France’s Snitem Demands Shock Cardiac Devices Reimbursement Decision Be Reversed
French medtech trade association, Snitem, and local cardiologists are stunned by the removal from the reimbursement list of two state-of-the art cardiology devices and are demanding their reinstatement.
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EU Regulatory Round-Up, March 2023: EU Deadlines Under MDR Amending Regulation Published And Clarified
This month’s round-up summarises the biggest EU medtech regulatory news in a year as legacy device transition periods are extended. A highly applauded commission summary of the new timelines under the EU’s MDR amending regulation provides key snapshot of the essential points.
Why Adding A Legacy Device To Eudamed Now, Before It is Mandatory, Is A Shrewd Move
The EU MDR amending regulation does not impact Eudamed directly, but it may make medtech manufacturers reconsider when to register legacy devices in Eudamed. Richard Houlihan of EirMed explains.
BSI Notified Body Highlights Crucial Elements Related To EU’s MDR Amending Regulation
BSI Group has issued a useful Q&A document on how it sees the new EU MDR amending Regulation, which extends the transition deadlines for legacy medical devices, impacting manufacturers and their relationship with notified bodies.