Amanda Maxwell
Managing Editor
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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
How The EU Must Address Regulatory Hurdles Deterring Medtech Investors
In the EU, developers struggle to tell potential investors how many trials a device might require, the potential duration or associated costs. Tom Melvin explains how to tackle these issues in a third piece* based on a recent interview.
EU Must Widen Debate Around Medtech Regulations Beyond Liese’s Proposal
The EU needs to conduct a deeper, more decisive analysis of its medtech regulatory problems before it decides how to adopt elements of MEP Peter Liese’s proposed amending regulation, regulatory expert Tom Melvin told Medtech Insight.
Why And How Last-Option, Essential Devices Must Now Be Identified As A Matter Of Urgency
With the axe falling on a growing number of essential legacy products, Tom Melvin explains why a plan around derogations for devices falling through the regulatory crack is now critical.
MedTech Europe Appeals To Re-elected Von Der Leyen To Address MDR/IVDR Problems
Early and comprehensive reform of the MDR and IVDR is critical to address overregulation and unpredictable medtech regulatory processes, medtech tells reelected Commission President.
AI Act Is Officially Published: Implementation Challenges Ahead For Medtech
The final text of the AI Act is now available for all to read but, for medtech, it may feel that work is only just beginning.
MDCG 2021-5 Rev. 1: EU’s Standardization Guidance Brought Up To Date
A new reference in the document reminds the medtech sector that EU harmonized standards remain voluntary to encourage innovation.