Even for experienced medical writers and regulatory staff, writing a compliant clinical evaluation report (CER) for medical devices can be tricky. Regulations and guidelines change, as does the attitude of the notified bodies.
A clinical evaluation report (CER) that was compliant ten years ago might not pass conformity assessment today, even though clinical evaluation remains, for the most part, based on MEDDEV 2.7/1 Revision 4, released in June 2016.
While most of us have read the Medical Device Regulation (MDR; 2017/745) more times than we care to remember, there is a big difference between reading the regulation and being able to actually draft a compliant medical device clinical evaluation report based on the regulation. Expertise comes from experience!
To save you from headaches after receiving feedback from the notified bodies, we’ve compiled five practical tips for writing a compliant clinical evaluation report that is easy to understand and implement.
Understand what is expected of your clinical evaluation
During conformity assessment, the notified body performs a detailed review of the medical device manufacturer’s clinical evaluation.
The conclusions and findings of their review are included in a clinical evaluation assessment report (CEAR).
In July 2020, the Medical Device Coordination Group (MDCG) issued a Clinical evaluation assessment report template (MDCG 2020-13) as an aid to notified bodies and medical device manufacturers. The template exists to help the notified body accurately document the conclusions of their clinical evaluation review.
The template includes sections for each part of the clinical evaluation for the notified body to fill out.
However, the template presents the minimum content required for the clinical evaluation assessment report and thus also for the clinical evaluation report provided by the manufacturer.
More details could be required depending on the medical device and its intended purpose.
Still, the template is an excellent place to start understanding the minimum section and details that should be included in every clinical evaluation report for medical devices.
Use the guidance available to you
Speaking of MEDDEV and MDCG guidelines, make sure to use all the guidance available to you.
The requirements for clinical evaluation in the MDR are not comprehensive enough to ensure a perfect clinical evaluation report. Therefore, although the guidelines provided by the MDCG are not legally binding, they can be considered an official interpretation of MDR requirements.
The same is true for MEDDEV 2.7/1 Rev.4 and several international standards that might not be harmonized under the MDR yet. However, they are still helpful and provide loads of useful information for all sections of the clinical evaluation report.
When using these standards, the correct hierarchy of significance is
- Typical specifications
- MDR harmonized standards
- International standards and
- MDCG guidance documents.
Quantify your benefit-risk ratio
It is not enough to state that your medical device performs “as well or better” than the competition.
You need to substantiate your performance claims by providing quantifiable/measurable acceptance criteria for your safety and performance objectives, i.e., numerical values.
This could mean listing out restoration volume before and after surgery in cm3, the size of an acceptable deformity following implantation in mm, or blood loss in mL during surgery.
You need to specify the parameters used to determine the acceptability of the benefit-risk ratio, so you can make an informed conclusion as to whether your medical device has more benefits than risks to the patient based on quantifiable evidence.
You must also describe how these parameters were established and why they are relevant.
Essentially, you want to place your medical device in a state-of-the-art context and prove that its safety and performance objectives are up to the current standards.
Use at least two literature and adverse event databases
When performing literature searches, the goal is to obtain a complete picture of your subject device’s safety and performance objectives and the current state-of-the-art.
While literature databases such as PubMed and Embase have thousands of journals indexed, there might still be publications that you won’t find in these search databases.
Clinical trial data, publications from smaller journals, and articles from non-western countries might not appear in searches on PubMed, which is why it is always good to search at least two literature databases.
The same goes for adverse event databases. Post-market surveillance data for your subject device and equivalent devices is a critical part of the clinical evaluation report and other technical documentation. Yes, you can find a lot of information in MAUDE, but searching at least one other, preferably 4-5, will get you a complete picture of the market behaviors of the medical devices you’re investigating.
Everything you say in a clinical evaluation report should always be backed up by science.
You must be objective and provide evidence for all your claims and statements in the report.
This may sound easy, but it’s a trap even the most experienced medical writers can fall into. For example, you might think, “well, everyone knows that orbital rim fractures are the most common injury in blunt force trauma to the face.”
While that might be true in your field, you still need to reference a few peer-reviewed studies that demonstrate that this is the case.
It can also be tempting to conclude that one treatment is better than another without adding references to studies that support your conclusions.
This is especially true when clinical evaluation reports are done in-house or if the clinical evaluation report (CER) writer has a lot of experience in the subject, as it becomes easy to sum up, the “knowledge” without demonstrating where that knowledge originates.
In short, reference everything.
While the European Medical Device Regulation is much more detailed than regulations in other parts of the world, it is still not a complete recipe book for a compliant clinical evaluation report.
On the surface, everything you could ever need to know is written in the MDR, MDCG GUIDANCE, and MEDDEV.
However, when it becomes time to put all the ingredients together, draft the clinical evaluation plan, and report, there are often missing ingredients or cooking steps.
Studying the regulation and guidelines can only take you so far.
The best learning experience when drafting compliant clinical evaluation reports is getting notified body feedback. Of course, it is a headache every time, but it is the best way to really understand what conformity assessment requires.
Frequently asked questions
Does my clinical evaluation report always need a literature search?
Yes, you should always include a literature search in your clinical evaluation report to demonstrate that you’ve done the appropriate work to demonstrate safety and efficiency.
Should I include equivalent devices in my clinical evaluation report?
Only if you have all the required device knowledge and device information readily available. If not, use a similar device instead.