From May 2025, regulatory professionals and other stakeholders involved with medical device oversight will benefit from an important update. The International Medical Device Regulators Forum (IMDRF) has announced that its membership application forms are now fully available online through its Citizen Space platform. This transition simplifies the application process and aligns with emerging digital expectations in regulatory affairs. The update affects various member-specific applications while preserving the existing criteria and procedures.
In this article:
- What changed?
- Who is affected?
- How will membership applications be submitted?
- What are the future implications?
- FAQ
- Conclusion
- Disclaimer
What changed?
As of May 2025, stakeholders seeking membership within the IMDRF must submit specific applications via an online platform hosted on IMDRF’s Citizen Space site. The change applies to the following forms:
- IMDRF Affiliate Member Application
- IMDRF Regional Health Initiative Application
- IMDRF Official Observer Application
- IMDRF Management Committee Member Application
While the previous PDF forms remain accessible in the document library for reference purposes, they are no longer accepted as primary submission documents.
Who is affected?
This update is crucial for entities and individuals involved in global medical device regulation, including regulatory agencies, policymakers, and organizations looking to participate in policy-making through IMDRF membership. It simplifies the workflow by enabling digital submissions while maintaining existing membership criteria outlined in the Terms of Reference.
How will membership applications be submitted?
Applicants are expected to complete their respective forms directly within the Citizen Space platform. The digital process helps ensure greater transparency and streamlined submissions. Users are encouraged to reference older forms found in the document library to prepare their applications. However, only submissions made through the online portal are considered valid.
It is also anticipated that the Working Group Member Applications will soon undergo a similar transition. Stakeholders are advised to monitor updates closely for the official announcement regarding this change.
What are the future implications?
IMDRF’s decision to digitize its membership forms is part of its broader objective to enhance stakeholder engagement through technology. The Citizen Space site is also expected to support additional functionalities, such as:
- Collecting feedback for annual updates to the Adverse Event Terminology.
- Facilitating consultations for new and upcoming initiatives.
These added features will allow IMDRF to leverage digital tools for greater inclusivity and efficiency in its decision-making processes.
FAQ
1. Will the membership criteria change?
No, the eligibility criteria and submission procedures as outlined in the Terms of Reference remain unchanged.
2. Are paper or PDF submissions still valid?
No, applications must be completed and submitted via the online Citizen Space platform. PDF forms are for reference purposes only.
3. Is support available for technical issues?
Yes, applicants experiencing difficulties with the online submission process should contact the IMDRF Secretariat for guidance.
4. When will Working Group Member Applications move online?
While no definitive date has been provided, stakeholders are advised to monitor updates, as this change is expected soon.
Conclusion
The shift to digital submission reflects IMDRF’s commitment to modernizing its processes. Applicants are encouraged to familiarize themselves with the Citizen Space platform and prepare for upcoming transitions, such as those affecting Working Group applications.
Disclaimer
This article provides general information intended for regulatory professionals. It does not constitute legal advice. Please refer to official IMDRF communications for authoritative guidance.
For full information about the announcement, see the link below.
https://www.imdrf.org/news-events/imdrf-membership-forms-now-online