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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

Council Of EU Agrees To Speedier Launch Of Medtech Database And Greater Transparency

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European Commission To Cast Its Own Critical Eye Over MDR And IVDR

The commission expects to reach its conclusions before the end of 2025. This will signal what regulatory changes the EU medtech sector can expect thereafter.

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Five Key Meetings Offering EU Medtech Regulatory Insights Over Next Four Months

With so many regulatory developments happening concurrently in the EU at present, five forthcoming conferences promise delegates a timely update and vibrant discussions.

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Implementing The MDR And IVDR: Checkered History Signposts Need For Revised Approach

With so much discussion now on the need for fundamental change in the future regulation of medtech products in the EU, Medtech Insight reflects on lessons to be learnt.

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Medtech Industry Produces Evidence In Bid For Updated eIFU Rules In Multilingual EU Marketplace

The EU medtech industry is calling for an update to the decades-old rules on electronic IFU for devices. A glimpse at the listings in the European Commission’s recently released table of member state language requirements reflects how punitive the demand for hard-copy IFU can be.

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EU Creates Manufacturer Vigilance Template And Cardio And Breast Implant Reporting Tables

Reports by manufacturers to authorities of serious incidents related to breast implants and some cardio products can now be standardized.

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