reg 44ZF Post-market surveillance plan
(1) The manufacturer must base the post-market surveillance system on a post-market surveillance plan (“PMS plan”) that complies with this regulation. (2) A PMS plan must be— (a) clear, organised and searchable, and (b) maintained for the PMS period of the device model. (3) A PMS plan must specify the lifetime of the device and must include— (a) processes for the collection and assessment of the following information in relation to the device— (i) information about serious incidents, other incidents and side-effects; (ii) information about field safety corrective actions; (iii) information for the purposes of identifying trends in incidents and if applicable, reporting those trends under regulation 44ZN (trend reporting); (iv) feedback and complaints provided by users and suppliers of the device; (v) information about user experience in relation to safety and performance, including through patient and public engagement, where appropriate; (vi) other information relevant to the post-market surveillance of the device, including information relating to similar devices available on the market and available outside Great Britain. (b) suitable indicators and threshold values to be used in the reassessment of the required risk analysis; (c) effective and appropriate processes to investigate complaints and analyse feedback and information about user experience; (d) processes to manage incidents and trends (whether or not they must be reported under regulation 44ZN (trend reporting)), including— (i) the statistical methodology to be used to determine a significant increase in the frequency or severity of incidents, and (ii) in relation to a device placed on the market or put into service in accordance with Part 4, the statistical methodology to be used to determine a significant increase in expected erroneous results; (e) a process for communicating effectively with the Secretary of State, the approved body for the device (if there is one), the UK responsible person (if there is one), users and suppliers of the device; (f) processes that provide for how the manufacturer will comply with their obligations under this Part; (g) a plan for any post-market clinical follow-up required under Part 2 or 3; (h) the post-market surveillance report required by regulation 44ZL (post-market surveillance report) or the periodic safety update report required by regulation 44ZM (periodic safety update report) and any reports issued by an approved body under paragraph (9) of regulation 44ZM. (4) The information collected under paragraph (3)(a) must enable— (a) an accurate characterisation of the performance of the device, and (b) a comparison between the device and similar devices available on the market. (5) The manufacturer and the UK responsible person (if there is one) must provide the PMS plan, including any post-market surveillance reports or periodic safety update reports and any reports issued by an approved body, to the Secretary of State upon request and within 3 working days of the date of any such request.