PMS报告模板（英文）.docx

P POST-MARKET SURVEILLANCE (PMS) / RISK MANAGEMENT PLAN TEMPLATE TMP-031 (PARENT PROCEDURE SYS-019) VERSION: A D2 EFFECTIVE: AUTHOR: M. Walker PAGE: PAGE 1 of 6 Purpose: To define the process and frequency of activities for gathering production and post- production data as an input into the clinical evaluation process (SYS-041) and risk management process (SYS-010). Scope: The scope of this post-market surveillance plan is limited to the [Product Family Name] during the period of [earliest date] to [latest date]. The post-market surveillance system referred to in Article 83 of Regulation (EU) 2017/745 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1.1 of Annex III. For devices other than custom-made devices, the post-market surveillance plan shall be part of the technical documentation specified in Annex II. This plan also addresses the production and post-production activities required as part of the risk management process as defined in ISO 14971:2019, Clause 10. Note: If different PMS and Risk Management inputs cover different periods of time, then this should be clarified in the PMS reports (TMP-032) and Risk Management reports (TMP-027). Often a table is ideal to communicate this information. These two report templates may also be combined into a single report. Responsibilities Authorities: The table in the PMS inputs section defines the personnel that are responsible for gathering each type of PMS data for [Product Family Name]. Each person is responsible for gathering the data, summarizing that data, writing a brief discussion of the data analysis and documenting a conclusion that states whether the data warrants updating the PMS report at this time or to continue gathering data until the next cycle is completed. Even if there is no new clinical data gathered during the period, the clinical evaluation report still requires updating the literature search, gathering of complaint data, and If the literat