Implementing the EU Medical Devices Directive 93/42/EEC

Stage 3: What risk 'Classification' is your device(s)

All devices (other than custom made and those for clinical investigation) must be classified as either Class I, Class I (Sterile or Measuring), IIa, IIb or Class III prior to determining which mandatory conformity route(s) are available. The classification rules are detailed in Annex IX of the Directive. Class I devices represent those with the lowest hazards, whilst Class III represent those with the highest.

In principle, the classification criteria consider:

The duration in which the device is in contact with the body
How the device is attached or penetrates the body
The nature of the device (active, re-usable, etc)
The part of the body that the device is in contact with

Device classification is based upon the manufacturer's intended purpose for the device. It is the manufacturer's responsibility to classify the device. However, the Notified Body (see exclusions in 'Stage 4') must agree with this classification and validate the evidence that your stated 'intended purpose' is achievable. AMTAC provide clients with free technical support and 'Expert System' software to assist with the classification of devices.

References 93/42/EEC
Article 1:2(d) - 'custom made device'
Custom made devices DO NOT carry 'CE' Marking
Article 1:2(e) - 'device intended for clinical investigation'
Devices for clinical investigation DO NOT carry 'CE' Marking
Article 1:2(g) - 'intended purpose'
Article 9 - Classification
Group your devices into families of similar type / function
Annex IX - Classification Criteria