MDD Classification for Pressure Monitoring Set


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Good day, Clover :)

I tried searching the thread but can't find anything that comes close to my doubt.

In regards to classifying a pressure monitoring set (consists of a range of consumables and single use components), is it possible to classify the whole device lower (based on the intended use of the final device) as Class IIa? The kit, however, contains a Class IIb component which is the pressure transducer.

Any advice please?

Thanks in advance :)


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Article 12 applies for systems and procedure packs.

If all of the items in your set are independently CE marked then you can write a declaration that all components are compatible. If you sterilise the components you need to involve a notified body to review the sterility aspects. The set is not in it's own classified as I IIa,b or III; it relies on the original CE marks.

It becomes a bit more complex if one or more of the components are not CE marked in their own right;
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