MDRG 05/06/2023 MDRG 05/06/2023

IMDRF Conference Presentations Available

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MDRG 02/06/2023 MDRG 02/06/2023

IMDRF publishes "Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity"

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MDRG 01/06/2023 MDRG 01/06/2023

MDSAP AU P0002.008: Audit Approach Key Changes in Latest Update

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MDRG 31/05/2023 MDRG 31/05/2023

MHRA's New Regulatory Model: Accelerating Global Medical Technology Approvals from 2024

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MDRG 30/05/2023 MDRG 30/05/2023

Team-NB Best Practice for the Submission of TD under MDR

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MDRG 29/05/2023 MDRG 29/05/2023

Team-NB Best Practice for the Submission of TD under Annex II/II of IVDR

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MDRG 26/05/2023 MDRG 26/05/2023

Team- NB Notified Body Confirmation Letter – EU 2023/607

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MDRG 25/05/2023 MDRG 25/05/2023

Guidance on content & structure of summary of the clinical investigation report (2023/C 163/06)

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MDRG 24/05/2023 MDRG 24/05/2023

MHRA Extension

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MDRG 23/05/2023 MDRG 23/05/2023

MDCG 2020-3 rev.01: Key Takeaways

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MDRG 10/03/2022 MDRG 10/03/2022

Swiss Medical Device Database 🔜

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MDRG 09/03/2022 MDRG 09/03/2022

MDCG Meetings Updated ❗️

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MDRG 08/03/2022 MDRG 08/03/2022

MDCG 2021-21 Rev.1 Performance Eval of SARS-CoV-2 IVDs ✅

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MDRG 07/03/2022 MDRG 07/03/2022

MDCG 2022-3 Verification of Class D IVDs 📚

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MDRG 04/03/2022 MDRG 04/03/2022

Common Specification Class D for IVDR 💥

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MDRG 03/03/2022 MDRG 03/03/2022

FDA proposal to incorporate ISO 13485:2016 into 21 CFR 820 🔗

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MDRG 02/03/2022 MDRG 02/03/2022

MDCG 2022-4 Surveillance under Article 120 MDR 🔍

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MDRG 14/02/2022 MDRG 14/02/2022

Update to Implementation & Preparedness Plan for IVDR 🔥

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MDRG 11/02/2022 MDRG 11/02/2022

EU 2021/2282 Regulation on Health Technology Assessment 🆕

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MDRG 10/02/2022 MDRG 10/02/2022

MDCG 2021-27 – Q&A on Articles 13 & 14 of MDR/IVDR ❗️

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