Swissmedic Updates Hospital Materiovigilance Inspection Checklist for Medical Devices and IVDs
Swissmedic’s updated hospital materiovigilance inspection checklist covers quality management, incident reporting, FSN and FSCA handling, traceability, UDI and staff training for medical devices and IVDs.
UK Government Accepts All 44 Recommendations on AI Regulation in Healthcare
The UK Government has accepted all 44 recommendations from the National Commission on AI in Healthcare, setting out a roadmap for lifecycle regulation, PCCPs, post-market oversight, cybersecurity and clearer pathways for AI-enabled medical devices.
Health Canada Implements Updated Bioequivalence and Biowaiver Evaluation Templates
Health Canada has implemented updated Version 2 templates for bioequivalence and BCS-based biowaiver submissions, aligned with ICH M10, M13A and M9.
Anvisa Publishes Implementation Plan for ICH E8(R1) and E6(R3) Guidelines
Anvisa has published its implementation plan for ICH E8(R1) and E6(R3), outlining a gradual approach to applying updated principles for clinical studies and Good Clinical Practice in Brazil.
MHRA Updates Safety Guidelines for MRI Equipment in Clinical Use
MHRA’s fifth edition of its MRI safety guidelines provides updated recommendations on MR hazards, governance, controlled access, implants, pregnancy, exposure, training, equipment lifecycle and incident reporting.
FDA List Highlights Authorized Companion Diagnostic Devices and Group Labeling
FDA’s companion diagnostic device list includes 232 authorized IVD and imaging entries, with group labeling approaches for oncology therapies and a new 2026 melanoma CDx authorization.
EU Expert Panel Raises Clinical Evidence Concerns for Bioabsorbable Orthopaedic Screws
An EU CECP Expert Panel has issued a scientific opinion on Class III bioabsorbable orthopaedic screws, identifying gaps in clinical evidence, benefit-risk assessment and PMCF planning.
Swissmedic Updates Guidance on Combined Studies Involving Medicines and Medical Devices
Swissmedic has updated its guidance on combined studies involving medicinal products, ATMPs, medical devices and IVDs, clarifying submissions, amendments, reporting duties and safety requirements.
European Commission Proposes EU Approach to Cardiovascular Health Checks
The European Commission has proposed a Council Recommendation on cardiovascular health checks, covering early detection, risk-based screening, digital tools, AI, EHDS data use and age-based monitoring.
IMDRF Publishes Materials from 30th Management Committee Meeting in Singapore
IMDRF has published materials from its 30th Management Committee Meeting in Singapore, covering digital health, software risk, AI governance, PCCPs, cybersecurity and jurisdictional regulatory updates.
FDA Issues Draft Guidance on Premarket Submissions for Robotically-Assisted Surgical Devices
FDA has issued draft guidance for robotically-assisted surgical device premarket submissions, covering performance testing, software, cybersecurity, human factors, training, clinical evidence and labeling.
Swissmedic Publishes New Guidance on the SMC Portal Profile Menu
Swissmedic has published a new information sheet explaining the SMC Portal profile menu, including profile information, eIAM access, profile switching, support, accessibility and logout.
EU Expert Panel Raises Clinical Evidence Concerns in CECP Opinion on Class III Knee Device
An EU CECP expert panel has issued a scientific opinion on a Class III intra-articular knee device, identifying limitations in the clinical evidence, benefit-risk assessment and PMCF strategy.
EMA Updates List of CECP Opinions Issued by Medical Device Expert Panels
The EMA has updated its list of CECP opinions issued by Expert Panels for medical devices undergoing conformity assessment, covering Class III implantable and selected Class IIb devices.
Swissmedic Updates Guidance on Field Safety Corrective Actions for Economic Operators
Swissmedic has updated its guidance on Field Safety Corrective Actions, clarifying reporting responsibilities, electronic submissions, FSN publication, timelines, customer follow-up and data protection.
Swissmedic Updates Guidance on Products Without an Intended Medical Purpose
Swissmedic has updated its guidance on products without an intended medical purpose under Annex 1 MedDO, covering transitional provisions, conformity assessment, registration, economic operators and vigilance requirements.
EU Adopts Implementing Regulation on MyHealth@EU Cross-Border Health Data Exchange
The European Commission has adopted Implementing Regulation (EU) 2026/2083 on MyHealth@EU, setting rules for cybersecurity, interoperability, compliance checks, incident management and cross-border health data exchange.
Portugal Reaches 86% eHealth Maturity in EU Digital Decade Study
Portugal achieved an 86% eHealth maturity score in 2023, above the EU-27 average, with strong digital access to health records and expanded healthcare provider participation.
ICH Publishes Updated E14/S7B Q&As on QT/QTc and Proarrhythmic Risk
ICH has published updated E14/S7B Questions & Answers (R1), providing new implementation support on QT/QTc prolongation, proarrhythmic risk, ECG methodology, study design and nonclinical assessment.