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The grace period is over. Registration deadlines at the BSI expired on March 6, 2026, and the Federal Office has moved to active enforcement. For managing directors in medical technology, this means: those who have treated NIS-2 as an IT issue so far may face unexpected personal consequences.
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Why EUDAMED was introduced The European Commission has launched the EUDAMED database
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Medical technology is facing numerous challenges due to strict regulations and rising costs. The MDR (Medical Device Regulation), in particular, presents companies with considerable challenges. Although transitional periods until the end of 2028 can be utilised, medium-sized medical technology companies in particular must take action.
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