Medical Devices: Post-Market Surveillance (PMS) Requirements in the UK

1. Overview of PMS Obligations Post-market surveillance (PMS) is a continuous process used by manufacturers to collect and maintain experience gained from devices already placed on the market. In the UK, manufacturers must implement a PMS system that is proportionate to the risk class and type of the device. This system ensures that any necessary corrective and preventive actions (CAPA) are taken promptly to protect public health. Source: UK Gov Guidance: Medical devices: post-market surveillance requirements

2. The Post-Market Surveillance Plan A manufacturer must document their PMS system in a formal Post-Market Surveillance Plan. This plan should outline the methods for collecting and evaluating data, including:

Information on adverse incidents and field safety corrective actions (FSCAs).

Records of non-serious incidents and data on any undesirable side-effects.

Feedback and complaints provided by users, distributors, and importers.

Relevant specialist or technical literature, databases, and registers. Source: UK Gov Guidance: Medical devices: post-market surveillance requirements

3. Post-Market Surveillance Report (PMSR) vs. PSUR The documentation requirements vary based on the risk classification of the device:

Class I Devices: Manufacturers must prepare a Post-Market Surveillance Report (PMSR). This report summarizes the conclusions of the PMS data collection and is updated when necessary.

Class IIa, IIb, and III Devices: Manufacturers must prepare a Periodic Safety Update Report (PSUR). The PSUR summarizes the results and conclusions of the PMS data, including the rationale and description of any preventive and corrective actions taken. Source: UK Gov Guidance: Medical devices: post-market surveillance requirements

4. Vigilance Reporting and Timelines Manufacturers are legally required to report specific incidents to the MHRA. These include any malfunction or deterioration in the characteristics or performance of a device, as well as any inadequacy in the labeling or instructions for use that might lead to or might have led to the death of a patient or user or a serious deterioration in their state of health. Source: UK Gov Guidance: Medical devices: post-market surveillance requirements

5. Retention of Records All PMS documentation and technical files must be kept available for the MHRA for a minimum period (typically 10 to 15 years depending on the device type) after the last device covered by the declaration of conformity has been placed on the market. Source: UK Gov Guidance: Medical devices: post-market surveillance requirements