MHRA Publishes Draft Post-Market Surveillance Requirements

By Karen Hill

Background

Following the publication of the draft PMS SI on the World Trade Organization (WTO) website on July 26, 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) has, after considering stakeholder responses to that draft, published the “final” draft PMS SI.

This instrument introduces new PMS requirements for medical devices that improve patient safety by establishing stricter surveillance obligations on manufacturers to ensure continuous monitoring of device performance, safety and quality after they are placed on the market.

Key changes

The final draft PMS SI includes:

• Updated definitions related to PMS, some of which diverge from EU MDR 2017/745 in order to either improve clarity, maintain global alignment or introduce new requirements to safeguard public health.
   
• Detail on what must be included as part of the PMS system, including the requirements for a PMS Plan that encompasses the lifetime of the device, and a regularly updated PMS Report or Periodic Safety Update Report (dependent on device classification).
   
• Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner.
   
• Clear obligations for manufacturers to consider when conducting a Field Safety Corrective Action (FSCA) to prevent or reduce the risk of a further serious incident.
   
• Detailed requirements relating to Field Safety Notices (FSN) to better target patients and users at risk.
   
• More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices.
   
• Introduction of a specified retention period for PMS documentation.

Implementation of the draft PMS SI

The PMS SI will apply to devices placed on the market on or after the regulation’s enforcement date. Devices with CE marking will be included in the scope. These are currently allowed onto the GB market under transition provisions within the U.K. MDR 2002, providing parity between the requirements for manufacturers to report to the MHRA devices with both CE and UKCA marking.

Comprehensive guidance will be published before the PMS SI comes into force to help manufacturers understand their obligations and facilitate the smooth implementation of these regulations.

Concluding remarks

The draft PMS SI will be debated in Parliament and is expected to come into force in the summer of 2025 following a 6-month implementation period.

Emergo by UL will continue to monitor developments in the U.K.