diagnostics Archives - HEALTH & LIFE SCIENCES NEWS

Five Questions With a Life Sciences Lawyer: Michael Ryan

Michael Ryan
Practice Focus Area: Market Access (Diagnostics, Life Sciences)
Office: Washington, DC
Years at Firm: 16

What is your favorite part about practicing life sciences law at McDermott?
Clients come to us with difficult questions that require not just a command of the law, but an in-depth understanding of their business – and in some cases, the technology that makes their business different. Even after more than 16 years, I’m constantly learning something new, and the job is never boring!

What is the biggest opportunity and greatest challenge facing clients in your area of focus today?
Diagnostics companies face a lot of challenges, such as IP and fundraising. But in my corner of the world, the biggest problem is the timeline to reimbursement. It can take companies three to five years to get reimbursement from the time they think they’re market ready. The length of this pathway creates many challenges, but also substantial opportunity for those clients who are able to make it through.

What advice would you give to junior lawyers looking to build their practice in your focus area?
Be curious, particularly when it comes to the science underlying a technology. Many lawyers are reluctant to get too “in the weeds,” but it can be a real differentiator when your clients see that you really understand how the technology works and how [...]

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Regulating Medical Devices Post Brexit

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in England, Wales and Scotland after the BREXIT transition period (different rules will apply to Northern Ireland). This On the Subject outlines key dates for implementation of the new rules and certain practical implications of changed regime.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance (the Guidance) on new rules that will govern the regulation of medical devices after the end of the transition period. Whilst some of this guidance is similar to guidance issued as part of the “No deal BREXIT” publications in 2019, the MHRA has also set out proposals to engage and consult on a new medicines and medical devices regulatory framework for the UK.

The UK left the European Union (EU) in January 2020 but is currently in a transition period. The Guidance was released as part of a collection of updates covering various MHRA-regulated sectors (including medicines, clinical trials and licencing procedures) which will also be subject to new rules from 1 January 2021.

This update focuses on the new regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) placed on the market in England, Wales and Scotland (Great Britain) only. Different rules will apply to Northern Ireland.

Existing law to continue
The rules that currently regulate medical [...]

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