Meet our MDR team and get free educational resources on the MDR. Taking into account the requirement of Post Market Surveillance … At this point it’s also worth reflecting on the purpose. Post-market surveillance is one of the several focus areas of the new EU MDR. To be consistent, in the opinion of the author, that requires a summary status update, for the period covered by the report, on the feedback received for each of the eight or nine processes listed in Article 83. a rationale and description of any preventive or corrective actions taken during the period covered by the report. data on sales volumes and estimates of user population and frequency of use. A medical device Post-Market Surveillance system should provide consistent information for devices already on the market… 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). if applicable, to contribute to the post-market surveillance of other devices. The new EU Medical Device Regulation (MDR) builds on the framework of the MDD with an increased emphasis on post-market surveillance (PMS) and post-market clinical follow-up (PMCF), similar to … The clinical investigation plan should include amongst others: … the main findings of the PMCF (Post Market Clinical Follow-up) activities during the period covered by the report. In this final installment of the new Post-Market Surveillance (PMS) requirements from the forthcoming Medical Device Regulation (MDR), we’ll examine trend reporting (Article 88 of the MDR… These reports are primarily for the Authorities. Your Notified Bodies will … As guidance becomes available, this commentary will be update https://apotekerendk.com. The MedTech: EU MDR Exchange 2021 virtual conference provides 3 days of focused knowledge exchange surrounding the key components of the European Medical Device Regulation. identify opportunities to improve the usability, performance and safety of the device. 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. For Class IIa devices, the PSUR must be produced/updated at least annually. The EU MDR post market surveillance requirements are quite simulate for both the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR. ISO 13485, for example, requires systematic monitoring of a product after its launch. MDR Article 83 outlines the requirements for Post-Market Surveillance … The PMS system is intended to continually re-verify and re-validate the results of the development phase with real world data, in order to continually improve the safety and performance of the device. Article 86: For all higher risk (Class IIa, IIb and III) devices, Manufacturers must produce a Periodic Safety Update Report (PSUR). The rationale for establishing a process to do this is; (a) the PMS plan is potentially complex and may … This article first appeared on Medium.. 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