Module 16 2024

17/10/2024

The post market surveillance plan

• PMS plan scope and objectives:

• Identify the devices covered by the plan, including model number, name, Basic-UDI, etc.

• Identify the objectives of the plan per MDR Article 83:

Article 83(2) - This PMS plan aims to actively and systematically gather, record, and analyze relevant data on the quality, performance, and safety of the DEVICE throughout its entire lifetime

Article 83(4) - MANUFACTURER shall use the collected data to draw the necessary conclusions and determine, implement, and monitor preventative and corrective actions

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The post market surveillance plan

• PMS plan scope and objectives:

The results of the plan shall be used to:

Article 83, 3(a) - Update the benefit-risk determination and improve the risk management as referred to in MDR Chapter I of Annex I;

Article 83, 3(b) - Update the design and manufacturing information, the instructions for use, and the labeling;

Article 83, 3(c) - Update the clinical evaluation;

Article 83, 3(d) - Update the summary of safety and clinical performance (SSCP) referred to in Article 32; (Only for implantable and Class III devices)

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