April 13, 2023 UDI for IVD Devices Used In-House: Part 3 For those that would say that the part of an IVD assay/test used only in a manufacturer’s in-house lab isn’t in “commercial distribution” and thus asserting that UDI requirements don’t apply: That is definitely a thought provoking stance. But I’m thinking that such […]
<h1 class="entry-title">Category: UDI</h1>
UDI for IVD Devices Used In-House: Part 2
April 13, 2023 UDI for IVD Devices Used In-House: Part 2 Once the reagent kit components (i.e., essential parts of the finished IVD device) of an IVD are sent to the healthcare facility for clinical use, then the finished IVD is in commercial distribution (thus triggering the UDI requirements) as I understand it. Also, […]
UDI for IVD Devices Used In-House: Part 1
April 12, 2023 UDI for IVD Devices Used In-House: Part 1 The U.S. FDA’s and the IVDR’s requirements for UDI aren’t generally contingent on where the subject device is used. Instead, the requirements are contingent on the definition of “medical device” and “in vitro diagnostic medical device” (hereinafter “device” / “devices”). Specifically and plainly, […]
EU MDR Basic UDI-DI “essential design and manufacturing characteristics”
April 7, 2023 EU MDR Basic UDI-DI “essential design and manufacturing characteristics” According to the MDCG (2018-1), the Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and […]
FDA UDI for Class 1 510(k)-Exempt Devices
March 10, 2023 FDA UDI for Class 1 510(k)-Exempt Devices I recently received an inquiry about the UDI implications of a device that the Labeler had previously miscategorized. FDA’s class-based UDI requirements are governed by the way FDA (i.e., the applicable U.S. classification regulation) categorizes/classifies the subject device; not by how the Labeler categorizes the subject […]