FDA Risk Management vs. CE Risk Management - Requirements Differences

What is the difference between FDA risk management requirements and CE risk management requirements?

Re: Risk Management difference from CE

In theory they would be the same... both regulations are risk-management based, meaning that they require that the device be safe during it´s lifecycle. This can only be accomplished by risk management.

Both regulation also have the problem that they "seem" to require just a risk analysis, but in fact the other parts of the risk management framework are inside the regs (for example, post-production monitoring)...this has been clarified in some documents, and also by the fact that both recognizes ISO 14971 as the best risk management scheme to be used.

In practice...well, it depends..i´ve seen a lot of FDA 510(k) documentation that do not implement a full risk management framework, focusing mostly in the risk analysis part of risk management (although they still claim compliance to ISO 14971). This also happens in CE, but the fact that ISO 14971 is harmonized (combined with a crescent require on the part of notified bodies) means that´s we can expect some more detalied requirements.

This i my general view by experience, and might not be totally true, some comments from others might be helpful.

Re: Risk Management difference from CE

The FDA defines certain fundamental goals and terms differently than the authors of 14971. The FDA, for instance, to the best of my awareness does not state in any guidance that environmental risk is to be controlled, or technically define environmental harm. (Which, by the way, is a can of worms to try to do...and it doesn't work in the US legal system to say "I can't define it, but I know it when I see it.")

The FDA also includes veterinary medicine within its regulatory scope, whereas EC regulation of human medicine normally does not include animal medicine.

The FDA also defines only ambiguously that a risk assessment is expected to be part of a premarket notification in the first place. None of the several competing guidances within the sprawling FDA website that discuss the proper contents of a 510(k), specifically include an ISO 14971 risk assessment within their lists of required elements. But, in any verbal discussion of a 510(k) with an examiner, a risk assessment will be expected. You just have to know.

And, the FDA fairly clearly does not require that a risk assessment be done for most FDA Class I devices, even if provided to users in sterile form. That's not very consistent with the MDD classification approach, of course.

I'm sure there are other differences, but those are a few to consider.