ISO 14971:2019 requires you to collect information related to state of the art (10.2 f)) in a Note it indicates that can include new or revised standards. In 10.3 the requirement is to review the information for relevance to safety and again whether the state of the art has changed. Actions regarding safety may need to be taken (10.4) including evaluating new risks and determining need for action for devices in the market.
So, the bottom line is that you need to have a documented review when a standard you have used has changed to determine if action is needed, including changes to a product. You make the decisions about if action is needed or not, and you document it in your Postmarket Surveillance processes. BUT document the review and results. Remember, if you didn't document it it didn't happen.
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com------------------------------
Original Message:
Sent: 12-Apr-2021 14:08
From: Kevin Randall
Subject: Design History File Updates
The requirement (or lack of a requirement) to update standards mentioned in the DHF is governed by the design input requirements. The design input requirements are the functional, performance, and interfacial requirements. Interfacial requirements include regulatory requirements. For a regulatory jurisdiction like Europe that requires conformity with the latest state of the art, it is expected that the conformity (and thus the DHF) would indeed need to be updated so as to align with the updated standard. But for other jurisdictions, like the U.S., it is generally acceptable that the product remains on the market without alignment with the latest standard; at least until there is a product change in an aspect for which an external standard is germane, in which case it would generally be expected that the latest standard would be applied for the change. So be sure to properly consider the applicable regulatory requirements.
Aside from such interfacial / regulatory origins, the organization may, commensurate with risk, voluntarily decide to update its functional/performance inputs to conform with the latest standard.
As a side note regarding the phrase "regulatory standards": Be sure to be sensitive to the fact that there are regulations (i.e., mandatory statutory/legislative requirements), and then there are standards (typically used voluntarily as one of a range of optional means for meeting regulatory or other requirements). In rare instances, regulations require conformity with a specific standard (e.g., Canada and ISO 13485), in which case I suppose the phrase "regulatory standard" may be acceptable. But most regulations don't refer to specific standards. So, as a general rule, it is best to carefully distinguish between regulations/legislation vs. standards.
Hope this helps.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 11-Apr-2021 21:30
From: Anonymous Member
Subject: Design History File Updates
This message was posted by a user wishing to remain anonymous
Good morning everyone,
Is there a requirement to update regulatory standards mentioned in the DHF?
Specifially if the Design Specifications, refer to a standard, and that standard has since been updated, is there a requirememt to update the design specification? Or is the Design Specification for the time period that it was conducted?
Example: A design specification was released in 2007 and included the stand ISO 23500. In 2019, the standard was updated. Is there a requirment for us to go back to the Design Specification and update the standard?
Comments and thoughts are apprciated.