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MDRG 28/06/2021 MDRG 28/06/2021

MHRA IVD Advice Update 🏆

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MDRG 18/06/2021 MDRG 18/06/2021

New IVDR-designated Notified Body - DEKRA 🏆

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MDRG 31/05/2021 MDRG 31/05/2021

Q&A on Application of Regulation on Medical Devices 🔍

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MDRG 27/05/2021 MDRG 27/05/2021

MDCG 2021-9: Positon Paper on UDI Implementation for Contact Lenses & Spectacles 🆕

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MDRG 23/05/2021 MDRG 23/05/2021

MDCG 2021-8: Clinical Investigation Application / Notification Documents 🆕

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MDRG 20/05/2021 MDRG 20/05/2021

UDI Helpdesk Online! 🆕

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MDCG 2018-1 Update on UDI-DI 🆕
MDRG 15/05/2021 MDRG 15/05/2021

MDCG 2018-1 Update on UDI-DI 🆕

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MDRG 13/05/2021 MDRG 13/05/2021

Factsheet for Class I Medical Devices ✔

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MDRG 09/05/2021 MDRG 09/05/2021

Clinical Investigation Q&A (MDCG 2021-6 MDR) 🔥

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MDRG 02/05/2021 MDRG 02/05/2021

MDD, AIMDD, and IVDD Harmonised Standards Amended 💥

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MDRG 29/04/2021 MDRG 29/04/2021

European Committees for Electrotechnical / Standardisation requested to revise standards 🔥

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MDRG 27/04/2021 MDRG 27/04/2021

EC EUDAMED Update On UDI Registration Modules 🔥

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MDRG 25/04/2021 MDRG 25/04/2021

New MDCG Q&A on IVDR Class D Provisions 📰

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MDRG 21/04/2021 MDRG 21/04/2021

New MDCG Guidance on Standardisation for Medical Devices 🔥

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MDRG 18/04/2021 MDRG 18/04/2021

Swiss Federal Council Prepare for Lack of Mutual Agreement 🏆

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MDRG 15/04/2021 MDRG 15/04/2021

New MDR-designated Notified Body - Eurofins 🏆

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MDRG 06/04/2021 MDRG 06/04/2021

Guidance on Admin Practices and Solutions until EUDAMED fully functional 📚

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

New MDR-designated Notified Body - ISS 🏆

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MDRG 31/03/2021 MDRG 31/03/2021

Swiss Mutual Recognition Agreement likely not updated by May 26 2021 ⏳

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MDRG 26/03/2021 MDRG 26/03/2021

Q&A on Custom-Made Devices

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