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.
G7 data protection authorities conclude Paris meeting on common principles for online child protection and rights-respecting AI governance.
Garante Privacy (Italian DPA) · ItalyNewThe eHealth Digital Service Infrastructure (eHDSI) is an infrastructure ensuring the continuity of care for European citizens while they are travelling abroad in the EU. This gives EU countries the possibility to exch...
MyHealth@EU Cross-Border Services · EU-wideNewThe AI Act Complaint Tool allows individuals and organisations to submit complaints to the AI
EU AI Act Implementation · EU-wideNewThe EU AI Act enforcement is shared between the European Commission's AI Office and member state authorities.
EU AI Act Implementation · EU-wideNewSwissmedic provides updated information on the implementation of eCTD v4.0 format for regulatory submissions.
Swissmedic · SwitzerlandNewSwissmedic updates guidance on electronic exchange of individual case safety reports in E2B(R3) format via B2B gateway, effective 01.08.2026.
Swissmedic · SwitzerlandNewSwissmedic updated its Q&A and guidance document on mobile technologies, effective 1 August 2026.
Swissmedic · SwitzerlandNewFAMHP updates on pending EU legislative initiatives including Biotech Act, MDR/IVDR revision, Critical Medicines Act, pharmaceutical legislation and online health information measures.
FAMHP (Belgian Medicine Agency) · BelgiumNewFDA draft guidance clarifies recommendations for developing container closure systems and device constituent parts for biosimilar and interchangeable biosimilar products.
US Federal Register - FDA Guidance Notices · United StatesNewInfarmed publishes guidance on the regulatory classification and requirements for digital health solutions when they qualify as medical devices.
Portugal INFARMED · PortugalEU Commission begins enforcement of AI Act rules and transparency requirements effective 2 August 2026.
EU AI Act Implementation · EU-wideMHRA guidance on safe use of MRI equipment in clinical settings.
UK MHRA · UKMHRA launches a regulatory sandbox in London to test AI-enabled devices in real-world environments.
UK MHRA · UKMHRA invites expressions of interest from AI-enabled medical device manufacturers and NHS providers to participate in a regulatory sandbox programme.
UK MHRA · UKMHRA guidance clarifies how existing medical device law applies to ambient voice technology products in UK health and care settings.
UK MHRA · UKMDCG guidance on allocation of unique device identification (UDI) responsibilities between manufacturers and distributors in the supply chain.
Czechia SUKL · Czech RepublicMHRA 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 classifies phase-changing fiducial marker for radiation therapy as class II with special controls.
US Federal Register - FDA Rules · United StatesAEMPS adopts a governance model and implementation roadmap for the EU health technology assessment framework, supported by EC technical assistance.
AEMPS (Spanish Medicine Agency) · SpainFimea will continue to provide guidance to clinical trial researchers on the Clinical Trials Information System (CTIS) as needed.
Finland Fimea · FinlandNICE conditionally recommends a lung preservation machine that keeps donated lungs viable outside the body, potentially enabling hundreds of additional transplants.
UK NICE · UKFDA 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 diabetes digital behavioral therapeutic devices into class II with special controls to ensure safety and effectiveness.
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 StatesFDA classifies intraoperative surgical angle measurement tool as class II device with special controls.
US Federal Register - FDA Rules · United StatesQuarterly bulletin reporting on implementation of EU medical device regulations, including Commission Implementing Regulation (EU) 2026/977 on quality management and conformity assessment procedures.
AEMPS (Spanish Medicine Agency) · SpainSpanish data protection authority examines how data quality, accuracy and minimisation principles apply to personal data processing by AI systems.
AEPD (Spanish Data Protection Agency) · Spain