Module 19 2021

24/05/2021

MDCG 2019-13 (EU) 2017/2185

3rd /4th level of EMDN

The Organisation for Professionals in Regulatory Affairs

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Conformity Assessment Procedures – Class A ● Declaration of Conformity (Art. 17) and Annex IV Meets requirements of Regulation including: ● Risk Management and all relevant General Safety and Performance Requirements (Annex I) ● Performance evaluation (Art. 56 and Annex XIII) ● Quality Management System (Art 10.8) ● Technical Documentation (Annexes II and III) including lifecycle maintenance (Annex III and XIII) ● Incident / Vigilance reporting procedures (Art 82-84) ● No notified body certification required unless for sterile products (either under Annex IX or XI)

The Organisation for Professionals in Regulatory Affairs

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