CE Certification vs FDA Strategy Webinar

On July 11, 2024, MedTech Leading Voice presented a webinar entitled "CE-Certification vs FDA Strategy," which discussed key points related to US FDA strategy, European CE certification, startup strategy, market access, and global regulatory partnerships.

Expert panelists Michelle Lott, Ronald Boumans, and Nika Mendelev highlighted the importance of understanding device classification, certification management, commercial potential, and market access.

The session included a Q&A segment addressing topics such as equivalence in the EU, choosing between conformity assessments, UK legislation updates, QMSR compliance for FDA applications, and usability studies.

Chapters
🌎 Introduction and US FDA Strategy [00:11]
Meeting about CE certification vs FDA strategy
Michelle Lott presented on US FDA strategy
FDA uses a risk-based approach for device classification
Different submission types: 510(k), De Novo, PMA
FDA has unique exemptions and controls for each device class
FDA offers pre-submission meetings and special programs for faster access

📊 European CE Certification [13:44]
Ronald Boumans presented on European CE certification
MDR and IVDR are currently the toughest regulations globally
Notified bodies face serious claims if they get certifications wrong
Importance of understanding product classification and certification management
Clinical investigations often necessary for innovative devices
Combining clinical strategy with commercial potential is crucial

💼 Startup Strategy and Market Access [23:29]
Importance of having an exit strategy for startups
Value of a startup lies in assets and promise (commercial potential x market access)
Demonstrating commercial potential in smaller markets can be more impactful
MDR compliance can add significant value to a startup's product
Quality management system, technical documentation, and risk management are crucial for MDR compliance

🤝 Global Regulatory Partnerships [33:06]
Nika discussed the trend toward globalization in regulatory systems
Medical Device Single Audit Program (MDSAP) bringing together requirements from different countries
European legislation compliance can provide easier access to other markets
Introduction of AR2C2, a new regulatory strategy group
Emphasis on providing comprehensive support for market access and regulatory strategy

❓ Q&A Session Part 1 [43:00]
Discussion on differences between equivalence in the EU and predicate devices in the US
Advice on choosing between Annex 9 and Annex 11 for conformity assessment
Updates on UK legislation and acceptance of CE marking
Clarification on QMSR compliance for FDA applications
Discussion on the acceptability of usability studies conducted in different regions

🌐 Q&A Session Part 2 and Conclusion [53:25]
Discussion on changing notified bodies during MDR certification process
Importance of communication in resolving issues with notified bodies
Advice on handling difficulties in the certification process
Encouragement for attendees to provide feedback and connect with speakers