Clinical Evaluation Reports under the EU MDR
|Understanding Clinical Evaluation Reports under the EU MDR||D Egbosimba|
|Every medical device sold into Europe, new or existing, and irrespective of specification, must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File. The manufacturer also needs to demonstrate that the device achieves its intended purpose and that any existing — or foreseeable — risks are minimised and weighed against the benefits of the intended use by the patient. Finally, any claims about the device’s performance must be supported by evidence.|
However, despite the CER being a critical compliance element for medtechs doing business in the EU, there continues to be significant lack of clarity regarding key requirements and best practices for creating these reports.
|MedDevice Online, 7 Nov 2018|
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