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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

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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Does The AI Act Apply To My Medtech Product And What Do I Need To Know?

The AI Act is due for publication in July 2024. Marco Caproni of notified body, TÜV SÜD, explained how requirements over and above those in the MDR and IVDR impact medtech manufacturers.

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MedTech Forum: Experts Suggest Short And Long-Term Solutions To EU’s Innovation Crisis

After focusing on the severity of the EU’s regulatory innovation crisis, Medtech Insight now reports on discussions in Austria last month on a range of changes that could improve the outlook for cutting-edge products.

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MedTech Forum: Is Global Regulatory Convergence Needed To Address EU’s Slow Innovation Exodus?

Does the difference in the height of the respective regulatory bars for innovation in the EU and US matter? And how severe are the problems being created by companies choosing to launch new products outside the EU? Hear the views of speakers at the Medtech Forum in Vienna in this first section of a two-part report from a session at the conference on innovation.

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Council Of EU Aligned With Parliament Over Need For Future MDR Amendments

The Council of the EU and Parliament agree that fundamental changes are needed to the medtech regulations. The commission, which would have to initiate any formal proposal, has yet to publicly lay its cards on the table.

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