EU Compliance

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MDCG 2024-10 Clinical Evaluation of Orphan Medical Devices

Published: July 1, 2024

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MHRA Statement of Policy Intent: International Recognition of Medical Devices

Published: June 13, 2024

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Understanding the Benefit-Risk Ratio in Clinical Reports: Avoiding 6 Common Mistakes

Published: June 5, 2024

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Best Practices for MDR-Compliant Clinical Evaluations

Published: May 2, 2024

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Navigating the New MDCG Guidance Documents on CIP and IB

Published: May 1, 2024

European Union blue flag with yellow stars waving in the wind, symbolizing NAMSA's work consulting on European Union medical device regulations

What Manufacturers Need to Know About the MDR Deadline Extension

Published: April 5, 2024

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Medical Device Software: Considerations for Device and Risk Characterization

Published: April 2, 2024

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Revolutionizing Healthcare: The Rise of Medical Device Software and EU Regulatory Compliance

Published: March 26, 2024

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MDCG 2024-2: Procedures for the Updates of the European Medical Device Nomenclature

Published: March 13, 2024

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MDR Vigilance: New MDCG Guidance Published

Published: February 13, 2024

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Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR

Published: January 29, 2024

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MDCG 2021-6 Rev 1: Clarifications on Clinical Investigations

Published: December 20, 2023

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MDCG 2022-11 Rev 1: Urgency for MDR and IVDR Compliance

Published: December 4, 2023

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Five Reasons Not to Delay Your MDR Certification

Published: December 1, 2023

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Why IVD Developers Must Embrace the IVDR Transition Now

Published: November 21, 2023

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MDCG 2023-4: Medical Device Software (MDSW) – Hardware Combinations

Published: November 1, 2023

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