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Amanda Maxwell

Managing Editor

London, UK

Amanda is EU medtech regulatory affairs editor at Medtech Insight. She has been reporting and providing analysis on developments in the field of medical technology regulatory affairs, with particular focus on the current and future EU regulations for medical devices, IVDs and device/drug combination products since the mid-1980s. She monitors and reports on all aspects of the implementation of the EU’s Medical Device and IVD Regulations, including relevant guidances, standards, expert opinions and ongoing challenges for all players in meeting the new requirements.

Her features have appeared in a variety of in-house publications and services. She also wrote medtech regulatory country profiles for Citeline’s former EU Law service and regularly contributes to In Vivo. Amanda regularly interviews experts in the EU medtech regulatory space and publishes interview podcasts. She also has experience in providing medtech regulatory strategy consultancy services, is often invited to speak and chair at EU meetings on medtech regulations and drug/device combination regulatory issues and is a frequent advisor to conference organizations.

Amanda enjoys taking part in LinkedIn discussions, has a background in the language and literature of Italy and France, and a passion for being part of the EU scene.

Latest From Amanda Maxwell

EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency

Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.

Regulation EU Legislative Reform

First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

Europe EU

First Danish Notified Body Named Under EU's Medical Device Regulation

The EU now has a total of 45 notified bodies under the MDR.

EU Europe

Why Vital EU Guidance For Clinical Investigation Plans Is So Challenging To Read

Errors or omissions are commonplace when sponsors write their clinical investigation plans. Good signposting is urgently needed. Industry expert Maria Donawa gave some useful tips in how to best read the latest EU clinical trials guidance.

EU Europe

Few High-Risk Devices Subject To EU’s Greatest Level Of Scrutiny

Just four devices were subject to a scientific opinion from an expert panel in the second year of reviews, compared with six in the previous year.

Europe EU

Fresh Opportunity For Free Scientific Advice For High-Risk Devices From EU Expert Panels

The EMA is extending the pilot phase of the EU’s scientific advice program and inviting a third round of applications by mid-2024.

EU Europe
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