MDRG 21/11/2023 MDRG 21/11/2023 Team-NB Notified Bodies Urge Manufacturers to Apply for IVDR Certification Read More MDRG 20/11/2023 MDRG 20/11/2023 New Q&A Document on Transitional Provisions for Products Without an Intended Medical Purpose Covered by Annex XVI of the MDR Read More MDRG 17/11/2023 MDRG 17/11/2023 MHRA Disapplies Requirement for Clinical Trial Sponsors to be Established in EU or Northern Ireland Read More MDRG 16/11/2023 MDRG 16/11/2023 MDCG Publishes New Guidance on Medical Device Software (MDSW) - Hardware Combinations Read More MDRG 14/11/2023 MDRG 14/11/2023 EUDAMED Development Timeline Extended to Q2 2027 Read More MDRG 13/11/2023 MDRG 13/11/2023 New EU Regulation to simplify UDI assignment for contact lenses Read More MDRG 04/10/2023 MDRG 04/10/2023 EU publication on AI in Healthcare Read More MDRG 03/10/2023 MDRG 03/10/2023 UK MHRA Addresses Discrepancy with UK Dept of Trade on CE Markings Read More MDRG 02/10/2023 MDRG 02/10/2023 EU MDR Experts Panel Scientific Opinions Read More MDRG 29/09/2023 MDRG 29/09/2023 Updates to Q&A on MDR transition and sell-off periods Read More MDRG 28/09/2023 MDRG 28/09/2023 Team NB MDR transition times and NB capacity Read More MDRG 27/09/2023 MDRG 27/09/2023 MDR Extension Flowchart Read More MDRG 26/09/2023 MDRG 26/09/2023 Medical Literature Review under MDR Read More MDRG 25/09/2023 MDRG 25/09/2023 FDA Updates Guidance on Informed Consent for Clinical Trials Read More MDRG 22/09/2023 MDRG 22/09/2023 Regulation 1025/2012: Adapting for Future Standards & #MDR/#IVDR Support Read More MDRG 21/09/2023 MDRG 21/09/2023 New IVDR Notified Body – Eurofins Electric & Electronics 🆕 🍾 🎉 Read More MDRG 02/08/2023 MDRG 02/08/2023 MDCG 2020-3 Rev.01 Published – Significant Change Guidance 👍 Read More MDRG 01/08/2023 MDRG 01/08/2023 Team-NB Position Paper on Hybrid Audits❗️ Read More MDRG 31/07/2023 MDRG 31/07/2023 Consolidated MDR Released 💥 Read More MDRG 28/07/2023 MDRG 28/07/2023 EUDAMED UDI Devices User Guide Update 📚 Read More Newer Posts Older Posts
MDRG 21/11/2023 MDRG 21/11/2023 Team-NB Notified Bodies Urge Manufacturers to Apply for IVDR Certification Read More
MDRG 20/11/2023 MDRG 20/11/2023 New Q&A Document on Transitional Provisions for Products Without an Intended Medical Purpose Covered by Annex XVI of the MDR Read More
MDRG 17/11/2023 MDRG 17/11/2023 MHRA Disapplies Requirement for Clinical Trial Sponsors to be Established in EU or Northern Ireland Read More
MDRG 16/11/2023 MDRG 16/11/2023 MDCG Publishes New Guidance on Medical Device Software (MDSW) - Hardware Combinations Read More
MDRG 13/11/2023 MDRG 13/11/2023 New EU Regulation to simplify UDI assignment for contact lenses Read More
MDRG 03/10/2023 MDRG 03/10/2023 UK MHRA Addresses Discrepancy with UK Dept of Trade on CE Markings Read More
MDRG 25/09/2023 MDRG 25/09/2023 FDA Updates Guidance on Informed Consent for Clinical Trials Read More
MDRG 22/09/2023 MDRG 22/09/2023 Regulation 1025/2012: Adapting for Future Standards & #MDR/#IVDR Support Read More
MDRG 21/09/2023 MDRG 21/09/2023 New IVDR Notified Body – Eurofins Electric & Electronics 🆕 🍾 🎉 Read More
MDRG 02/08/2023 MDRG 02/08/2023 MDCG 2020-3 Rev.01 Published – Significant Change Guidance 👍 Read More
