EUDAMED Module: Vigilance and Post-Market Surveillance System (Article 92, MDR; Article 87, IVDR) Moving on to the remaining EUDAMED requirements, we have vigilance and post-market surveillance. Gain insight into post-market surveillance for medical devices and in vitro diagnostic devices under the EU Regulations with this free download. TABLE OF CONTENTS. MDR IVDR Post-market surveillance system MDR Article 83: Post-market surveillance system of the manufacturer MDR Article 15: Person responsible for regulatory compliance Comprehensive system to gather experience from the use of devices Proactive and systematic Allows cooperation on vigilance and market surveillance Maximizing post-market surveillance with real world data.Medical device recalls are on the rise at the same time as the EU MDR and IVDR are bringing increased post-market surveillance … The feedback information required by each process is different: The risk management process requires information about the frequency and severity of harm which results from using the device, manufacturing requires information about nonconformities, the clinical evaluation requires information on clinical performance and so on. IVDR lays down the requirements in more details, among others in the Articles 78 et seqq. The requirements of the new European Regulations concerning medical devices in terms of post-market surveillance are significant. NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. The IVDR Preamble (75) gives direction that manufactures are to play an active role during the post-market phase of the product lifecycle. The PMS report is part of the Technical Documentation on Post Market Surveillance (Annex III, 2.). First Name. Ivdr Post Market Surveillance Plan Template On July 16, 2020 By Balmoon Mdcg 2019 15 mdcg 2020 1 eu medical device mdr 2017 745 and in to the regulation of medical devices For example, ISO13485:2016 mentions PMS activities in Section 8.2.1 regarding feedback processes which should include provision to gather data from production, as well as post-production activities and 8.5.1 improvement actions from QMS sections including PMS. PMS programs should actively and systematically gather information from a device in a way which allows for regular updates to technical documentation and competent authorities’ communication in the areas of vigilance and market surveillance. It is also connected to varied levels of QMS processes such as: A PMS system is an integral part of any IVDR-compliant QMS and is key in establishing a robust systems and long-term success. The PSUR is to be created at least annually, whereas the PMSR can be created every five (5) years. Data which has to first be collected, and then assessed in order to produce the needed feedback information. This at least has been the … Chapters, Sections, Articles and Annexes within the IVDR. Country. To do that successfully requires a comprehensive plan, defining the data needed, the processes for data collection, and the methods to assess the data. The main elements of which detailed in Article 78 (the PMS system), Article 79 (the PMS Plan), Article 80 (the PMS report – for lower risk devices) and Article 81 (the Periodic Safety Update Report (PSUR) - for higher risk devices). Post-Market Surveillance: Manufacturers must precisely plan and carry out post-market surveillance. Article 10, 9. lays down the requirement for all Manufacturers to have a Post Market Surveillance (PMS) System. There are new processes, including Post-Market Performance Follow-Up (PMPF), Periodic Safety Update Reporting (PSUR) and Post-Market Surveillance Planning and Reporting (PMSP/PMSR), all with an emphasis on the product lifecycle. CHAPTER ARTICLE. update the design and manufacturing information, the instructions for use and the labelling. It is the collection of the feedbacks loops which have a longer response time than say the vigilance process or the complaint process. Post-market surveillance under the MDR and IVDR. Classes C and D must generate a Periodic Safety Update Report (PSUR) per Article 81. Post-Market Performance Follow-Up Plan: Link Between the PMS System and Performance Evaluation. His work covered regulatory documentation such as design initiation, design scope, design history, verification and validation of the project and transfer of product. Note: At the time of writing this commentary, no guidance had been published by the European authorities on Post Market Surveillance. EU IVDR Transition Training course. In conclusion, PMS system requirements introduced by the IVDR links to other mandatory elements of this regulatory change, and provides the ability for changes to the technical documentation through collected data. You must review the new requirements, primarily defined in Chapter VII. Art. Post-market surveillance data and information has to be included in the post-market section of the Clinical Evaluation Report (CER). Last Name. The Periodic Safety Update Report (PSUR) is a document summarising the results and conclusions of the analysis of Post-Market Surveillance (PMS) data with usage data.. The IVDR Preamble (75) gives direction that manufactures are to play an active role during the post-market phase of the product lifecycle. The process to continuously update the clinical evaluation with this data is called Post-Market