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 mind, in order to (re-)establish confidence in regulatory processes, authorities are demanding greater patient protection. This has led to increased [...]
Breaking Down EU MDR Implementation for Class 1 Medical Devices 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, [...]
What is a clinical evaluation report? Clinical Evaluation Reports are a must for all medical devices in Europe. They must submit your CER to your Notified Body as an attachment to your European CE Technical File. The Technical File is an essential step to obtaining CE Marking for your device, which is necessary to [...]
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). Although both the forgoing regulatory frameworks permit equivalent devices as a basis for clinical data for a new device, the [...]
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 system by Notified Bodies (NBs), The need for risk-based classification and more clinical evidence through the device lifecycle. Thus, to better [...]
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 sell or distribute your devices in Europe. However, many manufacturers struggle to comply with European CER requirements as there is a significant [...]
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 [...]
