Manufacturers need to set a clear roadmap to compliant clinical evaluation reports, says David Egbosimba, solutions delivery manager, Maetrics.
Clinical Evaluation Reports (CERs) are a requirement for any medical device sold into Europe, irrespective of its classification. They are part of the product Technical File and must be kept up to date. But ask a handful of manufacturers or even Notified Bodies (NBs) exactly what process this entails, and the answers are likely to be varied. There are in fact some common misunderstandings relating to CERs that may lead to misfiling and leave manufacturers feeling uncertain as to whether their CER process will be considered compliant and their medical devices adequately supported or not.
Not passing an inspection may result in an expensive product recall and reputational damage. Having to repeat reviews of clinical data in response to deficiencies is also highly time-consuming and a drain on resources. In this scenario the new Medical Device Regulation (MDR) came into force on the 25th May 2017 making proactive implementation of CERs highly critical. The MDR specifically places greater emphasis on supporting clinical data requirements and highlights the need for planning and documenting the CER process.
In addition to this, NBs are also under increased scrutiny and need to improve their performance in terms of safeguarding public safety. In particular, they have been called upon to increase the use of unannounced inspections and limit their activities to devices where they have proven competence.
Two common misconceptions
Clinical evaluation is defined as the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance when used as intended. However, this definition doesn’t avert the misconception held by many manufacturers that it is a once-in-a-lifetime duty rather than an ongoing activity that needs to be updated and refreshed throughout the product’s entire lifecycle. The new MDR and the unannounced inspections by the NBs clearly highlights the importance for manufactures to put more focus on achieving ongoing compliance.
The first misconception is therefore not grasping the cyclical nature of the task, while a second typical challenge is caused by the underestimating of how long it takes to complete a properly documented CER. A methodical best-practice CER can actually take up to three months to finalise depending on expertise and resources available. This is a particularly difficult obstacle for manufacturers who have multiple devices which require new, updated or revised CERs, especially when these deadlines are grouped around the same date or fall at the same time.
Underestimating the time it takes to complete a CER can have repercussions on the whole production cycle as inhouse professionals are taken away from their key tasks to complete the CER. Yet ensuring that the CER is completed by qualified individuals who harbour the expertise to deal with the clinical data such as writers who have the knowledge of the device and therapy area as well as knowledge of research methodology and critical review skills is critical. Expertise and familiarity with the CER process itself is also important to avoid non-compliance, improve efficiency and overcome gaps in the guidance through expert interpretation.
Key checklist
Once the manufacturer has come to terms with these common misconceptions it is critical that manufacturers ensure they tackle the fall out from them. And therefore:
1. Develop CER and internal QMS procedures
The very basis for developing a CER procedure is ensuring that the business understands what the internal sources for the clinical evaluation are and ensures that the required information is available and can be obtained in the correct format when required.
When it comes to the CER, a standard operating procedure (SOP) needs to be developed to include comprehensive standard templates for evaluators to use to uniform the process and increase efficiency.
2. Appropriately resource the CER
The availability of dedicated staff is critical to help ensure the time-consuming elements are completed as swiftly as possible but needs to be sensitive to existing workloads. If a manufacturer does not have an experienced CER writer in house, it is critical to source the right level of expertise elsewhere and this too is a time-sensitive task.
3. Invest in training
CER writers need to be specialised and trained on the CER process. Developing in-house expertise is essential, whether for writing or for reviewing outsourced CERs. There are training courses available on clinical evaluation and also for other aspects of research methodology if necessary.
4. Accurately select CER writers and staff
To approach the CER efficiently and reduce time spent to complete it savvy manufactures will allocate certain elements of the process to different (appropriately trained) internal or external personnel that has the specific skill set.
Heightened expectations regarding the appropriate use of clinical data to support devices need to be met and manufacturers should not delay reviewing the CER process. Drafting a roadmap to CER compliance will help them meet regulatory changes and unannounced inspections with confidence.