Developing the state of the art section of the CER: challenges and pitfalls

At the 2018 MedTech Summit, on June 11 – 15 in Brussels, Belgium, Laurie Mitchell, our President, will be giving a presentation with Evidence Partners entitled: State of the Art: Best Practices and Literature Review Using DistillerSR. In this blog post, we will give you insight into some of that content, but to see the whole topic, we recommend you register for the conference, or check back on our blog in late June to download our full whitepaper. Below is a sneak peak at this topic.

There is no doubt that establishing state of the art is a challenge. It ranges from key information on the medical condition to a neutral, comprehensive analysis of treatment options, and culminates in a succinct yet comprehensive presentation that defines the currently accepted safety and performance standards against which the device is measured. Not surprisingly, common pitfalls include a perspective that is too broad and inclusion of too much detail, or a perspective that is too narrow, omitting relevant indications and alternative therapeutic options. An important critical aspect of the clinical evaluation that relies on state of the art data is also to appropriately define the position of the device within the currently available treatment portfolio.

To avoid such pitfalls, it can be helpful to develop a conceptual outline or “anatomy” of the state of the art section early during the review (see the figure below).

If you want to find out more about State of the Art according in MEDDEV 2.7/1 rev 4, you can come see our presentation at the 2018 MedTech Summit June 11 – 15 in Brussels, Belgium (register here), or check back on our blog after this date to download our full whitepaper.

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Generis American Medical Device Summit

October 24-25, 2018

The Westin Lombard Yorktown Center
Lombard, IL 60148


Schedule a meeting with our President, Laurie and our CEO, Lalitha

Haven’t registered yet? Contact us to get your 65% discount code!