The International Medical Device Regulators Forum (IMDRF) held a two-part workshop on September 11 and September 19, 2024, concentrating on the essential principles of safety and performance for medical and in vitro diagnostic (IVD) devices. Coordinated with the U.S. Food and Drug Administration (USFDA), this initiative targeted current and prospective IMDRF Affiliate Members. Participants were provided material aimed at enhancing awareness and strengthening capacities for medical device regulatory authorities globally.
In this article:
- What changed?
- Who is affected?
- Workshop details and goals
- Resources shared during the workshop
- FAQ
- Conclusion
- Disclaimer
- Learn more
What changed?
IMDRF continues to emphasize the importance of harmonizing regulatory practices for both medical devices and IVDs globally. By organizing this two-part workshop, IMDRF reinforced education on the foundational principles of device safety and performance, while collaborating closely with the USFDA. A focus was placed on increasing regulatory alignment and consolidating best practices.
Who is affected?
The workshop addressed two key groups:
- Medical Device National Regulatory Authorities (NRAs) tasked with overseeing device safety and compliance.
- Prospective IMDRF Affiliate Members seeking guidance into regulated pathways for both devices and diagnostics.
Additionally, stakeholders such as clinical and quality teams may benefit from understanding these regulatory shifts to ensure compliance and alignment with latest standards.
Workshop details and goals
The carefully structured sessions took place amid broader IMDRF meetings hosted by USFDA. Each session prioritized disseminating knowledge on principles of safety and performance established by IMDRF.
What did the sessions focus on?
- Strengthening fundamental knowledge among NRAs.
- Encouraging future partnerships among IMDRF affiliates.
- Reinforcing consistent mechanisms for device evaluations.
Attendees had access to interactive content and expert-led discussions focused on global device regulation alignment.
Resources shared during the workshop
Materials and recordings from the workshop are available through IMDRF’s Good Regulatory Review Practices (GRRP) Working Group Page. These resources are geared toward empowering regulators and affiliates.
Key takeaways include:
- Specific frameworks used for assessing medical and IVD product safety.
- Guidelines for regulatory harmonization among participating organizations.
- Case studies demonstrating practical implementation of IMDRF principles.
FAQ
The IMDRF is an international forum that works to promote harmonized medical device regulatory practices across regions.
2. How do these workshops benefit regulatory bodies?
They provide essential knowledge transfer and practical tools for assessing medical device and IVD safety effectively, ensuring better oversight.
3. Where can materials from the workshop be accessed?
Resources are available on IMDRF’s GRRP Working Group Page.
Conclusion
IMDRF’s two-part workshop on medical device safety and performance principles emphasized regulatory capacity building, providing actionable insights for NRAs and affiliates. Stakeholders should capitalize on the shared resources and adapt their strategies to align with global standards.
Disclaimer
The information provided above is intended for professional use and should not be used as legal advice. For specific regulatory concerns, consult a qualified legal expert or regulatory consultant.
Learn more
For full information about the announcement, see the link below.
https://www.imdrf.org/news-events/essential-principles-safety-and-performance-workshop-0