Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Classification Rules – In Vitro Diagnostic Medical Devices All near patient tests are classified on their own right (B, C, D)

Rule 1 Blood screening

Rule 2 Blood or tissue compatibilit y

Infectious disease Cancer testing Companion Diagnostics Genetic testing Congenital screening Rule 3

Rule 4 Rule 5 Rule 6 Rule 7

Self testing

Specific IVD reagents

None of the other rules

Controls no assigned values

High risk disease

Instruments

Specimen receptacles

High risk blood group

Self test (exempt list)

D C

D

C C

B

A

B

B

The Organisation for Professionals in Regulatory Affairs

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Classification –Implementing Rules

Classify each device separately Classification

Devices used in combination with another product

Accessories for an MD/ IVD device

Classify on its own right

Software that drives a device or influences its use Software independent of any other device

Classify into the same class as device

Classify on its own right

Annex VIII

The Organisation for Professionals in Regulatory Affairs

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