Amanda Maxwell
Managing Editor
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
Updated Notified Body Conduct Code Explains Permitted 'Structured Dialogue'
There is considerable focus at present on how far notified bodies can go in helping position their clients to have as smooth a conformity assessment passage as possible. It is a fine balancing act for all involved, but a new document gives useful insights.
Ursula Von Der Leyen Calls For EU Medtech Regulatory Framework To Be 'Stepped Up'
The commission's recently reelected president also wants the new commission to evaluate the need for potential changes to the medtech regulations.
How To Transfer Surveillance Oversight For IVDs From One EU Notified Body To Another
With the final deadlines for legacy products that need to comply with the IVD Regulation on the horizon next year, help is at hand to transfer responsibility for surveillance from one notified body to another. But who will need it and why?
Opinion: Is The EU Recreating A Different Monster Of A Regulatory Labyrinth?
Reflecting on 40 years of EU medtech regulation makes me realize how incredibly far we have come. But have we come full circle and replaced the frustrations of four decades ago with a different, but equally challenging, set of problems?
ISS Named As Italy’s First Notified Body Under The EU’s IVD Regulation
After a hiatus of nearly a year, the EU can celebrate another designation under the IVD Regulation.
Video: How To Efficiently Patch A Medtech Regulatory System ‘Set Up To Fail’
Centralization and rationalization of the EU’s medtech rules are critical, particularly for conformity assessment and clinical evidence. Hear the views of Tom Melvin and Erik Vollebregt first-hand in a new in-depth interview on regulatory problems and opportunities.