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Regulatory

MDR (Medical Device Regulation)

The EU regulation governing medical devices, replacing the older MDD.

MDR (effective 2021) raised the bar for device certification, especially for high-risk implants. Many older devices had to be re-certified or withdrawn from the EU market.

What this means for you: implants under MDR rules have stronger surveillance and traceability than older standards. Programs in EU jurisdictions follow MDR by default.

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