EU requirements vs US requirements for device file

[JP12345]

Hello, I am hoping someone can help point me in the right direction! We have a medical device file to MDD for a class IIa product (according to EU regulations) however in the US it is only classified as class I. We plan to list the the device with the FDA but do we need to put a new file together to meet US regulations (a DMR?) or will the existing EU medical device file be acceptable as it is? Also we do not intend to continue with EU certification due to increased costs of MDR, do we still need a clinical evaluation for a class I in the DMR for a FDA registered class I device? I know it is unlikely the FDA will ever look at the file, but our 13485 auditor might! Thank you in advance for any advice

 

[EmiliaBedelia]

There isn't an expectation for a "regulatory" file (ie, a separate folder of documents maintained only for the purpose of regulatory submissions), but you do need to maintain the required documentation per 21 CFR 820, which includes both a DHF and a DMR (and a DHR while you're at it ). If you have an MDD file already, you likely do have all of the information that you need.

However, you should review the US requirements and create an "informal" file index. I would do 2 things:
- a "point in time" gap assessment to identify what documents you have right now. The majority of this will be the MDD tech file. (I would not make this a controlled document; this would be an exercise for me just as a sanity check that I have everything needed, and if an auditor walked in tomorrow I would know what to give them)
- a more general list of procedures that fulfill each of the QSR requirements. I've seen this in the quality manual but that depends on how yours is set up. This shouldn't be difficult either if you are accustomed to ISO 13485 and MDD but you should clearly specify that you meet US QSR requirements.

The expectation for MDSAP and FDA will be that you are specifically calling out the regulations that you are fulfilling. It is not sufficient to say that you comply with FDA regulations because you have an MDD technical file; you need to demonstrate that your QMS/design control documents meet the US requirements. You can review the MDSAP audit approach to understand the links between ISO 13485 and the FDA regulations.

Clinical evaluation, in the manner that you are used to for the EU, is not required for the US. You do need to maintain complaint files and review complaints/adverse events/etc to ensure you don't have any quality issues and that the device performance meets the specifications you've set out.

 

[JP12345]

There isn't an expectation for a "regulatory" file (ie, a separate folder of documents maintained only for the purpose of regulatory submissions), but you do need to maintain the required documentation per 21 CFR 820, which includes both a DHF and a DMR (and a DHR while you're at it ). If you have an MDD file already, you likely do have all of the information that you need.

However, you should review the US requirements and create an "informal" file index. I would do 2 things:
- a "point in time" gap assessment to identify what documents you have right now. The majority of this will be the MDD tech file. (I would not make this a controlled document; this would be an exercise for me just as a sanity check that I have everything needed, and if an auditor walked in tomorrow I would know what to give them)
- a more general list of procedures that fulfill each of the QSR requirements. I've seen this in the quality manual but that depends on how yours is set up. This shouldn't be difficult either if you are accustomed to ISO 13485 and MDD but you should clearly specify that you meet US QSR requirements.

The expectation for MDSAP and FDA will be that you are specifically calling out the regulations that you are fulfilling. It is not sufficient to say that you comply with FDA regulations because you have an MDD technical file; you need to demonstrate that your QMS/design control documents meet the US requirements. You can review the MDSAP audit approach to understand the links between ISO 13485 and the FDA regulations.

Clinical evaluation, in the manner that you are used to for the EU, is not required for the US. You do need to maintain complaint files and review complaints/adverse events/etc to ensure you don't have any quality issues and that the device performance meets the specifications you've set out.

Thank you so much @EmiliaBedelia that is really helpful, thank you for taking the time!