5 Best Clinical Evaluation Report Writing Tips

The EU MDR has a significant impact on the manner in which medical devices are regulated in Europe. To ensure compliance with the regulations medical device manufacturers are required to prepare and keep the Clinical Evaluation Report (CER) which is a vital document for CE Marking. Here are some expert suggestions on the factors to consider prior to determining a strong CER strategy.

1. Define CER protocol and strategy. CER procedure and strategy

Determine essential requirements (Safety and performance requirements within the MDR) that must be supported by evidence from clinical studies. Define performance-related metrics as well as safety and risk/benefit.

2. Demonstrate equivalence

Equivalence is determined by the comparability between the medical equipment and similar CE-certified devices. The proof of equivalence will be determined by the relevant parameters which are set in the specifications of the manufacture. The reason for equivalence should be explained fully inside the CER. The criteria for equivalence has been made more complicated and stringent with more ties to the Essential Requirements. It is crucial to avoid making the common error of selecting devices with equivalents that aren’t relevant to your product. Documented data should be analyzed and identified for each device’s equivalent and also for differences between the devices.

3. Examine the data from the literature review

If equivalency can be established in a way, the clinical data gathered from previous studies’ literature is an important tool when creating a CER. It is important that the literature surveys are conducted in a methodical manner:

Create a complete procedure for conducting a literature review.

* Define the parameters and inputs like search terms, databases, as well as exclusion requirements (languages and study types and design and study setting, as well as conclusion points),
* Define the necessary security and performance requirements in relation to the comparable items and analysis of risk.
* Systematically collect relevant information from various data sources.
* Examine the data using an objective methodology like a framework, with multiple reviewers,
* Document the conclusions of the literature analysis to be included in the CER document. CER document.

4. Determine the necessity for clinical investigations.

The need for a clinical examination can be determined by the risk profiles of devices. Class III and high-risk devices are subject to a medical investigation. The novelty is also a crucial element, and devices that are based on new technologies or with a new purpose require the conduct of a clinical study. The clinical evidence available should cover all pertinent ERs. This is accomplished through sharing your Clinical Investigational Plan (CIP) with the appropriate NB prior to the implementation.

5. Monitor post-market activity

According to the MDR, PMS activities must be documented and properly planned and documented in CER. The process of evaluating current clinical information and updating CERs should also be documented. In order to ensure the CER is relevant throughout the entire lifecycle of the product and is updated frequently through a documented procedure. This involves evaluating the information and weighing the importance of any comparable devices.