It’s obvious that the impending European Commission’s implementation of the MDR (2020) is going to put a greater onus on the shoulders of the Manufacturers for providing more safety and efficacy information on European medical devices.
As defined within this draft legislation, there seems to be a lot of information out there on the documents required for submission and even more opinions on how these documents should be created.
In this article, we’re going to focus on the CER and more specifically accompanying Literature Review.
For a full checklist and big picture look at the submission process, you can read this article.
As part of meddev 2.7 rev 4, a regimented search and review must be conducted for your product. This means searching, compiling articles, and providing reviews of how the gathered research pertain to your product’s safety.
Keep in mind that all this research is getting submitted to a Notified Body for review and approval as part of your CE Marking process. Exactly what should be included in a Literature Review submission, is ambiguous in terms of your research methods and analysis… that’s why having a systematic approach to these Literature Reviews can be so powerful when you’re making multiple submissions.
Let’s consider the whole point of these regulations, it’s to prove through empirical research that your product is safe.
Think of the CER, as you pleading your case to the Notified Body while the containing Literature Review (inside the CER) is your supporting argument.
If you look at our pyramid graphic to the right this concept is illustrated much more clearly. The research (and conclusions drawn from it) are your base.