Device vigilance

Stakeholders, including manufacturers and clinicians, must review and potentially revise their post-market vigilance and safety monitoring protocols in response to the FDA's proposed regulatory approaches for generative AI devices.

Clinical safety and pharmacovigilance teams must ensure that their SUADR reporting processes are aligned with the new 7-day and 15-day notification timelines, and maintain robust systems for collecting safety data from international sites.

Manufacturers and stakeholders in South Korea must review and update their safety reporting systems and Standard Operating Procedures (SOPs) to comply with the revised regulations.

Regulatory teams must prepare for and implement processes for increased public disclosures and reporting obligations regarding medical device safety data in Australia.

Manufacturers must submit renewal applications for CTDA certificates with a £420 fee (discounted to £168 for small organizations) and respond to any requests for additional information within 20 working days.

Sponsors and investigators must develop an implementation plan for the ISO 14155:2026 standard and maintain records for review during TGA inspections, ensuring alignment with updated safety monitoring obligations.

Stakeholders involved in biosimilar product development must review the draft guidance, focus on comparative safety assessments, and submit relevant comments by the deadline of October 2, 2026.

MAHs and sponsors must review and potentially update internal SOPs and reporting forms that currently reference 'gender' to ensure compliance with the updated terminology and definitions.

PV and device vigilance teams need to review their AVT product portfolios to verify correct classification and ensure adherence to medical device vigilance reporting workflows, especially for those tools classified as medical devices.

Update electronic safety reporting systems and pharmacovigilance databases to implement new rules to ensure all submissions use GENC 3-letter country codes and include the required fields as of July 20, 2026.

Investigators need to modify trial protocols and safety reporting mechanisms in line with the latest ISO 14155 updates to ensure compliance for upcoming high-risk clinical trials.

Manufacturers must generate and maintain scientific, engineering, and clinical evidence demonstrating that their devices meet the Essential Principles for Safety and Performance.

Manufacturers must implement processes for device registration in swissdamed before placing devices on the market, with immediate attention needed for vigilance-reportable incidents.

Verify inventory of affected RelayPro Thoracic Stent-Graft System lots (model 28-N4-XX-XXX-XXS) and implement actions per the FSN document.

Check for affected batches of Mirtazapine 30mg Tablets as described in EL(26)A/28 and implement any necessary quarantining or recall steps.

Identify and remove affected devices from use until corrected; if use is necessary, follow additional precautions provided in the GE HealthCare customer letter.

Identify and quarantine affected products. Return or destroy as instructed. Complete the reply form.

Do not use VCV mode until corrected. Use PCV or PCV-VG mode. Perform Ventilation Screening Test. Return acknowledgement form to GE HealthCare.

Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.

Healthcare facilities should implement manufacturer's corrective actions to ensure safe operation.

Identify and quarantine affected HeartWare batteries; follow manufacturer's instructions for battery management and replacement; ensure patients and healthcare providers are informed.

Identify and quarantine products from lots 1725204004 and 1725069002; contact patients who received sensors from these lots; report adverse events if any.

Identify and quarantine all impacted batches of ChloraPrep 2% 1mL and Frepp 2% 1.5mL applicators; return to Becton Dickinson UK Ltd.

Immediately quarantine and return unused MonaTherm probes from affected lots; review patient records for potential exposure and adverse events.

Ask the safety/device vigilance and PV CSV leads to: (1) confirm whether any marketed/fielded SaMD/AIaMD uses adaptive ML or planned updates that would fit a PCCP-like approach; (2) review current change-control SOPs and technical documentation to ensure change governance and transparency artifacts are captured and retrievable; (3) verify post-market/vigilance processes explicitly account for algorithm updates (e.g., monitoring after updates, escalation criteria).

