Maetrics, a leading international life sciences regulatory and compliance consultancy, have launched a new report providing clarity to medical device manufacturers on the requirements for properly documented, up-to-date Clinical Evaluation Reports (CER).
Correctly implementing the requirements for clinical evaluation is paramount for any manufacturer wishing to introduce or maintain their medical device on the European market.
From a clinical perspective, manufacturers must be able to demonstrate that the device achieves its intended performance objectives and that any known risks are minimised and are deemed acceptable when weighed against the benefits of the intended use of the device. Any claims that are made about the device’s performance and safety must also be supported by suitable evidence.
This new whitepaper from Maetrics has been created to serve as a valuable tool for medical device manufacturers to: highlight common sources of non-compliance; clarify requirements; address gaps in clinical evaluation guidance; and help manufacturers attain compliance and prepare for future regulatory changes.
With the constantly changing regulatory landscape and increased pressure on Notified Bodies, manufacturers must be prepared for increasing scrutiny of their CERs and heightened expectations with regard to the appropriate use of clinical data to support their devices. Maetrics’ new whitepaper delves into the regulatory background, the requirements for clinical evaluation, the clinical evaluation process, the clinical evaluation report, resources challenges and potential solutions. The full guide is available to download here: https://bit.ly/2oVQ4KW
Steve Cottrell, president at Maetrics, said: “Effectively managing Clinical Evaluation Reports is vital to achieving successful compliance for the new MDR. Companies are taking a varied approach to addressing the CER requirements. Some of the approaches are leading to uncertainty about whether the CER process will be compliant and whether their devices will be adequately supported.
“The aim of this whitepaper is to demonstrate to manufacturers that when combining the right knowledge, resource and processes, they can adopt a new approach to CER management and forge a successful pathway to meet regulatory changes and market needs. Taking a proactive approach to clinical evaluation reporting, manufacturers will be better situated to reap business benefits that will keep them ahead in their market.”