IVDR DHF

Hello. Trying to come up with a minimum requirements for a DHF remediation to meet IVDR. Any suggestions? Thank you.

Did you do a gap analysis?

As Yodon said, start with a gap analysis, review what you data have and assess its compliance with modern procedures.

You can't recreate the Design Plan, but you should create a document explaining the purpose of the remediation and any issues that are present in the Verification and validation. If you have incomplete data, describe this with a risk assessment or if needed repeat the testing.

To do the remediation properly, you should re-create Design Inputs, Outputs, Verification and Validation. Also document any changes that have occurred since the V&V.

You probably wont have an original Design Transfer and it can't be recreated. Again document this with a risk assessment, and consider retrospective review of production against the design outputs.

I wouldn't hide the fact that it is being recreated, Given that this will all be reviewed by a notified body, make it as complete and thorough as possible. It will be easier to do this up front than get it rejected by the NB!

chris1price said:

As Yodon said, start with a gap analysis, review what you data have and assess its compliance with modern procedures.

You can't recreate the Design Plan, but you should create a document explaining the purpose of the remediation and any issues that are present in the Verification and validation. If you have incomplete data, describe this with a risk assessment or if needed repeat the testing.

To do the remediation properly, you should re-create Design Inputs, Outputs, Verification and Validation. Also document any changes that have occurred since the V&V.

You probably wont have an original Design Transfer and it can't be recreated. Again document this with a risk assessment, and consider retrospective review of production against the design outputs.

I wouldn't hide the fact that it is being recreated, Given that this will all be reviewed by a notified body, make it as complete and thorough as possible. It will be easier to do this up front than get it rejected by the NB!

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Thank you, that's really helpful. I have all IVDR performance evaluation data for the product. Is this usually sufficient to cover V&V for a remediation?

laslo3001 said:

Thank you, that's really helpful. I have all IVDR performance evaluation data for the product. Is this usually sufficient to cover V&V for a remediation?

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The DHF remediations I have done in the past were to a much higher standard than this one is going to be (different company, different NB) that's why I was looking at minimum requirements for a compliant DHF, as we currently have nothing.