While the projects that our team of experts face vary on a case by case basis, there are underlying themes that we often see. Since the EU MDR is dramatically more comprehensive compared to the MDD, it is mandatory that you are not only familiar with the MDR, but confident in your familiarity with these new regulations.
Recently, we supported an imaging company with their Class II Clinical Evaluation Reports. Not only were they facing an extremely tight timeline with only 28 days to provide a response to their Notified Body, they also required a complete overhaul of their literature review process, State of the Art, and their evaluation criteria.
With our guidance and technical support, their literature search process was streamlined for over a thousand articles while we simultaneously updated their clinical documentation. This was done throughout the duration of the project, as we utilized a flexible blend of resources to adjust to the client’s needs on a rolling basis. In the end, our client was able to achieve compliance within the 28 day timeframe and was able to keep their products on the market.
The most common EU MDR compliance issues that require service provider support are below: