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European Union

EU Pushes for “Right to Repair” for Products

As part of the widespread effort to boost environmental sustainability efforts in the European...

EU Commission Issues Regulation Regarding Single-Use Medical Devices

The Commission of the European Union (EU) has issued common specifications for the reprocessing...

EU Commission Amends Annex XVII of REACH

The Commission of the European Union (EU) has implemented new restrictions regarding the use...

EU Commission Releases 2019 RAPEX Summary Statistics on Unsafe Consumer Products

The Commission of the European Union (EU) has released statistics on notices of unsafe,...

EU Commission Releases Report on Notified Body Response to Medical Device Conformity Assessments During Pandemic

The Commission of the European Union (EU) has published the results of its survey...
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EU Commission Amends Annex II of REACH

The Commission of the European Union (EU) has implemented modified safety data sheet requirements...

EU Proposes Revisions to REACH Annex

The Commission of the European Union (EU) has sent to the World Trade Organization...

EUs MDR Date of Application Delayed Until 2021

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

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,...
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