Steps for Getting CE Marking

  A clinical evaluation report is important to healthcare because it confirms that a medical device has achieved its intended purpose. It also indicates that the medical device does not expose patients and other users to further risk. Clinical Evaluation Report (CER) makes a strong case for your device and its intended use backed by impactful scientific evidence. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device. IZiel  completes the Clinical Evaluation Report (CER) as per the following changes in revision Med-Dev Rev. 4 with focus on detailing and clarity on every step of the clinical evaluation process that has been conducted by the manufacturers and evaluators. Working in-tandem with our clients, we endeavor to provide every detail asked for and more, keeping a keen eye on objectivity, completeness and evidence-backed content, throughout the process.  

 The EU MDR has significantly impacted the way medical devices are regulated in Europe. As part of regulatory compliance, medical device manufacturers need to create and maintain a Clinical Evaluation Report(CER) , a document essential for CE Marking. Here are expert tips on what to consider defining a robust CER strategy. Clinical Evaluation Report (CER) makes a strong case for your device and its intended use backed by impactful scientific evidence. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device. Following are some steps to follow -   1.        Define a CER protocol and strategy 2.        Demonstrate equivalence 3.        Evaluate literature review data 4.        Determine requirement for clinical investigation  5.        Monitor post-market activities   ...

  These terms used for medical devices are sometime misunderstood and used one for another, but both are distinctly different. Though clinical investigation data is often used in Clinical evaluation report , clinical investigation is one of the requirements of MDR like clinical evaluation. Let us further examine to understand the difference better.   Though detailed discussion of clinical evaluation is not the subject of blog, it will be essential to briefly describe the process of Clinical Evaluation so that difference can be understood better. Let us go to the brief definition of Clinical Evaluation Report (CER). Clinical evaluation of medical device is a continuous process of generating, collecting, analyzing, and evaluating clinical data under assessment to demonstrate conformance with general safety and performance requirements as per the manufacture’s intended use. This process starts with development stage and continues through life cycle of device.   Clinica...