Revising a DoC for a legacy device under MDR/IVDR transitional periods

[coezbek]

Dear all,
we are in need of revising an existing DoC for a legacy IVD medical device because the company address has changed due to a office move. Following MDCG-2022-6 this isn't a significant change so is permitted even for device after the 26th of May 2022.

I am now a bit stumped how to revise the Doc given the following sentence of the IVDR 110 (3):

Devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body, for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with that Directive

Usually when creating a DoC I would have put the date of it being signed, but this date would be after 26th of May 2022. Should I create an amendment that mentions the new address, but leave the old "wrong" DoC intact?

I don't want to get into the situation that we lose the ability to put the legacy device on the market, while we transition to IVDR.

 

[IVDRegs01]

When my company had this issue, we revised and re-signed the DoCs then had a Note to File in the DHF (FDA style!) to explain why we had resigned post-26th May 2022. If you are challenged on the date being past the implementation date, archive the old DoC and you should be able to justify the resigning given that it's not a significant change as you said

 

[coezbek]

I have started an inquiry with the MDCG to get some clarity on the exact process.

 

[MarRz]

A change of office location can be a significant change if it also impacts the location of IVD related activities. We have it listed in our "change evaluation process", and we reference "EK-Med 3.9 B31, Section 5.2" for this part:

"
Does the change affect the location of the company’s activities? If yes, change is significant.
(EK-Med 3.9 B31, Section 5.2)
"

 

[coezbek]

@MarRz This is certainly an important consideration for changes which you need to inform your NB about, but under IVD 110 (3) this wouldn't be a significant change according to the MDCG-2022-6 guidance.

 

[Orca1]

Dear all,
we are in need of revising an existing DoC for a legacy IVD medical device because the company address has changed due to a office move. Following MDCG-2022-6 this isn't a significant change so is permitted even for device after the 26th of May 2022.

I am now a bit stumped how to revise the Doc given the following sentence of the IVDR 110 (3):



Usually when creating a DoC I would have put the date of it being signed, but this date would be after 26th of May 2022. Should I create an amendment that mentions the new address, but leave the old "wrong" DoC intact?

I don't want to get into the situation that we lose the ability to put the legacy device on the market, while we transition to IVDR.

In this situation, you should not amend the existing certificate. Instead, the notified body that issued the certificate in accordance with the IVDD may confirm in writing that the implementation of the change does not represent a significant change in design or intended purpose under IVDR Article 110(3) and that the related IVDD certificate remains valid after the date of application of the IVDR, but no longer than its expiry date or 26 May 2025, whichever comes first.

Such written confirmation corrects or complements information on an existing certificate but does not represent the issuance of a 'supplemented certificate.' In case of requests from authorities, the manufacturer should number such letters received from the notified body and submit them together with the certificate (MDCG 2022-6, Page 4, Paragraph 4).

 

[coezbek]

@Orca1: In our case, our IVD under IVDD did not require the involvement of a notified body, thus we don't have a certificate, only our DoC.

And again: This is about changes which need to performed to the certificate and DoC (such as a change in company name or address), which are permitted because they are not significant to the design and intended purpose.

 

[Orca1]

@Orca1: In our case, our IVD under IVDD did not require the involvement of a notified body, thus we don't have a certificate, only our DoC.

And again: This is about changes which need to performed to the certificate and DoC (such as a change in company name or address), which are permitted because they are not significant to the design and intended purpose.

You can create an amendment to the existing DoC that mentions the new address. This amendment should be kept together with the original DoC.

When creating the amendment, you can include the date it is signed, even if it is after the 26th of May 2022. The amendment should clearly state the reason for the change (i.e., the change in the company address) and confirm that this change does not affect the device's design or intended purpose. This way, you can maintain the validity of the original DoC while updating the necessary information.