From a new product development and manufacturing standpoint, the new MDR harmonizes with 21 CFR 820 and closes previous gaps in submissions, clinical requirements, effective evidence and the role of Notified Bodies (NBs).
What that means is the new product lifecycle process that’s been in place for many years is going to change dramatically. In the past, companies would typically introduce products to the European market first, collecting post-market information that would then prepare them for the more rigorous FDA submission process. This strategy allowed companies to deliver their products to market faster.
That’s going to change with the new MDR, because of the harmonization and rigor the new requirements introduce. Companies will have to reevaluate marketing, sales, and new product introduction strategies based on the changes.