Safety/Device Vigilance owner to: (1) confirm SOPs and training link to MHRA’s “Medical devices: post-market surveillance” collection as the live index; (2) validate operational readiness to submit adverse incident and FSCA-related reports via MHRA’s referenced MORE route; (3) confirm device PSUR process uses MHRA-linked standardised PSUR format and PSUR guidance tied to the Regulations 2024 framework; (4) update internal regulatory intelligence trackers with the 16 June 2025 in-force date cited across MHRA guidance, and monitor related MHRA future regime pages for further updates.

Fda update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.

Fda update requires triage for Local Affiliate Compliance, ICSR Submission, Device Vigilance; confirm local obligations and document follow-up actions.

Health Canada update requires triage for Local Affiliate Compliance, Device Vigilance, Inspection Readiness; confirm local obligations and document follow-up actions.

Customers are required to quarantine affected kits, complete response forms, and destroy the kits. Notification must also be sent to distributors who should inform their customers of these updated actions.

Health care professionals must complete and return the enclosed Reply Verification Tracking Form (RVTF) indicating the quantities of affected units to return, and monitor patients following the standard of care while discontinuing the use of these catheters.

Regulatory teams must update product labeling to reflect the new indication and assess signal management considerations for capivasertib.

All impacted products must be identified, segregated, and quarantined. Users are required to add appropriate warning labels and must exercise extreme caution if using the Manifolds is unavoidable.

Customers must immediately identify and quarantine all unused affected devices (Bravo CF capsule delivery devices, product numbers FGS-0635 and FGS-0636) and return them to Medtronic for replacement.

Health professionals and stakeholders should review the safety signals linked to CAROTONE products in their signal management processes.

Healthcare providers must implement a follow-up process for patients with identified cobalt-chrome modular neck components, monitoring for new or unexpected symptoms including pain, stiffness, or instability.

Affected healthcare facilities should remove all Automated Impella Controllers from use and stock, ensure annual preventive maintenance is followed, and report any adverse reactions to Abiomed or MedWatch.

Facilities using these devices must immediately cease their use, segregate them from other stock, and return them to Boston Scientific. Relevant personnel must be notified of this recall.

Stakeholders should incorporate the device authorization into labeling and signal management protocols to ensure compliance and effective communication regarding its capabilities.

Clinical investigations must now include justification for DDM selection and ensure that DHTs are verified and validated to support their intended clinical role.

Notified Bodies and medical device manufacturers should adhere to the updated requirement of using the IRIS platform for notification and submission processes concerning companion diagnostics, ensuring compliance with the new timelines and submission methods.

Ongoing investigations into unlawful vaping products are expected to result in further enforcement actions, including additional seizures and potential penalties for non-compliance with the Therapeutic Goods Act.

Regulatory intelligence workflows should address this enforcement action as part of ongoing compliance monitoring regarding the sale and promotion of unapproved therapeutic goods.

Organizations must enhance signal management processes to track and report adverse events related to Melanotan II products, ensuring compliance with safety regulations.

Ensure all patient implant cards are updated to include full UDI information in the mandated formats by the specified timeline to comply with TGA regulations.

Companies must implement a strategy to upgrade from Windows 10 to Windows 11 and ensure compliance with essential safety principles, including notifying customers about potential vulnerabilities.

Manufacturers must review and align their safety data compilation processes with the updated MHRA guidance to ensure that all necessary information is included in clinical investigation proposals.

Sponsors in the ILAP must update their Target Development Profiles to reflect the revised TDP and coordinate closely with pharmacovigilance teams for alignment with the new roadmap.

Healthcare facilities must utilize the new checklist during inspections to conduct gap analyses and ensure compliance with reporting requirements associated with their vigilance systems.

Stakeholders must integrate the new guidance into their signal management and literature surveillance processes to ensure compliance with updated PMDA expectations.

Organizations must update their adverse event reporting processes to align with the clarified classification of borderline products effective immediately.

Healthcare professionals must report all serious incidents involving injectable devices to Swissmedic as outlined in the new guidance.