Device, software, AI, health-data and reimbursement rules from 75 official public sources across the EU, UK, Switzerland and the US — classified, translated to English, and stripped of single-product noise. Updated several times a week.
FDA classifies diabetes digital behavioral therapeutic devices into class II with special controls to ensure safety and effectiveness.
US Federal Register - FDA Rules · United StatesEuropean regulations updating rules applicable to medical devices enter into force on 19 July 2026.
Portugal INFARMED · PortugalEU Delegated Regulation 2026/1451 amends MDR 2017/745, expanding implantable and Class III device requirements, effective 19 July 2026.
Latvia ZVA (State Agency of Medicines) · LatviaAEMPS reports a potential defect in the MiniMed Go diabetes management app affecting nighttime alert functionality.
AEMPS (Spanish Medicine Agency) · SpainEU Commission begins enforcement of AI Act rules and transparency requirements effective 2 August 2026.
EU AI Act Implementation · EU-wideTwo batches of Dexcom G7 continuous glucose monitoring sensors (1725204004 and 1725069002) were stolen and illegally distributed by unauthorised third parties; batches were discarded by manufacturer due to inadequate sterilisation.
AEMPS (Spanish Medicine Agency) · SpainBASG warns of unauthorised distribution of two batches of Dexcom G7 Sensor medical device by third parties.
Austria BASG · AustriaMandatory registration requirement for medical devices and in vitro diagnostic medical devices enters into force on 1 July 2026.
Swissmedic · SwitzerlandItalian Data Protection Authority fined Character.AI for GDPR violations including inadequate child safeguards and age-verification failures.
Garante Privacy (Italian DPA) · ItalyNewFDA classifies phase-changing fiducial marker for radiation therapy as class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies non-medicated topical formulation for erectile dysfunction treatment as Class II device with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies active noise attenuation systems for infant incubators as Class II devices subject to special controls.
US Federal Register - FDA Rules · United StatesFDA classifies prognostic test for chronic kidney disease progression assessment into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies intraoperative surgical angle measurement tool as class II device with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies over-the-counter SARS-CoV-2 test from clinical specimens into class II with special controls.
US Federal Register - FDA Rules · United StatesMHRA published field safety notices for medical devices issued between 20 and 24 July 2026.
UK MHRA · UKManufacturer withdraws specific batches of HomeChoice Personal Cycler equipment due to increased alarm emissions that could impair device function.
AEMPS (Spanish Medicine Agency) · SpainGreece EOF recalls specified batches of OverStritch Suture Cinch and Suture Cinch-Long Class IIb medical devices.
Greece EOF · GreeceMHRA published field safety notices for medical devices issued during the week of 13–17 July 2026.
UK MHRA · UKGreece EOF recalls batch 272955 of STA-C.K. Prest. in vitro diagnostic kits.
Greece EOF · GreeceAEMPS announces market withdrawal of specific single-piece Guedel cannulas for safety reasons.
AEMPS (Spanish Medicine Agency) · SpainMHRA published field safety notices for medical devices issued during 6–10 July 2026.
UK MHRA · UKGreece's EOF recalls batches of the CHORUS Ttg-G in-vitro diagnostic reagent product.
Greece EOF · GreeceEU delegated acts on well-established technologies for medical devices have been published.
EC Medical Devices · EU-wideFDA classifies computerized behavioral therapy device for fibromyalgia into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies radiological machine learning-based quantitative imaging software with predetermined change control plan as Class II medical devices.
US Federal Register - FDA Rules · United StatesNew Implementing Regulation establishes uniform requirements for conformity assessment and notified bodies under the Medical Devices Regulation.
EC Public Health · EU-wideInfarmed publishes guidance on the regulatory classification and requirements for digital health solutions when they qualify as medical devices.
Portugal INFARMED · PortugalMHRA invites expressions of interest from AI-enabled medical device manufacturers and NHS providers to participate in a regulatory sandbox programme.
UK MHRA · UKMHRA guidance to help manufacturers determine regulatory qualification and classification of digital mental health devices.
UK MHRA · UK