Clinical Evaluation Reports – CER

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 [...]