Requirements for an MDD approved device after 26/05/2021

#1
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 -
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.
 
Last edited:
Elsmar Forum Sponsor

Raisin picker

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#2
Hi MedicalResp,

1. My understanding is, if your NB applied for MDR and is just not yet notified, they will be able to audit you under MDD regulations. If they did not apply for MDR, or somehow managed to get a final "no", you need a new NB. See article 120 (3) and 123 (3a).
2. No idea
3. You have to follow the "requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices" (article 120 (3)). The PRRC is needed at least for registration of devices (art 29), PMS, reporting. Since these fall under the activities named in art. 120, I'd strongly recommend to have that person available.

HTH
 

monoj mon

Involved In Discussions
#3
2. Our EAR, requires us to sign a new contract with them before 25/05/2021. Is that a requirement for all EARs ?
I am not sure whether it is a requirement or not, but many EAR are doing it as they will take more risk and liability under MDR on behalf of the manufacturer. So you can expect to see more terms and conditions in your new agreement with your EAR.
 
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