Medical Devices & IVD

Register medical devices to place on the market

MHRA guidance on the registration process and requirements for medical devices in Great Britain and Northern Ireland.

Medical device instructions for use must be accessible and understandable to the user

Patient reported outcomes (PROs) resources for digital mental health technologies

Resources to help developers use patient-reported outcomes in digital mental health technologies for evidence generation, monitoring and user safety.

Guidance: Good machine learning practice for medical device development

Ten guiding principles for developing machine learning-based medical devices.

Clinical investigations for medical devices

Guidance on how to notify the MHRA of intention to carry out a clinical investigation for medical devices.

CLIA: Virtual Access, Gynecologic Cytology Proficiency Testing, Personnel Qualifications, and Other Changes — Proposed Rule

Proposed amendments to CLIA regulations to permit virtual access for laboratory testing data, digital images for cytology proficiency testing, and updated personnel and reporting requirements.

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.

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.

Bulletin on Medical Devices. April–June 2026

Bulletin implementing EU Regulation 2026/977 establishing uniform quality management and conformity assessment procedure requirements for medical devices.

Guidance: Ambient voice technology-enabled products

Guidance on device qualification and classification of ambient voice technology-enabled products as medical devices in Great Britain.

Robotically-Assisted Surgical Devices—Premarket Submissions; Draft Guidance for Industry and FDA Staff

FDA announces draft guidance on premarket submission requirements for robotically-assisted surgical devices.

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.

AI 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.

Guidance: Digital mental health technology: qualification and classification

Guidance to help manufacturers of digital mental health technologies determine regulatory qualification and appropriate device classification.

Health Bill: medical device licensing regime - impact assessment

Impact assessment of proposed changes to the UK medical device licensing regime under the Health Bill.

Regulatory 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.

EUDAMED 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 Vigilance Module Mandatory

Manufacturers must report all adverse events and post-market surveillance data through EUDAMED Vigilance module, replacing national systems.

Guidance 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.

Changes to the questions and answers and guidance document on mobile technologies

Swissmedic updated its Q&A and guidance document on mobile technologies.

INFARMED 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.

MHRA Real-World Evidence: knowledge and guidance

MHRA guidance on the use of real-world data and real-world evidence in regulatory decision-making for medicines and medical devices.

Learning from medical device incidents is possible when they are reported

Guidance on the importance of reporting medical device incidents to enable learning and safety improvements.

MHRA 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.

Application 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.

Health Bill: medicines and medical devices regulatory reforms - fact sheet

Fact sheet outlining regulatory changes to medicines and medical devices legislation in the Health Bill.

Guidance: AI Airlock Phase 3 application

Applications for phase 3 of the AI Airlock regulatory sandbox are now open.

New European regulations updating rules for medical devices enter into force

New European regulations updating medical device rules enter into force on 19 July 2026.

swissdamed: 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.

Published 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.

New 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.

Implementing 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.

Commission 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.

Correct 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.

Guidance: Approving clinical investigations

MHRA guidance on the approval process and criteria for clinical investigations of medical devices.

Guidance: 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.

Guidance: 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.

Medical Devices: Delegated acts on well-established technologies published

Delegated acts establishing criteria and procedures for well-established technologies under the MDR have been published.

Update - 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.

MDCG 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.

Guidance: Clinical investigations: investigators' responsibilities

Guidance on investigator obligations and requirements for clinical investigations of medical devices under MHRA regulation.

Guidance: 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.

Commission 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.

Regulation 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.

MDCG 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.

MDCG Position Paper: UDI assignment between manufacturers and distributors

MDCG guidance on practical application of UDI assignment responsibilities under MDR and IVDR.

Devices 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.

MDCG 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.

New guideline: Swiss Good Practice for Post-Market Surveillance of In-Vitro Diagnostics (GPMV-IVD)

Swissmedic publishes new guideline on post-market surveillance practices for in-vitro diagnostic devices.

AEMPS 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.