上市后监测的未来：数字化、集成化和以患者为中心

MIKE KING, Senior Director, Product & Strategy, IQVIA Table of contents Introduction: Why Post-Market Surveillance must be proactiveThe interplay: PMS insights fuel clinical evaluation, risk management, and market actions2From reactive to proactive: Multi-source data, trending, and signal managementDigitizing the PMS Core: Connecting plans, risks, NC/CAPA, complaints, Introduction: Why Post‑Market Surveillance must be proactive Post‑Market Surveillance (PMS) is the continuous,proactive, and systematic collection and analysis ofreal‑world data on device quality, performance, andsafety throughout the product lifecycle. Under theEU Medical Device Regulation (MDR) and the In VitroDiagnostic Regulation (IVDR), Post‑Market Surveillance Regulators concluded that broader, earlier, and moresystematic evidence is required to detect underlyingsignals of poor product performance. In the case ofMoM hip systems, risk understanding evolved overtime, ultimately shifting the devices into the PMA Global regulators echo this trend. In the U.S., Post‑Market Surveillance orders under Section 522 requirescientifically valid plans capable of generating usefuldata that identify unforeseen adverse events and inform Heightened PMS expectations emerged from severalhigh-profile safety issues, including Metal-on-Metal(MoM) hip implants and PIP breast implants, which High public awareness of product quality issues A dual focus on patient safety and commercial performance is universally beneficial These PMS feedback loops have direct clinical relevance.For example,UK MHRA guidance on Metal-on-Metal(MoM) hip replacementsprioritizes MARS MRI orultrasound over isolated metal ion levels for earlydetection of soft tissue reactions, demonstrating how The interplay: PMS insightsfuel clinical evaluation,risk management, and EU MDR and IVDR require PMS outputs to updatebenefit-risk determinations, risk management files,clinical evaluation/performance evaluation, labeling/IFU, ISO/TR 20416:2020 codifies this in a manufacturer-friendlyprocess model: Plan PMS, collect from appropriatesources proactively, analyze with defined methods,and route outputs to design, risk, production, clinical/ MDR Articles 85 and 86 formalize the PMS Report (PMSR)and Periodic Safety Update Report (PSUR), pushingmanufacturers to synthesize findings at defined intervalsand demonstrate that PMS is a living system, not a paper A proactive PMS program incorporates both reactivedata (e.g., complaints, vigilance/adverse events) andproactive sources (e.g. scientific and medical literature, •Defined thresholds and indicators for trends andsignals (e.g., statistically significant increases in Identifying the most suitable ‘proactive’ data sources is a key success criterion A modern, digital eQMS provides: Digitizing the PMS core:Connecting plans, risks,NC/CAPA, complaints, recalls, 1.A single source of truth for PMS activities, includingplans, signals, analyses, and PSURs, and their direct 2.Integrated quality workflows for NC, CAPA, complainthandling, and recall or FSCA processes, supported byshared metadata, audit trails, and Part 11 controls to Fragmented, manual processes hinder timely andeffective post-market surveillance. EU MDR and IVDRrequire cross‑functional integration across the PMSlifecycle, including alignment from PMS Plans to PMCF 3.Advanced analytics and dashboards for trenddetection and signal management, including real‑time 4.Change control orchestration that enables fieldsignals to trigger design changes and alignedregistration impact assessments, closing the loop to In the era of AI, significant pragmatic value can be addedby using the right type of AI to enhance a specific activitywithin the framework of a regulated QMS activity: •Drafting assistance: Auto‑generated PMS Plansections and PSUR summaries for human review, •Live analytics: Anomaly detection for early signalidentification, enabling proactive rather than •Data acquisition and normalization: Automatedextraction and structuring of complaints, service These uses align with regulators’ emphasis onscientifically valid, useful data and do not alter thefundamental requirement for human oversight and •NLP-assisted triage: Similarity matching, codesuggestions, and summarization to accelerate and Pragmatic AI — MedTech examples Patient safety, product quality, market access When PMS insights drive design enhancements ortechnical documentation updates, SmartSolve’s QMSmodules integrate directly with IQVIA SmartSolve®RIM, enabling organizations to manage the full change The SmartSolve®difference:A single, AI‑enabled platformthat unifies QMS and RIM IQVIA SmartSolve is a cloud‑based, AI‑enabled eQMSthat unifies core quality processes, including ChangeManagement, Document Management, Training,Quality Events (NC/CAPA/Deviations), Inspections, Conclusion Global regulators have set a clear mandate: Post‑market surveillance must be proactive, systematic, and tightlyintegrated with