Medical device - Major change or Minor change

[Julie]

Hi,
I'm looking for some assistance. I'm currently working on improving a Class I medical device and I'm unsure if the change that I'm doing would be classed as a Major change or a Minor change, and what safety testing I would need to redo.
The product itself is not changing, it will have the same function and is visibly the same. The change is to the PCB, as a number of the components are no longer available therefore we need to replace them with equivalent components.

We are going to carryout the EMC testing again, but I'm unsure if it requires IEC 60601-1 or IEC 60601-1-11.

There seems to be a lack of information (that i can find) on Google. So any help would be appreciated.

Thanks,

 

[Al_Z1]

If your device has MDD certification, you can look into this guide https://health.ec.europa.eu/system/files/2023-09/mdcg_2020-3_en_1.pdf

 

[Peter Selvey]

It's not really an issue of being "minor" or "major". Whenever you make a design change, no matter how small, somebody needs to judge if the previous reports remain representative of the newer design, and make a clear statement about this in the design records and technical file. This is the same regardless of the Class of the device. It's very much a case by case and requires engineering judgement and familiarity with the design and relevant standard(s). Also there are a range of possible actions from doing no tests (totally obvious by inspection), or no tests (by rationale or justification), through to spot checks, in-house tests and third party tests if the manufacturer doesn't have the expertise/equipment in-house. The important point is thought that no matter how small the change, it becomes a new (different) medical device and instantaneously invalidates the old reports as evidence until someone formally assesses the change and makes a statement that the old reports remain representative of the newer design.

The decision on which path to take (no test with or without justification, spot check, in-house, third party) can be subjective and there are often factors involved (costs, safety). So it's important to identify who in your quality management system will be responsible to prepare and sign the document(s) associated with the design change that assess if the old reports are still representative. Once that person is identified, get them to draft up their decision including any rationale.

I think the document linked by AI_Z1 is for devices covered by the old MDD and using the transitional provisions, which is a different case than the general decision associated with the need to re-test when there is a design change.

 

[Ed-Zhang]

I am not working with medical device, only for 3C and auto industrial.
it depends, for resist(R) and capacitor(C), (only change the supplier but not the spec) we don't regard this change as a formal change(neither inform customer nor do some experiment)
for IC (U) we regard it as a major change
for any other component minor change
only for reference

 

[Julie]

It's not really an issue of being "minor" or "major". Whenever you make a design change, no matter how small, somebody needs to judge if the previous reports remain representative of the newer design, and make a clear statement about this in the design records and technical file. This is the same regardless of the Class of the device. It's very much a case by case and requires engineering judgement and familiarity with the design and relevant standard(s). Also there are a range of possible actions from doing no tests (totally obvious by inspection), or no tests (by rationale or justification), through to spot checks, in-house tests and third party tests if the manufacturer doesn't have the expertise/equipment in-house. The important point is thought that no matter how small the change, it becomes a new (different) medical device and instantaneously invalidates the old reports as evidence until someone formally assesses the change and makes a statement that the old reports remain representative of the newer design.

The decision on which path to take (no test with or without justification, spot check, in-house, third party) can be subjective and there are often factors involved (costs, safety). So it's important to identify who in your quality management system will be responsible to prepare and sign the document(s) associated with the design change that assess if the old reports are still representative. Once that person is identified, get them to draft up their decision including any rationale.

I think the document linked by AI_Z1 is for devices covered by the old MDD and using the transitional provisions, which is a different case than the general decision associated with the need to re-test when there is a design change.

Thankyou for the information, that really helps.

 

[Ed Panek]

The FDA has a blue book and MDD/MDR have MDCG guidance on a checklist you cant create (we did) as part of every CN change to determine if regulatory notification is needed. If it is required they may allow you to impl ement the change and have it reviewed during the next audit or ask you to provide more information and testing on it. Aside from Safety and Effectiveness regulators try to keep abreast of the state of the art in each product type; promoting new and more safe and effective designs and discouraging older less safe and effective designs.

 

[SamKD]

The FDA has a blue book and MDD/MDR have MDCG guidance on a checklist you cant create (we did) as part of every CN change to determine if regulatory notification is needed. If it is required they may allow you to impl ement the change and have it reviewed during the next audit or ask you to provide more information and testing on it. Aside from Safety and Effectiveness regulators try to keep abreast of the state of the art in each product type; promoting new and more safe and effective designs and discouraging older less safe and effective designs.

Hi Ed, which MDCG guidance document did you use to create the checklist? I assume you evaluate all design changes and all significant changes are notified to the regulatory authority?