Amanda Maxwell

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

Ireland’s Medtech Keeps Calm While Trump Covets Its Healthcare Industry

The Republic of Ireland’s record in life sciences is impressive. Decades of investment, education and training have been major winners for the country’s successful economy. But its success is drawing unwanted attention from the US. Trump wants “to have that.”

Update: Italy’s IMQ And Belgium’s SGS Named 15th and 16th IVDR Notified Bodies

Ireland’s NSAI reinstated under IVD Regulation designation list

Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

Unlocking Potential: Could EU’s New Surgical Centers Drive Demand For Advanced Medtech?

Industry waits to see if there will be a surge in demand for orthopedic and cardiology devices as IHI’s EU Ambulatory Surgical Centers proposal awaits sign-off.

Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations

The deadline for comments is 30 June 2025

EU Harmonized Standards Continue To Trickle In Under MDR

Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.