Module 16 2024

10/17/2024

MDR - Post-Market Surveillance System - General Requirements

Article 83 Section 3

3. Data gathered by the manufacturer's post-market surveillance system shall in particular be used to update:

▪ (a) the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;

▪ (b) the design and manufacturing information , the instructions for use and the labelling ;

▪ (c) the clinical evaluation;

▪ (d) the summary of safety and performance for implants and Class III devices;

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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MDR - Post-Market Surveillance System - General Requirements Article 83 Section 3 continued Data gathered by the manufacturer's post-market surveillance system shall in particular be used:

(e) for the identification of needs for preventive, corrective or field safety corrective action ;

(f) for the identification of options to improve the usability, performance and safety of the device ;

(g) when relevant, to contribute to the post-market surveillance of other devices ; and

(h) to detect and report trends in accordance with [ Trend Reporting ].

The technical documentation shall be updated accordingly .

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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