Classifying Medical Devices - Medical Device Design: Innovation from Concept to Market - page 13

Table 2.2: EC Classification Rules in Comparison with
the Classes They Define

Class in rule Class I Class IIa Class IIb Class III

Rule

# 1 ⌧

# 2 ⌧ ⌧

# 3 ⌧ ⌧

# 4 ⌧ ⌧ ⌧

# 5 ⌧ ⌧

# 6 ⌧ ⌧ ⌧ ⌧

# 7 ⌧ ⌧ ⌧

# 8 ⌧ ⌧ ⌧

# 9 ⌧

# 10 ⌧ ⌧

# 11 ⌧ ⌧

# 12 ⌧

# 13 ⌧

# 14 ⌧ ⌧

# 15 ⌧ ⌧

# 16 ⌧

# 17 ⌧

# 18 ⌧

Hip, knee, and
shoulder replacements

⌧

Figure 2.1
A typical 3.2 mm bone drill. (Courtesy Intelligent Orthopaedics)

These definitions are almost universal, so you should have these emblazoned in your memory.
All regulatory requirements come with definitions; the documents are legal documents so
definitions are mandatory. If you have ever seen a legal document you will note that the first
few pages are definitions. . They are required so that everyone, as it is said in business school,
“ sings from the same song sheet .” The USA and Europe each have their own particular
wording so it is important that you keep abreast of them.

2.3 Classification Case Study
To understand classification and risk we will use a case study. For the purposes of this case
study we will use the humble orthopedic drill bit and an orthotic shoe insert as our examples.
Before we go any further we need to understand the devices. Figure 2.1 illustrates a typical
3.2 mm drill bit. It is used for drilling holes in bones. The process takes just a few minutes and
the devices can be reused until they are blunt. They are supplied nonsterile.