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
FDA have updated the consensus standards- as at 26/05/2025. For the degree of recognition click on the recognition information column - Recognized Consensus Standards: Medical Devices This includes many CLSI updates for IVDs including some software aspects. Below are just the IVD updates. 05/26/2025 InVitro Diagnostics 7-328 Partial CLSI M100 35th Edition Performance Standards for Antimicrobial Susceptibility Testing 05/26/2025…
Ben KempJune 9, 2025
MDSAP have launched their refreshed website providing information on the Medical Device Single Audit Program. Official members include TGA Australia, ANVISA, Brazil, Health Canada, PMDA Japan, and US FDA, With the EU, HSA Singapore, MHRA UK, and WHO having joined as official observers, and ANMAT Argentina, Israel’s Ministry of Health, Kenya’s Pharmacy and Poisons Board, Republic of Korea Ministry of…
Ben KempMay 28, 2025
Standardising Preoperative Urine Testing in Urology GIRFT has released a second guide in its preoperative testing series, focused on delivering a standardised approach to screening, managing, and treating urinary infections prior to elective urology surgery. Developed by GIRFT’s anaesthetic and perioperative medicine (APOM) clinical and nursing leads, the guide is aimed at clinicians and managers who work across the elective pathway…
Ben KempMay 15, 2025
CLSI have updated EP32 Metrological Traceability to align with ISO 17511: https://www.linkedin.com/posts/clsilabnews_out-now-is-clsi-ep32-implementation-of-metrological-activity-7326236959385821184-v66f?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAAeH9EBFpe2TIKx6c7gKShKVeAb46UjtpM
Ben KempMay 15, 2025