On International Clinical Trials Day, the UK’s MHRA unveiled a major shift: a consultation on using external control arms (ECAs) based on real-world data (RWD) for regulatory decisions. This move aims to leverage patient-level data collected outside clinical studies to compare the efficacy and safety of interventions in clinical trials. Stakeholders have until the end of June to weigh in. What’s the Focus? The guidelines target sponsors planning to use RWD ECAs in trials needing…
AI as a medical device (AIaMD) in Europe is at a crossroads. As manufacturers grapple with compliance under two separate legal regimes – the EU AI Act (AIA) and EU Medical Device Regulations (MDR) – concerns are mounting around the sluggish pace of Notified Body designations and glaring inconsistencies between the two frameworks. Can the EU stay competitive when the AIA is piling on more regulatory obstacles than ever before? In our blog post, we…
On 5th March 2025, the European Health Data Space (EHDS) Regulation was officially published in the Official Journal of the European Union. The EHDS enters into force on 26 March 2025 – this is the beginning of the transition phase towards application. At its core, the EHDS is about three things: (1) empowering patients with new health data rights (primary use); (2) a new pathway to access electronic health data for research and innovation (secondary…
After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for your organisation? This is the fourth post in our EHDS series. In this post, we focus on the new product regime for electronic health record (EHR) systems, including the impact on wellness apps, AI systems and medical devices. We examine the latest publicly available draft, dated 24…
After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for your organisation? This is the third post in our EHDS series. In this post, we focus on the change that has been generating all the headlines: a new pathway to access health data for secondary uses like research and innovation. We examine the impact of this pathway…
After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for your organisation? In this post, we focus on the change that has been generating all the headlines: a new pathway to access health data for secondary uses like research and innovation. So what can you expect? This is the second post in our EHDS series, and we…
After months in the pipeline, it looks like the European Health Data Space (EHDS) is finally entering into force later this year. But what does this mean for you? This is the first post in our series on the EHDS. This post focuses on new health data rights, and we examine the latest publicly available draft, dated 24 April 2024. So what’s the impact on the pharmaceutical and medtech industry? In one way, it’s limited…
In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) collaboratively identified ten guiding principles for good machine learning practice (GMLP). These principles aim to ensure the safe, effective, and high-quality development of AI/ML technologies in medical devices. Building on GMLP, these agencies are now developing a proposed regulatory framework for modifications to Artificial Intelligence / Machine Learning (AI/ML) – Based Software as a…
The UK’s MHRA has published a statement of policy intent for recognition of international regulators’ approvals of medical devices in Great Britain (GB). If your organisation’s medical device is authorised in any of Australia, Canada, the EU, or USA (together, Comparable Regulator Countries or CRCs), you may be able to leverage this to gain fast-tracked access to the GB market. This means that manufacturers may be able to side-step the full UK authorisation process for…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) on 30 April 2024 set out its strategic approach to artificial intelligence (AI). In particular, the MHRA welcomed the publication of the UK Government’s white paper ‘A pro-innovation approach to AI regulation’, published in 2023, and has taken significant steps in the past 12 months to adopt its recommendations in the work they do based on five key strategic principles. These principles encompass safety, security and robustness; appropriate…
