The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
An increase in serious adverse events tied to automatic external defibrillators (AEDs) may have less to do with faulty manufacturing issues than with industry confusion over the FDA’s medical device reporting (MDR) policy. To address the issue, the agency plans to revamp its 1994 MDR guidance, Megan Moynahan, leader of CDRH’s Cardiac Electrophysiology and Monitoring Devices Network, said. CDRH received more than 28,000 adverse event reports involving AEDs from January 2005 through May; the incidents include deaths, patient injuries and device malfunctions. Devices & Diagnostics Letter