This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2024 from the United Kingdom and European Union.
Regulatory and legislative reform is on the horizon in both the UK and in the EU, which will impact software and artificial intelligence (AI) medical devices. The UK government recently published the new medical devices post-market surveillance rules, which could be in place by summer 2025. Further, the Medicines and Healthcare products Regulatory Agency's (MHRA) priorities until spring 2025 are focused on the draft pre-market rules for devices, the in vitro diagnostics (IVD) roadmap, and guidance on AI development and deployment. In the EU, industry should watch the potential upcoming reform of the Medical Devices and In-Vitro Medical Devices Regulations, with increasingly urgent calls for reform from key stakeholders gaining traction with the institutions.
Regulatory Updates
New Post-Market Surveillance (PMS) Legislation Could Be Introduced in the UK by Summer 2025. On October 21, 2024, the UK government laid before Parliament the draft statutory instrument setting out proposed new PMS requirements for medical devices in Great Britain. The amendments will bring PMS requirements in Great Britain broadly into alignment with those in the EU Medical Devices Regulation 2017/745 (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). Further, the new PMS requirements will apply to all medical devices placed on the market in Great Britain, including devices CE marked under the EU regimes and made available in Great Britain under transitional arrangements. Read more in our Blog post.
MHRA Sets Out Key Points To Expect From Its
Regulatory Reforms to Medical Devices in 2024 and
2025. In a recent blog post, the MHRA sets out its
priorities for the reform of the rules for medical devices over the
next year. The industry can expect an early draft of the pre-market
legislation by the end of the year, and the full text by spring
2025. In addition, the MHRA expects to publish draft guidance on AI
development and deployment, as well as a revised IVD roadmap by
spring. The MHRA also reminds readers about the transition
timelines that will be included in the regulations that are being
developed, noting that next year will not be a regulatory
"cliff edge."
European Parliament Calls on the European Commission To
Revise the MDR and IVDR. On October 23, 2024, the European
Parliament adopted a resolution on the urgent need to revise the
MDR and IVDR. Given implementation difficulties, delays, and lack
of harmonization across the EU, the Parliament calls on the
European Commission and notified bodies to take various actions to
ensure advances in digital health, AI diagnostics, and personalized
medicine. However, as the Parliament cannot initiate amendments to
the MDR or IVDR itself, we will need to wait for the European
Commission's response before the full impact of this resolution
is known. You can read more in our Blog post.
EFPIA Recommendations on Use of AI in Medicines
Lifecycle. The European Federation of Pharmaceutical
Industries and Associations (EFPIA) published its position on the
use of AI in the medicinal product lifecycle, and proposed six
recommendations: (1) leveraging EU regulations and guidance for AI
in medicines; (2) entrusting the European Medicines Agency (EMA)
with the regulatory oversight of AI in medicine development; (3)
clarifying EMA's risk-based approach to AI within the
regulatory framework; (4) having AI policies that balance
transparency and innovation protection when sharing AI models and
datasets; (5) aligning global regulatory approaches through
collaboration to foster safe innovation; and (6) building trust and
capabilities in AI use through collaboration with industry,
regulators, patients, and stakeholders. These recommendations were
published shortly after the EMA reflection paper on the use of AI,
which you can read about in our Blog post.
A UK National Quantum Facility Has Opened to Further
Research in AI and Health Care. The newly opened National Quantum Computing Centre will house
state-of-the-art quantum computers that will be harnessed to fuel
advancements in areas such as AI, drug discovery, energy, and
climate prediction, and help cement the UK's position as a
global leader in quantum technology.
Reimbursement Updates
UK National Institute for Health and Care
Excellence (NICE) Consults on Recommendations for Four Different AI
Tools for Examination of X-Rays. Missed fractures are
one of the most common errors in the emergency department. The hope
is that using AI, along with the assessment of a health care
professional, will reduce the number of undetected fractures at
initial presentation and promote an equal standard of care across
the country. Clinical evidence suggests that the AI technologies
may improve fracture detection on X-rays in urgent care, compared
with a professional reviewing on their own, without increasing the
risk of incorrect diagnoses. NICE has issued draft guidance for
consultation recommending the use of four AI technologies to help
professionals detect fractures in urgent care settings.
NICE Recommends Remote-Monitoring Technologies
Shown To Reduce Hospitalizations by Half. The new
technologies can detect signs of heart failure by monitoring
individuals' general activity, heart rate variability, and
heart sounds. Data can be sent in real time to hospital staff who
can provide care over the phone and determine if hospitalization is
required.
Privacy Updates
ICO Publishes Report on the Use of Personal Data
in Quantum Technologies. Quantum technology is a broad
term for a range of technologies that deploy principles of quantum
mechanics in computing, sensing, timing, and imaging, among others.
Future uses of quantum technologies within medicine are being
explored by researchers, such as simulating novel chemicals and
complex modelling in the context of drug discovery and personalized
medicine. The Information Commissioner's Office (ICO) report
considers the impact of these technologies on personal data, and
individuals' privacy and information rights. It calls for
responsible innovation and for the early consideration of privacy
and data protection implications.
Data Use and Access Bill Laid Before UK
Parliament. The new bill aims to enhance data access
in order to support economic growth. Among the draft provisions are
proposals to enable the transfer of patient data across the
National Health Service to promote faster and higher quality care.
The ICO has published a response which highlights that the bill
provides positive reform while maintaining high data protection
standards.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
