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 · PortugalOfficial publication of the decree establishing the Ségur du numérique en santé programme for paramedical professionals and midwives, setting the regulatory framework for software interoperability and secure health data exchange.
ANS - French Digital Health Agency · FranceINFARMED 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 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 · UKFDA classifies fludeoxyglucose F18-guided radiation therapy system as class II with special controls.
US Federal Register - FDA Rules · United StatesFrom 2 August 2026, the AI Act becomes enforceable; transparency rules require AI systems to disclose AI use and label AI-generated or altered content.
EU AI Act Implementation · EU-wideFDA classifies prognostic test for chronic kidney disease progression assessment into class II with special controls.
US Federal Register - FDA Rules · United StatesVersion 2.1 of the health data hosting (HDS) certification framework, published October 2026, strengthens transparency requirements on third-country data transfers and foreign legislation submission; compliance required three months after publication.
ANS - French Digital Health Agency · FranceMHRA guidance clarifies how existing medical device law applies to ambient voice technology products in UK health and care settings.
UK MHRA · UKFDA 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 StatesGuidance on how to classify safety wristbands used in telecare services and the criteria for recognising them as medical devices.
Poland URPL · PolandHMA and EMA invite stakeholders to a forum on artificial intelligence and data governance in medicines regulation.
Slovenia JAZMP · SloveniaThe AI Act enforcement is shared between the EU AI Office, national competent authorities, and the EDPS, with each body responsible for different categories of AI systems.
EU AI Act Implementation · EU-wideSwissmedic 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 RepublicSpanish data protection authority examines how data quality, accuracy and minimisation principles apply to personal data processing by AI systems.
AEPD (Spanish Data Protection Agency) · SpainEU Commission publishes guidance on AI Act transparency obligations for interactive AI systems and AI-generated content, effective 2 August 2026.
EU AI Act Implementation · EU-wideEC Public Health issues guidance on AI use in preparing Joint Clinical Assessment dossiers for clinical trials.
EC Public Health · EU-widegematik publishes practical guidance for care facilities on implementing and using KIM, the secure health-sector email service within Germany's Telematikinfrastruktur.
gematik (German Digital Health) · GermanyManufacturers 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-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-wideFinland amended prescribing regulations to permit nurses, public health nurses and midwives to prescribe medicines via remote and telephone appointments, effective 8 June 2026.
Finnish Supervisory Agency (Lupa- ja valvontavirasto) · FinlandFindings from the National Commission's call for evidence and research activities on AI regulation in healthcare.
UK MHRA · UKCommission policy to increase AI experts and literacy among workers and the public; Article 4 AI Act obligations on providers and deployers to support staff AI literacy.
EU AI Act Implementation · EU-wideImplementing Regulation (EU) 2026/977 establishes uniform requirements for conformity assessment and notified bodies under the Medical Devices Regulation.
EC Public Health · EU-wide