Notified bodies are constantly under the spotlight as manufacturers struggle to comply in time with the new Medical Device and IVD Regulations. They are very much the linchpins when it comes to implementation. These pivotal structures are bearing the brunt of managing the missing aspects of the new medtech regulatory system as the pressures increase and having to adapt to extra work that new structures and documents create
Representatives from three EU notified bodies explained how MDR and IVDR will not work as intended unless notified bodies have...
