Currently, the UK MDR is based on the old EU directives, most notably the MDD, IVDD and AIMD. Although they were sufficient for the time, these legislations are becoming increasingly outdated with the advancement in medical technologies. Due to this, the MHRA intends to layout a new regulation that will be closer aligned to the MDR and IVDR for the regulation of medical devices.
In early January, the MHRA published its plan moving forward for the regulation of medical devices in the form of a roadmap. The roadmap details the steps that the agency will take over the next year.
The MHRA has stated that the aim of this regulatory framework is to “put patient safety first and help to ensure that patients continue to have access without delay to the devices they need, while enhancing the UK’s position as a world-leading environment for medical technology innovators.”
At first glance, it is clear that the roadmap shows the intent of the agency to run stakeholder discussions on the future core regulations in the first half of 2024. The aims of these discussions will be to:
- Introduce several improvements for implantable medical devices; up-classifying them which will result in more stringent pre and post market requirements and requiring manufacturers to provide implant cards to enable patients to know which device they have had implanted.
- Ensure devices have a unique device identifier (UDI).
- Change the classification of several types of devices, specifically increasing the class of 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, enabling swifter access for devices already approved by comparable regulators as well as for those who have Medical Device Single Audit Program (MDSAP) certificates.
- Include new requirements for exempt in-house manufactured devices and custom-made devices.
- 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.
- Bring the essential requirements for medical devices being placed on the market in GB into greater alignment with those of the EU. This will include cybersecurity requirements for software as a medical device including for artificial intelligence.
- Clarify the requirements for conformity assessments and approved bodies.
- Clarify the requirements for economic operators; manufacturers, importers and distributors, and introduce a requirement to have a Person Qualified in Regulatory Compliance.
It is also worth noting that in this published roadmap, there is an increased focus on the development of regulations for SaMD products and AI. This growing focus on AI can also be seen in the EU with the recently published AI Act. The roadmap shows that the agency is planning on publishing 3 guidance documents pertaining to SaMD in 2024, these being:
- Good machine learning practice for medical device development mapping
- AI as a Medical Device (AIaMD) development and deployment best practice
- Data-driven SaMD research, development and governance
In addition to the above-mentioned guidance documents, to further support the development of AI, the MHRA is planning to launch a virtual platform where AI developers can generate data for their products. This has been named the AI-Airlock project, known as the regulatory sandbox.
The roadmap also shows the intention by the agency to introduce legislation that will bring into force strengthened Post-Market Surveillance Requirements in Great Britain, reflecting the government’s policy of improving patient safety.
The current timing of the new legislation is as follows:
- First half of 2024: Stakeholder discussions on the future core regulations
- End of 2024: Draft legal text published by World Trade Organization
- 2025: Future core regulations laid in Parliament
- 2025: Future core regulations in force
More information on the AI Airlock project can be found using the following link
The Roadmap published by the MHRA can be accessed using the following link
