Christopher Bates

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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 IVDR

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 Products

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

On 27 November 2025, the European Commission published a notice in the Official Journal confirming that the first four modules of the European database on medical devices (EUDAMED) are fully functional. The notice starts a 6 month transition period at the end of which companies in the medical devices supply chain, as well as Notified Bodies and competent authorities, will need to comply with a range of new obligations regarding registrations and data submission under the Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR), as applicable. These include mandatory registration of devices and of economic operators.Continue Reading New Medical Device and IVD Registration and Transparency Requirements to Apply in 2026

On 10 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced the early launch of the “Aligned Pathway”. This is a joint initiative designed to streamline  the scheduling of the regulatory approval and health technology assessment processes in order to reduce the time before a new medicine is available on the NHS following the grant of the marketing authorisation (MA). The pathway supports the UK Government’s ambitions outlined in the 10-Year Health Plan for England and the Life Sciences Sector Plan to accelerate access to medicines and reduce regulatory burden, as discussed in our blog here.Continue Reading MHRA and NICE launch aligned approvals pathway

The Association of the British Pharmaceutical Industry (ABPI) and the Department of Health and Social Care (DHSC) have confirmed that they have ended negotiations on  amendments to the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG). The breakdown of the talks between the government and the ABPI mean that the pharmaceutical industry will continue to pay annual rebates on sales calculated by the current mechanism under VPAG, which produced a repayment rate of 22.9% on “newer” medicines for 2025.Continue Reading UK government and pharmaceutical industry fail to reach agreement on amendments to medicines pricing scheme

Introduction

On 4 June, EU Member States, meeting in the Council of the European Union (‘Council’), have agreed on a position on the pharmaceutical reform package.

This agreement was reached despite significant divergences between EU Member States in the preceding weeks. It marks a key milestone in the process for adoption of the EU revision of EU’s general pharmaceutical legislation, as it sets out the Council’s position for the trilogue negotiations to find a text agreeable to the Parliament and the Council, which can now begin.

The innovative pharmaceutical industry will welcome aspects of the Council’s adopted negotiating mandate as it provides greater certainty with regards to regulatory data protection and it lightens some of the obligations introduced in the European Commission proposal for reform of the EU pharmaceutical legislation adopted in April 2023 and the European Parliament’s position adopted on 10 April 2024 (see our detailed advisory). At the same time, the Council has adopted positions on some aspects of the proposals that could be seen as less favourable to industry.

We discuss some of the key provisions and changes in the Council’s adopted position below. This is, however, not covering all elements of the reform of the EU pharmaceutical legislation and the final outcome of the legislative process remains uncertain.Continue Reading Council of the European Union backs reforms to the EU Regulatory Framework for Medicinal Products

The European Medicines Agency (EMA) has published a draft Reflection Paper proposing a streamlined pathway for the approval for certain biosimilar medicinal products (biosimilars) in the EU by reducing the clinical data requirements where justified.

Biosimilars are biological medicinal products that are demonstrated to be highly similar to an already authorised biological medicinal product, known as the reference medicinal product (RMP), with no clinically meaningful differences in terms of quality, safety, or efficacy. Biosimilar marketing authorisation applications are subject to reduced data requirements compared to a full application. However, the applicant must submit a data package from a comparability exercise demonstrating that the purported biosimilar is highly similar to the RMP. Typically, this will require a comparative Clinical Efficacy Study (CES) to confirm the similarity (though this requirement can already be waived in certain circumstances).

In its Reflection Paper, the EMA sets out the prerequisites for more general principles for when requirements for a CES may be waived, and only a limited, targeted clinical data package (based on a comparative pharmacokinetic (PK) trial) will be accepted. Where this approach is adopted, this is likely to reduce the clinical development burdens for biosimilar companies.Continue Reading The European Medicines Agency Proposes Streamlined Pathway for the Approval of Biosimilar Medicinal Products in the EU

The Association of the British Pharmaceutical Industry (ABPI) has published a report (the Report) setting out its members’ concerns regarding the operation of the 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG).

VPAG is an agreement between the Department of Health and Social Care (DHSC), NHS England and ABPI, which came into effect on 1 January 2024.  It is the latest in a series of voluntary schemes, intended to manage NHS expenditure on branded health service medicines and operates by controlling prices, limiting profits and, importantly, by imposing a requirement for scheme members to make repayments to Government, reflecting NHS expenditure on medicines in excess of permitted growth and calculated as a percentage of eligible sales.  A key driver for changes introduced in VPAG was recognition that the level of repayments under the previous scheme had become unsustainably high (21.2% in 2023).  Therefore, while industry accepted what is described in the Report as an “exceptionally tough deal” this was in the expectation that the new scheme would, over time, bring repayment rates for newer medicines down to below 10%, consistent with the position up until 2021. However, while the repayment rate for newer medicines was set at 15.1% in the first year of VPAG, the rate for 2025 is 22.9% (with an additional 0.6% payable under an investment programme). The Report describes rates of this magnitude as “unsustainable”.

The Report analyses the reasons that repayment rates for newer medicines have ended up so much higher than predicted under VPAG, and calls for the Government to work with industry on its proposed solutions. It also sets out the consequences of requiring industry to pay such high repayments rates, including worse access to medicines for UK patients and lower investment by industry in the UK.Continue Reading ABPI calls for changes to “unsustainable” medicines pricing scheme

We recently published this Advisory for our US clients, but thought it may be a useful reminder for UK and EU teams given the number of updates in this area.

We are sure that you are aware that the European Union (EU) medical devices framework has been subject to significant changes over recent years. However, implementation of the new rules has been problematic since the beginning, as both the industry and the EU institutions, national authorities, and notified bodies have found it difficult to adapt to the stricter and demanding new legal requirements. There are ongoing delays in companies obtaining CE marks under the new regime, criticism that the rules are stifling innovation, and concerns about the impact on patients.

Given the calls for change, criticism, and ongoing consultations, this Advisory sets out the current status of developments and what is important to know when seeking to do business in the EU.Continue Reading EU Medical Devices Legislation: What You Need To Know Given Latest Developments and Ongoing Challenges