Latest International Clinical Investigations Standard Ready By June But EU Must Play Catch-Up
How will clinical investigation sponsors need to adapt to meet updated requirements in the updated ISO 14155 clinical investigations standard? And will all countries respond in the same way?
You may also be interested in...
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.