The Software as a Medical Device (SaMD) and Artificial Intelligence as a Medical Device (AIaMD) Change Programme was first announced by the Medicines and Healthcare products Regulatory Agency (MHRA) in September 2021 to ensure a regulatory standard for software and AI are clear, and patients are safe. This builds on the comprehensive reform of the medical device regulatory framework outlined in the government’s response to the consultation on the future UK medical device regulation, whose implementation timeline was recently extended by one year to July 2024.
The proposed changes are in response to a healthcare system that is under severe strain due to competing demands on limited resources and a post-COVID backlog, as well as the need to update existing medical device regulations, given that many products entering the market today were largely conceptual or aspirational when the regulations were first drafted.
MHRA publishes the roadmap for regulation of medical software and artificial intelligence (AI) in the UK
The primary stated objective of the MHRA’s Change Programme is to protect patients and the general public while establishing the UK as a worldwide leader in responsible innovation for SaMD and AIaMD. To do this, the MHRA focuses on safety (without compromising the functionality), clarity and simplifying procedures for manufacturers, and promoting worldwide harmonisation.
As part of the changes, the MHRA wants to collaborate with other national regulators through the International Medical Device Regulators Forum (IMDRF), important domestic partners, and data protection agencies to examine the processing of personal data in depth as part of the reforms.
The original roadmap presented in 2021 had 11 work packages (WPs) showing the path forward for the MHRA and other stakeholders. However, the amended roadmap includes just eight. This results from some packages (Innovative Access, SaMD Airlock, and Mobile Health and Apps) being included in or distributed across numerous WPs.
Each WP addresses a particular purpose within the reforms and presents specific deliverables addressing each problem.
- Qualification
- Classification
- Premarket requirements
- Post-market requirements
- Cyber secure medical devices
At a high level, the AIaMD-specific work packages can be categorised as follows:
- Rigour
- Interpretability
- Adaptivity
For each work package, the roadmap describes as follows:
- The problem the package seeks to address
- The objectives that break down that problem
- The specific deliverables that meet the ambition
The focus of the Software and AI as a Medical Device change programme
The SaMD and AIaMD Change Programme focus on the following:
- The requirements for software and AI as medical devices are to ensure that these devices are acceptably safe and function as intended, protecting patients and the public.
- The regulation for manufacturers is clear, supported by guidance and streamlined software processes, and bolstered with tools to demonstrate compliance, such as the designation of standards.
- Friction is removed from the market to align with key domestic partners, eliminate duplication, and combine requirements. Internationally, the MHRA collaborates with other regulators through the International Medical Device Regulators Forum to improve international convergence and consensus on software and artificial intelligence (AI) products.
MHRA declares a 12-month extension to the implementation of the future Medical Device Regulations to bring the new regulations into force by July 2024
The MHRA has stated that it will postpone the implementation of future Medical Device Regulations, to have new regulations in place by July 2024.
The government recognises that the future Medical Device Regulations are a significant reform of the current framework. It has delayed implementing the new Medical Device Regulations by a year to support system readiness and reduce the risk of supply disruptions for UK patients. Read the full MHRA announcement here.
MHRA also updated the transitional arrangements. England, Scotland, and Wales, known as Great Britain, had planned to discontinue accepting CE-marked products on 30 June 2023 under the previously published laws. Because of the arrangements of Brexit, the situation in Northern Ireland, the other British territory, is different.
After reviewing the responses to a consultation, the government detailed its approach to transitional arrangements throughout the summer. Officials will introduce legislation in the spring of the following year to implement the transitional agreement.
The update notes, “Bringing into force the new post-market surveillance requirements ahead of the wider future regulatory regime reflects the government’s priority of improving patient safety as part of the future Medical Device Regulations.”
European Federation of Pharmaceutical Industries and Associations (EFPIA) Statement
The HTA Regulation cleared the last legislative challenge late last year, prompting the EFPIA to express “regrets that the initial objective put out by the European Commission in its original proposal has been diluted” and to warn that it might result in “an unpredictable system.” Since then, EUnetHTA21, a group of 13 HTA agencies assembled by the Commission, has produced a draught of implementation advice to support the legislation. EFPIA and the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), the trade group for smaller drug producers, have condemned the process.
“More than 400 comments submitted by various stakeholder organisations had little to no influence on the drafting of the advice, with just a few linguistic modifications made to the final published document,” the trade organisations stated. “We are concerned that the lack of thoughtfulness and openness towards the involvement of stakeholders may jeopardise not just the quality of this crucial preparatory work but also the capacity to achieve all of the HTA Regulation’s objectives.”
The concern derives from the view that the implementation process may “lose sight of the objectives of the EU HTA Regulation,” namely the desire to build a predictable and more efficient system for joint clinical evaluation. EFPIA and EUCOPE believe the objective is still achievable if “appropriate engagement between industry, patients, clinicians, and HTA agencies” is maintained throughout the process.
