Guidance: Ambient voice technology-enabled products
Guidance on device qualification and classification of ambient voice technology-enabled products as medical devices in Great Britain.
UK MHRA · UKHealth-tech regulation, tracked.
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.
Regulation
Category
Impact
Date
MHRA clarifies regulatory status of ambient voice technologies used in the NHS
MHRA guidance clarifies how medical device law applies to ambient voice technology products in UK health and care settings.
UK MHRA · UKGuidance: Digital mental health technology: qualification and classification
Guidance to help manufacturers of digital mental health technologies determine regulatory qualification and appropriate device classification.
UK MHRA · UKGuidance on qualification and classification of safety wristbands used in telecare services and recognition as medical devices
Guidance on how to qualify and classify safety wristbands used in telecare services as medical devices and their regulatory classification.
Poland URPL · PolandChanges to the questions and answers and guidance document on mobile technologies
Swissmedic updated its Q&A and guidance document on mobile technologies.
Swissmedic · SwitzerlandINFARMED guidance on digital health solutions as medical devices
INFARMED publishes guidance clarifying the regulatory framework for digital health solutions including software, mobile applications and AI-based solutions as medical devices.
Portugal INFARMED · PortugalHDS Certification Framework v2.1: anticipated changes
Version 2.1 of the health data hosting certification framework, published October 2026, strengthens transparency requirements on third-country data transfers and foreign legislation submission.
ANS - French Digital Health Agency · FranceMedical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device
FDA classifies diabetes digital behavioral therapeutic devices into class II with special controls to ensure safety and effectiveness.
US Federal Register - FDA Rules · United StatesSégur du numérique en santé: regulatory framework for paramedical professionals and midwives published
Official 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 · FranceNew European regulations updating rules for medical devices enter into force
New European regulations updating medical device rules enter into force on 19 July 2026.
Portugal INFARMED · Portugalswissdamed: Mandatory registration of medical devices and in vitro diagnostic medical devices as of 1 July 2026
Mandatory registration of medical devices and in vitro diagnostic medical devices in the Swiss registry (swissdamed) enters into force.
Swissmedic · SwitzerlandPublished amendments to the regulation on medical devices
Commission Delegated Regulation (EU) 2026/1451 amending Regulation (EU) 2017/745 on medical devices enters into force on 19 July 2026, expanding requirements for implantable and Class III devices.
Latvia ZVA (State Agency of Medicines) · LatviaNew Guide: 'How to' KIM for Care Facilities
gematik publishes guidance on implementing and using KIM (secure healthcare email) in care facilities, based on pilot experience in Hamburg region.
gematik (German Digital Health) · GermanyMDCG Opinion 2026-5 on UDI assignment between manufacturers and distributors
Publication of MDCG guidance on the allocation of unique device identification (UDI) responsibilities between manufacturers and distributors.
Czechia SUKL · Czech RepublicBulletin on Medical Devices. April–June 2026
Bulletin implementing EU Regulation 2026/977 establishing uniform quality management and conformity assessment procedure requirements for medical devices.
AEMPS (Spanish Medicine Agency) · SpainAEMPS enables procedure for prior notification of in-house manufacture of in vitro diagnostic devices
AEMPS establishes a procedure for healthcare centres to submit prior notifications of in-house IVD manufacture pending the specific electronic application.
AEMPS (Spanish Medicine Agency) · SpainAEPD analysis of data quality, accuracy and minimisation in processing by AI systems
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AEPD (Spanish Data Protection Agency) · SpainGeneral Principles on the use of Artificial Intelligence in the preparation of the JCA dossier
EC Public Health publishes general principles governing AI use in preparing Joint Clinical Assessment dossiers.
EC Public Health · EU-wideLondon Region I MHRA Regulatory Sandbox: call for expressions of interest
MHRA invites expressions of interest from AI-enabled medical device manufacturers and NHS providers to participate in a regulatory sandbox.
UK MHRA · UKRegulatory Alignment for Predictable and Immediate Device Coverage Pathway (CMS-3487-NC) Procedural Notice Inviting Comment
CMS proposes a faster pathway for manufacturers to obtain Medicare coverage of new medical devices.
US CMS Newsroom · United StatesThe enforcement framework of the AI Act
The European Commission's AI Office, national competent authorities, and the European Data Protection Supervisor share enforcement of the AI Act across different AI system categories.
EU AI Act Implementation · EU-wideAI Act enforcement and transparency requirements begin 2 August 2026
From 2 August 2026, AI Act enforcement begins and transparency rules require AI systems to disclose interaction with users and label AI-generated or altered content.
EU AI Act Implementation · EU-wideChecklist for the inspection of medical device vigilance in hospitals
17.07.2026
Swissmedic · SwitzerlandGuidance: Custom-made medical devices in Great Britain
Explains regulatory compliance requirements for manufacturers of custom-made medical devices.
UK MHRA · UKCommission guidelines on transparency obligations for providers and deployers of certain AI systems
Guidelines clarify AI Act transparency obligations for interactive AI systems and AI-generated content, effective 2 August 2026.
EU AI Act Implementation · EU-wideGuidance: In vitro diagnostic point-of-care test devices
Guidance on management and use of point-of-care testing in vitro diagnostic devices.
UK MHRA · UKAI talent, skills and literacy
Commission policy to increase AI experts and literacy among workers and the public; Article 4 AI Act obligations on providers and deployers entered into force February 2025, amended July 2026.
EU AI Act Implementation · EU-wideMSSanté deployment guide: supporting healthcare facilities towards generalised use of secure messaging
Guidance on implementing MSSanté secure messaging across healthcare facilities in France.
ANS - French Digital Health Agency · FranceNew Implementing Regulation sets out uniform requirements for conformity assessment and notified bodies
An Implementing Regulation establishes uniform requirements for conformity assessment and notified bodies under the medical device framework.
EC Public Health · EU-wideNational Commission into the Regulation of AI in Healthcare: research, engagement and call for evidence findings
Findings from the National Commission's call for evidence and research activities on AI regulation in healthcare.
UK MHRA · UK
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