Medical Devices: EU takes over chairmanship of global harmonisation task force

The EU has chosen ‘Enhancing Patient Safety’ as the key theme for its three-year chairmanship of the Global Harmonisation Task Force on Medical Devices.

Background

The EU has begun its three-year term as chair of the Global Harmonisation Task Force (GHTF) on Medical Devices. Cornelis Berkelmans of DG Enterprise (European Commission) will act as Chairman for the period 2004-7. Maurice Wagner of the European Medical Technologies Industry Association (Eucomed) has been appointed Vice-Chair.

The overriding theme of the EU's term will be 'Enhancing Patient Safety' following the previous chair's (Japan's) focus on 'common data'. The EU intends to focus on designs for patient safety, medical device software and new technologies.

The GHTF was launched in 1992 with the objective of promoting regulatory harmonisation and facilitating international trade. Its members are Australia, Canada, the EU, Japan and the US.

The GHTF has developed guidance on regulatory harmonisation, including principles for safety and performance of medical devices, global vigilance and reporting mechanisms, quality management systems for medical devices and regulatory auditing practices.

 

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