The upcoming webinar on October 30 will address an important regulatory topic for the medical device industry: when clinical investigations are required for Class III or implantable devices under the Medical Device Regulation (MDR). This session is relevant for regulatory affairs professionals, quality assurance specialists, startup founders, and senior executives working in MedTech. It will provide clarity on MDR exemptions, helping participants understand when clinical investigations are mandatory and when they can be avoided.
When and where is the webinar?
The webinar is scheduled for Thursday, October 30 from 8:00 AM to 9:00 AM Eastern Daylight Time (1:00 PM CET). It will be delivered virtually, allowing participants to join from any location after registering via the provided link.
What topics will be covered?
The focus will be on MDR Article 61 and related MDCG guidance. The agenda includes practical insight on the four exemption cases where a clinical investigation can be avoided. Topics include:
- Identifying situations under MDR where exemptions apply
- Understanding the meaning of “sufficient access to data” and associated contractual needs
- Exploring equivalence based on own devices compared to devices from another manufacturer
- Examples showing how smaller companies can work with exemptions while remaining compliant
Who are the speakers?
The session will be hosted by Charles Rollet. The guest expert is Hatem, a Clinical Evaluation Expert for medical devices from Clinical Evaluation Navigator (CEN). Both have experience guiding companies through requirements under the MDR.
Who should attend?
The webinar is suitable for a range of roles in the medical device sector:
- Quality Assurance and Regulatory Affairs (QARA) engineers
- Founders of MedTech startups
- Senior executives responsible for compliance
Attending will help participants prepare for regulatory submissions by clarifying when costly and time-consuming clinical investigations are required and when they might be exempt.
FAQ
- How do I register for the webinar?
Use the registration link provided at the end of this article. You may be asked to verify token ownership with your wallet. - Is there a cost to attend?
The source information does not specify a cost. Registration is required. - Will there be a Q&A session?
Yes. The webinar will close with a live Q&A focused on clinical evaluations and equivalence challenges. - What platform will be used?
The webinar is virtual. Details will be provided after registration.
Key takeaways
This webinar offers targeted guidance on MDR clinical investigation requirements for Class III and implantable medical devices. By understanding exemption cases and data access rules, attendees can plan compliance strategies more efficiently. Interactive discussion will ensure practical understanding of complex regulatory provisions.
Disclaimer
This article is for informational purposes only and is not affiliated with the event organizers. All event details are based on provided source information.
For more information or to book, visit: https://luma.com/0ccy0xkf