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Articles tagged with: Regulations

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MDR and the Ecosystem of European Regulatory Sources

The hierarchy and comprehensive overview of MDR regulatory sources: regulations, EU acts, MDCG, CS, harmonized standards, and the state of the art.

Matteo Valtorta

Regulations Standards

Changes in the Management of Electronic IFUs

With Regulation (EU) 2025/1234, all devices intended for professional users can have electronic instructions for use.

Manufacturers' duties Regulations