The European Commission has recently published the new Medical Device Regulations which introduce new and more extensive requirements on manufacturers, Notified Bodies and other economic operators.
Because of the scrutiny and re-designation requirements, we have already seen a significant decrease in the total number of Notified Bodies, leaving many companies looking for new providers.
The MDR will be fully implemented by May 26, 2020 MDD certificates can continue to be valid potentially up to May 26, 2024 if the product meets certain conditions.
As the transition dates approach, many are concerned there will be a backlog as companies wait until the last minute to try to get device approvals so their device can continue to be sold on the EU market, even for existing products as there will be no grandfathering.
The revised MDR has been modified extensively and under the Regulations. These changes are significant and individuals in companies need to understand the impact of the changes on their job function and product line in order to properly plan and secure resources.
Parimiti offers end-to-end solution to transition your existing business operations to new MDR complient processes.