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EU Commission Opens Options for Remote Audits for Medical Devices

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

The EU Conflict Minerals Regulation

This article discusses and contextualizes the EU Conflict Minerals Regulation for the electronics sector. While electrical equipment manufacturers that place products on the EU market are not specifically targeted under the Regulation, the law applies to them if their operations involve importing conflict-implicated metals and minerals into the EU (e.g., for use in manufacturing their products). Regardless, the Regulation raises implications for any electrical equipment manufacturer that distributes and sells products in the EU, specifically when it comes to publicly reporting on uses of conflict minerals. The EU’s proposed “transparency platform” is detailed in this regard.

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...
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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...

EUs MDR Date of Application Delayed Until 2021

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