How To Properly Write A Clinical Evaluation Report: 4 Tips And Tricks
A clinical evaluation report (or CER) is a crucial document containing all the technical information required for marketing and selling a medical device in Europe. If you just ventured into the medical appliance business, you are probably unfamiliar with the newest medical device regulations. Preparing documentation for a report like this can be challenging, not to mention time-consuming. However, with a little bit of forethought and organization, you will be able to present your report professionally. Here is how to write a proper clinical evaluation report and get your product approved for sale.
1. Have a Strategy
Because writing a clinical evaluation report is a complex process, you will need to have a predetermined strategy for each of its steps. This way, you will have a coordinated approach that ensures much more efficient data collection and faster results. And the sooner you collect all the necessary information you need in your report, the easier you can get the approval for your product. For new products, writing a CER is pretty straightforward. After you familiarize yourself with the requirements, you will simply have to make sure you follow them in your documentation.
For products already on the market, it’s unfortunate that updating your previous evaluation is not the same as getting a current and new one done. With these devices, you will be required to include additional steps into your planning process. You will need to make sure the devices still fit in the same criteria of establishing equivalence. Additionally, your appliances need to conform to any newly established requirements, even if they were released shortly before the introduction of these rules.
2. Literature Review
In order to assess which medical literature could be relevant for your product, first, you need to familiarize yourself with the new regulations. After collecting the necessary information, you will need to include it in your report, whether it supports the need for your product or not. If you or your team have trouble understanding what medical publications are accepted as relevant, don’t hesitate to ask for professional help. The team behind CiteMedical.com explained that established CER writers can review your data and provide you with all the necessary information for your submission. CER literature review will help the quality control team to find their way smoothly and efficiently as they work through the process. The result will be a high-quality device that medical professionals or everyone else who relies on it daily can use with confidence.
3. Determine Clinical Investigation Requirements
For high-risk devices, medical literature won’t provide enough information – and any report you prepare on them will have to include the results of a clinical investigation. New products, devices based on innovative technology, and older appliances redesigned for new purposes should also be thoroughly investigated to ensure their safety and efficiency. The testing should be done by licensed medical professionals, following a predetermined clinical investigation plan. The testimony of the medical professionals and the collected clinical evidence must address all the relevant information you need in your final report. If your device doesn’t meet the clinical investigation requirements, then the testing won’t be necessary. In that case, you can use the medical data you have collected during the previous trial period and include that in your new CER as well.
4. Post-Market Analysis
Under new regulations, you are obligated to follow up with your product’s relevance and usability even after it’s released on the market. Because of this, your clinical evaluation report must include a group of planned post-market analysis activities. In these, you will need to show which parameters you will follow and how. If you are required to reevaluate an ongoing clinical relevance for updating older CER’s- this must also be documented.
To ensure that your product remains relevant throughout its entire life cycle, you will need to update your reports regularly. All the data you collect about a particular appliance must be included – and the relevance of the product questioned after collecting every crucial piece of information. This means keeping up an ongoing documented process for your device for as long as it’s on the market.
If you consider gathering all the relevant technical documentation needed for the approval, a tedious process, you’re not alone. Even owners whose products are already on the market are obligated to reevaluate theirs. However, you will have to keep in mind that the CER is about much more than evaluating your product to check for compliance. It’s a vital part of a medical device’s technical file that will assure the safety of your device. CER’s will allow you to market and sell more efficient products that customers can rely on – which will translate into a significant revenue increase.
