ConnectMe platform.

One track from the Berlin event will be live-streamed each day. View the full schedule here.

Antonios Katrantzis

Senior Quality and Regulatory Affairs Manager

D.med Consulting GmbH

MedTech Summit 2026 is going to be the place to be for next year.

MedTech Summit 2025 has been an inspiring event. MedTech Summit 2026 is going to be the place to be for next year.

Engage Quality Decision-Makers at MedTech Summit!

Showcase your services to industry leaders and innovators. Let’s customise a sponsorship package that drives real results for your business.

Contact Neha Singh at Neha.Singh@informa.com