in-vitro Archives - In Compliance Magazine

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 on its requirements regarding the electromagnetic compatibility (EMC) of in vitro diagnostic (IVD) medical devices. According... Read More...

EU Commission Sets Criteria for Reference Labs under the IVDR

The Commission of the European Union (EU) has recently detailed the criteria and tasks applicable to EU reference laboratories (EURLs) specializing in the assessment of high-risk in vitro diagnostic medical dev... Read More...

FDA Issues Updated EMC Guidance for Medical Devices

The U.S. Food and Drug Administration (FDA) has finalized its guidance on electromagnetic compatibility (EMC) in connection with medical devices, including in vitro diagnostic (IVD) devices. Posted to the FD... Read More...

EU Commission Updates Harmonized Standards for In Vitro Devices

The Commission of the European Union (EU) has updated its list of harmonized standards applicable to in-vitro medical devices to reflect the latest available technical and scientific information. According to ... Read More...

The EU’s MDR and IVDR Achieve Final Approval

The wait is nearly over for the official publication of the European Union’s (EU) new regulations applicable to medical devices and in vitro diagnostic devices. According to a posting on the website of the E... Read More...

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 that can be used to demonstrate compliance with the essential requirements of its Directive 98/79/EC, dealing with in-vitro d... Read More...

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 that can be used to demonstrate compliance with the essential requirements of its Directive 98/79/EC, dealing with in-vitro d... Read More...

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 that can be used to demonstrate compliance with the essential requirements of its Directive 98/79/EC, dealing with in-vitro d... Read More...

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 that can be used to demonstrate compliance with the essential requirements of its Directive 98/79/EC, dealing with in-vitro d... Read More...

EU Commission amends In-Vitro Medical Devices Directive

The Commission of the European Union (EU) has amended its Directive 98/79/EC on in-vitro medical devices. Published in December 2011 in the Official Journal of the European Union, the Commission’s action adds a... Read More...

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