ICH Adopts E6(R3) Annex 2: New Global Guidance for Decentralised Trials, Digital Technologies and Real-World Data
ICH has adopted E6(R3) Annex 2, introducing new Good Clinical Practice guidance for decentralised clinical trials, digital health technologies and real-world data. Learn what it means for medical device manufacturers.
FDA Establishes Class II Classification for TENS Devices Intended to Reduce Fibromyalgia Symptoms
FDA has established a new Class II classification with special controls for transcutaneous electrical nerve stimulators (TENS) intended to treat fibromyalgia symptoms, creating a new regulatory pathway for manufacturers.
Team-NB Publishes Position Paper on the Transfer of IVDR Applications and Legacy Device Surveillance Between Notified Bodies
Team-NB has published a position paper introducing a template agreement for transferring IVDR applications and legacy device surveillance between notified bodies.
Team-NB Publishes Updated Consensus Document on the MDR Certification Process
Team-NB has published Version 2 of its MDR Certification Process Consensus Document, providing detailed guidance on pre-application, application, conformity assessment and surveillance activities for medical device manufacturers under EU MDR 2017/745.
FDA Reports 1,284 Devices Granted Breakthrough Device Designation as of March 2026
The FDA has reported 1,284 Breakthrough Device designations and 198 market-authorised Breakthrough Devices as of March 2026. Learn what this means for medical device manufacturers and U.S. market access strategies.
FDA Adds Five Additional Unclassified Medical Devices to 510(k) Enforcement Discretion Policy
FDA has updated its guidance on unclassified medical devices, adding five additional device types to its 510(k) enforcement discretion policy. Learn what this means for manufacturers and ongoing FDA compliance obligations.
FDA Adopts ICH M11 CeSHarP Guidance: What Sponsors Need to Know About the Future of Clinical Trial Protocols
The FDA has adopted ICH M11 CeSHarP, introducing a harmonized framework for clinical trial protocols. Discover the impact on sponsors and global studies.
European Commission Publishes Third Version of Living Guidelines on the Responsible Use of Generative AI in Research
The European Commission has released Version 3 of its Living Guidelines on the Responsible Use of Generative AI in Research. Learn what the new recommendations mean for medical device manufacturers, clinical evaluation, data protection and research activities.
MedTech Europe Responds to Consultation on the Revision of the EU Cybersecurity Act
MedTech Europe responds to the EU Cybersecurity Act consultation, highlighting key implications for medical device and IVD manufacturers, including certification, vulnerability management, and supply chain security.
FDA Finalizes Risk-Based Guidance on Human Factors Information in Medical Device Submissions
The FDA has published its final guidance on Human Factors information in medical device submissions, introducing a new risk-based framework and three Human Factors Submission Categories. Learn what manufacturers need to know.
FDA Replaces 25-Year-Old Bioequivalence Statistical Guidance with Major Update
The FDA has released a major update to its Bioequivalence Statistical Guidance, replacing the 2001 version. The new document introduces adaptive designs, modern statistical methods, guidance for highly variable drugs, NTI products, missing data handling and model-based approaches for generic drug development.
Australia Updates Guidance on UDI Compliance Timeframes for Medical Devices
The TGA has updated its guidance on UDI compliance timeframes for medical devices in Australia, including clarifications on legacy devices, EU MDR transitions, consignment stock, and Surgical Loan Kits.
Proposed MDR Article 50 Raises Concerns Over Notified Body Independence and Financial Sustainability
A new legal opinion analyses the European Commission’s proposed MDR Article 50, highlighting potential impacts on notified bodies, SMEs, certification costs, and conformity assessment access.
ANVISA Publishes 2024–2025 Good Clinical Practice Inspection Metrics: What Clinical Trial Sponsors and Manufacturers Should Know
ANVISA’s new 2024–2025 GCP inspection report highlights critical findings in clinical trials, data integrity, electronic systems, SOPs, and investigational product management. Learn what manufacturers and sponsors should review.
Swissmedic Highlights Updated MIR Template for Serious Incident Reporting Under MDR/IVDR
Swissmedic highlights the updated MIR template version 7.3.1 for MDR/IVDR vigilance reporting. Learn how the new requirements impact medical device and IVD manufacturers.
TGA Introduces Streamlined UDI Consent-to-Supply Pathway for Non-Compliant Medical Devices
Australia’s TGA has released new guidance on streamlined UDI Consent-to-Supply applications for medical devices that do not meet UDI-related Essential Principles. Learn how the changes affect manufacturers, ARTG entries, timelines, fees, and compliance strategies.
European Commission Publishes Updated EUDAMED UDI Devices User Guide
The European Commission released version 2.27.0 of the EUDAMED UDI Devices User Guide, clarifying UDI registration, EMDN management, packaging levels, and lifecycle updates under MDR and IVDR.
HTA Coordination Group Adopts Guiding Principles on Data Transparency
The EU HTA Coordination Group has adopted new guiding principles on data transparency, clarifying confidentiality expectations for Joint Clinical Assessments involving medical devices and IVDs.
TGA Expands Recognition of UK Approved Bodies for Medical Devices and IVDs
The Australian TGA has updated its guidance to recognise UK Approved Bodies as comparable overseas regulators, potentially simplifying ARTG submissions for medical device and IVD manufacturers.
