Why the IVDR preapplication process matters for legacy manufacturers

Published: 13-May-2025
Regulatory

For many in vitro diagnostic device (IVD) manufacturers, the first direct interaction with regulators comes through a Notified Body (NB) under Regulation (EU) 2017/746 (IVDR). Understanding the NB’s role, responsibilities and processes is essential … especially for legacy manufacturers transitioning from pre-IVDR certifications

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Under the IVDR, all in vitro diagnostic (IVD) devices, except Class A non-sterile ones, require the involvement of a Notified Body. Dr Oliver Eikenberg, Global QA/RA and IVDR Manager at Pure Global, reports.

This is not a one-time compliance checkpoint but part of a comprehensive and ongoing conformity assessment process. Engaging an NB should therefore be viewed as a long-term regulatory partnership. 

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