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Scope of the IVDD 98/79/EC
The directive applies to In-Vitro Diagnostic Medical Devices and their accessories. Whereas it is assumed that accessories shall be treated as In-Vitro Diagnostic Medical Devices in their own right.
Certain devices are excluded from the scope of the directive. According to Article 1 of the directive, a decision whether a device is within the scope of the directive will depend upon the intended purpose of the device and the claims for it.
“For research use only” devices are not usually considered to be IVD medical devices. This means that the device must have no medical intended purpose, no medical objective and it should not have a performance evaluation function.
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