Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.
Draft EUDAMED Roadmap of Modules
EU Commission MDR & IVDR Standardization Request List – Will it Succeed?
COMMISSION IMPLEMENTATION DECISION M/575 was issued 14 April 2021: This is a list of standards the EU Commission is hoping to Harmonize under MDR and IVDR. One of the issues is the HAS consultant has issued a negative assessment on
MDCG March ’20 Meeting – Industry & Notified Bodies Provide Feedback
The Medical Device Coordination Group (MDCG) is meeting on March 11 & 12th to hold a series of meetings. Part of these meetings includes hearing feedback from industry and Notified Bodies on stakeholder preparedness for the application of the MDR