Post-market Surveillance

Extracted Attributes

• Scientific Field

  Pharmacovigilance

• Core Methodologies

  Spontaneous reporting databases, electronic health records (EHR), patient registries, and record linkage

• US Legal Authority

  Section 522 of the Federal Food, Drug, and Cosmetic Act

• Modernization Tools

  Artificial Intelligence (AI), Computational Modeling, and Bayesian Statistics

• Key Regulatory Framework (EU)

  Medical Device Regulation (EU) 2017/745 (MDR)

• Primary Regulatory Authority (US)

  Food and Drug Administration (FDA)

Timeline

• The European Union adopts Regulation (EU) 2017/745, establishing comprehensive requirements for post-market surveillance plans and periodic safety update reports (PSUR). (Source: Web Search (Wikipedia))

  2017-04-05

• Publication of industry guidance on MedTech Lifecycle Excellence, emphasizing the role of PMS in demonstrating device safety after regulatory approval. (Source: Web Search (Greenlight Guru))

  2023-02-26

• FDA Commissioner Marty Makary details plans to enhance post-market surveillance with AI during the JP Morgan Healthcare Conference in San Francisco. (Source: Document 065d2e96-4d40-49bd-8511-d8d35f8b01f4)

  2025-01-13

Postmarketing surveillance

Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose – meaning that they normally do not have other medical conditions which may exist in the general population – postmarketing surveillance can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions. Postmarketing surveillance uses a number of approaches to monitor drug and device safety, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linkage between health databases. These data are reviewed to highlight potential safety concerns in a process known as data mining.

Web Search Results

• Post Market Surveillance: What You Need to Know to Ensure… - NSF

  ## How NSF can help you with post-market surveillance Post-market surveillance is a vital aspect of medical device manufacturing. Ensuring devices remain safe and effective. It allows manufacturers to gather essential user feedback and comply with regulatory requirements. Manufacturers can quickly identify and resolve potential issues by implementing an effective post-market surveillance system, enhancing device performance, and fostering innovation. Success lies in thorough planning, robust data collection and analysis, prompt responses, and a dedication to continuous improvement. This approach not only prioritizes patient safety but also ensures device quality. [...] ## What is post-market surveillance for medical devices? Post-market surveillance serves as a vital mechanism for tracking the real-time performance and safety of medical devices once they are in use. Initial tests and clinical trials are incredibly insightful but do not always capture the full spectrum of potential issues in diverse, everyday environments. Post-market surveillance seeks to fill this gap, offering a broader, more fluid perspective by analyzing real-world usage data and experiences. [...] + Complaint handling is an essential element of post-market surveillance. The Code of Federal Regulations (CFR) Title 21, Sub Chapter H looks at complaint handling in medical devices. Part 820.198 looks at the specific issue and outlines detailed steps to effectively managing complaints, including the timely management of them. This is an area in which NSF has extensive experience in working with medical device companies. + Determining the frequency and methods of data analysis to identify trends, potential issues, and areas for improvement. + Integrating risk management strategies into the PMS system to proactively mitigate risks associated with devices. 2

• Postmarketing surveillance

  The concept of post market surveillance is linked to the concepts of vigilance and market surveillance. A manufacturer of medical devices is required to report incidents (serious adverse events) to the national competent authority of the member state the company resides in. The Medical Device Regulation (EU) 2017/745_2017/745 "Regulation (EU) 2017/745") (MDR) provides in §2 the following definition of post-market surveillance: [...] > ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions; Further requirements on PMS are given in §83 of the MDR; §84 details PMS Plan requirements and references Section 1.1 of Annex III of the MDR; §85 details the PMS report, while §86 describes the contents of the Periodic Safety Update Report (PSUR). The PMS Plan, PMS Report and PSUR are part of the technical documentation. [...] Postmarketing surveillance is overseen by the Food and Drug Administration "Food and Drug Administration (United States)") (FDA), which operates a system of passive surveillance called MedWatch, to which doctors or the general public can voluntarily report adverse reactions to drugs and medical devices. The FDA also conducts active surveillance of certain regulated products. For example, the FDA may monitor safety and effectiveness of medical devices through either a Post-Approval Study or through a 522 Postmarket Surveillance Study. With respect to regulation, two terms are defined: Postmarketing requirements are studies and clinical trials that sponsors are required to conduct and postmarketing commitments are studies or clinical trials that a sponsor has agreed to conduct, but that are

• [PDF] Guidance for post-market surveillance and market surveillance of ...

