Following the one-year delay in the MDR Date of Application, the Class I medical devices, in the lowest risk class, must also conform to the new European Medical Device Regulation (EU MDR) to the end of their required performance lists. Despite any extension period, all devices, regardless of their class, must comply with the [...]
MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its conformity assessment procedures. Through the CEAR, the MDCG aims to standardize the documentation of the NBs’ assessment of manufacturers’ clinical [...]
Medical device regulations in China are often likened 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). Although both the aforementioned regulatory frameworks permit the use of equivalent devices as a basis for clinical data for a [...]
The EU IVDR Regulation - An Overview - Part I The PIP breast implant scandal brought to light weaknesses in the overall regulatory process for control of IVDs including, but not limited to, the system of certification by Notified Bodies (NBs), the need for risk-based classification and more clinical evidence through the device lifecycle. [...]
EU MDR Clinical Evaluation Requirement – Understanding the CER A critical component of the Technical File Submission for the CE Marking /conformity assessment process, Clinical Evaluation Reports are essential to sell or distribute your devices in Europe. However, many manufacturers struggle to comply with European CER requirements as there is a significant lack [...]
MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its conformity assessment procedures. Through the CEAR, the MDCG aims to standardize the documentation of the NBs’ assessment of manufacturers’ clinical [...]
