A medical device line extension (by definition same intended use and key characteristics, minor differences in specifications from existing device) under development should obviously leverage your previous technical documentation, including the Essential Requirements Checklist (ERC).
At the start of a project and early in the design control process, the blank ERC serves as a template for the team to define requirements and identify appropriate standards, SOPs and guidance that will address each ER. As the project develops, the relevant technical documents are populated into the ERC. Aspects of the line extension that have not changed from the existing device (possibly with justification) are copied over, and revised requirements, specs, tests, labels, etc. as relevant to the line extension are entered. The completed ERC is then the output document from the Design & Development effort to release the device, and provides objective evidence of conformity.
Hope this helps.
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Homi Dalal RAC
Regulatory Affairs Leader
Christchurch
New Zealand
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Original Message:
Sent: 29-Apr-2019 09:34
From: Anonymous Member
Subject: Essential Requirements Question: Medical Devices Line Extension
This message was posted by a user wishing to remain anonymous
Hi Fellow RA Professionals,
I am looking for some guidance on when the Essential Requirements (ER) should be assessed in the design control process for a medical device line extension and what kind of documentation is needed. It seems that it should be assessed at the beginning (phase I) so you can define the requirements up front, but this is a commitment - not evidence of conformity - so it seems like can't really document that.
So, does it makes sense that the design team assesses the existing ER during Phase I and then produce a document later (Phase 3/4) that states we have, indeed, addressed them and conform to them? In other words, should this appear twice during design control?
Any advice would be appreciated. Thank you!