Scope

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.

Learn More

• 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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