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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