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MedTech Summit
16 - 20 June 2025
Mercure Hotel MOA Berlin, Berlin, GermanyHybrid Event I Attend In-Person or Digitally
16 - 20 June 2025
Mercure Hotel MOA Berlin, Berlin, Germany,
Hybrid Event I Attend In-Person or Digitally

18 June 2025

Medical Device Law and Compliance

Master European Legal Frameworks. Overcome EU MDR, IVDR and EU AI Act Compliance Hurdles. Analyse Recent Case Findings.

Keep Up with Evolving Medical Device, IVD and AI Legal Frameworks to Maximise Compliance

Mitigate legal risks to remain MDR and IVDR compliant

  • Lockdown software qualification and classification for successful device certification

  • Digest the interactions between the Regulations, ESG and more to ensure complete compliance

  • Delve into data to ensure product claims are supported and devices are protected


Take advantage of insights from top medtech law firms

  • Deep dive into the legal learnings of the RRR Manufacturing vs BSI case
  • Gain first-hand insight into the proposed Green Claims Directive to substantiate your sustainability claims
  • Navigate the ever-evolving web of proposed regulatory reforms and prepare for potential legal implications

Uncover legal best practices to safeguard your product

  • Understand the legal complexities of the EU MDR and IVDR to ease your transition
  • Stay ahead of data privacy laws and trends to ensure patient data remains secure

  • Develop a robust understanding of manufacturer implications under the European Product Liability Directive

SME Survival Guide Workshop

Monday 16 June

  • Understand the EU regulatory landscape for innovation
  • Identify key stakeholders to bring devices and IVDs to market
  • Curate effective regulatory and clinical strategies
  • Develop and complete technical files for submission
  • Pinpoint funding pathways and develop pitches
  • Navigate pricing and reimbursement options

Explore the Full MedTech Summit Agenda and Speaker Line-up