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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.

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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.

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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.

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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.

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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.

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EU Regulatory Roundup, May And June 2024: Sweeping New Proposals Take Medtech By Surprise

During this period of intense regulatory pressure for the medtech industry, work has been ongoing in the background to try and find a better way forward for the medtech industry, for innovation and for patients.

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