New roadmap sets out U.K. device regulation timelines
To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. Stakeholders need to be prepared to incorporate the new requirements into their systems, though the regulator does promise there will be a transition period, similar to what the E.U. has done.
Quick background on the status of U.K. medical device regulations
- How MHRA regulates devices: The Medicines and Healthcare products Regulatory Agency (MHRA) oversees devices in the U.K., both pre- and post-market. In addition to the current device regulations, it offers assistance and guidance on a variety of medical device topics, including custom-made devices, exportation, vigilance, off-label use, software apps, virtual manufacturing, clinical investigations, and how to register devices with the agency. MHRA also provides step-by-step instructions on ensuring sponsors’ devices comply with all U.K. legal requirements. Guidance issued by the organization has covered many Covid-19-specific matters, plus electronic instructions for use, IVDs, compliance and enforcement, and other topics. It also oversees device recalls and reportable adverse events.
- MHRA has been in the process of remaking itself, driven by several factors. Brexit, of course, is one, since the regulator is no longer part of the European regulatory group. The second is an independent review published in 2020 on device safety issues, “First Do No Harm,” that drove enactment of the Medicines and Medical Devices Act 2021, which gave the Secretary of State for Health wide-ranging powers to create a new framework for devices and medicines while maintaining the attractiveness of the U.K. as a center of device innovation. MHRA responded with a plan to update life sciences regulation, “The Medicines and Healthcare products Regulatory Agency Delivery Plan 2021 – 2023,” a big part of which focused on patient engagement.
- The regulator is also responding to a Regulatory Horizons Council report on medical devices, in which MHRA received 11 recommendations in five topic areas. Device advice centered around alternative routes to market for devices already approved by other trusted regulators, addressing bottlenecks in device approvals and U.K. Approved Body capacity, and developing a new patient safety database that includes patient wellbeing.
- In partial response, MHRA in 2021 launched a proposal for a new medical device regulation that would tackle similar topics as the European Medical Device Regulation (MDR) but also offer unique solutions, such as use of Global Medical Device Nomenclature (GMDN), fewer conformity assessment routes, and including environmental impacts. Other recommendations from the Horizon Council included a domestic assurance route to approval for devices that would make use of approvals from other countries, and incorporating recognition of the Medical Device Single Audit Program (MDSAP), currently recognized in the U.S., Canada, Japan, Brazil and Australia. The regulator is also working on an Innovative Device Access Pathway (IDAP) that mirrors the pathway already in place for drugs (the Innovative Licensing Access Pathway, or ILAP). [Read AgencyIQ’s complete history and analysis of the lead-up to the proposed medical device regulations here.]
- The regulator planned to release the regulations in three parts – the CE recognition extension, a post-market surveillance regulation, and then the rest of the device and IVD regulation. The first, the Medical Devices (Amendment) (Great Britain) Regulations 2023, published in June, extended recognition of the E.U. CE mark, both in recognition of the extended MDR transition timeline and to give U.K. regulators time to publish and implement their own regulations. The second would provide new post-market requirements, and the third will be the main regulation describing requirements for medical devices (including IVD medical devices) on the Great Britain market (Northern Ireland is following the E.U. MDR and IVDR and has special accommodations – and rules).
- A new pilot program would add special pathways for innovative devices. Ultimately, the pilot will carve out a program for joint scientific advice on an innovative device’s clinical program and quality management system and provide end-to-end assistance for developers of innovative devices addressing unmet needs, including reimbursement, via the development and execution of a specific target development profile (TDP).
- The regulator initially planned to release the regulations in mid-2023 but has announced two delays so far, one in October 2022 and a second one-year extension in May 2023. The current target is July 2025 for the core elements of the device regulation to come into force. Initially, the regulator hoped to introduce the Post-Market Surveillance (PMS) legislation in summer 2023 after mandatory review by the World Trade Organization, according to an MHRA webinar on the proposed regulations in January 2023. The WTO did see the proposed PMS legislation at the end of July 2023, with the 60-day review ending on September 24, 2023, and the government at that point planned to lay the legislation in the winter (the WTO notice specified December 2023), with the PMS legislation coming into force in mid-2024.
This week, MHRA announced a new roadmap and timeline for the new regulations, spelling out completed actions and those planned for 2024 and 2025
- According to the press release, “a clear path ahead has been set out for the development of new and robust regulations for medical devices in the UK. The new regulations will put patient safety first and help to ensure that patients continue to have access without delay to the devices they need, whilst enhancing the UK’s position as a world-leading environment for medical technology innovators.” The roadmap sets out a series of new statutory instruments, with priority measures going into place this year and core elements in place by 2025, and designed to “offer greater international harmonisation.”
