What Top 10 EU And UK Life Sciences Regulatory developments are we following in 2026?

There is so much legislative change in the EU and UK in the life sciences sector at the moment that it is sometimes difficult to keep up with it all. Here are the top 10 developments we are following in 2026.

1. The EU pharma package

With a political agreement having been reached by the EU institutions on the reform of the pharmaceutical law framework, we expect the final text of the new legislation to be with us at some point very soon. Amongst many other things, the new framework will say goodbye to the well-known “8+2(+1)” regulatory data protection period, which will be substituted for a more complex “8+1(+1+1)” formula; will change the exclusivities for orphan medicines; will expand the scope of the Bolar exemption; and will introduce a transferrable exclusivity voucher for priority antimicrobials.

With the potential for the new regime to apply as early as H1 of 2028 (it is rumoured that both the new Directive and Regulation will have transitional periods of 24 months), there is plenty for pharmaceutical and biotech companies to do to get ready to comply with the changes in the legal framework. From checking that supply chains and financial transactions comply with the future regime, to recalculating dates of loss of exclusivity for assets in the pipeline, to seizing new opportunities for development and growth under the future regime, legal teams will play a key role in helping companies navigate a new and more complex system.

See here for a more detailed overview of what we know about the political agreement and what to expect.

2. The EU Biotech Act

December of 2025 was also the month of the Commission’s Proposal for a European Biotech Act. With limited access to risk capital and other sources of funding, skill shortages, processes that slow down the development of biotech innovation, and fragmented and complex legal frameworks, the EU has been and is losing ground to other regions with increasingly agile regulatory and financial systems, namely the US and China. To address this competitiveness gap, the Commission has proposed a series of measures to incentivise the development, research, manufacture and commercialisation of health biotechnologies.

One of the most exciting tools to incentivise the development and placing on the EU market of biotech medicinal products for human use is the introduction of a 12-month extension of the SPC for medicinal products developed by means of biotech processes and for advanced therapy medicinal products.

In 2026 the Commission’s proposal will follow the EU’s ordinary legislative procedure, with the European Parliament and the Council adding their proposals to this legislative proposal.

Subscribe here to receive Bristows’ Biotech Review of the Year, to be published at the end of January 2026. It will include our article “Proposal for a European Biotech Act: will the Commission’s proposal unlock the potential of the health biotech industry in the EU?”

3. Changes to the EU MDR and EU IVDR

After years of experiencing many challenges with the implementation of the EU Medical Device Regulation and EU In Vitro Device Regulation (the EU MDR and EU IVDR), in December 2025 the Commission finally published a long-awaited proposal for a regulation to simplify the legal framework for medical devices and in vitro diagnostics in the EU. The most important and welcome proposed change is to effectively exempt medical devices and IVDs from the scope of regulation as “high-risk AI systems” under the EU AI Act. Instead, AI-enabled medical devices and IVDs would be treated in the same way as AI systems used in sectors such as civil aviation, railways and automotive: subject to sector-specific regulation only, which may be updated by the Commission in a way that is consistent with the general approach adopted by the EU AI Act.

We expect (and very much hope) that the final text will apply before entry into application of the obligations related to high-risk AI systems under the EU AI Act. This, in turn, is a moving target, with the proposal to delay the application of the provisions applicable to high-risk AI systems in the Digital Omnibus on AI Regulation Proposal. 2026 should bring much-needed clarity to the way in which manufacturers of AI as medical devices should approach safety, reliability, bias management and clinical performance, to name a few key issues for these tools.

See here for a detailed overview of the Commission’s proposed simplification of the EU MDR and EU IVDR.

4. New pre-market legal framework for medical devices in Great Britain

New legislation that strengthens the post-market surveillance requirements for medical devices in use in Great Britain started to apply in June 2025. The pre-market statutory instrument is expected to progress in the UK Parliament this year. Amongst other things, the future legislation is expected to require devices to have a Unique Device Identifier (UDI); change the classification of several types of devices, specifically increasing the class of certain software as a medical device; strengthen the requirements for technical documentation; and introduce a framework for international recognition.

