The Medical Devices Introductory Course 2020

IVD Classification

Highest Risk High Third Party Scrutiny

D

Significant Risk Third Party Scrutiny

C

Medium Risk Limited Third Party Scrutiny

B

A

Low Risk

The Organisation for Professionals in Regulatory Affairs

• New grouping under IVDR. Point Of Care is Dead! • This category has previously not been clearly differentiated in the EU. • Specific requirements for − Intended purpose and use environment − Training of users

− Validation − Labelling − NB Approval

The Organisation for Professionals in Regulatory Affairs