Does the requirement for an independent person at design reviews no longer apply?

The FDA’s recent implementation of the Quality Management System Regulation (QMSR) introduces significant changes. Notably, one of those changes is that the QMSR does not explicitly mandate the presence of an independent reviewer during design reviews.

In the current QSR 820.30 Design Controls, Section (e) Design review, FDA clearly outlines that: “The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed.”

Since the new QSMR directly refer to ISO 13485:2016 in this section without any additions, the future requirement in section 7.3.5 Design and development review: “Participants in such reviews shall include representatives of functions concerned with the design and development stage being reviewed, as well as other specialist personnel”, can suddenly become a free card. Specifically for small companies that struggle to find a person that is both independent but also competent enough to add value to the review.

In the FDA Medical Devices; Quality System Regulation Amendments you can read FDAs response to this on Comment 46. The FDA concludes that the section in 13485 about “specialist personnel” also could include “the important contribution of independent review”.
It can therefore be reasonably assumed that even after February 2, 2026, the FDA will anticipate the presence of an independent reviewer. This expectation isn’t solely due to regulatory mandates but rather reflects a widely recognized industry best practice. And even though the standard itself does not mention independent reviewers, the 13485 Handbook (ISO 13485:2016 – Medical devices – A practical guide) describes that design and development reviews are not conducted just by the team directly but should also include independent reviewers.

As FDA so eloquently put it, the independent reviewer adds an important contribution, such as a fresh perspective to matters and can challenge general assumptions made by the design and development team. It is also easy to be “blind to flaws at home” when you are deeply involved in a project. Taking a new perspective could reveal mistakes, oversights, or discrepancies in testing outcomes. Surprisingly often the independent reviewer finds issues that need to be corrected and sometimes this even makes the design better and safer.

Conclusion is that an independent reviewer is a vital asset during design reviews and should be handled as such. It’s not just to “tick a box”. Otherwise, the first “independent reviewer” of your technical file will be the FDA, Notified Body or a Regulatory Authority. This might not be the most preferred option as it may affect your product approval and delay your launch to the market.

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