While larger manufacturers, global players, and multinational companies most likely won’t have problems complying with the European MDR due to having both the financial and human resources to comply in time, smaller and medium-sized manufacturers could find it difficult to implement the updated requirements.
Fundamental for the success of your device with the notified body, the clinical evaluation report (CER) is a critical step in demonstrating the safety and compliance of your device. CER writing for small manufacturers provides its own set of unique challenges, which we will discuss here.
With the transition to the Medical Device Regulation (MDR) 2017/745 in May 2021, medical device manufacturers are facing constant monitoring and life-cycle management of their clinical data. In the European Union, the Clinical Evaluation Report (CER) is critical to obtaining the initial CE-marking and it must be updated continuously throughout the lifetime of the device.
Challenges for Small Manufacturers
Even in well-established companies with fully staffed regulatory and quality departments, finding the time and resources to write a compliant CER can be difficult. In smaller companies, where the regulatory and quality department is frequently comprised of smaller teams of 2-3 people or even of a single person, maintaining clinical evidence compliance and updating it annually can turn out to be almost impossible.
For smaller manufacturers with limited financial resources, a vital step to evaluate if all the products in the portfolio should be transitioned to the MDR or if the investment can only be justified for some products. Developing a plan for each part of the product portfolio, whether it be for remediation, retirement, and/or transition, can be helpful in understanding longer term consequences and developing clear plans for each product.
Compliance and Non-Conformities
Writing a compliant clinical evaluation report is comprised of several processes and the CER writer needs to have the scientific, clinical, regulatory and technical competences to plan and execute each process. The CER writer should be able to author the entire CER report and dominate both clinical evidence, clinical data, literature search and review, and post-market surveillance, and have the overview to put it all together to a coherent and conforming report.
To do this, the CER writer must have a good knowledge of the European Medical Device Regulation (MDR), guidance documents issued by the Medical Device Coordination Groups, and be trained in the processing of clinical and post-market surveillance data and statistics. Furthermore, the CER writer should be able to process and answer non-conformities issued by the notified body in the review of the CER.
Literature Search and Review
For many smaller manufacturers that do not have equivalent devices on the market, or who do not have access to larger manufacturers clinical data, the literature search can comprise a large part, if not all, of the clinical data included in the CER. Furthermore, Class I and Class II CERs rely heavily on clinical data from literature reviews and require emphasized focus on the literature search planning and execution.
The literature search and review is a complicated process at best and each stage must be planned and executed correctly and systematically. Most regulatory staff has scientific backgrounds and are well-versed in science and medicine, but might be lacking in analytical reading and processing skills.
Writing the CER
Most regulatory staff has experience in compliance in their local markets, and while larger manufacturers might have regulatory staff spread all over the world, smaller manufacturers is typically comprised of local regulatory staff that might not be familiar with requirements in other markets. Regulatory staff usually also have a narrower clinical knowledge and are less able to correctly understand, assess, and explain clinical data than for example medical writers, if they are not specifically specialized in the topic.
For manufacturers in non-english speaking countries, requirements to avoid translation costs and write and submit the CER in English adds a second layer of difficulties for staff who are not 100% comfortable with or qualified for writing in English.
Outsourcing your CER
Considering the complications of writing a well-planned and well-executed clinical evaluation report for smaller manufacturers, a good solution could be outsourcing your CER to external CER companies or to freelance medical writers. This way, you can produce high-quality CERs in short time frames without damaging internal regulatory processes and compliance for existing approvals. Training internal staff can be expensive and time-consuming and hiring an external CER writer can be the best way to a beautiful CER in your required timeframe when financial and staff resources are limited.
Medical writing companies can be found online or in your local community. They typically have specialized staff and can provide package solutions for performing various services at once. The safety of being backed by a company structure is preferable to some and most medical writing companies provide continuous high-quality and professional service.
Freelancers can be hired directly through freelance sites online or through local networks and social media. They are usually flexible in terms of what can be provided and when. Most freelancers can be hired on project basis, i.e. for a fixed fee.
CER Writer Skills and Qualifications
A good CER writer is a well-established industry insider, who has worked within the regulatory and clinical sphere for years and is a specialist within their field. They should have a defined process (and be able to follow it), and understand the applied methodology and be able to analyze results accordingly. You need someone who is precise, organized, thorough, and easily understandable, and who is able to craft a CER report that does not receive a long list of corrections from the notified body after submission.
The knowledge base of your CER writer depends on what type of CER you need. If your medical device is Class I or Class II and relies heavily on clinical data from the literature and post-market surveillance data, you need a writer with a general clinical and therapeutic knowledge, but you might not need someone who is a specialist in clinical trials data and processes. If your CER is for a Class III or a novel device, you will need someone with a good understanding of pre-clinical data and clinical trials.
Lastly, you need to consider the timelines and deadlines involved in your clinical evaluation and find a CER writer who has the bandwidth to provide what you need within the required timeframe.
Writing a compliant CER report as a small manufacturer has its own set of distinct challenges, most of which differ from those of multinational manufacturers with regulatory staff spread across the world. Small regulatory and quality teams with limited resources, time, and skills are typically not able to keep up with all requirements in all markets. Writing a well-crafted and compliant Clinical Evaluation Report is a specialized skill that requires training and experience that regulatory staff in smaller companies simply might not have. Outsourcing your CER report can be a good solution for crafting a beautiful CER and obtaining rapid MDR compliance.