Technical documentation on post-market surveillance
The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.
1.1. The post-market surveillance plan drawn up in accordance with Article 84.
The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83.
|(a)||The post-market surveillance plan shall address the collection and |
utilization of available information, in particular:
— information concerning serious incidents, including information
from PSURs, and field safety corrective actions;
— records referring to non-serious incidents and data on any
— information from trend reporting;
— relevant specialist or technical literature, databases and/or
— information, including feedbacks and complaints, provided by
users, distributors and importers; and
— publicly available information about similar medical devices.
|(b)||The post-market surveillance plan shall cover at least: |
— a proactive and systematic process to collect any information
referred to in point (a). The process shall allow a correct
characterisation of the performance of the devices and shall also
allow a comparison to be made between the device and similar
products available on the market;
— effective and appropriate methods and processes to assess the
— suitable indicators and threshold values that shall be used in the
continuous reassessment of the benefit- risk analysis and of the riskmanagement 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
— 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
— methods and protocols to communicate effectively with
competent authorities, notified bodies, economic operators and
— 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.