Mercure Hotel MOA Berlin, Berlin, Germany,
Hybrid Event I Attend In-Person or Digitally
16 - 17 June 2025
In Vitro Diagnostic Regulations
Accelerate IVD and CDx Certification. Meet Your EU IVDR Transition Goals. Optimise for Global Compliance.
Accelerate Your IVD Compliance Pathways with Expert Guidance
Streamline regulatory approval across multiple global regions
Uncover the EU IVDR current state of play and identify methods to ensure you meet the 2027-2029 transition deadlines
Deep dive into the latest UKCA updates and diversify the reach of your diagnostic(s) with insights from BIVDA
Streamline your global QMS strategy with insights on the US ISO 13485 merge from Illumina
Utilise industry experience for successful IVD certification
Get the latest updates on in-house and laboratory developed tests to understand the implications for industry, patients and the public
Enhance your diagnostic portfolio management with shared experiences from large manufacturers such as Abbott and Illumina
Understand the processes behind structured dialogues to benefit from more open discussions with your Notified Body
Adopt a holistic approach to developing and certifying your IVD(s)
Develop best practices for cross-collaboration with pharma in a multi-stakeholder panel discussion to meet your shared compliance goals
Gain clarity on IVDR and EMA expectations for Companion Diagnostics through in-depth discussions
Compare and contrast experiences of certifying orphan IVDs under the MDR and IVDR
IVDR: Time Critical Insights From an Expert Speaker Line-Up
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
