Post-market Surveillance Protocols

Effective post-market surveillance (PMS) **Post-Market Surveillance (PMS) for Medical Devices (IMDR 2017 - CDSCO)**: 1. **What is Post-Market Surveillance?**: - **Definition**: PMS involves the proactive collection, analysis, and interpretation of data related to the performance and safety of medical devices after they have been released to the market. - **Purpose**: To monitor the long-term performance, identify any potential issues, and ensure ongoing compliance with regulatory requirements. 2. **Key Components of PMS**: **1. Data Collection**: - **Sources**: Collect data from various sources, including clinical studies, customer feedback, incident reports, and routine checks. - **Methods**: Use both passive (e.g., spontaneous reporting) and active (e.g., post-market clinical follow-up) surveillance methods. **2. Data Analysis**: - **Trend Analysis**: Perform statistical analysis to identify trends or patterns that might indicate potential safety or performance issues. - **Risk Assessment**: Continuously assess risks associated with the medical device based on the collected data. **3. Reporting**: - **Adverse Event Reporting**: Promptly report any adverse events or significant performance issues to the CDSCO. - **Periodic Safety Update Reports (PSURs)**: Submit regular PSURs summarizing the findings from PMS activities. **4. Corrective and Preventive Actions (CAPA)**: - **Root Cause Analysis**: Identify the root causes of any identified issues and implement corrective actions. - **Preventive Measures**: Develop and apply preventive measures to mitigate future risks. **5. Feedback Loop**: - **Continuous Improvement**: Use the insights gained from PMS to continuously improve product design, manufacturing processes, and overall quality management. - **Stakeholder Communication**: Keep healthcare professionals, patients, and regulatory authorities informed about any updates or changes resulting from PMS activities. 3. **Regulatory Compliance**: - **IMDR 2017**: Ensure PMS activities align with the requirements outlined in the Indian Medical Device Rules (IMDR) 2017. - **CDSCO Guidelines**: Follow the Central Drugs Standard Control Organization (CDSCO) guidelines for post-market surveillance. 4. **Benefits**: - **Patient Safety**: Ensures ongoing safety and effectiveness of medical devices in the market. - **Regulatory Compliance**: Demonstrates adherence to national and international regulatory standards. - **Quality Improvement**: Provides valuable insights for continuous product. #IMDR2017 #CDSCO #PostMarketSurveillance #MedicalDevices #PatientSafety #RegulatoryCompliance #ContinuousImprovement

Post-market surveillance doesn’t start – or stop – with the PSUR. It’s a living ecosystem that runs continuously, far beyond a periodic report. Throughout the lifecycle of a medical device, data should be actively and systematically collected. Not just when the PSUR is due. This includes sales data, user profiles, clinical experience, complaints, literature, trend reports, usability surveys, and more... All this data feeds into the PSUR (mandatory for class IIa devices and above). But the goal of PMS isn’t just to write a report. It’s to take action based on the data as it becomes available. That’s what makes PMS proactive. Waiting for a reporting deadline before reassessing your risks is reactive. Instead, risks should be continuously reviewed, signals identified early, and actions taken in real time. This includes vigilance activities. When an unacceptable increase in risk is identified, a FSCA must be issued. This is followed by a Field Safety Notice (FSN) to inform users, often including updated instructions. And if an incident occurs, a Manufacturer Incident Report (MIR) must be submitted to the competent authority – following strict timelines: → Serious public health threat: within 2 days → Death or unanticipated serious deterioration: within 10 days → Other serious incidents: within 15 days None of these are optional. They are key tools within a truly operational PMS process. Once data is gathered, it must lead to analysis and concrete actions. → Were new risks identified? → Could known risks be re-evaluated? → Do trends reveal emerging issues? If the answer is yes, manufacturers must conduct a root cause analysis, update the risk assessment, implement or adapt risk controls, and update relevant documentation. That includes the technical documentation, IFU, clinical evaluation, risk management file, and more. Because in the end, PMS is not a document. It’s a decision-making process based on real-time evidence. Need more about Post-Market Surveillance ? Grab our PMS templates (plan + PSUR), take advantage of : → Pre-written paragraphs and tables → Collection and analysis methods → Clear links to MDR 2017/745 and ISO 20416 → Concrete examples with a medical device Save time and be efficient in your PMS → https://lnkd.in/ezMXxxMc

