Some clarifications probably are necessary. The EUDAMED database exists currently. I believe what is being delayed is some of the functionality. For instance, the electronic reporting of adverse events by manufacturers into the database could be delayed, but reports will still need to be made and could be uploaded by the competent authorities for sharing.
The ability of manufacturers to query the system may be delayed, but competent authorities would still have access (the same as they do today).
While this affects the processes at manufacturers, we need to be aware of the development and use of these by regulators as well. If someone could provide additional clarity (wouldn't that be nice for all of these changes?) that would be helpful to the whole community.
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Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States
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Original Message:
Sent: 30-Oct-2019 09:45
From: Mac McKeen, RAC
Subject: EUDAMED delay 2 years
It is being reported that the EUDAMED database implementation will be delayed up to 2 years. For you EU MDR experts, does this have any impact on the May 26, 2020 MDR date?
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Mac McKeen, RAC RAC, MBA
Fellow, Regulatory Science
Maple Grove MN
United States
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