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) · LatviaEU Commission begins enforcement of AI Act rules and transparency requirements effective 2 August 2026.
EU AI Act Implementation · EU-wideMandatory registration requirement for medical devices and in vitro diagnostic medical devices enters into force on 1 July 2026.
Swissmedic · SwitzerlandFDA 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 over-the-counter SARS-CoV-2 test from clinical specimens 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 prognostic test for chronic kidney disease progression assessment into class II with special controls.
US Federal Register - FDA Rules · United StatesEU 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 · UKMHRA guidance on device qualification and classification of ambient voice technology-enabled medical devices for the Great Britain market.
UK MHRA · UKANS announces upcoming changes to the HDS (Health Data Hosting) framework v2.1 that organisations should prepare for now.
ANS - French Digital Health Agency · FranceEUDAMED database core modules (UDI/Device, economic actor registration, notified body certificates, market surveillance) become mandatory 6 months after Official Journal publication; national registrations replaced.
EUDAMED · EU-wideManufacturers must report all adverse events and post-market surveillance data through EUDAMED Vigilance module, replacing national systems.
EUDAMED · EU-wideEHDS Regulation becomes binding law 20 days after publication in the EU Official Journal.
European Commission · EU-wideFDA classifies skin patch for hyperhidrosis treatment into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies monitor for opioid-induced impairment of oxygenation into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies medial knee implanted shock absorber as class II device subject to special controls.
US Federal Register - FDA Rules · United StatesFDA classifies external lower extremity nerve stimulator for Restless Legs Syndrome as Class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies SARS-CoV-2 serology test as class II device with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies prognostic test for preeclampsia development or progression into class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies infant supine sleep system as class II device with special controls to ensure safety and effectiveness.
US Federal Register - FDA Rules · United States