Post-Market Surveillance (PMS) Requirements

As part of its priority to improve patient safety, the government intends to introduce legislation late in 2024 (with accompanying guidance) to strengthen post-market surveillance requirements. The proposed legislation will be laid before Parliament early in 2024. Proposed legislative changes seen in the draft Statutory Instrument included:

  • Details of what must be included as part of a PMS system, including the methods for collecting PMS data;
  • Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner; and
  • More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices.

Future Core Medical Device Regulations

Stakeholder discussions will be run in the early part of 2024 and will give early sight of the more detailed policy on the future core regulations, but the government has already indicated the regulations will include provisions to:

  • Introduce improvements for implantable medical devices, up-classifying them to subject them to more stringent pre and post market requirements;
  • Ensure devices have a unique device identifier (UDI);
  • Change the classification system for several types of devices, including up-classifying certain software as a medical device and aligning IVD classifications with those of the International Medical Device Regulators Forum;
  • Strengthen the requirements for quality management systems and technical documentation;
  • Introduce a framework for international recognition;
  • Include new requirements for the claims manufacturers can make about their medical devices, requiring them to align with their statement of intended purpose;
  • Include new requirements for clinical investigations; and
  • Bring the essential requirements for medical devices being placed on the market in Great Britain into greater alignment with those of the EU.

Proposals for Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD)

The Roadmap also indicates there will be important guidance and best practice issued in 2024 on SaMD and AIaMD. This will include:

  • Guidance on good machine learning practice for medical device development mapping;
  • Guidance on data driven SaMD research, development and governance;
  • Development and deployment of best practice guidance for AIaMD.

The government also intends to launch an AI Airlock regulatory sandbox. This will provide a regulator-monitored virtual area for developers to generate robust evidence for their AI technology development in a real-world NHS setting, with strict safety controls, allowing developers to determine whether they need to build more evidence for a safety and efficacy assessment ahead of navigating regulatory approval.

In order to ensure system readiness and minimise the risk of supply disruptions the government is adopting a phased, proportionate approach to the new regulatory framework, which means this is very much one to watch, as more information on the PMS requirements, core regulations and proposals for SaMD, AIaMD guidance become forthcoming over the course of this year.