The MHRA recently launched its public consultation on the future regulation of medical devices in the UK. The consultation is open until the 25th of November and the timeline is definitely tight for stakeholders to provide views.
In this Lexology hosted webinar, experts Alex Denoon and Xisca Borrás take an in-depth look at all of the published proposals and consider how these are likely to impact the UK’s medical devices framework and industry.
This comprehensive overview will be useful to all those who want to be brought up-to-date with the proposed regulation, and especially the companies and individuals who wish to respond to the consultation.
For more information and to register, click here.
Alex Denoon, Partner, Bristows LLP
In addition to a wide array of contentious (judicial review) matters, he enjoys working with clients to devise and implement regulatory strategies throughout the product life cycle of pharmaceuticals and medical devices (including in vitro diagnostics).
Alex advises clients in relation to challenging issues including genomics, cell and gene therapies, 3D printing, healthcare Apps, companion diagnostics, borderline products and combination products.
The Life Sciences sector sees some of the most exciting and influential deployments of Artificial Intelligence and machine learning. The increasing use of AI in the sector poses a number of regulatory challenges (including entirely new regulations) and he specialises in helping clients navigate these.
Alex has been involved in the development of a number of regulatory frameworks and guidelines.
Xisca Borrás, Of Counsel, Bristows LLP
Xisca is a dual-qualified lawyer in England & Wales and Spain who specialises in all aspects of EU and UK regulatory law in the biopharmaceutical sector.
Previously she was an in-house lawyer at a leading innovative biopharmaceutical company, where she provided regulatory law support to all business units and functions at EU and global level, gaining excellent knowledge of the pharmaceutical industry enabling her to bring a strong business approach to her legal advice.
Xisca advises on a broad range of regulatory law topics including: regulatory strategies for bringing products to market, product lifecycle management, regulatory exclusivities, clinical trials and non-interventional trials, including the implementation of the Clinical Trial Regulation, orphan medicinal products, obligations and rewards in relation to paediatric research including agreeing and modifying PIPs, waivers and deferrals and compliance with agreed PIPs, and parallel trade of medicines.
Xisca also advises on the consequences of Brexit, including changes required to ensure business continuity further to the UK’s withdrawal from the EU.