U.S. Urges EU to Delay Implementing EU MDR/IVDR by Three Years

With only nine months to go before the EU’s Medical Device Regulation hits its May 26 application date, the U.S. is pressing the EU to delay implementation for another three years. Read More

IMDRF Seeks Feedback on Adverse Event Reporting Terms

The International Medical Device Regulators Forum (IMDRF) has issued a new draft document on harmonizing terminology and codes for reporting adverse events for medical devices and in vitro diagnostics. Read More

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