Did you miss it? MDCG 2025-10 is a new EU guidance, and it spells out what “good” post-market surveillance looks like under MDR and IVDR. If your PMS plan is still mainly complaints plus a yearly report, this guidance is a useful reality check. What changed: ↳ MDCG 2025-10 was issued in December 2025 ↳ Type: MDCG guidance | Region: EU (MDR and IVDR) ↳ Source: MDCG document (Medical Device Coordination Group) 3 changes that matter most: 1. PMS is framed as a proactive, continuous system across the device lifetime, integrated into the QMS and used to drive updates to risk management and clinical or performance evaluation. 2. The guidance gets practical about the PMS plan: it should define what you monitor, how often, which methods you use, and why those choices fit the device risk profile, including deliberate sourcing beyond complaints. 3. It clarifies the PMS loop into outputs and actions: how PMS data should translate into conclusions, corrective or preventive actions, and updates to technical documentation, with an overview of PMS report and PSUR obligations plus worked scenarios. What this means for manufacturers: ↳ Expect more focus on whether your PMS is truly proactive, including how you select and justify data sources like literature, registries, surveys, and real-world feedback. ↳ Your PMS plan may need tightening so scope, monitoring frequency, and analysis methods are explicit and traceable to device risk and intended use. ↳ QMS linkages matter: auditors will look for clean handoffs from PMS into CAPA, risk management, and clinical or performance evaluation updates. What to do next: 1. Benchmark your PMS system against the guidance and check you have documented structures, procedures, resources, and management reporting in place. 2. Rework the PMS plan to clearly state scope, monitoring approach, data sources, analysis method, and triggers for action or technical documentation updates. 3. Stress-test your evidence trail: pick one PMS signal and confirm it flows through assessment, conclusion, CAPA decision, and documentation updates. P.S. what is your current weak spot: proactive data sourcing, PMS plan clarity, or closing the loop into CAPA and risk management? ⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡ MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference. I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed. Let's connect and collaborate to streamline regulatory work for everyone! #automation #regulatoryaffairs #medicaldevices

Is your PSUR strategy costing you millions? Or saving you millions? When auditors come knocking, your post-market  surveillance system is their first stop. And the PSUR isn't just another regulatory requirement. It's the document that keeps your devices  on the market. Yet many MedTech companies treat it  as an afterthought. Why PSURs matter more than you think: — They reveal hidden product issues ↳ Before they turn into costly recalls  or harm patients. — They protect your market access ↳ Non-compliance can block EU sales ↳ Regulators are ramping up PSUR audits. — They improve product lifecycles ↳ Turns real-world data into risk insights. ↳ Turns compliance into innovation 5 ways smart leaders master PSURs: 1. Automate data collection ↳ Let software gather what humans miss. 2. Establish risk-based reviews ↳ Focus resources where risks are highest. 3. Connect PSURs with CAPA systems ↳ Turn findings into meaningful improvements. 4. Keep documentation audit-ready ↳ Stay prepared, not scrambling. 5. Make PSURs a leadership priority ↳ When executives care, teams deliver. Remember: The real cost of poor PSUR management  isn't just regulatory fines. • It’s product recalls • Patient safety risks • Market withdrawals • Lost EU market access But when done right? PSURs become your early warning system. And compliance becomes your advantage. What's your biggest PSUR challenge? Let me know in the comments. ♻️ Find this valuable? Repost for your network. Follow Bastian Krapinger-Ruether for expert insights on MedTech compliance and QM.

