Classifying Medical Devices - Medical Device Design: Innovation from Concept to Market - page 24

Figure 2.8
Design effort versus classification.
Basically this means that the level of investigation into your design processes before giving
any CE mark, or clearance to market, is negligible for Class I products. Indeed it is virtually
self-regulated. You may be tempted to think that this means you do not need to do any “real
design” but you would be wrong. You have to think about the situation when something
goes wrong: for example, when you are placed in court defending your product that has just
maimed someone, or when you have to defend your design to an expert designer with no
evidence. Self-regulation, therefore, means you make sure you have the design files in place.
The higher the classification, the “thicker” your design's file becomes as it will contain more
investigations to make sure it is safe to use. The overall process is the same; it's the amount of
work that increases. Your company will have to defend its submission to the authorities before
it can be placed on the market. The file has to be bulletproof; the higher the classification the
bigger and faster the bullets. The people that audit your files are not stupid, they are highly
intelligent scientists and engineers so do not try to fool them - you will fail.
Figure 2.8 illustrates the amount of effort required for each classification. The amount of
external control is negligible for Class I products, but the company's internal control is
significant. For Class III devices the amount of control exerted by external factors is probably
equal to (if not more than) that of your company. This does not means your hands are tied
and you cannot make any design decisions; it simply means you have to justify them - fully.
Hence the amount of effort you must apply to the design process increases too.
External control does not only come from the regulatory bodies. As the classification
increases so does the number of standards that apply. There are many standard bodies to
work with but in general we will be talking about ASTM (American Society for Testing and