The International Medical Device Regulators Forum (IMDRF) held a pivotal two-part workshop on 11 and 19 September 2024. This initiative aimed to strengthen regulatory capacities and deepen understanding of the IMDRF Essential Principles of Safety and Performance for Medical Devices and In Vitro Diagnostic (IVD) Medical Devices. Co-hosted with the U.S. Food and Drug Administration (USFDA), the workshop gathered current and prospective IMDRF Affiliate Members and sought to enhance National Regulatory Authority (NRA) implementation worldwide.
In this article:
What changed?
The IMDRF launched this workshop series as part of its ongoing effort to improve global medical device regulation knowledge and harmonization. The Essential Principles of Safety and Performance serve as a foundational benchmark for ensuring medical device quality, safety, and efficacy. The workshop provided actionable insights and practical strategies for NRAs to enhance compliance and oversight mechanisms.
Who is affected?
The workshops were curated for regulatory professionals, compliance teams, and medical device stakeholders. Current and prospective IMDRF Affiliate Members stand to benefit most, as the sessions addressed common challenges in regulatory processes and offered guidance to improve alignment with IMDRF standards. By enhancing NRA capacities, manufacturers and healthcare providers may see smoother premarket pathways and improved device safety assessments globally.
Session details
What topics were covered?
The two-part workshop delved into the Essential Principles of Safety and Performance for Medical Devices and IVDs. These principles are structured to ensure rigorous device testing, mitigate risks, and validate clinical effectiveness. Attendees explored strategies for integrating these principles into their regulatory frameworks, including real-life case studies and collaborative exercises for practical application.
Where to access materials?
Participants and stakeholders who missed the live sessions can access recordings and materials via the GRRP Working Group Page on the IMDRF website. These resources include presentation slides, discussion highlights, and supplementary tools aimed at reinforcing the learning outcomes.
Why does this matter?
As the medical device industry becomes increasingly globalized, harmonized standards like the Essential Principles enable clearer market access pathways while safeguarding public health. Regulatory authorities equipped with advanced knowledge of these standards are better positioned to evaluate innovative technologies and address emerging risks.
FAQ
Q1: What are the IMDRF Essential Principles?
A1: The Essential Principles outline requirements for ensuring the safety, quality, and performance of medical devices throughout their lifecycle.
Q2: Who manages the IMDRF?
A2: The IMDRF is a voluntary international group consisting of medical device regulators and relevant stakeholders globally.
Q3: Can individuals participate in IMDRF events?
A3: Generally, IMDRF workshops target regulatory bodies and affiliate organizations. Specific eligibility criteria are detailed for each event.
Conclusion
The IMDRF’s two-part workshop represents a significant step forward in harmonizing regulatory standards and empowering NRAs globally. By emphasizing safety and performance principles for both general and IVD medical devices, the workshop underscores the commitment to public health and advancing medical technology.
Disclaimer
This content is intended for informational use by regulatory and clinical professionals. It does not constitute legal advice. Attendees or readers should consult official regulatory guidance for compliance purposes.
For full information about the announcement, see the link below.
https://www.imdrf.org/news-events/essential-principles-safety-and-performance-workshop-0