Module 14 2022

22/03/2022

Conformity Assessment

LINK

Class I

•Self-certification •Approved bodies needed for Sterility and metrology

Class IIa

•Examination and testing of each product- Annex IV Part II •Audit of the production quality assurance system – Annex V Part II •Audit of final inspection and testing – Annex VI Part II •Audit of full QMS – Annex II Part II

Approved Body

Class IIb

•Annex II part II •Annex III part II

Class III

•Annex II Part II •Annex III Part II

The Organisation for Professionals in Regulatory Affairs

Diverging approaches to MD requirements – EEA and UK

11

Designated Standards

The Organisation for Professionals in Regulatory Affairs

Diverging approaches to MD requirements – EEA and UK

12

6