The current regulatory framework for medical devices in Great Britain is the UK MDR. Since Brexit came into effect in January 2021, the EU legislation no longer applies Great Britain (England, Wales, and Scotland). The EU legislation still applies in Northern Ireland due to the agreements between Ireland, which is part of the EU, and Northern Ireland, part of the United Kingdom. To avoid a sudden shortage of medical devices, the UK government extended the acceptance of CE marked medical devices up until 2028 or 2030, depending on the class. However, in addition to this, the country intends to introduce new regulations for medical devices, expected to be in place in 2025.
MHRA roadmap towards new regulations
In January 2024, the MHRA (Medicines & Healthcare products Regulatory Agency) updated the roadmap towards the future regulatory framework for medical devices. Following significant steps taken in 2023, the UK plans essential developments in 2024 which might lead to the future regulations entering into force in 2025.
Future core regulations developments in 2024
In the first half of 2024, the MHRA plans stakeholders’ discussions on the future core regulations to collect details in the policy. During the year, the planned actions will address the following topics:
- Up-classification of medical devices
- Introduction of a unique device identifier (UDI)
- Enhanced requirements for quality management systems and technical documentation
- Introduce a framework for international recognition
- Provisions for exempt in-house manufactured devices and custom-made devices
- Requirements for claims
- Provisions for clinical investigations
- Align essential requirements with the EU legislation on medical devices
- Clarification on requirements for conformity assessments, approved bodies, and economic operators
Post-market surveillance requirements
In July 2023, the World Trade Organisation (WTO) published a notification of the draft Post-market Surveillance Requirements Statutory Instrument (PMS SI). The draft includes details part of PMS system, serious incident reporting obligations, and provisions for manufacturers to conduct periodic reviews of their PMS data. Following the comments’ closure in September 2023, the UK expects the PMS statutory instrument (SI) to be laid in the first half of 2024 and published around the end of the year. The MHRA is also planning to publish an accompanying guidance on the topic.
AI and good machine learning practice
In October 2023, the MHRA announced the AI-Airlock sandbox, a regulator-monitored virtual area for developers of AI medical devices, planned to be launched in 2024. Through this virtual testing environment, developers of AI medical devices will be able to navigate the regulatory requirements for software and AI medical devices. In addition, stakeholders can expect the publication of three important SaMD guidance documents: Software as a Medical Device, Good machine learning practice for medical device development mapping, AI as a Medical Device (AIaMD) development and deployment best practice, and Data-driven SaMD research, development and governance.
Next steps in the new regulations implementation
For IVDs manufacturers, the implementation for their regulatory framework could arrive in the first half of 2024. By the end of the year, the government plans a public consultation on the future regulations. The Parliament should negotiate the text already in 2025, with its entering into force programmed for the same year.
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Obelis is a well-known company in the regulatory sector, offering representative and consultancy services for 35 years. We are the ideal regulatory partner for you: our team will be at your side during the whole compliance process, ensuring that your cosmetic products can enter the UK market without any issues.
Check our cosmetic services and contact us for further information on how we can support your business.
Simona Varrella
Regulatory Intelligence & Innovation Department
26/01/2024
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The information contained on Obelis UK is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.