Is the IVD Regulation Framework ready for Class D Devices?

Under the IVD Regulation (EU) 2017/746 (‘IVDR’), Class D devices rely on a complex conformity assessment infrastructure involving not only a notified body but also an EU reference laboratory, the uploading of specific information to the EUDAMED database and – for novel devices in the absence of common specifications – additional assessment by an Expert … Continue reading Is the IVD Regulation Framework ready for Class D Devices?