UK MHRA, Finalizes Legislation on Post-Market Surveillance

 

On December 20, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) emphasized the importance of Post-Market Surveillance (PMS) by announcing the final PMS Statutory Instrument (PMS SI) as the Medical Devices (Post-Market Surveillance Requirements) (Amendment) Regulations 2024 (SI 2024 No. 1368).

 

While most of the PMS SI requirements align with EU PMS requirements, new requirements have been introduced to protect public health. The newly introduced requirements are as follows:

 

The structure of the PMS system consists of the PMS Plan, PMS Report (PMSR), Periodic Safety Update Report (PSUR), and Trending Report.

●   The PMSR must be updated at least every 3 years until the end of the PMS period for the device.

●   The PSUR must be updated during the PMS period in accordance with the device’s classification:

   * High-risk medical devices: updated annually

   * Class IIa devices: updated at least every 2 years

●   For implantable medical devices, PMS records must be kept for the longer of the PMS period or 15 years, and for other medical devices, records must be kept for 10 years.

●   A single PSUR may be prepared for a category or group of devices in the following cases:

   * When the same clinical evaluation report under Regulation (EU) 2017/745 or the performance evaluation report under Regulation (EU) 2017/746 applies to the devices, or

   * When the devices are similar, and the manufacturer considers that the similarity justifies preparing a single PSUR for those devices.

 

Please refer to the link below. 

https://www.legislation.gov.uk/uksi/2024/1368/made

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024

 

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