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Multi-Stakeholder Workshop of the Joint EFGCP-MedTech Europe Working Party on

Clinical Development of Medical Devices: Regulatory Intelligence and Risk Management

This multi-stakeholder workshop explores the interaction between clinical development and risk management for medical devices, in light of the forthcoming EU Regulation on Medical Devices and the existing best practices. Participants will learn about and debate the role that risk management plays in the design, clinical evaluation, and CE marking of medical devices.Following their entry into the market, the design of medical devices continually evolves, introducing step-by-step improvements, according to an iterative development plan. Post-market surveillance, customer feedback and risk management are key drivers of the innovations applied to medical devices.In general, such innovations or modifications aim at improving the safety and/or the performance of the device. However, expanding a device’s range of indications requires a careful evaluation to identify potential new risks. In order to assure a positive benefit-to-risk ratio for patients and users over the life cycle of the device and to meet the notified bodies and the competent authorities’ growing expectations manufacturers should continually update their device’s clinical evaluation and monitor and manage the device’s risk management file.All participants to this workshop will be guided through the risk management process and the interaction with the clinical development plan that typically drives innovation of product design. Contributors to the workshop will include key stakeholders including regulators,Notified Bodies, physicians, patient organization representatives and industry members.


26 Oct 2015 @ 10:00 am

27 Oct 2015 @ 04:00 pm

Duration: 1 days, 6 hours


Centre Hospitalier de Luxembourg (CHL)

4 Rue Nicolas Ernest Barblé




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