Module 15 2022

19/05/2022

MDCG 2019-9 – Overview

• Article 103 establishes the Medical Device Coordination Group (MDCG) • IVD/Medical Device Expert group

which represents each member state, • Tasked to provide further guidance on MDR requirements, • Not legally binding, not EU Commission position.

• MDCG have provided guidance as to the expected content of a SSCP…

Module 15 Lecture 5

The Organisation for Professionals in Regulatory Affairs

9

MDCG 2019-9 – Overview

• MDCG 2019-9, Rev 1: • SSCP Template and guidance on content • Separate summaries for the user and if appropriate the patient • Readability requirements • Only contains information held within technical documentation – excludes promotional elements • Favourable and unfavourable data • Language requirements • Updated in line with PSUR, CER, IFU

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

10

5