Deep Dive into the impact of the changes to the EU Medical Device Regulations – A Notified Body Point of View
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. To properly assess the work that needs to be done, UL’s Head of Notified Body, Dr. Itoro Udofia will provide a detailed explanation of the new MD regulations and share his 10 years of industry MDD experience on how to effectively assess the challenge to transition.
Date: Thursday, October 12th, 2017
Time: 11 AM – 12:15 PM Eastern time (GMT -4)
Where: Live online
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How to prepare for new EU MDR Requirements for Clinical Evaluation and Technical Documentation – A Notified Body perspective
The clinical evaluation is an essential part of the technical documentation, which manufacturers are required to use to document their compliance with the general safety and performance requirements. The new medical Device Regulations places greater emphasis on the use of clinical data to demonstrate compliance with the general safety and performance requirements. And for certain high risk and innovative devices, new processes have been introduced which involve additional scrutiny of the manufacturer’s clinical evaluation.
With the new Medical Device Regulation and 3-year transition, manufacturers need to be prepared now to meet the requirements in place when their device is being assessed for certification. This includes updating processes to make sure documentation for new requirements is in place. In order to avoid rework and time needed for resubmission, it’s critical to start establishing processes that align with the new requirements as soon as possible. With a reduction in the number of Notified Bodies, there may be a wait and grandfathering of existing devices is not allowed.
In this 60 minute session, UL’s Head of Notified Body, Dr. Itoro Udofia, will share his experience on what exactly has changed, what that means for device manufacturers, and how the Notified Bodies will approach the updated requirements.
Date: Tuesday November 7th, 2017
Time: 11 AM – 12 PM Eastern time (GMT -4)
Where: Live online