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Meetings

The IMDRF Management Committee meets bi-annually. The first meeting was held in Singapore on 28th Feburary - 1st March 2012. The second meeting took place in Sydney on 25 to 27 September 2012. The Sydney meeting included an Open Stakeholder Forum attended by a wide range of stakeholders. An outcome statement is located below.

An update to IMDRF’s priority work items was provided. A copy of each presentation is located below. In relation to IMDRF’s Regulated Product Submission work item, an invitation to RPS Tool Vendors was issued. A copy is located below.

The next IMDRF Meeting will be held in France on 19 to 21 March 2013. Details of the Open Stakeholder Forum will be advised as soon as they become available.

Interested parties can signal their preliminary interest in attending the next open session in 2013 in Europe, by contacting the IMDRF Secretariat at EC-IMDRF2013-SECRETARIAT@ec.europa.eu.

For a list of GHTF meeting minutes, see the GHTF Archived Documents page.

Upcoming meetings

Meeting no. Location Date Links
4 Brussels, Belgium 12-14 November 2013  

Past meetings

Meeting no. Location Date Links
3 Nice, France 19-21 March 2013 IMDRF France meeting outcome statement - PDF (60kb) IMDRF France meeting outcome statement - DOC (159kb) IMDRF Presentation - GHTF to IMDRF What's next? - PDF (962kb) IMDRF Presentation - Regulatory convergence WHO's perspective - PDF (954kb) IMDRF Presentation - International Regulatory Convergence: Challenges of the Global Health System - PDF (473kb) IMDRF Presentation - International Regulatory Convergence: Meeting Patients' Needs - PDF (274kb) IMDRF Presentation - International Regulatory Convergence: strategic reflections from the ESC - PDF (1.6Mb) IMDRF Presentation - AHWP - IMDRF Articulation Towards Regulatory Convergence - PDF (248kb) IMDRF Presentation - DITTA - IMDRF Stakeholders Meeting - PDF (551kb) IMDRF Presentation - Definition and regulation in terms of mechanism of action and intended use - PDF (246kb) IMDRF Presentation - Regulatory guidance for validation and approval of standardized apheresis connectors - PDF (203kb) IMDRF Presentation - IMDRF RPS ToC WG Update - PDF (266kb) IMDRF Presentation - IMDRF RPS Update - PDF (349kb) IMDRF Presentation - IMDRF Project: List of international standards recognized by IMDRF management committee members - PDF (153kb) IMDRF Presentation - Medical Device Single Audit Program (MDSAP) Working Group - PDF (79kb) IMDRF Presentation - Unique Device Identification for medical devices and in vitro diagnostics medical devices - PDF (1.5Mb) IMDRF Presentation - Review of the NCAR Exchange Program - PDF (155kb) IMDRF Presentation - China: Update on jurisdictional regulatory developments - PDF (113kb) IMDRF Presentation - Update on the Brazilian regulatory aspects on medical devices - PDF (184kb) IMDRF Presentation - Revision of the EU legislation on medical devices and in vitro diagnostic medical devices - PDF (569kb)
2 Sydney, Australia 25-27 September 2012 IMDRF Sydney meeting outcome statement - PDF (63kb) IMDRF Sydney meeting outcome statement - DOC (160kb) List of international standards recognized by IMDRF management committee members - PDF (61kb) Roadmap for Implementation of UDI System - PDF (220kb) The Regulated Product Submission: Progress Update - PDF (40kb) Revision of the NCAR Exchange Program - PDF (66kb) International Medical Device Regulators Forum (IMDRF)and Medical Device Single Audit Program (MDSAP) Working Group - PDF (30kb) Letter to RPS Vendors - PDF (85kb)
1 Singapore 28 February - 1 March 2012 IMDRF Singapore meeting outcome statement - PDF (56kb) IMDRF Singapore meeting outcome statement Word document (58kb) IMDRF Singapore meeting media release - PDF (167kb) IMDRF Singapore meeting media release - DOCX (13kb)
- Ottawa, Canada 6-7 October 2011 IMDRF Ottawa meeting outcome statement - PDF (52kb) IMDRF Ottawa meeting outcome statement - DOC (63kb)

Invitation to Next Stakeholder Open Forum

Details of the next Stakeholder Forum will be published as soon as they become available.

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