Post Market Surveillance Under IVDR (2017/746)

about the Course

The success of an organisation, the penetration of its products and services in the market, efficient internal procedures, and a healthy economic status depends essentially on how MD-QMS requirements and requirements for regulatory purposes are consistently ensured, maintained, and improved. To provide adequate knowledge to the participants about Post-Market Surveillance and PMC Report and PSUR. PMS and in this context, Post-Market Performance Follow-Up (PMPF), is assigned an important role under the IVDR. Post-market data must be used to update essential documents, e.g. risk management and performance evaluation. This course aims to provide learners with the knowledge of Post-Market Surveillance (PMS) with respect to Medical Devices classified under IVDR. The program also provides an overview of other concepts like Traceability, UDI and EUDAMED. 

Course contents/OUTLINE

1. Introduction to Post -Market Surveillance

• Transitional Provisions – Applicability
• Consequences for products CE marked under IVDD
• Content for Technical Documentation in brief
• Traceability of Devices by means of Unique Device Identification system (UDI)

2. Post-Market Surveillance

• Definition
• System for Post-Market Surveillance (Chapter VII)
• Audit life cycle
• Post-Market Surveillance Report (PMS)
• Periodic Safety and Update Report (PSUR)

3. Post-Market Performance Follow up (PMPF)

• Applicability
• The Post-Market Performance Follow up Plan
• Preventive and Corrective actions – Vigilance
• Auditors qualification and certifications

4.Traceability

• Criteria to ensure traceability

• UDI in brief
• UDI and SRN
• Key Features of EUDAMED with respect to traceability
• UDI Carrier – GS1, HIBCC
• Process

Training duration

1 Day

Prerequisites

Having prior knowledge about IVD Regulation 2017/746 and MD-QMS auditing would be helpful.

CERTIFICATION

A course attendance certificate will be provided to the attendees at the end of the course.