The European Union Medical Device Regulation (EU MDR) has set higher standards for medical device clinical evaluation ERs) standards. With stricter regulations and guidelines, clinical evaluation report writing requires expertise, experience, and knowledge of the regulatory landscape.
What are the CER or Clinical Evaluation Requirements?
According to the EU Medical Device Regulation (MDR), several requirements are needed for your medical device to get CE marked. One of the most important ones, understandably, is that the clinical evaluation report must be written in compliance with the MDR to ensure that the device is safe and effective for its intended use.
Here are some of the requirements for writing a CER under the MDR:
- State the device’s intended purpose: The clinical evaluation report should clearly state the intended purpose of the device. This includes the patient population, clinical indication, and target market.
- Identify the clinical data sources: The clinical evaluation report should identify the clinical data sources used for the evaluation. These sources should be relevant, scientific, and up-to-date. In addition, theIn addition, the literature review should contain scientific literature with relevant data and clinical outcomes.
- Analyze and evaluate the clinical data: The clinical evaluation report should include an analysis and evaluation of the clinical data. This analysis should assess the safety and performance of the device.
- Identify the gaps in clinical data: The clinical evaluation report should identify any gaps in clinical data and propose strategies to address these gaps. This includes a plan for collecting additional clinical data, if necessary.
- Discuss the risk-benefit analysis: The clinical evaluation report should include a risk-benefit analysis that considers the risks associated with the device’s use and the benefits to patients.
- Include a post-market surveillance plan: The clinical evaluation report should include a post-market surveillance plan that outlines how the manufacturer will monitor the device’s performance and safety after it is on the market.
This is a general overview of what the notified body will check when going over your clinical evaluation report. In reality, they will have a checklist to ensure you have supplied all relevant valid documents and sufficient clinical evidence to prove the medical device’s compliance.
For example, according to MEDDEV2.7/1, the notified body will assess around 22 factors, including the suitability and limitations of the clinical data given in the CER regarding the device’s safety and performance and any justification.
Although the elements of the clinical evaluation process conformity assessment are listed, the applicable standards are based on the current knowledge and state of the art. In other words, a manufacturer should ensure the clinical evaluation requirements are adequately met. Therefore, the understanding comes mainly from the clinical experience of the manufacturer/CER writer.
To Hire or Not to Hire: The Ups and Downs
When you hire a CER writer, you are hiring another team member whose job is to take all clinical data generated through the clinical trials and clinical investigations your team has conducted, add necessary research and info, and turn in a finalized polished document to get the medical device’s CE marking.
However, the benefits of hiring a professional for the CER process are apparent. CERs provide a comprehensive analysis of the safety and effectiveness of a medical device and are an essential tool for regulatory compliance. However, creating a high-quality CER can be complex and time-consuming, requiring a deep understanding of medical device regulations and clinical research methodologies.
Let’s face it; manufacturing teams usually have a lot on their plate – they’re busy designing and developing medical devices, conducting clinical trials, and navigating regulatory requirements.
That’s where the expert CER writer comes in. They have years of experience crafting top-notch reports that meet regulatory requirements and provide a comprehensive overview of the and performance of the device. They know the ins and outs of the regulatory landscape and can navigate it easily.
For example, an expert CER writer can identify the most relevant data sources, such as clinical studies and literature reviews, quickly extract the key findings and establish solid proof of the device’s safety and performance. This, in turn, expedites the review process and minimizes the risk of requests for additional information or clarification.
Let’s talk about the downsides now, although they are few. Understandably, the cost is a factor. Expert CER writers typically command higher fees due to their experience and specialized knowledge. However, with a bit of management on your behalf and considering the streamlining of the process, hiring is cost-effective in the long run.
Limited availability can be another issue. Make sure that whoever you are hiring is available to assist you even after the project is done, to manage any unforeseen hiccups.
Hiring a Clinical Evaluation Report CER Writer
The professional medical writer will usually know their way around clinical evaluations. Still, you want to hire the right person for the job.
Here is a checklist of attributes to look for:
In-depth knowledge of regulatory requirements
EU MDR requires a thorough understanding of the regulatory landscape, including relevant laws, regulations, and guidelines. Therefore, an expert medical writer should have in-depth knowledge of the regulatory requirements and ensures that the CER complies with all regulatory standards.
Experience in medical writing
Expert medical writers have years of experience writing CERs, which is essential for successfully completing a CER. In addition, they are familiar with the structure, format, and language of CERs, making it easier to write a comprehensive and well-organized report.
Ability to interpret clinical data
CERs require a detailed analysis of relevant clinical data, which can be complex and challenging. Expert medical writers are trained to interpret and analyze clinical data to provide an accurate and comprehensive analysis of the device’s safety and effectiveness.
Scientific writing skills
CERs require scientific writing skills, including writing clearly and concisely, accurately representing data, and effectively communicating findings. Expert medical writers have solid scientific writing skills and can present data concisely and compellingly.
Ability to work collaboratively
CER writing is a collaborative effort involving input from various stakeholders, including clinical experts, regulatory affairs professionals, and statisticians. An expert medical writer can work effectively with all stakeholders to ensure the CER meets all requirements and standards.
Project management skills
CER writing requires project management skills to ensure the report is completed on time and within budget. Expert medical writers have the necessary project management skills to manage timelines, budgets, and resources effectively.
Knowledge of medical device technology
CERs require an understanding of medical device technology, including the device’s design, materials, and manufacturing processes. Expert medical writers have the necessary knowledge to understand and explain the device’s technical aspects as required.
The CER writer should thoroughly understand medical device regulations and guidelines, including EU MDR and FDA regulations (in case you want to expand). The MDR documents can get confusing: experience and thorough knowledge will get you through the process much faster.
Data analysis skills
CER writing requires the analysis and interpretation of clinical data. Therefore, the writer should have strong data analysis skills and be able to present data clearly and concisely.
Education and training
A CER writer should have a relevant educational background and training in medical writing, such as a medicine and life sciences degree. In addition, look for candidates with certifications, training in regulatory writing, or medical device regulations.
CER writing requires specific skills and experience, including knowledge of medical device regulations, medical writing, data analysis, and project management. Therefore, ensure that the candidate has relevant experience in CER writing, preferably in your field of medical device development.
References and portfolio
Ask the candidate for references from previous clients or employers and samples of their previous work. Review their portfolio to determine if their writing style and experience align with your project’s needs.
If you already have a team member trained in these, then it certainly is easy to use the in-house writer. However, remember that all your efforts, and months of work, comes down to the clinical evaluation report and getting the CE marking. You wouldn’t want to take risks!