Lifecycle Regulatory Requirements for SaMD in Europe This analysis examines how the EU regulatory framework—MDR 2017/745 and associated standards—maps onto every phase of the Software as a Medical Device (SaMD) lifecycle. It identifies how lifecycle-based oversight shapes development predictability, certification complexity, and long-term maintenance obligations for software-driven medical technologies. Key Takeaways: 1️⃣ Lifecycle compliance relies on a multi-standard architecture. The paper shows that MDR, ISO 14971, ISO 13485, IEC 62304, IEC 62366 and IEC 82304 must be applied together across development, maintenance and post-market phases, forming an integrated compliance stack rather than isolated requirements. 2️⃣ Rule 11 drives higher-risk classification for software. Under MDR Annex VIII Rule 11, many software products transition to higher risk classes, triggering more complex conformity assessment processes and third-party notified-body involvement. 3️⃣ Maintenance and change control are major regulatory burdens. The authors highlight that adaptive, corrective and preventive updates require structured change-control, re-validation when needed, and risk reassessment—making post-market phases as resource-intensive as development. 4️⃣ Post-market surveillance is continuous and multi-layered. PMS requirements include incident reporting, usability monitoring, cybersecurity management, UDI traceability and updates to technical documentation, embedding ongoing regulatory obligations throughout the product lifecycle. Synthesis: The authors conclude that SaMD regulation is fragmented across standards, but becomes coherent when mapped onto lifecycle stages. They identify key risks stemming from unaligned processes, insufficient early planning, and the growing regulatory impact of iterative software modifications. They recommend lifecycle-integrated planning using MDR-aligned standards, structured risk and usability processes, and rigorous post-market surveillance to maintain safety, performance and compliance. ➡️ How should investors factor lifecycle-wide compliance and change-control obligations into valuation models for SaMD companies? 🔗 Source(s): Navigating Regulatory Challenges Across the Life Cycle of a SaMD. Francesconi M., et al. Journal of Biomedical Informatics, 2025. #digitalhealth #healthinvesting #venturecapital #healthcareinnovation #governance

Monday News Issue #2 1️⃣ New MDCG Guidance on PMS under EU MDR/IVDR 𝘞𝘩𝘢𝘵 𝘩𝘢𝘱𝘱𝘦𝘯𝘦𝘥:  On 19 Dec 2025 the MDCG published MDCG 2025-10, consolidating post-market surveillance (PMS) requirements and reporting pathways under EU MDR and IVDR. 𝘔𝘢𝘳𝘪𝘯𝘢’𝘴 𝘵𝘢𝘬𝘦: Section 5.2 Collecting necessary data is particularly strong. It makes explicit that PMS is not limited to complaints or vigilance, but requires systematic intake and evaluation of diverse data sources — including scientific literature and third-party feedback. From a biological safety perspective, this is critical. PMS data increasingly feeds directly into biological evaluation through: -new studies on materials and their degradation products -emerging data on competitor devices -updates to CMR classifications and regulatory expectations In practice, PMS is no longer “post-approval housekeeping”. It is a live input into biological safety, risk management, and regulatory defensibility. 𝘞𝘩𝘰 𝘴𝘩𝘰𝘶𝘭𝘥 𝘤𝘢𝘳𝘦: Manufacturers, PMS owners, biocompatibility and toxicology experts, especially those aligning PMS, risk management, and biological evaluation into a single, auditable system. 2️⃣ AI-Driven Blood Analyzer Wins Manufacturing Approval & Distribution Deal 𝘞𝘩𝘢𝘵 𝘩𝘢𝘱𝘱𝘦𝘯𝘦𝘥:  On 29 Dec 2025 WORK Medical’s subsidiary Hunan Saitumofei received Class II manufacturing approval in China for an AI-automated human blood cell morphology analyzer. The company also signed an exclusive East China distribution agreement for 2026, targeting ~RMB 10M (~USD 1.4M) in sales. 𝘞𝘩𝘺 𝘪𝘵 𝘮𝘢𝘵𝘵𝘦𝘳𝘴: This is another signal that AI-enabled diagnostics are moving decisively from pilots to scaled clinical deployment. As adoption grows, regulators and manufacturers alike will face increasing scrutiny on: -algorithm validation and lifecycle control -human-AI interaction in routine diagnostics -post-market performance monitoring of adaptive systems AI in diagnostics is no longer a future discussion. It is becoming operational, regulated, and commercial. 3️⃣ Open Career Mic: Toxicology (live, no recording) 📅 Wed, 14 Jan 🕔 5 pm CET / 11 am EST Next Open Career Mic by Intrinsic Medical Group, LLC features Sarah Belperain, an experienced toxicologist working at the intersection of biological evaluation, toxicological risk assessment, and regulatory decision-making. Based on feedback from our previous session, we’ve extended the format to 45 minutes, allowing more time for practical questions and deeper discussion. This conversation will focus on: -how toxicology fits into modern biological evaluation strategies -transitioning from BE authorship into toxicological risk assessment -why toxicology is becoming a core, high-value capability in MedTech No recording by design. This is a closed, candid discussion. Bring the questions you wouldn’t ask on a webinar. #10993 #biocompaitiblity

