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medical devices

EUs MDR Date of Application Delayed Until 2021

In a major development for medical device manufacturers, the Parliament and Council of the European...

U.S. FDA Temporarily Eases Enforcement Policies for Certain Digital Health Devices

Moving quickly to address the need for advanced medical technologies during the COVID-19 outbreak...

U.S. FDA Allows Expanded Use of Medical Devices for Remote Patient Monitoring

In an action to support the healthcare system care for patients during the COVID-19...

Creating A Smart Insulin Patch The Size Of A Coin

UCLA researchers are making strides to create a smart patch capable of delivering insulin to patients directly through their skin.

FDA Updates Database of Recognized Consensus Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has updated its list of recognized standards...
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EU Commission Extends MDR Transition Period for Certain Class 1 Devices

The EU has approved a “correction” to its Medical Devices Regulation (Regulation (EU) 2017/745,...

FDA Proposes Updates to List of Class II Exempt Devices

The U.S. Food and Drug Administration (FDA) has proposed updates to its list of...

A Tsunami of Regulatory Changes is Coming

Medical device veteran Jon Speer breaks down the latest changes in the medical device regulatory landscape, both in Europe and the U.S.

The Future of the IEC 60601 Series: An Update

This article discusses where we are currently with the IEC 60601 series of standards and where we are headed for the next round of amendments (2020 - 2022). Further down the line is the development of the next full edition of the IEC 60601 Series (targeting around 2024 publication).

Med Device Company Receives Partial Waiver of Part 15 Rules

The U.S. Federal Communications Commission (FCC) has granted a request from a medical device...
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