suitable indicators and threshold values that shall be used in the continuous – reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I; effective and appropriate methods and tools to investigate complaints and – analyse market-related experience collected in the field; – methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period; methods and protocols to communicate effectively with competent authorities, – notified bodies, economic operators and users; reference to procedures to fulfil the manufacturers obligations laid down in – Articles 83, 84 and 86; systematic procedures to identify and initiate appropriate measures including – corrective actions; effective tools to trace and identify devices for which corrective actions might – be necessary; and a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why – a PMCF is not applicable. 1.2. The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.
– suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I; – effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field; – methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period; – methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users; – reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86; – systematic procedures to identify and initiate appropriate measures including corrective actions; – effective tools to trace and identify devices for which corrective actions might be necessary; and – a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable. 1.2. The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.