I've been working around the US, EU, and IMDRF (
Guidance,
Application Guide) since most jurisdictions where we do business will be aligning with one of these three.
I don't have any sort of "universal" gap analysis handy, but (just off the top of my head) relevant to the products produced where I'm at, I found that:
- EU or IMDRF didn't carve out any PI exemptions for their lowest class devices.
- FDA didn't provide any guidance specific to configurable medical device systems.
- EU and FDA differed on prioritizing human-readable or machine-readable direct marks when space for both was an issue.
- FDA's interpretation of when a direct mark is required is more narrowly defined in their guidance documents, as opposed to the EU which is more broad. (But that FDA requirement for direct mark seemed to have something like laser etching in mind, whereas I believe a robust "paper" label affixed directly to the device proven to remain affixed and legible under reprocessing and use conditions for the life of the device would satisfy any direct marking requirements under these three regimes.)
Differences weren't
huge for us, but I wanted to ensure that if we're going through this big project, we wouldn't have to revisit in a few years for Europe. The types of devices your company manufactures will likely inform which differences are relevant.
Unfortunately I never ran across any point-by-point analysis of differences between the different regulations.