Thomas Regulatory

  Because clinical evaluation is a crucial component of the technical documentation required for regulatory compliance of medical devices sold in the European Union (EU), a well-designed and written clinical evaluation report is essential for manufacturers of both new and existing medical devices. This is particularly accurate in light of the recent passage of the Medical Device Regulation 2017/745 (MDR). The safety and effectiveness of medical devices are subject to stricter regulations under the MDR directive. If you have so little time left to meet the MDR transition deadline, you might want to consider getting help from a Clinical Evaluation Report Consultant . Why Is The CER Important For Marketing Within The European Union? The CER is necessary for regulatory compliance to market a medical device in the EU. It documents the entire clinical evaluation process of a device. The CER lays out the evaluation and clinical data that determine whether there is enough evidence to s...

  A well-designed and written clinical evaluation report (CER) is essential for manufacturers of both new and existing medical devices because clinical evaluation is a crucial part of the technical documentation needed for regulatory compliance of medical devices sold in the European Union (EU). This is especially true now that the Medical Device Regulation 2017/745 (MDR) has been passed. The MDR directive imposes stricter regulations on the safety and performance of medical devices.  Not only are new devices seeking regulatory compliance impacted, but devices that were on the market before the implementation of the MDR directive are also impacted, as each device must be resubmitted for CE certification before the transitional period is over. To be in regulatory compliance, manufacturers will need to update the CER for each device to current MDR standards. According to a survey of medical device manufacturers, 78% do not understand MDR sufficiently, and 58% do not have a str...