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Frequently Asked Questions

What is Investigational Device?

‘Investigational device’ means a device that is assessed in a clinical investigation.

What is Clinical Investigation?

‘Clinical Investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.

Who is a Sponsor?

‘Sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation.

Who is a Subject?

‘Subject’ means an individual who participates in a clinical investigation.

Who is an Investigator?

‘Investigator’ is an individual responsible for the conduct of a clinical investigation at a clinical investigation site.

What is Adverse Event?

‘Adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.

What is Device Deficiency?

‘Device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer.



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