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BioWorld - Wednesday, May 21, 2025
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2024 Med Tech Conference

EU's MDR pain points exacerbated by lack of member state harmony

Oct. 16, 2024
By Mark McCarty
The saga of the EU's Medical Device Regulation (MDR) is far from over, but stakeholders were treated to another related dose of reality in a session at this year's Med Tech Conference here in Toronto. Several panelists pointed to a lack of harmonization regarding notified bodies' interpretation of the regulation, but Stryker Inc.'s Michel Marboeuf said this problem flows to some extent from a lack of harmonization among the member states' competent authorities, a condition that is likely to resist treatment in the near term.
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