The Law Commission, an independent organisation established to keep the law of England & Wales under review and recommend reform, has announced a review of the law in relation to liability for defective products.
Continue Reading Is change on the horizon for the UK product liability regime? [Updated]Virtual and Digital Health Digest – December 2025
Posted in AI, Data protection, Digital Health, EU Legislation, EU Regulatory Framework, IVDR, MDR, MHRA, Product Liability
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during December 2025 and early January 2026 from the the United Kingdom, and European Union.
Continue Reading Virtual and Digital Health Digest – December 2025UK Clinical Trials Reform: Early Growth Indicators and Key MHRA Guidance
By Libby Amos-Stone, Eleri Abreo & Sofia Holmquist on
Growth in UK clinical trials
The UK’s ambition to strengthen its position as a leading destination for global clinical research is beginning to show results. According to a recent MHRA publication, clinical trial applications submitted between January and November 2025 were 9% higher than during the same period in 2024, with particularly notable increases in:
- Trials in healthy volunteers (+16%)
- First‑in‑human studies (+5%)
- Trials being run in the UK for the first time (+7%)
The publication notes that “growth was strongest in early and innovative research, where speed and expert regulatory support can make or break decisions on where companies invest.”
Continue Reading UK Clinical Trials Reform: Early Growth Indicators and Key MHRA GuidanceUK Government to Issue Guidance on Industry Payment Transparency
By Libby Amos-Stone on
Following a public consultation, the UK government has outlined plans to publish guidance on disclosing payments made by the medicines and medical devices industries to the healthcare sector. While some stakeholders favour a legislative approach, the government believes that a guidance-based model will enable patients to benefit from industry reporting more quickly, avoiding delays that could arise from introducing legislation and establishing a formal compliance system.
Continue Reading UK Government to Issue Guidance on Industry Payment TransparencyFrom complexity to clarity: How the EU Commission plans to overhaul the MDR and IVDR
Introduction
The European Commission has published its proposals on the amendment of the Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR) (“the proposals”). This marks a pivotal moment for the EU healthcare and MedTech landscape, following a public consultation by the Commission in early 2025 (see our blog here) and a call for evidence in September 2025 (see our blog here). The proposals respond to industry concerns over complexity, cost, and delays which have been substantially hammering the MedTech industry since the implementation of the MDR and IVDR.
The proposals aim to streamline regulatory processes, reduce administrative burden, and enhance predictability, while maintaining patient safety and public health. From adaptive pathways for breakthrough and orphan devices to leaner conformity assessments, stronger notified body (NB) governance, and changes to classification, these changes are designed to future-proof the regulatory framework and foster innovation. For manufacturers, healthcare institutions, innovators, and industry stakeholders, the proposals signal a shift toward a more proportionate, risk-based system that supports timely access to critical technologies without compromising quality.
Below, we have set out an overview of some of the key proposals. Additionally, while not released with the proposals, the European Commission published a draft Implementing Regulation on certain uniform quality management and procedural requirements for the conformity assessment activities carried out by Notified Bodies – see our separate blog on this here.
The proposals have now been submitted to the European Parliament and Council for review. Once the Parliament and Council have adopted their own positions on the text, there will be negotiations to agree a final text which can be formally adopted by the Council and the Parliament. At this stage, it is challenging to anticipate what would be the result of the political negotiations and unclear when the new rules will start to apply.
A feedback period has been opened, running from 7 January to 5 March 2026. All feedback received will be summarised by the Commission and presented to the European Parliament and Council with the aim of feeding into the legislative debate.
Continue Reading From complexity to clarity: How the EU Commission plans to overhaul the MDR and IVDRA Deep Dive into the EU’s New Implementing Regulation for Notified Bodies
By Alexander Roussanov & Eleri Abreo on
On 12 December 2025, the European Commission published a draft Implementing Regulation (“the Regulation”) on certain uniform quality management and procedural requirements for the conformity assessment activities carried out by Notified Bodies (“NBs”), introducing detailed requirements for NBs operating under the Medical Device Regulations (EU) 2017/745 (“MDR”) and the In Vitro Diagnostic Medical Device Regulations (EU) 2017/746 (“IVDR”).
The recitals describe serious systemic challenges that have emerged since the implementation of the MDR/IVDR and the proposals aim to set out a structured resolution to these challenges. An overview of these proposals is set out below. Overall, the Regulation aims to create a harmonised NB landscape that is predictable, transparent, and fair – supporting patient safety while easing unnecessary administrative burdens for manufacturers. Whether this goes far enough to address the challenges identified will have to be seen.
The Regulation is open for public consultation until 23 January 2026. Once feedback has been reviewed by the Commission, it will be published. The Commission anticipates adoption of the Regulations in the first quarter of 2026, following which it will be sent to the European Parliament and Council for consideration. The timing of the formal adoption of the Regulation is not yet clear.
Continue Reading A Deep Dive into the EU’s New Implementing Regulation for Notified BodiesUpdated NHS IP Guidance: Unlocking Healthcare Innovation
By Dr Beatriz San Martin on
The UK government has published its first major update to the NHS Intellectual Property (IP) guidance in over two decades. Developed by the Department of Health and Social Care (DHSC) and NHS England with support from the National Institute for Health and Care Research (NIHR), the framework aims to remove long-standing barriers to innovation and accelerate the adoption of new technologies.
The previous guidance, dating back to 2002, was designed for a pre-digital era and struggled to accommodate modern technologies such as AI and machine learning. As a result, innovators and NHS partners often faced prolonged negotiations and unclear ownership rules, delaying patient access to life-changing solutions. In some cases, promising collaborations collapsed after years of legal uncertainty, highlighting the urgent need for reform.
Continue Reading Updated NHS IP Guidance: Unlocking Healthcare InnovationEuropean institutions agree on the reform to the EU Regulatory Framework for Medicinal Products
On 11 December, after overnight interinstitutional negotiations between the European Parliament and the Council of the European Union (“Council”) and the European Commission, the institutions reached a provisional political agreement on the reform of the European Union (“EU”) pharmaceutical legislation.
This agreement concludes months of trilogue discussions and follows a much longer legislative process that began with the European Commission’s proposal adopted in April 2023, the European Parliament’s position adopted on 10 April 2024, and the Council’s position adopted on 4 June 2025 (see our detailed advisory on the Commission’s proposal and our BioSlice blog posts on the Parliament’s and Council’s positions here and here).
The provisional agreement must now be formally adopted by both the Parliament and the Council.
Continue Reading European institutions agree on the reform to the EU Regulatory Framework for Medicinal ProductsVirtual and Digital Health Digest – November 2025
Posted in AI, Clinical Trials, Data protection, Digital Health, EU Legislation, HTA, Medical Devices, MHRA
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2025 from the the United Kingdom, and European Union.
Continue Reading Virtual and Digital Health Digest – November 2025US-UK Pharmaceutical Pricing Deal: UK agrees increase in amounts it can pay for innovative medicines and reduction of rebate rates
By Adela Williams & Christopher Bates on
The UK and US governments have announced that they have reached an agreement on pharmaceutical pricing and tariffs. Under the arrangement, the tariffs charged by the US government on imports of pharmaceutical products from the UK will remain at zero for three years, in exchange for the UK agreeing to pay higher amounts for innovative medicines and reducing the rebates payable by pharmaceutical companies on newer branded medicines.
The changes to UK pricing of medicines have been welcomed by industry, which has criticised the UK environment for supply of and access to medicines.
Continue Reading US-UK Pharmaceutical Pricing Deal: UK agrees increase in amounts it can pay for innovative medicines and reduction of rebate rates