FAQs

The MedTech Summit is Europe’s leading conference on medical device regulation, bringing together regulatory affairs professionals, notified bodies, competent authorities, and industry leaders. It is designed for professionals involved in MDR/IVDR compliance, regulatory strategy, quality assurance, clinical affairs, and global market access.

The MedTech Summit will take place from 15–18 June 2026 at the JW Marriott Hotel Berlin, Berlin, Germany.

You can register directly on the website, where you’ll find ticket options, pricing, and additional event details.

Yes, the MedTech Summit offers a special SME rate for eligible applicants. To qualify, applicants must meet the following criteria:

• The SME must have fewer than 250 employees.
• The SME must be an active member of a medical device or in vitro diagnostic organisation with a device or diagnostic that is either already on the market or in the process of gaining certification.
• Applicants cannot be from a Competent Authority, Notified Body, Consultancy, or Vendor organisation.
• Applicants cannot be from an existing event sponsor or exhibitor organisation.
• Applicants cannot have a job title or focus in sales, marketing, account management, or business development.

The Digital Experience Pass allows attendees to participate in the MedTech Summit virtually, offering live-streamed sessions, on-demand content, and interactive features. It is ideal for professionals unable to attend in person but who want to benefit from the summit’s insights and networking opportunities.

Each day, one track from the Berlin event will be live-streamed, allowing digital attendees to engage in real time and be part of the excitement. Also, the pass includes access to all session recordings, including those not live-streamed, on demand for up to 12 months after the event (subject to speaker permission).

Livestream Schedule:

• Day 1: Welcome Keynote Plenary & European Regulatory Affairs
• Day 2: European Regulatory Affairs
• Day 3: Clinical Evaluations & PMS
• Day 4: Clinical Evaluations & PMS

The agenda addresses critical areas shaping the future of medical device regulation, including:

• European Regulatory Affairs (MDR & IVDR)
• Clinical Evaluations and Clinical Evidence
• Software as a Medical Device (SaMD) & Artificial Intelligence (AI)
• Post-Market Surveillance (PMS) and Vigilance
• Global Market Access and Regulatory Strategy
• Biocompatibility and Safety Requirements

Also, the agenda features keynote presentations, panel discussions, case studies, interactive roundtables, workshops, and deep-dive sessions.

With anticipated updates to EU MDR and ongoing IVDR transitions, 2026 is a pivotal year for regulatory compliance. The summit delivers direct insights from regulators and industry experts, equipping companies to navigate evolving requirements and mitigate compliance risks.

Yes, dedicated sessions will cover expected EU MDR revisions, including implementation challenges, timelines, and strategic adaptations.

Absolutely. The summit features in-depth discussions on IVDR implementation, performance evaluation, timelines, and challenges faced by IVD manufacturers.

Yes, dedicated sessions on Software as a Medical Device (SaMD) and AI focus on regulatory expectations, compliance challenges, and future developments.

Absolutely. Clinical evaluation and clinical evidence are key focus areas, with sessions covering best practices, regulatory expectations, and real-world case studies.

The summit includes sessions on PMS and vigilance, providing insights into compliance requirements, data collection, and reporting obligations under MDR and IVDR.

Attendees can connect through:

• The ConnectMe app for scheduling 1:1 meetings, messaging, and browsing the attendee list
• Networking drinks and informal lunch breaks
• Interactive roundtable discussions
• Hands-on workshops for small group engagement
  These formats foster meaningful connections and maximise networking potential

Professionals from medical device manufacturers, in vitro diagnostics companies, consultancies, regulatory agencies, and notified bodies attend the summit.

Yes, the summit is highly relevant for global MedTech companies, as EU regulations often influence international regulatory strategies and market access planning.

EU regulations like MDR and IVDR increasingly influence global market access strategies. Attending the MedTech Summit helps US companies align with European requirements and anticipate global regulatory trends.

Yes, the event covers global markets and regulatory alignment, helping companies understand how European regulations impact international expansion. Key regions include:

• Europe (EU MDR & IVDR)
• United States (FDA regulatory landscape)
• China
• Japan
• Latin America
• ASEAN (Association of Southeast Asian Nations)
• GCC (Gulf Cooperation Council)
• UK
• Emerging markets

Attendees gain up-to-date regulatory knowledge, practical strategies, and valuable connections with industry leaders and regulators — all in one of Europe’s key MedTech hubs.

The MedTech Summit stands out for its strong regulatory focus, high-level speaker faculty (including regulators and notified bodies), and strategy-driven content tailored to real-world challenges.