Qualio’s Post

💥Breaking: EUDAMED...Mandatory use of several modules could then start as early as Q4/2025💥 Commission proposal...#MDR #IVDR...as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices. Source: https://lnkd.in/dM4T_rrP #eudamed #medtech #medicaldevices #regulatoryaffairs #regulatorycompliance #EUDAMED 

Interesting update re: EUDAMED. Manufacturers should be actively working to achieve MDR certification, this is a reminder that the transition extension does not mean MDR work can stall or slow down. If you require any support in your transition to MDR then tranScrip can help. See our website for more details: https://lnkd.in/ereE2yyH #MDR #EUDAMED #medicaldevices

💥Breaking: EUDAMED..."Mandatory use of several modules could then start as early as Q4/2025"💥 Commission proposal...#MDR #IVDR...as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices. Source: https://lnkd.in/dsxG_-nu #eudamed #medtech #medicaldevices #regulatoryaffairs #regulatorycompliance #EUDAMED 

New guidance has been recently released by the MDCG. Check out Qmed's latest "ALL ABOUT" slide deck for the key takeaways. #Qmed #RegulatoryAffairs #IVDs #MedicalDevices

Let’s stay compliant and innovate safely in the evolving world of in vitro diagnostics! — A new guidance (MDCG 2024-11) has just been released by the Medical Device Coordination Group (MDCG) that aims to support the qualification of in vitro diagnostic medical devices (IVDs). Let's take a look at some of the main takeaways... Follow us for the latest on medical device regulations updates and industry standards, and as always, feel free to reach out with any questions or concerns. We are always happy to help! #Qmed #RegulatoryAffairs #ClinicalAffairs #MedicalDevices #InVitroDiagnostics #IVD

🌍 The European Commission has published a detailed Q&A document outlining the extended transitional periods for the In Vitro Diagnostic Medical Devices Regulation (IVDR), following the recent amendments introduced by Regulation (EU) 2024/1860. The document provides comprehensive guidance on the practical aspects of these extensions, ensuring stakeholders are well-informed about the changes and their implications. Stay informed and ensure compliance with the latest regulations! Follow us for more updates! Biomedista #IVDR #MedicalDevices #Regulation #EuropeanCommission #Compliance #Eudamed

Dear Followers the Medical Devices Coordination Group has published the following document "MDCG 2020-16 rev.3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746". In this revision, among other revisions, some classification rules have been revised, but most importantly, the definition of kit, which unfortunately before now remained very vague, has been given. Source: https://lnkd.in/eQJ7zvz9 #mdcg #classificationrules #ivd #ivdr #ivdkit #rev3 #qualityassurance #regulatoryaffairs #vlfconsulting

The European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. Class D --> new transition period until December 2027 Class C --> new transition period until December 2028 Class B/A* --> new transition period until December 2029 The proposal will now be forwarded to the European Parliament and Council for adoption. https://lnkd.in/eqM__DK2 #eumediq #ivdr #medicaldevice

The European Parliament's amendment to the Medical Device Regulation (#MDR) has introduced a longer compliance period for specific #medicaldevices and in vitro diagnostic devices. This move provides manufacturers with room to refine their products and align with the latest European #regulatory updates. Read more below on how it might affect your device submissions. https://hubs.ly/Q02spg3Y0 #regulatorychanges #notifiedbodies #stateoftheart

JULY 2024  Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices  #medicaldevice #wyrobymedyczne #medtech ##medicaldevices #mdr #ivdr Link: https://lnkd.in/deyX6U76