**Questions? [[Contact us!]]** ## Introduction Post-market surveillance involves the ongoing mandatory monitoring and evaluation of healthcare products and high-risk AI systems, after they're available to the public. Its main goal is to ensure their safety, effectiveness, and quality in real-world use, addressing any issues that may arise and informing regulatory decisions and improvements. ## Relevant legislation ### [[AI Act]] In the context of the AI Act, post-market monitoring refers to what AI system [[Provider|providers]] do to keep an eye on how their AI systems are used once they are available to the public. They do this to quickly spot and address any problems or improvements that may be needed. [[High-risk flowchart]] AI systems are obliged by art. 9(2)(c) and art. 61 of the AI Act to conduct such post-market monitoring and to evaluate the possible risks based on the data gathered from that monitoring. This is all part of the so called 'quality management system' (art. 17(1)(h) AI Act). The post-market monitoring system must be based on a post-market monitoring plan. The European Commission will establish a template for the post-market monitoring plan and the list of elements to be included in the plan, more information will follow. The post-market monitoring system furthermore should actively and systematically collect, document and analyse relevant data provided by users or collected through other sources on the performance of high-risk AI systems throughout their lifetime. This post-market surveillance of a high risk AI system, is indepent of the post-market surveillance of medical devices. ### [[MDR]] Post-market surveillance is the process of monitoring medical devices after they have been placed on the market. The MDR sets out specific requirements for manufacturers in chapter VII, section 1 to implement and maintain post-market surveillance. Post-market surveillance must be performed throughout the product's life cycle. Through surveillance, manufacturers ensure that their medical device continues to meet the requirements of the regulation. Periodic safety reports must also be submitted to ensure continuous assessment of the safety of the device. Data gathered by the manufacturer's post-market surveillance system shall be used for (not limited): - to update [[The benefit-risk determination]] and to improve the risk management as referred to in Chapter I of Annex I; - to update the design and manufacturing information; - to update the clinical evaluation. Based on the data resulting from post-market surveillance, it may be necessary to conduct additional clinical evaluations. This mainly occurs if there is new scientific knowledge relevant to the safety or performance of the device. ##### Post-market surveillance plan The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83. ##### Post-market surveillance report Manufacturers of class I devices shall prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data. The report shall be updated when necessary and made available to the competent authority upon request. Manufacturers of other class devices shall prepare a [[Periodic Safety Update Report (‘PSUR’)]] for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data. See Article 86 of the MDR.