Classifying Medical Devices - Medical Device Design: Innovation from Concept to Market - page 25

Figure 2.9
A common orthopedic power drill. (Courtesy Desoutter)
Materials), ISO (International Standards Organization) and BS (British Standards). These are
the three standard bodies for the USA, international community, and Britain, respectively.
Unfortunately, working with a standard in the USA does not necessarily make this compliant
with a standard within the EU; hence the recognized consensus standards become a very good
starting point to determine which standards apply.
Also, your device may cross discipline boundaries, one example being a simple orthopedic
drill ( Figure 2.9 ). While this is clearly a medical device, because it is powered it also
falls under the remit of powered hand tools; it could well be subject to electromagnetic
compatibility regulations too, and because it makes a noise it falls under noise emissions
regulations. As the designer you must make sure that your device meets all relevant standards
and guidelines. Unfortunately Class I designers only find this out when it is too late; Class II,
and above, design teams have the failings pointed out to them when they have their first audit.
This is the main drawback of self-regulation!
2.6 Summary
In this chapter we were introduced to classifications. We saw that there are two different
approaches in the USA and Europe but that they ultimately end in the same place. We saw
that the classification in the USA may not directly match that in the EU. We learned how to
classify our devices and determined what the classifications mean to our design controls and
our development costs. Therefore you now have a few tasks to complete to ensure that you
familiarise yourself fully with the classification methodology.
Task 1: Make yourself fully aware of the FDA database of product classifications.
Task 2: Determine the classification (EU and USA) for
i) A single-use scalpel
ii) A dental filling (you will need to think to find this)
iii) An x-ray imaging machine
Task 3: Produce a chart similar to Figure 2.7 for Class IIa devices.