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EU’s MDCG Updates MDR Guidance

The Medical Device Coordination Group (MDCG) of the Commission of the European Union (EU)...

FDA Warns of Medical Device Cyber Vulnerabilities

The U.S. Food and Drug Administration (FDA) has issued an alert to medical device...

FDA Releases Final Guidance on Voluntary Recalls

The U.S. Food and Drug Administration (FDA) has issued a final guidance to help...

Industry Groups Call for 2-Year Extension of MDR Transition Period

Two leading medical industry groups in the European Union (EU) are calling on the...

FDA to Amend Medical Device Quality System Regulation

The U.S. Food and Drug Administration (FDA) has requested public comment on its plan...
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EU Commission Extends Transitional Provisions for In Vitro Diagnostics

The Commission of the European Union (EU) has amended key transitional provisions for certain...

FDA Updates 510(k) Third-Party Performance Metrics

The U.S. Food and Drug Administration (FDA) has published its most recent data on...

Medical Devices Increasingly Vulnerable to Cyberattacks

Despite ongoing publicity around the need to secure systems and equipment against the threat...

EU Commission Updates Biological Safety Standards Applicable under MDR

The Commission of the European Union (EU) has updated the list of standards that...

FDA Publishes Discussion Paper on 3D Printing of Medical Devices

The U.S. Food and Drug Administration (FDA) has released a discussion paper on the...
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