What Everybody Needs to Know about Clinical Evaluation Reports?

 

If you've never written a clinical evaluation report for a medical device, you're probably worried about how involved the report needs to be and how many resources you'll need to complete it. The updated European Medical Device Regulation (MDR), which went into effect in May 2017, includes new, stricter CER reporting criteria. The level of detail contained in a CER, as you might expect, varies depending on the device. A device with higher potential patient risks necessitates a more detailed CER report. The greater the stakes, the more detailed the report must be. However, regardless of how many resources are required to complete a CER report, the structure remains constant. As one of the best CER Consultant providers in the market, Thomas Regulatory Resolutions is always there to help you get the clinical evaluation report done for your medical device quite comfortably.

A clinical evaluation report is a complete examination of pre and post-market clinical data pertinent to a medical device. Any medical device approved for sale in Europe must be accompanied by a detailed CER report. Clinical performance and safety analysis should be included in this report. For European approval, medical device manufacturers must submit a CER. Comparable reports must also be submitted for other international markets.

For example, the US FDA requires medical device manufacturers to submit annual premarket approval (PMA) reports. It is the manufacturer's duty to provide agencies or other notified bodies with a clinical data summary on device performance. The architecture of an effective CER report does not change regardless of the type of device manufacturing, despite the specifics of an effective report varying.

What Are Its Justifications?

The CER conclusion is founded on a clear statement that justifies the device's compliance with essential patient safety requirements. It should address the benefit/risk profile developed during clinical data analysis and draw on current knowledge to demonstrate whether the device and any associated risks outperform medical alternatives. In addition to a clear statement on compliance, the conclusions should cover topics like the sufficiency of manufacturer information materials, guidance on risk reduction and adequacy of the intended purpose, the device's suitability for the intended users adequacy of manufacturer claims, to determine whether these materials are consistent or if there are discrepancies.

The analysis of the clinical data should be compared to the safety claims, educational materials, and clinical state-of-the-art for treating the intended condition made by the manufacturer. The conclusion should also address any remaining risks or unanswered questions, and if necessary, make a case for CE-marking. The conclusion should address ongoing research and safety activities if the clinical data analysis produced conflicting results or if residual risks existed.

Wrapping Up

Because the CER is quite important for your medical device to get regulatory approval under the MDR, it is required that the manufacturers are aware of and understand the requirements for developing CERs under the new legislation. At Thomas Regulatory Resolutions (TRR), we can assist you in completing your CER report in compliance with the MDR (Medical Device Regulations). We also provide the best FDA medical device consultant services for manufacturers.

Source.

Why There Is A Need For A Clinical Evaluation Report (CER) For Your Medical Devices?