Steps for Getting CE Marking

  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. 6 Requirements of a Clinical Evaluation Report for Medical Device Manufacturers – ·          Scope and plan ·          Identification of pertinent data ·          Appraisal of pertinent data ·          Analysis of the clinical data ·          Finalize the report ·          Physician Review & Approval   After data analysis, the evaluation report should summarize the data analysis. This report should provide strong clinical evidence for conformity assessment so the device can be app...

 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...