By David Egbosimba, Maetrics
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.
Without a clear understanding of what is required, both manufacturers and Notified Bodies (NBs) struggle to apply a consistent approach to the CER process. The result is that manufacturers feel uncertain about whether their CER process will be considered compliant, as well as whether their medical devices will be deemed adequately supported by the NB.
Should their CERs not pass scrutiny, these medtechs will be unable to keep their devices on the market — resulting in a loss of 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 (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. As new data becomes available once the device is on the market and being used, the CER needs to be continually updated to ensure that the risk/benefit assessment remains up-to-date and acceptable, and the safety and performance claims for the device continue to be supported. Specifically, this point of confusion is more clearly defined in Rev.4 of the guidance, which specifies that active updates should occur every one to five years, based on the device’s risk profile and/or the availability of PMS information that may change the CER.
In addition to regulatory uncertainty, manufacturers sometimes operate on the misconception that CERs are a one-off task that needs to be carried out only once, or on an ad-hoc basis. Clinical evaluation is, in fact, an ongoing activity throughout the product life cycle. Another common mistake is considering clinical evaluation as a standalone activity when, actually, regularly gathering and updating this information plays a critical role in many other processes, such as postmarket surveillance and risk management activities.
Manufacturers also typically struggle to estimate the time required to carry out a complete CER — up to three months — and have multiple devices requiring updates to their CERs at the same time. This results in staff shortages and stalls production, but also leaves manufacturers open to risk in case of an unannounced inspection by a Notified Body. Scheduling ongoing and routine literature reviews, as well as updates, can save manufacturers time when a CER comes up for review by a regulatory body.
To seamlessly manage the CER process so that clinical data is regularly updated without causing major bottlenecks, or stalling, in productivity, it is critical that manufacturers establish a clear strategy towards CERs. Typically, an efficient approach starts at the research stage, with businesses understanding the inputs critical to clinical evaluation, from external literature to internal sources.
First, manufacturers should perform a gap analysis on their existing CER or CER system; what is the CER 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 the business? Is it redeveloped each time a CER comes up for review? How are the writers on CERs selected?
It also is important that the manufacturer has a clear understanding of the information sources feeding the CER — typically, product information, risk and PMS data, and what format that information takes. This understanding should be used to create a standard operating procedure (SOP) that includes comprehensive and standard templates, so evaluators are equipped to consistently follow the correct process without reinventing the wheel each time around, ultimately saving time when a device is up for review.
CER evaluators also require training and an appropriate background. Ensuring that CER writers are trained on the CER process, and are not relying solely on guidance, will remove the likelihood of time-consuming revisions during the production phase or after NB review. It also is important that the CER be completed by individuals with the expertise to deal with the clinical data.
Ideally, CER writers will have knowledge of the device and the therapy area, as well as knowledge of research methodology and critical review skills. Expertise and familiarity regarding the CER process also is important to avoid non-compliance, improve efficiency, and overcome gaps in the guidance through expert interpretation. Developing this in-house expertise is essential, whether for writing or for reviewing outsourced CERs.
Similarly, it is important to evaluate staff skillsets to understand which staff members are prepared to collate data — falling under their area of expertise — for the CER author. For example, equivalent device product data likely would be best provided by the technical team. This process saves time and maximises the strengths of the whole team. There also exist training courses on clinical evaluation and other aspects of research methodology, if a company deems that step necessary. Finally, many manufacturers struggle to ensure sufficient manpower to complete the CER process in the time required. For all these challenges, organizations must weigh the advantages and disadvantages of developing in-house talent versus outsourcing.
In the EU’s complex regulatory landscape, manufacturers need to ensure their CER processes can withstand heightened scrutiny from NBs and the public. Developing a clear approach to CERs and understanding where potential bottlenecks may appear is critical to ensuring that products stay on the market and remain safe to use.
About The Author
David Egbosimba is a Solutions Delivery Manager at Maetrics with extensive experience as a medical writer, authoring numerous Clinical Evaluation Reports in a variety of medical device therapy areas. David is a clinical professional with a background in clinical affairs, clinical development, and clinical research. At Maetrics, David has supported clients in their transition to the EU MDR, created CER gap analyses, and developed CER strategies for novel devices. Prior to joining Maetrics, David was a Clinical Affairs Manager for Mologic Ltd., where he established a Clinical Affairs department.