What is a Clinical Evaluation Report (CER)?
A CER includes an analysis of clinical data collected from clinical investigation of a manufacturers’ device, or the results of evaluation of equivalent devices. The CER’s purpose is to demonstrate adequate clinical performance and clinical safety of the device..
An Overview about Clinical Evaluation Reports Under The EU MDR
A Notified Body CE certified or Maufactures applied, new or existing Technical File holders irrespective of device specification and risk class, must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File.
Clinical Evaluation Report being a critical compliance document for CE Marking of Medical Device and doing business in the EU. Manufactures and regulatory team has lack of clarity regarding key requirements and best practices for creating Clinical Evaluation Reports. Without a clear understanding of what is required, manufacturers struggle to apply a consistent approach to the CER process. The result is that manufacturers loose the certification validty or application will be rejected by Notified Body. Therby manufactures loss market share or they will have to run repeat reviews of clinical data each time a deficiency is recorded. Further, inefficient CERs can lead to costly recalls and reputational damage. Now that the new Medical Device Regulation 2017/745 (MDR) has come into force in the EU, there is even greater emphasis on providing supporting clinical data, combined with the need to suitably plan CERs and fully document the approach and process. Under both the MDD and the MDR, manufacturers are required to proactively conduct postmarket surveillance (PMS) as part of their quality management system (QMS), and results from these activities are a key part of the clinical evaluation Report. In addition when device in the market and being used by patients the CER needs to be continually updated to ensure that the risk benefit analysis remains up-to-date and acceptable, and the safety and performance claims for the device mentioned in IFU / User Manual is justified and supported.
Challenges and the Solutions
Clinical evaluation is an ongoing activity throughout the product life cycle. Clinical Evaluation is not a standalone activity. Monitoring and regularly gathering and updating information on key processes, such as postmarket surveillance and risk management activities.
Manufacturers cannot predicat or estimate the time required to carry out a complete Clinical Evaluation Report or how many persons must be deputed to complete one product or if have multiple devices what will be the manpower requirmnet and time. This results in staff shortages and non avliablity of experienced man power.
First, manufacturers should perform a GAP analysis on their existing CER with the help of QARA team of consultants; what is the missing, or what weaknesses does it exhibit? Where is the system used to develop and update CERs failing the manufacturer? Is this development and update process inconsistent across all the products?Is any Notified Body comments pending with manufacturer?
QARA team of offshore medical writers and consultants are there to help manufactures desiring to affix CE Marking on medical devices.
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Activities followed by QARA for Clinical Evaluation
How we help in annual CER updates