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European Union

The EU’s MDR is Now in Effect

The European Union’s (EU’s) new regulation for medical devices sold or imported into the...

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 Opens Options for Remote Audits for Medical Devices

The Regulatory Affairs Professional Society (RAPS) reports that the Commission of the 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...
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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...

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...
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