Health-tech regulation, tracked.

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.

MDCG Position Paper on the management of SSCP in EUDAMED after mandatory use

Revised guidance on managing serious incidents and periodic safety update reports in EUDAMED following mandatory implementation.

Government confirms indefinite recognition of CE marked medical devices

UK extends indefinite recognition of CE-marked medical devices and IVDs already approved for the EU market.

Bill: Reprocessing of single-use medical devices permitted from 1 January 2027

Finland proposes legislation permitting reprocessing of single-use medical devices from 1 January 2027.

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.

Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; Revised Draft Guidance for Industry

FDA revises draft guidance on drug delivery device performance characteristics, data organization and regulatory review standards for combination products.

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.

Health Bill: medical device licensing regime - impact assessment

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

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.

MDCG guidance on clinical evidence for orphan IVDs (diagnostic tests for rare conditions)

MDCG published guidance establishing a proportionate regulatory framework for in vitro diagnostic devices used in rare conditions or exceptional clinical situations.

MDCG 2026-6: Guidance on clinical evidence for orphan IVDs

Updated guidance on classification rules and clinical evidence requirements for in vitro diagnostic devices under IVDR.

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.

Digital Mental Health Technologies (DMHT): Phase 1 evaluation survey

MHRA and NICE seek feedback on resources developed through the Wellcome Digital Mental Health Technologies programme.

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.

Clinical investigations for medical devices

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

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.

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: Ambient voice technology-enabled products

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

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.

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.