Clinical Follow-up (PMCF) and outlined in Part 2 of Annex XIV. The purpose of the PSUR is to track the conclusions of the benefit-risk determination, the main findings of the Post-Market Clinical Follow-Up (PMCF) and the volume of sales throughout the lifetime of the device concerned. Analytical Performance (Performance Evaluation). Company. Download this free excerpt from Compliance Navigator's Smart Support series of expert commentaries on the MDR/IVDR for: BSI takes your privacy seriously. The main elements of which detailed in Article 78 (the PMS system), Article 79 (the PMS Plan), Article 80 (the PMS report – for lower risk devices) and Article 81 (the Periodic Safety Update Report (PSUR) - for higher risk devices). The incorporation of the plan into the QMS as either a procedure or a template to be completed as part of a device’s technical file, may also be used. Data collected from post-market surveillance (PMS) and performance follow-up (PMPF) is consistently reported to monitor risk management, performance standards and practices. Please note: If the PMPF is not deemed appropriate for a specific device, then a justification shall be provided and documented in PER. Additionally, NAMSA provides support to market authorization holders, including implementation of IVDR requirements, IVDR conformity strategies and compilation of appropriate Technical Documentation for submission to Notified Bodies. Our consultants will educate your team on why and how the new regulations will likely impact your IVD products. as part of a post-market surveillance plan. III. Post Market Surveillance (PMS) is primarily concerned with establishing the PMS plan for the device. New Requirements for Post-market Surveillance. The feedback information in the PMS system is use to: Therefore, when designing a PMS system, one must start by considering the types of information those eight or nine processes use as feedback. Official Journal of the European Union on 5 May 2017. This includes the requirement of implementing appropriate and necessary CAPA activities and communication with competent authorities regarding: The IVDR expands PMS activity requirements, even for those manufacturers who are ISO13485:2016 compliant, as the standard is not explicit enough to meet requirements of Article 78. From time to time we would like to contact you with details of products and/or services we offer. Thus, MDR/IVDR has a section with 5 articles concerning post-market surveillance (Section I of Chapter VII). Post Market Surveillance (PMS) is primarily concerned with establishing the PMS plan for the device. The process to continuously update the clinical evaluation with this data is called Post-Market Clinical Follow-up (PMCF) and outlined in Part 2 of Annex XIV. Post market surveillance 1. Email. At this point it’s also worth reflecting on the purpose. Ensuring your Post-Market Surveillance Process Meets the New ISO 14971:2019 Guidance and MDR/IVDR Requirements Learn More. They are intended to provide the objective evidence of safety, performance, … Country. Post Market Surveillance System Article 10, 10. lays down the requirement for all Manufacturers to have a Post Market Surveillance (PMS) System. Post Market Surveillance System Article 10, 10. lays down the requirement for all Manufacturers to have a Post Market Surveillance (PMS) System. The following 157 pages were published in the . Clinical Performance Studies: Very comparable to the MDR, requirements for carrying out clinical performance studies increased dramatically. Introduction – Post Market Surveillance & Adverse Event Reporting. The Person Responsible for Regulatory Compliance (PRRC) is, under the MDR and the IVDR, a person responsible for ensuring compliance with the MDR/IVDR requirements regarding the conformity of the devices, the technical documentation, the EU declaration of conformity, the post-market surveillance obligations and the reporting of serious incidents and field safety corrective … Post-market surveillance aims to ensure that IVDs continue to meet the same quality, safety and performance requirements as when they were initially placed on the market. Webinar. Within the last years the importance of post-market surveillance has been underlined more and more. Check out our . BSI takes your privacy seriously. But that means it must be produced/updated from time to time. This is shown by Articles 57 et seqq. These are intended to confirm that devices on the market do not endanger health, safety or any other aspect of public interest. identify opportunities to improve the usability, performance and safety of the device. The PMPF is a proactive collection and evaluation of the performance and relevant data from the use of a device as described in Annex XIII (part B). Use of UDI System. IVDR lays down the requirements in more details, among others in the Articles 78 et seqq. The main elements of which detailed in Article 83 (the PMS system), Article 84 (the PMS Plan), Article 85 (the PMS report – for lower risk devices) and Article 86 (the Periodic Safety Update Report (PSUR) - for higher risk devices). Article 78 states that manufacturers should have for each device, a well-structured PMS system that is appropriate for the risk class and device type (see previous NAMSA blog on IVDR technical documentation and risk).