5. EMA and FDA joint "Guiding Principles of Good AI Practice in Drug Development"

With the brand new Guiding Principles of Good AI Practice in Drug Development, we expect the 10 principles that the EMA and the FDA have put together to support medicines developers and marketing authorisation applicants and holders make advances in the development of global AI strategies. They should serve as tools for the detailed design, governance, and deployment of AI choices, and support earlier, more structured, and more meaningful engagement with regulators. The advances taking place in AI in 2026 will probably take AI to the next level in drug development. We expect the EU to issue development guidelines, further to the EMA AI reflection paper on the use of AI in medicinal product lifecycle from 2024.

6. The UK’s regulation of AI in healthcare

The National Commission into the Regulation of AI in Healthcare was established by the MHRA in 2025 to support the assessment of what the regulatory rules should be for AI as a medical device. Informed by the results of a call for evidence that will end at the beginning of February 2026, the National Commission will tackle crucial questions about how AI should be regulated and give recommendations to the MHRA in 2026.

Our very own Alex Denoon is a member of the Technology Working Group of the National Commission.

7. Increased accountability of Notified Bodies

Following the Commission’s draft piece of legislation to introduce more prescriptive rules for Notified Bodies conducting conformity assessments of medical devices and IVDs, we expect to see more standardisation of some of the business practices of the various Notified Bodies appointed under the EU MDR and EU IVDR. This should lead to more consistent manufacturer experiences when dealing with Notified Bodies, an acceleration of conformity assessments for new medical devices and IVDs coming to market, and  improved access to novel medical technologies after years of tumult and uncertainty created by the introduction of EU MDR and IVDR.

This proposal should be welcome news for manufacturers of medical devices, as it improves the efficiency and accountability of Notified Bodies and increases the predictability of the conformity assessment procedure.

See here for a more detailed overview of the Commission’s proposal.

8. EUDAMED goes fully functional for four of its modules

In 2026 we will see a lot more transparency in relation to medical devices and IVDs thanks to the “go live” of the first four modules of EUDAMED, the EU’s central database for medical devices, structured around 6 modules. From 28 May, the modules related to Actors (registration of economic operators), UDI/Devices (database of devices and their UDIs), Notified Bodies & Certificates (management of certificates) and Market Surveillance (actions and measures taken by the competent authorities) will be fully operational.

The modules related to Vigilance & Post-market surveillance, and Clinical Investigations & Performance Studies are still under development. It is expected that the full-functionality notice for the Vigilance module will be published in Q4 2026, in which case its implementation would take place in Q2 2027.

9. Changes to the framework regulating medicines for rare diseases in the UK

A major reform in the UK is expected to accelerate rare disease therapy discovery, development, and approval. The policy paper ‘Rare therapies and UK regulatory considerations’ published by the MHRA in November 2025 outlines the current approach to design a forward-looking framework that meets the needs of patients with rare diseases, while ensuring robust evidence generation, system sustainability, and international convergence. A public consultation on this framework will begin in early 2026. The MHRA’s objective is to establish a refined and implementable model by late 2026.

10. Can a chemical medicinal product be a generic of a biological medicinal product?

We expect the decision of the Court of Justice of the European Union in Case C-118/24 to bring clarity on the question of whether a chemical medicinal product can be a generic of a biological product. With the Advocate General having reached the conclusion that chemically synthesised products can indeed meet the criteria to be a generic of a reference biological medicinal product, it remains to be seen whether the CJEU will confirm this. A confirmatory decision would certainly have broad implications across the EU, as some key biological medicines could be affected (amongst others, insulin fragments and analogues, and GLP-1 analogues), with the potential for easier (and cheaper) access to “copies” of biologics on the EU market.