Writing a clinical evaluation report compliant with the European Medical Device Regulation (MDR; 2017/745) can be challenging.
Ever stricter requirements for clinical evidence, data appraisal, and literature search processes have caused many medical writers to despair.
The updates to the regulation are also causing problems for medical device manufacturers, who can no longer find the internal resources to comply fully and must look elsewhere for clinical evaluation report (CER) writers.
So, what do you look for when evaluating clinical evaluation author qualifications?
This article reviews the experience required to write compliant clinical evaluation reports for medical devices. In addition, we review the qualifications of the ideal medical writer, both technical and organizational, and discuss what soft skills you should expect from them.
The most important qualification to look for in a medical writer is the technical experience.
Technical experience encompasses the different knowledge areas your CER writer should be familiar with. The CER writer should be an expert in at least one, but preferably all, of these areas.
Arguably the most important skill for a CER writer is regulatory knowledge to ensure compliance.
The writer should be versed in the current medical device regulations (MDR and IVDR), applicable guidelines, such as MEDDEV 2.7 1 rev., standards, and typical notified body feedback.
Knowledge of quality management systems, adverse event databases and searches, risk management, and device design and development are areas where the medical writer should have some experience.
Likewise, the medical writers should be experts in post-market surveillance data, clinical performance, the EU regulatory framework, and clinical documentation (clinical study reports, clinical performance reports, clinical evidence, clinical trial data, etc.).
Clinical Evaluation Report
Any CER writer should have practical experience with regulatory documents, technical documentation, and clinical data for medical devices – theoretical expertise is not enough.
Drafting clinical evaluation reports efficiently and correctly requires an understanding of the different sections of the report and their particular challenges.
Most CER writers will not be able to give samples of their work, as CERs are typically confidential.
However, you can ask the medical writer how many reports they have worked on, what they find most challenging, what their favorite part of the CER is, and other questions that will convey their expertise in the field and demonstrate their practical experience.
Apart from the technical aspect, it is essential that clinical evaluation reports, like any other written report, should be as enjoyable to read as possible.
Regulatory reports are by nature formal and technical, but that does not mean they should be tedious or confusing to read.
A CER writer with excellent writing skills and writing experience should be able to convey ideas succinctly and clearly, without too many tangents and confusing phrases.
Looking for a CER writer that also offers services in copywriting or editing can be a simple way to find a writer with an engaging style, as they also write for different audiences and can edit.
If they do edit or write professionally in other arenas, you also ensure you get a writer who dominates English, which is currently the main language used for CERs.
CER writers from the regulatory industry might have experience with a particular type of product, such as ophthalmic devices or X-ray devices, if they have worked for the same type of medical device manufacturers.
However, most medical writers have either been employed from the beginning as medical writers or come from regulatory companies that do not specialize in specific devices.
This makes their device knowledge exceptionally wide, meaning they are able to write CERs for many different types of devices. Clinical knowledge, medical terminology, and experiences with scientific or medical content, such as clinical research, clinical trials, and technical content, are all areas where the writer can contribute positively to the required device knowledge.
Specialty medical devices, such as human-origin devices, software, and very high-risk devices, might require specialized knowledge. In this case, you should look for a CER writer who has previously written similar reports.
Organizational skills are critical for CER writers. However, drafting CERs can be tedious, depending on the amount of clinical data.
Systematic literature reviews and adverse event searches can quickly return thousands of results, as can complaints and sales data.
Understanding how to minimize the effort and time required while optimizing the final result is a finely tuned skill only experienced CER writers possess.
Document formatting and editing are something most writers are familiar with.
However, during CER writing, you are formatting many tables, appendices, and similar items in documents that are often more than 100 pages long.
A good CER writer knows how to format and edit to make their reports look professional and clean.
While writing the actual report is usually a one-person job, obtaining all the documents required for the report while maintaining communication with the client regarding project timelines, capacities of everyone involved, and budgets is a team effort.
Any writer involved in regulatory efforts must have some project management skills.
Otherwise, the probability of the clinical evaluation report finishing on time and within budget is low.
Soft skills are difficult to quantify. They are, however, some of the most vital parts of establishing a good partnership and obtaining good results when hiring a CER writer.
Maintaining the focus is critical when it comes to CER writing.
Many parts of the CER process are tedious and require handling large datasets and paying attention to details and the big picture.
Literature and adverse event searches can return thousands of results that all have to be organized and easily retrieved.
Likewise, trend reporting and complaint data can quickly become a mathematical exercise threatening your sanity.
The ability to focus on the task at hand and how it relates to the bigger picture significantly lowers the revisions needed once the report is finished.
Likewise, it will most likely decrease the number of comments received from notified bodies.
Most people agree that good communication is vital for the success of any project. What does good communication mean, though?
Managing expectations, establishing a good working relationship, and addressing any issues coming up during the CER writing depend on both parties exhibiting good communication skills.
Above all, good communication is clear, without judgment, and professional.
Whether you are looking for freelance CER writers or hiring a specialized company to do your CERs, understanding what is required of the writer is vital for medical device manufacturers.
It might be worth it to take five minutes before starting the hiring process to determine what exactly you are looking for.
Of course, it is preferable that all potential writers have all the desirable qualities, but most likely, you will have to compromise in certain areas.
Decide which areas you can compromise on before talking to the potential candidates.
And be flexible – the perfect CER writer might not be what you expected, but you could still be the right person for your project.