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MDCG 2021-6 Rev 1: Clarifications on Clinical Investigations

Posted 1 year ago

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

Posted 1 year ago

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Five Reasons Not to Delay Your MDR Certification

Posted 1 year ago

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

Posted 1 year and 1 month ago

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

Posted 2 years ago

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

Posted 2 years ago

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Auditing a QMS According to ISO 13485

Posted 2 years ago

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

Posted 2 years and 3 months ago

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

Posted 2 years and 3 months ago

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

Posted 2 years and 4 months ago

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

Posted 2 years and 5 months ago

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

Posted 2 years and 6 months ago

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

Posted 2 years and 7 months ago

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New MDCG 2022-4 Guidance Released

Posted 2 years and 9 months ago

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MDCG Publishes New Legacy Device Guidance 2021-25

Posted 3 years and 1 month ago

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

Posted 3 years and 2 months ago

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