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) · SpainOfficial 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 · FranceTwo 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 · SwitzerlandFDA classifies fludeoxyglucose F18-guided radiation therapy system as class II with special controls.
US Federal Register - FDA Rules · United StatesPotential electrical component failure in Astral 100 and Astral 150 ventilators manufactured before October 2024 may interrupt therapy delivery.
AEMPS (Spanish Medicine Agency) · SpainFrom 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 phase-changing fiducial marker for radiation therapy as class II with special controls.
US Federal Register - FDA Rules · United StatesNICE conditionally recommends the XVIVO Perfusion System for organ preservation during a 4-year evidence-generation period.
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 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 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 · FranceGreece EOF recalls specified batches of Smartbag-Liquid Acid Concentrates, a Class IIb medical device.
Greece EOF · GreeceDräger expanded Field Safety Notice for Atlan Anaesthesia workstations due to manufacturing defect risking mechanical ventilation failure.
UK MHRA · UKMHRA 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-wide