Description: The transition to the MDR for EU manufactures has been significantly slower than initially expected. Multiples delays and actions have been put in place by the EU Commission to mitigate the risk of a shortage of Medical Devices in EU. Across 2023, clear and definitive timelines have been set for completing the transition. A proactive boost from all the stakeholders is necessary to achieve and complete the MDR transition avoiding a negative impact for the caregivers and the patients. Manufacturers have been stressed to provide comprehensive clinical data supporting the safety and the performance based on the “real world” use of their medical devices. Dedicated tools can help fulfilling this task reducing the burden for the Manufacturers and supporting a proactive digital innovation.
Learning Objectives:
Figure out an overall picture of the current status of MDR implementation
Identify the main gaps to be filled in by the stakeholders to achieve a successful transition
Explore the opportunities for proactively optimizing the collection supporting data for medical devices based on innovative digital solutions.
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