MDRG 09/02/2022 MDRG 09/02/2022 MDCG 2021-28 – Substantial Modification of Clinical Investigation under MDR 🆕 Read More MDRG 08/02/2022 MDRG 08/02/2022 EUDAMED Actor FAQ Updated 🆕 Read More MDRG 07/02/2022 MDRG 07/02/2022 New Harmonized Standards for IVDR 👍 Read More MDRG 04/02/2022 MDRG 04/02/2022 New Harmonized Standards for MDR 👍 Read More MDRG 03/02/2022 MDRG 03/02/2022 Regulation of the EU Parliament and Council amending IVDR 🔥 Read More MDRG 02/02/2022 MDRG 02/02/2022 MDCG 2022-2 – Guidance on General Principles of Clinical Evidence for IVD 📰 Read More MDRG 01/02/2022 MDRG 01/02/2022 Latest MDR Notified Body – TUV NORD CERT GmbH 📢 Read More MDRG 31/01/2022 MDRG 31/01/2022 MDCG 2022-1 – Notice to 3rd country manf. of SARS-CoV-2 IVD 📚 Read More MDRG 28/01/2022 MDRG 28/01/2022 Latest MDR Notified Body - ITALCERT SRL 📢 Read More MDRG 27/01/2022 MDRG 27/01/2022 MDR Annex XVI Common Specification Draft Published 📚 Read More MDRG 26/01/2022 MDRG 26/01/2022 List of Meetings of the MDCG & Sub-groups 📰 Read More MDRG 02/11/2021 MDRG 02/11/2021 MDCG 2021-26 : Q&A on repackaging & relabelling activities under Article 16 of MDR and IVDR 🔥 Read More MDRG 01/11/2021 MDRG 01/11/2021 New MDR Notified Body – Certiquality Srl ⚡ Read More MDRG 29/10/2021 MDRG 29/10/2021 MDCG 2021-25 : Application of MDR requirements to ‘legacy devices’ & devices placed on the market prior to 26 May 2021 (In accordance with Directives 90/385/EEC or 93/42/EEC) 🆕 Read More MDRG 28/10/2021 MDRG 28/10/2021 MDCG 2021-24 : Guidance on Classification of Medical Devices ✔ Read More MDRG 27/10/2021 MDRG 27/10/2021 MDCG 2019-6 Rev 3 – Updates to Q&A for Requirements relating to Notified Bodies ❗️ Read More MDRG 26/10/2021 MDRG 26/10/2021 EUDAMED New Modules are Open! Read More MDRG 25/10/2021 MDRG 25/10/2021 MDCG 2021-23 : Guidance for Notified Bodies, Distributers & Importers on Certification Activities per Article 16(4) of MDR & IVDR 🔥 Read More MDRG 30/08/2021 MDRG 30/08/2021 New MDR Notified Body – Kiwa Cermet Italia S.P.A ⚡ Read More MDRG 27/08/2021 MDRG 27/08/2021 MDCG 2021-19 : Guidance note integration of the UDI within an organisation’s quality management system 📰 Read More Newer Posts Older Posts
MDRG 09/02/2022 MDRG 09/02/2022 MDCG 2021-28 – Substantial Modification of Clinical Investigation under MDR 🆕 Read More
MDRG 03/02/2022 MDRG 03/02/2022 Regulation of the EU Parliament and Council amending IVDR 🔥 Read More
MDRG 02/02/2022 MDRG 02/02/2022 MDCG 2022-2 – Guidance on General Principles of Clinical Evidence for IVD 📰 Read More
MDRG 31/01/2022 MDRG 31/01/2022 MDCG 2022-1 – Notice to 3rd country manf. of SARS-CoV-2 IVD 📚 Read More
MDRG 02/11/2021 MDRG 02/11/2021 MDCG 2021-26 : Q&A on repackaging & relabelling activities under Article 16 of MDR and IVDR 🔥 Read More
MDRG 29/10/2021 MDRG 29/10/2021 MDCG 2021-25 : Application of MDR requirements to ‘legacy devices’ & devices placed on the market prior to 26 May 2021 (In accordance with Directives 90/385/EEC or 93/42/EEC) 🆕 Read More
MDRG 28/10/2021 MDRG 28/10/2021 MDCG 2021-24 : Guidance on Classification of Medical Devices ✔ Read More
MDRG 27/10/2021 MDRG 27/10/2021 MDCG 2019-6 Rev 3 – Updates to Q&A for Requirements relating to Notified Bodies ❗️ Read More
MDRG 25/10/2021 MDRG 25/10/2021 MDCG 2021-23 : Guidance for Notified Bodies, Distributers & Importers on Certification Activities per Article 16(4) of MDR & IVDR 🔥 Read More
MDRG 27/08/2021 MDRG 27/08/2021 MDCG 2021-19 : Guidance note integration of the UDI within an organisation’s quality management system 📰 Read More
