Latest Updates on Clinical Evidence – Panel Discussion with a Consultant and 3 Notified Bodies

Description: Two years after the date of application of the EU MDR and after the recent extension of the transition period there are still uncertainties when it comes to sufficient clinical evidence to demonstrate compliance with the GSPRs.
Manufacturers of legacy devices are facing the challenge to close potential gaps in clinical data for their MDR submissions. With the extension of the transition period there will be more time, but manufacturers need to act now.
In general, there is a higher focus on Real-world Evidence (RWE) in the scientific and regulatory community. RWE, like data from registries, are increasingly replacing traditional PMCF studies but it is important to ensure that these RWE provide sufficient data on the required safety and performance outcome parameters.
The EU MDR implemented independent Expert Panels similar to the advisory committees of the FDA in the US. Based on the published scientific opinions by the Expert Panels there are some key take-away lessons for manufacturers and Notified Bodies.
In this session a consultant and representatives from three different Notified Bodies will come together and discuss the most recent challenges on collecting clinical evidence. During short presentations the most relevant aspects will be highlighted by one speaker before the attendees will be able to ask questions that will be discussed from the consultant and the Notified Bodies perspective.