Last week, I was reviewing a client's lifecycle process. They had a strong design control system and a clean FDA 510(k). But when I asked how post-market surveillance (PMS) feeds back into product improvements, there was a long pause. That pause said a lot. It’s not that companies don’t care, it’s just that PMS still feels like a compliance checkbox to many teams. But it's so much more than that. PMS isn't just about meeting FDA or EU MDR expectations, it's your direct line to reality. With both the FDA and EU MDR placing heavier emphasis on continuous monitoring and feedback loops, PMS is no longer optional or reactive. It’s part of your product’s clinical story. PMS includes: 📝 Customer complaints 📦 Returned devices 🔧 Field service reports 🚨 Adverse events 💬 User feedback 📊 Post-market clinical follow-up (PMCF) 📚 Literature, databases, and competitor surveillance When gathered and reviewed with intention, this data can provide actionable insight to retain customer trust and guide: 🔁 Design updates ✨ Usability enhancements 🎯 Indications for use refinement 💰 Reimbursement strategy alignment ⚠️ I want to reiterate that a regulatory submission isn't the finish line; it's the starting point for responsibility. Founders and QA/RA teams should ask themselves: Are we collecting the right signals, and listening well enough? #MedTech #PostMarketSurveillance #HealthTechLeadership #FDACompliance #EUMDR

𝙋𝙎𝙐𝙍 𝙞𝙨𝙣’𝙩 𝙟𝙪𝙨𝙩 𝙖 𝙧𝙚𝙥𝙤𝙧𝙩. 𝙄𝙩’𝙨 𝙖 𝙧𝙞𝙨𝙠 𝙘𝙤𝙣𝙩𝙧𝙤𝙡 𝙡𝙚𝙫𝙚𝙧 𝙪𝙣𝙙𝙚𝙧 𝙀𝙐 𝙈𝘿𝙍. ⚠️ Under EU MDR Article 86, the Periodic Safety Update Report (PSUR) is a core element of Post-Market Surveillance (PMS). Its role: continuously prove that your device remains safe and effective. 𝗪𝗵𝗮𝘁 𝗮 𝗣𝗦𝗨𝗥 𝗮𝗰𝘁𝘂𝗮𝗹𝗹𝘆 𝗰𝗼𝘃𝗲𝗿𝘀 👇 • 𝘽𝙚𝙣𝙚𝙛𝙞𝙩–𝙍𝙞𝙨𝙠 𝙀𝙫𝙖𝙡𝙪𝙖𝙩𝙞𝙤𝙣 → confirms ongoing safety & performance • 𝙑𝙞𝙜𝙞𝙡𝙖𝙣𝙘𝙚 & 𝙄𝙣𝙘𝙞𝙙𝙚𝙣𝙩 𝘿𝙖𝙩𝙖 → adverse events & FSCA trends • 𝙋𝙈𝘾𝙁 → long-term clinical performance • 𝙎𝙖𝙡𝙚𝙨 & 𝙐𝙨𝙖𝙜𝙚 𝘿𝙖𝙩𝙖 → input for trend analysis • 𝘾𝘼𝙋𝘼 → actions taken to improve safety & compliance 𝗣𝗦𝗨𝗥 𝗼𝗯𝗹𝗶𝗴𝗮𝘁𝗶𝗼𝗻𝘀 𝗱𝗲𝗽𝗲𝗻𝗱 𝗼𝗻 𝗱𝗲𝘃𝗶𝗰𝗲 𝗰𝗹𝗮𝘀𝘀 📊 • 𝘾𝙡𝙖𝙨𝙨 𝙄 → PSUR not required • 𝘾𝙡𝙖𝙨𝙨 𝙄𝙄𝙖 → every 2 years (technical documentation) • 𝘾𝙡𝙖𝙨𝙨 𝙄𝙄𝙗 → annually • 𝘾𝙡𝙖𝙨𝙨 𝙄𝙄𝙄 → annually + submitted to EUDAMED & reviewed by a Notified Body 𝗪𝗵𝘆 𝙜𝙚𝙩𝙩𝙞𝙣𝙜 𝙞𝙩 𝙬𝙧𝙤𝙣𝙜 𝙞𝙨 𝙚𝙭𝙥𝙚𝙣𝙨𝙞𝙫𝙚 🚨 • Regulatory actions & fines • Increased audit scrutiny • Loss of CE marking • Patient safety risks • Blocked EU market access 𝗧𝗮𝗸𝗲𝗮𝘄𝗮𝘆 💡 PSUR works best when it’s integrated — with vigilance, CAPA and PMCF — and kept audit-ready through structured data and risk-based reviews. How confident are you that your PSUR would stand up in the next audit? Let’s discuss 👇 #EUMDR #PSUR #MedTechCompliance #PostMarketSurveillance #RegulatoryAffairs #QualityManagement #MedicalDevices