  The most basic form of post-market surveillance, which shall always be performed, is reactive post-market surveillance. Reactive post-market surveillance is done through collection and evaluation of feedback. All feedback is evaluated to establish the severity of the incident and establish if it should be reported to the NRA. A root cause investigation might be launched, and further actions undertaken such as correction or corrective action. Proactive post-market surveillance is the detection of issues through observing users during trainings, user support, scientific literature, conferences/trade shows and publicly accessible market surveillance information including FSNs, etc. 9 Introduction Post-market surveillance linked to risk management Risk management of medical devices is a [...] Stakeholders’ roles and responsibilities Post-market surveillance should be implemented by every manufacturer, at least in its most basic form, as a system to monitor, collect, evaluate and react to feedback. Other economic operators, such as importers, distributors and authorized representatives, play an important supportive role to ensure feedback from users reaches the manufacturer, including overcoming language barriers. National or regional legislation can require the manufacturer to perform more elaborate post-market surveillance, as simply reacting to feedback will only provide limited information on the experiences with the medical devices in actual use. Therefore, it then leaves information unused that could have been used to improve safety, quality and performance. NRAs should [...] Post-market surveillance mechanisms Post-market surveillance depends upon the information that can be/is to be collected. The manufacturer shall first establish the objectives of the post-market surveillance activities for each specific medical device or group of medical devices. Then, the manufacturer shall decide which sources are needed to fulfil these objectives. Based on this, the data shall be collected and analysed.

• Ultimate Guide to Postmarket Surveillance of Medical Devices

  ### Postmarket surveillance (PMS) plan What is it? The PMS plan is part of your device’s required technical documentation and details your strategy for continuously monitoring and collecting data and safety information on the device. The plan is part of the requirements for a PMS system, and is intended to outline the criteria for the benefit-risk assessment of the device and processes for: Collecting and analyzing data Addressing submitted complaints Communicating data to regulatory bodies and users Implementing corrective actions on devices Additionally, the PMS plan is used to determine whether or not a post-market clinical followup (PMCF) is required. [...] FDA has put out a guidance document on the subject: Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff. The guidance document lists a number of different types of postmarket surveillance designs you may need to use to address the surveillance question(s) the agency has raised. These include: Randomized clinical trial Prospective cohort study Retrospective cohort study Cross-sectional study Enhanced surveillance Active surveillance Meta-analysis Prospective & retrospective study Case control study Non-clinical study Animal study Other designs that don’t fall into one of these categories [...] # Ultimate Guide to Postmarket Surveillance of Medical Devices Written by: Brittani Smith February 26, 2023 ░░░░░░ | | | | --- | | | | | | | | The pursuit of MedTech Lifecycle Excellence requires that you consider the entire lifecycle of your medical device. This includes systematic monitoring of your device after it’s been placed on the market—in other words, postmarket surveillance (PMS). Postmarket surveillance is vital to demonstrating that your device continues to be safe and effective after it’s gained regulatory approval. This is especially important for implantable devices.

• [PDF] MDCG 2025-10 Guidance on post-market surveillance of medical ...

  Quality Management System Post-Market Surveillance System Technical Documentation on Post-Market Surveillance consists of • Post-Market Surveillance Plan (PMS plan) • Reports: PMS Report / PSUR Post-Market Surveillance plan (PMS plan) Clinical Evaluation (MDR) Performance Evaluation (IVDR) Benefit-Risk Determination and Risk Management, Annex I, Chapter I MDR/IVDR Reports Post-Market Surveillance Report (PMS report) Periodic Safety Update Report (PSUR) Systematically and actively gathering information from post-market experience with their devices. [...] a post-market surveillance report. • This guidance does not cover the requirements for health institution exemption under Article 5(5) MDR/IVDR (in-house devices), though it is expected that health institutions review experience gained from the use of in-house devices and take all necessary corrective actions6. Where this guidance references terms defined or aspects clarified in other documents, the relevant sources are cited. Unless otherwise stated, the definitions provided in Article 2 MDR and IVDR apply for this guidance document. Furthermore, the term ‘device‘ is used as outlined in Article 1(4) MDR and Article 1(2) IVDR. 3 The PMS System required by the MDR/IVDR Article 10(9)(i) MDR and Article 10(8)(i) IVDR refer to a PMS system in accordance with Article 83 MDR/Article 78 IVDR.