Inspection Readiness

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.

Ensure compliance with updated SUSAR reporting timelines (15 days), notify SFDA of Phase IV trials within 20 working days post-IRB approval, and prepare for the financial fee of 15,000 Saudi Riyals for clinical trial evaluations.

1) Map portfolio to MHRA’s Category 1 vs Category 2/NI MA status referenced in the Windsor Framework PV guidance; 2) Update PSUR submission SOPs/work-instructions and submission trackers to ensure Category 1 PSURs route via the MHRA PSUR portal and Category 2/NI MA PSURs route via the EU PSUR Repository (and confirm when no separate MHRA submission is needed); 3) Re-check related MHRA PV procedure guidance for any additional submission/documentation expectations impacting signals, RMPs and PASS.

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.

1) Inventory AI use cases that could feed regulated decisions (including PV/safety-related analyses or summaries used in regulatory interactions) and map owners/vendors. 2) For each AI use case, document context of use, intended outputs, and controls (e.g., review/approval, traceability, change management) aligned to a draft-guidance tracking plan. 3) Track the Federal Register notice and plan whether to submit comments within the window described by FDA (90 days after Federal Register publication).

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

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

Ema update requires triage for Local Affiliate Compliance, Vendor Oversight, Inspection Readiness; confirm local obligations and document follow-up actions.

Mhra update requires triage for Signal Validation, Risk Management, Local Affiliate Compliance; 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.

This update requires triage for Risk Management, Vendor Oversight, 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 are encouraged to utilize the provided e-learning modules to improve their inspection readiness and compliance with GCP standards in Australia.

Implement mandatory quality checks and oversight for all AI-generated inspection responses to meet MHRA expectations for accuracy.

MAHs and trial sponsors must align their safety monitoring and data collection workflows with the new GCP principles established in ICH E6(R3) Annex 2.

Utilize the IB template provided for cell therapy products in clinical trial applications, available under the 'Special Product Areas' section of the Danish Medicines Agency's website.