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16 - 20 June 2025
Mercure Hotel MOA Berlin, GermanyAttend In-Person or 100% Digitally16 - 20 June 2025
Mercure Hotel MOA Berlin, Germany,
Attend In-Person or 100% Digitally
Mercure Hotel MOA Berlin, Germany,
Attend In-Person or 100% Digitally
16 - 17 June 2025
European Medical Device Regulations
Streamline Device Certification. Secure Your Transition Deadline Approvals. Stay Audit-Ready Year-Round.
Maximise Market Access in Europe and Align Global Strategies
Navigate the intricacies of the evolving European regulatory landscape
- Ensure you’re transition ready with updates on the current regulatory timelines and transition periods
- Learn best practices for coping with cross legislation: from batteries to ESG, from data to digital
- Evaluate the EU MDR’s impact on workloads, enhance employee happiness and sustain your team
Accelerate device approvals with industry’s current learnings
- Apply lessons from SOFMEDICA GROUP on achieving MDR compliance in 6 European countries
- Ensure compliance to Article 10a and reporting shortages with feedback from Bausch + Lomb and AKRA Team GmbH
- Get data ready with updates on EUDAMED and the European Health Data Space
Unlock global market access and expand device reach
- UKCA: Understand the new UK regulations and how to leverage data from European submissions
- Accessing Switzerland: Discover how the Mutual Recognition Agreement will help to streamline documentation across markets
- Unlock innovative certification pathways to maximise European market access
Talk EU MDR Best Practice With The Experts
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
