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Events

Friday, March 20th

Webinars

IVDR Proposed Revision: Practical Breakdown & Implications for IVD Manufacturers

1679063923703 AKRA TEAM Logo new 33 In collaboration with MedTech Leading Voice and AKRA TEAM, a webinar will be held to discuss the European Commission’s December 2025 proposal to revise the IVDR.

The amendment introduces several major regulatory changes, including:

redesigned conformity assessment pathways,
expanded provisions for in‑house devices,
new innovation routes,
adjusted performance study requirements.

The session will highlight the main elements of the proposal, their practical impact, and what manufacturers should anticipate as the legislative process evolves.

Tom Patten, IVDR/IVD International Manager, will join the discussion and share GMED’s perspective.

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