Looking for documents relating to Medical Device Design Changes


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Dear Cove members,

I need some guidance pertaining to product change and the decision as to when to submit and when to document LTF and update the QMS.

I am fully aware about the below guidance document :
1) When to submit a 510k - FDA
2) Guidance for the interpretation of significant change- HC
3) NB-MED: Reporting design change (EU)

The above mentioned guidance document helped me in streamlining the process for respective countries health authority requirements , the question I am seeking for an answer now :
1) If you can kindly share some doc's or process you use to handle design change decisions.
2)How can I further classify the design change to class specific.

Your input is highly appreciated!

Thank you


Super Moderator
Re: Looking for documents relating to design changes

A Quick Bump!

Please help a fellow Cover with answering a question!

Thank you very much!!


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Re: Looking for documents relating to design changes

Ideally, you or an RA person is involved in the project early so you can perform an initial analysis whether the changes to be made may only need an LTF (letter to file) or a submission (in US) or a Medical Device amendment in Canada. Europe will depend on the class and your relationship with the NB; I'm not sure if they always require a tech file review prior to release. In the past for some NBs you didn't have to for Class Is/Im or IIa, sometimes IIb.

I would typically make a full assessment at the end of the project and file that assessment as part of the DHF {Design History File} (if you determine that you don't have to submit). For the actual document you can use the 510(k) flowcharts from the guidance doc; similar for Canada.
For EU, you just update the Tech File and make sure you still meet the Essential Requirements; unless your NB requires you to send them file for review.

If your assessment determines that you have to submit a 510(k), or another submission, then naturally you have to submit and receive the clearance before you can release the product.

I hope this helps. I think this covers question 1; I'm not sure if I understand question 2.


Re: Looking for documents relating to design changes

The below may give you some insight...

For product changes the matters that are considered when deciding whether or not particular changes are Significant include the following. Does the change:

- Introduce new hazards which have not been previously addressed?
- Adversely affect the risk associated with existing hazards?
- Alter the classification of the device?
- Alter the details on intended use and/or compliance with the essential requirements given in the Device Master Record submitted to the Notified Body?
- Mean that the device will have different end users or be used in a different manner or for a different purpose?
- Mean that the clinical data for the original device is not sufficient to confirm Conformity of the changed device with the required characteristics and Performance?
- Any malfunction or deterioration, which is technically or medically connected with characteristics or performance of a device, as well as inadequacy in the instruction may lead to a serious deterioration for a patient or user and which may lead to a systematic recall of the same type of devices.

Feel free to use the attachment with or without modifications ~~~


  • Significant Change Analysis.docx
    17 KB · Views: 383
Last edited:


Just an addition. You indicated the NB-MED guidance document, there is also (published last November) the equivalent Notified Body Operations Group (NBOG) guidance document:

"Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System"

(broken link removed)

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