This position paper clearly and concisely presents the view of Notified Bodies on positive elements and on major concerns with the proposed revisions.
Team-NB-PositionPaper-MDR-IVDR-revision-impact-on-the-sector-20260302.pdf
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Team-NB Position Paper MDR/IVDR revision: impact on the sector
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Team‑NB supports measures that genuinely reduce administrative burden, promote innovation, and enable earlier regulatory dialogue. At the same time, any reforms must safeguard patient safety and maintain robust oversight.
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