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EU Notified Body Shake-Up: What the NSAI and TÜV NORD Exits Mean for MDR Certification
The EU Notified Body landscape was shaken in August 2024 with announcements that the National Standards Authority of Ireland (NSAI) will exit its MDR designation by 2026 and TÜV NORD Scandinavia has filed for bankruptcy. This episode breaks down the immediate impact on manufacturers certified by these bodies, the broader implications for Notified Body capacity under the MDR, and the critical strategic steps regulatory teams must take now to protect their EU market access. Key Questions: - What were the specific announcements from NSAI and TÜV NORD Scandinavia in August 2024? - Why is the…
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