Device Classification - Autoclave validation system



Hi Everyone,

Can some please advise on whether the temperature/time datalogger device

(intended to validate the performance of autoclaves and has software that can make pass/fail determinations on sterilization cycles according to user defined parameters) would be regulated in the EU as medical device??

I took a look at the MDD Annex IX classification rules and was wondering if autoclaves (steam sterilizers) are Class IIa per Rule 15? If so, would an autoclave validation system as described above be considered an accessory?

Your help is really appreciated.


You asked about EU. There, I think your classification is unclear. It however is a little more clear on the US FDA side, and maybe it would make sense to use the US classification in a rationale for how you handle the EU lack of clarity.

To the best of my knowledge, industrial-scale EO sterilization equipment, and components thereto, are not regulated as medical devices on the US FDA side. There is no applicable Product Code that includes "sterilizer" in its description and is not specifically targeted to health care providers, as opposed to manufacturers.

On the other hand, clearly FDA wants benchtop and central-sterilization-services sterilizers to be considered medical devices. PEC, ECG, MLR, KMH and KOK all are applicable Product Codes.

My thinking is that you're in a gray area, but it would be conservative to assume that your product is an accessory under 21CFR 880.6880.

So I'd rationalize that your product is an MDD Class I device-accessory.

Having written such a rationale, you'd then want to go to your NB and get them to review and concur or otherwise.
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