Hey Ginger. Ultimately, this topic can certainly be sliced and viewed different ways. And since, for example with ISO 13485, there is no direct normative / standardized requirement to state the device class in the Quality Manual, then we certainly can choose to not, as you say, "clutter" the Quality Manual with a few words identifying the device class(es). Yet it may be debatable whether such a few words would actually "clutter" the Quality Manual. It could also be debatable whether we can truly realize an effective ISO 13485 Quality Manual without those few words. Either way, I'm thankful that ISO 13485, for example, and the FDA's 21 CFR Part 820, as another, allows us the flexibility to decide which approach we take.That said, my experience with ISO 13485 Registrars and Notified Bodies is that those few additional words about classification, in my opinion, actually bring continuity and coherence to an ISO 13485 Quality Manual's required QMS scope narrative and justification, and thus to the ISO 13485 QMS itself, since these are fundamentally driven by the device class. Indeed, for some folks or scenarios, it might actually be more cluttered if the Quality Manual's required QMS scope narrative and justification can't stand alone, where it instead is forced to rely on an additional separate QMS document(s) (e.g., a regulatory plan) maintained somewhere else, that oftentimes isn't needed at all, and that isn't a normative requirement.Here's a few other angles I've considered that seem to make it beneficial if the Quality Manual includes a few words identifying the covered device class(es):
In any event, as has been shared by Anne's, Ginger's, and Dan's great posts, there are a variety of alternative approaches that can work.
In this minimalist approach, the class of your devices is at the wrong level for the Quality Manual.Someplace in your QMS a list of your devices and the class in each regulatory region is useful to help implement regulatory requirements. This should cover all the regulatory regions in which you market any device.
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