MHRA Introduces PMS Update to UK Medical Device Regulations

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has introduced the first significant update to the medical device regulations in Great Britain through a new Post-market Surveillance (PMS) Statutory Instrument (SI). This follows a 2021 consultation in response to the 2020 Independent Medicines and Medical Devices Safety (IMMDS) review. The consultation revealed strong support for clearer and more robust PMS requirements to enhance patient and public safety and align more closely with international approaches. 

Since January 2021, all medical devices must be registered with the MHRA before entering the Great Britain market, allowing for quicker responses to safety concerns. The new legislation aims to improve patient safety and the final draft of the PMS SI.

What are the key changes in the MHRA PMS update?

• • Detail on what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers. 
  • Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner. 
  • Clearer obligations on manufacturers to consider conducting a Field Safety Corrective Action (FSCA) to prevent or reduce the risk of a further serious incident. Accompanied by 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. This aims to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device 

Laura Squire at MHRA highlighted that the measures prioritize patient safety while facilitating innovation with collecting real-world data to improve products. 

The regulations also lay the groundwork for future measures like international reliance, which could expedite patient access to approved medical devices from other countries. 

The MHRA will provide comprehensive guidance for manufacturers post-Parliamentary approval, with a proposed six-month implementation period, potentially making the regulation law by Summer 2025. 

You can read the full document here.

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