RegDesk Regulatory Roundup

Navigating EU MDR: Key Challenges and Compliance Strategies Medical Devices

Navigating EU MDR: Key Challenges and Compliance Strategies

The European Union Medical Device Regulation (EU MDR) significantly reshaped the landscape for medical device manufacturers, introducing stringent regulatory requirements aimed at enhancing patient safety and device efficacy. Enforced since May 2021, the MDR replaced the older Medical Device Directive (MDD), demanding greater transparency and accountability from manufacturers operating within the EU market.

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