Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
You can find the document here.
Ben KempJuly 4, 2025
FDA have announced a number of reclassifications of Class III devices to lower classifications such as Class II ( with special controls). These include: muscular dystrophy newborn screening tests herpes simplex virus nucleic acid-based assay for central nervous system infections fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies lysosomal storage disorder newborn screening test systems.
Ben KempJuly 4, 2025
Please note that this consultation closes 11th August 2025. The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing…
Ben KempJuly 4, 2025
Please see this list of FDA consensus standards (updated last month). Of note are the items below including AAMI TIR45 on AGILE practices in software development, and the updated Common Vulnerability Scoring System (CVSS), noting that both 3.1 and 4.0 are recognised, but that the period for which 3.1 is recognised is 7 months then 4.0 is recognised. As usual,…
Ben KempJuly 4, 2025
NEW — CLSI EP46 Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measurement Procedures CLSI EP46 provides models and approaches for setting allowable total error (ATE) goals and limits, helping developers and laboratories define acceptance criteria for quantitative test methods. This essential resource covers: Approaches for determining ATE based on clinical outcomes, biological variation, and…
Ben KempJune 26, 2025
An update from Taylor Wessing on international patents and the United Patent Court decisions, and approach: Synapse | Two years of UPC patent litigation
Ben KempJune 18, 2025
Not sector specific, but the requirements are commonly applied as horizontal legislation impacting the sector, and apply to IVD instruments or accessories with WiFi, Bluetooth, Cellular and/or Near Field Communications (NFC) functions: Comply with wireless regulations. For manufacturers, importers and suppliers of Bluetooth®, Wi-Fi, cellular and short-range devices, compliance with regulatory requirements is key to global market access. At UL…
Ben KempJune 18, 2025
Note that MHRA have issued the below notice regarding Biotin Interference with Thyroid Function Tests (Immunoassays). FDA had previously issued guidance regarding this topic Testing for Biotin Interference in In Vitro Diagnostic Devices | FDA. Although MHRA have specifically highlighted the issue with TFT tests, manufacturers should consider Biotin interference with their Immunoassays more generally. MHRA have an ongoing consultation…
Ben KempJune 9, 2025