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DoseMeRx Submitted a Formal Application for CE Certification Under MDR, Ensuring Uninterrupted Service and Safety for Customers and Patients

ZOLL Medical Corporation: ZOLL One of the First to Receive Approval for AEDs Under the EU Medical Device Regulation (MDR) Certification

EU continues struggle with rollout of new device regs in 2023

Regulation of medical devices is always a messy and complicated task, but that has proven to be particularly true of the European Union’s (EU) Medical Device Regulation (MDR). Thanks largely to problems with the capacity of notified bodies (NBs) to review renewals of existing CE marks, patients in the EU may experience a significant dearth of medical devices over the next couple of years, a nightmare scenario that has all stakeholders scrambling for solutions.

Effective Clinical Evaluation Preparation Enables EU Mdr Compliance

Femasys Inc. EU MDR Final Audit Successfully Completed

– Completion of the European Union Medical Device Regulation final audit is the last step in obtaining an MDR certificate and CE marking, confirming Femasys’ compliance with the highest required.