European Medicines Agency (EMA) Notice
The EMA has announced the outlines of a proof-of-concept initiative that will pilot the submission and analysis of raw data from clinical trials, commonly known as standardised study data.
The Committee for Medicinal Products for Human Use (CHMP) primarily evaluates information from clinical summaries and clinical study reports. According to the EMA, “these data are given in a manner that does not immediately permit disaggregation or further analysis.”
EMA expects to receive around ten applications throughout the course of the pilot’s two-year duration, which started in September last year. The pilot is available to applications for first marketing authorisation and post-authorisation in all disease categories.
Applicants may notify EMA by email of their want to participate in the trial programme. The CHMP rapporteurs will determine whether a process will be included in the programme. The studies will be conducted by CHMP rapporteurs, EMA personnel, or contractors who adhere to the same data security rules as in-house workers. CHMP’s approval of the scientific opinion will not be delayed by participation in the programme.
EFPIA, MedTech Europe, and other organisations have commented on the proposed European Health Data Space (EHDS). The 29 bodies support EHDS but urge officials to address “key aspects” in the “broad sweeping” to ensure it achieves its objective.
The seven recommendations include for EHDS to “align with all applicable horizontal and European sectoral regulations” and for “harmonised interpretation and implementation of the Regulation across the EU.” According to the organisations, compliance with the Clinical Trial Regulation, Medical Devices Regulation, and In Vitro Diagnostic Regulation is “a must.”
The emphasis on harmonised interpretation and implementation across the EU reflects a concern that, in the absence of “clearer definitions of the data in scope,” the initiative may result in “27 fundamentally separate data spaces,” one for each member state. EFPIA and its cosignatories demand legal and ethical requirements for allowing the use of pseudonymised data and linking data to be set at the EU level.
Other recommendations address the need for a broad range of stakeholders to be “strongly involved” from the beginning of the process, the significance of clearly defining the scope of electronic health record systems, and the value of leveraging existing health data infrastructures to “allow continuity and utilise expertise.”
Transitional arrangements
The most challenging issue for manufacturers is the implementation of transition periods:
Transitional arrangements for UKCA-marked devices until July 2023: This transitional arrangement for medical devices will permit products to be placed on the market for at least three years or until the certificate expires, whichever comes first.
Transitional arrangements for CE-marked medical devices under the EU Medical Devices Regulation (MDR 2017/745): This transitional arrangement for medical devices will permit products to be placed on the market at the very least until the certificate expires or until five years after the new regulations will take effect, whichever comes first.
Transitional arrangements apply to devices that have valid CE certificates issued under the EU Medical Devices Directive (MDD 93/42/EEC & AIMD 90/385/EEC): This transitional arrangement for medical devices will allow products to be put on the market at the very least until the certificate expires or for three years and after the new regulations go into effect, whichever comes first.
Two (2) conditions will apply to all three (3) transitional arrangements, which are somewhat matched with Article 120 of the EU MDR:
- These requirements do not apply to devices with significant design or intended use modifications; and
- All products covered by the agreements must comply with all post-market requirements relevant to the new regulatory framework.
Other key timelines include:
- Draft of UK MDR to be published and open for consultation – 2023.
- UK MDR submitted to Parliament – 2023.
- The new UK MDR enters into force – on 1 July 2024
- Transitional arrangements for adherence to the future UK MDR for currently CE- and UKCA-marked devices – July 2024 to July 2029
What does it mean for medical device manufacturers?
- Until 30 June 2024, CE-marked devices will be permitted on the British market.
- The necessity to get a UK CA marking and the introduction of the new UK MDR have been postponed until 1 July 2024 for new devices, with further transitional provisions available for CE-marked or UKCA-marked devices.
- Manufacturers must comply with revised post-market restrictions, which started in July 2023. (a year before the rest of the new UK MDR).
- After July 2024, devices subject to major changes in design and intended purpose will no longer be eligible for the transitional arrangement and will be required to conform with the new UK MDR.
The UK Government and the MHRA have developed a new set of rules that are currently based on the standard of the EU MDR 2017/745 with differences in particular areas with enhanced requirements and to take into consideration local needs. However, the changes for manufacturers with CE certification are not as extensive as first anticipated. There are also new and intriguing concepts, notably about innovative products and SaMD, that may be expanded upon in the future.
Significant changes brought about by these new regulations require that regulatory leaders take proactive action on multiple activities and implementation choices. The update affects all aspects of a business, including supply chain arrangements, regulatory resources, and processes.
Law Notion can help support companies with these new challenges. We have extensive experience assisting the Regulation Team in MedTech companies with compliance obligations and bringing clarity and focus to the UK’s regulatory system of those affected by any new policies introduced.