Classifying Medical Devices - Medical Device Design: Innovation from Concept to Market - page 21

Table 2.3: Comparison of Classifications in the USA
and Europe

Class USA Europe

Device
Reusable surgical instrument I I

Disposable suture needle I IIa

Bone screw II IIa (short duration)/

IIb (long duration)

Blood sample container I I

Hip prosthesis (implant) II III

Do not use this table for classification purposes, it is only for
comparison.

Table 2.3 illustrates some comparisons between classifications of devices in Europe and in the
USA. By and large (apart from IIa and IIb) the classifications match. But do not let this fool
you, you must check the classification and not simply assume.

… when you assume, you make an ASS out of U and ME 1

2.3.3 Special Cases
There are two special cases to consider. The first is custom-made devices and the second is a
device intended for clinical investigation. These are defined as follows:

“custom-made device” means any device specifically made in accordance with a duly
qualified medical practitioner's written prescription which gives, under his responsibility,
specific design characteristics and is intended for the sole use of a particular patient.

The above mentioned prescription may also be made out by any other person authorized by
virtue of his professional qualifications to do so.

Mass-produced devices which need to be adapted to meet the specific requirements of the
medical practitioner or any other professional user are not considered to be custom-made
devices; ( EC, 1993 )

Basically, this means the device is a one-off. Clearly one cannot go through the full regulatory
process for every single one-off device, but this does not mean that the rules of engagement
do not apply. Consider, for example, a simple walking frame specifically designed for a
patient or, in comparison, a designed-for-patient replacement hip. Both are one-offs but
the risks are, clearly, not the same. Due consideration has still to be taken with the design
process - this is not a “get out clause.” One should still ascertain the device's classification
to assess the diligence one needs to apply.

1 Attributed to Benny Hill - much maligned British comedian - from his television series of the 1970s