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 · UK
Category
Medical Devices & IVD
Medical device regulation covers the safety, performance, and market access of everything from bandages to implantable and software-based products. In the EU the Medical Device Regulation and the In Vitro Diagnostic Regulation set the conformity assessment, clinical evidence, notified body, and post-market surveillance requirements.
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 StatesGuidance: 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 · PortugalNew 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) · LatviaBulletin 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-wideDevices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine (DSI/2026/007)
MHRA enforcement notice requiring removal and quarantine of medical devices supplied without valid UKCA/CE markings or certification.
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-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-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 · UKContent of Human Factors Information in Medical Device Marketing Submissions; Guidance for Industry and FDA Staff
FDA guidance establishes a risk-based framework for human factors information required in device marketing submissions to CDRH.
US Federal Register - FDA Guidance Notices · United StatesLondon 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 · UKMedical Device User Fee Rates for Fiscal Year 2027
FDA announces medical device user fee rates and payment procedures for FY 2027 (October 1, 2026 – September 30, 2027) under MDUFA V.
US Federal Register - FDA Notices · United StatesNew 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-wideCorrect completion of data when registering an economic operator in EUDAMED
Guidance on proper and complete data entry and document submission for economic operator registration in EUDAMED to expedite registration and assignment of Single Registration Number.
Slovakia SUKL · SlovakiaGuidance: Approving clinical investigations
MHRA guidance on the approval process and criteria for clinical investigations of medical devices.
UK MHRA · UKGuidance: Timelines for acceptance of CE marked medical devices in Great Britain
MHRA guidance on transitional arrangements and timelines for accepting CE marked medical devices in GB.
UK MHRA · UKGuidance: Medical devices: post-market surveillance requirements
Guidance on interpreting post-market surveillance requirements for medical devices in Great Britain.
UK MHRA · UKUpdate - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5
Version 5 of the EC manual on borderline and classification decisions under MDR and IVDR published.
EC Public Health · EU-wideMDCG 2021-24 rev.1 - Guidance on classification of medical devices (April 2026)
Updated guidance on medical device classification issued by the Medical Device Coordination Group.
EC Public Health · EU-wideGuidance: Clinical investigations: investigators' responsibilities
Guidance on investigator obligations and requirements for clinical investigations of medical devices under MHRA regulation.
UK MHRA · UKGuidance: Medical devices that need a clinical investigation
Explains how to determine whether a medical device requires a clinical investigation or qualifies for exemption under regulations.
UK MHRA · UKCommission Delegated Regulation (EU) 2026/1451 amending MDR as regards exemptions from clinical investigation for implantable and Class III devices
Amendment to MDR exemption list for implantable and Class III devices from clinical investigation obligations.
EUR-Lex Official Journal · EU-wideRegulation of medical devices in Northern Ireland
MHRA guidance on the regulatory framework and applicable legislation for medical device manufacturers and suppliers operating in Northern Ireland.
UK MHRA · UKMDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices
MDCG guidance on post-market surveillance obligations for medical devices and IVDs under MDR and IVDR.
EC Public Health · EU-wideMDCG Position Paper: Management of SSCP in EUDAMED after mandatory use
MDCG guidance on managing Summary of Safety and Clinical Performance in EUDAMED following mandatory use implementation.
EC Public Health · EU-wideHealth Technology Assessment: Commission adopts rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices
Commission adopts rules enabling joint clinical assessments of medical devices and IVDs under the HTA Regulation.
EC Public Health · EU-wideUpdate - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - September 2025
European Commission updates the manual on borderline and classification decisions for medical devices and in-vitro diagnostics.
EC Medical Devices · EU-wideGuidance: Medical devices: Standardised format for the post market surveillance report
MHRA provides standardised format and recommendations for manufacturers preparing post-market surveillance reports.
UK MHRA · UKMDCG 2025-6 – FAQ on Interplay between the Medical Devices Regulation, In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act
FAQ clarifying how MDR, IVDR and the AI Act interact in the regulation of AI-enabled medical devices and diagnostics.
EC Medical Devices · EU-wideAEMPS 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) · SpainIntent To Exempt Certain Unclassified Medical Devices From Premarket Notification Requirements; Guidance for Industry and FDA Staff
FDA guidance describing its intent to exempt certain unclassified medical devices from premarket notification requirements.
US Federal Register - FDA Guidance Notices · United StatesFrequently Asked Questions on SiNATS Review: First Answers Now Available
INFARMED publishes initial FAQ clarifying changes to Portugal's National Health Technology Assessment System (SiNATS) introduced by Decree-Law 118/2026.
Portugal INFARMED · PortugalGuidance: AI Airlock Phase 2 Cohort
Phase 2 of the Airlock programme will include seven additional AI-powered technologies for clinical documentation, cancer diagnostics, eye disease detection, and obesity treatment.
UK MHRA · UKMHRA invites views on proposed changes to medical device regulation
MHRA publishes new pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the GB market and invites stakeholder views.
UK MHRA · UKPre-market medical devices regulation – stakeholder impact survey
MHRA seeks stakeholder evidence on proposed GB pre-market medical device and IVD regulation changes to inform impact assessment.
UK MHRA · UKMedical devices regulations: targeted consultation on the indefinite recognition of CE marked devices
MHRA invites views on proposals for recognising CE marked medical devices in Great Britain.
UK MHRA · UKChecklist for the inspection of medical device vigilance in hospitals
17.07.2026
Swissmedic · Switzerland
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