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Clinical
Clinical
MDD 93/42/EEC (Medical Device Directive), amended by the 2007/47/EC, requires clinical
data and an evaluation of that data to ensure the safety of the medical device. Clinical data
is collected or generated from the clinical use of the device and observing the performance
of this device and its safety. The following activities allow for obtaining this data:
The medical devices must go through clinical evaluation which is the process of assessing
clinical data and making sure that the data is in conformity with the harmonized standards
and essential requirements that have been established by the European Union. This clinical
evaluation proves that the device is safe and performs according to its intended purpose
established by the manufacturer.
When a clinical evaluation is not appropriate, there must be adequate justification based on
risk management output and under consideration of the specifics of the device/body
interaction, the performances intended and claims of the manufacturer. Clinical evaluation
also is focused on those elements of safety and/ or performance that could not be based on
laboratory testing. Medical Device Directive Annex VIII requires that all clinical testing has
been performed properly.
Manufacturer’s responsibility
The clinical evaluation and its documentation must continually be updated by its post-
market surveillance information. If this post-market surveillance is not needed for some
reason in following up on the medical device, an acceptable justification must be given and
documented. For high risk devices, there must be a clinical follow-up report given with the
final report.
Investigation must be reviewed by the Notified Body who has such authority.