As organizations grapple with the challenges of developing an EU MDR-compliant Clinical Evaluation Report (CER), the first question after “What is a CER?” is usually, “Who will write it?” Assembling the right team with the right skill set is critically important, as your CER must prove to the notified body that you have:
- Reliably established the safety and performance of the device and the state of the art, and
- Clearly articulated the results of post market surveillance.
Achieving these results requires that you perform an intensive process of research into free and paid content resources, establish effective search terms, and otherwise cast a wide net to learn all there is to know about your product in the marketplace.
Set the Stage for a Successful CER
When choosing members of your CER team, consider selecting those who possess the specialized skills required to quickly and effectively achieve the intentions of the Clinical Evaluation Report. At a minimum, we recommend a team consisting of:
- An experienced researcher
- A professional technical writer
- A CER project manager
The combined experience and talents of these team members will result in a CER that's been fully researched, professionally written, properly managed, and ready to submit to a notified body.
Consider Specialized Skill Sets
To choose the right person for each role, it takes careful consideration and an understanding of each position. Let's take a closer look.
The Experienced Researcher
Curious by nature, a researcher lives on the front lines of information gathering for the device and should have experience in the research process. Budget limitations and short time frames make it tempting to assign this task to an intern or admin, but be careful — errors in this fundamentally important information will undermine your results and may result in rejections from a notified body. To perform the most accurate research, assign an experienced professional to your team who has an advanced degree in Life Sciences. Without someone who has been through the process of accessing and defending information from reputable sources, you’re likely to cast your research net too wide or too narrow, and the resulting records will show it.
Professional Technical Writer
Clear, unambiguous language is critically important and is almost impossible to achieve using an inexperienced writer. Voice, tone, wording and ambiguity are often ignored, but they are critical aspects of communication across languages and cultures. A CER is not a place for slang terms, colloquialisms, and conversational style. More than likely, your CER will be read by someone who speaks English as a second language and unless the reviewer looks for proper sentence structure, active voice, and clarity, your report will be extremely difficult and time-consuming to evaluate.
CER Project Manager
Communication and organizational abilities are critical, as it's the project manager's job to track schedule, budget and goals of the project. Beyond that, gaining access to public and paid databases, coordinating with internal resources for adverse events, information, and complaints, and otherwise enabling the process are key elements of this position. When selecting a project manager, choose someone who knows the process well, can identify issues upfront and early, and keep the project moving in the right direction.
Sail Through EU MDR Regulations
The EU MDR requirements are real and for medical device companies that want to sell in EU countries, they are unavoidable. While it is sometimes difficult, sometimes puzzling, and likely a strain on your internal resources, if you form a team with experience and expertise, you’ll sail through the process and meet your goals.
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