# Medical Device Post-Market Surveillance Plan Template > Source: https://netray.co/tools/medical-device-post-market-surveillance-plan-template > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: Free Tools ## Short answer Plan template covering data sources, analysis methods, trend triggers and reporting for post-market surveillance. ## Category compliance-legal ## Industry Medical Devices ## Region European Union ## Audience - Regulatory affairs - Quality manager - Clinical affairs ## Tool **Kind:** template **Output:** document **Fields:** #### Manufacturer **Key:** company **Type:** text **Default:** Acme Medical Devices Inc. #### Device or family **Key:** device **Type:** text **Default:** Infusion set family IS-200 #### Device class **Key:** class **Type:** select **Options:** - Class I - Class IIa - Class IIb - Class III **Default:** Class IIa #### Plan number **Key:** plan_no **Type:** text **Default:** PMS-0007 #### Plan date **Key:** date **Type:** date **Default:** 2026-10-20 #### Data sources **Key:** sources **Type:** textarea **Default:** Complaints, vigilance reports, service records, literature search, registries, social media, customer surveys, PMCF data #### Analysis methods **Key:** methods **Type:** textarea **Default:** Complaint rate per 10,000 units by failure mode, statistical trending with control limits, comparison to risk file occurrence estimates #### Trend trigger **Key:** trigger **Type:** text **Default:** Rate above upper control limit for two consecutive months, or any serious injury #### Review cadence **Key:** cadence **Type:** select **Options:** - Monthly - Quarterly - Annually - Per PSUR schedule **Default:** Quarterly #### Plan owner **Key:** owner **Type:** text **Default:** Head of Regulatory Affairs **Blocks:** #### Post-Market Surveillance Plan **Body:** Manufacturer: {{company}} Device: {{device}} Class: {{class}} Plan No: {{plan_no}} Date: {{date}} #### 1. Purpose and Scope **Body:** This plan describes how {{company}} proactively collects and analyses data on the quality, performance and safety of {{device}} throughout its lifetime. #### 2. Data Sources **Body:** {{sources}} #### 3. Analysis Methods **Body:** {{methods}} #### 4. Triggers and Actions **Body:** Trend trigger: {{trigger}} When a trigger is met the plan owner opens an investigation, reviews the risk management file, and decides on CAPA, field action or vigilance reporting. #### 5. Review and Reporting **Body:** Review cadence: {{cadence}} Owner: {{owner}} Results feed the risk management file, clinical evaluation and the periodic report appropriate to the device class. #### Responsibilities **Table:** **Columns:** - Activity - Owner - Frequency **Rows:** **0:** Complaint trending **0:** Literature search **0:** PMCF activities **0:** Risk file update #### Approvals **Signatures:** - Regulatory affairs - Quality assurance - Clinical affairs **Notes:** Starting point, not legal or regulatory advice. EU MDR Articles 83 to 86 and Annex III set the expected content for the EU, and other markets have their own requirements. Align this with your QMS procedure. ## Content **Intro:** A post-market surveillance plan describes how you will actively gather and assess real-world data on a device after release. This template gives you the standard sections to adapt for your product. **Sections:** #### How to use the template **Body:** Name the device family and class, list every data source you will use, and state how you will analyse it. The trigger field is the part reviewers read closely: it says in advance what level of signal causes an investigation. Choose a review cadence that matches the class and risk. Export to PDF or Word and add it to the technical documentation. #### What the regulation expects **Body:** Under EU MDR Article 84 and Annex III, the PMS plan is part of the technical documentation and should cover proactive and systematic data collection, suitable indicators and thresholds, methods for complaint investigation, trend reporting tools, and PMCF where applicable. Class IIa devices produce a PMS report, while Class IIb and III produce a PSUR. The FDA expects complaint files and medical device reporting under 21 CFR 803 and 820.198. **Bullets:** - Proactive, not just reactive complaint handling - Defined thresholds for action - Link to risk management and clinical evaluation - PMCF plan where clinical data is needed #### Common mistakes **Body:** Plans often list sources that are never actually searched, such as registries or literature. Others lack numeric triggers, so no one can say when a trend became a signal. Keep the plan honest about what you will do, connect it to the risk file, and keep evidence that each source was reviewed on schedule. **Cta:** If complaint and service data sit in your ERP, Netray can help set up automated trend reports. Ask for a short review. **Faq:** #### Is a PMS plan required outside the EU? **Answer:** Other markets expect similar activity under different names, such as complaint handling, MDR reporting and vigilance. A single global plan can satisfy several if mapped to each requirement. #### What is the difference between PMS and PMCF? **Answer:** PMS covers all post-market data collection. PMCF is the specific, planned clinical follow-up that generates clinical data on a CE-marked device to confirm safety and performance. #### Do I need one plan per device? **Answer:** You may cover a family if the devices share design, risks and data sources, but justify the grouping in the plan. #### How often is the plan updated? **Answer:** Whenever findings, regulation or the device change, and at least in line with your periodic review, usually annually. ## Search terms post market surveillance plan template, PMS plan EU MDR, medical device PMS template, post-market surveillance report format, MDR Article 84 plan, PMCF plan template --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json