Module 15 2022

19/05/2022

MDCG 2019-9 – Overview

Minor changes (March 2022): ● Clarification on relationship between Basic UDI DI and SSCP. ● Manufacturer to create a unique SSCP reference number within their QMS. ● SSCP reference number will remain the same for the entire lifetime of the SSCP. ● The manufacturer’s SRN + SSCP reference number is a unique identifier for the SSCP in EUDAMED. ● Template now includes a placeholder for inserting the Manufacturer’s reference number for the SSCP.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

11

MDCG 2019-9 – Overview

• SSCP section for the healthcare professional: • Every Class III or implantable device.

• SSCP section for the patient: • Implantable devices for which patients are given implant cards. • Class III devices intended to be used directly by the patient. • MDR Annex XVI (non-medical purpose), Class III or implantable.

• A manufacturer may opt to provide a patient SSCP even if not required to. • If a patient SSCP is required – separate section of the same document.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

12

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