March 2, 2023

Regulatory is Part of the Design and Design Team: Part 1

ISO 13485 demands that regulatory requirements be included in the required design inputs and outputs along with the corresponding verification (and maybe also validation depending on how a client approaches it). Consequently, the person who authored those regulatory design inputs, outputs, and/or verifications can’t be used as an independent reviewer of those design elements.

Although ISO 13485 doesn’t state a requirement for an independent reviewer, clients’ SOPs often do.  This is typically for addressing other jurisdictional requirements calling for an independent reviewer like those of the FDA.  If the SOP demands an independent reviewer and defines it in the usual way (i.e., as someone who doesn’t have direct responsibility for the stage/artifact being reviewed), then the team’s regulatory member who authored the regulatory inputs/outputs/verification is disqualified from being the independent reviewer of those artifacts.  Accordingly, a Notified Body (NB) nonconformity (NC) cited on this basis is in fact a valid NC.  In such a case, it can be necessary for an outside consultant/contract reviewer to be deployed for fulfilling the independent reviewer role.

On the topic of asserting that the regulatory team member is a part of the “project” team rather than the design team, the aforesaid ISO 13485 (and FDA) requirement for specific regulatory design inputs, outputs, verification, etc., precludes arguing that the person who authored those regulatory artifacts is a “project” team member rather than a design team member.  Such an argument will not hold up under scrutiny, as that notion conflicts with ISO 13485’s (and FDA’s) requirement for integration of regulatory requirements into the design requirements.

The person who authored the regulatory artifacts also cannot function as “other specialist personnel”.  This is because ISO 13485 requires that the design review team shall first include representatives of the functions concerned (i.e., the regulatory team member who authored the regulatory artifacts) as well as other specialist personnel.

In light of all this, I think one would be unsuccessful trying to argue against an NC asserting that Regulatory needs to be considered part of the design team rather than an independent reviewer, other specialist personnel, or just a “project” team member.  Instead, it would be better to find a sustainable solution(s) that will be within the boundaries I’ve laid out above.  For example, if a client has already hired three outside workers, then hiring another one on a limited basis for supporting design reviews should be within reason in my opinion.