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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...

EU Market Surveillance Regulation Takes Effect

A landmark piece of European Union (EU) legislation intended to strengthen market surveillance of...

EU Commission Moves to Require USB-C Charging

In a move that will have significant consequences for developers of a wide range...

EU Proposes Rules on the Use of AI

The Commission of the European Union (EU) has released a comprehensive proposal for a...

The EU’s MDR is Now in Effect

The European Union’s (EU’s) new regulation for medical devices sold or imported into the...
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EU Commission Updates Harmonized EMC Standards for Certain Equipment

The Commission of the European Union (EU) has taken steps to update the versions...

EU Commission Updates Lists of Harmonized Standards Under RED

The Commission of the European Union (EU) has amended the Annexes of the EU’s Radio Equipment...

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,...

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.

EU Commission Updates Harmonized Standards List for Toys

The Commission of the European Union (EU) has published an updated list of harmonized...
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