IVD

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Understanding the New MDCG 2024-4 Guideline for IVD Safety Reporting

Published: May 21, 2024

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

Published: January 29, 2024

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Why IVD Developers Must Embrace the IVDR Transition Now

Published: November 21, 2023

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U.S. FDA Emergency Use Authorization: CRO Lessons Learned for the MedTech Industry

Published: February 8, 2023

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MDCG 2022-14: Transition to the MDR and IVDR – Notified Body Capacity and Availability of Medical Devices and IVDs

Published: September 1, 2022

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MDCG 2022-10: Interfaces between the Clinical Trial Regulation and IVDR

Published: August 15, 2022

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MDCG 2022-3: Verification of Manufactured Class D IVDs in accordance to the IVDR—One Size Fits All?

Published: July 21, 2022

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MDCG 2022-8: Clarification of IVDR Requirements for Legacy Devices

Published: June 23, 2022

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MDCG 2022-2: Recommended Strategies for Data Retrieval and Literature Reviews

Published: June 16, 2022

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MDCG 2022-6: Transitional Provision Considerations for IVDR Conformity

Published: June 1, 2022

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MDCG Releases Guidance on Classification of Medical Devices (MDCG 2021-24

Published: October 11, 2021

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MDCG Publishes New Guidance on Use of Standards Under MDR/IVDR

Published: April 21, 2021

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New Guidance: Classification of IVD under the IVDR

Published: November 24, 2020

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Key Considerations for Executing Clinical Trials for Dual 510(k) and CLIA Waiver Applications

Published: August 11, 2020

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The IVDR Compliance Roadmap: From Start to Finish

Published: July 8, 2020

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Key Requirements of Post-Market Surveillance under IVDR

Published: November 18, 2019

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