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Selection of certification routes
(conformity assessment procedures)
The European Medical
Devices Directives focus on the responsibility of the device manufacturers. Therefore for
CE marking of all In-vitro diagnostic devices 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.
IVD manufacturers, which have devices that are not listed in Annex II, devices not for
self-testing nor devices for performance evaluation 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.
Devices according to Annex ll and devices for self-testing 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 lsting of the in-vitro diagnostic device
the manufacturer has the choice between different certification routes as graphically
shown on the following links:
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