How Often Should a CER Be Updated?
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If a company intends to sell its medical devices in the EU, it must produce and maintain a clinical evaluation report (CER) for the medical device that complies with Regulation (EU) 2017/745 Medical Device Regulation (MDR) and takes guidelines set forth in MEDDEV 2.7/1 revision 4 into account. The CER documents the result of the clinical evaluation of a medical device, and performing a thorough CER literature search is vital to writing an effective CER. An AI-based automated literature review software such as DistillerSR can expedite this and other tasks involved in writing a CER to a great extent.
Understanding the regulations a CER needs to comply with is essential to producing and maintaining a compliant CER. In the EU, based on the type of medical device, there are two major sets of regulations–the MDR and the IVDR. The difference between MDR and IVDR is that the MDR requires a clinical evaluation report (CER) for a medical device, whereas the IVDR requires a performance evaluation report (PER) for an in-vitro diagnostic device.
In this post, let’s dive into the various aspects of a CER, as well as how often a CER should be updated.
What Is a CER?
A Clinical Evaluation Report is a standalone document that is an important step toward procuring the CE mark for any device that is to be produced or distributed in the EU. A clinical evaluation involves the assessment and analysis of all available clinical data pertaining to a medical device to verify the safety and performance of the device. Article 2, Section 48 of the MDR defines clinical data as information concerning safety or performance, generated from the use of a device, sourced from clinical investigation(s), scientific literature, equivalent devices, or post-market surveillance and post-market clinical follow-up reports.
The CER is therefore based on clinical data extracted from existing literature, clinical experience, clinical trials, or any combination of the three. An effective CER should support strong evidence that the device achieves its intended purpose without exposing patients and users to risk and should justify any claims made by the manufacturer against the product.
A medical device manufacturer is required to prepare and submit a CER with the technical file as a part of the CE Marking/Conformity assessment process.
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When to Update a CER
Preparing and submitting the initial report is just the beginning of the CER life cycle. It is a document that needs to be updated regularly. Updates to a CER are required either annually, when the manufacturer receives new triggering information from post-market surveillance that could change the current evaluation, or every two to five years if the medical device is well established and does not pose any significant risks to the users and patients, depending on the risk class the device belongs to.
Section 6.2.3 of MEDDEV 2.7/1 revision 4 provides guidance to manufacturers on how often to update clinical evaluations. It says that the “manufacturer should define and justify the frequency” of CER updates. The frequency of the CER update depends on factors such as the invasiveness of the medical device, the complexity, and design of the device, the risk class of the device, the overall risk of the target population on which the device is used, the adverse event reporting ratios for devices placed on the market, and the addition of the latest clinical research data pertaining to the device, among others.
Using these and other metrics, a manufacturer needs to follow a systematic approach to ascertain the CER update frequency of a particular device.
However, regardless of the proposed rationalization of the CER update frequency, the manufacturer must update a CER after getting new information from post-market surveillance activities which might change the current clinical evaluation. For example, safety reports, newly published literature, or Post-Market Clinical Follow-Up (PCMF) studies may uncover previously unknown safety concerns. Clinical data from these sources must be continually evaluated because it may change the risk/benefit profile of the medical device. If new clinical data implies a change in the risk/benefit profile, compromises the safety and/or performance of the device, or negates any claims made against the device, the manufacturer must update the CER and further actions may be needed.
Final Thoughts
The CER is a centerpiece of the technical documentation needed to acquire a CE marking so that a medical device can be produced and distributed in the EU. Because the ultimate goal of preparing a CER is to ensure patient safety and device performance, it is a document that needs to be updated regularly. The frequency of CER update depends on the risk class of the device, the data from the latest research, and post-market surveillance activities, among other factors.
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