Ellie is a dual-qualified lawyer in England & Wales and Ireland who advises on EU and UK life sciences regulatory law. Ellie focuses on pharmaceutical and medical device matters.

Ellie has extensive experience working for medical technology companies and tech clients working in the software and AI space. She advises on a broad range of topics including: the qualification and classification of devices, clinical investigations, pre-market and post-market requirements, Brexit and the implications of new laws and guidance on AI. Ellie has also provided companies with advice on in vitro diagnostic medical devices. Particularly considering the issues around performance evaluations and companion diagnostics.

Ellie advises on a broad range of regulatory matters for pharmaceutical companies. These include: strategies to bring products to market, regulatory exclusivities, clinical trials, orphan medicinal products, requirements and rewards for paediatric research, and manufacturing and distribution. Ellie has previously spent a number of years working at a US law firm. She has gained valuable in-house experience on secondment at a large pharmaceutical company.

Some of Ellie’s work highlights include:

• Advising leading tech companies on issues around qualification of software products as medical devices and the classification rules.
• Advising medtech clients on issues under the EU’s Medical Devices Regulation (EU) 2017/745, including user error reporting requirements, transition periods and QMS requirements.
• Advising tech companies on the implications of the EU’s AI Act.
• Advising leading pharmaceutical and device companies on the application of the EU’s In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, including performance evaluations and companion diagnostics.
• Advising pharmaceutical companies on EMA submissions, including for duplicates and paediatric investigation plans.
• Advising pharmaceutical clients on regulatory protection periods.
• Advising pharmaceutical companies on claims and advertising rules.
• Advising pharmaceutical companies on supply chain issues involving importation and distribution.

Ellie undertook a legal secondment to Gilead from 2019 – 2020. She also completed University of Oxford’s Online Short Course: Artificial Intelligence: An Introduction.