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Selection of
certification routes
(conformity assessment procedures)
The European Medical
Devices Directives focus on the responsibility of the device manufacturers. There is no CE
marking without technical documentation, including risk analysis and reference to the
essential requirements of the directive, as well as the declaration of conformity with the
concerned directive issued by the manufacturer.
Only non-sterile class I devices without measuring function do not require the involvement
of a Notified Body. The manufacturer of such devices marks them under his sole
responsibility with the CE mark without a number.
All other devices require the certification by a Notified Body before the manufacturer
puts the CE mark in combination with the number of the Notified Body on the device.
Depending on the device class the manufacturer has the choice between different
certification routes as graphically shown on the following links:
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