Claire Burrows, partner at Brabners LLP and Thorrun Govind, solicitor at Brabners LLP, pharmacist and TV health expert, provide further insight into ongoing MHRA work on legislation covering medical devices. If you missed their last piece click here.

The explosion of innovation in health technology in recent years has the potential to bring transformative approaches to healthcare. Now, planned new regulations for medical devices will assist in ensuring that this progress is made as safely as possible.

Key elements of proposed changes to legislation around medical devices include:

  • Detailed requirements for what must be included as part of a post-market surveillance (PMS) system, including 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.
  • 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 impact the safety of a medical device.

What is happening and when?

The Medicines and Healthcare products Regulatory Agency (MHRA) consulted on the ‘Future Regulation of Medical Devices in the UK’ in 2021 in response to the Independent Medicines and Medical Devices Safety (IMMDS) review published in 2020.

The consultation responses strongly supported the introduction of clearer and more robust post-market surveillance (PMS) requirements to improve patient and public safety, calling for closer alignment with international standards.

The MHRA has emphasised that the new legislation will introduce clearer and risk-proportionate requirements to enhance the safety of medical devices across Great Britain. This will also provide certainty for manufacturers ahead of broader future regulatory regime changes.

The long-awaited draft Statutory Instrument (SI) on future PMS requirements was laid before Parliament on 21 October 2024, accompanied by a comprehensive impact assessment.

The exact timescale for the draft SI to be implemented will depend on the parliamentary process, but it will now progress through both Houses of Parliament.

It is expected to be presented in its final form within the next few weeks. A six-month transition period will then follow, likely concluding in the summer of 2025.

What does this mean?

PMS requires manufacturers to monitor the safety of a medical device after it has been released on the market and, where necessary, take appropriate action to prevent or reduce the risk of an identified safety issue.

The draft PMS SI represents the new Government’s first step in updating the UK’s legal framework for medical devices. It is expected to bring the UK into greater alignment with the EU’s regulation of medical devices while also taking advantage of opportunities resulting from the UK’s withdrawal from the EU to build on and diverge from this legislation.

The initial draft of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (PMSR) was published in August 2023. The current provisions feature only minor amendments introduced by the MHRA, which should provide comfort to those who will be bound by the future regulations.

Benefits to expect

Since January 2021, all medical devices must be registered with the MHRA before being placed on the market in Great Britain. This step-change in oversight has allowed for more rapid action when safety concerns are identified.

The aim of the new legislation is to build on these measures by introducing clear, risk-proportionate requirements that improve patient safety, facilitate greater traceability of incidents, and enhance reporting trends for both CE marked devices and UKCA marked devices that are placed on the market or put into service in GB.

The MHRA has emphasised that these new measures are expected to further reduce adverse incidents by ensuring manufacturers identify and address issues earlier and reduce the time for corrective actions to be taken. They have also indicated that this will benefit innovation and growth in life sciences, with the collection of real-world data helping manufacturers to further improve existing products.

The new approach may support fewer recalls for pharmacists to deal with and provide a strong foundation for patient safety before further measures, such as such as international reliance, are introduced.

The MHRA intends to publish guidance for medical device manufacturers on the PMSR requirements in advance of implementation, and pharmacists will want to familiarise themselves with the guidance when it is available.