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.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. 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.This continued evaluation is essential for identifying further risks that occur with use of the device and, if necessary, may result in labelling changes. 3 Clinical Evaluation: Guide for Manufacturers and Notified Bodies provides details on the process of conducting clinical evaluations and the requirements for creating a CER, such as (but not limited to) starting with either a Standard Operating Procedure (SOP) or a Clinical Evaluation Plan (CEP) describing the literature search, objectives, methods, and endpoints.Durnescu: “We hope that by unlocking knowledge on probation, we encourage many people to start thinking about this subject, to ask questions and to keep the debate open.” Further to updating and refining the site’s information, the team has a next stage in mind.Durnescu: “A book, with more comprehensive information on the topics included on the website.“Big challenge was to choose the key questions and keep the answers short”, says Dr.
Leading experts on the various issues have contributed.
The regulations regarding CER updates are open-ended, leaving the details up to the manufacturer.
Notified Bodies (NBs), who are responsible for reviewing clinical evaluations, do not require a set schedule for CER updates but do require manufacturers to have their own processes in place for when and how the CER will be updated.
Clinical evaluation is the assessment and analysis of clinical data needed to verify the clinical safety and performance of your medical device.
A Clinical Evaluation Report (CER) outlines the scope and context of the clinical evaluation of your device and includes the actual clinical data, the appraisal and analysis stages of the evaluation, and conclusions about device safety and performance.