Module 19 2021

24/05/2021

Conformity Assessment Procedures – Class D

Notified Body

Manufacturer’s choice

QMS with technical documentation assessment - Annex IX and EU Ref Lab

EC Type Examination (Annex X) and EU Ref Lab

Production QA (Annex XI)

Notified Body issues an EU Quality Management System certificate and an EU Technical Documentation certificate

Notified Body issues an EU Type and Production Quality Assurance certificate

NB #

The Organisation for Professionals in Regulatory Affairs

15

Conformity Assessment Procedures – special cases. Class B, C or D Devices for self-testing and near- patient testing ● NO sampling of technical documentation ● EU technical documentation assessment certificate issued for each device ● Specific requirements apply – Demonstrate usability – Show studies Class C or D Companion Diagnostics ● No sampling of technical documentation ● EU technical documentation assessment certificate issued for each device ● Involvement of European Medicines Agency (EMA) – guidance awaited

The Organisation for Professionals in Regulatory Affairs

16

8