Clinical Evaluation Report-Does One Size Fit All?

According to MEDDEV 2.7.1 2009 any company wishing to market their medical device in Europe must submit (among other things) a Clinical Evaluation Review (CER). There is a useful guidance document available for downloading (http://ec.europa.eu/health/medical-devices/files/meddev/2_7_1rev_3_en.pdf) but the question remains is there one single correct way to write a CER with equal emphasis on all the sections mentioned in the guidance. In other words should a CER for an infusion pump that has been on the market for 10 years and has been sold in the tens of thousands of units look like a CER for a new dental implant that has not yet been marketed?

To answer this question we should look at what is going through the reviewer’s head when she is reading the CER. Besides checking off the checkboxes on the form provided to make sure that all relevant sections are included in the document, the reviewer is asking one main question: do the potential benefits provided by the device to the patient outweigh the risks?

How can the medical device manufacturer prove to the reviewer that their device is both safe and effective? This is where the main difference in approach for the two devices mentioned above enters. If I am writing a CER about a device that has an extensive history of clinical use I will emphasize that as my strong suit. I will present post-marketing data about number of complaints and adverse events per unit sold (hopefully low). In addition, in many cases there may be articles published in peer reviewed journals that deal with the device in question. In accordance with this strategy I will de-emphasize bench testing, comparison with similar devices, animal studies or cadaver studies, as ten years of data about actual real world clinical use is of much higher value.  For a new dental implant, because I have no clinical data, I will emphasize bench testing and the similarity of my implant to other implants already in the market. I will then show through the literature search how safe and effective these similar devices are.

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