Writing an exemplar Clinical Evaluation Report (CER) requires skills that blend scientific, medical/clinical, regulatory, and technical competences. A CER writer should also have experience in medical devices and the European MDR regulation (EU MDR 2017/745). It is not easy to find medical writers that master such a broad range of experience!
A CER writer can author the entire Clinical Evaluation Report or be in charge of particular sections, such as clinical evidence, clinical data analysis, or literature reviews. Currently, many CER writers are focusing on performing MDD-to-MDR gap analysis to ensure that the CER meets MEDDEV 2.7/1 rev. 4 requirements to comply with the European Medical Device Regulation (MDR).
Most medical writers have much experience in writing clinical trial documents such as clinical protocols, informed consent documents, and clinical study reports (CSR). While this experience is relevant, it may not be applicable when writing a comprehensible CER that should be adapted to the EU regulatory framework. On the other hand, many regulatory affairs professionals are experienced in writing technical content; but may have little or no experience with scientific or medical content. Finally, medical writers are likely to have robust clinical knowledge, while regulatory professionals usually have a more narrow clinical knowledge, defined by the intended purpose of the device under investigation. Understandably, for many medical device manufacturers, it is challenging to find a CER writer that would be a perfect match!
Here we summarized what we consider relevant skills and experiences to focus on when evaluating a CER writer. We also share some of our best practices to successfully write CERs and technical documentation for different classes of medical devices.
1. Writing experience.
Involve a medical writer that has a lot of writing experience. Having a significant experience writing scientific, medical, clinical, and technical content is a requirement for a good CER writer.
2. Clinical knowledge.
It is an advantage to involve a CER writer who is knowledgeable in the therapeutic area and the intended purpose of the device under investigation.
3. Device knowledge.
Involve an expert with knowledge of the technology (e.g., implantable devices, diagnostics, software, imaging). Most medical writers have little device knowledge. Some have knowledge limited to specific devices that were the subject of clinical trials.
4. Regulatory knowledge.
Involve a writer with a solid knowledge of MEDDEV 2.7/1 rev 4, including an understanding of the EU regulatory framework for devices, especially the role of the notified bodies in the review of a CER.
A Class III CER depends heavily on clinical trial data. Therefore a writer with a good understanding of clinical trials and CE-mark and PMA data collection is necessary. On the other hand, CERs for Class I and Class II devices use literature and post-market surveillance data, so clinical trial knowledge is less critical. Instead, experience in evaluating literature data and comparing it to similar or equivalent devices is essential.
In conclusion, a writer with broad content experience, familiarity with devices with the same type of technology, and knowledge of MEDDEV 2.7/1 rev 4 will be entirely up to the task of writing a CER. If needed, a medical doctor can provide specialist competence about a specific therapeutic area, and be a clinical evaluator and part of the CER-approver team.