Clinical, quality, and regulatory teams take note: Starting May 2025, the International Medical Device Regulators Forum (IMDRF) is transitioning its membership application process to an all-digital platform. Professionals will now access and submit their applications directly on the IMDRF Citizen Space website, ensuring a simplified and transparent experience. The updated process applies to several key membership roles. While historical PDF forms remain accessible for reference, online submission is mandatory moving forward.
In this article
- What changed?
- Which forms are affected?
- What happens with feedback and consultations?
- Key implications for stakeholders
- FAQ
- Conclusion
- Disclaimer
- Mandatory announcement link
What changed?
As of May 2025, the IMDRF will exclusively accept membership applications via its Citizen Space portal. This marks a significant modernization from the traditional PDF-reliant system. Key membership categories, including Regional Health Initiative applicants, Affiliate Members, Official Observers, and Management Committee Members, will now utilize the streamlined online forms.
While the revamped system introduces a digital-first approach, the terms of reference and submission procedures remain unchanged. Aspiring candidates should continue to ensure their compliance with existing membership criteria as they transition to the new platform.
Which forms are affected?
The following application types are now required to be submitted through the online system:
- IMDRF Regional Health Initiative Application
- IMDRF Affiliate Member Application
- IMDRF Official Observer Application
- IMDRF Management Committee Member Application
Future adoption of the online platform is anticipated for IMDRF Working Group Member applications, although a specific launch date has not been disclosed.
What happens with feedback and consultations?
Feedback mechanisms for two critical areas—annual Adverse Event Terminology updates and upcoming consultations—will also migrate to the Citizen Space site. By consolidating submission processes, IMDRF aims to enhance stakeholder engagement and simplify data collection procedures, benefiting both applicants and administrators.
Key implications for stakeholders
For clinical, quality, and regulatory teams, this transition underscores the necessity of familiarizing themselves with online submission protocols. Key points include:
- Ensuring adherence to digital form requirements to avoid submission delays.
- Utilizing legacy PDF resources as supplemental reference material, not as submission tools.
- Monitoring for subsequent updates regarding Working Group Member applications and other initiatives.
Stakeholders are encouraged to contact the IMDRF Secretariat for any clarifications or support during this transition.
FAQ
1. Why is IMDRF moving to a digital platform?
The transition to online-only applications aims to streamline the submission process, improve access, and ensure efficient data collection.
2. Are the membership criteria changing?
No, the terms of reference and criteria for membership remain unchanged.
3. Can I still use PDF forms?
Legacy PDF forms from the document library may be referenced but cannot be used for official submissions.
4. When will Working Group Member applications go online?
A specific timeline for this transition has not been announced, but it is expected soon.
5. Where do I submit feedback on future consultations?
Feedback will be collected through the Citizen Space website as part of the ongoing digital migration.
Conclusion
The shift to online membership applications stands as a critical development for IMDRF stakeholders. Applicants should prepare to navigate the digital portal starting May 2025, ensuring compliance with established criteria and procedures. This update emphasizes a broader move toward digitalization in regulatory frameworks.
Disclaimer
This article is intended for informational purposes only and should not be considered legal or regulatory advice. Consult the IMDRF Secretariat for guidance tailored to individual circumstances.
Mandatory announcement link
For full information about the announcement, see the link below.
https://www.imdrf.org/news-events/imdrf-membership-forms-now-online