reg 44ZN Trend reporting
(1) The manufacturer must report to the Secretary of State any significant increases in the frequency or severity of incidents involving a device if the manufacturer considers that increase could have a significant adverse impact on the required risk analysis. (2) A “significant increase” under paragraph (1) is to be determined in comparison to the foreseeable frequency or severity of the incidents and in accordance with the statistical methodology set out in the post-market surveillance plan. (3) In relation to a device placed on the market or put into service in accordance with Part 4, the manufacturer must also report to the Secretary of State any significant increase in expected erroneous results in comparison to the stated performance of the device in the instructions for use. (4) The reporting duties in paragraphs (1) and (3) apply throughout the PMS period for the device model. (5) An initial report under this regulation must include— (a) the manufacturer’s name and contact details; (b) the UK responsible person’s name and contact details (if there is one); (c) a description of the device, including any unique device identifiers; (d) the number of devices placed on the market or put into service in Great Britain and the estimated number of users affected; (e) information in relation to the identified trend. (6) As soon as possible after submitting an initial report, the manufacturer must— (a) investigate the identified trend and the device or devices concerned, and (b) submit a final report to the Secretary of State setting out— (i) the manufacturer’s conclusions into causes of the identified trend; (ii) a description of any preventive and corrective actions taken or to be taken by the manufacturer in response to the identified trend. (7) The manufacturer must provide the Secretary of State with updates and documents relevant to the investigation under paragraph (6)(a) upon request and within 3 working days of the date of any such request.