What Are Clinical Evaluation Reports (CER)?
A Clinical Evaluation Report (CER) catalogs the conclusion of a clinical evaluation of your medical device. A CER embraces scrutinized clinical data that was accumulated either from a clinical investigation of your device, or the upshots of other studies on significantly analogous devices. The CER exemplifies that your device has its prepended purpose without revealing users and patients to further instability.
Purpose Behind Medical Device Clinical Evaluation
The main purpose behind the medical device clinical evaluation is assessment stratagem conducted by registered applicants to certify whether the application specifications or purposive use of the device(s) under application can be attained based on clinical literature, clinical data, and information assembled from the clinical trial(s).
How To Prepare A CER?
A medical device clinical evaluation generally takes place in the following three steps:
- Manufacturers ascertain clinical data from enduring literature, clinical experience, clinical trials, or any blending of the three.
- The second step is to appraise the data’s relevance, applicability, quality, and significance.
- The last step requires you to eloquent your closure in the CER, based on the data you composed.
What Does CER Consists Of?
- General information about the device and the manufacturer’s name.
- Consists of physical and technical device illustrations and deliberated application.
- Brief summary of purposive therapeutic or diagnostic claims.
- Clinical evaluation and data types
- Summary of clinical data and review
- Chronicle analyses used to gauge performance, safety, and accuracy of product literature
- Conclusions about safety, performance, and conformity
How frequently the clinical evaluation report should be updated?
The initial medical device clinical evaluation report is drafted during the development phase of the device and for the requirement for EU market approval. After marketing, it has to be regularly updated to reflect data from post-market surveillance.
It’s important to realize that the entire process including the report writing should be repeated on a regular basis.
The report must be updated when new post-market surveillance information could affect the conclusion of the clinical evaluation report (CER). Low-risk devices are established and have undergone no changes, the update would be necessary every 2 to 5 years Device carrying significant risk, device used in high-risk patient populations devices must be updated at least annually.
Class IIa device manufacturers must update the report at least every two years; Class IIb and Class III device manufacturers must update the report at least annually.
