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medical devices

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...

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...

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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EU Commission Regulates Electronic Instructions for Medical Device Use

The Commission of the European Union (EU) has also published requirements for providing medical...

FDA Updates List of Recognized Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international...

EU Commission Sets Out Regulations for Medical Devices Database

The Commission of the European Union (EU) has issued its requirements for the medical...

FDA Publishes Principles for AI and ML in Medical Devices

Medical device regulatory agencies in the U.S., Canada, and the United Kingdom have recently...

EU Task Force Offers Clarification of Surveillance Requirements for Legacy Medical Devices

A European Union (EU) task force has issued a document intended to clarify the...
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