The International Medical Device Regulators Forum (IMDRF 2024) has released several important updates for 2024, focusing on enhancing regulatory convergence and ensuring the currency of its documentation. Below is a summary of the key updates and procedural changes:
1. Revision and Maintenance of IMDRF Documents
IMDRF 2024 has instituted a systematic review process for all its documents to ensure they remain up-to-date and relevant. Typically, documents will be reviewed three years after publication. This revision procedure allows for modifications when new information becomes available, enhancing the guidance documents' effectiveness and accuracy【6:1†source】.
Minor Updates and Major Revisions IMDRF 2024
For minor updates, such as correcting out-of-date references or links, the IMDRF Secretariat can update documents without forming a Working Group. These minor changes will be designated with an additional decimal in the edition number (e.g., Edition 3.1). In contrast, major revisions will require IMDRF Management Committee (MC) endorsement and may involve forming a Subcommittee or Working Group if the topic is not covered by an active group【6:0†source】【6:1†source】.
2. Management of GHTF Documents
Documents created under the Global Harmonization Task Force (GHTF) will be maintained on the IMDRF website and reviewed periodically. If any GHTF documents become outdated, stakeholders are encouraged to notify the IMDRF Secretariat. The IMDRF Chair will annually review these documents and recommend updates as necessary【6:1†source】.
3. IMDRF Sessions and Meetings
The IMDRF MC will continue to hold its sessions in March and September, with physical attendance expected. However, hybrid sessions (combining in-person and virtual attendance) may be facilitated under special circumstances. Additionally, virtual meetings via web/teleconference will be held in January and June each year【6:5†source】.
4. Membership and New Work Item Proposals
The procedures for suspending or terminating IMDRF membership, as well as processes for proposing new work items, have been clarified. This includes a template for New Work Item Proposals (NWIP) to streamline the submission and review process. The NWIP template outlines the project title, purpose, rationale, scope, work plan, and necessary expertise【6:2†source】【6:4†source】.
5. Translation of IMDRF Documents
IMDRF encourages translations of its documents to include a statement indicating the document's origin and version to maintain consistency and reliability across different languages. This ensures that all translated documents are clearly identified as derivatives of the original IMDRF English version【6:5†source】.
Conclusion
These updates highlight IMDRF's commitment to maintaining high standards in medical device regulation through regular review and revision of its documents, improved management of legacy documents, and enhanced procedural clarity. These changes aim to support global regulatory convergence and ensure that IMDRF's guidance remains relevant and useful to stakeholders worldwide.
For more detailed information on these updates, you can access the full document on the IMDRF 2024 document by clicking below:
These updates reflect significant efforts by IMDRF to streamline and improve its regulatory processes. The focus on regular document maintenance, clear procedural guidelines, and inclusive participation in meetings and proposals underscores the forum's dedication to advancing global medical device regulatory practices.
If you need support contact us here!
Comments