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in-vitro

UK Aligns with EU on IVD Device Regulations

The government of the United Kingdom is working to align its requirements for certain medical devices with those of the European Union (EU).

EU Commission Proposes More Time for Compliance with IVDR

The Commission of the European Union (EU) has proposed providing manufacturers of certain medical...

FDA to Host Webinar on In Vitro Diagnostic Devices EMC

The U.S. Food and Drug Administration (FDA) will host a webinar in early February...

EU Commission Sets Criteria for Reference Labs under the IVDR

The Commission of the European Union (EU) has recently detailed the criteria and tasks...

FDA Issues Updated EMC Guidance for Medical Devices

The U.S. Food and Drug Administration (FDA) has finalized its guidance on electromagnetic compatibility...
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EU Commission Updates Harmonized Standards for In Vitro Devices

The Commission of the European Union (EU) has updated its list of harmonized standards...

The EU’s MDR and IVDR Achieve Final Approval

The wait is nearly over for the official publication of the European Union’s (EU)...

EU Commission Issues New Standards List for In Vitro Diagnostic Medical Devices Directive

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

EU Commission issues new standards list for In Vitro Diagnostic Medical Devices Directive

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

EU Commission issues new standards list for In Vitro Diagnostic Medical Devices Directive

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