Module 19 2021

24/05/2021

Conformity Assessment Procedures – Class B

Notified Body

Manufacturer

Annex IX (Quality Management System and Assessment of TD)

Notified Body issues an EU Quality Management System certificate – including TD assessment

NB #

The Organisation for Professionals in Regulatory Affairs

11

Conformity Assessment Procedures – Class C ● EU Quality Management System certificate (Annex IX) – Technical documentation assessment of at least one device made by Notified Body according to the generic device grouping plan – Technical documentation assessed of subsequent devices in group as part of NB surveillance audits over certification period ● OR : EC Type Examination certificate (Annex X) coupled to EU production quality assurance certificate (Annex XI)

The Organisation for Professionals in Regulatory Affairs

12

6