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First EU Notified Body Designations Could Come Earlier Than Expected, But Caution Advised

 
• By Amanda Maxwell

There's been progress toward designating notified bodies against the EU's medtech regulations, but the developments need to be scrutinized so that the sector preserves a sense of reality about capacity issues, MedTech Europe's Oliver Bisazza says.

EU flags fly in front of Brussels parliament buildings

The very first designations of notified bodies against the EU Medical Devices Regulation could happen in early 2019, earlier than the original forecast of summer 2019, according to Oliver Bisazza, director of regulations and industry policy at trade association MedTech Europe.

Speaking to Medtech Insight, Bisazza said that his association understands that about 10 on-site assessments of notified bodies have been conducted by designating authorities ­- seven under the MDR and three under the IVD

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