The MHRA has published a timeline showing when it expects reforms to the UK medical device regulations to be consulted on and brought into force.

Publishing timescales for the expected changes will be a welcome move for medical device providers and the health tech industry, providing some of the clarity needed to plan and prepare for reforms. 

The MHRA hopes the regulatory roadmap, which reinforces their aim to deliver a proportionate, phased implementation and smooth transition to the future regulatory framework, will help the UK to avoid some of the pitfalls that have beset the implementation of the new MDR regime in the EU. A less bumpy ride during implementation will be crucial to ensure continuity of supply of existing medical devices and to support introduction of new devices. 

In the second instalment of our Health Tech series, we noted that the MHRA had confirmed its intention to implement the “core aspects” of the UK regulation no later than July 2025, the roadmap sticks to this timeline, with the core regulations due before Parliament in early 2025. However, these timescales do come with a health warning as the current plan does not take into account the general election (expected no later than January 2025) which could result in further change or delay if there is a change of government. 

Regulatory Roadmap

The proposed regulatory roadmap has been published to enable the UK to improve its ability to provide patients with innovative and rapidly advancing medical technology and ensure  swift patient access to the most beneficial technology.  It also aims to enhance the UK’s healthcare position as a hub for world-leading medical technology innovators, delivering greater international harmonisation. 

The MHRA intends to deliver the regulatory roadmap through a series of new statutory instruments (SI’s) with priority measures to protect patient safety expected to be put in place in 2024. 2025 will see the implementation of core elements of the new framework. 

The planned 2024 – 2025 roadmap includes the following:

Early 2024:

  • The international recognition stakeholder discussions in relation to future core regulations will be launched.
  • Following the published draft in 2023 of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023, the post marketing surveillance (PMS) guidance for stakeholder focus groups will be released.
  • The in-vitro diagnostics (IVD) roadmap will be published.
  • Stakeholder discussions will be held on the scope and classification, essential requirements (including labelling and instructions for use), approved bodies and exempted devices relating to the future core regulations.
  • The in-vitro diagnostics regulations for Northern Ireland (IVDR-NI) will come into force.
  • Guidance will be published on software as medical devices (SaMD) relating to good machine learning practice for medical device development mapping and AI as a Medical Device (AlaMD) development and deployment best practice.

Mid 2024:

  • The AI Airlock regulatory sandbox will be launched.
  • PMS regulations will be laid in Parliament with draft guidance published and webinars held.
  • Stakeholder discussions will be held on clinical investigations, obligations of economic operators including quality management systems and qualified persons and conformity assessments relating to the future core regulations. 

Late 2024:

  • SaMD guidance on data-driven SaMD research, development and governance will be published.
  • Stakeholder discussions will be held on unique device identification and implantables, transitional arrangements relating to future core regulations. 
  • A public consultation on future enhancement regulations will be launched.
  • Draft legal text will be sent to the World Trade Organisation for publishing. 
  • Later than previously predicted, the PMS regulations will come into force. 

2025

  • Future core regulations will be laid in Parliament.
  • Future core regulations will come into force in later 2025. 

Future core regulations

The roadmap indicates that the MHRA intend to run stakeholder discussions throughout 2024 on the future core regulations, with the intention of providing an insight into the policy following on from the consultation responses. The MHRA hopes that 2025 will be the year the future core regulations are laid in Parliament and subsequently come into force.   

Alongside the regulatory roadmap the MHRA also published an outline of what will be included in the future core regulations. 

The MHRA plans to introduce several improvements to implantable medical devices such as a requirement for manufacturers to provide implant cards, allowing patients to identify the device that’s been implanted and ensuring that the devices have a unique device identifier (UDI). Pre and post market requirements will become more stringent. 

The classification of implantable medical devices will undergo a change, for example IVD classifications will be aligned with the International Medical Device Regulators Forum. 

A new framework for international recognition of devices that have already been approved by comparable regulators and those who hold a Medical Device Single Audit Program certificate will be introduced through the regulations. 

Requirements for exempt in-house manufactured devices and custom-made devices will be introduced. New requirements for aligning claims made by manufacturers about their medical devices with the statement of intended purpose will be introduced, as well as new requirements for clinical investigations.

In line with the MHRA’s ambitions to harmonise the UK’s approach with the EU, Cybersecurity requirements as well as any other requirements that must be met to place a medical device on the GB market will be improved and brought into alignment with the EU.

Clarity will be provided on conformity assessments, approved bodies, and economic operators, in addition to the introduction of the requirement to have a Person Qualified in Regulatory Compliance. 

Finally, in addition to the future core regulations, the UK government also intends to introduce legislation that will bring into force more robust Post-Market Surveillance requirements, reflecting the primary aim of improving patient safety as part of the future medical devices regulations.

The MHRA is demonstrating a clear intention to align the UK’s Health Tech regulations with the EU, for the benefit of patients and to ensure the UK remains at the cutting edge of medical technology. We will continue to follow the progress of the MHRA as it advances through the stages of the current roadmap outlined. 

If you would like to discuss any issues relating to the regulatory framework surrounding Health Tech in the UK, or its reform, please contact a member of our Health Tech team. 

This article was written by Katie Carter, Rory Trust and Carys Cox. 

Previous articles in our Health Tech Series:
HealthTech and AI – the current legal landscape 
Key regulatory changes for Health Tech developers 
Health Tech and Personal Data