Five common pitfalls when writing a Clinical Evaluation Report

Pitfall 1 - Not being ready
In some cases, manufacturers attempt to write a CER too early in a device’s developmental journey. Because a CER considers a broad range of evidence including pre-clinical bench tests, clinical evidence and PMS data, there’s little point conducting a CER until such information is available.
Pitfall 2 - Incorrect structure
It goes without saying that it’s vital to know what needs to be included in a CER. Difficulties can arise because requirements are dynamic, meaning that what constituted correct structure a year ago might not be sufficient today.
Pitfall 3 - Not accounting for exclusions
All good CERs require an extensive review of the medical literature. In fact, done properly, a CER actually calls for two reviews - one against the subject device itself, and another against the clinical background and any comparable alternative devices. The latter is used to determine safety and performance benchmarks against which to assess the subject device.
Pitfall 4 - Incorrect use of language and ‘naked’ opinions
This is a pitfall that even the most experienced writers can fall into.
Pitfall 5 - Lack of objectivity
When writing a CER for your own product, this is perhaps the most difficult pitfall to avoid. The MDR calls for an objective approach with equal weighting (allowing for variances in study design and quality) given to sources that are favourable and unfavourable to the subject device. Presenting negative data against one’s own device is never comfortable or easy.
Summary
Our team of medical writers are all highly qualified medical professionals, meaning they deliver the highest standards of independent objectivity alongside their peerless ability to work with clinical evidence and their unparalleled subject matter expertise.
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We recommend visiting our MDR Compliance guide section of the website for FREE content on how to conduct Clinical Evaluation effectively as well as utilising the best procedures for writing Clinical Evaluation Reports.
Clinical Evaluation Guide:
www.mantrasystems.co.uk/eu-md...
Clinical Evaluation Report writing:
www.mantrasystems.co.uk/eu-md...
Be sure to check out our article on how to choose a CER writer for your MDR Clinical Evaluations too:-
www.mantrasystems.co.uk/artic...
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