Hi all,
Thank you for the valuable information in the forum.
Our company has recently received its MDD certification for our class IIb device that will be valid until 2024.
As we are located outside the EU, we have a signed agreement with and EAR for the MDD.
We plan to keep the MDD certificate for at least until 2022.
I am trying to understand how to properly be ready for 26/05/2021, as I have received contradicting inputs -
Thank you for the valuable information in the forum.
Our company has recently received its MDD certification for our class IIb device that will be valid until 2024.
As we are located outside the EU, we have a signed agreement with and EAR for the MDD.
We plan to keep the MDD certificate for at least until 2022.
I am trying to understand how to properly be ready for 26/05/2021, as I have received contradicting inputs -
1. If our NB will not be accredited to audit according to the MDR. Will they still be allowed to audit us according to MDD after 25/05/2021 ?
As I understand that there are a few new requirements taking effect following this date, even for MDD approved devices.
2. Our EAR, requires us to sign a new contract with them before 25/05/2021. Is that a requirement for all EARs ?
3. Is our company have to have a PRRC after 25/05/2021 even if we still operating under the MDD?
Thank you in advance.
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