reg 44ZE Post-market surveillance system
(1) The manufacturer must maintain a post-market surveillance system (“PMS system”) for each device that is placed on the market or put into service. (2) The manufacturer must ensure the PMS system— (a) is proportionate to the risk posed by the device; (b) is appropriate to the type of device; (c) includes the analysis of data relevant to the quality, performance and safety of the device throughout its lifetime, and a record of the manufacturer’s conclusions based on that analysis. (3) The manufacturer must ensure that the PMS system is used throughout the PMS period to identify— (a) preventive actions and corrective actions, including field safety corrective actions; (b) trends in incidents, including those on which the manufacturer must report under regulation 44ZN (trend reporting); (c) options to improve the usability, performance and safety of the device; (d) any impact on the post-market surveillance of other devices. (4) The manufacturer must ensure that data gathered through the PMS system is used to update the following— (a) for devices placed on the market or put into service in accordance with Part 2 or 3— (i) the instructions for use and labelling of the device; (ii) design and manufacturing information; (iii) the required risk analysis; (iv) the evaluation of clinical data referred to in regulations 9(2) and 23(2) for the purposes of confirming conformity with the relevant essential requirements; (v) any other technical documentation required by the conformity assessment procedure carried out in respect of the device in accordance with Part 2 or 3. (b) for devices placed on the market or put into service in accordance with Part 4— (i) the instructions for use and labelling of the device; (ii) design and manufacturing information; (iii) the required risk analysis; (iv) any evaluation of performance evaluation data confirming conformity with the relevant essential requirements; (v) any other technical documentation required by the conformity assessment procedure carried out in respect of the device in accordance with Part 4. (5) Paragraph (4) does not apply in respect of a device placed on the market in accordance with regulation 19B, 19C, 30A, 44ZA or 44ZB.