Clinical Evaluation Reports – CER

Clinical trials are a crucial piece of launching a medical device. Publishing the data you have gathered regarding the safety and effectiveness of your product is the first step of proving its quality attributes. [...]

The EU MDR emphasizes field safety corrective actions to correct non-conformances of the distributed product, but since these principles are used throughout the quality system, they are not limited to the distributed product alone. Preventive [...]

While larger manufacturers, global players, and multinational companies most likely won’t have problems complying with the European MDR due to having both the financial and human resources to comply in time, smaller and medium-sized [...]

In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof of and document the performance and safety of medical devices in a "clinical evaluation"’. With the breast implant scandal in [...]

Breaking Down EU MDR Implementation for Class 1 Medical Devices   Breaking Down EU MDR Implementation for Class 1 Medical Devices Following the one-year delay in the MDR Date of Application, the Class I [...]

Looking For A World Class CER Writer for your EU MDR Submission? EU MDR has certainly made things more difficult for manufacturers seeking the CE mark, especially in regard to Clinical Evaluation. If you [...]

Medical device regulations in China are often similar to the European Union (EU)’s MDR. With a vital prerequisite of Clinical Evaluation Reports (CERs), as required by China’s National Medical Products Administration NMPA (formerly CFDA). [...]

The EU IVDR Regulation - An Overview - Part I The PIP breast implant scandal brought to light weaknesses in the overall regulatory process to control IVDs.   It may include - The certification [...]

EU MDR Clinical Evaluation Requirement – Understanding the CER A critical component of the Technical File Submission for the CE Marking /conformity assessment process is that clinical evaluation reports are essential to selling or [...]

MDCG's Guidance document, released in July 2020, introduces and details the essential requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its [...]