MDRG 26/08/2021 MDRG 26/08/2021

New MDR Notified Body – Eurofins Product Testing Italy Srl ⚡

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MDRG 25/08/2021 MDRG 25/08/2021

MDCG 2021-20 : Instructions for generating CIV-ID for MDR Clinical Investigations📰

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MDRG 24/08/2021 MDRG 24/08/2021

MDCG 2021-21 : Guidance on Performance Evaluation of SARS-CoV-2 IVDD📰

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MDRG 23/08/2021 MDRG 23/08/2021

Swiss Medtech Guidance for Authorized Representatives 🆕

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MDRG 20/08/2021 MDRG 20/08/2021

MDCG 2021-22 : Clarification of First Certification for that type of device and corresponding procedures 📢

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MDRG 18/08/2021 MDRG 18/08/2021

Harmonized Standards for Biological Evaluation and Sterilization Published 💥

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MDRG 23/07/2021 MDRG 23/07/2021

MDCG 2021-10 – Status of Appendixes E-I of IMDRF N48 under EU Regulatory Framework ✅

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MDRG 22/07/2021 MDRG 22/07/2021

MDCG 2021-12 – FAQ on European Medical Device Nomenclature (EMDN) ✅

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MDRG 21/07/2021 MDRG 21/07/2021

Joint Implementation & Preparedness Plan for IVDR ✅

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MDRG 20/07/2021 MDRG 20/07/2021

MDCG 2021-11 – Guidance on Implant Card “Device Types” ❔

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MDRG 19/07/2021 MDRG 19/07/2021

EC European Medical Device Nomenclature Q&A ❗️

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MDRG 06/07/2021 MDRG 06/07/2021

MDSAP Audit Approach Update 👍

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MDRG 06/07/2021 MDRG 06/07/2021

Personalized Medical Devices Framework TGA 👍

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MDRG 05/07/2021 MDRG 05/07/2021

MDR IVDR Planned Harmonized Standards ✅

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MDRG 04/07/2021 MDRG 04/07/2021

Updated MDR IVDR Implementation Rolling Plan 🔥

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MDRG 04/07/2021 MDRG 04/07/2021

MDR - First Opinion of Panels in Med Device Published 🔥

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MDRG 03/07/2021 MDRG 03/07/2021

MDCG 2021 Rev.1 – Guidance before EUDAMED fully functional ⏳

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MDRG 02/07/2021 MDRG 02/07/2021

Implantable Medical Devices Factsheet 📚

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MDRG 01/07/2021 MDRG 01/07/2021

EMDN Codes 💥

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MDRG 29/06/2021 MDRG 29/06/2021

MDCG 2021-13 - EUDAMED Registration Q&A 📢

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