MDCG 2025-10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices. Provides practical, harmonised guidance on PMS for MD and IVDs under the MDR/IVDR. 📌 Takeaways: ● Clarifies PMS obligations: from planning through continuous data collection and analysis to corrective actions. ● Reinforces that real-world data must actively drive safety, quality and performance improvements. ● Strengthens the link between PMS systems and QMS, helping manufacturers better align regulatory expectations with everyday practice. ● Reinforces the lifecycle approach to monitoring devices once on the market - a key pillar for patient safety and compliance under EU MDR/IVDR. Let’s keep the momentum on real-world evidence & proactive surveillance! #MDCG #MDR #IVDR #PostMarketSurveillance #PMS #MedTech

Difference between PMSP, PSUR and PMCF Each serves a different purpose in ensuring the safety and efficacy of medical devices once they are on the market. PMSP: Purpose: The PMSP outlines the systematic plan that a manufacturer will follow to monitor the safety and performance of a medical device after it has been released to the market. Content: It includes the methods and procedures for gathering, recording, and analyzing data on the device’s performance. This might include user feedback, incident reports, variant details, SKUs in scope, EPR, life time statement and scientific literature. Regulatory Basis: The PMSP is a proactive requirement, mandated by regulations like the EU Medical Device Regulation (MDR), to ensure ongoing compliance and to identify any potential issues with the device over its lifecycle. PSUR: Purpose: The PSUR is a comprehensive report that provides a periodic update on the safety and performance of a medical device, summarizing the findings from the post-market surveillance activities. Content: It includes a summary of data collected, a critical evaluation of the benefit-risk profile, results of any corrective actions taken, literature data, sales & complaint, registry data of implant and conclusions regarding the overall safety and performance of the device. The frequency of the PSUR depends on the risk classification of the device. Regulatory Basis: The PSUR is required by regulations such as the EU MDR for certain classes of medical devices. It ensures continuous monitoring and reassessment of the device’s risk-benefit profile over time. PMCF: Purpose: The PMCF is part of the PMSP, focusing specifically on collecting and evaluating clinical data regarding the device’s performance and safety in real-world use. Content: It involves ongoing clinical studies, surveys, registries, and other activities designed to gather clinical evidence. The aim is to confirm the device's performance as specified by the manufacturer, identify previously unknown side effects, and ensure that the device remains safe and effective. Regulatory Basis: PMCF is a requirement under regulations like the EU MDR for certain types of medical devices, especially those where clinical data is critical for ongoing risk assessment. In summary: PMSP is the overall plan for monitoring a device post-market. PSUR is a periodic report that summarizes the findings from the PMS activities, ensuring the ongoing assessment of the device’s safety and performance. PMCF is a specific activity within the PMS framework that focuses on gathering clinical data to confirm the device’s real-world safety and efficacy. Together, these elements ensure a comprehensive approach to monitoring and maintaining the safety and effectiveness of medical devices after they enter the market. Tata Elxsi