Module 19 2021

24/05/2021

Conformity Assessment Procedures – Class A

Manufacturer’s device

Sterile

Notified Body

Not sterile

Sterility (Annex IX or XI)

EC Declaration of Conformity (Annex IV)

The Organisation for Professionals in Regulatory Affairs

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Conformity Assessment Procedures – Class B Annex IX only route available for Class B devices. Conformity Assessment based upon a Quality Management System and on assessment of Technical Documentation ● Technical documentation assessment prior to issue of EU QMS Certificate – At least one device per category of devices covered by application

● Technical documentation assessed of subsequent devices in group as part of NB surveillance audits over certification period

The Organisation for Professionals in Regulatory Affairs

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