EU Compliance

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MDR Update: EPSCO Proposes Transition Improvements and EU Commission Issues MDCG 2022-18

Published: December 16, 2022

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EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)

Published: December 6, 2022

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Auditing a QMS According to ISO 13485

Published: November 28, 2022

ISO 10993-18 Primer: Medical Device Chemical Characterization

Published: October 31, 2022

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First Manual on Borderline and Classification under MDR Published by the European Commission

Published: September 13, 2022

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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 2022-3: 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 2022-6: Transitional Provision Considerations for IVDR Conformity

Published: June 1, 2022

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New MDCG 2022-5 Guidance on Borderline between Devices and Drugs under MDR

Published: May 9, 2022

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New MDCG 2022-4 Guidance Released

Published: March 1, 2022

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MDCG Publishes New Legacy Device Guidance 2021-25

Published: October 27, 2021

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

Published: October 11, 2021

A rare disease patient filling out an online survey on a laptop.

What to Ask Before Submitting Your Medical Device for Approval

Published: June 7, 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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