Module 16 2024

10/17/2024

MDR - Art. 84 & Annex III: Post-market surveillance plan

Shall cover at least: • proactive and systematic process to collect the information referred to in previous slide [EN ISO 13485:2016, 8.2.1]

• effective methods to assess the collected data (including complaints, market-related experience, trend reporting, recognise significant data) [EN ISO 13485:2016, 8.2 & 8.4]

• suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and risk management [ ISO 14971:2019 and Annex I, SPR 3]

• Complaint investigation and analysis [ EN ISO 13485:2016, 8.2.2]

• Methods & protocols to manage events subject to the trend reporting regarding any statistically significate increase in the frequency or severity of incidents

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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MDR - Art. 84 & Annex III: Post-market surveillance plan

Shall cover at least [continued]:

• Methods to communicate effectively with NB, CA, economic operators and users [EN ISO 13485 Sections 7.2.3 and 8.2.3]

• Reference to procedures to fulfil MDR PMS obligations [EN ISO 13485 Section 4.2]

• Procedures to initiate appropriate corrective measures/corrective actions [EN ISO 13485 Section 8.5

• Tools to trace and identify affected devices [ EN ISO 13485 Section 7.5.8. & 7.5.9]#

• PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not

applicable.

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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15