- Completed actions include a 2021 public consultation on the proposed regulations and the regulator’s response to the public feedback. The instrument extending recognition of the CE mark came out mid-2023, along with designation of three new U.K. Approved Bodies, nearly doubling capacity. In 2022, the regulator published a roadmap for software as a medical device (SaMD) and guidance on reporting adverse events and creating a robust intended purpose for SaMD. MHRA also offered a predetermined change control plan guidance for SaMD developers. As discussed above, 2023 also saw the launch of the pilot for IDAP.
- Behind the scenes, the regulator moved forward on PMS and future device and IVD regulations. Stakeholder focus groups commented on the proposed PMS regulation, which then went before the WTO for review in mid-2023. Stakeholders also discussed the future core regulations and how IVDs will be regulated in Northern Ireland; regulations for IVDs in that country were laid before Parliament at the end of 2023.
The future items promised in 2024 and 2025
- The “core” regulations are a big focus this year. Early this year, the British regulator is planning stakeholder discussions on international recognition (the “domestic assurance” route), followed shortly by stakeholder discussions on scope and classification, labeling and instructions, essential requirements and exempted devices. In mid-2024, MHRA will talk with stakeholders on clinical investigations, the responsibilities of economic operators, quality management systems, qualified persons and conformity assessments. Toward the fall, stakeholder discussions will focus on unique device identification (UDI), implantable devices and the transition period for the proposed regulation. Finally, the regulator plans to have the draft legal text to the WTO for review late in 2024.
- MHRA has updated its webpage on the future device regulations. These regulations would upclassify implantable devices and require implant cards for patients, outline UDI requirements, and “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.” It also promises to bolster clinical investigation requirements, introduce new requirements for devices made in-house and custom-made devices, and better align the U.K. device essential requirements with the European general safety and performance requirements (MDR and IVDR Annex I). The new regulations intend to introduce a requirement for a Person Qualified in Regulatory Compliance, similar to the PRRC in Europe (Person Responsible for Regulatory Compliance).
- IVDs will get their own roadmap early in 2024, followed shortly by Northern Ireland-only IVD regulations.
- 2024 will see a lot of action in the post-market surveillance space. Just after MHRA engages stakeholders on possible PMS guidance via focus groups, it plans to put the PMS regulations before Parliament in early to mid-2024 and hold a public webinar on the topic soon thereafter.
- Developers of artificial intelligence solution should see the AI Airlock regulatory sandbox by Q2 2024. AgencyIQ took a look at the proposed sandbox a few months ago, when the government announced the airlock and funding of 21 million pounds to “roll out AI tools to speed up the diagnosis and treatment of lung cancer.” The intention was to offer a collaboration space for regulators, developers, U.K. Approved Bodies, the government and the National Health Service (NHS) for products that might be difficult to assess with traditional clinical trial models. Regulators hope to ensure early access while maintaining robust safety protocols.
- Potential enhancements to the future regulations will open for public consultation late in the 2024 calendar year, though little is known at this point what those might be,
- Promised guidance documents focus largely on software, with guidance forthcoming around good machine learning practice during medical device development and best practices for AI as a Medical Device (AIaMD). MHRA also wants to release another SaMD guidance document, this time on data-driven research, development and governance.
- The core regulation should be laid in Parliament early in 2025 and come into force soon thereafter, within the same calendar year.
- After a quiet few months, MHRA has now released concrete plans for its future device and IVD regulations. The roadmap lays out a high-level view of both planned statutory instruments (PMS, core regulation) and promised guidance documents, largely around SaMD and AI. The regulator is also planning a regulatory sandbox for AI-enabled devices.
- The new roadmap promises the core device regulations in 2025. As mentioned above, initially the regulator hoped for the regulations to come into force in mid-2023 but a number of factors lead to delay, likely much of it focused on the challenges encountered in implementation of the European device regulations and the impact those challenges have had on innovation. The British regulator is no doubt trying to learn from the rollout of the European MDR and avoid some of the sticky situations encountered by the European Commission.
- We’re still waiting on the PMS portion of the regulation. After the extension to recognition of the European CE mark in June 2023, we were hoping to see at least a draft of the PMS regulation for public feedback by December 2023. But there’s still time to meet the “winter” deadline and we did get a sneak peek at the regulation when it underwent WTO review.
- Stakeholders need to be prepared to incorporate the new U.K. regulations into their quality management systems, but at least the PMS legislation will be released ahead of the core legislation, giving manufacturers time to incorporate both parts of the regulation over time. But first, stakeholders should have the opportunity to give feedback on both regulations; AgencyIQ will let you know when that happens.
Key Documents and Dates
- Press release: Regulatory Roadmap points the way ahead for new measures to support safe access to medical technology including AI and diagnostics, published January 9, 2024.
- Document link: Roadmap towards the future regulatory framework for medical devices, posted January 9, 2024.