Device, software, AI, health-data and reimbursement rules from 75 official public sources across the EU, UK, Switzerland and the US — all of it stored and classified, so you can filter to what binds you. Translated to English. Updated daily.
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) · LatviaMandatory registration requirement for medical devices and in vitro diagnostic medical devices enters into force on 1 July 2026.
Swissmedic · SwitzerlandINFARMED publishes guidance clarifying the regulatory framework for digital health solutions, including software, mobile applications and AI-based solutions, 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 on device qualification and classification of ambient voice technology-enabled medical devices for the Great Britain market.
UK MHRA · UKMHRA guidance to help manufacturers determine regulatory qualification and classification of digital mental health devices.
UK MHRA · UKFDA proposes reclassifying digital breast tomosynthesis systems from class III (premarket approval) to class II (special controls) with premarket notification.
US Federal Register - FDA Rules · United StatesFDA classifies fludeoxyglucose F18-guided radiation therapy system as class II with special controls.
US Federal Register - FDA Rules · United StatesFDA classifies phase-changing fiducial marker for radiation therapy as class II 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 non-medicated topical formulation for erectile dysfunction treatment as Class II device 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 StatesFDA classifies prognostic test for chronic kidney disease progression assessment into class II with special controls.
US Federal Register - FDA Rules · United StatesMHRA guidance clarifies how existing medical device law applies to ambient voice technology products in UK health and care settings.
UK MHRA · UKEU 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-wideCMS proposes a faster pathway for manufacturers to obtain Medicare coverage of new medical devices.
US CMS Newsroom · United StatesGuidance on how to classify safety wristbands used in telecare services and the criteria for recognising them as medical devices.
Poland URPL · PolandSwissmedic updated its Q&A and guidance document on mobile technologies, effective 1 August 2026.
Swissmedic · SwitzerlandMDCG guidance on allocation of unique device identification (UDI) responsibilities between manufacturers and distributors in the supply chain.
Czechia SUKL · Czech RepublicMHRA guidance on regulatory compliance requirements for manufacturing custom-made medical devices in Great Britain.
UK MHRA · UKParliamentary amendments to proposed European Biotech Act framework amending regulations on food safety, advanced therapies, clinical trials, veterinary medicines, and biomanufacturing.
European Parliament - SANT Subcommittee (Public Health) · EU-wide Also reported by European Parliament - SANT Subcommittee (Public Health)EUDAMED 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-wideHigh-risk AI systems in medical devices must meet AI Act requirements: risk management, data governance, documentation, logging, transparency, oversight, cybersecurity; penalties up to €15M or 3% global turnover.
EC AI Act & Regulation · EU-wide