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, a decision whether a device can be classified as IVD will depend upon the intended purpose of the device and its claims.
“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.
- The Directive: IVDD 98/79/EEC
- Path to EU Market Entry
- Pre-Market Notification
- Notified Body
- Authorized Representative
- Risks of Non-Compliance
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