FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

MedTech Europe Lays Out Plan to Help Implement MDR

July 1, 2019

Device association MedTech Europe takes the lead on helping EU member states tackle the looming MDR/IVDR implementation deadlines in a new seven-point plan.

The call to action covers notified bodies for certification of new products, product recertification, Eudamed, quality guidance, scientific bodies and harmonized standards. The plan points out gaping holes in critical infrastructure.

MedTech Europe notes that the system is far from being functional with the implementation date for the MDR less than a year away. It says the first step is to designate notified bodes more quickly.

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