A well-researched Clinical Evaluation Report assures regulators such as notified Bodies, competent authorities, patients, and clinicians alike the confidence that medical devices have been validated by strictly following guidelines, thus ensuring that their potential benefits outweigh any possible risks associated with their use. Complete clinical evidence collected during the clinical evaluation process is to be documented in CER and it shall be a part of the technical documentation which will support the assessment of the conformity of the device. As per this guidance, the CER should contain enough information to be read and understood by an independent party such as a regulatory authority or notified body. Thus, it should provide enough detail for understanding the search criteria adopted by the evaluators, data that are available, all assumptions made, and all conclusions reached.
Medical Device Literature Reviews for EU MDR Clinical Evaluation Reports
Medical Device Literature Reviews for EU MDR CERs
No one knows your products and their use history better than you and your team. This is why we so often tell clients that have the staff to write their own CERs. In our experience, the CER is not the problem. Save your CER Writer time with our approach. They have the experience and skill to address the most pertinent clinical literature to your devices. Use Our Proprietary Template.
Your Expert-Driven Process to EU MDR Approval – CER Writers and Literature Search
Send us a message! The clinical evaluation is part of the medical device development and verifies the safety and performance of medical devices. Clinical evaluation of medical devices is a systematic and planned process that contributes to the continuous generation, collection, analysis and evaluation of clinical data on a particular device. That way, it also verifies the safety and performance including the clinical benefit of a device for its intended use just as indicated by the manufacturer. The clinical evaluation is part of medical device development and must comply with the general safety and performance requirements GSLA so that the device can be approved, and CE marked.
The selected clinical data identified undergo a series of stringent checks to assess its suitability before being included in the clinical evaluation. The data obtained from various sources are appraised to evaluate their relevance and contribution to the evaluation of safety and clinical performance. The appraised data-set is then analyzed to check if they can be used collectively to demonstrate the compliance of the device to general safety and performance requirements.