Clinical investigations for medical devices
Guidance on how to notify the MHRA of intention to carry out a clinical investigation for medical devices.
UK MHRA · UKHealth-tech regulation, tracked.
Device, software, AI, health-data and reimbursement rules from 77 official sources across the EU, UK, Switzerland and the US. Updated daily.
Regulation
Category
Type · Breadth
Date
MDCG 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 RepublicGuidance: 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 · UKMHRA 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 · 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 StatesHDS 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 · FranceGuidance: 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 · UKThe 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-wideGuidance 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 · PortugalAI 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-wideNew 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) · Latvia Also reported by UK MHRANational 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 · UKBulletin 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) · SpainAEPD analysis of data quality, accuracy and minimisation in processing by AI systems
The Spanish Data Protection Authority examines GDPR compliance requirements for data quality, accuracy and minimisation in AI-based processing.
AEPD (Spanish Data Protection Agency) · SpainGuidance: Borderline products: medical devices and other products
MHRA guidance on how it determines whether a borderline product meets the definition of a medical device and whether device regulations apply.
UK MHRA · UKMedical Devices: Delegated acts on well-established technologies published
Delegated acts establishing criteria and procedures for well-established technologies under the MDR have been published.
EC Medical Devices · EU-wideIberoamerican Network approves reference document on enhanced safeguards required for neurodata processing in non-health settings
The Iberoamerican Network of Data Protection Authorities has approved a reference document establishing enhanced safeguards for processing neurodata outside healthcare contexts.
AEPD (Spanish Data Protection Agency) · SpainNew impulse paper provides recommendations for cross-process digital transformation
Working group recommends criteria and priorities for digitising paper-based healthcare and care processes under the 'Gemeinsam Digital' strategy.
gematik (German Digital Health) · GermanyAI Act for Medical Devices
High-risk AI systems in medical devices must meet AI Act requirements on risk management, data governance, documentation, logging, transparency and oversight, with penalties up to €15M or 3% of global turnover.
EC AI Act & Regulation · EU-wideEUDAMED Core Modules Become Mandatory
EUDAMED core modules (economic actor, UDI/device, certificate, market surveillance) become mandatory 6 months after Official Journal publication; national registrations replaced.
EUDAMED · EU-wideEUDAMED Vigilance Module Mandatory
Manufacturers must report all adverse events and post-market surveillance data through EUDAMED Vigilance module, replacing national systems.
EUDAMED · EU-wideEuropean Health Data Space (EHDS) Regulation: overview
The EHDS is the EU's first sector-specific common data space, establishing a framework for health data access and use across member states.
European Health Data Space · EU-wideEuropean Health Data Space Regulation: entry into force
EHDS Regulation becomes law 20 days after publication in the EU Official Journal.
European Commission · EU-wideCommission 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: Innovation Accelerator
MHRA establishes an Innovation Accelerator programme offering scientific expertise, regulatory guidance and enhanced advice to developers of innovative health products.
UK MHRA · UK
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