EU guidance on Notified Body clinical evaluation assessment reports

The European Commission’s Medical Devices Coordination Group (MDCG) has issued a guidance document outlining the role of the Notified Body’s clinical evaluation assessment report (CEAR) in assessing a device under Regulation EU 2017/745 on medical devices (MDR). It includes a 24-page standardised template which Notified Bodies should employ to record their reviews of a companies’ clinical evaluations.

The MDCG says that “A harmonised CEAR template provides a standardised method for documenting the Notified Body’s assessment of the manufacturer’s clinical evaluation and related documents. CEARs in this format will also support specific additional requirements, such as the clinical evaluation consultation procedure and reviews by designating authorities.”

The CEAR is a particularly crucial document for high-risk products that are being reviewed by expert panels. When carrying out a clinical evaluation procedure (CECP) for certain class III and IIb devices, they must appraise the CEAR.

The CEAR has to give adequate information regarding the clinical evidence given by the manufacturer, especially regarding the benefit-risk calculation, the reliability of that evidence with the intended purpose, including the medical indication or indications and the post-market clinical follow-up PMCF plan. 

The Notified Bodies’ designating authorities will have access to the complete audit trail of the Notified Body. They will decide if the clinical evaluation assessment was carried out correctly, considering the assessment, procedures, associated documentation and the conclusions.

The document may provide useful insights also for manufacturers how clinical evaluations will be assessed under the MDR regime.

Source: Medtech Insight (an Informa product)

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