What is a CER?
A Clinical Evaluation Report (CER) comprises the results of a clinical evaluation of your medical device. A CER includes analyzed clinical information that was obtained from either a clinical investigation of your device or the conclusions of other studies on substantially equivalent devices. The CER ascertains that your device accomplishes its premeditated objective without bringing risk or harm to users and patients.
Clinical Evaluation Reports are expected for all medical devices in Europe. Your CER must be submitted to your Notified body as an attachment to your European CE Technical File. The Technical File is an important step if you want to obtain CE Marking for your device, which is needed to sell or distribute medical devices in Europe.
Who is a CER writer?
A CER (Clinical Evaluation Report) writer is someone who writes the whole clinical evaluation report or is in charge of certain categories which include clinical evidence, clinical data analysis, or literature reviews. However, most CER writers focus on accomplishing MDD-to-MDR gap examination to guarantee that the CER is up to the MEDDEV 2.7/1 rev. 4 statutes to harmonize with the European Medical Device Regulation (MDR).
A CER writer needs abilities that combine scientific, medical/clinical, regulatory, and technical competencies. A CER writer also needs experience in medical devices as the European MDR regulations (EU MDR 2017/745). Oftentimes, it is not easy to discover medical writers that have total mastery of such a wide range of experience. Also, CER writers should have the ability to deal with queries on medical device safety, design quality, manufacturing certifications, manufacturer’s instructions for use, and other suitable compliance requirements.
Things to know before Writing a CER
Writing a Clinical Evaluation Report happens in three phases. In the first phase, manufacturers observe clinical data from subsisting literature, clinical experience, clinical trials, or any combination of the three.
The second phase encompasses evaluating the data’s applicability, pertinence, excellence, and importance. The third stage needs you to convey your outcomes in the CER, based on the data you have gathered. Approach the CER as an individual document even though it will be included in the technical file or design dossier.
However, some things should be included in the CER. Some of them are as follows;
- General Information: Device name. and Manufacturer name.
- Succinct physical and technical device description and planned application (what it was designed to be used for).
- Summary of planned therapeutic or diagnostic declarations.
- Clinical tryout and data types.
- Outline of clinical data and review.
- Explain the analyses that were used to examine the performance, safety, and relevance/accuracy of product literature.
- Conclusions about safety, performance, and unity.
What to look out for before hiring CER writers
Freelance medical writers can be hired online on different freelance platforms. However, there are some qualifications one must look for before hiring a CER writer. Some of those criteria or qualifications include:
- Writing Experience: The writer must have ample experience in writing medical/clinical, and technical content. It would be a bonus if the writer has experience writing CERs that comply with MEDDEV 2.7. 1.
- Clinical knowledge: The writer must be well-versed in the therapeutic field. If the knowledge is similar to or applicable to the particular device, it would be a plus.
- Device Knowledge: The writer must be knowledgeable about the devices employed in the therapeutic field and oftentimes, in technology (e.g diagnostics, software, and imaging). Mastery of the particular device type would be an addition.
- Regulatory Knowledge: A writer that has strong proficiency in MEDDEV 2.7.1 would be the best. Knowledge about the latest update, a mastery of the EU regulatory framework for devices, particularly the function of the notified bodies in the review of a CER, would be a bonus.
While looking out for these qualifications in the CER medical writer, it is also important to evaluate the exact needs of your CER. For instance, a Class III CER depends heavily on clinical trial data, and thus requires a writer with a good mastery of clinical trials, most likely a medical writer, or a device RA professional with PMA experience.
By hiring a CER writer that pays attention to details, you will get a perfectly written literature search that will not require further editing. The Clinical Evaluation Report will be submitted directly to the notified body. As a result, you will not get a long list of editing from the notified body.