The UK unveils a new roadmap for medical device regulations.
The UK government has announced a new plan to develop a robust and innovative regulatory framework for medical devices to enhance patient safety and access to cutting-edge technologies.
The Medicines and Healthcare products Regulatory Agency (MHRA) published a roadmap on Tuesday (09/01/2024), outlining the steps to implement new regulations for medical devices, including artificial intelligence, software, and diagnostics. The roadmap sets out a timeline for introducing new Statutory Instruments (SIs) that will replace the current UK Medical Devices Regulation 2002.
According to the MHRA, the new regulations will put patient safety first and help ensure patients continue to have access without delay to the devices they need, while fostering a world-leading environment for medical technology innovators. The new framework will also align with international standards and best practices, with more patient-centred and proportionate requirements responsive to technological advances.
The roadmap indicates that priority measures to protect patient safety will be implemented this year, with core elements of the new framework intended to be in place by 2025. The MHRA said it will work closely with stakeholders, including patients, industry, and healthcare professionals, to provide guidance and feedback.
The announcement was welcomed by several industry associations, such as the Association of British HealthTech Industries (ABHI), the British In Vitro Diagnostics Association (BIVDA), and the UK Med Tech Forum. They praised the MHRA’s approach as a positive step towards ensuring safe and effective health technologies for patients and driving innovation and growth in the UK medical device sector.
The entire Roadmap can be found by clicking here.
The roadmap highlights the following action points for 2024-25:
- Publish IVD roadmap: The MHRA will publish a roadmap for In Vitro Diagnostics (IVD) regulation, which will cover the scope, classification, essential requirements, conformity assessments, and transitional arrangements for IVD devices.
- Future core regulations: The MHRA will draft and publish the legal text for the future core regulations, which will define the general principles and requirements for medical devices, such as labelling, quality management, clinical investigations, and post-market surveillance. The MHRA will also consult with stakeholders and seek international recognition for the future core regulations.
- PMS regulations: The MHRA will lay in Parliament and enforce the post-market surveillance (PMS) regulations, which will specify the obligations and responsibilities of manufacturers, importers, distributors, and users for monitoring and reporting the safety and performance of medical devices. The MHRA will also publish guidance and hold webinars on PMS regulations.
- SaMD and AI guidance: The MHRA will publish several guidance documents on Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD), covering topics such as intended purpose, data-driven research and development, machine learning practice, and change control plans. The MHRA will also launch an AI Airlock regulatory sandbox to test and evaluate AIaMD solutions.
According to certain experts, Start-Up MedTech companies should focus on the following:
- Understand the new regulations: Familiarise yourself with the new regulatory framework for medical devices in the UK1. This includes understanding the definitions of medical devices, the types of medical devices, and their associated parts in the UK Medical Devices Regulations 2002.
- Prepare for priority measures: The MHRA plans to introduce some priority measures this year, such as strengthening the post-market surveillance system, establishing a UK database for medical devices, and implementing new rules for software and AI products. Start-ups should prepare to comply with these measures.
- Plan for core elements: The MHRA aims to have the core elements of the new framework in place by 2025. These include a new risk-based classification system, a UK conformity assessment process, and a UK-notified body system. Start-ups should plan their product development and launch timelines accordingly.
- Align with international standards: The MHRA intends to align the new framework with international standards and best practices. If your company operates in multiple markets, consider aligning your products and processes with international standards, such as ISO 13485, to streamline compliance efforts across borders.
- Continuous Training: Provide ongoing training and education to your employees, ensuring they understand and comply with regulations.
- Engage with UK-approved bodies: A UK-approved body ensures manufacturers comply with the regulations, including reviewing clinical and scientific data, manufacturing processes, and the quality management system. Engaging with these bodies can help ensure compliance. Seek regulatory support for categorising your product in the correct risk classification, as certain devices do not need engagement with a UK-approved body.
While startups have the advantage of starting their regulatory journey from scratch, SMEs would have to pay more attention and focus on the following points:
- Understand the New Regulations: Familiarise yourself with the new regulatory framework for medical devices in the UK. This includes understanding the definitions of medical devices, the types of medical devices, and their associated parts in the UK Medical Devices Regulations 2002.
- Prepare for Priority Measures: The MHRA plans to introduce some priority measures this year, such as strengthening the post-market surveillance system, establishing a UK database for medical devices, and implementing new rules for software and AI products. SMEs should prepare to comply with these measures for existing products.
- Plan for Core Elements by 2025: The MHRA aims to have the core elements of the new framework in place by 2025. These include a new risk-based classification system, a UK conformity assessment process, and a UK-notified body system. SMEs should plan their product development and launch timelines accordingly.
- Align with International Standards: The MHRA intends to align the new framework with international standards and best practices. If your company operates in multiple markets, consider aligning your products and processes with international standards, such as ISO 13485, to streamline compliance efforts across borders.
- Leverage Available Support: A new £7 million Health Technology Regulatory and Innovation Programme, funded by Innovate UK, has been announced. This joint initiative with ABHI will help small and medium-sized health tech companies navigate health tech regulatory processes. This funding and support programme will help HealthTech SMEs access regulatory assistance and knowledge for medical technology and in-vitro diagnostics.
While the government is overhauling these regulations for all MedTech manufacturers, AI, ML, SaMD and SiMD-related companies should have an additional focus on the following points:
- Patient safety first: The new regulations aim to put patient safety at the forefront of medical device regulation and require manufacturers to demonstrate the safety and performance of their products, especially for high-risk devices such as AI and software.
- Innovation and access: The new regulations also seek to foster innovation and enable timely access to new and beneficial medical technologies for UK patients by providing a more flexible and proportionate regulatory framework responsive to technological advances.
- International harmonisation: The new regulations will align with the international standards and best practices for medical device regulation and facilitate the global trade and recognition of UK medical devices, especially in the post-Brexit context.
- Stakeholder engagement: The new regulations will be developed and implemented through a collaborative and transparent process involving various stakeholders such as patients, healthcare professionals, industry, academia, and regulators. The MHRA will provide guidance and support to help stakeholders comply with the new requirements and benefit from the new opportunities.
Along with the roadmap, the UK MedTech industry should focus on Implementation of the Future Regulations which highlights:
- Implementation of the future regulations: The UK government plans to introduce new regulations for medical devices that prioritise patient safety, access, and innovation. The regulations will be delivered through four Statutory Instruments, with priority measures to enhance post-market surveillance in 2024 and core elements of the new framework in 2025.
- Transitional arrangements: The UK government has extended the acceptance of CE-marked medical devices on the Great Britain market until 2028 or 2030, depending on the type and class of the device. This will ease the transition to the future regulatory framework and ensure the supply of medical devices to Great Britain. More information on the extensions can be found on the infographic released by the MHRA by clicking here.
- Post-Market Surveillance requirements: The UK government intends to introduce legislation in 2024 that will strengthen the post-market surveillance requirements for medical devices in Great Britain, ahead of the wider future regime. This will include more stringent reporting obligations, periodic reviews, and harmonisation of methods for collecting data.
- Future core regulations: The UK government intends to introduce legislation in 2025 to implement the core elements of the future regulatory framework for medical devices in Great Britain. This will include several improvements for implantable medical devices, unique device identifiers, classification changes, quality management systems, technical documentation, international recognition, exempt and custom-made devices, claims, clinical investigations, essential requirements, conformity assessments, and economic operators.
- Updates to guidance: The UK government is working with stakeholders to support the effective implementation of the new regulations. The regulatory changes will be accompanied by guidance to help the MedTech sector interpret the new requirements.
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