July 6, 2021

[FEATURED] Commission Calls For Notified Body Applicants As It Recognizes EU IVD Industry In Some Trouble

The European Commission is publicly recognizing the huge hurdles ahead for the IVD industry in complying with the IVD Regulation. Delaying the regulation has long been off its agenda, but it is struggling to find solutions.

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October 29, 2018

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

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.

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