MDCG 2020-16 rev.5 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
Revised guidance on IVDR classification rules for in vitro diagnostic devices published.
EC Public Health · EU-wideHealth-tech regulation, tracked.
Health policy and regulation from official public bodies across the EU, UK, Switzerland, Norway and the US.
Regulation
Category
Type
Date
Health Bill: medical device licensing regime - impact assessment
Impact assessment of proposed changes to the UK medical device licensing regime under the Health Bill.
UK DHSC Policy Papers & Consultations · UKMHRA regulatory reform amendments tabled in Government's Health Bill
Proposed amendments to enable information sharing, regulatory reform, and development of a future medical device licensing regime.
UK MHRA · UKHealth Bill: medicines and medical devices regulatory reforms - fact sheet
Fact sheet outlining regulatory changes to medicines and medical devices legislation in the Health Bill.
UK DHSC Policy Papers & Consultations · UKClinical investigations for medical devices
Guidance on how to notify the MHRA of intention to carry out a clinical investigation for medical devices.
UK MHRA · UKNew 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) · LatviaMDCG 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) · 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-wideGuidance: 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 · UKAI 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-wideGuidance: 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 · 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 StatesEUDAMED 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-wideNew guideline: Swiss Good Practice for Materiovigilance in In-vitro Diagnostics (GPMV-IVD)
Guidance on serious incident reporting obligations for IVD professionals, defining incidents and specifying required information for Swissmedic notification.
Swissmedic · SwitzerlandGuidance: Innovation Accelerator
MHRA establishes an Innovation Accelerator programme offering scientific expertise, regulatory guidance and enhanced advice to developers of innovative health products.
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 · PortugalApplication of the AI Act transparency obligation in medical devices
Guidance on how the AI Act's transparency requirements apply to artificial intelligence used in medical devices.
Finland Fimea · FinlandRadiofrequency (RF) Safety Considerations for Wireless Cardiotocography (CTG) Monitoring Systems
MHRA guidance on RF safety risks in wireless CTG systems, including signal crossover, erroneous traces and dropouts.
UK MHRA · UKNew guidance for sponsors on the synchronised procedure for combined CTR–MDR/IVDR studies
Belgium introduces synchronised procedure guidance for combined clinical trials with medicinal products and device performance or clinical investigations.
FAMHP (Belgian Medicine Agency) · BelgiumNew 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-wideImplementing Regulation (EU) 2026/977 – uniform requirements for conformity assessment and notified bodies (Annex VII)
Implementing Regulation (EU) 2026/977 establishes uniform requirements for conformity assessment and notified bodies under the MDR/IVDR regime.
EC Public Health · EU-wideCommission Implementing Regulation (EU) 2026/977 laying down uniform quality management and procedural requirements for notified body conformity assessment activities under MDR and IVDR
Implementing regulation establishing uniform quality management and procedural requirements for notified bodies conducting conformity assessment under MDR and IVDR.
EUR-Lex Official Journal · EU-wide
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