Previously, we talked about how the EU regulates Software as Medical Device (SaMD), including AI-based software. Given that UK is no longer in EU since Brexit, in this blog post we will take a deeper look at this specific market.
Until Brexit, the UK’s regulatory framework for healthcare products was governed by the directives of the European Commission. However, after the referendum took place and the decision to leave became clear in 2017, the UK government began to take necessary measures for independent medical device market surveillance as well as decision making over the marketing and supply of devices in the UK.
The Medicines and Healthcare products Regulatory Agency (MHRA) has transitioned to become the sole medical device regulatory authority in the UK. It should be noted here that when it comes to placing a device on the UK market, Northern Ireland continues to be governed by the European regulatory framework as a result of the Northern Ireland Protocol. Although the UKCA (UK Conformity Assessed) marking is available for use in Great Britain (England, Wales and Scotland), a CE marking is needed for devices placed on the Northern Ireland market and EU rules have to be met.
Nevertheless, since 2014, the MHRA had published guidance on when software applications are considered as a medical device and how they are regulated to assist manufacturers of software apps qualify and classify their products when considering commercialization in the UK. This guidance has since been updated a few times to reflect the current status of regulations governing the UK.
In 2019, the Regulatory Horizons Council (RHC) was first established by the UK government. This is a committee of experts providing the government guidance on regulatory reform and ensuring a smooth transition into a new system.
Since 01 Jan 2021, devices are regulated in Great Britain under the Medical Devices Regulations 2002 (UK MDR 2002, as amended) which gave effect in UK law to the previous EU directives listed below:
- Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
- Directive 93/42/EEC on medical devices (EU MDD)
- Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
All medical devices must be registered with the MHRA before being placed on the Great Britain market. In parallel, medical device manufacturers based outside the UK, wishing to place a device on the GB market, need to appoint a single UK Responsible Person for all their devices, who will act on their behalf to carry out specified tasks, such as registration.
The UKCA marking is a UK product marking used for certain goods, including medical devices, being placed on the Great Britain market. Manufacturers of medical devices were initially allowed to use either the UKCA marking or the CE marking on devices they placed on the GB market until 30 June 2023. This deadline has been extended and there is an opportunity to utilize CE marking as a way to enter the UK market latest until the 30th of June 2030. Specific information about applicable deadlines depending on classification or MDD/IVDD vs MDR/IVDR CE marking can be found within the infographic of the timelines for placement of CE marked medical devices on the GB market under the Medical Devices (Amendment) (Great Britain) Regulations 2023.
Where third party conformity assessment is required for UKCA, a UK Approved Body (UKAB) is needed. The UK approved bodies for medical devices list serves as the UK’s database of conformity assessment bodies. Manufacturers of non-sterile and non-measuring Class I devices and general IVDs can self-certify against the UKCA marking.
In 2021, the MHRA also published the guidance “Software and AI as a Medical Device Change Programme” as a step in the reform of medical devices so that software, including AI, is correctly regulated. It is a key document in establishing clear guidelines for software and AI regulation. This programme builds on the reforms aimed at general medical devices.
Earlier in the same year, the RHC had submitted a focused report on medical devices, which explored several topics including, the transition and consequences of converting the EU CE mark into the new UKCA mark, and the options for integrating current internationally marketed medical devices into the UK system. The government responded to this report with many recommendations accepted or accepted in principle with a rationale. In addition to this response, the government also responded to the public consultation on the future regulation of medical devices in the United Kingdom, where it highlighted the importance to align medical device regulations with other existing frameworks, such the EU Medical Devices Regulation (MDR) 2017/745 with its General Safety and Performance Requirements (GSPR), as well as the International Medical Device Regulators Forum (IMDRF) frameworks. But they also expressed the need to go further, providing more precise definitions, guidelines, and legislations. This is in the aim to build a regulatory framework built on 5 pillars:
- Strengthening MHRA power to act to keep patients safe.
- Making the UK a focus for innovation, the best place to develop and introduce innovative medical devices.
- Addressing health inequalities and mitigating biases throughout medical device product lifecycles.
- Proportionate regulation which supports businesses through access routes that build on synergies with both EU and wider global standards.
