Device vigilance

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.

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.

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.

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.

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

Sponsors and MAHs must replace the 2021 form with the new 2026 approved form for all six-monthly reports on unapproved therapeutic goods supplied under SAS and CTA schemes.

Identify which unclassified medical devices are affected by the exemption; update regulatory submissions and post-market surveillance plans accordingly; ensure compliance with general controls and post-market surveillance obligations.

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

Check stock for the affected batches of Ponlimsi (Denosumab) 60mg solution for injection and follow the instructions in the MHRA notice.

1) Add/confirm the TGA 'medical device post-market monitoring and safety updates' page as a tracked regulatory intelligence source for routine review. 2) Cross-check internal Australia device vigilance SOPs/work instructions against TGA guidance on sponsor/manufacturer post-market responsibilities and document any gaps for CAPA/change control as needed.

Innovators must now utilize the Innovation Accelerator for access to regulatory expertise and guidance on pharmacovigilance and risk management strategies.

Review impact brief for required actions.