Clinical Evaluation Report (CER) for medical devices
During your medical device journey to market, you must produce and maintain a Clinical Evaluation Report (CER) that complies with Article 61 and Part A of Annex XIV of Medical Devices Regulation (MDR) 2017/745. Clinical evaluation involves the assessment and analysis of clinical data pertaining to a medical device and evaluation of clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the your medical device Instructions for Use. Clinical evaluation reports are an important step in the process of CE Marking.
Medical device clinical evaluation must be based on a comprehensive analysis of available pre- and post-market clinical data relevant to the intended purpose of the medical device, including clinical performance data and clinical safety data. Following predefined methods and the guideline of MEDDEV 2.7.1 Rev 4 your CER journey can be made easy at Test Labs. We will follow these steps:
All medical devices, regardless of the classification, require a clinical evaluation to be conducted to justify the level of clinical evidence required to demonstrate conformity. The clinical evaluation should be planned, conducted, and documented in accordance with Article 61 and Part A of Annex XIV and should consider the following:
• Available alternative treatment options
• Incorporation of clinical data
• Acceptability of the benefit-risk ratio
If there is not enough clinical data to demonstrate compliance with the MDR, then a clinical investigation may be required. Learn more