- Setting world leading standards – Building the UKCA mark as a global exemplar.
The government communicated the importance of creating specific guidelines aimed at software as a medical device, whether standalone software or integrated into hardware. Therefore, a definition of Software in the UK medical devices regulations was proposed, “a set of instructions that processes input data and creates output data,” which is in line with the EU definition in previous (MEDDEV 2.1/6) as well as current (MDGC 2019-11) guidance documents.
Moreover, the IMDRF SaMD classification rules would be added for general medical devices (not IVDs) in the UK; IVDs have been excluded at this stage because this significantly diverges from the EU IVDR classification system and would therefore not be in line with the approach being taken around close alignment with other jurisdictions and international harmonization. There was also interest shown in introducing a temporary classification to SaMD when the risk profile is not clear, under an ‘airlock classification rule,’ or the option to establish a similar process to FDA’s De Novo pathway. The thinking behind those approached is to maintain costs low and help accelerate innovation but in a safe and controlled way.
AI as a medical device (AIaMD) is considered as a subset of software and can be regulated under the same requirements as SaMD. To further explore the outcome of the report, see Consultation on the future regulation of medical devices in the UK.
In the meantime, the “Software and AI as a Medical Device Change Programme” has also been updated to include a set of objectives, required deliverables and additional information on implementation. This update covers the 8 main work packages in the programme, each addressing a challenge, and which can be sub-categorized into specific points. The work package topics are listed in the table below, but the details of the objectives and deliverables can be further explored on the MHRA website. Since this list was first released, good progress has been observed on several fronts, nevertheless manufacturers and developers are keen to see the finer details available to them before they further invest into the UK market.
|
Work Package # and Title |
Work Package Scope |
Progress examples |
| WP1 Qualification | provide clarity and qualification definition of what is a SaMD | Medical devices: software applications (apps) – further changes expected
Crafting an intended purpose in the context of Software as a Medical Device (SaMD) |
| WP2 Classification | ensure software classification is proportionate to the risk it might pose to patient and public safety | MHRA to launch the AI-Airlock, a new regulatory sandbox for AI developers |
| WP3 Premarket Requirements | define a clear set of criteria for software that facilitates market approval, bearing in mind both manufacturers and the public | Manufacturers may need to carry out a clinical investigation as part of the process to obtain a UKCA / CE / CE UKNI marking for their medical device and may need to inform the MHRA of this. To enable manufacturers to decide if they are required to submit a formal clinical investigation, the linked flowchart can be used. |
| WP4 Post Market | ensure proper market surveillance is done by manufacturers, by efficiently detecting risk signals and provide clear change management requirements for SaMD | Reporting adverse incidents involving Software as a Medical Device under the vigilance system |
| WP5 Cyber Secure Medical Devices | explore cyber security issues and challenges that may arise, and the protection options | |
| WP9 on AI Rigor | ensure the safety and correct function of artificial intelligence as a medical device, including technical methods to test it | Good Machine Learning Practice for Medical Device Development: Guiding Principles |
| WP10 AI Interpretability | explore the impact of human interpretability and its effect on safety and proper function of AI as a medical device | |
| WP11 AI Adaptivity | define streamlined process and requirements for the notification and management of AIaMD | Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles |
Thankfully, early in January 2024, MHRA also released its roadmap towards the future regulatory framework for medical devices, which provides an update on the intended timelines to implement the future core regulations, currently expected to come into force in July 2025; strengthened Post-Market Surveillance requirements (PMS) expected to be applicable towards the end of 2024, ahead of the wider future regulatory regime.
Finally, at the beginning of 2023, the National Institute for Health and Care excellence (NICE), in collaboration with the Care Quality Commission (CQC), the Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) released a public beta version of the Artificial intelligence (AI) and digital regulations service. The aim of this service is to help innovators know what regulations they need to meet and when, and to help health and social care professionals feel confident in using AI and data-driven technologies in health and care. Guidance is provided on each stage of the Health Technology Assessment (HTA) pathway for AI and digital technologies, and regular updates will be made to account for new developments in this area. The adopter pathway was also made available later in 2023.
Published on: February 26, 2024
