International Medical Device Regulators Forum (IMDRF) Progresses

At a meeting held in Singapore the International Medical Device Regulators Forum (IMDRF) (initiated to carry out a similar role to the now disbanded Global Harmonisation Task Force (GHTF)) a number of progressions were made. The Forum includes international medical device regulators from Australia, Brazil, Canada, Europe, Japan and the USA and has an aim to strategically accelerate international medical device regulatory convergence. It is hoped that this will provide medical device manufacturers with a more efficient path to certification worldwide. As indicated above, the Forum has fundamentally similar objectives to the GHTF.

The Forum’s chair, Dr. Larry Kelly confirmed that the IMDRF plans to reinforce the value of GHTF documents, the importance of establishing strong partnerships with affiliate organisations, a commitment to transparency and the vital role that industry and other vested stakeholders will play in contributing to the development of new work items and the overall success of the IMDRF.

The structure of IMDRF was developed and confirmed during the March meeting, including confirmation of initial membership, the adoption of a Terms of Reference and a robust work plan, and agreement on elements of an operating procedures document. In addition, the following proposals for work items were discussed:

• A review of the NCAR system (the NCAR Exchange Program facilitates the exchange of relevant post market safety information on medical devices with global distribution)
• Roadmap for implementation of a Unique Device Identified system
• Standardised submission requirements for pre-market assessment of medical devices
• Medical Device Single Audit Program (MDSAP)
• Non-clinical and clinical evaluation regarding nanomaterials
• International Standards recognised by IMDRF Management Committee members
• Guidance on how to determine risk/benefit analysis
• Regulated product submission.

The IMDRF meets again in Sydney in September 2012. Time will tell how effective the IMDRF will be for medical device manufacturers and if it can come close to filling the GHTF’s enormous shoes!