You are in the best position to determine what is most reasonable, while keeping in mind that unpreparedness at audit time carries a variable amount of risk that has to be balanced with the substantial amount of labor that would be involved in continuously updating your CER.Ultimately, it is up to you as the manufacturer to monitor the use and status of your device and determine when to update your CER, in conjunction with your Risk Management strategy per EN ISO 14912. EN ISO 14912: Medical devices – Application of risk management to medical devices.
When an update is available, an icon appears in the taskbar until you apply the update.Events that are more likely to trigger an update include substantial new data from clinical studies and Post Production surveillance per EN ISO 14912, or significant modification to the device function, design, or materials. 3 Clinical evaluation: Guide for manufacturers and notified bodies. Obviously, should the market surveillance raise new risks (recalls, complaints, adverse events, etc) or frequent issues in the performance of the device, you will be required to promptly update your CER to make sure this information is included and your device is safe. If you are using a subscription version of CS6 or the Creative Cloud (CC), updates are installed through the Creative Cloud desktop app.To troubleshoot the CC desktop app, see: Troubleshoot Creative Cloud download and install issues If AAM freezes when you apply an update, download and install the update manually.Wir verwenden Cookies, um Inhalte zu personalisieren, Werbeanzeigen maßzuschneidern und zu messen sowie die Sicherheit unserer Nutzer zu erhöhen.Wenn du auf unsere Webseite klickst oder hier navigierst, stimmst du der Erfassung von Informationen durch Cookies auf und außerhalb von Facebook zu.This continues throughout post-marketing with the maintenance of surveillance programs that monitor performance and safety.Depending on the device in question, this can include adverse event reports, results from published literature on the actual device and/or substantially equivalent devices, clinical investigations, and formal post-marketing surveillance, including Post-Market Clinical Follow-Up Studies.Once you have set your update processes in place, the update itself will require some time. It is important to identify the steps needed and how long each step will take: At the end of the clinical evaluation, you should have a document that describes the clinical evidence supporting the use of your device that conforms to the Essential Requirements, as outlined in the appropriate Medical Device Directive. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.