Digitalising Medical Device Conformity Assessment
Funds one coordination project that pilots a digital, data-driven replacement for the paper-heavy conformity assessment process device makers use to get CE marking under the MDR and IVDR.
Digitalising Medical Device Conformity Assessment is a European Commission grant that funds one coordination project piloting a digital, data-driven replacement for the paper-heavy MDR/IVDR conformity assessment process device makers use to get CE marking, run by a consortium of Notified Bodies, device manufacturers and regulators. This topic is one of thirteen filed under the same call, HORIZON-H…
This call is for a consortium of Notified Bodies, device manufacturers and regulators that wants to turn the current document-heavy MDR/IVDR conformity assessment process into a data-driven one. It covers every step from a manufacturer's technical documentation through to certificate issuance.
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