Module 18 2021

06/02/2021

a physiological or pathological state

congenital physical or mental impairments

The specific information that is intended to be provided by the manufacturer in the context of

the predisposition to a medical condition or a disease

the determination of the safety and compatibility with potential recipients

the prediction of treatment response or reactions

the definition or monitoring of therapeutic measures

Specific information for what ?

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The Organisation for Professionals in Regulatory Affairs

The medical interpretation becomes more important

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Class A sterile, class B,C and D come under Notified Body review

There will be no grandfathering of IVDs

With thanks to FAMHP

Classification changes with IVDR (see your notes for the new classifications)

The Organisation for Professionals in Regulatory Affairs

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5