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The MedTech industry is going through a period of unprecedented change with the EU MDR and IVDR implementation deadlines just over one year and three years away respectively. But how well really is the industry prepared for the changes ahead? Are Competent Authorities ready? Do Notified Bodies have the resource and capacity? Do manufacturers have the tools and processes in place to ensure compliance? What are the key issues beyond compliance? Will the MDR and IVDR be fit for purpose? Will they facilitate innovation and ultimately, will they improve patient outcomes?
In February 2019, MedTech Summit conducted a survey of medical device and IVD professionals around the world. Based on 291 responses, this report reveals unique insights into the state of the industry today as we head towards the key 2020 and 2022 deadlines, the biggest challenges and how industry insiders are tackling them.
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