Module 19 2021

24/05/2021

Conformity Assessment Procedures – Class C

Notified Body

Manufacturer’s choice

Annex IX (Quality management system with assessment of technical documentation

EC Type Examination (Annex X)

Production QA (Annex XI)

Notified Body issues an EU Quality Management System certificate (includes TD assessment)

Notified Body issues an EU Type and Production Quality Assurance certificate

NB #

The Organisation for Professionals in Regulatory Affairs

13

Conformity Assessment Procedures – Class D

● EU Quality Management System certificate (Annex IX) and EU technical documentation assessment certificate. ● OR : EC Type Examination certificate (Annex X) coupled to EU production quality assurance certificate (Annex XI) ● No sampling, Technical Documentation reviewed and approved by NB for each device. ● Verification of design (conformity to Common Specifications) by EU Reference Lab (pre-approval) ● 60 day review period. NB must receive a positive opinion from the EU Ref Lab ● Batch verification (post-approval)

The Organisation for Professionals in Regulatory Affairs

14

7